Dental Sleep Practice: Summer 2016 by MedMark, LLC

Thoughts on the Current and Future

Practice of DSM by Gilles Lavigne, DMD, MSc, FRCD, PhD

Combining

TECHNOLOGIES for Successful Outcomes with Innovations Like i-CAT, Ez Sleep, Night Shift and Apnea Guard®

PLUS

SUMMER 2016

Airway, Bruxism and Craniofacial Pain

Cross-Coding by Rose Nierman, RDH

From A to ZQuiet®

The Unforgettable Story of Dan and Trina Webster

Supporting Dentists Through PRACTICAL Sleep Apnea Education

by Lou Shuman, DMD, CAGS

INTRODUCTION

Take this seriously

o you find yourself wondering sometimes ‘What’s all the fuss about how dental sleep medicine is so complicated?” Do you think that you’ve been doing pretty good supplying MAD and gathering reports of improved symptoms? Is the ‘dirty secret’ that it’s not really all that difficult? If that’s you, do not read Dr. Gilles Lavigne’s article. He challenges all of us to embrace the complexity that is medicine, the need to engage with the whole of our patients – thinking of ‘phenotype’ as a framework for identifying, diagnosing, treating and managing patients. If you want things to carry on simple, you will not be comfortable with this essay. Dr. Lavigne is at the pinnacle of dentists who influence research, define practice, and reveal physiologic connections between sleep disordered breathing and other signs and symptoms in our patients. In this issue, he calls all doctors (and not just dentists) to action to embrace Precision Medicine – the framework for knowing your patient so well that you can apply just what is needed to alleviate their diagnosed problems. This challenge is echoed by commentary from Dr. John Remmers, who named “Obstructive Sleep Apnea’ and continues innovation to this day, and Dr. Rob Rogers, founder of Sleep Disorders Dental Society (later AADSM). Technology allows us to approach our patients with more knowledge and a greater sense of collaborative care. When we ask our patients to bring us reports from their smartphone app or FitBit, we involve them. When we show them their own anatomy on a big screen, we involve them. When

we use a scanner to take photos of their teeth to create an appliance, instead of ‘data’ or ‘records’, they see themselves. Nothing we can do replaces a commitment by our patients to take up the MAD and manage their own disease. We can offer the right solution, the precise treatment aimed at their individual problem, but our fas- Steve Carstensen, DDS cination with technology, our focus on Diplomate, American Board of the things we use to document, pro- Dental Sleep Medicine duce, and deliver oral appliance therapy must never take precedence over the personal connection. Technology serves the doctor-patient relationship, not the other way around. Our offices have a culture – you choose Technology serves how you are perceived by your patients, your the doctor-patient colleagues, your medical peers. It’s how your office looks, how it feels, how you approach relationship, not the managing your patient’s health. Is your culother way around. ture everything it should be? Dr. Lavigne lays it out for us. We have a challenge. We need to employ every means we have to meet this worthy goal and make our communities healthier. If we are going to make a serious difference, we need to be serious parts of the health care team. If you think dental sleep medicine is pretty simple, think deeper.

Do you like what you are reading in DSP? Do you have ideas you want to share about what works in your practice? I would be happy to consider essays from any reader! Don’t be shy – we’ll help polish your ideas and spread the wisdom of Practical Sleep Education. Contact me at SteveC@MedMarkAZ.com.

DentalSleepPractice.com

CONTENTS

Cover Story

Combining Technologies for Successful Outcomes by Todd Morgan, DMD, ABDSM Predicting outcome and gaining confidence.

Future Focus

Thoughts on the Current and Future Practice of DSM

Todd Morgan, DMD, ABDSM Co-Inventor of Apnea GuardÂŽ, researcher and author

by Gilles Lavigne, DMD, MSc, FRCD, PhD Perhaps the most important article you will read this year.

Technology Update

Consumer-Driven Sleep Technologies

by Ping-Ru Teresa Ko, MD Everyone loves electronics. Are they useful for us?

The Precision Medicine Paradigm for DSM

Practice Management

by Pat Mc Bride, Sleep Clinician Committment to patient outcomes means paying attention to many details.

Airway, Bruxism and Craniofacial Pain Cross-Coding by Rose Nierman, RDH Medical insurance is the key for treatment acceptance and smooth office success.

Origin Stories

From A to ZQuietÂŽ by Lou Shuman, DMD, CAGS Getting problems solved fast is the mission of this company.

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Meaningful Conversation

Team Focus

The Use of Technology in a Dental Sleep Practice

by Glennine Varga, AAS, RDA, CTA Your team may be more comfortable with technology: maximize the advantage.

Legal Ledger

Stark Law and Anti-Kickback Statute

by Ken Berley, DDS, JD, and Jayme Matchinski, JD Think again about your relationship with your referring providers.

CONTENTS

Financial Focus

Living with the choices we make

by Tony Robbins and Tom Zgainer Retirement plan fees affect your future.

Education Spotlight

Foundation for Airway Health

Medical Insights

Airway, Bruxism and Craniofacial Pain: What’s the Connection? by Mayoor Patel, DDS, MS

Product Spotlight

Is Apnea Guard®… becoming the New Normal to work with MDs? by Todd Morgan, DMD, ABDSM

Clinical Focus

How to Read a Sleep Study

by Jamison Spencer, DMD, MS There may be no standard report, but there is common data.

Starting Early

The Healthy Start System Provides an Effective Treatment for the Root Cause of Sleep Disordered Breathing...

No one should endure years of poor breathing just because they are young!

Product Spotlight

Don’t Make Your Patients Wait!

Adjunctive Care

Dental Sleep Medicine: Beyond Oral Appliance Therapy by Drs. Richard Drake and Craig Schwimmer Dentists can do more with the palate than just look at it.

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Practice Management

The Four Pillars for Dental Sleep Medicine Success

by Gy Yatros, DMD There is much more to success than fitting acrylic.

Product Spotlight

A Story of Progress and Adaptation: the Panthera D-SAD

Product Spotlight

OravanOSA: Sleep Appliances with a Truly Open Anterior Design

Avoid the cost of missing desaturation events or having to repeat an overnight study

Inside the Lab

Retrofitting Crowns Under Sleep Appliances by Deborah Curson-Vieira Simplifying a common problem for dentists.

Choosing Appliances

Is Selecting the Appropriate Sleep Device for You and Your Patient Important? by Dr. David “Trey” Carlton III Case report series illuminates differences in patient outcomes.

Sleep Humor

Summer 2016 Publisher | Lisa Moler lmoler@medmarkaz.com Editor in Chief | Steve Carstensen, DDS stevec@medmarkaz.com Managing Editor | Lou Shuman, DMD, CAGS lou@medmarkaz.com Editorial Advisors Steve Bender, DDS Ken Berley, DDS, JD Ofer Jacobowitz, MD Christina LaJoie Steve Lamberg, DDS, DABDSM Dale Miles, DDS Amy Morgan John Remmers, MD Rob Rogers, DMD Sarah Shoaf, DDS, MSD Bruce Templeton, DDS, MS Jason Tierney Glennine Varga, AAS, RDA, CTA

National Account Manager | Adrienne Good agood@medmarkaz.com Creative Director/Production Manager Amanda Culver amanda@medmarkaz.com Website Manager | Anne Watson-Barber anne@medmarkaz.com E-media Project Coordinator | Michelle Kang michellekang@medmarkaz.com Front Office Manager | Theresa Jones tjones@medmarkaz.com MedMark, LLC 15720 N. Greenway-Hayden Loop #9 Scottsdale, AZ 85260 Fax: (480) 629-4002 Tel: (480) 621-8955 Toll-free: (866) 579-9496 www.DentalSleepPractice.com Subscription Rates 1 year (4 issues) 3 years (12 issues)

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©MedMark, LLC 2016. All rights reserved. The publisher’s written consent must be obtained before any part of this publication may be reproduced in any form whatsoever, including photocopies and information retrieval systems. While every care has been taken in the preparation of this magazine, the publisher cannot be held responsible for the accuracy of the information printed herein, or in any consequence arising from it. The views expressed herein are those of the author(s) and not necessarily the opinion of either Dental Sleep Practice magazine or the publisher.

COVERstory

Combining

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COVERstory

for Successful Outcomes

with Innovations Like i-CAT, Ez Sleep, Night Shift and Apnea Guard® by Todd Morgan, DMD, ABDSM

“T

argeted and disruptive technologies” is the space where Dental Sleep Medicine dentists have always lived. Whether we know it or not, we have been all about disruptive innovation in the medical device field, and more specifically within the field of sleep medicine. Positive Airway Pressure, introduced by Collin Sullivan in 1981, would become the treatment of choice for decades. But always close by were the dentists with their hunks of acrylic swimming in saliva, making up ground slowly, deliberately. Introduced in 1995 by Harvard University professor Clayton Christensen, the theory of disruptive innovation has proven to be a powerful way of thinking about innovation-driven growth. The medical device industry, especially PAP-based technology, has enjoyed stability, strong growth, and good financial return over the last 35 years. However, disruptive change is already under way and the future of the industry will be different as patients seek and demand individualized approaches to their problems. Enter disruptive technologies, like Oral Appliance Therapy, positional therapy, Pharma approaches, gastric and nerve stimulation surgical modalities, as well as self-help technology like oropharyngeal exercise, to name only a few! But how does this disruptive technology get to patients and then lead to a personalized approach to care?

Technological Advancements that Help the Dentist

Change requires not only innovation but getting folks to think differently. That isn’t

easy, especially when the existing technology works so well. CPAP works, and, it works great. Our patients are savvy and they are requesting treatment choices based on stories from their friends and family, and what they’ve researched on the Internet. I was fortunate enough to begin my career in DSM among an elite and forward-thinking group of sleep docs at Scripps Clinic in La Jolla, California. My participation was interesting to them, and over time they be-

Dr. Todd Morgan is board certified in Dentistry and Dental Sleep Medicine. Dr. Morgan graduated from the Washington University School of Dental Medicine in 1985, promptly returned to his hometown San Diego and began his practice in 1986. Dr. Morgan is internationally recognized as an expert in the field of Dental Sleep Medicine and has completed several clinical research studies and published many scientific papers on the treatment of snoring, sleep apnea, and headache with dental devices. Dr. Morgan is a co-inventor of the Apnea Guard. He has no ownership interest in EZ Sleep and receives no royalties from sales of Apnea Guard.

DentalSleepPractice.com

COVERstory gan to see the benefits of my expertise. We came to agree to invest some time and resources into a formalized study that produced a sentinel clinical trial on the “Jaw Advancement Device. But even after showing very good outcomes, OAT remained little more than a curiosity for my docs, a rescue, a small possibility. But just as they said in the old Virginia Slims commercials: “You’ve come a long way way, Baby!” Back in the day, I could not have imagined the impact a digital workflow would have on my practice. Digital dentistry is here to stay and has spilled over into the DSM world with the advent of computer-guided appliance fabrication, such as the Narval and MicrO2 sleep appliances. Kudos to ResMed Inc. and MicroDental Laboratory for advancing this disruptive technology – a sure game-changer. Another game-changer that I have come to count on for evaluation and thoroughness in my patient consultation and work-up is CBCT technology. I like that the i-CAT technology in particular has the least radiation exposure for my patients, and incredible imaging software abilities. In my observations of the images over the last two years, I have come to recognize traits that help me predict outcomes and what combination of therapies may be most helpful to that individual patient. The strongest impact is with patient education and helping the patient grasp an understanding of their condition and “own” the problem. They can then share ownership in the treatment as well. One of the greatest weaknesses of OAT is difficulty predicting when patient success may be expected, and so far there is no reliable predictive model or phenotype. Then there’s the problem of our definitions: What is a successful outcome? An AHI that drops below 5? Below 10? Whichever of these is your treatment goal, (and we’ll save that argument for later) treatment with oral appliances all too often falls short of expectations. The dedicated clinicians must ask themselves: What else can I do to help my patient?

position of the mandible at the beginning remains critical. Relief from apnea can actually be facilitated very early in the therapy. In one novel and scientifically validated technique, the dentist may use a trial oral appliance called the Apnea Guard to correctly determine the starting position for a custom appliance. The Apnea Guard protocol takes both vertical and protrusive variables into account to correctly predict the most efficacious position of the jaw through a proprietary algorithm. Since the Apnea Guard has proven outcome equivalency compared to a custom appliances, the device provides the dentist and the sleep physician an added opportunity to accurately identify responders to OAT before a custom appliance is offered to a patient. This system has the added benefit of providing the patient with immediate treatment of their sleep disordered breathing while the patient waits for the weeks necessary for the custom MAD. Having the ability to correctly predict which patient will respond to therapy is an astounding breakthrough for skeptical physicians and unsure patients. Never before have we had a scientifically proven, inexpensive, trial device to identify the ideal jaw position for effectiveness that also provides immediate treatment for our drowsy patients. CPAP therapy has always been quick to initiate; Apnea Guard allows OAT to progress from testing to therapy almost immediately as patients leave the sleep center.

i-CAT CBCT airway images

Maximizing Outcome Through Titration Strategies

Although titration strategies are becoming more refined, finding the right starting

8 DSP | Summer 2016

Apnea Guard

COVERstory Deploy Additional Therapies When Expectations Aren’t Met

So what is the trained, caring dentist to do next? What therapies can be added to our Oral Appliance in order to improve results? Well, we have more options than you may think. And it all started with a tennis ball…

Positional Therapy

Positional therapy was first formally studied by Cartwright and others, who used biofeedback to keep folks off their backs when they slept. Feedback came from a tennis ball sewn into the back of the nightshirt. They demonstrated successfully that positional-dependent patients improved their AHI with the tennis ball shirt by eliminating supine sleep. Fantastic! So, would it help the dentist to add positional therapy when their patient has residual apnea while supine and wearing their appliance? One would think so. The good news about positional therapy is that it’s not so dependent on full cooperation. People can be encouraged to behave in their best interest, by sleeping on their sides, with a simple ‘reminder’ device worn on the body that gently prods the patient out of supine sleep. The Night Shift is a comfortable, electronic trainer that vibrates quietly to prompt a turn, kind of like a bed partner, but without the elbows! The Night Shift has been carefully validated and FDA cleared for use by every member of the sleep health team, including dentists. The vibration produced is similar to your cell phone, does not diminish sleep efficiency, and reduces supine sleep to lower AHI.

Tongue Push-ups?

It is reasonably well understood now that there are two primarily important medi-

Night Shift

The good news about positional therapy is that it’s not so dependent on full cooperation. People can be encouraged to behave in their best interest...

ators of airway collapse in sleep: Anatomical deficiency and/or an inadequate neuromuscular response. Oral appliances, like CPAP or surgery address anatomical narrowing by enlarging the retro-glossal or velopharyngeal spaces. The chief difference that most likely accounts for the superior effects of PAP over other treatments is that pneumatic inflation eliminates any need for airway dilation muscles to function. Other treatments that improve airway caliber still rely on the patient’s muscle tone to defend against the challenge of airway collapse, a function that is commonly lost in OSA patients. Can that response be rehabilitated? The answer is most likely yes. Enter the myofunctional therapist. If you haven’t explored this field and made friends with a local therapist yet, you should consider it. The myofunctional therapist can play an important role in helping the DSM dentist reach success through rehabilitation of muscle strength, and a restoration of proper resting tongue posture. There is good evidence to support its use either as a standalone therapy in the correctly selected patient, or as an adjunct to OAT.

Conclusion

In summary, the DSM dentist has more tools than ever to help them succeed, by whatever definition you choose. First of all, seek out a reliable clinical approach driven by evidence clinical approach and made practical by convenience. Secondly, be prepared to supply adjunctive therapies that push your results into that winning zone. And third, partner with a disruptive Home Sleep Testing Company like Ez Sleep to combine technologies that can enable you to reach successful outcomes. Build your reputation around versatility and achieving great results every time. Stay disruptive! DentalSleepPractice.com

FINANCIALfocus

Living with the choices we make by Tony Robbins and Tom Zgainer

s this article was written, the presidential campaign had officially started with the Iowa caucus now completed. In each of our states, we’ll soon enjoy the great individual privilege of choosing who we think will be the most suitable candidate in each party. When November 9 rolls around, and the results of the previous day’s election are confirmed, we’ll then have to live with the choices we made, or did not make, for the next 4 years.

When it comes to our retirement planning, the choices we make today related to our investment options and their associated fees need to be made with a much longer time horizon in mind. Twenty to thirty years of life after active work has completed is now the norm. And if we intend to work another 10-25 years, the opportunity for the positive effects of compounding growth in your retirement savings will make all the difference in the quality of life we might enjoy in retirement. Different from what you might choose for yourself, be it a presidential candidate or a particular investment, if you are the sponsor of a retirement plan, your employees are counting on your decisions, and the ramifications of those choices good or bad. You are choosing for them, as they generally have no say so in the matter. And yet it’s their money, their future. It is a very significant responsibility often overlooked. We review hundreds of 401k plans per month, and while the employers are certainly well intentioned, so little is often understood regarding the effect of investment-related fees over time. A recent study found that the average total cost for a small business retirement plan declined to 1.46% over the past year, and that within this amount, the investment-related expenses typically borne by participants average 1.37%. This particular study defined small plans as those with 50 participants or $2.5 million in assets. However, if you own or work for a business that has fewer than 50 participants or less than $2.5 million in plan assets, odds are you’re paying a substantial amount more in 401k fees. Plans in this demographic are defined as “micro” plans. It is not uncommon for the underlying investments in these plans to have expense ratios averaging between 1.50% and 2.50%. This has a major impact on retirement savings over time that can be difficult to decipher. Why is this important to you? While 1.00% may sound insignificant, the costs of your investments can have a staggering effect on your retirement savings over time. According to the Department of Labor (DOL), paying just 1 percentage point more in expenses over the course of 35 years could reduce a worker’s retirement savings by nearly 28%. For example, Bob is a participant in a plan offered by his employer with a 401k balance of $25,000 that earns 7% over the next 35 years. If Bob paid 0.50% in fees, even if he stopped making new contributions, his account would grow to $227,000 at retirement. But if he paid fees totaling 1.5%, the savings would rise to only $163,000, or 28% less.

10 DSP | Summer 2016

A startling statistic is that in a recent survey by the AARP, nearly 70% of participants in 401k plans believe they are paying no investment-related expenses or that their employer absorbs these fees. Nearly 40% of plan sponsors, the business owners bearing the fiduciary liability of the plan, who have chosen the providers and investments in the plan, do not know the average expense ratios of the funds in the plan. Both figures are truly astonishing. A review of your own 401k fees and investment options should be a near-term action item. Plan sponsors are required by the Department of Labor to compare their current plans against alternatives on a regular basis to be sure all fees are reasonable and prudent. With the proliferation of lawsuits that exist — many very high-profile — recently in the news brought on by plan participants and almost always related to excessive fees or the use of proprietary funds in the 401k plan, it makes all sense to have a documented process and report of your findings in case a DOL examiner knocks on your door. We’ve made it easy for you to get a quick check to see how your plan compares to industry averages here: http://americasbest 401k.com/medmark. A couple of pieces of information are all we’ll need to complete the analysis. You’ll know right away if the path your retirement plan is heading is a place you’ll want to end up — or if a change will do you, and your employees who are counting on you, a world of good. Nothing is more important regarding your money than knowing how much you have, where it is, and if it is invested, how the costs of those investments will affect your future. Consider taking these steps for you, your family, and those you employ, who most likely do not even understand how your choices affect their future.

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EDUCATIONspotlight

Foundation for Airway Health

he Foundation for Airway Health will host an “Airway Summit”, September 15, 2016 at the El Conquistador Hotel in Tucson, Arizona. We’re calling it a “White Flag Event.” Why “white flag”? Because we’re asking you to momentarily set aside the focus on competition in the marketplace and serve patients by and articulating a unified airway health message.

Please accept our invitation to help craft and deliver the airway message

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The Mission of the Foundation for Airway Health is to help people realize their maximum potential by championing the recognition, diagnosis and treatment of airway related disorders through collaboration, awareness, research, education and access to care. Healthcare thought leaders, academies, educational organizations, and companies are invited to collaborate on our the message and address a prevalent, unrecognized and unmet public health problem: underidentified compromised airway. Do you understand the important role airway structure and function plays in health, function, performance and well-being? You are invited to participate and help craft our Foundation message and will be listed as a resource for the many who will seek care. We are in a public health crisis of epic proportions, and it has been steadily worsening. It affects the bodies, minds and spirits of young and old and can be measured in the percentage of the population with obesity, diabetes, heart disease, dementia, cancer, as well as ADHD, anxiety and depression. It can be measured in the dollars spent on healthcare, developmental and learning problems, and in the volume of medications prescribed – often for the expression, but not addressing the underlying cause – for all of the above conditions. When these diagnoses are driven

by airway/sleep/breathing disorders, treating airways has to be part of the solution. Do you know? • More than 50% of U.S. adults suffer from sleep disorder breathing (SDB) • 50% of Americans snore. One in five has mild to moderate apnea • One in 15 has moderate to severe apnea • Even today only 15% of patients with airway/sleep disorders (ASD) are diagnosed. In spite of new research, news stories, and conferences, this has not changed much in the past five years. • The list of airway disorders and their comorbidities is growing This is not a new healthcare problem that requires years of research to find a cure. There are already treatments that are successful and effective. The challenge is getting the message to the 85% in need and providing resources for screening, diagnosis and treatment. The Foundation believes the dental community is in a unique position to take the lead, halting and reversing the epidemic of airway-driven chronic illness. So often the airway obstruction involves the tongue and other oral architecture. More and more thought leaders, organizations, laboratories and corporations are recognizing the role of airway health in chronic illness. Every week new approaches and treatments, instrumentation and products are introduced and marketed. But as noted, the percentage of cases that gets diagnosed has hardly changed. The Foundation envisions a future where no child will be denied the opportunity to reach his or her potential because of an unrecognized airway/sleep problem. For everyone, of any age, we envision a future where the incidence of inflammatory and chronic illnesses falls, not rises. Do you represent an organization, a healthcare company or are you a passionate and concerned practitioner? Please accept our invitation to help craft and deliver our airway message and serve as a resource for those discovering that there is hope for a fuller, happier life. For more information, contact us at whiteflag@foundationforairwayhealth.org.

September 15, 2016

Airway Summit Hilton El Conquistador Resort Tucson, Arizona

For this “White Flag Event,” we’re asking you to momentarily set aside the focus on competition in the marketplace and serve patients by articulating a unified airway health message. Only 15% of airway/sleep disorders are diagnosed. Help address this major unrecognized public healthcare crisis by joining thought leaders, academies, organizations and corporations to create and bring a unified message to the public.

whiteflag@foundationforairwayhealth.org www.foundationforairwayhealth.org

FUTUREfocus

Thoughts on the Current and Future Practice of Dental Sleep Medicine by Gilles Lavigne, DMD, MSc, FRCD, PhD

his paper presents some personal thoughts, none of which should be taken as final pronouncements at this stage. My hope is to spark further thinking, open discussions and relevant research in the field, as well as collaborations with other healthcare professionals. Currently, we are coping with major challenges in dental sleep medicine. We must be able to: 1. be aware of the complexity of sleepdisordered breathing (SDB) in order to make accurate screening or differential diagnoses while taking into account the impact of comorbidities on management planning (see Table 1). 2. understand the principles of precision medicine, a comprehensive, patientcentered approach. 3. improve access to healthcare, from prevention and screening to diagnosis

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and treatment, in order to address this critical public health issue. 4. balance information obtained from evidence-based medicine and dentistry with guidelines for daily clinical practice. 5. translate sleep society guidelines into practice and develop efficient updating strategies for the fast-moving world of sleep medicine. The prevalence of SDB has risen dramatically over the past two decades, from 14% to 55%, depending on the patient group, i.e., age and gender who are also critical factors (Peppard PE et al, Am J Epidemiol 2013). Prevention and early detection of SDB are critical due to the health consequences, which frequently begin in adolescence and peak in adulthood. These consequences include metabolic alterations (higher fasting insulin and, blood glucose plus insulin resistance) as well as higher risks for cardiovascular morbidity and mortality, and accidents due to sleepi-

FUTUREfocus ness (Bhushan B et al, Int J Pediatr Otorhinolaryngol. 2015; Mukherjee S et al, American Journal of Respiratory and Critical Care Medicine, 2015; Peppard PE et al, Am J Epidemiol 2013). Fortunately, dental sleep medicine is making continuous advances in terms of knowledge and technology. Unlike my usual publications, this is not a report of a randomized clinical trial, an experimental trial, or a systematic meta-analysis. My intention was to gather together some recurrent thoughts arising from lectures I have delivered to dental and medical practitioners in various parts of the world. These thoughts have been inspired by your comments and questions as well as my own reading and ongoing research. I have chosen to publish this paper in a nonacademic style journal in order to reach an audience of dentists in clinical practice.

The Challenges of Dental Sleep Medicine

The dentist’s role in sleep had been primarily for sleep bruxism management but about 30 years ago it strongly emerged for sleep disordered breathing with the development of a few oral appliances that were designed to reduce snoring and help preserve airway patency during sleep. Clinicians and scientists in dentistry and medicine began sharing their experiences, questions, and visions in an unprecedented way. Sleep medicine became a shining example of an integrated, interdisciplinary health domain. Of course, not everything is perfect, and much progress is needed before optimal dental care can be provided to the greatest number of SDB patients in need.

Table 1: A nonexhaustive list of conditions to screen for in dental sleep medicine Sleep Disorders that may overlap in your patients: Snoring Sleep-disordered breathing, such as obstructive sleep apnea, apnea-hypopnea syndrome, respiratory effort-related arousal (RERA), etc. Periodic limb movements with or without waketime restless leg syndrome REM behavior disorder (RBD) with risk for severe neurological disease Sleep epilepsy, which may be concomitant to tooth grinding in some patients Sleep gastroesophageal reflux, observed in both sleep bruxism and sleep-disordered breathing patients Sleep walking (somnambulism ) Sleep talking, sleep enuresis (a triad with sleep bruxism in children) Headache: sleep-related (e.g., associated with sleep apnea or bruxism), hypnic, cluster, tension, or migraine

Orodental Sleep tooth tapping, which is most frequently idiopathic.You may need to exclude sleep epilepsy and RBD. Sleep bruxism, frequently reported during the night. Observed or measured jaw movements that most of us confuse with sleep bruxism are mainly rhythmic (i.e., repeated rhythmic masticatory muscle activity episodes over the sleep period). Waketime tooth clenching. In this case, the patient is aware of clenching. Reactive tic or habit such as frequent non-functional tooth contact during waketime (it is not considered clenching, due to the low force used) or tongue pushing Waketime nail or object biting, another oral tic or habit Large tonsils or adenoids (in the latter case, they cannot be seen with a simple mouth inspection) Large tongue with or without scalloping Small oral box (small upper or lower jaw or retrognathia, flat palate, or deep and narrow palate)

Other conditions Sleepiness during the daytime (while at work, driving, reading, watching TV, etc.) Cognitive alterations, including mood, memory, and other behavioral changes Temporomandibular disorders and orofacial pain Allergies Attention deficit hyperactive disorder (ADHD) Addiction Parkinson’s disease, oromandibular dystonia-dyskinesia Other conditions under investigation Adapted from Mayer P et al, Chest, 2015

Gilles Lavigne, DMD (U Montreal, Canada), PhD (U Toronto, Canada) and FRCD (oral medicine, Georgetown U, USA) completed a postdoctoral training on the neurobiology of pain at NIH, Bethesda. He received a Doctor honoris causa from the Faculty of Medicine, University of Zurich (April 2009). He currently holds a Canada Research Chair in Pain, Sleep & Trauma and is Dean of the Faculty of Dental Medicine at the Université de Montréal. He is the Past President of the Canadian Sleep Society and currently the president elect of the Canadian Pain Society. He is the co-founder and past director of the 3 research networks in Oral Health, Pain and Placebo Mechanisms of the Fonds de la Recherche en Santé du Quebec and the Canadian Institutes of Health Research (CIHR). He was also the co-director of the training grant Pain M2C of the CIHR. Internationally recognized for his experimental and clinical researches on sleep bruxism and the interactions between sleep, pain and breathing disorders, Dr Lavigne is conducting studies on: 1) the role of sleep on placebo analgesia, 2) the influence of airway on sleep of teenagers with craniofacial malformations and, 3) sleep and pain in brain injury patients. Conflict of Interest: No Commercial Share; Royalties received for book publications (Quintessence and IASP Press); Research grant and salary (governments of Canada and Quebec: CIHR, CFI, CRC, FRQS), oral appliances provided free of charge for research protocols (ResMed; Somnodent).

DentalSleepPractice.com

FUTUREfocus Some clinicians continue to view dental sleep medicine as a jackpot field. More rationally, most of us realize that sleep medicine is a demanding domain of dentistry. Patients with sleep disorders have special needs and specific expectations that require a different approach than the usual dental-tooth-periodontal care. In restorative dentistry, we focus on the immediate outcome. In other words, we fix problems that we can see in front of us. In contrast, SDB management requires us to shift this modus operandi to pursue a more long-term objective of patient wellbeing. In SDB, the patient is the central figure, and we inform and guide patients according to their expectations, beliefs, and medical and socioeconomic situations. In sleep medicine, improved health appears to be better achieved by: 1. active patient involvement in management, such as diet, exercise, and sleep hygiene 2. high patient compliance in the use of mechanical tools such as oral appliances and continuous positive airway pressure (CPAP) or sleep position devices 3. in some cases, physical or myofunctional therapy and psychology, such as cognitive behavioral therapy (CBT), or nerve stimulation to open the airway, or corrective surgery on the nose, maxillary, or upper airway. So far, no medications have been recognized or approved as treatments for managing SDB, except for patients who are living at high altitudes. Oral appliances, albeit considered the second choice after traditional CPAP devices for SDB management, have been suggested to be equally effective in the long term for reducing morbidity and mortality (Young D and Collop N, Curr Treat Options Neurolo 2014; Anandam A et al, Respirology 2013; Bratton DJ et al, JAMA 2015). However, this significant finding needs to be replicated to reassure those who remain skeptical about the benefits. As scientists, we are skeptical by nature and by training. The fact that both oral appliances and CPAPs are mechanical methods that work by improving airway function during sleep raises questions in my mind. Are they not only the best but also the only effective methods for preventing or improving SDB, including the conse-

16 DSP | Summer 2016

quences for health? The future of these devices in sleep medicine remains an open question, and particularly when we consider the substantial burden of SDB in terms of health and medical costs. Simple cases need to be identified early in life (i.e., in children), and preventive actions need to be taken to avoid more extensive care in adults with high medical risks or those who hold decision-making positions requiring alertness and fully cognitive functioning, such as aircraft pilots, finance investors, surgeons and... politicians. Children with craniofacial syndromes such as Pierre Robin or with recurrent infections or metabolic syndromes should receive comprehensive early treatment (Tan HL et al, Sleep Med Review, 2015). Moreover, the value of orthodontics and preventive or corrective surgery to treat obstructive sleep apnea in children is debatable. Most children with retrognathia and narrow palate appear to benefit from palatal expansion and improved airway. However, adenotonsillectomy is not a panacea for all children. It was recently shown to improve obstructive sleep apnea in only 25% of children, and in only 10% of obese cases (Koren D et al, CHEST, 2015). This finding suggests that certain phenotypes (i.e., physical and biochemical characteristics and their interactions with genetics and the environment) need to be identified to predict best outcomes in a given SDB population. This approach is called precision medicine (PM), as described below.

Precision medicine in dentistry: From a one-size-fits-all paradigm to an advanced decision-making process

In the last three decades, the dentistry field has introduced innovations that are at once amazing and polarizing. They include implants, aesthetic dentistry, 3D imaging, electronic aids, and restorative dentistry tools such as periodontal biomaterials. Gene and immune mediators for diagnosis and therapeutics are also gaining ground, and although it is generally recognized that they cannot resolve all issues, they have opened up promising avenues for future interventions. It is well known that patients differ in terms of biological and environmental risk factors. Hence, more integrated and intelligent phenotyping (e.g., morphology, familial history, health status and life style, genetic and immune biomarkers) is needed to help estimate the probability that cluster risk and predicted

FUTUREfocus success factors are associated with the highest outcome probability. Wikipedia currently defines Precision Medicine (PM) according to the National Research Council’s vision, as follows: Precision Medicine refers to the tailoring of medical treatment to the individual characteristics of each patient. It does not literally mean the creation of drugs or medical devices that are unique to a patient, but rather the ability to classify individuals into subpopulations that differ in their susceptibility to a particular disease, in the biology and/or prognosis of Simple cases need to those diseases they may develop, or in their response to a specific treatment. be identified early in Preventive or therapeutic interventions life (i.e., in children), can then be concentrated on those who will benefit, sparing expense and side and preventive actions effects for those who will not. Although term ‘Personalized Medicine’ is also need to be taken to the used to convey this meaning, that term avoid more extensive is sometimes misinterpreted as implying that unique treatments can be designed care in adults with for each individual (https://en.wikipedia. high medical risks. org/wiki/Precision_medicine). Bearing this in mind, dentists may tend to do what they feel is best based on their own beliefs. However, beliefs and convictions are not supposed to be the modus operandi of medical professionals, and decision making in dentistry should not involve gambles. Healthcare decisions should be based on the best available evidence and assessments of the benefits and risks for the patient as well as the patient’s capacity. In this case, capacity refers to the patient’s medical condition, age, and socioeconomic situation. It does not mean the dentist’s capacity to say, “I think so,” or “I’m telling you!” In PM, a growing number of tools are available for use by doctors, not as disinterested technicians, but in order to make decisions in collaboration with the patient. These tools include molecular diagnostics (currently under development; e.g., Nizankowska-Jedrzejczyk A et al, J Clin Sleep Med 2014; DeLuca Canto G et al, Sleep Medicine 2015), imaging (already used to improve airways, with brain imaging developments expected), and analytical software (see a preliminary model in Trenaman et al, Sleep Breathing, 2015). Algorithm-based analytical software will allow sharing information stored in large databanks to help fine-tune tools such as phenotyping for decision making. This approach

18 DSP | Summer 2016

also raises new ethical issues to consider, and patients’ consent will be required. It is worth repeating here that the use of an apnea-hypopnea index (AHI) alone is insufficiently reliable or predictive of the health risks when selecting a treatment and assessing outcomes. This index should be used as a guide, and not a hard-and-fast rule. If assessments of hypoxia and autonomic activity along with the patient’s risk factors and medical and familial history are missing, we may find ourselves in a blurry situation of maybe yes, maybe no. I call this the gray area of patient assessment. Other challenges include too many false negatives in at-risk cases, too much variability in one-night recordings due to AHI fluctuations over time in mild cases, and lack of interest in the role of intermittent hypoxia on morbidity and mortality (Cairns A et al, J Clin Sleep Med, 2014; Punjabi NM et al, PLOS 2009; Punjabi NM, CHEST 2015). We also need to gain a deeper understanding of phenotyping. We must be aware that certain psychosocial, anatomical, biological, and clinical risk factors are frequently clustered in certain population subgroups. This calls for more precise diagnostic and treatment decisions. For instance, a recent study on the benefits of PM found that patients with resistant hypertension showed a better response (i.e., reduced blood pressure) when treated with a CPAP within a cluster of patients having 3 (plasma) mRNA (Sanchez-de-la Torre, M et al., J Am Coll Cardiol, 2015). Dentistry cannot progress without embracing modern biotechnologies that incorporate our clinical examination findings, are valid, and are accessible. If they are too costly, they will not be accessible. Furthermore, no machine can replace the dentist’s role in patient diagnosis, or the personal input required to manage treatments and to inform, reassure, comfort, provide relief to, and follow the patient. A sleep recording device can assist in the decision-making process and help guide management planning. We can look forward to more precise methods and tools in the future as well. Nevertheless, most methods and tools involve an inherent degree of uncertainty. Based on my experience, I expect from 5 to 30% false positives or negatives with any new approach. For example, a large population study on patients who underwent screening and portable recording suggests the need for personal attention to patients with a history of

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FUTUREfocus insomnia, stroke, and/or lung disease and with a low apnea-hypopnea index (Cairns A et al, J Clin Sleep Med, 2014). Although oral appliances are used in combination with more precise monitoring tools to manage SDB, the patient’s medical history and any new medical events should always be taken into consideration.

Evidence-based and Management Approaches

It is a no-brainer that dentists should select the best management approach. This could include screening, a physician’s diagnosis, or treatment with an oral appliance, CPAP, or surgery, always based on the strongest available evidence. In the presence of SDB, recent guidelines recommend that sleep physicians should prescribe oral appliance therapy administered by a qualified dentist (Ramar K et al, J Cli Sleep Med, 2015). This recommendation is based on the literature and consensus between the physician and dentist. However, although consensus guidelines are great tools that help us share a common language and strategies, they are not completely free of bias, and their relevance may have a short shelf life as new evidence emerges. They are meant as guides, and not definitive prescriptions for SDB management. It is important to retain a critical stance in order to select the best treatment in a professional manner. It is where PM and evidence based medicine are coming important. What is more, recent guidelines are silent on what to do when patients present other dental conditions or comorbidities. In the presence of sleep bruxism alone, that is, with no evidence of SDB or insomnia, we must assess the role of bruxism in pain or headache onset or recurrence, tooth damage, and quality of life. At that point, we may have to decide that a referral to a sleep physician is or is not necessary. But what if you suspect that SDB, sleep bruxism, insomnia, or tooth tapping (which is a sign of potential sleeprelated epilepsy or RBD, a neurodegenerative condition)? Incidentally, the so-called interrelationship between sleep bruxism and SDB needs further corroboration, as concluded in a recent review (Mayer P et al, Chest 2015). Although a randomized control trial design is the strongest method for initial assessment of the effectiveness and advantages of new

20 DSP | Summer 2016

treatments, we should remember that in the case of medications, most trials are run by private firms in the aim of obtaining government approval, and they do not necessarily address actual clinical settings. Before adopting a new clinical procedure, it is essential to get a physician’s professional opinion. We need to balance the freshness of a new discovery with common sense. When a medication or device gets approved, data are provided to convince healthcare decision makers that there is a reasonable efficacy–safety ratio for a given population. However, only time and real-world follow-up will confirm the appropriateness and effectiveness of new treatments. Effectiveness studies are also known as pragmatic studies: they “examine interventions under circumstances that more closely approach real-world practice, with more heterogeneous patient populations, less-standardized treatment protocols, and delivery in routine clinical settings” (Singal AG et al, Clinical and Translational Gastroenterology, 2014). These studies provide the most convincing evidence, but they take years to complete, and multicentre collaboration is needed to get enough subjects to participate for shorter periods. Should we wait years? Of course not! We have to decide on the best management strategy now, based on the patient’s condition, capacity (physical, psychological, and economic), and needs. I should remind you here that the government approval process for oral appliances differs from that for medications. It is much less rigorous. But again, we have to wait for long-term follow-up studies on effectiveness. Time is therefore a major limiting factor.

Comorbidities: Screening and Diagnosis

Many dentists are surprised to find out that we actually do not cure bruxism. Instead, we manage or reduce the consequences, including tooth damage, grinding sounds, pain, and headache. In this respect, it is similar to SDB management. However, patients frequently have comorbidities. So what should we do? Some of your patients may have sleep breathing disorders that are associated with sleep bruxism or temporomandibular disorders (TMD). These may be coincidental, due to the patient’s age. This is known as interesting epidemiology. For example, children and teenagers tend to grind their teeth, middle-aged women have a higher probability of TMD, and older patients have higher probabilities of

FUTUREfocus snoring and sleep apnea. We need to identify the patient’s phenotype (i.e., morphological, environmental, or genetic), comorbidities, and other risk factors. And we should keep in mind that no definitive causal associations have been found in the interactions between sleep breathing disorders and either TMD or bruxism. Do not fall for an attractive one-sizefits-all paradigm. As dentists working in dental sleep medicine, we are responsible for being competent to provide a sound sleep medicine screening and, when indicated, differential diagnosis. We have the expertise to diEach time you collect agnose sleep bruxism, orofacial pain, biological signals with and TMD. Physicians, for their part, can diagnose other conditions such these recording devices, as SDB, insomnia, RBD, the causes sleepiness and cognitive alterations you are responsible for of during daytime, unstable hypertenensuring that the data sion, unexplained headache, and so on. However, we should be able to are carefully read and recognize these conditions, screen for interpreted by an them, and request referrals for a final diagnosis. Table 1 presents a list of coexpert in the field. morbidities that you may come across. Please note that this list is not exhaustive. For instance, it does not include all the craniofacial syndromes. Because not all physicians have expertise in sleep medicine, we are also responsible for referring patients to trained sleep physicians when there are potential risk factors (e.g., obesity, hypertension, sleepiness, retrognathia, mood and/or cognitive alterations, craniofacial syndrome). The screening tools that dentists use are generally based on history, dental and oral examinations, questionnaires (Epworth for sleepiness, or Stop-Bang for apnea), or a combination (exam and questionnaire) with or without type 3 (three–four-channel) or 4 (one-channel) recording devices. Type 3 recording devices are economical and easy to use at home to monitor sleep breathing and jaw or leg muscle activity when a breathing disorder, bruxism, or periodic limb movements are suspected. They include just a few channels (for breathing, muscle activity, oxygen, and sometimes brain activity) and use intelligent software to guide the examiner to make a diagnosis. Nevertheless, no machine is perfect, nor can it replace a human healthcare professional. The diagnosis falls within the doctor’s purview, and when SDB is at issue, the diagnosis should be made by a trained

22 DSP | Summer 2016

sleep physician. Type 4 devices use one muscle channel (leg or jaw) or finger oximetry recording. This is fine for first-line detection and for rapid, low-cost CPAP or oral appliance monitoring. However, oximetry alone cannot discriminate central from obstructive sleep apnea, nor can identify the apnea or hypopnea events occurring in the absence of oxygen desaturation. For atypical and moderate-to-severe cases (mainly if a medical comorbidity is present, or if sleepiness or cognitive alterations are reported), a full sleep laboratory or home polysomnography system (type 1 or 2) under medical supervision is the ideal tool for scoring and diagnosis. Moreover, each time you collect biological signals with these recording devices, you are responsible for ensuring that the data are carefully read and interpreted by an expert in the field. There has been much debate recently about the need for more and better SDB diagnosis and management, presaging a move from the expert physician-only paradigm to a more open approach, including minimally sleeptrained family physicians and nonphysicians. This possible change, if it ever happens, should take place in an organized fashion so as to improve early prevention and care for simpler cases (Phillips B et al. Am J Respir Crit Care Med. 2015). Again, this does not mean a freefor-all. Instead, this calls for the development of professional collaborations. Solo performances are counter-indicated in sleep medicine. To improve your expertise in patient screening, I suggest the following: • Take formal continuing education courses in sleep medicine, and not just in dentistry, and attend medical sleep meetings to keep abreast of new developments. • Join independent dental sleep academies. • Join a study club where dentists, physicians, and other sleep-related professionals (psychologists, respiratory technicians, etc.) can share their experiences and ideas. • Fine-tune your expertise in recognizing comorbidities. • Move on from the traditional silo dentistry model and build a collaborative network. It will benefit both you and your patients in terms of health and quality of life. N.B.: References cited and related abstract are available at: http://www.ncbi.nlm.nih.gov/ pubmed/.

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COMMENTARY

Dental Sleep Medicine at a Crossroads Can we seize the moment and join the precision medicine movement? by John E. Remmers, MD

gnore the “M.D.” behind my name; in spirit I am a dental scientist devoted to dental sleep medicine. My heart and soul are focused on the massive public health problem we face in the epidemic of sleep disordered breathing (SDB). My advice: Read This Article By Gilles Lavigne. It’s the best analysis of our current status and challenges, and it is clad in beautiful prose with touches of pure poetry. Don’t miss a word of it. The article grapples with all of sleep medicine, traditional medical and dental. The thesis is deceptively simple, namely: practice “precision medicine”. To this end, we should “classify individuals to subpopulations that differ in their response to a specific treatment... so that therapeutic interventions can then be concentrated on those who will benefit, sparing expense and side for those who will not.” This is the gospel according to Gilles, and what a message it is, provocative and compelling. The author spares no one and trucks no sacred cows. He asserts, for instance, that: AHI is a flawed parameter that pretends that oxyhemoglobin saturation is unimportant; that guidelines are guides, not laws, established by committee members with vested interests; and we have not established a causal link between bruxism or TMD and SDB. Heavy stuff and so right! The article ends with sage advice for the practitioner: “move on from the traditional silo dentistry model and build a collaborative network”. Let’s get on with precision medicine.

FUTUREfocus

Thoughts on the Current and Future Practice of Dental Sleep Medicine by Gilles Lavigne, DMD, MSc, FRCD, PhD

his paper presents some personal thoughts, none of which should be taken as final pronouncements at this stage. My hope is to spark further thinking, open discus-

sions and relevant research in the field, as well as collaborations with other healthcare professionals. Currently, we are coping with major challenges in dental sleep medicine. We must be able to: 1. be aware of the complexity of sleepdisordered breathing (SDB) in order to make accurate screening or differential diagnoses while taking into account the impact of comorbidities on management planning (see Table 1). 2. understand the principles of precision medicine, a comprehensive, patientcentered approach. 3. improve access to healthcare, from prevention and screening to diagnosis

14 DSP | Summer 2016

Commentary on “Thoughts on the Current and Future Practice of Dental Sleep Medicine” by Robert R. Rogers, DMD, DABDSM

fter more than a quarter century, the field of dental sleep medicine is expanding and evolving at lightning speed. We dental sleep medicine practitioners are now granted the luxury of improved technology, recognition by physicians and third-party insurance carriers, and acceptance by patients. So now what? The article by Dr. Gilles Lavigne leverages the unique intellect and experience of one of our finest researchers, educators and thinkers. By choosing to publish this paper in a non-academic style journal, he steps slightly out of character but offers us a wonderful glimpse into our fast-changing field. He urges us focus on what he considers some major challenges such as the complexities of sleep disordered breathing, understanding the principles of a patient-centered approach (Precision Medicine), improved access to address critical public health issues, balancing guidelines with evidence-based medicine and updating strategies for a fast-moving sleep medicine world. He notes that sleep medicine has become a shining example of an integrated, interdisciplinary health domain but progress is needed before optimal oral appliance therapy can be provided to the greatest number of sleep-disordered breathing patients. As a jumping-off point, effective management of sleep-disordered breathing requires a shift from fix-

24 DSP | Summer 2016

ing what’s in front of us to a longer-term objective of focusing on patient well-being. Regarding treatment, Dr. Lavigne speaks of the importance of identifying cases early in life and preventative actions needing to be taken to avoid more extensive care in adults. But when adults do need to be treated, the need to identify certain phenotypes to predict best outcomes in a given population. Becoming known as precision medicine or personalized medicine (PM), he urges us to move from a one-size-fitsall paradigm to an advanced decision-making process. The article goes on to underscore the reality that an apnea-hypopnea index (AHI) alone is insufficiently reliable or predictive of health risks when selecting a treatment and assessing outcomes. Absent a keen understanding of hypoxia and autonomic activity along with other risk factors we are likely to land in a place he describes as “the gray area of patient assessment”. The contemporary need for more and better sleep-disordered breathing diagnosis and management seems to be giving rise to a move from the expert physician-only paradigm to a more open approach including minimally sleep-trained family physicians and non-physicians (dentists, for instance). Dr. Lavigne points out that this does not mean a free-forall and suggests that integrity and responsibility must prevail through the development of professional collaborations. Are we up for the challenge?

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MEDICALinsight

Airway, Bruxism and Craniofacial Pain: What’s the Connection?

he majority of dentists are not well versed in sleep medicine and related disorders. Studies have shown that many dentists were not able to recognize the risks of sleep apnea, let alone manage patients with oral appliances.1 By understanding the connection and interrelationship between the airway, bruxism and craniofacial pain, you open your practice to more areas of diagnosis and treatment that will help your patients live healthier, happier lives. A Look at Sleep Disordered Breathing (SDB) – the Airway

Dental practices are in a unique position to identify patients at risk for SDB. Intra oral findings can be highly suggestive of such a condition (see figure). Once testing has been completed to evaluate a suspect compromised airway, the diagnosis may contain a combination of diagnostic details. A respiratory effort related arousal (RERA) is scored

26 DSP | Summer 2016

by Mayoor Patel, DDS, MS

when a series of breaths with an ever-increasing respiratory effort against a narrowed upper airway terminates with arousal from sleep before criteria for a true apnea or hypopnea event are met. Upper airway resistance syndrome (UARS) is the condition of excessive sleepiness associated with 10 or more RERAs per hour. Obstructive apneas and hypopneas are characterized by repetitive periods of complete (apnea) or partial (hypopnea) airflow reduction. The events must be at least 10 seconds in duration in association with respiratory efforts, and they usually end with arousal from sleep.

Understanding Bruxism

Bruxism is a term used to describe gnashing and grinding of the teeth that occurs without a functional purpose.2 Whether it is due to a nervous habit, stress or with no known cause, bruxism can cause a lot of damage to your patient’s teeth. In 2005, sleep bruxism

MEDICALinsight was categorized as a sleep related movement disorder and defined as an oral parafunctional activity characterized by tooth grinding or jaw clenching during sleep, which is usually associated with sleep arousals.3 Repeated episodes of bruxism produce microtrauma in associated structures. Dentists, of course, deal with the consequences: breakage of dental restorations, tooth damage, induction of temporal headaches and temporomandibular joint disorders (TMD).

Craniofacial Pain

Craniofacial pain covers a wide spectrum of symptoms reported in many areas of the head and neck. Problems involving facial pain can include TMJ discomfort, muscle spasms in the head, neck and jaw, cluster or frequent headaches, or pain in the teeth, face or jaw. The majority of craniofacial pain complications can be associated with TMD. As an essential part of the routine dental examination for all patients, the gold standard for the diagnosis of TMD is based on the evaluation of history, clinical examination, and appropriate imaging.4 The Journal of the American Dental Association states 44% to 98% of TMJ problems are caused by trauma, with microtrauma hypothesized to be a cause of TMD because of its sustained and repetitive adverse loading of the masticatory system that occurs with sleep bruxism.5

The Connection and Interrelationship

The connection between sleep disordered breathing (airway issues), Bruxism, and TMD (craniofacial pain) is no longer a question of ‘if’. It is a question of proper evaluation and diagnosis by the dental and medical teams. However, it is essentially up to the dental clinician to determine this because it is the dentist who is in the optimum clinical position to evaluate, refer, and possibly manage these issues that impact such a large percentage of the population. With an evident relationship, we look to understand that clenching or grinding of one’s teeth may be a way for the brain to protect itself from suffocation during sleep. The screening process is important in helping us identify bruxism as either a cause of TMJ/Craniofacial Pain or a protective mechanism – even though research is ongoing to fully link these findings. By keeping this link between the three conditions in mind as we

diagnose our patients, we can properly manage each disorder without thinking of them as fully distinct. It has become increasingly clear that dentists involved in either sleep apnea, TMD or bruxism treatment should be knowledgeable in all three areas because the connection is evident.

1. 2. 3. 4.

Bian, Hui. “Knowledge, opinions, and clinical experience of general practice dentists toward obstructive sleep apnea and oral appliances.” Sleep and Breathing 8, no. 2 (2004): 85-90. Bader G, Lavigne G. Sleep bruxism; an overview of an oromandibular sleep movement disorder. Sleep Med Rev. 2000;4:27–43 Sleep related bruxism. In: International classification of sleep disorders: diagnosis and coding manual. 2nd ed. Westchester, IL.: American Academy of Sleep Medicine; 2005:189-92. McNeill, Charles, Norman D. Mohl, John D. Rugh, and Terry T. Tanaka. “Temporomandibular disorders: diagnosis, management, education, and research.” The Journal of the American Dental Association 120, no. 3 (1990): 253-263. Camparis, Cinara Maria, and J. T. T. Siqueira. “Sleep bruxism: clinical aspects and characteristics in patients with and without chronic orofacial pain.” Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology 101, no. 2 (2006): 188-193.

Dr. Mayoor Patel has taken well over 1400 hours of postgraduate education courses in the area of Sleep Medicine, Craniofacial Pain, Sleep disorders and Orthodontics. Since 2003, he has limited his practice to the treatment of TMJ Disorders, Headaches, Facial Pain, Sleep Apnea and Snoring.

DentalSleepPractice.com

PRACTICEmanagement

Airway, Bruxism and Craniofacial Pain Cross-Coding by Rose Nierman, RDH CEO Nierman Practice Management

hat does ABC (Airway, Bruxism, and Craniofacial Pain) have to do with cross-coding from dental to medical insurance? Services for two of these are typically reimbursed by health insurance and one of them may be paid under certain circumstances.

Airway Airway management is the most predicable in dental to medical cross-coding. Most medical insurers reimburse for the HCPCS code E0486 for a custom appliance to reduce upper airway collapsibility when paired with the ICD code for Obstructive Sleep Apnea (OSA), G47.33. It is importItems that require ant to know what coverage criteria and documentation various medical repeated adjustments insurers require supporting medical and modification beyond necessity; This criterion is in the medinsurer’s medical policies (clinithe initial 90-day fitting ical cal policy bulletin, local coverage and adjustment period determination, etc.), which are typiin order to maintain cally located on their main website on their providers page. Criteria for fit and/or effectiveness medical necessity coverage can vary; are not eligible for for example, various commercial carriers are now following the guidelines classification as DME. set by the Pricing, Data Analysis, & Coding (PDAC) contractor (currently Noridian Healthcare Solutions) for E0486. Because Medicare DME has required PDAC approval for custom-made oral appliances for OSA for some time now, you will often hear this referred to as the “Medicare approved appliances.” What this means is that some commercial insurers require appliance PDAC approval to be billed as E0486. The list of devices are on PDAC’s website, www.dmepdac.com. The current

28 DSP | Summer 2016

criteria to meet PDAC approval as stated in the Medical LCD for Oral Appliance for OSA is below: 1. Have a fixed mechanical hinge (see below) at the sides, front or palate; and, 2. Be able to protrude the individual beneficiary’s mandible beyond the front teeth when adjusted to maximum protrusion; and, 3. Incorporate a mechanism that allows the mandible to be easily advanced by the beneficiary in increments of one millimeter or less; and, 4. Retain the adjustment setting when removed from the mouth; and, 5. Maintain the adjusted mouth position during sleep; and, 6. Remain fixed in place during sleep so as to prevent dislodging the device; and, 7. Require no return dental visits beyond the initial 90-day fitting and adjustment period to perform ongoing modification and adjustments in order to maintain effectiveness (see below) A fixed hinge is defined as a mechanical joint, containing an inseparable pivot point. Interlocking flanges, tongue and groove mechanisms, hook and loop or hook and eye clasps, elastic straps or bands, etc. (not all-inclusive) do not meet this requirement.

PRACTICEmanagement The biggest barrier dental practices encounter in TMD/craniofacial pain reimbursement is the absence of a narrative report of medical necessity, written by the dentist, and sent with the claim or the preauthorization.

Items that require repeated adjustments and modification beyond the initial 90-day fitting and adjustment period in order to maintain fit and/or effectiveness are not eligible for classification as DME. These items are considered as dental therapies, which are not eligible for reimbursement by Medicare under the DME benefit. They must not be coded using E0486.”

That brings us to Bruxism Billing for a bruxism appliance to medical insurance will very likely be reclassified as “dental treatment” – not as a medical necessity. There are two bruxism ICD codes to consider: G47.63 for “Sleep-related bruxism” and F45.8 for “Other somatoform disorders”, which include bruxism. Recent medical policies show that a “bruxism” diagnosis may be reimbursed for Botox when the patient has “painful bruxism”. For example,

Rose Nierman has been at the forefront of educating dental practices on medical billing in dentistry, cross-coding and the expansion of patient services for over 26 years. She is the creator of DentalWriter™ Software and a CE provider for CrossCoding; Unlocking the Code to Medical Billing in Dentistry™. Contact Nierman Practice Management at 1-800-879-6468 or www.NiermanPM.com.

30 DSP | Summer 2016

Aetna’s general medical policy titled “Botulinum Toxin” states that: “OnabotulinumtoxinA (Botox Brand of Botulinum Toxin Type A): Aetna considers onabotulinumtoxinA (Botox) medically necessary for any of the following conditions: V. Painful bruxism”

Craniofacial Pain Cross-Coding The biggest barrier dental practices encounter in TMD/craniofacial pain reimbursement is the absence of a narrative report of medical necessity, written by the dentist, and sent with the claim or the preauthorization. A well-written narrative report based on a detailed history taking and exam is a key to TMJ treatment reimbursement. Another factor that will make or break a TMD claim is the selection of an International Classification of Diseases (ICD) diagnosis code that is covered based on the medical policies. While there are many ICD codes pertaining to a patient suffering from craniofacial pain to represent symptoms and conditions like facial pain, myalgia, headaches, tinnitus, etc., most insurers will only consider the ICD codes that represent Temporomandibular Disorders (TMD) as the primary diagnosis. These TMD diagnosis codes range from M26.60-M26.69. Thirdly, think about your language when calling for a “benefits check” and in your narrative report. Medical carriers want to see the medical necessity for TMJ disorder indicating, perhaps, a disc derangement diagnosis with head and facial pain to ensure that the treatment is medical in nature instead of a bruxism appliance to protect teeth. The fact that over 35 states mandate TMJ treatment coverage under medical plans improves access to care. When TMJ services are covered, an exam, a panorex, the orthotic and follow-up visits are typically reimbursable. A TMJ appliance is referred to as an “orthotic” or “jaw repositioning appliance” to treat the condition, not a bite “guard or an occlusal splint” designed to protect the teeth. Incorporating Airway, Bruxism and Craniofacial Pain services increases the services your practice offers. Learning the latest trends in successful reimbursement helps your practice, but more importantly, your patients with life-changing treatments.

PRODUCTspotlight

Is Apnea Guard … becoming the New Normal to work with MDs? ®

by Dr. Todd Morgan

“T

hat’s fantastic! You can do that?” These were the words of my physician colleague when he learned that I could use the Apnea Guard trial appliance to tell AHEAD OF TIME whether a custom oral appliance would work for his patients. Now he is my number one referral for Oral Appliance Therapy! The Apnea Guard has greatly improved, and changed the way I work with physicians. An evidence-based approach to medicine is the cornerstone of the clinical medical practice, and the Apnea Guard provides a way to interface with my medical colleagues on this level like never before. Thanks to the solid clinical evidence from our validation studies showing equivalency of the Apnea Guard to a custom appliance, the hurdles I used to encounter with my docs have begun to come down. In a short period of time I have gained their total trust now by proving OAT will work before ordering a custom appliance. Many docs who were skeptics about Oral Appliances before have now been convinced by the logic of “pre-qualifying” their patients for OAT! As you might guess, the Apnea Guard has become a bridge for me to physicians (and insurance carriers). Last year I made Apnea Guard an integral part of my MD outreach program.

Apnea Guard catalyst scoop

I was asked recently asked what I believe are the strongest benefits of the Apnea Guard System. That’s easy. First and foremost, the Apnea Guard was built to be a trial oral appliance, and this is its biggest strength. Our original plans for AG included the hospital where it could be fitted to OSA patient emerging from general anesthesia – a time of heightened risk for those patients. That is why the Apnea Guard was designed to be fitted easily by any healthcare worker so that we could reach those patients at special risk. As soon as it came to market, we realized it added value by providing dentists with a precision immediate treatment AND accurate treatment planning. Precision in the sense that the dentist can find the correct position of the jaw for the most effective and rapid outcome possible, and that treatment can start now. Accurate in the sense that a responder to OAT can be identified immediately using simple tests like HST while wear-

Retention materials mixed

Retention material added to tray

Material distributed evenly in tray

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PRODUCTspotlight The dentist can find the correct position of the jaw for the most effective and rapid outcome possible, and that treatment can start now.

ing the Apnea Guard on night one: BTW: One more new opportunity to cement the DDS and MD relationship, and AG has done that for me. What do I love the most about the Apnea Guard in my hands? First of all, it’s easy, and I’m done fitting it in about 10 minutes. I love that I can capture a precise and predictable bite and jaw position, and then transfer that proven position without hassle to the custom device in a simple lab process. I love that the Apnea Guard system, thanks to EZ Sleep In-Home Testing, is totally seamless to incorporate into your practice routines. And, since their program includes 2 nights of test-

ing each time they study a patient at home, you’ll have blended data that is more reflective of true sleep patterns and best practices. All of their studies are interpreted by Board certified sleep docs so you get the real deal. In fact, if you use all of their DSM tools to identify, test and treat the OSA patient in your practice, it’s really hard to fail. I love teaching my students how to use the Apnea Guard because I know it will mean success, whether they are new to DSM or more advanced, saving time, appointments spent on titration, and overhead dollars. It makes the apnea conversation with your patient easier, too. Because of a special offer from EZ Sleep, there’s very little to lose in offering a no-cost AG Trial to your patients. My final thought almost always returns to the awesome ability to help my most desperate patients feel better NOW. “Mrs. Jones, I think we can begin helping you with your apnea starting tonight,” and as I wait for the smile to happen. For more information on incorporating an Apnea Guard trial appliance protocol to increase your MD referrals, case patient acceptance and treatment outcomes, please contact EZ Sleep In-Home Testing at ApneaGuard@EzSleepTest.com or RyanJ@ EzSleepNetwork.com.

Adjustment

32 DSP | Summer 2016

Apnea Guard fitting

Log settings

Finishing in water

CLINICALfocus

How to Read a Sleep Study Report by Jamison Spencer, DMD, MS

leep study reports come in a lot of variety. Some reports will be “just the facts.” Others will have TONS of data. Here are the things that are important for us to review as dentists, and what we should point out to our patients.

Is it an in lab test, a home sleep test, or are you looking at the CPAP titration? The first thing you need to determine is what type of study report you are looking at. You want to be looking at a baseline study, not the CPAP (continuous positive airway pressure) titration. Here are the different types of studies: 1. Inlab polysomnogram, or PSG. This is the gold standard test and is performed with the patient going to a sleep lab, getting wired up, and spending the night in the lab while a technician attends the study. 2. A “home sleep test” or “out of center sleep test” (OCST). These are small devices that are usually sent home with the patient or sometimes mailed to them. They usually consist of a pulse-oximeter, 1 or 2 strain gauges, and a nasal cannula. Some home test units can also measure brainwaves or have another means to determine if the patient is actually asleep or not (most home units only assume the patient is asleep…making them less accurate). 3. A “split night study.” This is an inlab PSG where the first part of the nightis the diagnostic phase, and then, IF the patient shows significant sleep apnea, the patient is awoken and placed on CPAP. The rest of the night is used to find the optimal CPAP pressure to treat the sleep apnea.

4. CPAP titration study. This is an inlab PSG where the entire night is used to adjust the CPAP. Usually in these reports there will be an initial sentence about what the baseline PSG showed. Once you know that you are looking at the baseline PSG or OCST, here are the things you want to look for: 1. AHI: What was the overall Apnea/ Hypopnea Index (AHI)? The AHI is the measure of how bad the patient’s sleep apnea is. The scale of AHI is: • < 5 = normal in an adult. (In a child > 1.5 indicates clinically significant sleep apnea) • 5-15 = mild • 15-30 = moderate • > 30 = severe Now, let’s take this AHI number and break it down a bit. Obstructive apneas and central apneas are added together to get the “A” in the AHI. Central sleep apnea is where the brain doesn’t tell the person to try to breathe. [As a brief note, pure central sleep apnea is very, very rare, BUT if you ever see a patient with a high percentage of central sleep apnea, instead of obstructive, you will want to review the goals of oral appliancet herapy with their physician, as oral appliance therapy typically will not affect central sleep apnea — neither does CPAP.] Hypopneas are the “H.” A hypopnea is a reduction in ventilation by at least 50% that also results in a decrease of the O2 saturation by 4% or more. In other words, a hypopnea is shallow

So why do we care? I believe it is important to show the patient what is going on with them so that they better understand their problem.

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CLINICALfocus breathing that results in desaturation. These are usuallyo bstructive in nature, like partly kinking a hose, but not completely blocking the flow. I enjoy showing the patient the difference between an apnea and a hypopnea by drawing on the back of one of the forms. I say, “in the sleep lab, or in you rhomestudy, you had a nasal cannula in your nose. Normally when you see these things they are to givesomeone extra oxygen. In this case, the cannula was measuring your breathing in and out. On the computer screen it would look like this:

I’ll tell the patient that this, an apnea, happened “X number of times” throughout the whole night. This number will usually, but not always, be in the report. This is not the “index” but the actual number of obstructive and central apneas that occurred throughout the night. If the number of apneas is not specified in the report, then you can’t show this. I will then show the patient what a hypopnea would look like on the computer screen in the sleep lab:

I’ll tell the patient that this, a hypopnea, occurred “X number of times” throughout the whole night.

Jamison Spencer, DMD, MS is the Director of the Center for Sleep Apnea and TMJ in Boise Idaho, and the Director of Dental Sleep Medicine for the 24 practices of Lane and Associates Family Dentistry in North Carolina. He is adjunct faculty at Tufts University, University of the Pacific, and the University of North Carolina at Chapel Hill. Dr. Spencer teaches mini-residencies in Dental Sleep Medicine at Tufts and UOP, and lectures around the world on Dental Sleep Medicine and TMD. He is a Diplomate of the Board of Dental Sleep Medicine, a Diplomate of the Board of Craniofacial Pain, the inventor of an FDA approved oral appliance, and recently launched the “Spencer Study Club“ as an online education and mentoring resource to help dentists take Dental Sleep Medicine and TMD to new levels in their practices. For more information go to www.JamisonSpencer.com, or email Dr. Spencer at Jamison@JamisonSpencer.com.

34 DSP | Summer 2016

By showing the patient the difference between an apnea and a hypopnea, it helps them to understand their problem better, and makes the severity of their sleep apnea make more sense… because the AHI does not tell the whole story. Speaking of story, here’s a little mathematical story problem for you: Patient A’s study shows that he had 60 obstructive apneas throughout the night. He had 30 hypopneas throughout the night. He slept 6 hours total. Therefore his AHI is (60 + 30) / 6 = 15. Patient B’s study shows that he had 30 obstructive apneas throughout the night. He had 60 hypopneas throughout the night. He slept 6 hours total. Therefore his AHI is (30 + 60) / 6 = 15. Wait a second! They both have an AHI of 15 eventhough one had half as many actual episodes of stopping breathing? Yep! Now let’s take this to the extreme. What is the AHI if the patient had 180 apneas for the night, 0 hypopneas for the night, and slept 6 hours? (180 + 0) / 6 = 30. What is the AHI if the patient had 0 apneas for the night (literally NEVER stoppedbreathing), 180 hypopneas for the night, and slept 6 hours? (0 + 180) / 6 = 30. What? So BOTH of these patients have“ severe sleep apnea,” even though the second one NEVER stopped breathing?! That’s correct. So why do we care? I believe it is important to show the patient what is going on with them so that they better understand their problem. If you are told that you have severe sleep apnea and that you stop breathing 30 times per hour, but your wife of 20 years says that she has only rarely noticed you stopped breathing, are you going to believe the report? Probably not. So it is important to explain to the patient that even though they have been told that they “stop breathing X times per hour” (which is what they will think the AHI is) that they don’t actually completely stop breathing all of those times (unless of course they have 0 hypopneas throughout the night). It’s also important for us to look at this as I believe, through experience, that we tend to have an easier time treating patients with more hypopneas than apneas. That doesn’t mean that we don’t treat people with lots of apneas, but it just means that we might “lower their expectations” a little of oral appliance therapy completely resolving their apneas.

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CLINICALfocus

For some of our patients you will be the first one to go over the baseline sleep study with them.

36 DSP | Summer 2016

2. Sleep Position: In conjunction with the AHI you will also usually find information about sleep position and the AHI when the patient is sleeping supine versus on their side. For most peopletheir obstructive sleep apnea is worse on their back (supine). For some people you will notice that their problem almost exclusively occurs when they sleep supine. When you notice this, you should talk to the patient about this fact and encourage them to sleep as much as possible on their side, including once they get their oral appliance. 3. O2 Saturation: What is the O2 saturation nadir (lowest point), and how much time didthe patient spend with an O2 saturation below 90%? This is a pretty obvious one to us as to why it is important. However, most patients will not realize what the O2 saturation means. Explain to them that our blood O2 levels, atthis elevation, should be above 95% most of the time. Explain that if they were in a hospital and their O2 level went below 90, alarms would go off! Then tell them that their O2 level dropped to a low of X and was below 90 X% of the night. 4. Sleep Stages: How much time the patient spent in the different levels of sleep during the study. Non REM sleep stages are referred to as N1, N2 and N3. Here are the“ ideal” percentages: • N1 is “light sleep” or “transitional sleep.” This should only account for about 5-10% of the total sleep time. • N2 is “restful sleep.” This should be about 45-55% of the total sleep time. When people have reduced deep sleep and REM sleep, they usually have increased N1 and N2 sleep. • N3 is “deep sleep” or “slow wave sleep.” This should beabout 1020% (much more in children, and becomes less as we get older). • REM is Rapid Eye Movement sleep, or “dreamsleep.” We should have about 20-25% of our sleep be REM sleep. In REM sleep the muscles have much less tone (some will say paralyzed), and as such obstructive sleep apnea tends to be worse in REM sleep.

While there are a lot of things that are fascinating about how sleep works, here are the simple things you need to know and share with your patients. First, if they have reduced deep sleep (N3) they will feel physically tired. They may also have muscle pain, or even “fibromyalgia” type symptoms. Second, if they have reduced REM sleep they will feel mentally tired. They may also have memory problems and a “clouded intellect.” For some of our patients youwill be the first one to go over the baseline sleep study with them. For many of our patients it was months or years ago that their doctor reviewed their sleep study with them, so they have likely forgotten much of the information. Going over this information with the patient will help them, and you, to understand their problem much better and make them, in my opinion, more likely to stick with treatment. Each sleep lab and sleep doctor will present their data a little different, but you should be able to find the above information in all sleep studies and help the patient to understand it. We DO NOT base our appliance selection on any of this information. ALL oral appliances work the same way… they keep the mandible from falling back, or keep it slightlyf orward. The data WILL help us to know how bad the patient’s obstructive sleep apnea is so that we will better know how to treat them and how important it will be for them to return to their physician for objective follow up and adjustment of the oral appliance in the sleep lab.

Follow Up Sleep Study

I believe that ALL patients should be referred back to the referring physician (the one who wrote the prescription for the oral appliance) for consideration of a follow up sleep study with the oral appliance in place. IF the physician does decide to have a follow up sleep study, I also believe that it is ideal to have the appliance adjusted in the sleep lab by the sleep techs (you will normally need to teach them how to do this and have written protocols for this). When comparing a baseline study to a follow up study, make sure that you compare apples to apples, and look for:

CLINICALfocus • PSG to a PSG is apples to apples, but o How long has it been since the last PSG? o Were both studies at the same lab? o Were both studies read by the same doctor? • PSG to HST, or HST to PSG = not apples to apples = tough to make conclusions • HST to HST maybe apples to apples, but o How long since the last HST? o Is the same HST device being used (if not, probably not apples to apples)? Once you understand the differences between the technical aspects of the baseline study versus the follow up study, look for the following things that may be different from the baseline study to the follow up study: • How long has it been since the baseline study? Sleep apnea usually gets worse as we get older. • Has there been any weight gain? Sleep apnea usually gets worse with weight gain. • Different sleep posture? Sleep apnea is usually worse in the supine position. • Look at more than just the AHI o Was there a change in the number of apneas? o Was there a change in the number of hypopneas? o Was there a change in the average O2 saturation? The nadir? I have had several patients that prior to me referring them back to the physician for consideration of a follow up sleep study with adjustment of the appliance in the sleep lab, the patient reported feeling fantastic and having a major improvement of their snoring. However, when they went in for the follow up sleep study the report came back that they didn’t do as well as I would have liked. In almost all of these cases I was able to compare the baseline study to the follow up study and find the reasons that we didn’t see a big change in the AHI, eventhough the patient felt much better. The most common things I’ve seen that made the follow up study numbers not a sgood as I would have liked were: • It had been 5 or more years since the baseline study.

• The patient had gained significant weight. • The patient slept mostly non-supine on their baseline study, and mostly on their back on their follow up study. The bottom-line is that it is important for us as dentists to understand what is presented in sleep study reports AND when follow up studies are completed to make sure that we compare the follow up study to the baseline study, and make sure that our objective data appears to be consistent with the subjective data of what the patient is reporting to us.

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ORIGINstories

The Unforgettable Story of Dan and Trina Webster

From A to

an and Trina Webster understand the torment felt by sleepdeprived people. Dan’s incessant snoring resulted in sleepless nights for Trina, and the couple’s frustration escalated dramatically when their first daughter, Hannah, was born. The old cliché “banned to the living room couch” became a nightly routine, and the baby and new mom’s sleep still were disturbed by his snores even a room away. Dan’s personal journey resulted in an unforgettable story. While looking for a solution for the Webster family, the couple have become true leaders in the sleep appliance marketplace. Now, each night more than a half a million consumers place their ZQuiet signature snoring appliances in their mouths, transforming their nights from incessant intolerable snoring to a world where, “all through the house, not a creature is stirring not even a spouse!”

Dan’s quest for a resolution was first to visit his primary care physician in the small Vermont town where they lived – and on to a specialist who recommended elective airway surgery. The recovery was lengthy and painful. Since the surgery was not covered by insurance, it was also very expensive. But what hurt the most was after a few weeks, the snoring returned – just as badly as before. The family was at a loss about what to do next. Determined to find a solution, Dan learned about oral appliance therapy, tried a mandibular advancement device, and the Webster’s lives literally changed overnight! Dan and Trina were surprised that this simple straightforward option wasn’t more

38 DSP | Summer 2016

by Lou Shuman, DMD, CAGS readily available and known by the consumer community. Dan never would have had to go through the unsuccessful surgery in the first place. Dan and Trina decided to embark on a personal mission to investigate snoring appliances, become more aware of the best options, and then focus on educating consumers like them. They found that there really wasn’t an easy-to-use, affordable option available and decided to create their own. In 2008, working in conjunction with a renowned reputable dental sleep practitioner, an engineer, and using Dan’s own background as a gifted sculptor, the ZQuiet consumer appliance was born along with their company, Sleeping Well LLC. Money was raised, a patent was secured, and FDA clearance was granted. Seven years later, ZQuiet is the leading consumer brand in snoring treatment. Dan and Trina’s mission of educating the consumer community on the concept of Oral Appliance Therapy has been realized through TV, radio, and social media, reaching millions of Americans. But the story does not end there! Recognizing the correlation between snoring and sleep apnea and its association with numerous medical risks, a new mission arose. It’s hard to believe, but an estimated 22 million consumers suffer from sleep apnea, and a whopping 85% are undiagnosed. Working in conjunction with John T. Herald, DDS, a 20-year veteran in sleep dentistry, Sleeping Well, LLC entered the dental sleep medicine market with a custom oral appliance created to treat both snoring and sleep apnea, obtained FDA 510k clearance, and the ZQuiet Pro Plus was launched. Now Dan and Trina could communicate the correlation between snoring and sleep apnea to their formidable customer base as well as the consumer community as a whole. They could not only encourage these people to be screened and tested for sleep apnea, but also extend their trusted line of appliances, keeping it all in the family. To assist Dental Sleep Practitioners increase the number of sleep cases and grow their

ORIGINstories practice, they are creating a national dentist locator. This patient marketing program will fully leverage the expansive consumer reach ZQuiet has with snoring – they have over a half million existing customers – by listing trained sleep dentists on their website. Webster notes, “For us, it’s simple. We want to get as many people screened, tested, and treated as possible. Connecting consumers with trained dental sleep medicine practitioners is further helping our mission of better sleep and better health.” Recognizing the importance of providing a complete continuum in oral appliance therapy, Dan continued to develop appliances to meet the diverse needs of the individual patient and the preferences of the dental sleep practitioner. Beyond the introductory, interim device, ZQuiet offers a complete line of professional lab-fabricated custom appliances: ZQuiet Pro-Plus, ZQuiet Pro Herbst, and ZQuiet Pro Flex. The ZQuiet S.A. Interim Appliance is a breakthrough product. It is highlighted on page 46 in DSP’s product spotlight section. As Webster states, “The innovative ZQuiet S.A. offers a temporary but immediate solution to both the newly diagnosed and those currently in treatment. Our goal in developing the ZQuiet S.A. was to provide a product that fills the important need of offering immediate relief for patients as part of a continuum of uninterrupted patient care in their treatment protocol.” The ZQuiet S.A.’s open tray design requires no boiling, molding, forming, or impressions, requiring virtually no chair time, which creates efficiency in the practice and time to see more patients. The device retention is cleverly created by the resilient hinging, which gently keeps it in contact with the dentition. Webster notes, “The beauty of the device’s simplicity is that it doesn’t compete or take the place of the custom appliance so there is no risk of losing the sale of the custom appliance. Dentists appreciate the health value of using a temporary appliance to provide immediate patient relief. Additionally, the price point is so low, they don’t even hesitate to fold the cost of the device into the treatment, providing a nice value-add to the patient.”

Regarding the ZQuiet Pro-Plus, Pro Herbst, and Pro Flex

“We researched the market and determined that the traditional dorsal fin and

Herbst style devices were the most popular and preferred appliances by both the practitioners and patients alike. With the ZQuiet Pro Plus and the ZQuiet Pro Herbst, we now offer both of these popular appliances in our product line at a very competitive price.” Both are available in hard or soft linings and can be customized to meet the dentist’s personal build specifications. The ZQuiet Pro Flex is the lightest and thinnest lab appliance available and is nearly invisible when worn. The advanced thermoplastic is stronger than acrylic which allows the appliance to be built with minimal bulk, and it is stain and odor resistant. The tried and true designs of the ZQuiet Pro Plus and ZQuiet Pro Herbst devices are not unlike the appliances dentists may be ordering currently. The biggest difference is that ZQuiet widely markets OAT to consumers through national TV, radio and Internet marketing programs. Dental professionals can leverage the awareness created by ZQuiet to provide custom OAT devices where they are prescribed.

Final Thoughts

As the Managing Editor of Dental Sleep Practice magazine, and as the founder of the Pride Best of Class Technology Awards, I am exposed to hundreds of dental companies every year. Every once in a while, a company comes along that really gets it right. One that is driven to make a difference; that is totally dedicated to its products and its cause. One that makes you proud to be a customer. Such a company is ZQuiet, and more specifically, Dan and Trina Webster. Their appliances are well thought out and beautifully constructed combining science with the esthetic eye of a sculptor. They stand by their work and their untiring mission to improve the quality of life of their customers. They are not a billion dollar company with a sleep appliance line, nor a multinational public company. They are the kind of company that is totally dedicated to its dentists, and one any of us would be proud to be involved in. If you are attending AADSM, drop by booth 412, or pick up the phone and call Dan or Trina. Then you will understand how fortunate we are to have them as part of our dental community and how much they have added to the famous ending “to all a good night.”

ZQuiet S.A.: Interim Appliance for dental sleep medicine practitioners who have a responsibility to keep a patient’s airway open while the new oral appliance is being made or repaired. ZQuiet S.A. is indicated to treat simple snoring and/ or mild to moderate OSA under FDA Clearance: #K140777.

ZQuiet Pro-Plus: A patient-friendly, dorsal-style appliance. The twopiece construction provides lateral jaw movement enabling the patient to open and close normally with less bulk and less stress to the temporomandibular joint.

ZQuiet Pro Herbst: The wellproven appliance consists of 2 acrylic splints which are bilaterally connected via an adjustable telescoping Herbst mechanism. Since the device is E0486 approved, it is frequently used for Medicare cases.

ZQuiet Pro Flex: The lightest and thinnest lab fabricated dorsal-style appliance available. Made from a proprietary flexible partial material that is 10 times stronger than acrylic and virtually stain and odor resistant.

DentalSleepPractice.com

TECHNOLOGYupdate

Consumer-Driven Sleep Technologies by Ping-Ru Teresa Ko, MD

itness and sleep trackers entered the market in 2010 and have exploded in sales over the last 5-6 years. Nearly 33 million of these devices have been purchased in the United States alone as of the end of 2015.1 Worldwide, it was estimated that approximately 8.5 million units were sold in the U.S. in 2015, leading the global market, followed by estimated sales in Western Europe and the Asia-Pacific region of 7.1 and 4.9 million units in 2015, respectively.2 It is predicted that 60 million fitness trackers will be in use globally by 2018.3

40 DSP | Summer 2016

With an estimated 50-70 million U.S. adults having a sleep or wakefulness disorder,4 it is little wonder that sleep trackers and other consumer-driven sleep technologies have gained a significant marketing presence. These devices have a fascinating range of purported applications, from tracking sleep duration and quality, to self-guided sleep assessment and education, to entertainment and health-driven social interaction. To this end, sleep technologies take on a sometimes dizzying variety of forms. Sleep specialists and other healthcare professionals are increasingly exposed to these unregulated sleep technologies via their patients, families, or friends, and may be asked to try to interpret the data from these devices. In this article, we will review some of the more popular or illustrative technologies. We will categorize them into four main spheres: mobile apps and other software, wearables, mattress-embedded devices, and nightstand devices. This article is not meant to be a comprehensive review of all available sleep technologies, but aims to encourage reflection and discussion on current popular and emerging consumer-driven sleep technologies.

TECHNOLOGYupdate Mobile Apps and Software

Mobile applications, or “apps,” and similar software which run on computer-based operating systems such as Android OS, Apple iOS, or Microsoft Windows, can be run on smartphones, tablets, or other electronic devices. Many are free; features-enriched versions generally cost no more than a few dollars. Some apps are simple sleep logs, or noise generators with white noise, nature sounds, hypnosis recordings, or other vocal tracks or light displays which claim to aid in sleep induction. Apps such as Sleep Cycle (Android OS, iOS)5, SleepBot (Android OS, iOS)6, Sleep As Android (Android OS)7 claim to work as sleep trackers, assessing sleep quality and duration. The apps often require the mobile device to be placed on the bed mattress next to the user, and use accelerometer technology available on many smart mobile devices to monitor sleep. Using proprietary algorithms, many of these apps claim to differentiate deep from light sleep, and employ a “smart alarm” that try to wake sleepers during a period of light sleep rather than deep sleep, ostensibly avoiding excessive grogginess upon awakening. Another novel feature employs taskbased alarm systems, requiring the user to complete arithmetic or motor-based tasks, or forcing the user to get out of bed, walk, and scan a QR barcode located in another part of the physical environment, thereby guaranteeing a certain degree of wakefulness before the alarm will shut off. An app called GO! to Sleep (iOS)8, developed by the Cleveland Clinic Sleep Disorders Center, uses a standard questionnaire for sleep hygiene, self-reported sleep duration, and other factors to derive a sleep score, and offers daily sleep tips and trivia. SnoreLab (iOS)9 records snoring intensity; it also provides advice to improve snoring and allows users to track efficacy of these therapies by trending their “Snore Scores.” Expanding into Internet-based resources, online interactive websites such as Sleepio10 and SHUTi11 provide customizable cognitive behavioral therapy for insomnia via multimedia modules for a time-based fee. Free software such as SleepyHead,12 available on most major desktop operating systems, provides access to CPAP usage data for end-users.

Wearables

One of the trendier spheres of consumerdriven sleep technologies, wearables in-

clude sleep tracker bracelets, necklaces, smart watches, or other technologies which can be attached directly to users or to their clothing. These bear similarities to conventional actigraphy, and often use three-dimensional accelerometer technology to track exercise as well as sleep. Certain devices even employ heart rate, perspiration, and temperature sensors to aid in sleep monitoring. Popular examples of wearables include Fitbit,13 Jawbone,14 Android Wear watches,15 and Microsoft Band.16 Apple Watch17 also supports several apps to track sleep; however, the high battery consumption rate of the Apple Watch typically necessitates nightly recharging, which may limit its use as a sleep tracker. Other examples of wearables include baby clothing with built-in sensors to monitor sleep quality, position, and temperature for infants; and hats and other clothing accessories that claim to track and improve sleep.

It is predicted that 60 million fitness trackers will be in use globally by 2018.3

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TECHNOLOGYupdate Mattress-Embedded Devices

These technologies are exciting glimpses into potential future tools for sleep evaluation and sleep health, and even in their novelty and entertainment value can entice the average consumer to think more about their sleep...

Sleep mattresses such as Sleep Number’s IT,18 Kingsdown Sleep Smart Intuitive,19 and Molten Corp’s Leios mattress,20 as well as mattress covers like Luna’s Eight,21 use embedded sensors to measure sleep activity, heart rate, breathing rate, temperature, and even ambient humidity, light, and noise. These technologies often communicate with an accompanying mobile device app to report sleep quality and duration, and offer sleep advice. Some of these devices may even automatically adjust mattress firmness, temperature, and elevation of the head or foot of the bed to optimize comfort.

Nightstand Devices

Several sleep and bedroom sensor standalone monitors can be placed on the nightstand, but often pair with mobile devices placed on the mattress to track sleep and other environmental factors. Smart bulb technology such as the Philips Wake-Up Light22 can be programmed to turn on at a certain time and gradually increase in light intensity over 30 minutes, simulating sunrise and aiming to wake the user gently. Users can also program the color and intensity of smart light bulbs to minimize blue wavelength exposure near bedtime, which may help enforce a normal circadian rhythm.

Conclusion

As a general rule of thumb, very few of these consumer sleep technologies are medically validated, and even fewer have been robustly tested. For many of these technologies, the algorithms used to derive sleep quality and duration are proprietary. Until further research is done, data from these devices cannot be reliably interpreted and requests for medical interpretation must be approached with caution. When encountering

these technologies, one must question how data is collected, what artifact may be introduced (for instance, for mattress-derived sensors, the degree to which sensor artifact from sleep partners, pets, and different mattress textures may affect results), and the level of quality of sleep education and information that is offered by the device or that may be shared through social media or other potentially un-validated sources. In addition, one must consider how these media-rich devices may be negatively impacting sleep through noise and light pollution. However, these technologies are exciting glimpses into potential future tools for sleep evaluation and sleep health, and even in their novelty and entertainment value can entice the average consumer to think more about their sleep – and ultimately fall to sleep, and in love, with healthy sleep practices.

5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16.

Ping-Ru Teresa Ko, MD is a pediatric neurologist who trained at Children’s Hospital of Oakland and the University of Washington, and completed a sleep medicine fellowship at the University of Washington. She currently works at Kaiser Permanente in Santa Clara, CA. She is highly interested in medical technology and sleep technology in particular, and potential applications of technology in the fields of sleep medicine and neurology.

42 DSP | Summer 2016

17. 18. 19.

20. 21. 22.

“Year-Over-Year Wearables Spending Doubles, According to NPD.” NPD. Online: https://www.npd.com/wps/portal/npd/us/news/press releases/2016/year-over-year-wearables-spending-doubles-according-tonpd/ Published: Feb 1, 2016. Accessed: March 14, 2016. “Forecast unit sales of health and fitness trackers worldwide from 2014 to 2015 (in millions), by region.” Statista.com. Online: http://www. statista.com/statistics/413265/health-and-fitness-tracker-worldwideunit-sales-region/ Published: 2016. Accessed: March 14, 2016. Sullivan, Mark. “Fitness tracker sales will triple by 2018, then smartwatches take over (report).” Venturebeat.com. Online: http://venturebeat.com/2014/11/25/fitness-tracker-sales-will-triple-by-2018-thensmartwatches-take-over-report/ Published: Nov 25, 2014. Accessed: March 14, 2016. “Insufficient Sleep Is a Public Health Problem.” Centers for Disease Control and Prevention. Online: http://www.cdc.gov/features/dssleep/ Published: Sept 3, 2015. Accessed: March 14, 2016. Sleep Cycle. Online: http://www.sleepcycle.com/ Accessed: March 14, 2016. SleepBot. Online: https://mysleepbot.com/ Accessed: March 14, 2016. Sleep As Android. Online: https://play.google.com/store/apps/details? id=com.urbandroid.sleep&hl=en/ Accessed: March 14, 2016. “Go! to Sleep.” Online: https://itunes.apple.com/us/app/go!-to-sleep/ id450775914?mt=8 Accessed: March 14, 2016. SnoreLab. Online: http://www.snorelab.com/ Accessed: March 14, 2016. Sleepio. Online: https://www.sleepio.com/ Accessed: March 14, 2016. SHUTi. Online: http://shuti.me/ Accessed: March 14, 2016. SleepyHead. Online: https://sourceforge.net/projects/sleepyhead/ Accessed: March 14, 2016. Fitbit. Online: https://www.fitbit.com/ Accessed: March 14, 2016. Jawbone. Online: https://jawbone.com/ Accessed: March 14, 2016. Android Wear. Online: https://www.android.com/wear/ Accessed: March 14, 2016. Microsoft Band. Online: https://www.microsoft.com/microsoft-band/ Accessed: March 14, 2016. Apple Watch. Online: http://www.apple.com/watch/ Accessed: March 14, 2016. Sleep Number IT.” Sleep Number. Online: http://itbed.sleepnumber. com/it. Accessed: March 14, 2016. Colon, Alex. “PCMag Review: Kingsdown Sleep Smart Intuitive.” PC Magazine. Online: http://www.pcmag.com/article2/0,2817, 2476614,00.asp Published: Feb 20, 2015. Accessed: March 14, 2016. Bolton, Adam. “Sleep smart: Japanese mattress adjusts air pressure for better rest.” Published: January 15, 2016. Accessed: March 14, 2016. “Eight.” Online: https://www.eightsleep.com/ Online: March 14, 2016. “Philips Wake-up light.” Philips. Online: https://www.usa.philips. com/c-m-li/light-therapy/wake-up-light/latest Accessed: March 14, 2016.

STARTINGearly

The Healthy Start System Provides an Effective Treatment for the Root Cause of Sleep Disordered Breathing and Straightening Teeth Without Braces

leep Disordered Breathing in children is a much more critical and common problem that what has previously been thought. SDB can manifest itself in a variety of symptoms that can be easily overlooked, misdiagnosed, and most unfortunately left untreated. The Healthy Start system educates the dental community to identify the symptoms, understand the underlying root cause, and create a treatment plan that both cures the breathing disorders and corrects the orthodontic condition.

Early intervention is critical when addressing sleep issues. The optimal age for a Healthy Start patient is as soon as the problem is identified. Any age from 2-12 might be best for any individual patient â&#x20AC;&#x201C; the first step in identifying SDB symptoms is with the Healthy Start Sleep Questionnaire. The Healthy Start requires a parent to assign a frequency number to Sleep Disordered Breathing symptoms apparent in their child: 1. Day or nighttime mouth breathing 2. Snoring 3. Talking in sleep 4. Tooth grinding 5. Difficulty listening / often interrupting 6. Allergic symptoms including eczema 7. Fidgeting with hands 8. Waking up at night 9. Restless sleep 10. ADHD 11. Excessive sweating while asleep 12. Bed wetting 13. Hyperactivity 14. Excessive daytime sleepiness 15. Nightmares / night terrors 16. Lack of focusing 17. Difficulty with school subjects of math, science, and spelling

18. Falling asleep during the day 19. Headaches in the morning 20. Speech problems A recent study of 501 Healthy Start patients from the ages of 2 to 19 found that nine out of ten children display at least one symptom of Sleep Disorder Breathing. Previous research found SDB occurring in only 1% to 3% of children from the ages of 5 to 13 yeas of age, however, the findings of this study provides evidence that SDB is much more common affecting 90% of children and the SDB symptoms can be seen in children as young as 2 years of age. (Stevens, 2016) Conclusions of this recent study found: 1. Mouth breathing and snoring are commonly associated with more SDB symptoms than the other symptoms studied. 2. The four most commonly occurring symptoms are: Mouth breathing at night, snoring, talks in sleep, and teeth grinding. 3. 90% of the sample had one or more symptoms commonly associated with SDB. 4. 60% of the sample had four or more symptoms.

DentalSleepPractice.com

STARTINGearly 5. Between 4 and 12 years of age, 92.6% of symptoms did not self correct while 30% worsened with age. 6. The dentist is well positioned to be able to utilize appliances that can modify the common symptoms. The implications of this study are essential in finding a way to improve the health of children today. Observations of these SDB symptoms can be seen as early as two years of age. Treating early not only allows the Healthy Start system to take advantage of growth and development and promote proper oral habits but to also ensure a healthier life for children (Stevens, 2016).

Training Before Healthy Start

After Healthy Start

44 DSP | Summer 2016

Professionals interested in gaining a greater understanding of SDB and how the Healthy Start System addresses both the sleep and orthodontic conditions can participate in a three-day course. The first two days of this course provide the necessary information for both Dr. and staff to identify, evaluate, and understand the treatment protocols. The third day is a hands-on day with patients and parents. Please visit www.TheHealthyStart.com for upcoming dates and more information.

Treatment

The Healthy Start System is a noninvasive, non pharmaceutical, natural form of treatment that uses a series of specially designed appliances to promote proper breathing habits. The Healthy Start addresses mouth breathing, open-bite, crossbite, narrow palate, speech difficulties, sucking and swallowing problems. The Healthy Start System also treats orthodontic problems such as crowding, overbite, overjet, gummy smiles, and class lll corrections. The Healthy Start system uses the natural forces of eruption to guide incoming teeth so natural fiber bundles develop and anchor these newly erupted permanent teeth into a perfectly created occlusion. The sequence for this case is typical: a sleep questionnaire filled out by parent rating their child’s symptoms on a scale indicated the degree of risk. Finding an open-bite condition usually represents a tongue thrust, improper swallow, and mouth breathing. The Healthy Start system was introduced with the first of a three-appliances series given to address the habit and breathing issues for a period of three months. The second appliance was issued when the first tooth was lost and was used only at night to guide the incoming dentition and ensure proper

habits. The third and final appliance was given as the laterals began to erupt and continues to guide the incoming teeth into the correct position. The natural eruptive forces will expand the arches and allow more space for the tongue to be forward and out of the airway.

FAQ

Q: What is the ideal age to begin Healthy Start treatment? A: The earlier the better. Ideally every child should have a comprehensive exam by a Healthy Start Provider by the age of two (2). Healthy Start dentists and their staff have received special training to ensure that the overall health and wellbeing of every child is carefully evaluated and taken into consideration when formulating a treatment plan. Q: What are the benefits of the Healthy Start system? A: The Healthy Start addresses health issues in children as well as straightening teeth without braces. Nine out of ten children present with at least one symptom of Sleep Disorder Breathing. Healthy Start looks at the root cause of these symptoms: a compromised airway, a narrow arch which compromises the proper tongue position, and mouth breathing. The Healthy Start addresses the root issues while straightening the teeth. Q: How long will the Healthy Start System for kids prevention technique take when done at this young age? A: Since treatment in young patients occurs as the adult teeth erupt, the process will need to last until all permanent teeth have come in. This is not as daunting as it may seem since the appliances may be worn passively at night or for brief periods during the day. Our devices work to ensure the jaw and teeth fit and work properly together, therefore allowing the achieved results to be stable for life. Typically, the child is completely finished by 12 years of age. Q: Can you predict at age 5 what a child’s teeth are going to look like at 12 years of age? A: Yes. Actually, many aspects of malocclusions (overbite, jaw relationship, cross-bite, crowding, and overjet) are predictable by 2 years of age. Left untreated, at best they stay the same but in over 75% of individuals, the problems become more severe while the child suffers from breathing problems every night from age 5 to 12 – years of development they’ll never get back. 1.

Stevens, B. (2016). The Incidence of Sleep Disordered Breathing Symptoms in Children from 2 to 19 Years of Age. Journal of the American Orthodontic Society, 24-28.

PRODUCTspotlight

Don’t Make Your Patients Wait!

our patient is sitting in the chair, ready to move forward with oral appliance therapy. His bed partner is desperate for relief, and he fully understands that treating his apnea is critical to his health and his quality of life. Why spend weeks waiting for his custom appliance and delay beginning treatment that is necessary today?

Trina and I started ZQuiet because of our commitment to help people get better sleep and live healthier, happier lives.

46 DSP | Summer 2016

Mayoor Patel, DDS, an Atlanta, GA dental sleep practitioner and educator, doesn’t think your patient should wait. “Patients usually do not want to wait 3 to 4 weeks to get their custom device in order to begin treatment,” said Patel. He uses the ZQuiet S.A., a new device specifically created to meet the needs of patients waiting for a custom device, allowing them to begin oral appliance therapy or maintain treatment while a device is repaired. “As an educator of Dental Sleep Medicine, I explain to clinicians the importance and benefits of having a cost effective option that can be used in clinical situations as a temporary appliance or a trial device,” noted Patel. “I have incorporated the ZQuiet S.A. for many different clinical situations and see great patient satisfaction as a result.” ZQuiet cofounder, Dan Webster, recounts, “The ZQuiet S.A. was developed as a product that fills an important treatment need. The new appliance offers immediate relief for patients and provides a continuum of uninterrupted patient care in the treatment protocol.“ Brock Rondeau, DDS, DADSM of London, Ontario is pleased with the interim appliance option. “I particularly like to use the ZQuiet S.A. temporary appliance for OSA patients who have lost or damaged their oral appliance.” The ZQuiet S.A.’s open tray design requires no boiling, molding, forming, or impressions, requiring virtually no chair time which creates more efficiency in the practice to see more patients. The device retention is cleverly created by the resilient hinging which gently keeps it in contact with the dentition. “The beauty of the device’s simplicity is that it doesn’t replace or compete with a custom appliance so there is no risk of losing the sale of the custom appliance. Dentists appreciate the health value of using a temporary appliance to start immediate treatment or main-

tain interim treatment. Additionally the price point is so low, they don’t even hesitate to fold the cost of the device into the treatment, providing a nice value add to the patient.” The ZQuiet SA is available in four protrusive sizes allowing the practitioner to provide temporary advancement at a clinically appropriate level. Each appliance is packaged individually with a storage case for easy dispensing to the patient. Practitioners nationwide have embraced the new device, incorporating the temporary appliance in their treatment protocol. “I always doubted the need for a temporary appliance in my sleep practice, but after using the ZQuiet S.A. I am now a believer. Every patient with an appliance repair gets one, and my new cases benefit from immediate relief while their appliance is fabricated,” says Brian Shuman, DMD of South Burlington, VT. Webster, along with his wife Trina, founded Sleeping Well, parent company of the ZQuiet brand of snoring and OSA treatment solutions, after their struggle to treat his snoring. “We know first-hand how snoring disrupts families and impacts relationships,” said Webster. The couple is passionate about providing education that can help consumers recognize the health dangers of OSA, and reaches millions of consumers through media campaigns offering treatment and support for anyone struggling with snoring and OSA. “Trina and I started ZQuiet because of our commitment to help people get better sleep and live healthier, happier lives. We see this same passion from the dental sleep practitioners we have met.” Dr. Rondeau agrees. “We have a responsibility to keep a patient’s airway open while the new oral appliance is being made or repaired. Otherwise, in my opinion, we are practicing below the standard of care.”

ADJUNCTIVEcare

Dental Sleep Medicine:

Beyond Oral Appliance Therapy by Drs. Richard Drake and Craig Schwimmer

leep disordered breathing continues to plague millions of Americans. Our traditional way of managing patients has been inconvenient, intrusive, and ultimately offered solutions most patients simply don’t want (CPAP or surgery). Between the high cost and inconvenience of in-lab sleep studies, and the aversion that most people have to the idea of sleeping with a CPAP device or having “half their throat ripped out”, most people with sleep apnea have never even been diagnosed. Perhaps more telling is the fact that most people who have been diagnosed currently go untreated! With real-world CPAP compliance rates as low as 35%, many patients simply need better treatment options. Over the past 10 years, dental sleep medicine has played an increasingly vital role because Oral Appliance Therapy (OAT) has proven efficacy and is better tolerated than CPAP. More and more dentists are educated about what sleep apnea is and help their patients with custom oral appliances. In fact, independent healthcare business analysts Frost and Sullivan recently reported that they anticipate a five-

fold increase in the number of dental devices made in the US over the next 5 years. But is OAT all we have to offer? As a dentist, what can you do for your patient who can’t tolerate OAT? What about those who refuse to wear a dental device? Or those patients for whom OAT offers partial, but incomplete relief? What else can we do for these patients? The Pillar Procedure is another tool you can use to better meet the needs of your snoring and sleep apnea patients. First approved by the FDA in 2002, the Pillar Procedure has been used to treat over 50,000 patients with snoring and mild-to-moderate sleep apnea. The Pillar Procedure is a minimally invasive technique, performed chair-side, that works by inserting small woven sutures into the soft palate (see diagram). Performed under local anesthesia in about 10 minutes, it has been shown to significantly reduce snoring (bed-partner satisfaction rates average around 80%),1,2 and to effectively treat mild-to-moderate sleep apnea (approximately 80% of patients experience significant reduction in AHI).3,4 DentalSleepPractice.com

ADJUNCTIVEcare

Stiffening the soft palate has been a primary method of procedural sleep apnea treatment for over 40 years. The UvuloPalato-Pharyngo-Plasty (UPPP) was first introduced in the 1970s as a treatment for OSA, and remained the standard surgical treatment for It is a simple, essentially many years. Over the years, painless chair-side procedure... the technique has been modified numerous times, but even now remains an extremely invasive and painful procedure. In contrast, the Pillar Procedure does not require the removal or destruction of any soft tissue. The Pillar Procedure stiffens the soft palate by stimulating a foreign body reaction. In response to the placement of the palatal implants, the patientâ&#x20AC;&#x2122;s natural fibrotic response stiffens the soft palate, thereby decreasing palatal flutter. So instead of an invasive, painful surgical procedure, it is a simple, essentially painless chair-side procedure that allows patients to immediately return to normal diet and activities.

Dr. Craig Schwimmer is a practicing ENT from Dallas, TX, who has performed thousands of Pillar Procedures, and serves as Chief Medical Officer of Pillar Palatal, LLC. He can be reached at CSchwimmer@PillarPalatal.com Dr. Richard Drake is a practicing dentist in San Antonio, TX, and co-founder of Dental Sleep Solutions and DS3 software. He routinely utilizes the Pillar Procedure in his dental office.

48 DSP | Summer 2016

OK, but what does the Pillar Procedure have to do with dentistry? Simple, as a dentist, you can perform the Pillar Procedure. While most Pillar Procedures performed to date have been done by ENT physicians, the FDA authorizes trained dentists to perform this procedure. Eager to offer their patients more than just OAT, an increasing number of dentists are adding the Pillar Procedure to their practices. In the dental setting, the Pillar Procedure has been shown to augment the efficacy of OAT, reducing the amount of protrusion required to achieve a desired end point. The theory is that the two techniques work synergistically, because airway stabilization is accomplished both retro-palatally and retro-lingually. It also allows a dentist to help patients for whom OAT is not an option. Performing the procedure: The patient is typically given ibuprofen 800 mg po, and then asked to rinse with an antiseptic solution immediately prior to the procedure. The palate is anesthetized topically, and then injected with approximately 3 cc of a short acting local anesthetic (with epi). The implants are then placed approximately 2 mm apart and parallel, with the first implant inserted along the midline raphe. The entry point for the delivery device is the junction of the hard and soft palate, allowing the implants to be placed as close to that junction as possible. The implants are placed 2mm apart and parallel (see illustration). Typically, 5 implants are placed per patient. Fifteen minutes later, the patient is driving back to work. Post operatively, most patients experience very little discomfort, typically

ADJUNCTIVEcare managed with ibuprofen and cold liquids. It takes several weeks for the scar tissue in the soft palate to form, and to integrate with the implant material. Therefore, patients are advised not to expect clinical improvement for at least two weeks, and that maximal improvement can take up to three months. Decreasing palatal flutter in this way can directly decrease snoring and apnea, and (anecdotally) it can also synergistically augment the effect of OAT, thereby providing the assist that some dental devices need to get to the end zone. Over 50,000 patients have been treated with the Pillar Procedure, and not a single significant complication has been reported. The most commonly reported complication is “partial extrusion” of one or more of the implants. This occurs in between 1 and

2% of patients, and is managed by removing the exposed implant. Pillar Procedure courses are offered throughout the year and sometimes in conjunction with Dental Sleep Solutions. You can get more information by calling Pillar’s manufacturer at 214-369-2347 or by visiting www.PillarProcedure.com. 1.

Long-term Results of Palatal Implants for Primary Snoring. Maurer JT, Verse T, Stuck BA, Hormann K, Hein G. Otolaryngol Head Neck Surg. 2005; 132: 125-132. Patient Outcomes After Soft Palate Implant Placement for Treatment of Snoring. Rosenberg B, Alsaffar H, Kandessamy T. Journal of Otolaryngol Head Neck Surg. 2010; 39:323-328. Extended Follow-up of Palatal Implants for OSA Treatment. Walker RP, Levine HL, Hopp ML, Greene D. Otolaryngol Head Neck Surg. 2007; 137:822-827. One-year Results: Palatal Implants for the Treatment of Obstructive Sleep Apnea. Norgard S, Hein G, Stene BK, Skjostad KW, Maurer JT. Otolaryngol Head Neck Surg. 2007; 136: 818-822.

Proven Palatal Stiffening

50,000 % 50 % 80

Patients Treated*

Long Term Reduction in AHI**

Long Term Satisfaction**

ZERO **

Serious Adverse Events Reported*

Neruntarat C. Eur Arch Otorhinolaryngol. 2011

10 Minutes to Perform

1,300

Average Profit*

Manufacturer’s data on file

Good for Your Patients. Good for Your Practice.

www.pillarprocedure.com | 214-369-2347 DentalSleepPractice.com

PRACTICEmanagement

The Four Pillars for Dental Sleep Medicine

Success

by Gy Yatros, DMD

n the spirit of full disclosure, I need to tell you that I own a dental sleep medicine implementation company. Because of that, I have my finger on the pulse of what is on the mind of other dentists that have entered the burgeoning field of Dental Sleep Medicine (DSM). Our Member Support team fields calls every day from dentists that proclaim some version of the following:

• “I want to practice DSM more, but I just don’t have the patients.” • “I send patients to the sleep lab, but they all just get slapped with a CPAP.” • “I just don’t know which appliance to use and I heard this can change bites.” • “I have treated a few patients and it went well but insurance won’t pay for it.”

I’ve been providing Oral Appliance Therapy (OAT) for a long time and at one time or another, I’ve experienced each of the above frustrations. How do you identify patients, ensure they get properly diagnosed, treat them appropriately, and get paid for your potentially life-saving therapy? Welcome to the Four Pillars necessary to successfully implement and sustain DSM production in your practice; Screening, Testing, Treating, and Billing. Each of these must be a part of a firmly established system in your practice if you are going to attain success.

Pillar 1 – Screening

Sleep Disordered Breathing (SDB) affects greater than 35% of our adult population and as many as 1 in 5 adults have Obstructive Sleep Apnea (OSA). Still, less than 10 % of patients know they have this serious disorder. They are in your waiting room right now. We’re remiss if we assume that someone else is broaching this issue with them. Their physicians have packed schedules and are unlikely to have a dialogue about sleep with them. That assumes it’s even on their radar. It is time that we step up to the plate and boost awareness. Compared to our patients’ other medical care givers we spend more time annually with our patients and we are more familiar with cranio-facial anatomy which can put patients at risk for SDB and OSA. How do you identify patients that suffer from OSA and may benefit from OAT? Our

Patient screening

50 DSP | Summer 2016

PRACTICEmanagement team fields some iteration of this question frequently. Should I advertise on radio, buy billboards or what? Screening your existing patients is where it all begins. Most dental offices routinely do oral cancer screenings. Have you considered why? Is it because we were told to do so, that oral cancer occurs in the mouth, to avoid litigation or because we care about our patients’ well-being? All are good reasons and the same can be said for screening our patients for SDB. How many oral cancers do most offices find in a year? One or two per year? Yet, we still do it because it is an important service and we care about our patients. Screening for SDB takes no more time than screening for oral cancer while the number of our patients with airway problems far exceeds the number of oral cancer patients we will encounter. The first pillar requires launching a system to quickly identify at-risk patients. This can easily be accomplished through readily available sleep screening questionnaires. An ideal questionnaire should include questions about Excessive Daytime Sleepiness (EDS), snoring, sleep quality, witnessed apneas/ gasping while sleeping, morning headaches and difficulty in maintaining sleep. The questionnaire should also include common OSA co-morbidities such has hypertension, diabetes, weight gain, GERD, and cardiac problems. The Screener should be comprehensive and easy to complete by the patient. Identifying these patients is a step in the right direction. What do you do next though? You need to be educated and prepared to discuss these results with patients. You AND your team need to have a defined approach to handling these conversations. You need to be passionate and caring as you help patients understand their risks. The goal is to have an informed and sincere conversation with patients about their risks, and ultimately, move forward to the next pillar of DSM: a sleep test.

Pillar 2 – Testing

The goal of sleep testing is to objectively determine if the patient has an airway problem. It is paramount to note that dentists cannot make the diagnosis for OSA but we can facilitate testing and work closely with the patient’s other health care providers to treat this serious problem. Sleep testing is one of the many areas of DSM that has become significantly more “dentist friendly” over the past few years.

Years ago, the only option was to refer our patients to a sleep lab where the patients would spend the night for a Polysomnogram (PSG). If their OSA was severe enough, they were likely given a CPAP and the dentist never heard back about the patient’s status. Now many patients can be tested in the comfort of their own home with a Home Sleep Test (HST). Our job is to build a pillar to support sleep testing for all of our patients. The last thing we want is HST testing to identify an at-risk patient with a need to be tested and then drop the ball. Again, to successfully establish this pillar, it’s imperative that a system is firmly established. To shore up this DSM pillar we most certainly need to also provide ways for our patients to be home sleep tested. There are currently three ways this can be accomplished. First, the dental office can work with local medical professionals (PCPs, ENTs, sleep MD’s, etc.) to whom they can refer their patients for HST. The other two methods of obtaining HST are a bit more ambiguous. There is debate in the medical community about whether dentists should be directly involved in facilitating sleep testing. Furthermore, federal and state laws may regulate or prohibit our offices from these practices. With that said, some practices order HST from third parties that provide these services directly for their patients. These companies have sleep specialists who provide an interpretation and diagnosis while billing the patient directly. This protocol reduces the dentist’s capital expenditure and also introduces significant efficiency to the process. Other dentists directly provide their patients with an HST and sub-

Dr. Gy Yatros has been practicing dental sleep medicine for over a dozen years and is a well-respected international lecturer in the field of sleep-disordered breathing and dental sleep medicine. He has offices in Bradenton, Sarasota and Tampa, Florida devoted exclusively to the treatment of sleep disordered breathing. He is a Diplomate of the American Board of Dental Sleep Medicine (ABDSM), past president of the Manatee Dental Society and is an Affiliate Assistant Professor of the Department of Internal Medicine with the University of South Florida, College of Medicine. He is a Co-Founder of the Dental Sleep Solutions system.

DentalSleepPractice.com

PRACTICEmanagement

Screener result

Device selection

mit the data to sleep specialists who provide the interpretation and diagnosis. Regardless of how we build this DSM pillar we need a foundation that will work for all of our patients and we should always include the patient’s PCP in the process. This can easily be done through a phone call or auto-generated correspondence through your DSM practice management software.

You need to be passionate and caring as you help patients understand their risks.

52 DSP | Summer 2016

Pillar 3 – Treating

Treating is the DSM pillar with which dentists are most familiar. Oftentimes, we get calls from dentists that just want to know which device to use without any thought devoted to the first two pillars. While it’s understandable because appliances fall within our wheelhouse, this view is a disservice to the patient and the process. It is of utmost importance that a diagnosed patient be treated properly with an effective modality with which they will be compliant. Doing nothing is simply not an option. There are several treatment options for patients diagnosed with OSA including PAP therapy, surgery, and OAT. The most common therapy, positive airway pressure such as CPAP, has a high level of efficacy but generally low compliance. Depending on whose statistics you read, the compliance rate is approximately 50%. Surgery can be very helpful but with it comes significant risk. OAT, namely Mandibular Advancement Devices (MAD) is very effective and has been demonstrated to have high compliance rates through myriad studies over the past few years. It can also create some minor complications. Dr. Keith Thornton, inventor of the TAP family of MAD, once said that “Effectiveness = Efficacy X Compliance.” I think this is a useful algorithm to consider

when weighing treatment options with your patients and their other healthcare providers. Treatment shouldn’t be done without collaborating with other health care professionals – namely boarded sleep physicians. Over the years, oral appliances have become more widely accepted as an integral part of SDB therapy. This pillar is made sound through education, readily available online or at meetings, and within each practice, led by the dentist and the ‘sleep ambassador’ team member. Take some courses. They are available from different organizations, labs, and device manufacturers.

Pillar 4 – Billing

This is the pillar we receive the most calls about and the one I encounter most in my lectures. It’s understandable. We have to be paid for our services. With that said, it may also be the most difficult to navigate. It’s cliché but medical billing truly is a different beast than dental billing. There is no way around that. It simply is. Over the years, I’ve seen the following situation play out hundreds, if not thousands of times. A dentist decides to begin offering DSM services but the pillar is not firmly established. She tasks a team member with submitting claims. Seemingly easy enough? The claim is faxed to the payer with some supporting documentation and after countless hours navigating voice prompts, the dentist angrily exclaims that insurance doesn’t pay for OAT and she ceases to offer this valuable service. This is unfortunate for the patients, the practice, and the profession. This is a medical problem. Dental insurance will not cover OAT under any circumstances. This leaves fee-for-service or medical insurance as payment options. Fee-for-service

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PRACTICEmanagement

Billing

may seem like a no-brainer. Think again. This choice is typically unknown in medical care. Patients don’t expect to pay for medical services out of their own pockets and our medical colleagues are dumbfounded when they learn that we’ve asked patients to pay up front. Additionally, most insurance companies require a pre-authorization of benefits before treatment, which means even if you provide patients with a properly completed form, they may not get any insurance payment at all because it wasn’t filled out prior to the date of service. It’s easily understandable why this model can translate into patients declining treatment, physicians opting not to refer to dentists, and a lack of OAT production in the dental practice. Fortunately, there is another option. Utilize a third party biller. Use your DSM practice management software to transmit the claim along with the supporting documenta-

tion directly to them. Their core competency is getting dentists reimbursed for OAT. They are masters of navigating voice prompt purgatory, deciphering payers’ jargon, and getting you paid. Hiccups may still arise because you are a dentist billing medical, probably doing it out of network, and you’re submitting an unfamiliar code. However, outsourcing your billing will increase the likelihood of maximum reimbursement while empowering your team to do the jobs you’ve hired them to do. There are several third party billers. Do a web search. Ask for references. Inquire about their services and fee structures. DSM provides us with amazing rewards unseen in any other facet of dentistry. We can save lives and realize significant revenues doing it. DSM is a phenomenal way for a practice to differentiate itself from others in the area while serving the community. To do this effectively and efficiently requires a solid foundation on which to erect these 4 pillars. Build your team. Establish these pillars and change the world one breath at a time.

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54 DSP | Summer 2016

Flexible working time, unique initial hydrophilicity immediately overcomes moisture and provides direct contact with the moist tooth surface. Accurate impressions of the preparation margin, clinical conditions (moist oral cavity) improve the initial hydrophilicity. The material ows well under pressure, yet doesn`t drip or slump. Call 877-532-2123 for more information. www.kettenbachusa.com

PRODUCTspotlight

A Story of Progress and Adaptation: the Panthera D-SAD T

he Panthera Digital – Sleep Apnea Device (Panthera D-SAD) is the second-generation of the world’s first CAD/CAM appliance. Jean Robichaud, R.D.T., is the genius behind this invention. In 2006, with his company Biocad, he created the world’s first software to design dental sleep apnea devices. In 2012, Jean Robichaud’s two sons, Bernard and Gabriel, designed a new software application using the latest technology in order to offer an improved version of the first-generation oral appliance. Thanks to this advanced design tool, the Panthera D-SAD offers more options than ever regarding the design of bands and plates for occlusal contact. Moreover, the design of the firstgeneration device was greatly improved with a new patent-pending mechanism that connects the retentive rods to the appliance so that they never disengage during sleep. These rods are supple yet resistant, so they are also suitable for patients with bruxism. Another advantage of the new software is a better control over the retention of the splints. Instead of determining the retention over a group of teeth, the new software calculates it for each tooth, thus making the appliance suitable for a broader range of patients. The appliance is manufactured using an industrial 3D printer and made of an incredible material. The type 12 organic polyamide is a biocompatible hydrophobic nylon. Polyamide possesses a distinctive feature: it remains very resistant to failure of every kind, even when very thin.

Developing the software system enabled Panthera Dental to adapt the appliance effectively and develop it according to the needs of its customers. This year Canadian customers can now benefit from the Braebon DentiTrac integrated in the Panthera D-SAD (awaiting FDA approval for the US market). With this sensor, dentists and physicians can now track the compliance of their patients and also monitor the position in which they sleep. This is a game changer for unions and the transport industry. However, the greatest addition to the design software application this year is its compatibility with intra-oral scanning. There is no need for regular dental impressions anymore. With intra-oral scanning, we improve the customer experience while increasing the accuracy and the quality of our product. Indeed, we avoid bubbles and porosity in plaster models, which are common and may cause issues regarding the fit of the device. The Panthera D-SAD is available worldwide and comes with a 5-year warranty, the longest warranty available on the market for dental sleep appliances.

DentalSleepPractice.com

MEANINGFULconversations

The Precision Medicine

PARADIGM for Dental

Sleep Medicine

by Pat Mc Bride, BA, RDA, CCSH, Sleep Clinician

rue partnership between medicine and dentistry must exist if we are to make any headway treating the exponential increase in breathing disordered sleep. The days where a one page medical history in a paper chart sufficed are long gone. It has been replaced by behemoth electronic/cloud based systems with digital forms compiling massive amounts of patient health data; all of which must be carefully reviewed prior to definitive diagnosis and treatment planning. Electronic health records (EHR) – already a mainstay of medical practice will soon be mandated for the dental practitioner. Patient portals must be opened for access to records requiring seamless correspondence back and forth between physician, dentist, laboratory and patient. Moving a general dental practice into one that includes a medical model can be overwhelming when one takes into consideration balancing the dental aspects of the practice with the demanding needs of medical patients. When a practice partners with and relies upon community physicians to care collectively for patients, a comprehensive precision medical system must be carefully established. Don’t question wheth-

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er a small practice just starting to treat sleep can “afford” to implement a medical system, it is the future of medical management and treatment for SDB is medical. You simply cannot afford not to. SF Bay Area based Mike Selleck, DDS, DABDSM began his sleep medicine practice years ago the way many of our colleagues have… with the tragic loss of a friend who pulled a C-PAP mask off in the night and died. Devastated, he looked for answers and his journey towards establishing an airway dental/medical model began. Initially dayto-day logistical documentation and communications with physicians was frustrating and “detached.” Shocking many local physicians and colleague dentists, he threw caution to the wind and kicked down as many MD doors as he could to gain acceptance in one of the most forward thinking hospital based pulmonology systems in the area. To do this he set out to fully incorporate “their” hospital-based EHR into his solo practice. Anyone who knows what a hospital based

MEANINGFULconversations EHR looks like understands that no one in their right mind who is NOT connected with the hospital directly would ever consider the idea. According to Mike, “It didn’t take long to realize that without a two-way means to connect us directly with the physicians, labs, ...and patients, systematic care provision and management was going to be chaotic. Yes, it was a nightmare to get it all going, but the level of communication, quality of care and clinical outcomes have risen substantially. The patient’s perceptions of the quality of care and concern they receive have dramatically improved. Understanding what it means to the patients we serve and the wonderful relationships established with local medical community now, we’d do it all over again in a minute. It has been so worth the effort. We have become a 100% physician referral source for the kind of care management we offer firstly because we serve the underserved, and secondly because we have the ability to move seamlessly back and forth through the system to serve patients effectively and efficiently.” Gilles Lavigne’s brilliant placement of the Wikipedia definition of Precision Medicine in his recent article states that it is the tailoring of medical treatment to the individual characteristics of each patient (https://en.wikipedia.org/wiki/Precision_medicine), taking into consideration genetic predisposition, health status, lifestyle, culture, race, sex, biological and environmental risk factors. It is an advanced decision making process. In other words, precision medicine takes into account individual differences in the genes, environments, and lifestyles of people allowing the design of targeted disease interventions from the start. What does this mean? In conventional medicine, our patients are more often than not treated with the same therapies that everyone else with the same disorder gets. Individual differences get overlooked. One cannot know which therapies will work and have fewer side effects for one set of patients over another. Precision medicine uses health information technology to integrate medical history into patient centric approaches, improve health, and treat disease, all while focusing on targeted longitudinal care outcomes. This individualized methodology actually requires a population-based perspective. Primary is learning what works and does not work for a person while at the

same time knowing that causality cannot be inferred on one person at a time. The information gathered from individuals must be compared against that of large numbers of other people in order to recognize individual characteristics that are important and identify relevant population subgroups that are likely to respond differently to treatment. Allowing for large data sets that include all strata of patient affords less bias and unreliable disease prediction models. Precision medicine’s current focus is on treatment; the exciting future plan gives attention to early detection and disease prevention. Understanding the complexity of SDB and attendant comorbidities is essential for the dentist partnering with physicians. Within the EHR are numerous areas where patient data regarding health status, medications, lifestyle and comorbidities are noted. Careful review of this information aids tremendously in definitive diagnosis and treatment

Precision medicine takes into account individual differences in the genes, environments, and lifestyles of people allowing the design of targeted disease interventions from the start.

planning. As an example, when the dentist reviews data prior to patient intake he/she may note not one, but two or three medications for hypertension on board. What that tells us before we ever see this patient with diagnosed OSA is that they also have a level of brain damage resultant of the OSA. That

Pat McBride, BA, RDA, CCSH, has spent 35 years as a full time clinician in the fields of dentistry, respiratory medicine, and dental sleep medicine. Her extensive experience in clinical, laboratory and educational arenas led to the development of interdisciplinary care model delivery systems used by physicians and dentists across the globe. She sits on the Board of Directors for the Academy of Dental and Physiological Medicine in New York. Pat continues to work as hands on with patients while lecturing internationally on subjects relating to sleep medicine, dentistry, and protocol development to best serve patient populations. Serving the underserved remains a priority and passion for her. She has one grown daughter, a teacher in Spain.

DentalSleepPractice.com

MEANINGFULconversations brain damage acts to perpetuate the OSA syndrome and the patient ends up with high set point hypertension, which is medication resistant. Treatment for this patient may resolve the OSA with C-PAP or combination therapy but not always. If they are PAP resistant/fail your treatment plan of oral appliance must include assessment and management of the hypertension as well as the OSA by monitoring the patient’s BP at every visit, asking whether they have taken their medications regularly and if necessary referring them back to PCP if it remains too high. But, you also must be completely informed as to what the BP norms for this patient are by age, sex, and comorbidity factor. During treatment, significant resolution of the respiratory disturbance index numbers (RDI) can be achieved, but could hit a “stopping point” where the dial simply refuses to move; the OSA damaged brain just cannot cope with anything else. This is where the impact of the comorbidity factors in, and you as the care provider need special understanding of just how far you can take a patient with a particular therapy.

Understanding, monitoring and treating nutrient deficiency is well within the treatment paradigm for sleep disordered therapy.

All patients... child or adult, man or woman presents differently with inspiratory flow limitation (IFL), upper airway resistance syndrome (UARS) or OSA. The factors mitigating and influencing treatment selection will be precise to each age group and their particular sets of accumulated data. Information recently published by Dr. Harper and colleagues at UCLA notes that SDB patients are routinely deficient in Magnesium and Thiamine, especially if they sweat in their sleep. Understanding, monitoring and treating nutrient deficiency is well within the treatment paradigm for sleep disordered therapy. Ergo these levels must be reviewed and adjusted throughout therapy. A strong understanding and partnership with the patient’s MD can make this a much easier process. Stasha Gominak, MD’s work on D3 deficiency in SDB and neurology patients is groundbreaking,

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and should be foundational in assessment and treatment for sleep patients. D3 plays an important role in sleep. The pacemaker cells of the brainstem appear to directly impact the timing of sleep. Most people walk around these days vitamin D3 deficient simply because we don’t go into the sun like we used to. For good sleep, levels should be 60-80 ng/ml. Most of our OSA patients tested with levels well under 30 ng/ml. If a patient takes a statin drug it further blocks what little vitamin D3 the body gets from the sun. Correcting D3 levels can substantially improve sleep and the attendant daily headaches, digestive issues (GERD), initiation and maintenance of sleep. Additionally, if that same patient is deficient in thiamine and magnesium, takes a statin, and has leg cramp/muscle issues, can you contact the prescribing MD through an EHR and discuss changing the dosing time of day to help alleviate the leg cramps, and improve sleep fragmentation. Often moving a dose to a few hours earlier in the day allows the patient to “walk off” the cramp/ twitch side effects. If there is communication with the MD regarding the collective comorbidities and presentation complaints, these issues are easily handled and quality of clinical outcome improves. This access and open line communication is a hallmark of precision medicine and centers on patient need based on presentation and symptomology criteria. Having scientific knowledge of and evidentiary support to share with your physicians always advances your cause and helps your patients. Constant vigilance is required with regard to obtaining education regarding new data and therapy discoveries. These are just a few examples of the global diagnosis and treatment thought process required of the dentist who embarks upon treating the SDB population. Definitive testing and MD diagnosis of the disorder is always required prior to embarking on alternative/adjunctive therapy for the SDB patient. There is no way treating the SDB community of patients can be a turnkey or cash cow revenue producing operation. Besides, in my experience, a turnkey is only ever as good as the person turning the key. Anything quick and easy will never factor in longitudinal health outcomes, tends not to be patient centric or participatory, does not provide public education or address the health concerns of the underserved. There must be access to

MEANINGFULconversations care for every level of the economic strata, and specific treatment paradigms established to ensure that care is provided at the highest level with utmost efficiency. Being patient centered should be a core value for all physicians and dentists. If we are to look at a metric design for care provision in this manner we must start with the clinician first. Does he or she have specific curiosity regarding the patient’s disease process and the four dimensions of the “illness experience?” Our job when a patient either presents or is referred into our care is to first establish rapport. We must both elicit and understand the patient’s feelings about their diagnosis, their actual level of understanding of what is wrong with them, the impact the disorder has on their ability to function during the day, and finally their expectations as to what should or can be done. Critical is the ability and desire to understand the patient as a whole person. Longitudinal treatment success can only be achieved if the dentist and patient can find common ground regarding the management of the disorder. Common ground incorporates patient education and participation in the entire process of walking towards wellness. This doesn’t mean that the patient directs the care, but rather that the dentist operates in an realm where they can respond fully to the unique needs of the patient, and address appropriately issues as they come up during treatment. When the patient is placed at the center of the care paradigm and perceives a common ground with the dentist, they accept recommended treatment options more readily, cooperate with referral out of the DDS setting into an adjunctive therapist or MD providers practice for associated care willingly, participate in the process directly and take responsibil-

1. 2.

3. 4. 5. 6.

ity. It is after all their health being cared for. They need to own the process. We are just the facilitators to that end. Patients who have providers who actively promote precision medicine report feeling better faster, have higher levels of care satisfaction, have fewer complications and report improved health and emotional status overall. Whether you have been treating the SDB patient for a long time, or are just starting out, expanding into a medical model that places the patient at the center of the paradigm is essential. Use technology and a precision medical model to improve the level of care you provide your dental patients as well. Whatever it takes to turn your vision to the future to improve the emotional and overall health status of your patients is time, effort and money well spent. Educate yourselves as to what options exist for your practice and demographic of patient. Dentistry has so much to offer the medical community in terms of supportive care and concern for the patients. It needs to be diligent in its mission to join the medical community fully engaging the sleep-disordered patient in a management model where patient needs are addressed as fully as possible. What dentistry absolutely does not want is for the medical community of peers to view us as cavalier or myopic in our understanding of the seriousness of this issue. There are millions of unscreened and as yet to be diagnosed people suffering. Make it your goal to reach out and touch as many of these people as you can, if only to screen them and make them aware. You may never treat them with an appliance, orthodontics, surgical therapy for sleep or other dental therapy, but you may educate them and perhaps save their life.

Water Exchange across the Blood-Brain Barrier in Obstructive Sleep Apnea: Sleep. 2008 Jul 1; 31(7): 967–977. Brain Structural Changes in Obstructive Sleep Apnea. Paul M. Macey, PhD, Rajesh Kumar, PhD, Mary A. Woo, DNSc, Edwin M. Valladares, BS, Frisca L. Yan-Go, MD, and Ronald M. Harper, PhD, Jose A. Palomares, Sudhakar Tummala, Danny J.J. Wang, Bumhee Park, Mary A. Woo, Daniel W. Kang, Keith S. St Lawrence, Ronald M. Harper andRajesh Kumar*. Article first published online: 29 AUG 2015 DOI: 10.1111/jon.12288 The World Epidemic of Sleep Disorders is Linked to Vitamin D Deficiency. S.C. Gominak, East Texas Medical Center, Neurologic Institute, Tyler, TX, USA; W.E. Stumpf, University of North Carolina, Chapel Hill, NC, USA The Impact of Patient-Centered Care on Outcomes. Moira Stewart, PhD; Judith Belle Brown, PhD; Allan Donner, PhD; Ian R. McWhinney, OC, MD; Julian Oates, MD; W. Wayne Weston, MD; John Jordan, MD Preparing for Precision Medicine. Reza Mirnezami, M.R.C.S., Jeremy Nicholson, Ph.D., and Ara Darzi, M.D. N Engl J Med 2012; 366:489-491 February 9, 2012 DOI: 10.1056/NEJMp1114866 Resistant Hypertension and Obstructive Sleep Apnea. Akram Khan, Nimesh K. Patel, Daniel J. O’Hearn, Division of Pulmonary and Critical Care Medicine, Oregon Health & Science University, Portland OR & Portland VA Medical Center, 3181 SW Sam Jackson Park Road, UHN67, Portland, Oregon 97239-3098, USA; and Supriya Khan, Division of Nephrology and Hypertension, Oregon Health & Science University, Portland OR & Portland VA Medical Center, Portland, OR 97239, USA.Received 28 February 2013; Revised 21 April 2013; Accepted 27 April 2013 Vitamin D3 Effects on Lipids Differ in Statin and Non-Statin-Treated Humans: Superiority of Free 25-OH D Levels in Detecting Relationships. Lynn Kane, Kelly Moore, Dieter Lütjohann, Daniel Bikle, and Janice B. Schwartz. J Clin Endocrinol Metab. 2013 Nov; 98(11): 4400–4409. Published online 2013 Sep 12. doi: 10.1210/jc.2013-1922

60 DSP | Summer 2016

Are you losing patients to an in-network Dental Sleep Medicine or TMJ provider?

WE CAN HELP! OUT-OF-NETWORK

IN-NETWORK

Triton Medical Solutions has been working with dentists to obtain in-network status with medical insurance companies since 2011! In fact, we are one of the only companies who have been successful at doing so! Many skeptics told us it was impossible, and while a difficult and timely process, we assure you it can be done!

How can your practice benefit?

Additional Service Offerings

• Increased referrals from MD’s: The first question an MD will want to know when working with your office is what medical insurance companies you are contracted with; if the answer is none, good luck getting referrals. • Patient acceptance: Patients don’t like using outof-network providers because they know it will cost them more out-of-pocket, it’s that simple!

• Medical billing specializing in Dental Sleep, TMJ, Orofacial Pain, Oral Surgery, Accidental Dental and Oral Cancer Screening. If it can be billed to medical insurance by a dentist, we can help! • Eligibility checks, prior authorizations and gap exceptions. • Medicare Contracting (DME and Part B), Commercial Contracting and Credentialing.

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PRODUCTspotlight

OravanOSA Sleep Appliances with a Truly Open Anterior Design

he Oravan and Oravan Herbst sleep apnea devices by OravanOSA encourage natural protrusion of the tongue, maximum patient comfort and less clinical chair time at the fitting session.

Oravan™

Oravan™ Herbst

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The company takes pride in not only providing the highest quality products, but also ensuring the best in customer service. “We specialize in sleep and understand how important it is to work with our dentists in meeting individual patient needs. We will do everything in our power to tailor the appliances to the doctor’s request for maximum effectiveness,” Daniel said. OravanOSA offers various design features on the Oravan such as a 90 degree wing to keep the mandible forward when the patient opens their mouth or an angled wing for those patients who may have difficulty acclimating to the initial forward position. “I have been using OravanOSA sleep apnea appliances exclusively to treat my patients with sleep apnea,” stated James Andrews, DMD, of South Carolina. “The appliances are quick and easy to deliver with minimal adjustment. Patient compliance is great as they are very comfortable and patients tell us how much more alert and better they feel after wearing the appliance. This is the appliance that I personally wear and do not sleep without it.”

Ivan Stein, DDS, a NJ based dental sleep practitioner, is the proud inventor of the Oravan and Oravan Herbst. “After many years of practicing sleep medicine, I was frustrated with the lack of comfort my patients were facing with other appliances as well as the amount of extra chair time having to refit and adjust them,” said Stein. He has incorporated the Oravan and Oravan Herbst devices in his practice and is astounded by the results. “The results have been excellent and documented. Our patients have only rave reviews and actually use these appliances every night. By eliminating the anterior and incisal coverage, patient comfort is maximized and the tongue protrudes naturally. Patients tell us all the time how great they are sleeping, how they have more energy during the day and how their partner no longer is up all night listening to them snore. The appliances are easy to seat, and I never need to worry about anterior cosmetic work being a problem.” Mandibular advancement of “Patient compliance is great as they these appliances are easy to do and are very comfortable and patients tell can be accomplished in very small increments for best results. Oravan us how much more alert and better can be advanced 0.1mm at a time, they feel after wearing the appliance.” with 6mm of advancement. Oravan Herbst can be advanced 0.0625mm at a time, with 5mm of advancement. OravanOSA introduced its dorsal Recent estimates show that 80-90% fin appliance, Oravan, at the 24th AADSM conference in Seattle last year. Daniel Stein, of patients with Obstructive Sleep Apnea CEO of OravanOSA said, “We’ve really come remain undiagnosed. With this evidence, it is a long way. After receiving such amazing clear that there is no other disease or disorder feedback on the Oravan, we knew we had to as life threatening as sleep apnea that is undioffer this treatment option to as many patients agnosed and untreated to this level. As oral as possible. Obtaining Medicare approval on appliance therapy continues to gain poputhe Oravan Herbst last December was a huge larity as a leading treatment option, Oravastep. We look forward in continuing to part- nOSA is excited in helping more patients get ner with more dentists to get this incredible the sleep they deserve. After all, everyone deserves to Sleep with the Best! treatment option to their patients.”

PRODUCTspotlight

Avoid the cost of missing desaturation events or having to repeat an overnight study When buying a pulse oximeter to pre-screen for OSA and verify the effectiveness of OAT, look for an accurate, easy-to-use, cost-effective device

hat costs more – multiple sleep tests to find out if the therapy is working or missing the problem altogether? There may be no clear answer, but there is a product that helps the sleep dentist with both of these expensive problems. Continuous positive airway pressure (CPAP), the treatment of choice of most physicians, is unfortunately abandoned by more than half of all patients within a year due to discomfort.1 Oral appliance therapy (OAT) is often deployed by dentists working with referring sleep physicians. Studies have shown that patients are more compliant with OAT than with CPAP,2 but the mandibular advancement devices do not have a performance or compliance smartcard. The physicians and the dentists need to know whether the airway problem is being solved. Repeat PSG? Not covered. HST? Patients may find them complicated and unreliable.

Nonin Medical’s WristOx2 3150 pulse oximeter and soft sensor

Overnight pulse oximetry monitoring is essential in pre-confirming the effectiveness of OAT for treating OSA

The American Academy of Sleep Medicine / American Academy of Dental Sleep Medicine 2015 guidelines recommend oral appliances as a first line treatment option for many OSA patients.3 According to the AADSM and the AASM, overnight pulse oximetry has been shown to be an effective sleep screening tool used to evaluate the response to OAT prior to sending patients back for follow-up polysomnography (PSG) testing at a sleep lab.4 Pulse oximeters are noninvasive medical devices used for measuring pulse rate and blood oxygen saturation (SpO2). There are many FDA-cleared brands on the market, but it’s important to understand that not all FDA-cleared pulse oximeters and sensors perform alike. Accurate readings are crucial to avoid missing desaturation events or having to repeat sleep studies.

Obtain Reliable SpO2 Results the First Time

Engineered with proven PureSAT® SpO2 technology, Nonin Medical’s WristOx2® Model 3150 wrist-worn pulse oximeter provides accurate, continuous oxygen saturation and pulse rate monitoring during overnight sleep studies. Nonin PureSAT SpO2 technology is clinically proven accurate in the most challenging patients and settings – even in patients with poor circulation or dark skin, or with excessive motion.5 It’s little surprise, then, that 90% of PSG manufacturers use Nonin pulse oximetry! Designed for pediatric and adult patients, the WristOx2 is comfortable to wear and easy to use. Patients simply attach the WristOx2 like a watch, put their finger in the soft sensor and go to sleep. The device turns on automatically when a finger is inserted and turns off when the finger is removed. And the best part? Dental sleep practitioners save valuable training time and minimize the risk of patient set-up errors by pre-programming the device before it goes home with patients.

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The WristOx2 is rugged (it’s manufactured and serviced in the USA) and efficient (it provides up to 48 hours of continuous use on two AAA batteries), so clinicians can spend more time treating their patients and less time worrying about device maintenance and repairs. And when it’s time to analyze the data, Nonin’s nVISION® data management software provides simple viewing, reporting and patient file storage.

Learn More

Visit nonin.com/dentistrysr for case studies, product information, instructional videos, practice guidelines and more.

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3. 4.

Weaver T, Chasens E. Continuous positive airway pressure treatment for sleep apnea in older adults. Sleep Med Rev. 2007; 11:99–111. Ferguson KA, Ono T, Lowe A, et al. A randomized crossover trial of an oral appliance vs nasal-continuous positive airway pressure in the treatment of mild-moderate obstructive sleep apnea. Chest.1996;109:1269-1275. Menta A, Qian J, Petocz P, Darendeliler MA, Cistulli PA. A randomized, controlled study of a mandibular advancement splint for obstructive sleep apnea. Am J Respir Crit Care Med. 2001;163:1457-1461. AADSM Protocol for Oral Appliance Therapy for Sleep Disordered Breathing in Adults: An Update for 2013, American Academy of Dental Sleep Medicine, 2013. AASM Clinical Guidelines for the Use of Unattended Portable Monitors in the Diagnosis of Obstructive Sleep Apnea in Adult Patients: Portable Monitoring Task Force of the American Academy of Sleep Medicine, JCSM Journal of Clinical Sleep Medicine, Vol. 3, No. 7, 2007. Nonin Technical Bulletins and study data on file.

INSIDEtheLAB

Retrofitting Crowns Under Sleep Using Crown and Bridge Technology in the Dental Sleep World by Deborah Curson-Vieira Director of Customer Care, Dental Prosthetic Services

he relationship patients have with their sleep appliances is well documented. Patients have come to rely on their particular appliance and when they need a crown made, they are hesitant to give up their appliance, let alone have a new one made. In some cases, dentists can adjust the existing appliance to fit the crown, however not all appliances are easily adjusted.

Using digital crown and bridge technology, Dental Prosthetic Services (DPS) has developed a protocol for retrofitting a new restoration under an existing sleep appliance, allowing your patient, in many cases to continue wearing his or her appliance, and avoid the cost of a new appliance. This process also helps you build value in your practice. Patients like knowing their dentist is state of the art, designing the crown and appliance to work together instead of just “making it fit.” “From a clinical and patient satisfaction perspective, the ability to retrofit a crown under an existing appliance saves time and expense,” said Dr. Laura Fauchier of Marion Dental. “I recently had a patient who needed a restoration under The retrofitting process her appliance. She was concerned can be used with almost about purchasing another appliance because this one would be all sleep appliances. out of pocket. It was a relief to her to know that we would be able to make the restoration work with her current appliance.” The process begins with the clinician using PVS bite material to fill the area in the sleep appliance where the tooth is being restored, creating a “positive” of the existing dentition. Enough material to fully capture the tooth and tissue around the tooth being restored should be used. After the material sets up, remove it from the appliance and

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send it along with the prescription, impression of the crown prep, pre-operative study models, and bite. If the patient is having multiple crowns done, it may be necessary to send the sleep appliance to the lab. “For the best outcome, in addition to the positive of the tooth being restored, we require a pre-operative study model of the arch. If the appliance is not well adapted to the tooth because of undercuts or ball clasps, it is difficult to achieve a good fit with just the positive. We use both the model and the positive in our digital design and manufacturing process to mimic the existing dentition,” said David Stricker, Research and Development Specialist for DPS. The fit of the appliance on the new crown may be more passive than the previous fit. The crown is designed to fit under the appliance, but not fully engage it. Just as you would not want a pontic to bear the full occlusal load on a bridge, you do not want the new crown to bear the majority of the retention of the appliance. “If the tooth that is being restored is the primary source of retention for a quadrant of the sleep appliance, the retrofitting process is not ideal and I generally recommend a new appliance,” said DPS’s Dental Sleep Medicine Supervisor, Colleen Digmann. Due to retention concerns, the retrofitting process is indicated for single tooth restorations only. Stricker also suggests that monolithic crowns, like zirconia, work best under oral appliances, “Because we are mill-

INSIDEtheLAB

Appliances: ing solid crowns and not hand-stacking porcelain, the monolithic crowns tend to have a more consistent fit.â&#x20AC;? The retrofitting process can be used with almost all sleep appliances. However, those appliances that have more room for adjustment work best. By using advanced crown and bridge technology to retrofit crowns under sleep appliances, your patient does not have to be without his or her appliance while a new crown is being made, nor do they have the expense of purchasing another appliance, saving them frustration and continuing to build value for the service you provide with oral appliance therapy.

DentalSleepPractice.com

CHOOSINGappliances

Is Selecting the Appropriate Sleep Device for You and Your Patient Important? by Dr. David “Trey” Carlton III

ecently, I gathered patient data to take a retrospective look at the performance of two sleep breathing appliances I was using to treat patients. I suspected that one of the sleep appliances was out performing the other in overall practice efficiency and in patient outcomes. The analysis of data was conducted on patients whom I treated over about a three year time period. I reviewed data from one group of patients treated for a sleep breathing disorder with a popular dorsal fin appliance titrated with a jack screw mechanism, called Population 1. The second group of patients reviewed, population 2, was treated with a twin fin CAD/CAM sleep appliance, titrated using combinations of splints. Within Population 1, 17 cases that were diagnosed between the dates of April 2013 and April 2014 and consecutively completed treatment were analyzed. Within Population 2, 20 cases that had been diagnosed between the dates of October 2014 and November 2015 and consecutively completed treatment were chosen. “Consecutively completed treatment” is defined as patients who had an initial polysomnogram (PSG), followed the treatment protocol with the delivered sleep appliance, followed up with a final home sleep test (HST) and had reported significant improvement in symptoms and quality of sleep. The patients who fell within these populations but did not follow up with a final HST or have not reached a conclusion in their treatment were not included in the data for this report. Additionally, patients who started treatment with one sleep device and then chose to use a different sleep appliance will be discussed in detail in a separate communication. The technique for capturing the bite for all of the patients in both Populations 1 and 2 was consistent over the 3 year span. A physiologic approach utilizing TENS (Transcutaneous Electrical Neural Stimulation) to prepare the patient for the bite and determining the

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CHOOSINGappliances bite position as taught at the Las Vegas InstiTable 1: Patient Path tute (LVI, Las Vegas NV) was used for all the Step Activity patients treated with sleep devices. Any variation to patient treatment was subject to pa1 Symptom Discovery and OSA Screening in office tient compliance and their schedule, but the 2 PSG consult referral and MD OAT Prescription, Insurance Coordination and plan typically was as follows in Table 1. Documentation For steps 1 and 2, patients presented with 3 Appliance Selection and Patient Records symptoms which ultimately lead to Obstructive Sleep Apnea (OSA) screening, diagnosis 4 Appliance Delivery and Education and treatment. The Epworth Sleepiness Scale 5 2-4 week Follow Up for Symptom Review and Initial Calibration/Titration and an OSA assessment worksheet were used in these populations to help understand pa6 Final HST and additional Follow Up as needed tient symptoms in terms of pain and overall wellbeing. I worked closely with physicians in my area to treat CPAP intolerant patients and patients whom the physicians believe were good candidates for oral appliance therapy (OAT). Specifics of Steps 1 and 2 were not included in this report as this was widely variable due to insurance plans, required documentation for acceptance and sleep physician appointment availability. Details of Step 3, capturing the patient’s physical reFigure 1A Figure 1B cords for appliance fabrication and ordering, was also not included. For this analysis, data regarding the patients in the two populations begins with Step 4, the appliance delivery appointments and continued through Step 6, once the final HST report showed that the patients sleep breathing disorders were “treated”. Technically, a “treated” patient is described as having a 50% reduction Figure 1C Figure 1D in AHI or achieving an AHI of less then 10, with the goal of complete treatment at an years, an average BMI of 32.4 +/- 5.9, startAHI of less than 5. Oftentimes, patients will ing with an average PSG AHI score of 35.6 +/complete their own treatment, vis-a-vis by 23.1. This group had 14 Females and 6 Males. feeling significantly better and/or they stopped All patients in Population 2 were treated with seeing the need for further appointments. Of the MicrO2™ Sleep Device (MicroDental course, our goal as doctors is to achieve the Labs, Dublin, CA) shown in Figure 1B and 1D. Figures 2 and 3 show the initial diagnostic best possible outcome by encouraging patient PSG AHI data in blue for each patient and follow through and completion. In Population 1, there were 17 patients overall, with an average age of 57.0 +/- 10.4 David Carlton III, DDS, is a graduate and Fellow years, an average BMI of 31.4 +/- 7.1, an avof the Las Vegas Institute for Advanced Dental erage starting PSG AHI score of 33.5 +/- 22.7 Studies (LVI). He has taken over 100 hours of In Population 1, there were 11 Females and 6 training in Dental Sleep Medicine and treats paMales. All patients in Population 1 were treattients at his Center for Dental Sleep Solutions in ed with the SomnoDent® Lingual-less Sleep Alexandria, LA. Device (Aurum Labs, Las Vegas NV) shown in Figure 1A and 1C. Population 2 consisted of 20 patients with an average age of 54.1 +/- 12.0 DentalSleepPractice.com

CHOOSINGappliances

Figure 2: Pop. 1 PSG-HST data

Figure 3: Pop. 2 PSG-HST data

the final HST AHI data for each patient in red. Table 2 shows a summary of the difference between the average outcomes based on AHI results between the two populations, with Population 2 having a greater than 27% improved AHI average of 9.0 compared to that of 11.9 for Population 1. The table also shows that the change (delta) from initial AHI to final AHI for Population 2 compared to Population 1 is about 11% greater for all patients with a reduction in AHI, except for 4 patients in Population 1 who had an increase in AHI vs. 1 patient in Population 2. Table 3 further compares the success in treating each population. Using the standard guidelines previously discussed, 85.0% of Population 2 were successfully “Treated” compared to 58.8% of Population 1. Those who did not meet the guidelines, but still had a significant change in AHI outcome were classified as “Patient Responded.” Those patients who revealed no change or a negative change (AHI actually increased with OAT) were classified as “Not Treated”. Table 4 reveals data regarding practice efficiency. The data here includes all patient

appointments during treatment steps 4, 5 and 6 in which clinical notes in the patient charts described fitting/delivering the appliance, titrating the appliance, adjusting the acrylic to the appliance, and/or responding to a patient concern about the appliance comfort or pain possibly due to OAT. Using standard It is important to note the differences in guidelines 85.0% of titration modalities of the two appliances to help understand and analyze practice effiPopulation 2 were ciency. The SomnoDent oral appliance utisuccessfully treated lizes a jack screw with a 0.1mm titration per turn which is a standard adjustment type in compared to 58.8% some sleep devices. Titrations for this appliof Population 1. ance was as few as 1 to 3 turns as commonly taught in the sleep appliance arena. The MicrO2 sleep device Series A used offered 1mm adjustments, therefore I titrated my patients at those increments. Not only did my patients tolerate those adjustments well, they moved to a successful treatment position more quickly. This is easily seen in the number of appointments and treatment duration. Typically for either appliance I would make the initial titration and educate the patients to do their own subsequent titrations. Patients responded well and easily titrated the MicrO2 Sleep Table 2: Comparison of average PSG outcomes for Populations 1 and 2 Devices. However, for the jack screw adjustments, some patients could not easily manage Population AVG Initial PSG AVG Final HST AVG Delta AHI the adjustment process due to age, dexterity 1 33.5 +/- 22.7 11.9 +/- 8.9 24.9 +/- 16.3 or simply making adjustment mistakes. This added to the number of clinical appointments 2 35.6 +/- 23.1 9.0 +/- 8.6 27.8 +/- 21.1 for Population 1. The patients in Population 2 showed Table 3: AHI Comparison of successfully treated patients in Populations 1 and 2 30% fewer overall patient appointments from 7.8 to 6.0 and even more Population AHI<5 AHI<10 AHI Reduced 50% Patient Responded Not Treated % Treated significant reduction in overall treatment duration, from an average of 10.3 1 5 3 2 3 4 58.8% months for Population 1 to 3.8 months 2 8 5 4 2 1 85.0% for Population 2.

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CHOOSINGappliances The data shows that Populations 1 and 2 had very acceptable outcomes with both groups having over 58% treatment success. The discussion comes as to why there are outcome differences between the Populations and to what the success and efficiency in treating OSA with specific Oral Devices can be attributed? I believe that proper device selection is paramount in the success seen in the above data. Specifically, a device that is fabricated into a sleek profile, low volume design and allows as much space for the tongue as possible. Both the lingual-less SomnoDent and the CAD-CAM MicrO2 oral appliances provide significantly more space for the tongue than most appliances on the market, with the MicrO2 Sleep Device providing even more room. You can see in comparing Figure 1C to 1D that the MicrO2 Sleep Device has significantly less material behind the anterior teeth and overall less bulk. In my opinion, this specific feature may be the reason for the high treatment success of 85.0% for this group. It also contributes to what may be the most important aspect of treatment success, patient comfort and compliance. Another specific feature that differentiates these two appliances is the angle degree of the dorsal fins. The SomnoDent oral appliance features a 70-degree fin vs. the 90-degree fin on the MicrO2 Sleep Device. It is hard to identify specific reasons for treatment success, but I believe the design of the 90-degree fin does in fact maintain better protrusion during the full range of mouth positions during sleep. In my observation, there have been no negatives to this feature and could be one more explanation to the impressive results of Population 2 when compared with Population 1. The difference in the titration modalities definitely contributed to the “ease of use” of the appliances in Population 2. More patients struggled with the jack screw mechanism than they did placing the MicrO2 Sleep Device splints. The extra appointments needed by some patients in Population 1 prolonged treatment time contributing to delayed health outcomes and potentially added to decreased patient follow through. Additionally, it would make sense that the smaller increments of titration used for the first population also contributed to prolonged treatment. Both the simplicity of the MicrO2 system and the increased titration increments has led to

Table 4: Comparison of Appointment Efficiency for Populations 1 and 2 Population

Treatment Appointments

Treatment Duration Months

7.8 +/- 3.6

10.3 +/- 7.0

6.0 +/- 3.0

3.8 +/- 2.9

quicker resolutions of patient symptoms and faster patient treatment completions. I suspect that more positive patient experiences and increased patient referrals also resulted with this appliance therapy. In summary, I believe proper oral appliance selection has delivered two very important outcomes: Impressive results showing lowered AHI scores matched with patient reports of better sleep quality, increased daytime energy and an overall better sense of well-being. Additionally, patients required fewer appointments and less time to treatment objectives, resulting in greatly enhanced practice efficiency. I believe these factors are important when it comes to patient satisfaction and overall sleep practice success.

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TEAMfocus The Use of

Technology in a Dental Sleep Practice

by Glennine Varga, AAS, RDA, CTA

n the past few years there have been some wonderful technological advances in sleep research and sleep observation and even more amazing advances are on the horizon. Any dental team member can get excited about something that will enhance the job at hand making it fun and rewarding. Technology can play a big role and has its place in a dental sleep practice.

Let’s reflect on the history of technology in the dental field. Prior to 1896, we had no way of viewing the inside of a tooth or the integrity of its structure. However, in 1924 the bitewing radiograph gave us this ability. Now we have cone beam technology making it possible to see a 3D image of our patients’ teeth and airway structures. We have seen dental offices transition from paper charts to digital charts allowing electronic charting for every encounter. We have seen intra-oral cameras evolve to magnify small structures so patients can visually experience what is being evaluated. In some offices we’ve seen the transition from articulating paper to the use of digital bite recording with T-scan to measure timing versus force and electro-diagnostic equipment to measure muscle activity, jaw tracking and joint vibration analysis (JVA). The dental profession has evolved to scanning impressions instead of the use of impression material. These advances play a significant role in educating patients to move forward with treatment, help dentists get a full picture of their patient’s dental and musculoskeletal health and enhance the ability of dentists and dental team members. In the sleep industry the technological advances have also evolved to help practitioners glean what is occurring during a night of sleep. The first electroencephalogram (EEG) of man was recorded in 1929 to help understand brain function during sleep. In 1953 the same technology was used to identify sleep stages REM and NREM and in 1970 the first sleep lab was established. Today the sleep industry has several different types of Home Sleep Apnea Testing (HSAT) units to work with and several new wearable technology pieces are available to the average consumer. Let’s evaluate sleep technology currently on the market and what is on the horizon and how it can play a role in a dental sleep practice. An educated patient will make educated decisions. Patient education is a fundamental staple in any dental practice offering dental sleep medicine. Educational videos and presentations are great especially if the information is illustrating the patient’s specific condition. The use of cone beam technology and 3D images are a fascinating way to educate patients because patients are able to see their own airway and how it can be affected with mandible position. The procedure Drug-Induced Sleep Endoscopy (DISE) is also a great advancement in technology, unfortunately is used only by otolaryngologists, not dentists. DISE is the closest thing to evaluating a collapsing airway in real

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sleep. Identification of the site of obstruction and pattern of upper airway changes during sleep is a key point to guide therapeutic approaches of OSA. What is really exciting is the work of Zephyr Sleep Technologies. Zephyr is the only company evaluating the ideal position of the mandible for maximum airway patency during sleep. The MATRx system is patient specific and is available for dentists to use at many sleep labs. Keep your eye on this company as technology is constantly advancing (www.zephyrsleep.com). Since seeing is believing, any time a patient can experience what is happening with their own airway during sleep, it’s a winner! Wearable technology is becoming the norm and the average consumer can get a pretty good idea of the quality of sleep he or she is experiencing. This technology is very new and only has room to improve. Some of these products include: Fitbit to track movement and hours slept, the Oura ring is specially designed for sleep to measure data and provide textual message flow showing trends, details and changes over time (Ouraring.com). Even one of the largest gaming companies in the world wanted to watch us sleep – Nintendo had plans to release a bedside sensor that tracks sleep and sends data up to the cloud for analysis that would provide suggestions for better sleep. Sadly, the project came to a halt in February 2016 but may be revived anytime. Products like inclining beds and cooling pillows are all the rage in the sleep market. These tools are great to amp the awareness of sleep quality! The app technology is providing some great tools for a dental sleep practice. Recently, Dr. Gail Demko, Dental Director of Sleep Apnea Dentists of New England pointed out a couple great apps for patients regarding positional therapy. She was excited that the SomnoPose app used for iPhones and the Apnea Sleep Position app used for Android phones

TEAMfocus can monitor a patient’s position during sleep. These apps sound alarms to alert the patient to get off their back. Check out the many sleep apps available today like SnoreLab, SleepCycle, SleepBot and Sleep Time. They use your phone’s accelerometer to record sleep habits and sleep cycle theory to wake you up at the right time to ensure optimal rest. Of course there are a slew of apps providing soothing soundtracks and white noise to help the onset of sleep like Pzizz, White Noise and Sleep Genius. Mediation for sleep apps like Relax & Sleep Well Hypnosis and dream journal apps like Awoken may be helpful for some patients. These types of technology will only help the dental sleep medicine industry as along as we (dental professionals especially TEAM) take advantage of them! Ask your patients if they have ever purchased any such technology, keep a sleep diary or use any type of sleep app. Your patients may not want to bring up consumer products with your doctor, but they’ll be happy when you are willing to explore with them. Talk with your doctor and possibly suggest apps or ancillary products to

your oral appliance therapy that will help your patients get the best night’s sleep possible. This Sleep Team Column will be dedicated to the team and provide practical tips and resourceful information. Let us know your specific issues by email to: SteveC@MedmarkAZ. com, while we can’t respond to every individual. Your feedback will help us create the most useful Sleep Team Column we can!

Glennine Varga is a certified TMD assistant and educator with an AA of sciences. She is a certified TMD assistant with the American Academy of Craniofacial Pain. She has been employed in dental education for over 19 years. Glennine has been a TMD/Sleep Apnea trainer and speaker with emphasis on medical billing and documentation for over ten years and has tried the use of electrodiagnostic equipment for five years. Glennine is CEO of Dental Sleep Medicine Boot Camp and Co-Founder or Dental Sleep Medicine Interactive Team Training with Jan Palmer offering Administrative Aspect of DSM courses across the country. For more information, visit www. dsmbootcamp.com, www.dsmitt.com or email g@dsmbootcamp.com.

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LEGALledger

Stark Law and Anti-Kickback Statute Key Issues You Should Consider to Protect Yourself and Your Practice by Ken Berley, DDS, JD, and Jayme Matchinski, JD

n this issue, I have asked Jayme Matchinski, Attorney at Law, to join me in writing this important article. Jayme has many years of experience in healthcare law and is considered an expert in the field. I am truly grateful for her input and expertise in researching and writing of this article. Investigations, audits, and indictments related to the Stark Law and Anti-Kickback Statute violations in the dental sleep community are likely to become more common place in the near future. Sadly, most dentists who are at risk of violating these federal laws may not even know these laws exist. In this article, we will discuss these statutes and outline the types of patient referrals that are prohibited under the law. Additionally, we will explain the risk associated with violating these federal statutes and the civil and criminal penalties that could be imposed. Why should dentists and dental practices be concerned about the Stark Law (SL) and the Anti-Kickback Statute (AKS)? Many dentists and dental practices are making deals with physicians to get referrals for Oral Appliance Therapy. The SL and AKS were

74 DSP | Summer 2016

enacted to ensure that health care professionals do not enter into prohibited referral agreements and to prevent overutilization of health care services. If a dentist or dental practice is considering entering into a quid pro quo agreement and arrangement with physicians to get referrals, proceed forward cautiously and ensure that any agreements are in full compliance with the federal SL and AKS, as well as any applicable state regulations regarding patient referrals and payment terms between providers. Any time a dentist and physician enters into an agreement where the dentist expects to receive referrals and the physician receives some type of benefit, the SL and AKS are most likely triggered. The federal SL and AKS only apply if providers provide services to patients who are beneficiaries of a government program, including but not limited to, the Medicare and Medicaid programs. Therefore, if you do not accept Medicare, Medicaid, Tricare or other federally funded plans, these statutes may not apply to you. However, most states have their own versions of the SL and AKS and some states, for example Florida, are more restrictive than

LEGALledger the federal statutes. Therefore, make sure you check your state’s statutes before you enter into any agreements for the provision of oral appliance therapy. During the past few years, several dental organizations have emerged that are signing up dentists and selling the “right” to implement their dentist/physician referral program within certain zip codes. These organizations and dentists are recruiting physicians to participate in patient screening programs where the dentist get referrals for oral appliance therapy. In these organizations, dentists provide physicians with a dental sleep employee to work in the physician’s office to screen all patients for Obstructive Sleep Apnea (“OSA”). When a potential OSA patient is identified, the physician then orders a Home Sleep Test (“HST”). The HST equipment is supplied by the dentist without cost to the physician. The physician is then paid by the patient’s medical insurance or Medicare for the HST and OSA diagnosis. After the diagnosis of OSA, the physician then rewards the dentist with a referral for oral appliance therapy. After oral appliance therapy is completed, the patient returns to the physician’s office for a final HST to confirm efficacy. The physician is again paid for an HST by the patient’s health insurance.

Overview of the SL and AKS

The SL (Ethics in Patient Referral Act) prohibits physicians from referring Medicare patients for “designated health services”

(“DHS”) to any facility or other entity with which the referring physician (or any of his or her immediate family members) has any financial relationship, unless an exception in the SL or related regulations is satisfied.1 Furthermore, the entity providing the DHS would be prohibited from billing Medicare for the services. The SL also prohibits the entity from presenting, or causing to be presented, claims to Medicare (or billing another individual, entity, or third party payer) for those referred services. The SL establishes a number of specific exceptions and grants the Secretary the authority to create regulatory exceptions for financial relationships that do not pose a risk of program or patient abuse. The original SL (Stark I) applied only to Medicare referrals for clinical laboratory services. Stark II, enacted in August 1993, expanded the prohibition to apply to an additional list of DHS and to referrals to Medicaid as well as Medicare patients. Under Stark I and Stark II, prohibited financial relationships include: ownership or investment interests through equity, debt or other means and include indirect ownership interests through other entities, as well as compensation arrangements including virtually any form of remuneration. Possible sanctions for violation of the SL include: civil monetary penalties, exclusion from the federal health care programs (including Medicare and Medicaid) and forfeiture of all improperly collected amounts.

The False Claims Act offers whistleblowers an effective way to expose and stop kickbacks in the health care system.

Dr. Ken Berley is a practicing general dentist with over 30 years of private practice experience focusing on complex reconstruction and 20 years of experience as an attorney licensed to practice law in Arkansas and Texas. He has extensive experience as a litigator and was a full partner in Travis, Borland and Berley, Attorneys’ at Law before moving to Northwest Arkansas. Dr. Berley is a Diplomate of the American Sleep and Breathing Academy and a Diplomate for the ABDSM. He lectures in the area of sleep medicine risk management. He has provided TMD treatment for many years and has incorporated Sleep Medicine in his office for the last 3 years. Jayme Matchinski, JD, concentrates her private law practice on health care and corporate law. She works with physicians, as well as not-for-profit and for-profit health care systems in the licensure, certification, legal structure and reimbursement structuring of post-acute venues of care, including sleep disorder centers, rehabilitation hospitals, ambulatory surgery centers, long term acute care hospitals, skilled nursing facilities, among others. She is the former vice president of a national health care consulting firm. Jayme is a member of the editorial advisory board of Sleep Diagnosis and Therapy Journal, and an advisory member of the board for the Sleep Center Management Institute in Atlanta, Georgia. She serves as the Chair of the National Council for Valparaiso University School of Law. Jayme serves on the Board of Directors of Volunteer Optometric Services to Humanity (VOSH) Illinois Chapter.

DentalSleepPractice.com

LEGALledger

Sanctions for violating the statute are often severe and sometimes lead to disproportionally large damage amounts compared to the severity of the violation.

76 DSP | Summer 2016

The following are some DHS prohibited by Stark II : • Physical therapy, occupational therapy, and speech-language pathology services; • The professional and technical components of radiology and certain other imaging services, including MRIs, CT scans and ultrasound services, but excluding nuclear medicine and certain other procedures; • Durable medical equipment and supplies; • Prosthetics, orthotics and prosthetic devices and supplies; In general, a “referral” is a physician’s request for, ordering of (or certifying or recertifying the need for), any DHS for Medicare patients, including a consultation request and tests or procedures ordered, performed or supervised by the consulting physician or the physician’s request or establishment of a plan of care involving Medicare DHS. In addition, a physician who directs or controls referrals by others is deemed to be a “referring physician”. A financial relationship includes ownership, investment interest, and compensation arrangements. (42 U.S.C. 1395nn(h)(5).) Durable medical equipment includes oral appliance therapy, and referrals for and the provision of DME between providers, including physicians and dentists, and triggers analysis under the SL to ensure that such referrals would not be a prohibited referral between the parties. Penalties for Violation of the SL include: • Denial of payment for the DHS provided; • Refund of monies received by physicians and facilities for amounts collected; • Payment of civil penalties of up to $15,000 for each service that a person “knows or should know” was provided in violation of the SL, and three times the amount of improper payment the entity received from the Medicare program; • Exclusion from the Medicare program and/or state healthcare programs including Medicaid; and • Payment of civil penalties for attempting to circumvent the SL of up to $100,000 for each circumvention scheme.

The consequences for non-compliance with the SL are the denial of payment or recoupment of overpayment. Specifically, the SL states, “no payment may be made” for DHS provided in violation of the physician self-referral statute and that “if a person collects any amounts that were billed in violation of the statute, the person shall be liable to the individual for, and shall refund on a timely basis to the individual, any amounts so collected.” Sanctions for violating the statute are often severe and sometimes lead to disproportionally large damage amounts compared to the severity of the violation. Because all claims associated with the prohibited referrals for DHS, even if medically necessary, are not payable, providers who submit such claims are subject to significant overpayment liability. The statute’s overpayment sanction creates a significant potential financial burden on health care providers.

Federal Anti-Kickback Statute

The Federal AKS was enacted to protect patients and federal health care programs from fraud and abuse by prohibiting the use of money, remuneration, either directly or indirectly, to influence health care decisions. The AKS specifically provides that anyone who knowingly and willfully accepts or offers remuneration of any sort and in any manner intended to influence the referral of Medicare and Medicaid services can be held accountable for a felony. The AKS, 42 U.S.C. § 1320a-7b(b), prohibits any person or entity from making or accepting payment to induce or reward any person for referring, recommending or arranging for the purchase of any item for which payment may be made under a federally funded health care program. The statute not only prohibits outright bribes, but also prohibits offering inducements or remuneration that has as one of its purposes the inducement of a physician to refer patients for services that will be reimbursed by a federal healthcare program. The statute ascribes liability to both sides of an impermissible kickback relationship. Any person, including a dentist, physician, or other third party or entity, who is involved in making or accepting payment to induce referrals may be indicted. Illegal remuneration includes bribes and rebates, gifts, above or below market rent or lease

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LEGALledger arrangements, discounts, supplying services or equipment for free or at aboveor below-market rates, cash of any kind, whether they are paid directly or indirectly. Almost anything bought by or between medical providers can be characterized as remuneration, if given with the intent to influence medical decision making. If a dentist is providing an employee to a physician to screen the physician’s patients for free or is providing equipment (HST) free or below market rates, the AKS may be triggered. The federal AKS incurs a criminal violation charge because by definition it requires a specific intent to induce referrals or orders for services. Anti-Kickback violations are punishable by up to five years in prison, with the potential for additional criminal fines up to $25,000, and administrative civil money penalties reaching as much as $50,000 per occurrence. Additionally, the Department of Health and Human Services’ Office of Inspector General may commence administrative proceedings to prohibit anyone convicted of an Anti-Kickback violation from participation in federal and state health care programs or impose civil monetary penalties for fraud, kickbacks, and other prohibited activities. To assist the federal government in policing the referral process, federal whistleblower statutes have been promulgated where employees of health care practitioners or other knowledgeable parties can initiate federal or state investigations into referral or kickback violations. The False Claims Act offers whistleblowers an effective way to expose and stop kickbacks in the health care system. Kickbacks, which are hidden financial arrangements between doctors and hospitals or other healthcare providers or companies, are one of the most complicated and troubling aspects of the health care system. Qui tam lawsuits are a type of civil lawsuit whistleblowers bring under the False Claims Act, a law that rewards whistleblowers if their qui tam cases recover funds for the government. Under the False Claims Act, a private citizen or employee may sue an individual or a business that is defrauding the government and recover funds on the government’s behalf. The qui tam lawsuit is filed “under seal,” meaning that it is kept secret from everyone but the government to give the Justice Department time to investigate the allegations. Even the person or entity

78 DSP | Summer 2016

being accused of fraud is not told about the qui tam case. The qui tam lawsuit and supporting documents should provide the government with detailed information about the fraud. Under the Affordable Care Act and its False Claims provision a party with general knowledge or suspicion of fraud or violation can act as a whistleblower. As an incentive, whistleblowers receive a percentage of the funds recovered from wrongdoers. Therefore, any disgruntled employee or a dentist practicing next door can take his evidence to an attorney and sue you as a federal whistleblower. Consider the potential risk exposure. Any party with knowledge of a referral scheme could potentially act as a federal whistleblower, including employees and competing providers.

Conclusion

Don’t get me wrong, I am sympathetic to any dentist trying to get a dental sleep practice established. I am not trying to rain on your parade. I am aware that it is difficult to establish a referral network! We are all trying to develop relationships with referring physicians and there is nothing innately wrong with that. However, contracting with physicians for referrals is too risky for me. DO NOT give a physician anything of value for a referral! If you are sued by a whistleblower attorney, it could be financially devastating. All it takes for you to get into trouble is for you to make a staff member mad enough for her or him to contact a whistleblower attorney. The employee could initiate the lawsuit and still be working for your office since the relater is undisclosed and unidentified. Ultimately, the employee could be paid a portion of any recovery. Sadly, even if you win the case you will lose financially. I don’t want to be the dentist who has to defend this in court. “If you are currently participating in some type of arrangement with a physician where you receive referrals, I strongly urge you to consider hiring a good health care attorney and have him review your protocol and any agreements (contracts) that you have with physicians. “If in doubt, Get Out!” 1.

Section 1903(s) of the Social Security Act, 42 U.S.C. Section 1396b(s), expanded the SL to cover Medicaid by denying federal payment to states for DHS resulting from prohibited referrals. While CMs has not yet issued regulations on Medicaid referrals, we recommend that all Medicaid DHS referrals satisfy the same standards as Medicare referrals.

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Guided Implantology CERECÂŽ Integration

Advanced technology thatâ&#x20AC;&#x2122;s easy to use With a single 14-second scan, Sirona 3D provides you with all the 3D images required to confidently diagnose and accomplish any procedure. With three models to choose from, each configurable with several software possibilities, Sirona 3D provides you with a future-proof system with room for expansion as your practice needs grow.

Contact your Patterson Representative for more information. Or call Sirona directly: 800.659.5977 Sirona3D.com

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