Dental Sleep Practice: Winter 2015 by MedMark, LLC

There at the Start:

The First Years of Mandibular Advancement Devices by Thomas E. Meade, DDS

Working Off the Same Matrix:

Toward an Integrated Care Model for Obstructive Sleep Apnea by Liana Groza, DDS

Elizabeth Tietjen Chief Innovation Officer, Ez Sleep

PLUS

Tony Robbins & Tom Zgainer Advise How to Achieve Peak Performance in Retirement Plans

WINTER 2015

Ways 5 to Promote

Oral Appliance Therapy

by Glennine Varga, AAS, RDA, CTA

Getting MAD Right Choosing Oral Appliances by Steve Carstensen, DDS, DABDSM Supporting Dentists Through PRACTICAL Sleep Apnea Education

INTRODUCTION

It’s All For Returning to Normal

omeostasis. It may be my favorite word. The more I learn about how the body works, the more impressed I become by the exquisite interconnection and fundamental perfection of the systems. It’s amazing to learn how a disruption such as interrupted breathing patterns during sleep will cascade into the variety of disease that we observe in our patients. Science is increasingly adept at connecting the dots but cause-and-effect links remain elusive due to human variation. It’s becoming difficult to look past the growing body of evidence that giving the body the ability to move air with the least restriction possible, at all times, simultaneously minimizes destructive stress and maximizes the regenerative process. Restore best conditions and health returns. Of course, there are many health issues that affect humans ‘unrelated’ to sleep and breathing and thus are not directly responsive to restoration of the patent airway. It is safe to say, however that no person ever suffers from a good night’s sleep, with quiet, unstressed breathing. Dentists who seek their place in this worthy endeavor are constantly curious about what’s next in the advancement of the field. Origin stories help us all know how we came to be where we are. Part of knowing how to chart a course for the future involves understanding where we were before, what lessons were learned, and who has been willing to accompany us on the journey. I’m fascinated by these tales of discovery. Dr. Thomas Meade was one of those pioneers – smart, dedicated and fearless dentists trying to find novel ways of impacting the health of their patients beyond the typical range of dentistry. Navigating these new areas required making connections outside our offices, with medical professionals, government regulatory bodies, unfamiliar lab requirements, medical researchers, and frighteningly different third-party payer relationships to contend with. Pioneers paved the way, demand and response kept the pressure up, and research came around for support, resulting in acceptance of oral appliance therapy by most, but not all, the gatekeepers. Mandibular Advancement Devices. As if the posture forward was all that mattered, or happened, in the course of stabilizing the

Steve Carstensen, DDS Diplomate, American Board of Dental Sleep Medicine

airway. It’s far more complex than that, with serious, simultaneous consequences of therapy that must be dealt with, as they might be the least impactful choice available to the patient. Not only does this require us to be adept at discovery and management of the patient’s emotions related to therapy, but our own, as well. Like several readers of this magazine, and seen with increasing frequency across the profession, I have transitioned my practice to focus exclusively on dental sleep medicine, a career move wholly unanticipated when Dr. Keith Thornton started badgering me to treat sleep problems in the early 1990’s. Who knew where any of us would be from those days? As if ‘those days’ were far in the past – of course, they are not. This young profession thrives on the dedication of pioneers and the insight of dentists fresh from the latest introductory course – it’s all of us together that build the foundation of wisdom from which to launch the innovations of fresh ideas. Human physiology demands simple-to-describe yet hard-to-achieve benchmarks to achieve homeostasis. Good thing there are so many of us working on it.

This young profession thrives on the dedication of pioneers and the insights of dentists new to the field.

DentalSleepPractice.com

CONTENTS

Cover Story

Ez Sleep + Apnea Guard: Love At First Bite Rethink how you get patients started with therapy. Pictured on cover: Elizabeth Tietjen, Chief Innovation Officer, Ez Sleep

Financial Focus

Tony Robbins and Tom Zgainer Advise How to Achieve Peak Performance in Retirement Plans MedMark is proud to launch a new column that will help dental professionals make important decisions about retirement plans.

Origin Stories

There at the Start: The First Years of Mandibular Advancement Devices

by Thomas E. Meade, DDS The least-known founder of Dental Sleep Medicine tells his story.

Back in the Old Days... by Sarah C. Shoaf, DDS, MEd, MS, D.ABO There are many ways to start – this orthodontist took things into her own hands early on.

Choosing Appliances

Getting MAD Right by Steve Carstensen, DDS, DABDSM How do you choose? Here’s a way to organize your thoughts about matching patients to devices.

Team Focus

5 Ways to Promote Oral Appliance Therapy by Glennine Varga, AAS, RDA, CTA It doesn’t matter how much we know, it’s about how we help patients choose what’s in their best interests.

Meaningful Conversations

Working Off the Same Matrix: Toward an Integrated Care Model for Obstructive Sleep Apnea by Liana Groza, DDS Implementing this model for collaborative care would revolutionize sleep medicine.

2 DSP | Winter 2015

Origin Stories

Legal Ledger

Insurance Fraud, Part II by Ken Berley, DDS, JD, DABDSM Be careful, be safe in your business of sleep medicine. There’s always a right way to do things.

PRODUCTprofile

MicrO2™ SLEEP DEVICE. MORE SLEEP. LESS HASSLE.

MicrO2 Sleep and Snore Device

OR FI ND A DO CT

www.micro2sleepdevice.com

Digital simplicity and precision make the new MicrO2 OSA device the comfortable choice for dentists and patients. How effective are CPAP or Sleep Devices if patients do not wear them? Or if it is difficult for patients and dentists to use or adjust the device? With the goal of answering these questions, and more, the new MicrO2 Sleep Device offers: CONTACT MICRODENTAL FOR FREE MicrO2 PATIENT EDUCATION BROCHURES

Patient Comfort & Compliance MicrO2 has no mechanisms or tools to manage, and is compact. Patient Peace of Mind Digital files on record mill new arches quickly without new impressions. Design Accuracy & Consistency The bite you take is digitally scanned and precisely replicated. Strength & Durability The exclusive design and material optimize strength and comfort. Design Freedom You Expect Your preferences can be repeatedly made each time the same way. NEW! Find a Doctor Feature The MicrO2 website makes it easier for patients to find you as a local MicrO2 Sleep Doctor. Join our doctor list by visiting micro2sleepdevice.com and click on

the “Join Doctor List” under the “Doctors” tab at the top.

CLE ARED

Visit micro2sleepdevice.com to learn more about MicrO2 and for a list of authorized laboratory providers.

PATENT PENDING DESIGN

SMILES MATTER MicroDental.com 800.229.0936

DentalSleepPractice.com

CONTENTS

MD Connection

Pushing Air or Pulling the Jaw by John E. Remmers, MD PAP or MAD? Sleep physicians choose based on research – but what’s new?

Therapy Choices

No More “One Size Fits All” Sleep Appliance Therapy by Rob Vies, DDS Space Maintainers Lab works with you to help you solve patient problems with unique devices.

FDA Oversight

The Regulatory Side of Oral Sleep Devices by Laura Sheppard, CDT, TE We know the FDA approves devices – this lab professional tells us how this happens.

Meaningful Conversations

Can Physicians and Sleep Dentists Create Lasting Symbiotic Relationships by Pat McBride, BA, RDA, CCSH Sleep docs, yes, but there are many other medical providers involved that need your help.

Product Spotlight

Narval CC by Tom Barman It takes constant innovation to keep up with new learning in sleep.

Ortho Connection

Moving Teeth and Moving Air by Mark Abramson, DDS There’s more to opening the airway than just moving the mandible forward.

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Product Spotlight

Positional Therapy by Shad Morris, DMD

Inside the Lab

Oral Sleep Appliance Management, Simplified! by Stephen Tracy, DDS, MS Here’s a way to make sure your device fits just right, every time, and can be adapted over any tooth changes needed.

New Ideas

From Necessity, Innovation is Launched by Simon Ash, FDS, MSc, MOrth, BDS Here’s something you probably never thought of: a cast-metal MAD. Talk about something different!

Patient Education

To Soak or Not to Soak, That is the Question...

Winter 2015 Publisher | Lisa Moler Email: lmoler@medmarkaz.com Editor in Chief | Steve Carstensen, DDS Email: stevec@medmarkaz.com Managing Editor | Lou Shuman, DMD, CAGS Email: lou@medmarkaz.com Editorial Advisors Steve Bender, DDS Ken Berley, DDS, JD David Gergen, CDT Ofer Jacobowitz, MD Christina LaJoie 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

by Dr. Christina Cairns Teaching patients how to take great care of their MAD will help with compliance and longevity.

National Account Manager | Adrienne Good Email: agood@medmarkaz.com

Case Report

Allergic to PAP! by Ronald S. Prehn, DDS Don’t give up! MAD therapy combined with PAP is something you should consider.

Measure

Why Measure for Parafunctional EMG During Sleep? by Jeff Wyscarver, RPSGT We know about sleep and bruxism. How about showing how they occur together?

Sleep Humor

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©MedMark, LLC 2015. 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.

MESSAGEfromPUBLISHER

When Inspiration Meets Reality Dear Readers: With this issue of Dental Sleep Practice, I am delighted to introduce a new series of articles that have the potential to change the course of your life. I know this to be true because over the years, the author of these articles, Tony Robbins, has impacted me both professionally and personally. This story begins when I was in my 20s. At that time, life’s challenges were daunting, and the road ahead seemed not only to be winding, but filled with potholes and roadblocks. Also, I was searching for a career path that would also be my life’s passion. It was then I discovered peak performance strategist and bestselling author Tony Robbins. Listening to his motivational tapes in my car on the way to and from work was often the only positive voice that I would hear all day. “Human beings have the awesome ability to take any experience of their lives and create a meaning that disempowers them or one that can literally save their lives.” His insights catapulted me to achievement of my professional aspirations, as well as personal fulfillment. I remember wishing that I could attend one of Tony’s seminars in person. Fast-forward 25 years later. As a successful publisher and entrepreneur, I had the opportunity to attend CEREC® 30, an educational event sponsored by one of our long-term clients, Sirona Dental, Inc. I was beyond excited that Tony was going to be a featured speaker at this event! It was a surreal moment when I had the opportunity to stand up in front of upwards of 6,000 attendees and ask a question Tony Robbins, peak performance strategist and of my mentor, who wasn’t even aware of the impression he had made on me over bestselling author, with Lisa Moler, publisher and the years. It was even more incredible when he was gracious enough to schedule CEO of MedMark, LLC, at CEREC 30 a personal interview with MedMark for our magazines. This brings me to good news for our readers. I am so proud and honored that Tony Robbins and Tom Zgainer, founder and CEO of America’s Best 401k, will be authoring “In life, you need a Financial Focus column for our publications in 2016. This column will discuss what to look either inspiration for in a 401k plan, show how fees can erode 401k savings, and will also discuss the fiduciary or desperation.” responsibility of plan sponsors and the serious ramifications of non-compliance with The Employee Retirement Income Security Act of 1974 (ERISA). This federal law sets minimum – Tony Robbins standards for most voluntarily established pension and health plans in private industry to provide protection for individuals in these plans. Sadly, many plan sponsors do not live up to their duties, and as a result, the savings of all the participants in their plan may be subjected to needless and excessive fees. Tony said, “The abuse is mind-boggling.” At MedMark, we pride ourselves on educating the dental community on new techniques, the latest products, and creative practice management methods. Now, Tony Robbins and Tom Zgainer will share their expertise to protect and help grow your retirement savings. At our interview, Tony Robbins and I discussed living in the moment and letting go of the ghosts of the past. He once said, “In life, you need either inspiration or desperation.” It was in times of desperation that I found inspiration in his powerful insights. Now, I am honored that it’s my turn to be a catalyst, through this new Financial Focus column, for our readers to have more control over their financial success in retirement. All the best,

Tom Zgainer, founder and CEO of America’s Best 401k, with Lisa Moler at CEREC 30

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FINANCIALfocus

Tony Robbins and Tom Zgainer Advise How to Achieve Peak Performance in Retirement Plans

isa Moler, publisher and CEO of MedMark, LLC, recently experienced one of the pinnacle events of her career at the CEREC® 30 conference in Las Vegas. She had the privilege of holding an in-person meeting with peak performance strategist and bestselling author, Tony Robbins, and Tom Zgainer, founder and CEO of America’s Best 401k. These two visionaries discussed the changing landscape of employer-sponsored retirement plans and the information that business owners need to adhere to the Department of Labor regulations.

This topic was discussed at the event and is also highlighted in Tony Robbins’ bestselling book, Money: Master the Game: 7 Simple Steps to Financial Freedom. After seeing America’s Best 401k’s unique, low-cost firsthand, Tony Robbins became a You can’t know where approach you are going partner in the business, and the pair set out if you don’t know where you are. on a mission to help Americans across the country rescue their retirement. Robbins’ Step 1. Send us your fee disclosure (also called a 408b2) from your existing provider. If you don’t where has been widely He to locate it, call us and we will direct you. Keep knowledge in mind that Department of Labor regularlyrecognized. requires plan sponsors to benchmark their plan so this will fulfill fiduciary to obligation. wasyournamed the Worth Power 100 as No. on the list401k of onthe world’s most retirement, is your course? A member of ourpowerful team Step 2. If the destination is a financially secure49 will walk you through your complimentary “side-by-side” fee comparison so you can see the impact that players in global finance. higher fees will have on your account balance over time. Working with America’s Best 401k, Step 3. Take action and make the switch to America’s Best 401k. There is no conversion fee and our team business alleviate theirbegin. fiduciamakes the conversion process painless. The quicker you makeowners the change,can the quicker your savings ry responsibility while providing their employees with a plan that does not sacrifice performance for lower fees. The company has worked with numerous dental practice owners to help them drastically reduce the investment fees associated with their plans,

YOUR NEXT STEPS

helping clients save an average of 57%. At the meeting with Robbins and Zgainer, Lisa Moler discussed the changing landscape of the 401k space, what dental practitioners across the country need to know in order to meet DOL regulations, and the pair’s mission to save America’s retirement. “If you offer your employees a run-of-themill 401k plan, there’s a good chance you are vulnerable to Department of Labor oversight, which has become more aggressive in recent months,” Zgainer said. Robbins adds, “Small business owners often have no idea that they are the fiduciaries for their plan. That means that they have to benchmark that plan annually or they have to pay penalties, with average penalties that can reach $600,000. We can help these people meet their responsibilities in this area.” In as little as 60 seconds, dentists and business owners can access the company’s free Fee Checker (americasbest401k.com/medmark), which can help them meet their fiduciary obligation and ensure their retirement plans are for the sole benefit of their employees. When a dentist sponsors a retirement plan, he/she takes on new responsibilities in addition to being a doctor and a business owner. They also need to meet their fiduciary obligation and fulfill their trustee responsibility. Robbins and Zgainer’s advice can lead to employees keeping more of what they’ve saved, and enjoying a longer, more-secure retirement. America’s Best 401k has assembled a team of world-class retirement plan experts across design, administration, recordkeeping, and actuarial disciplines to offer an alternative to expensive, complex plans. Working with America’s Best, business owners can alleviate their fiduciary responsibility while providing their employees with a plan that doesn’t sacrifice performance for lower fees. For information, contact America’s Best 401k at 855-905-4015 or info@americasbest 401k.com. Readers of Dental Sleep Practice will be able to share more of this exciting and informative conversation with Robbins and Zgainer through a series of interview articles that will appear in upcoming issues.

AmericasBest401k.com

DentalSleepPractice.com

COVERstory

Love At First Bite Ez Sleep & Apnea Guard – A Game Changer for Dental Sleep Medicine

z Sleep is dominating the home sleep testing industry – that is why the pairing of Apnea Guard with Ez Sleep’s baseline and efficacy home sleep testing offering is the perfect marriage to test and treat OSA patients. Dentists will now be able to deliver immediate trial therapy with AG in the very same appointment as discussing a patient’s baseline HST results.

The Dental Sleep Medicine industry has changed drastically in the past 5 years, and Ez Sleep is leading the industry with its continued forward thinking, cutting-edge disruptive technologies, and products provided through an ever expanding multidisciplinary network of experts in both the Sleep Medicine and Dental Sleep Medicine industries. Ez Sleep’s network of highly impressive and experienced strategic partners currently includes Invisalign, i-CAT, Henry Schein, DS3 Software, Nierman Billing and SML Laboratories. Ez Sleep adds yet another powerful piece to the dental sleep medicine puzzle with Advanced Brain Monitoring (ABM), Carlsbad, CA.

Why is the Apnea Guard a game changer? The AG is an immediate 30-Day trial oral appliance that provides outcomes equivalent to a custom OA for OSA treatment.1 A trained healthcare staff member can fit the device in less than 15 minutes. It allows easy determination of an efficacious jaw position which can be prescribed and transferred to the custom appliance. It is an inexpensive and simple method to determine who will respond to oral appliance therapy and way to save chair time. To test these claims, the AG was trialed in 2006.

The Science Behind the Apnea Guard® Obstructive sleep apnea (OSA) research was initiated in 2006 with a $1.05M grant, funded by the National Institute of Dental and Craniofacial Research, to investigate how to improve oral appliance therapy outcomes with Dan Levendowski serving as the Principal Investigator, Todd Morgan the sub-investigator, and Victoria Melzer the site administrator for the novice dental office.

8 DSP | Winter 2015

COVERstory DSP had the opportunity to spend a few minutes with Elizabeth Tietjen, Chief Innovation Officer/COO of Ez Sleep (pictured at left). DSP: What was it about Ez Sleep that gave you the desire to join their team? ET: “I was very impressed with the company’s commitment to building a dedicated team. They are mission driven trailblazers... accelerating access to screening, testing, and treating of OSA; and they wear groovy socks! The opportunity to help scale this business to widely increase access to care for one of the most under-diagnosed disorders, Obstructive Sleep Apnea (and SDB) is a huge challenge – and we are hoping to put a dent in the OSA universe.“ DSP: Can you share some plans on how Ez Sleep plans to do this? ET: “Sure. With our current launch of Apnea Guard, dentists are able to provide immediate therapy, decreased cost, increased compliance with fewer appointments, etc. Oral Appliance Therapy is a great option for travel and those who cannot tolerate CPAP. Apnea Guard can help with this transition. A follow up Home Sleep Test by Ez Sleep provides efficacy and improvement metrics at designated intervals. It will be a game changer in access to care alone. We’ve only had it in the field a few months and we’re already seeing impact on quality of life. DSP: That’s exciting. Anything else you can share? ET: I am excited by the digital revolution in healthcare and IoT (Internet of Things). Ez Sleep is embracing this via data driven product offerings...we recently launched Night Shift, for Positional Sleep Therapy, (supine) – it pings the user when sleeping in Supine to trigger them to “shift” to their side, without waking them up. This helps with snoring and comorbidities like hypertension and weight loss. A portal stores the metrics of their sleep in supine, etc. Real time, actionable data allows patients to actively participate in their own health and drives collaboration with their provider. DSP: Any closing thoughts? ET: We are setting the pace of the industry through our collaborations with manufacturers, our partners such as Advanced Brain Monitoring, i-CAT, Invisalign, and our network of medical doctors and dentists countrywide. By training on effective screening, providing efficient testing and the options for treatment of OSA we significantly improve lives...left untreated, Sleep Apnea leads to diabetes, hypertension, cardiac issues, risk of stroke and even death. We are moving the science of dental sleep medicine forward. Ez Sleep is rapidly expanding – our awesome team of super-heroes is disrupting the status quo with our innovative products and crushing it with mind blowing service.

Elizabeth Tietjen, Chief Innovation Officer/COO of Ez Sleep, is a graduate of the Wharton School of Business at the University of Pennsylvania. She was previously VP National Sales at Classic SleepCare and held leadership roles at The Nielsen Company.

DentalSleepPractice.com

COVERstory

Apnea Guard

Fabrication process of Apnea Guard

Additional Key Benefits and Features: • An immediate 30 day trial therapy appliance • FDA Approved • 1 mm incremental advancements across full range of protrusive settings • Three vertical sizes proven to improve outcomes in men and women • Accommodates full range of arch widths • Systematic approach for selecting optimized advancement • Improves outcome consistency across dental providers • Saves chair time to efficacy • Accurate lab translation to custom appliance • Can be tested with HST proving benefits of long term OAT • Conditions jaw for OAT allowing for smooth transition to custom OA

10 DSP | Winter 2015

The primary conclusion from their research was too much ‘trial and error’ was involved in the determination of a jaw-forward position that optimizes oral appliance outcomes for the treatment of OSA. Their finding resulted in five manuscripts and ten conference proceedings and led to the development and validation of the Apnea Guard®. A summary of their research findings are presented below: Can a novice dental sleep medicine dentist achieve treatment outcomes equivalent to an expert dentist? • There were no differences in outcomes between the novice and expert dentist based on OSA severity. • More consistent follow-up and coaching by the novice practice achieved better outcomes after one-month as compared to the expert. • The vast majority of patients do not advance their custom appliance as instructed upon delivery without telephone follow-up. • The novice managed all complications without assistance using the expert’s protocol. Conclusion: The faster a patient advances to 70% protrusion, the sooner they will be optimally treated. A novice can achieve results similar to an expert dentist so long as they follow proven protocols. Should oral appliance therapy be limited to only patients with mildto-moderate OSA severity? • With proper titration, 96% of these with severe OSA and 83% of those with moderate OSA achieved >50% reduction in OSA severity. • In addition to achieving a >50% reduction in OSA severity, 54% with severe OSA and 80% of those with moderate OSA also achieved a post-treatment severity <10 events/hr. • Significant improvement in sleep-disordered-breathing, hypoxemia, snoring, daytime somnolence and depression were achieved with oral appliance therapy. Conclusion: The vast majority of patients respond to oral appliance therapy. A trial appliance should be offered to identify those who respond to oral appliance therapy. How similar are the outcomes of a trial appliance using a predicted setting vs. a custom appliance titrated with multiple home sleep tests to achieve optimal outcomes? • The custom appliance provided slightly better outcomes in the supine and slightly worse outcomes in the non-supine position vs. the custom appliance. • Over 80% of the patients were titrated to 70% protrusion in order to achieve optimal custom appliance outcomes. Conclusion: A trial appliance can be used to predict treatment response and predict the protrusion setting that achieves optimal outcomes. If the optimal jaw-forward position for a custom appliance can be optimally predicted with a trial appliance, what impact does it have on patient care and outcomes? • The time to reach optimal custom appliance titration was reduced from an average of 136 to 34 days and the number of office visits was reduced by an average 2.2 visits.

COVERstory • Use of the trial appliance while waiting for the custom appliance to be fabricated decreased time to treatment from an average of 33 days to 0. • The “trial appliance technique” improved outcomes as compared to the “George Gauge technique” by 24%, with optimal outcomes increased by 14% and non-responder outcomes reduced by 10%. Conclusions: The “trial appliance technique” is superior to the “George Gauge technique” in determining the optimal jaw-forward position. Treatment outcomes and patient care can be improved, and practice profitability can be increased with the use of a trial appliance.

Meet the Inventors of the Apnea Guard

Dan Levendowski – Co-Founder of Advanced Brain Monitoring and Co-Inventor of the ARES HST sleep device. Among the achievements of ABM: Their medical devices have been used on over 300,000 patients worldwide. Their innovations have resulted in 20 patents and 12 patents-pending. They have been awarded over 40 research grants totaling over $32 million dollars. Their clinical studies have resulted in over 100 scientific publications. Dr. Todd Morgan – has been recognized as an expert in the field of Dental Sleep Medicine. He has been in practice for over 25 years in California. His team has collaborated on several NIH funded clinical trials and authored many peer-reviewed articles and books on the treatment of OSA with OAT. Dr. Morgan has served twice on the AADSM Board of Directors. He is the current Vice Chair for the 2014 and 2015 AADSM Advanced Dental Sleep Medicine Courses, and is the architect of the new Board Examination Review that was launched in 2013. He is an invited speaker around the world. Dr. Morgan believes that patient care should revolve around information, a comfortable environment, and providing treatment that works! Victoria Melzer, RDH, BS – working in practice for over 30 years, Co-investigator on several sleep-focused studies, has co-authored eight publications and is a co-inventor of the Apnea Guard.

Inventors of the Apnea Guard Victoria Melzer, RDH, BS; Dr. Todd Morgan; and Dan Levendowski proudly displaying their patent.

A New Business Model for DSM Using the Apnea Guard Trial Appliance by Dr. Todd Morgan I’ve been practicing Dental Sleep Medicine for many years now and I have become quite good at spotting likely responders to Oral Appliance Therapy. But I still get fooled. One of the realities we face in our field is one that is quite contrary to our training in dental school, and that is that failure is acceptable. Those that choose to begin treating patients with SA will find tremendous rewards and receive tremendous thanks from our patients. I like to say to my students that “It’s better than doing six veneers.” But it is also hard to accept defeat when our efforts fail. After 25 years it is still as hard for me to admit that my best effort has failed, but nowadays that is not happening anymore with the Apnea Guard trial appliance and a new model for success in DSM. Just recently I began to explore working in tandem with a local DME company with the common goal of leaving no patients behind. DME companies who deliver Positive Airway Pressure therapy know the stark reality: many patients will fail despite their best efforts to provide good care. Where do these patients go who abandon PAP? The answer, unfortunately, is often they are left behind and fall away unless they have the courage to re-engage their sleep or family physician and ask for other options. Many do, but many more than that are left untreated. We set out to change that. Our unique manage care model identifies non-adherent CPAP patients at 45-60 days using data from modem-transmitted PAP usage download data, and then generates a protocol for moving those patients into an oral appliance treatment arm of therapy. In order to identify OAT responders another protocol is then deployed using the Apnea Guard trial device and HST. Since the Apnea Guard device is proven to be equivalent to custom device therapy we can now reliably identify candidates and proceed further with custom appliance therapy. Sure, a few managed health care systems have used a similar approach using “boil and bite” trial devices. But, of course, there is no evidence to support this when the jaw position is not accurately determined. We have been quite well received by Insurance Payers in our area who are delighted to pay for trial therapy with the Apnea Guard plus HST in order to avoid paying for the failures that they see using expensive custom devices on everyone out of the gate. In our setting we are contracting with local systems that are managing a limited number of health care lives. Our system uses the existing medical code E0485 for billing a trial appliance, and the standard coding for the HST to show efficacy. I love the fact that we are potentially saving many more lives by identifying PAP failures early on, and that we are not wasting our patients’ time or money by identifying them immediately for OAT. This model will improve our image as DSM practitioners among payers and physicians, who have asked me for more years than I like to think about, for a way to pre-identify OAT candidates. I am finding it much easier these days to confidently recommend OAT while watching my case acceptance and success rate soar.

DentalSleepPractice.com

COVERstory Victoria shares her story

It is exhilarating as a hygienist to be able to fabricate an Apnea Guard – a simple putty filled tray – and to watch the AHI, RDI and desaturations plummet in an interpreted Type III HST. As a co-inventor of the Apnea Guard device, I have been able to treat medically-referred OSA patients. I have personally witnessed the transformation of these sleep-deprived individuals. It is incumbent on us as hygienists to ‘save lives’ as we educate our patients towards better periodontal and dental health. Treating OSA saves lives too, and it is right in front of us every day. In an average dental office, a significant number of patient’s present with OSA.2 Hygienists can recognize and document the obvious oral manifestations of this disorder in our routine cleanings and bring these patients to our doctor’s attention so the Apnea Guard may be employed. The beauty of the Apnea Guard is that it is a temporary, FDA-approved, titratable device that most medical health care professionals can quickly fabricate to help save lives. Hygienists have many things in their tool box to aid in the care of our dental patients; we even have tools for our patients to use at home. Now we have another tool, the Apnea Guard. One of my favorite patients said to me: “I am sure you saved my life, or at least extended it.”

“Ez Sleep has made all the difference in the world to our dental sleep medicine practice. It took Ez Sleep’s screening and management system to help us actually generate real patient flow How does the ‘Love at First Bite’ program work? Let’s ask in screening, testing and oral appli- Ez Sleep CEO Keith Woods “We are really excited about the launch of the AG. ance therapy. They have helped us As an innovator in the sleep medicine industry, I see future of DSM going down the path of required build dental sleep medicine into a the patient-proven responses to trial appliance therapy significant part of our practice and prior to custom appliance fabrication. A model of outmedicine for dentists to continue to reI would highly recommend them.” come-based ceive custom OAT reimbursement is in our future. We – Brandon Quijada at Smile for Life Dentistry in Phoenix, AZ

“I’ve used the George Gauge for several years, and I’m impressed with the predictability, stability, and simplicity of the Apnea Guard. I especially love the way it provides my patient the opportunity to ‘test-drive’ a mandibular advancement device before committing to a long-term appliance.” The Apnea Guard “Fit-It” training process was thorough and excellent.” – Dr. Brian Jacobsen of Jacobsen Dental in Ephrata, WA

12 DSP | Winter 2015

support this approach and model as we believe this will be the best way to unite both the medical and Keith Woods, CEO dental communities together. In the last 7 years, I worked with many physicians and dentists in both our Sleep Centers and with Ez Sleep nationally. I kept hearing the same two concerns and questions being asked by physicians to dentists when being approached to collaborate and receive medical patient referrals: 1. “How do I know if Oral Appliance Therapy is actually going to work for my patient?” 2. “How much is it going to cost my patient ‘out-of-pocket’ to try Oral Appliance Therapy?” Until now, the answers to these questions often remained a big mystery to both disciplines and this lack of a guaranteed successful outcome has always been the key reason for physicians to be hesitant when referring their OSA patients to dentists for treatment management by use of OAT. The “Love at first bite” outreach program is now helping physicians, dentists and patients all across the country be given a risk-free option to recommend, provide or receive Apnea Guard. Once a 30-day trial of Oral Appliance Therapy is recommended by a physician, Apnea Guard is then delivered by any dentist who has been previously trained on how to “Fit-It”. Yes, you heard correct, in-conjunction with an Apnea Guard prescription and a home sleep test, Ez Sleep now provides a “no-cost” trial oral appliance to its patients via its network of dentists trained on how to “Fit-It”!

COVERstory Ez Sleep’s patient outreach with Apnea Guard program aims to bridge the gap between both the medical and dental fields, it plans to revolutionize and shape the way both Sleep Medicine and the Dental Sleep Medicine industries can now “Fit-It,” and work together to Screen, Test and Treat those suffering from Obstructive Sleep Apnea. As the dental industry’s leading in-home sleep testing service, Ez Sleep already provides the most simple and effective, yet comprehensive screening and testing network for dental and medical practices all over the country; assisting doctors and their staff in navigating through the dental sleep medicine process with ease. As the “Exclusive Distributor” of the Apnea Guard, we invite you to join your many colleagues that are already benefiting from our “Love at First Bite” patient outreach program. Our simple approach to Screen, Test and Treat with Apnea Guard empowers affordable treatment options and patient-informed choice. You get results, with increased revenue, while focusing on the most important aspect of the puzzle – patient care.

The Team Behind the Operations and Training of the Ez Sleep Academy

Justin Fu, MD, MBA, FAASM is Ez Sleep’s Chief Medical Officer. Dr. Fu is double board certified in Sleep Medicine and Internal Medicine by the American Board of Internal Medicine and a Fellow of the American Academy of Sleep Medicine. Sal Rodas, Chief Strategy Officer, holds an MBA from Babson College Graduate School of Business and was formerly COO of SML Laboratories for 10 years. Victoria Melzer, a co-inventor of the Apnea Guard teams up with April in the “hands on” tele-training of the Apnea Guard across the country to ensure the most effective, precise and personalized training. April Sallie, PSS, is a key leader responsible for the creation of the Ez Sleep screening training process and program. She has been with Ez Sleep since it was founded. April has worked with patients one on one screening in numerous medical and dental offices over the last 9 years learning and developing the most effective, patient-friendly screening process. Autumn Bodily, Lead Educator and developer of the Ez Sleep Academy, joins them to make up “The Dream Team” of DSM practice staff training. Ryan Javanbakht, National Sales Manager, has a strong background of dental, orthodontic and surgical sales management. Ryan is responsible for leading Ez Sleep’s national team of DSM practice building business experts.

“I am so thankful that you offered me this. Ever since I have been wearing it, I haven’t felt that sensation of my throat closing. That’s why I call it my Lifeguard. It’s rescued me and makes sure I keep breathing. It was love at first bite.” –Patient, Sharon Ray, Los Angeles, CA After CEO, Founder of Ez Sleep, Keith Woods heard about this patient’s response to her Apnea Guard experience this is what he had to say:

“It’s the real life stories and experiences like this one that keep us motivated to continue helping each client and patient as much as possible.” Ez Sleep Academy trainers Autumn Bodily, left, and April Sallie, right. The Ez Sleep Academy currently assists and provides training to more than 1,300 dentists and healthcare professionals across the country.

Company Contact

For more information on Apnea Guard or Ez Sleep In-home Testing, please contact Ryan Javanbakht at 888-240-7735 or Inquiries@EzSleep Test.com, or visit the websites www.EzSleepTest.com or www.Loveat FirstBite.Buzz.

Sal Rodas, CSO

Ryan Javanbakht

This information was provided by Ez Sleep. References 1. Treatment Outcomes of Mandibular Advancement Devices in Positional and Non-Positional Patients. Chung JW, Enciso R, Levendowski DJ et al. Surg Oral med Oral Pathol Oral Radiol Endod, 2010; 109(5),724-731. Voted by Editorial Board for H. Dean Millard Best Paper Award for 2010. 2. In-Home Evaluation of Efficacy and Titration of a Mandibular Advancement Device for Obstructive Sleep Apnea; Levendowski D, Morgan T, Patrickus J, et al. Sleep Breath 2007 11(3):139-147. 3. Initial Evaluation of a Titration Appliance for Temporary Treatment of Obstructive Sleep Apnea. Levendowski D, Morgan T, Westbrook P. J Sleep Disord Ther, 2011; 1:1. 4. Benefit of Mandibular Repositioning Device (MRD) Therapy in Patients with Moderate and Severe OSA. Levendowski D, Morgan T, Melzer V et al. Sleep 2009 32:203. 5. Predicting Changes in AHI Resulting from Mandibular Repositioning Device Therapy. Levendowski D, Morgan T, Patrikus J et al. Sleep Breath 2009;13:308. 6. Comparison of Mandibular Repositioning Device Outcomes for the Treatment of Obstructive Sleep Apnea Using Alternative Approaches for Determining the Optimal Jaw-Forward Position. Morgan T, Myers, A, Melzer V. Conference preceding of American Academy of Dental Sleep Medicine, 2014; Minneapolis, MN 7. Treatment Efficacy Using a Trial Oral Appliance to Determine the Optimal Jaw Forward Position for a Custom Appliance. Morgan T, Meyers A, Melzer V, Levendowski D. Sleep 2014; 37:A361.

DentalSleepPractice.com

MDconnection

Pushing Air or Pulling the Jaw: Which is better for which patient? by John E. Remmers, MD

The “halcyon days” of CPAP

hirty years ago, nasal continuous positive airway pressure (CPAP) became established as standard therapy for obstructive sleep apnea (OSA). At that time clinicians were faced with horribly sick, massively obese folks having extremely severe OSA. They died regularly and often required a tracheostomy. That all changed in 1982, when Sullivan discovered that air pressure applied to the nasal airway miraculously and immediately eliminated the problem. Suddenly, we could rescue these severely ill patients with simple air pressure. Our unbelievable amazement and relief cemented CPAP in our therapeutic armamentarium forever. And why not? We all thought it always works and never hurts, and it uses one of our favorite tools, air pressure. In the 1990’s we learned that OSA was prevalent in the general Collin Sullivan, MD 1982 population. We began to encounter commonly apneics who, while overweight did not have “morbid” obesity. Lacking an alternative, CPAP became standard therapy for the burgeoning OSA population, even though some found it unacceptable, even barbaric. At the time, we believed that we were simply treating compromised quality of life, so whether or not the patient used CPAP represented his/her choice between improved quality of life and refusal to use awkward therapy. Our mantra was firmly established: “when in doubt, pressurize the snout”.

14 DSP | Winter 2015

New knowledge disturbs our comfortable treatment paradigm

The arrival of new knowledge ten years ago changed everything. We learned that OSA presents a significant mortality risk. For instance, population studies indicated that severe OSA was associated with a 40% mortality risk in 15-20 years. This meant that OSA could no longer be viewed only as a problem that impaired quality of life. We were faced with the jarring reality that OSA was a chronic disease linked to cardiovascular consequences and having a mortality risk comparable to hypertension and diabetes. The new reality implied that the clinician managing OSA would have to take a longterm view, focusing on compliance with therapy and health outcomes. Accordingly, poor adherence with CPAP therapy is now seen in a different light as the untreated patient may be at risk of serious co-morbid illness. At the same time, an alternative therapy with higher adherence emerged, oral appliance therapy (OAT). This viable therapeutic alternative raises the question: which is better for any particular patient, pressurizing the airway or protruding the mandible?

MDconnection CPAP or OAT, which is better?

Each of the two therapies has pros and cons. While benign and highly efficacious, CPAP is not an attractive therapy to many patients, and long-term compliance is low. OAT, while preferred and associated with higher compliance, is inconsistently efficacious, producing a satisfactory response in 50-75% of cases. Recent studies have shown that, when applied to unselected patients with OSA, the two therapies produce comparable outcomes. This suggests that the poor compliance of CPAP offsets the inconsistent efficacy of OAT. In other words, each treatment has a drawback, and these drawbacks offset each other in long-term treatment. So, apparently, it does not matter which treatment you pick; each is suboptimal, and the outcomes are equivalent. But wait, that’s not the end of the story; unlike CPAP, the drawback with OAT is fixable. Imagine if we had the capability to select for OAT only those patients whom we know in advance will experience a successful therapeutic outcome. This would make OAT a highly efficacious therapy. Thus, OAT could be as efficacious as CPAP but would have better compliance. Thus, for patients who respond favorably to the therapy, OAT will result in better outcomes than CPAP.

Selecting patients for OAT

Attempts to prospectively identify OSA patients who will respond favorably to OAT using clinical features or pharyngeal imaging have proved disappointing. But, an encouraging development has recently occurred with the appearance of a test, called MATRx. This polysomnographically-based mandibular titration study prospectively identifies OAT responders and predicts an efficacious protrusive position of the mandible. Because of the high predictive accuracy, the physician and dentist can be completely confident that patients identified as favorable candidates will, in fact, experience elimination of OSA with OAT. As well, the dentist knows that the prescribed protrusive position will be adequate and probably less protrusive than that reached using the traditional trial-and-error adjustment of the appliance.

A more efficient and confident dentist MATRx is the only prospectively validated method for selecting patients for OAT and

determining an efficacious mandibular position. Together, these clinical predictions convey efficiency gains for the treating dentist. First, the dentist undertakes OAT with confidence knowing that the therapy will successfully eliminate OSA. Since the dentist never treats a patient who is a therapeutic failure, the number of visits per case is substantially reduced. Moreover, patient acceptance and adherence is greater. As well, because the dentist can expeditiously set the mandible at a minimal protrusive position that eliminates OSA, efficacious OAT is quickly established, a benefit both to the patient and the dentist. As one sleep medicine dentist put it: “Every MATRx case I do is a slam dunk”.

MATRx In-Lab Titration System

The next breakthrough – an in-home test

And, there’s another breakthrough to come; Zephyr, the company that makes MATRx, has another breakthrough in the pipeline, one of particular importance for sleep medicine. The company is developing a home sleep test that employs a computercontrolled mandibular positioner. This test, like MATRx, identifies prospectively favorable candidates for OAT and determines a minimal protrusive position. The test apparatus can be dispensed from a dental office, a homecare provider, a sleep clinic or a general physician’s office and applied by the patient in the home. The data is automatically analyzed and provided to the physician and dentist. Early clinical trials show predictive accuracy comparable to that reported for MATRx. So stay tuned. I believe that fantastic advances in sleep medicine are on the horizon. Patients with OSA will be provided therapeutic options, and for many, a simple oral appliance will be more effective therapy than pushing air.

David Binder, DDS, Diplomate ABDSM (Dental Sleep Apnea New York) fitting his patient’s MATRx Titration Trays

Dr. John E. Remmers is a well-known figure in sleep medicine, having contributed importantly to understanding of the pathogenesis of obstructive sleep apnea. He is an inventor of modern CPAP and home sleep recorder technologies. Dr. Remmers has been active in the field of sleep dentistry for 15 years where his principal contribution has been the invention and development of the remotely controlled mandibular positioner, now available as the product MATRx. He works full time for Zephyr Sleep Technologies as their Chief Medical Officer.

DentalSleepPractice.com

ORIGINstories

There at the Start:

The First Years of Mandibular Advancement Devices by Thomas E. Meade, DDS

t was March 1985; I was at a dental meeting in Clearwater Florida, enjoying a warm weather respite from my home in Albuquerque. After a short run on the beach, I went to get a cup of coffee and found my colleagues talking about the term “sleep apnea.” Someone told an early morning joke and I missed the part about what sleep apnea was or why we were talking about it. Two weeks later, a local otolaryngologist and I were driving our sons to Vail for a ski race that the boys had been invited to. For some reason the term sleep apnea popped into my head, so I asked him about it. He had very limited knowledge of sleep apnea, however he recalled a recent article from two DDS/MD’s at Stanford that he would send

16 DSP | Winter 2015

me. He also knew of someone at University of New Mexico Medical School interested in this area. Approximately one week later, I received the article concerning surgical repositioning of the mandible and the name of Dr. Wolfgang Schmidt-Nowara [WSN]. This got me thinking about other ways to open the airway, because many people didn’t want to have invasive, expensive surgery. I knew about Bionators and other orthodontic devices used to hold the jaw forward, so by May of 1985, I had developed a plan for an acrylic appliance, and I just needed some patients. I tried to contact Dr. Schmidt-Nowara several times – he finally agreed to 15 minutes in November late in the day to meet. He was really not interested in my plan until I told him I was not going

ORIGINstories to charge the patients anything for the 8-10 hours each device would take for me to position and fabricate the appliance. He agreed to send some patients. Fabrication protocols for these patients included making a set of models and a protrusive bite. The position for the protrusive bite was determined after approximately one hour on a TENS unit and the use of a Silascope from Myo-Tronics to identify maximum protrusion of the mandible. I felt that this might be too much, so I built the appliance 3mm short of maximum protrusion. I can’t be sure why I decided on this number. WSN started sending some patients to me. Most of them had failed or refused C-PAP and had UPPP surgery done, which also failed in fixing the apnea, but did decrease the number of events. The appliance I made (by myself, in my office lab) was an acrylic one-piece that I cannot describe as comfortable. I am my own test subject prior to using on patients, and my wife told me I did not snore with it. The results of this study are published in Chest.1 We thought we had the answer but soon learned that for severe sleep apneics it was very limited. I attended the first meeting of the medical sleep society in the spring of 1986 in Columbus, Ohio. At this meeting, I heard of an appliance called the Equalizer, made by Glaze Laboratory. This was a very bulky appliance and did not seem practical to me, however WSN wanted me to try one, since he was sure something better was out there than the one I had used so far. I tried an Equalizer and could not get it to fit the patient. When that meeting moved to Minneapolis in 1987, I was introduced to the Tongue Retaining Device. I also learned what the medical doctors thought of dentists doing anything in this field. I can’t remember all the names I was called, but I know I did not appreciate WSN calling me a “huckster.” Late 1986 and 1987 was the introduction of the Snore Guard, which I created. I had to find injectable materials to fabricate the appliance in mass to keep costs reasonable, since insurance wasn’t going to pay for it. The outer shell of the appliance, Lexan, was easy to find. The moldable inside was not so easy. The mouth guard companies all claimed their materials as proprietary. Obtaining samples and then melting them involved ruining a few of my wife’s pots, but I ended up with

Elvax, a DuPont product. At least these new appliances were being made in a manufacturing facility! Over the years I shared this information with several dentists who had different projects working toward the same objective. This is about the time I started giving seminars around the country where most of the key founders of the Sleep Disorders Dental Society [now American Academy of Dental Sleep Medicine (AADSM)] first heard the idea of treating snoring with a dental device. Dr. Rob Rogers, who first convened the SDDS, told me at the AADSM annual meeting in 2012 that my three-hour course changed his life. My schedule was fun and relaxed – I would leave Albuquerque on Friday to speak somewhere that afternoon, somewhere else on Saturday and Sunday mornings, then home for four days in my practice. I would usually do this twice a month. My wife, mother-in-law, and I would paste labels, mail letters, and hope for a good response. On a nice snowy Friday in February, 1985, Dr. Alan Lowe invited me to Vancouver to speak to a group of dentists and hear about his research concerning the tongue. By this time I had heard of Dr. Peter George (who claims to be the first with a device), Glenn Clark in Los Angeles, who was taking an orthodontic-centered approach, and Kent Toones, a Utah dentist who was producing an appliance that had a minimum of 20mm vertical opening. In my seminars, I would tell everybody that anything that would hold the mandible forward would help prevent snoring. In the late 1980’s, we did not have FDA clearance to talk about treating sleep apnea, but the future was becoming clear. In 1990 or 1991, I met Christina LaJoie from Great Lakes Orthodontics Lab at a meeting in Los Angeles. She seemed to be

the first meeting of the medical sleep society was in the spring of 1986 in Columbus, Ohio

Dr. Thomas E. Meade has been a practicing dentist in Albuquerque, New Mexico since 1971. Dr. Meade has been researching and writing about the implications of sleep disorders for over 25 years and has conducted seminars throughout the United States and Canada from 1987 till 2001. During that time, Dr. Meade lectured in many countries in Europe, as well as in Australia. Dr. Meade invented the Snore Guard in 1987, the TheraSnore 1994, the adjustable TheraSnore in 1997, and custom fabricated Thera-Som Cast in 2009.

DentalSleepPractice.com

ORIGINstories

In my 70’s I’m having a great time treating 8-9 patients a month.

a great friend of WSN but not interested in the Snore Guard. Because WSN supported and approved appliance therapy, she came around. Without WSN and her backing this new therapy, I feel the dental profession would have had to fight for several years longer to be accepted by the medical groups, which led directly to insurance companies paying for the therapy. In 1993, I developed the Thera-Snore and two years later the Adjustable TheraSnore. These were both fitted with hot water – no laboratory required. And they received FDA clearance to treat sleep apnea along with snoring. I sold my dental practice in 2002, keeping the right to treat patients with mandibular advancement appliances. Besides the TheraSnore, I wanted to try out some of the other choices available, so I delivered several and was not satisfied when they seemed to last only two years. I thought my patients should expect more like five years of service. I wanted an appliance that would not stain and develop offensive odors. I jumped back into device development and spent two years of work with my dental lab technician producing what I wanted: a device that is nothing fancy but is basically indestructible. These goals along with a desire to minimize tongue

space impingement led to the TheraSom Cast – a chrome-cobalt cast framework with about 7mm of advancement and a vertical of about the same. For patients with large tongues/restricted jaws, I usually open them about 10 millimeters, with generally good success. I received the first appliance February 2009 and with a trip through the dishwasher once a week since then, it stays shiny. I have no idea how long it will last. I have found no reason to fabricate a morning deprogrammer appliance with this device, since I get great results with less protrusion. I am “retired” but still work a couple of four-hour days per week with no staff and nobody looking over my shoulder. With over half my professional career involved in this field, I still enjoy an ability to help people in a stress-free environment, independent of insurance or payment hassles. In my 70’s, I’m having a great time providing eight or nine new devices each month. The only thing I am missing in these 30 years since working so hard to start appliance therapy for sleep breathing is any recognition from the AADSM. This is a short essay of my journey, with a lot of interesting sidelines left out. Hope this helps you know a bit more about the history of dental involvement in this area of health care.

1. Chest. 1991 Jun;99(6):1378-85. Treatment of snoring and obstructive sleep apnea with a dental orthosis. Schmidt-Nowara WW1, Meade TE, Hays MB.

18 DSP | Winter 2015

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MEANINGFULconversations

Working Off The Same Matrix: Toward an Integrated Care Model for Obstructive Sleep Apnea by Liana Groza, DDS

Our assistant Carol demonstrating attachment between CPAP Pro and OASYS Hinge appliance (Dream Systems Dental Lab) for Combination Therapy

ow do you define CPAP failure? The CMS guidelines set the generally accepted compliance threshold at 4hr/ night on 70% of nights. What about Oral Appliance Therapy (OAT) failure? Here the definition gets more fuzzy. In a 2014 review, Sutherland et al. identified several alternative success criteria used by clinicians and researchers: a treatment AHI <5 (complete resolution of OSA) or <10 (very mild disease), or a 50% reduction from baseline AHI. In reality, each of these thresholds circumscribes only half of the problem: after all we are not treating numbers, but health outcomes, and the recently introduced concept of Mean Disease Alleviation (MDA) points to the fact that the higher compliance rate of OAT tends to balance its lower efficacy, resulting in a remarkable outcomes equivalence (Phillips et al. 2013; Roy 2014; Sutherland et al., 2014; Vanderveken 2015). 20 DSP | Winter 2015

Nevertheless, the concept of “failure” haunts the field of sleep medicine – from sleep physicians and DME suppliers who worry about the patient abandoning CPAP therapy after trying multiple mask interfaces and pressure settings, to the dentist who knows that only approximately half of oral appliance users are going to fully respond to therapy, depending on one’s definition of success (Sutherland et al. 2014) and ultimately to the patients themselves, who wonder whether failing to achieve the target AHI with an oral appliance means they will be forced to give up on this option and turn (or return) to CPAP, contemplate surgical solutions, or resign themselves to living with untreated apnea – which unfortunately is not an uncommon outcome. But knowing what we currently know about combination therapy options for sleep

MEANINGFULconversations apnea, is this success-failure dichotomy the best way to frame the issue to our patients? Is it the most constructive way to formulate a treatment plan with the patient’s other healthcare providers – the much-touted multidisciplinary approach that is the cornerstone for successful long term management of sleep disordered breathing? Considering that only 10-20% of the estimated 25 million Americans with OSA are currently diagnosed, that approximately 15-30% of those diagnosed patients refuse CPAP while another 20-40% discontinue CPAP after 3 months (Ravesloot 2011), yet only a very small fraction of OSA patients pursue treatment with oral appliance therapy or surgery, it is obvious that the vast majority are unable to successfully navigate the current system and receive adequate treatment. Is there a better, integrated way to screen, test, counsel and follow up OSA patients as they move through our healthcare network? Over the past few years, combination therapy has emerged as a still exploratory, yet tremendously promising and versatile concept in the treatment of sleep apnea. Multiple studies show a significant positive effect on AHI with weight loss (Peppard 2000, Smith et al 1985), which may allow an OSA patient to tolerate CPAP at a lower pressure (Vanderveken 2015). Positional therapy studies have consistently demonstrated that AHI values can move from the moderate and severe ranges to mild scores when using a sleep position trainer, which could lead to a successful treatment when combined with oral appliance therapy (Heinzer et al 2012, Lee et al 2012, Dieltjens et al. 2014, Levendowski 2014). Oropharyngeal exercises designed to improve muscle tonus and functionality have been shown to considerably reduce AHI, improve snoring frequency, daytime sleepiness and sleep quality score (Guimaraes et al 2009, Ieto et al 2015). Most significantly, the concomitant use of mandibular repositioning devices has been shown to provide a very successful rescue approach in previous CPAP failure cases, as the lower pressure requirements result in a much more acceptable patient experience (Sanders 2015, el Sohl et al. 2011). In light of these results, Olivier Vanderveken’s 2015 JDSM editorial seems fully justified as it raises a fundamental question: should combination therapy remain

relegated to the status of taboo, or should it become the new standard of care? Such a paradigm shift would have significant implications, because the new framework would allow us to define clear roles for everyone involved in the management process, from patient to the primary care team, to the specialists treating his/her pulmonary or cardiometabolic problems. While we are familiar with the notion that OSA is a progressive disease which must be monitored with long-term follow-ups and re-evaluations as patients age and gain or lose weight, an equally important conversation should take place at the start about the multiple factors affecting the success of various OSA treatments and their short- to intermediate-term management. If OSA treatment is not presented as a “win or lose” alternative but as a dynamic process in which the patient can play an active role, with clearly defined and achievable intermediate clinical goals, then perhaps the very common desire to transition from CPAP to OAT or an even more conservative positional therapy could be used as an incentive to motivate lifestyle changes, as the patient works through a matrix of modifiable risk factors and little by little gets closer to an effective OAT solution. While it is true that with comparable adherence rates CPAP

1530%

of OSA diagnosed patients refuse CPAP

Dr. Liana Groza graduated with honors from the University of Toronto Faculty of Dentistry in 1995. After a series of moves with her physician husband, they’ve settled in Spokane, Washington. Dr. Groza was on staff with the Community Health Association of Spokane from 2007 until 2014, when personal experience with OSA and her life-long fascination with interdisciplinary sciences converged, leading to a decision to open Spokane Sleep Apnea and Oral Systemic Dentistry – a private general practice limited to sleep-disordered breathing, salivary diagnostics and periodontal contributions to systemic inflammation. Dr. Groza is a Fellow of the Academy of General Dentistry and a member of the American Academy of Sleep Medicine, the American Academy of Dental Sleep Medicine and the American Academy for Oral Systemic Health. As the founder/coordinator of the Spokane Regional Sleep Apnea Network (http://www.spokanesleepapneanetwork.com) her goal is not only to educate and help her community of patients manage their cardiovascular and metabolic risk, but to work with local healthcare and research organizations toward the development of smarter, more effective, integrated protocols. Dr. Groza can be reached at drgroza@spokanesleepapneadentistry.com

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MEANINGFULconversations

Dr. Groza with Linda, our medical insurance coordinator, and Carol, our dental assistant

22 DSP | Winter 2015

tends to provide the best and most predictable improvement in AHI values and that such “weaning off” CPAP may not be achievable in a significant percentage of cases, depending on the patient’s phenotype, it is also essential to recognize the importance of educating patients about the modifiable risk factors and adjunctive approaches available to them, as each component of the therapeutic equation (weight loss, reducing nasal resistance, strengthening oropharyngeal muscle tone, positional therapy, biomimetic DNA appliance therapy as well as surgery and even proper sleep hygiene) represents an additional contribution to the success of the treatment, with or without CPAP. When and for whom should hybrid therapy be introduced as an alternative? The concept of Mean AHI/Mean Disease Alleviation (Ravensloot 2011, Sutherland et al 2014, Vanderveken 2015), in combination with objective OA adherence monitors like DentiTrac (Braebon) will allow us, in principle, to set targets for overall outcomes and determine whether an individual patient is doing better on CPAP, combination or oral appliance therapy, taking into account both the efficacy of the treatment and the amount of time that the patient is able to tolerate the treatment each night. While no one disputes the superior benefits of CPAP that is worn nightly for the full duration of the sleep period, in patients who are marginally compliant, refuse or fail CPAP per the current CMS benchmark, an oral appliance is the typical second line of treatment, unless surgery is indicated for obvious craniofacial abnormalities. Since phenotyping plays such an important role in patient response to oral appliance therapy, the patient should understand from the start what the OAT statistics (probability of an optimal response) are and that where a suboptimal result is achieved, hybrid therapy using lower-pressure CPAP or compliance-monitoring positional training devices such as Night Shift (Advanced Brain Monitoring) should be immediately introduced, calibrating these multi-modal interventions until the target MDA is achieved, possibly in combination with weight loss, oropharyngeal exercises and ENT referral where nasal airway resistance is suspected. Thus framed, the OAT alternative is no longer defined by

“success or failure”, but by a customized combination of factors that can be modified to achieve an acceptable therapeutic response, and by the length of time required to reach it. Critical to this approach would be establishing a close follow-up schedule for the first year of treatment, so that any adherence problems are identified and addressed in a timely manner by the interdisciplinary team managing that patient. At the same time, it is important to realize that obstructive sleep apnea does not exist in isolation, but is pathophysiologically connected to other systemic inflammatory risk factors, such as periodontal disease (see Billings, 2015). Weight loss becomes more difficult to achieve in the presence of sleep disordered breathing, and insulin resistance is markedly affected by both sleep apnea and periodontal inflammation - to mention just a few of the mutually reinforcing mechanisms which make cardiometabolic conditions so challenging to control. Therefore, developing a common matrix of goals and clinical parameters (Table 1) could provide patients and their physicians with a road map in the management of these interconnected chronic diseases. What if instead of struggling independently, providers were able to share this common work sheet, entering the results of various lab tests and clinical findings into a common EHR Systemic Inflammatory Risk Matrix? Beginning with primary care sleep apnea screening and referral guidelines in high-risk populations (such as patients presenting with diabetes, hypertension, or a history of heart disease or stroke, per 2009 AASM guidelines – Force 2009), a shared EHR matrix would allow each clinician to see an instant snapshot of where the patient is in relation to the current goals, point out the factors that are well managed versus the ones that need improved compliance, and reinforce those short-term steps required to improve both apnea and systemic health outcomes. For example, an increase in hsCRP or HbA1c on a routine PCP visit could trigger a matrix check for the latest CPAP or OAT compliance numbers, periodontal status (bleeding index or semi-quantitative biofilm reports such as MyPerioPath from OralDNA Labs), weight changes, or even prompt questions about a

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MEANINGFULconversations history of recent nasal allergies. Depending on the individual patient history and changes in matrix values, a PCP might recommend dietary counseling or short-term manageable weight loss goals; a follow-up with their dentist to discuss OralDNA testing and adjunctive methods (such as Perio Protect) to reduce the impact of periodontal biofilm on systemic inflammation and glycemic control; or temporary nasal decongestants/steroids to deal with the effect of seasonal allergies and their impact on CPAP/OAT efficacy. Because patients don’t routinely see their sleep physician every few months, having multiple providers keep tabs on the number of parameters affecting the systemic inflammatory equation Table 1: A Shared EHR Systemic Inflammatory Matrix for Co-Management of OSA Jan-Mar 2015

STOP-BANG Risk

High

Referred for Sleep Test

01/20

Apr-Jun 2015

Jull-Sep 2015

Oct-Dec 2015

04/10

Baseline AHI

OSA Treatment

CPAP

OAT/CPAP

Treatment AHI

OSA Treatment Adherence hr/night; % nights

5 hr; 50%

6 hr; 90%

150/95

150/92

143/90

140/85

BMI

HbA1c

7.2

hsCRP

7.0 3.1

6.8 0.4

Lp-PLA2

240

170

148

HDL

LDL

Bleeding on Probing (% sites)

MyPerioPath

High Aa High Pg High Pi

Low Cr, Ec

My Perio ID IL-6 genotype/risk

G/G high perio risk

Other markers

Waist: 42" Neck: 18"

Celsus One panel (Oral DNA) Red values are abnormal, red rows denote tests/ follow-ups ordered but not completed (including F/U sleep test to confirm OAT effectiveness). A basic legend assisting all involved providers with interpreting these results and a “work flow tab” allowing any of the treating providers to fax a request to a partner specialist team might also be considered to streamline co-management of CPAP failures or cardiometabolic patients with periodontal disease.

24 DSP | Winter 2015

and reinforce the same message may transform the patchwork of uncoordinated PCP and specialist consultations into a more coherent program of manageable steps, maximizing the benefits of shared EHR to help the patient correct course more frequently and keep tighter control over the desired health outcomes. Equally important, built-in algorithms could take into account clinical value inputs and dates to highlight recommended tests, missed follow-ups, abnormal results and suboptimal compliance: a shared EHR matrix to which all providers have access, from the referring PCP or dentist to the sleep physician prescribing CPAP to the CPAP supplier, will quickly allow the PCP on a routine visit to document lack of CPAP compliance, triggering the request for a follow up consultation with the sleep physician and dentist to discuss Oral Appliance or Combination Therapy. A similar request could also be initiated by a CPAP supplier anticipating case failure and trying to rescue it with combination therapy before the patient drops out of the system. Given that approximately 20% of patients who are advised by their PCP to get a sleep test do not pursue it (Sleep Review, 2014) and that a significant percentage of required post-treatment sleep tests are never completed, that lack of follow-through would also trigger a recurrent alert and reminders from different providers on all subsequent visits until the test was completed. When clinicians and patients establish a common, standardized flow chart of objective tests and biomarkers, coordinated follow-up becomes tighter and overall health outcomes such as blood pressure or measures of glycemic and weight control can be more readily managed as part of the overall therapeutic equation. Such an integrated, dynamic treatment matrix may be an unrealistic proposal at this point, however our healthcare system is rapidly evolving, along with our treatment paradigms. As the focus shifts toward outcomes-based medicine, the time may come when evaluation and effective therapy for sleep apnea becomes as routine as checking blood pressure or glycemic status, and a treatment prescription may involve not one but multiple specialists.

MEANINGFULconversations References 1. Billings, M. E. “Putting Some Teeth into It: Connecting Periodontitis with Sleep Apnea.” Sleep (2015). 2. Dieltjens, Marijke, et al. “A promising concept of combination therapy for positional obstructive sleep apnea.” Sleep and Breathing 19.2 (2014): 637-644. 3. El-Solh, Ali A., et al. “Combined oral appliance and positive airway pressure therapy for obstructive sleep apnea: a pilot study.” Sleep and Breathing 15.2 (2011): 203-208. 4. Force, Adult Obstructive Sleep Apnea Task, and American Academy of Sleep Medicine. “Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults.” Journal of clinical sleep medicine: JCSM: official publication of the American Academy of Sleep Medicine 5.3 (2009): 263 5. Guimarães, Kátia C., et al. “Effects of oropharyngeal exercises on patients with moderate obstructive sleep apnea syndrome.” American journal of respiratory and critical care medicine 179.10 (2009): 962-966. 6. Heinzer, Raphael C., et al. “Positional therapy for obstructive sleep apnea: An objective measurement of patients’ usage and efficacy at home.” Sleep medicine 13.4 (2012): 425-428. 7. Ieto, Vanessa, et al. “Effects of oropharyngeal exercises on snoring: a randomized trial.” CHEST Journal (2015). 8. Lee, Chul-Hee, et al. “The effect of positional dependency on outcomes of treatment with a mandibular advancement device.” Archives of Otolaryngology–Head & Neck Surgery 138.5 (2012): 479-483. 9. Levendowski, Daniel J., et al. “Assessment of a neck-based treatment and monitoring device for positional obstructive sleep apnea.” Journal of clinical sleep medicine: JCSM: official publication of the American Academy of Sleep Medicine 10.8 (2013): 863-871. 10. Sleep Review June 9, 2014 “Main sleep referral source is PCPs, but many don’t connect the dots” 11. Smith, Philip L., et al. “Weight loss in mildly to moderately obese patients with obstructive sleep apnea.” Annals of internal medicine 103.6_Part_1 (1985): 850-855. 12. Peppard, Paul E., et al. “Longitudinal study of moderate weight change and sleep-disordered breathing.” Jama 284.23 (2000): 3015-3021 13. Phillips, Craig L., et al. “Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: a randomized controlled trial.” American journal of respiratory and critical care medicine 187.8 (2013): 879-887. 14. Ravesloot, M. J. L., and N. De Vries. “Reliable calculation of the efficacy of non-surgical and surgical treatment of obstructive sleep apnea revisited.” Sleep 34.1 (2011): 105. 15. Roy, Sree. “ 9 Alternative Therapies for Obstructive Sleep Apnea” Sleep Review. September 18, 2014 16. Sanders, Anne E., et al. “Dental Clinicians’ Observations of Combination Therapy in PAP-Intolerant Patients Published on March 9, 2015.” 17. Sutherland, K., et al. “ Oral appliance treatment for obstructive sleep apnea: an update.” J Clin Sleep Med 10.2 (2014): 215-227. 18. Vanderveken, O. M. “Combination therapy for obstructive sleep apnea in order to achieve complete disease alleviation: from taboo to new standard of care.” Journal of Dental Sleep Medicine 2.1 (2015): 7-8.

DentalSleepPractice.com

THERAPYchoices

No More “One Size Fits All” Sleep Appliance Therapy: Where It Is And What It Needs To Be by Rob Veis, DDS

here are easily more than a hundred dental sleep appliances on the market today. All of them are different – some in ways more subtle than others – but different nonetheless. And that number is growing, bringing us better designs that include modifications on current appliances and totally new appliances, as well. Every patient is unique. One may have periodontal issues, another may be partially edentulous and yet another may be a severe bruxer. Each has their own “dental landscape.” When you take into account the variety of appliances and the uniqueness of every patient, it becomes crystal clear that finding the ideal sleep appliance to treat your patient is not and has never been a matter of “one size fits all.”

26 DSP | Winter 2015

So how do you know which sleep appliance is the right one for any given patient? Almost all of us begin our venture into sleep therapy by using one appliance. Whatever the reason, whether your friend or colleague recommended it or you read about it in an article or you went to your first sleep class and that’s the appliance they taught… chances are you start with one. Even if you’re lucky and your “oneappliance armamentarium” ends up being the perfect choice for most of your sleep patients, you’ll still need to learn how to meet the basic criteria for helping your lab provide you with a workable functioning appliance. You’ll need to know how to take a proper construction bite and/or impression for the

THERAPYchoices appliance in question. You’ll need to determine what your starting point is for securing the construction bite. Is it an end-to-end bite? Is it made at a point that captures a position that is 50%-70% of the maximum slide from centric relation to the most protrusive position? After you have treated your first two or three patients, it likely becomes quite clear that no single appliance will be the perfect fit for every patient. Each appliance has its own limitations and every patient is different. For example: • One type of appliance may hold the upper and lower jaw firmly together. For someone who is a mouth breather, this can prove to be nothing short of torturous. Claustrophobia and feeling locked-in easily leads to failure. • Or let’s say your appliance of choice is retained in the patient’s mouth by grabbing the undercuts that naturally occur in the dentition. If the patient doesn’t have enough back teeth to anchor the appliance, the appliance will not stay in the mouth. That can prove to be an expensive mistake. • Some patients are lateral bruxers, so any appliance that prevents lateral movement may be less than ideal. In fact some sleep appliances will not survive the force of bruxing and will simply break. To be successful in deciding upon the right sleep appliance, you need to know: 1. Materials, qualities, design and functional specifics of the different appliances. Hard acrylic? Cad-Cam Appli-

ance? Does it allow lateral movement? Is it easily adjustable for patient and/ or doctor? How is it retained – ball clasps? Is it lined with thermoplastic material? Can you adjust it and reline it easily? 2. What are the controlling parameters in relation to the patient? You will need to perform a full and complete dental sleep examination and a TMJ exam. What are the number of teeth in both arches? Any signs of periodontal disease or decay? Are there broken fillings or crowns that Each appliance has its need to be replaced? Signs of lateral bruxism? Does the own limitations and patient open and close com- every patient is different. fortably? What is the range of lateral movement? What is the range of movement from centric relation to the most protrusive position? What is the size of their tongue, the size of their arches, the patency of their nasal airway? Look at the tonsils, adenoids, the soft palate, hard palate. Do they have a high vaulted palate? Are they a skeletal class l, ll, or lll? As a dentist we should be looking at all possible levels of obstruction: nasal, oral and hypopharyngeal airway space. Knowing the answers to these questions is of primary importance. 3. Is a combined therapeutic approach warranted? I feel that one of the main reasons that appliances don’t work at a higher success rate overall is a combined therapeutic approach, while often needed, is seldom considered.

Dr. Rob Veis began practicing in 1984 as a solo general dentist and has been a part of both solo and group practices since then. A graduate of USC Dental School, he taught for 12 years at the University of Southern California as a Clinical Professor in Restorative Dentistry; is an internationally renowned lecturer (at locations including UNLV, Columbia University, Loma Linda University and NYU) on the topics of Dental Sleep Medicine, Orthodontics for the General Practice and Appliance Therapy; and has served on the faculty of the Las Vegas Institute of Advanced Dental Studies. He is the co-author of The Principles of Appliance Therapy for Adults and Children – considered one of the definitive texts on the subject – and has lectured extensively for the Academy of General Dentistry-sponsored mastership program.

DentalSleepPractice.com

THERAPYchoices Even when you choose what you believe to be the best appliance for the patient, even when you have a firm grasp of the patient landscape, even when you cover all the basics and evaluate all the single appliance possibilities, it may not be enough. You still may need to implement a combined therapy approach. I feel that one of the main This approach may prove as simple as prescribing a sleep appliance reasons that appliances don’t work at a higher with a nasal strip – to encourage the patient to breathe nasally and keep success rate overall is that the air passage open. It may be as a combined therapeutic detailed and in-depth as employing CPAP with an appliance of choice. approach, while often What if your patient’s nose is needed, is seldom completely blocked? Perhaps they considered. have a significantly deviated septum or polyps obstructing the nasal airway. For a patient like that, therapy may include airway surgery before adding an appliance. Because every patient is different, here are some sample combination approaches for your consideration:

to evaluate those patients for sleep apnea. They may be your orthodontic patients, but you should also view them as potential sleep patients. Luckily for those undergoing Invisalign therapy, we have an appliance – the ASA -that can be utilized during Invisalign treatment and will allow you to treat that patient’s apnea concomitantly. Not only will you be improving the size of their arches and their intraoral volume, you also will be helping them sleep better during the treatment. For those of you doing orthodontic appliance therapy with adult patients, a DNA appliance (and its partner, the mRNA device) are both known to be successful at treating their apnea as well.

The Lamberg™ Sleepwell

The Aligner Sleep Appliance™ (ASA) and the DNA Appliance

Lamberg™ Sleepwell appliance

Aligner Sleep Appliance™ (ASA)

DNA Appliance

I think it’s fair to say that there is a direct correlation between malocclusion and sleep apnea. Research will back me up on this. Those of you who are treating malocclusion patients – Invisalign or adult patients – with an appliance approach, need

28 DSP | Winter 2015

If you’re treating a patient for bruxism, TMJ or any condition somewhere within the spectrum of joint dysfunction – pop/click, pain, etc., it’s in your best interest to exercise caution when prescribing a splint/orthotic without testing them for a sleep disorder. Numerous articles and investigations confirm a definite link between bruxism and sleep apnea. And although the research is ongoing, it’s pretty clear that a high percentage of the bruxing population will also suffer from sleep apnea. Designed to stop bruxism and reposition the mandible, the Lamberg™ SleepWell may be the ideal solution for a bruxer.

SPACE MAINTAINERS LABORATORIES

Narval™ CC

EMA

The Adjustable Herbst™

Medicare Approved

Lamberg™ SleepWell

Aligner Sleep Appliance™ (ASA)

The Full Breath™ Solution

Zyppah® V

The Adjustable Dorsal

Tap 3 Elite

ISTRA

Medicare Approved

R O P

THERAPYchoices The Full Breath™ Solution and Zyppah™

Full Breath™ Solution

Zyppah™ appliance

Many doctors will swear that it is better to control the tongue without venturing into Mandibular Advancement Devices. MADs change the occlusion. They just do. For patients with a large tongue, mandibular advancement may not be successful enough. Sometimes tongue retention is preferable for correcting what is wrong, if a patient experiences pain The future of sleep is especially with a MAD. The Full Breath Solution™ active prevention and and Zyppah™ Appliances provide the active treatment of greatest promise for such approaches. In many cases, the expectation that the entire spectrum you might get everything done with of sleep disorders. a single appliance approach – or that one size fits all and all you have to do is put the thing in your patient’s mouth – is foundational to why we experience a 50% success rate as opposed to a 90% success rate. You can improve your success rate if you take a close look at both appliance potentiality and pre-existing patient conditions – the full patient landscape, variables and all – and select an approach that will work best for the patient. The goal, simply stated, is to open the airway and keep it open. Whatever it takes.

Taking into consideration appliance characteristics and patient parameters, try and get as close as possible to the appliance – or combination approach -- that you think is going to work. What does the future hold? In addition to that steady stream of new designs spoken of earlier – and ongoing research and development into the utilization of low level oxygen delivery/mechanisms for treating OSA – there’s another emerging trend/concept/ awareness that has my immediate attention: the application of microchips in what I term “accountability therapy.” We must be able to make sure that our appliances are actually being used. Taking a sleep test to show that the appliance works when it’s worn just isn’t enough. We’re going to have to show that the patient is actually wearing the appliance – similar to what is already being done in CPAP therapy. That level of accountability promises to be a definite game changer in the field of sleep. Early recognition and prevention are the real game changers. Most sleep appliances today are essentially band-aids. They manage the problem of OSA but they don’t prevent it. The future of sleep is active prevention and active treatment of the entire spectrum of sleep disorders. The possibilities, as they say, are endless. Confidence in the here and now of sleep appliance therapy is a function of first embracing the fact that selecting the right appliance for your patients is never a case of “one size fits all.” Even when you’ve chosen what you believe to be the perfect appliance, it may still fail for a host of other reasons, e.g. inaccurate records, incomplete information, reluctance to consider combination therapy. Match the materials and technological componentry to the existing dental landscape of each individual patient….and then explore the third variable – the possibility that combined therapy may just be the “fitting” solution.

For more on the range of available sleep appliances for all types of sleep appliance therapy, be sure to access and review our extensive sleep section at SMLglobal.com. Or call us at 800-423-3270 to schedule a 30-minute Powerpoint presentation or custom webinar/workshop detailing how our sleep experts and appliances can help you integrate sleep therapy into your growing practice.

30 DSP | Winter 2015

FDAoversight

The Regulatory Side of Oral Sleep Devices by Laura Sheppard, CDT, TE

dental laboratory technician is rarely seen by the patient, yet is always in the foreground of a successful device. For many years, when lecturing to my contemporaries and newcomers, I often joked that “we are the Men in Black, no one knows we exist”.

Up until the 1990’s, dental labs and technicians have only been required to comply with the state Dental Practice Acts of the states they conduct business in. And while each state has differing requirements, it is and has always been the responsibility of the technician and the dentist to insure this compliance. But in 1994 the Food and Drug Administration determined that dental devices for obstructive sleep apnea were to be classified as Class II medical devices. This meant that any device carrying the claim of treating a medical disease, had to be registered with the FDA. Those of us that had been making sleep devices for our dental clients were sent into a tail spin, not knowing what the implications would be. For dental labs, the FDA stepped forward as our new regulatory body to insure patient safety. Any labs manufacturing these devices would have to register and pay annual fees. For inventors, in order to register a device, premarket approval would be required. Section 510(k) of the Food, Drug and Cosmetic Act requires that a Class II medical device owner must notify FDA of their intent to market a medical device at least 90 days in advance. While a notification sounds simple enough, it’s the approval process that has

evolved into an incredibly laborious and costly venture for all parties. And it’s that approval that must be obtained before a device can be registered or manufactured for patient use. The testing and documentation required to earn a 510(k) approval in the best case scenario can actually take from 6-9 months and most often requires the services of a regulatory professional and possibly even chemical laboratory and material testing facilities. Further historical events have shaped the regulatory oversight that is in force today. In 1997, the FDA established 21 CFR Part 820 as a code to regulate imported dental items. Known as the Quality System Regulation code, it identifies Good Manufacturing Practices (GMP) for manufacturers. Then in 2004, the FDA confirmed to the National Association of Dental Laboratories (NADL), that all labs must comply with the FDA’s QSR code and GMP requirements insuring properly labeled and designed dental products for their intended dental procedure. The most common third-party auditable GMP system certification for labs is the DAMAS (Dental Appliance Manufacturing Audit System) or ISO (International Standards Organization) certifications. Finally, you may remember in 2008 we had the “Lead in Crowns” scare, which DentalSleepPractice.com

FDAoversight

Any device carrying the claim of treating a medical disease has to be registered with the FDA.

opened up an entirely different realm of issues, but most importantly placed a public spotlight on dental laboratories. No longer the Men in Black, this lead to the FDA’s determination and notification that all dental laboratories would now be under their purview and part of their “investigational inventory“, and as such would be subject to inspection. Dental labs would now be audited for their GMP’s to include complaint systems, lot number tracking for materials, vendor verification systems, recall systems, and much, much more. They also must understand and be able to verify the safety of dental devices, outsourcing requirements, dental technician competency, gray market materials, etc. Today, many labs are rolling the dice. Some know their dentist-clients are unaware and are counting on the lack of FDA resources to conduct audits. Others are unaware or misinformed. They do not have quality systems in place. They are not registered nor do they follow regulatory requirements. Many dentists do not know these requirements, either. It remains the joint responsibility of the lab and the dentist to insure regulatory compliance for the safety of the patient. The most significant facts and rules that are unknown or overlooked are: • U.S. Law: Unlike our EU counterparts, United States dental lab technicians are not required to have a formal education, specific training or demonstrate core competency. Like ‘Diplomat’ status, becoming a Certified Dental Technician is a challenging, but voluntary achievement. • All State Dental Practice Acts: A lab may NOT proceed with manufacturing a den-

•

tal device or restoration without a signed Rx. FDA GMP will require you to call the prescribing dentist and ask for a signature. In all my years, it is rare I that I find a dentist that is understanding and not angry at the required ’stop work order’. Inconvenient? Yes. But it’s the law. In fact, it’s the dentist’s own law. All State Dental Practice Acts: A lab may NOT proceed with manufacturing a dental device unless prescribed by a dentist; not an ENT, medical doctor or surgeon (unless a dental/oral surgeon). Some State Dental Practice Acts: State requirements vary and may not include any patient safety measures at all. While some states require such things as lab registration in state, full material disclosure on invoices, point of origin disclosure on invoices, jurisprudence testing, a Certified Dental Technician (CDT) on staff, denture/partial or removable appliance identification, etc. And some states do not allow such things as technician shade taking and denturism. FDA: Even with a dentist’s prescription, dental technicians may NOT design or manufacture a device for a dentist (even as a singular patient-specific device) if the prescription states it is for the treatment of obstructive sleep apnea (a Class II device) and it does not already have a 510(k). ◦◦ Lab prescriptions and invoices are subject to FDA audit FDA: Labs may NOT manufacture a Class II medical device unless they are FDA registered as a Manufacturer or a Contract Manufacturer.

A practicing dental technician since 1979, Laura Sheppard holds an Associate’s Degree in Dental Technology and a Bachelor’s Degree in Allied Health Teaching. She is certified in Orthodontics, Crown & Bridge and Complete Dentures. Laura owned her own full service dental lab for 7 years then moved to serve Dental Services Group’s Davis Laboratory for 22 years. At DSG Davis, she developed their Ortho and Splint and Sleep departments, then served as their Director of Training & Education and Director of Quality & Compliance. In 2012, Laura joined the Microdental Laboratories team where she was Senior Director of Quality, Compliance and Regulatory Affairs. Laura has earned DAMAS certifications, successfully coached over 45 technicians to achieve their national certifications and was instrumental in the invention, patent and 510(k) submission process of several successful proprietary Class II medical device products for both of these laboratory conglomerate companies. Laura has been manufacturing dental sleep devices since 1988 and has been an active participant with the AADSM since 1991. She is now the owner and managing member of Device Masters Dental Laboratory in Traverse City, Michigan, providing devices for dental sleep medicine, TMJ dysfunction and orthodontics. Laura currently serves on the NADL Board of Directors and is the Immediate Past-Chair of the National Board of Certification. Laura lectures for both, the dental practitioner and dental technician communities, and is well published having written numerous articles for JDT, IDT, DPR, DLP, LMT and Sleep Review. In 2011, she was named one of the Top 25 Women in Dentistry by Dental Products Report.

32 DSP | Winter 2015

FDAoversight ◦◦ Some labs assume that vendors who sell the parts or kits are the liable party for registration. This is not true. If you are not the 510(k) owner and manufacturer, then you are a Contract Manufacturer (approved to manufacture by the owner) and must be registered as such. • FDA: U.S. labs that outsource a Class II medical device to be manufactured in a different domestic facility must be FDA registered as a Repackager/Relabeler. ◦◦ These labs must also disclose the outsourcing to the dentist on the invoice. For an entirely outsourced case, this message may look like “designed and distributed by ABC Lab” (not “manufactured by ABC Lab”). For a portioned case, the message should look like “x part manufactured by ABC lab” and “x part distributed by ABC Lab”. • FDA: U.S. labs that outsource a Class II medical device to a non-domestic facility for manufacture and then import directly from the non-domestic facility must be FDA registered as an Initial Importer. ◦◦ FDA: These labs must also disclose the outsourcing to the dentist on the invoice, in the same manner as domestic requirements. ◦◦ CBP: Customs and Border Protection Act also requires the end user (defined as the dentist not the patient) to have been given notice of the actual address of the manufacturing facility if it is located out of the United States. • FDA: U.S. labs that outsource a Class II medical device to a domestic facility for non-domestic manufacture and then receive from the domestic (exporter) facility must be FDA registered as a Distributor. ◦◦ These labs must also disclose the outsourcing to the dentist on the invoice, in the same manner as domestic requirements. ◦◦ CBP: Customs and Border Protection Act also requires the end user (defined as the dentist not the patient) to have been given notice of the actual address of the manufacturing facility if it is located out of the United States. As a final point in fact, in the United States, healthcare compliance is also required and guaranteed by law. Understanding the existing laws, whether we agree with them or not, is imperative to patient safety. We all know

that healthcare should be offered with the best and safest services possible. We’re no longer the Men in Black. Regulatory oversight is here. And they’re here to stay. When it comes to designing devices, inventors need to operate within the FDA and 510(k) guidelines, instead of asking a laboratory to manufacture a non-regulated device design. Dental labs should only be manufacturing a licensed device with the contract approval of the inventor or 510(k) owner and they should be registered as a contractmanufacturer. Additionally, all sleep device manufacturing labs need to be FDA registered, outsourcing must be done with full and proper disclosure and materials must be FDA registered and accepted. Ignorance of the law excuses no one. Dentistry, clinicians and laboratories alike, must do their best to become informed and act in accordance to provide the highest level of medical device service for their patients.

Understanding the existing laws, whether we agree with them or not, is imperative to patient safety.

It’s Here!! Wear it. Trac it ®. DentiTrac ® DentiTrac is now available in the USA for use with select appliances.

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DentalSleepPractice.com

ORIGINstories

by Sarah C. Shoaf, DDS, MEd, MS, D.ABO, Editorial Advisor for Dental Sleep Practice

t is hard to believe, but some of us were working with sleep appliances in the early 80’s! I was asked to teach a special “Orthodontic Topics” course to residents, and thought the creation of oral appliances for sleep disorders was a “cutting edge” topic. Some of the early sleep appliances were shown in the literature at that time with only anecdotal evidence of their efficacy.

My first position as faculty in a medical school with a dental residency program continued the interest in the appliances. Our medical school was just beginning to develop its sleep program, and the new director of this program asked me if I had any interest in providing sleep appliances to the program patients. After much research into the available appliances, I worked with Allesee Orthodontic Appliances with an initial design and began learning more about appliance positioning, fabrication, and adjustments. As I continued to work with the AOA lab, one of its laboratory supervisors also gained an interest in sleep appliances due to his personal diagnosis of mild obstructive apnea, so the Breathe Easy appliance was born. Since its inception, the one-piece appliance has undergone FDA certification. I find this appliance to be extraordinarily durable (lasting many patients 5+ years) and comfortable to wear due to a softer lining with a harder outer shell. Its only drawback is due to its one-piece nature, it is not adjustable, and must be remade if changes in jaw position are required. Over the years, I have “inherited” a number of adjustable, multiple-piece appliances as resDr. Shoaf with her staff and her 1500th orthodontic idents and patients moved in banding patient. Dr. Shoaf started her own office in January 2012. This photo was taken in July 2015. and out of the medical center,

34 DSP | Winter 2015

and found most of the multi-piece appliances tended to break within 6-18 months. As most insurance companies are hard-pressed to pay for one appliance, paying for a replacement appliance was even more difficult to effect. Therefore, I traded durability for adjustability. The whole design and effort really came home when I myself was diagnosed with mild sleep apnea. As a proud wearer of an oral appliance, I came to appreciate good retention, durability, and an easy-to-clean appliance. I faithfully take lateral cephalograms on my patients with and without the appliance, and do feel the ones who receive the most benefit are those who achieve good protrusion and opening. Appliances are not all “one hit wonders” and long-term follow-up of patients is crucial. A number of patients, including myself, eventually develop changes in occlusion due to long term wear of the appliance, as it is similar to an orthodontic functional appliance. My present endeavors are to work with AOA to develop a system to allow Invisalign treatment for orthodontic correction while an appliance is worn, to allow arch alignment as well as A-P alignment using elastics. I also have a number of patients who would like to align their teeth, but find they cannot survive without their oral sleep appliance, and therefore have to make a choice of alignment vs. sleep. With new developments of the Breathe Easy, I believe both can be achieved for the best overall treatment of a patient. My biggest excitement over the years comes from the changing of technology and how that has modified how I make sleep appliances. Initially, alginate impressions were made, with a stack of 3 wax bites together to make the protrusive bite registration. The wax was unreliable at best, with changes just from placement to removal from the patient’s mouth, not to mention having to ship it from my southern location during the hot months of

ORIGINstories the year. PVS bite registrations eliminated the wax problems, but still left alginate impressions and their relative inaccuracies. For the last 2 years, I’ve used an iTero scanner to scan my sleep appliance patients. This gives us greater accuracy, as well as “instant shipping” of the virtual models directly to AOA lab for 3-D printing. The iTero scanning software allows a direct connection with AOA lab. Patients love the scanner as they are no longer held hostage by gaggy PVS material that seems to take forever to solidify. The patients also love that any remakes only require a quick bite registration, as the “models” are digitally stored. I also note

the appliances made from the scans fit better and need fewer adjustments at the initial appointment, which saves both the patients and my staff additional time. This has been a wonderful 25 year journey of sleep patient treatment. My collaborations with sleep medicine colleagues, changes with insurance policies for payment, scanning technology, and alternative designs have all made the construction of an oral sleep appliance more enjoyable and more accurate for the patients. I look forward to another 25 years of sleep medicine and its help to all needy patients.

Originally trained as a Physician Assistant with an undergraduate degree from Wake Forest University, Dr. Sarah C. Shoaf completed a Masters in Education at University of New Orleans before matriculating to dental school at the University of North Carolina at Chapel Hill. A Dentist-Scientist award recipient, Dr. Shoaf received her Orthodontic Specialty Certificate and Masters in Biochemistry/Genetics from Eastman Dental Center and University of Rochester. Dr. Shoaf became a Diplomate of the American Board of Orthodontics in 2003. On faculty as the Staff Orthodontist at Wake Forest University School of Medicine for 17 years, Dr. Shoaf moved to private practice in 2009. Along with interests in Dental Sleep Medicine, Dr. Shoaf is also a trained forensic odontologist and worked with the NC Center for Cleft and Craniofacial Deformities. Her husband, Alan, is an underwater photographer, so she enjoys scuba diving and traveling the world, along with golfing, sourdough bread baking, and jewelry making.

Breathe Easy™ Appliance Options Breathe Easy Splint - made of a durable, dual hardness thermoplastic. The soft inside portion fits against the teeth and is flexible for maximum comfort while the outer edge is firm for maximum durability. Breathe Easy Splint is just 3mm thick and under normal use lasts for at least three years. Also available in upper only.

“The Breathe Easy Sleep Appliance by AOA is durable, easy to fit, comfortable, and quite effective with our mild to moderate sleep apnea patients. With scanner technology, we find we can get great turn around at reasonable pricing. My patients have used this appliance since its inception, and find it very patient-friendly, simple to clean, and easy to wear.” Dr. Sarah Shoaf, Winston Salem, NC

Breathe Easy Herbst - postures the mandible forward into a “Class III” relationship. It is fully adjustable, providing patients the ability to advance the mandible in small increments until the OSA symptoms have diminished. Breathe Easy EMA - consists of upper and lower pressure formed splints. Special pads are embedded in the posterior quadrants to produce a freeway opening. A kit of interchangeable elastic straps provide for easy advancement.

For more information on our Breathe Easy appliance options, Call Today 800.262.5221, or visit us at aoalab.com.

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MEANINGFULconversations

te a e r C s t s nti e D ep e ? l s S p i d h n s a n s o i n t a a i l c e ip i h R s s r y e c Ph mbioti Partn n n a a i C y ysic h S P g n and i t t s i t s n La De p cian e e l Clini S e

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, BA Bride

H, S , CCS

reating patients with breathing disorders associated with sleep has become the fastest growing new area of diagnosis and treatment in Dentistry today. Thatâ&#x20AC;&#x2122;s right; breathing disordered sleep, not sleep disordered breathing. Improper breathing dis-orders the sleep, not the other way around. The time is rapidly coming when patients will be referred to us from just about every medical specialty, and we need to know what is expected, wanted and needed by each and every one of these referring physicians. 36 DSP | Winter 2015

Today, there is an increased urgency to partner the Dentist and Physician symbiotically to better serve an exploding patient population. Not only are the numbers of affected people growing at an alarming rate, but the age demographic of the patients screened and treated has decreased dramatically from the early days when OSA was considered a disease of big fat old men to one where very young children and thin fit women have been discovered to suffer from the very same breathing disordered sleep problems. These

MEANINGFULconversations include UARS (upper airway resistance syndrome), OSA (obstructive sleep apnea), and many other disorders of breathing and sleep, all of which fragment sleep and affect their daily lives. For the dentist, the obvious place to start screening patients for airway disorders is with one’s entire patient database. No man, woman or child should be left unscreened. But, what happens next and how do you relate your findings to the patient’s physician? Depending on the state where you practice, it can be illegal for the dentist to order diagnostic testing. If ordering diagnostic testing is permitted, referring a patient for testing, circumventing the physician of record, may not win friends or influence potential referrals to your growing “sleep practice.” A positive screening is the door-opener to a partnership conversation with a primary care physician or specialist. Garnering and keeping relationships with the physicians of your own patients can definitely lead to referrals of their other patients to your practice. One way to begin the process is to locate the Sleep Lab(s) in your area and start there. The director MD of the lab can be a critical ally in your mission to serve your community and treat these patients. And, physicians want to hear just that. You are reaching out in partnership to help them walk these people towards wellness with much more than a plastic appliance to help open the airway while they sleep. They want to know how you are going to help, what modalities of additional therapy you use besides the oral appliance, and whether or not you are going to fully invest in the wellbeing of these people’s lives and futures. They desperately need help managing the patients who RTC (return to clinic) or loop back over and over again throughout the year with ailments stemming from untreated breathing disorders of sleep. What they absolutely do not want to hear is that you want to sell anyone anything. Oral appliance therapy is a precise and exacting dental application to treat a serious and potentially life threatening medical condition. Stepping into the world of the physician requires that you speak their language. Are you fully informed about the signs and symptoms of disordered breathing as it applies to each of the medical specialties-pulmonary, neurology, etc.? Can you speak to

a pulmonologist or cardiologist in terms he or she understands, and are you able to show them refereed literature supporting what you are telling them? Believe it or not, they will notice if you belong to their own organizations: The American Thoracic Society, American Academy of Sleep Medicine, American Top left: Contra Costa Sleep Lab with Dr. Michael Academy of Dental Sleep Med- Cohen. Top right: Sleep clinician in Dental Sleep icine, or the American Acade- Medicine Offices of Michael J Selleck. Bottom right: my of Physiological Dentistry Lecturing at AAPMD and Medicine. It is essential to have a complete understanding of just what they deal with on a dayto-day basis in terms of economics. Let’s be honest here: dentistry is a fee for service basis in many areas, yet it simply doesn’t work that way in medicine. If you wish to capture and keep MD referrals, you had better be prepared to change your business model and expectations regarding fees. As an example, if the MD you really want to partner with be-

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

Interactive patient care

Specialist Physicians, first and foremost, want to understand what you know and exactly what you are doing with the patients they entrust to you.

38 DSP | Winter 2015

longs to a medical system or an IPA (Independent Practice Association) they often cannot refer to you unless there is absolutely no one in the network who performs the services required. If even one dentist is in their system, you will never get the referrals, nor will you get out of network fees, out of network exceptions (GAP), or letters of agreement (LOA) for payment on your submitted fees. If you are out of network, the patient’s pre-certification for care will come back either rejected, or with a list of in network providers and a strong warning about the consequences of going out of network. Making the decision to join any managed care network should never be made lightly, but if it insures that the referral doors open and people walk through, it’s worth considering. When referring physicians treat Medicare patients, they are going to want to know that you can work within the confines of that system as well. We used to believe that treating the underserved and Medicare was important because, “It’s like taking care of our parents.” Okay fine, that was then, this is now, and now it’s us. Referring MD’s don’t ever want to send a patient over only to have them come screaming back through their doors upset that you either can’t or won’t deal with their insurance, and they are expected to pay the entire fee out of pocket and hope to be reimbursed. People generally want their insurance to pay for their care, and will expect you, their Dental Physician, to take care of the billing and claims processing just like at their primary care MD’s office. Specialist Physicians, first and foremost, want to understand what you know and exactly what you are doing with the patients they entrust to you. The Pulmonologist/Sleep MD for example will be thrilled that you want to help with the PAP (positive airway pressure) fail/refusal patient. These are often non-compliant patients in general, and of course we recognize there are many reasons for not using PAP therapy. These patients don’t watch their diets, don’t take medications regularly, don’t exercise, mouth breathe, have poor structural and oral postures, metabolic syndromes, do not control their stress, and present with numerous co-morbidities associated with sleep apnea. These people have likely already been through a lot already, so simply placing an oral appliance and doing nothing else, then hoping the AHI/RDI will

go down, is tantamount to rearranging the deck chairs on the Titanic. Do something positive with these patients; by demonstrating real improvement in their overall health status longitudinally, and you will win big with the referring MD’s. Pulmonologists are breathing gurus and clinicians of fairly singular focus when it comes to the Sleep dentists. Michael Cohen, MD, ABSM Chairman of Sleep and Pulmonary Medicine at Respiratory Medical Group in California states the expectations of the Sleep MD/ Pulmonologist simply: “We require that the Sleep dentist carefully evaluate the patient for an oral appliance. He or she must have a complete understanding of the polysomnography or out of center sleep test report results and how they relate to each particular patient’s general health status. If the patient has hypoventilation syndrome for example, the expectation is that the Sleep dentist has some sort of plan as to how to deal with this issue in addition to placing the oral appliance. We leave the process of appliance selection and fabrication to the Sleep DDS. This of course is where we rely on his or her particular expertise and abilities. The referred patient may have failed or refused PAP therapy, but alternative treatment modalities presented to them must have specific value to their particular syndrome. Prior to referral back, we like to see a written report documenting the nature and scope of the care rendered with request for post therapeutic sleep testing to prove efficacy and derived clinical benefit from the treatment.” So, this isn’t just about screening patients, and making them an oral appliance, is it? If you cannot get the patients to breathe properly during the day, how do you expect to fully help them at night? We breathe 24/7, so retraining brains to unlearn bad habits with proper breathing and oral posture will be part of the process. Eliciting the partnership of a local Otolaryngologist (ENT) is a must. People who cannot breathe through their nose may require any number of interventions in addition to oral appliance and breathing therapy. Everything from tonsils, adenoids, nasal turbinate reduction, septorhinoplasty, genioglossus and hyoid advancement surgery must be considered during treatment planning. The ENT and expansion/Orthotropic orthodontist will be your frontline referral for children. Referring back and forth to the

MEANINGFULconversations

Pat McBride with Dr. Andy Benn in office cardiology partnership

It’s what YOU do with the patients entrusted into your care by your colleagues, the local physicians, that really counts.

40 DSP | Winter 2015

ENT will exponentially improve the level of care delivered and patient outcomes. Good ENT’s will appreciate your referrals and if they understand the damage occurring in children with OSA, they will take an aggressive approach to removing tonsils and adenoids prior to or concurrent with expansion. Incorporating breathing exercise programs like Buteyko, or Pranayama Universal Breathing into your treatment model can seriously help move the airway patient further along towards wellness. Sleep apnea patients literally need to learn to shut their mouths and breathe through their noses. It is very likely that no one else before you has ever told them they should. Correcting oral posture through Myofunctional therapy, and possible release of frenulum or tongue-ties in addition to oral appliance therapy will effectively show the physician you possess a level of knowledge, expertise and understanding to treat their patients effectively. You will always spend more minutes per visit with your patients than any other care provider will. Incorporating many modalities to better serve this population will further improve your ability to partner with their physicians. When a patient is referred back to the Pulmonologist for follow-up sleep testing with the appliance, be sure to include a study or journal which further gives the therapy you render credibility. Many physicians know little or nothing about Myofunctional therapy, Orthotropics and or oral posture retraining. Andrew Benn, MD, FACC, Chairman, Section of Cardiology John Muir Medical Centers, is very clear about what the referring cardiologist wants and needs from the Dental Sleep Medicine Provider. “Cardiologists hope for three things in an alliance with a dental sleep provider 1) a diagnostic approach that patients will accept and be willing to undergo 2) a therapy they will accept, tolerate and use over a prolonged period of time 3) committed follow up to tweak therapies as needed, reevaluate the efficacy of implemented therapies and be a resource for patients rather than them looping back to the cardiologists who often are less informed on OSA and its treatment. Ideally, the dental sleep center would also provide a fourth, educational function for the cardiologists but that would require a more consistent commitment within the cardiology community to accept that: - OSA occurs in a high per-

centage of our patients. - OSA is, from an epidemiology standpoint, imparting negative prognostic effects on these patients – we can improve the quality of their lives if we are willing to get the ball rolling in the diagnosis and treatment of their OSA.” The Endocrinologist deals with metabolic syndrome, and like the cardiologist understands the direct correlation between disordered breathing of sleep and increases in metabolic syndrome. If they partner with you, they will fully expect the Sleep DDS to monitor the patient’s adherence to their medication and dietary needs during appliance therapy and beyond. Many of these patients suffer from significant GERD, a common comorbidity of the metabolic syndrome and they often do not realize that the GERD may be sequelae of apnea. Acid erosion on the teeth is a warning sign of both GERD and OSA. Physicians expect that a large portion of the time you spend with the patient will be in education and retraining of habits to improve overall health status. Meticulously study medical intake forms. Review the medications, and it will not be a surprise that the psychiatrist will be a specific and important partner for your practice. Obstructive sleep apnea has been associated with psychiatric pathology. Psychiatric comorbidity in OSA may affect patient quality of life and adherence to traditional PAP therapy. Psychiatrists don’t like having to constantly increase or change psychotherapeutics medications. Transitions on and off these drugs are always unpredictable and patients have a particularly difficult time with it. Many patients dealing with significant depression have some level of disordered breathing and sleep issues. Reach out to the Psychiatrist with literature regarding this direct correlation, and offer to help screen and treat their patients. You will find that compliance to PAP therapy is dismally low in depressed patients, but compliance with OA is relatively high, and once the sleep/respiratory disorder is treated, the depression often lifts considerably, requiring less medication. Patients with co-morbidities like metabolic syndrome, OSA and heart disease also suffer from ocular issues. Many a referral into our sleep lab has come from an Opthalmologist. Author and clinician Arun Prasad, MD notes, “There are a number of ocular conditions associated with sleep apnea: floppy eye-

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MEANINGFULconversations lid syndrome, nonarteritic anterior ischemic optic neuropathy, retinal vein occlusion, papilledema, and glaucoma, to name a few. As an ophthalmologist who specializes in glaucoma, I’ve sent several patients for sleep apnea testing. Studies have shown a correlation between sleep apnea severity and intraocular pressure, presence of visual field defects, and even decreased optic nerve perfusion. While more research needs to be done to further elucidate the relationship, it is important to be able to identify these patients so that they can undergo testing and be treated if necessary to decrease the risk of cardiovascular and neurological sequelae from untreated sleep apnea. Whether the Contra Costa Sleep Lab with Dr. Michael Cohen treatment is continuous positive airway pressure, an oral appliance or surgery, it is becoming increasingly clear that we need to adopt a multidisciplinary approach when it comes to sleep apnea.” As an author and researcher on glaucoma, Dr. Prasad values what the Sleep Dentist brings to the table. He understands that patients need a multidisciplinary approach to treat all of their issues, and therapy that they can live with on a day-to-day basis. Finally, we come to the physician who treats what I consider the most fragile breathing disorder patient, the pregnant woman. Regardless of her age, number of pregnancies or pre-pregnancy health status, pregnancy carries a host of medical complications which can threaten both mother and baby. Women in the second and third trimesters with a tendency towards hypertension and preeclampsia often present with sleep apnea. Partnering with the OB/GYN can quite

literally save lives. Getting that pregnancy to a full term delivery is critical; telling a tired, pregnant woman who isn’t sleeping well and feels exhausted that she now needs to strap on a PAP mask does not go over well at all. If she already has a small child she is getting up with at night, it’s guaranteed she’ll never treat her sleep. Assuming she did not have OSA prior to her pregnancy, we don’t really know at what point the OSA could be the result of the weight gain and stress from the pregnancy and may resolve post-partum. In these cases, you as the partner Sleep dentist can help tremendously by putting these PAP non-compliant/ refusal patients into a temporary appliance to get her through the delivery. The increase in her oxygen saturation levels and improved sleep quality during that final trimester may result in a birth at appropriate gestational age and fewer complications to both mother and baby. Pregnant moms are far more likely to place a provisional “boil and bite” you have made to get them through the pregnancy and then retest after delivery. If she tests positive for OSA, at that point you can decide which direction of therapy is appropriate. Partnering with physicians is critical to the development and health of your sleep medicine practice. Sharing is critical. Don’t be overwhelmed by “Everyone wanting a piece of the sleep dentistry pie.” There are going to be more people to treat than you will ever be able to handle alone. It’s what YOU do with the patients entrusted into your care by your colleagues, the local physicians, that really counts. Building these relationships takes time, perseverance and patience, but if even one person walks away healthier, happier and living their life as they should, I say it’s all good.

References 1. Cardiovascular Benefits of Oral Appliance Therapy in Obstructive Sleep Apnea: A Systematic Review. http://dx.doi.org/10.15331/jdsm.4430 Gilles Van Haesendonck, BSc1; Marijke Dieltjens, MBS1,2; Chloé Kastoer, MD3; Bharati Shivalkar, MD, PhD1,4; Christiaan Vrints, MD, PhD1,4; Caroline M. Van De Heyning, MD, PhD1,4; Marc J. Braem, DDS, PhD1,2; Olivier M. Vanderveken, MD, PhD1,3. University of Antwerp, Faculty of Medicine and Health Sciences, Antwerp, Belgium; 2Antwerp University Hospital, Department of Special Care Dentistry, Edegem, Antwerp, Belgium; 3Antwerp University Hospital, Otolaryngology and Head and Neck Surgery, Edegem, Antwerp, Belgium; 4Antwerp University Hospital, Cardiology, Edegem, Antwerp, Belgium 2. J Clin Sleep Med. 2015 Jan 15;11(2):165-75. doi: 10.5664/jcsm.4466. Obstructive sleep apnea and psychiatric disorders: a systematic review. Gupta MA1, Simpson FC1. 3. J Clin Endocrinol Metab. 2010 Feb;95(2):483-95. doi: 10.1210/jc.2009-1912. Epub 2010 Jan 8. Endocrine aspects of obstructive sleep apnea. Attal P1, Chanson P. Association of Psychiatric Disorders and Sleep Apnea in a Large Cohort. Amir Sharafkhaneh, MD1,3; Nilgun Giray, MD2,3; Peter Richardson, PhD1; Terry Young, PhD4; Max Hirshkowitz, 4. PhD1-3. 1Department of Medicine at Baylor College of Medicine, Houston, TX; 2Meninger Department of Psychiatry at Baylor College of Medicine, Houston, 5. Sleep Med Rev. 2005 Jun;9(3):211-24. Sleep apnea is a manifestation of the metabolic syndrome. Vgontzas AN1, Bixler EO, Chrousos GP. 1Department of Psychiatry H073, Penn State College of Medicine, 500 University Drive, Hershey, PA 17033, USA. axv3@psu.edu TX; 3Michael E. DeBakey VA Medical Center, Houston, TX; 4University of Wisconsin, Madison, WI 6. Sleep-Disordered Breathing During Pregnancy. Chakradhar Venkata, MD and Saiprakash B. Venkateshiah, MD Crit Pathw Cardiol. 2015 Jun;14(2):81-5. doi: 10.1097/HPC.0000000000000044. Obstructive Sleep Apnea and Atrial Fibrillation: Pathophysiology and Implications for Treatment. Maan 7. A1, Mansour M, Anter E, Patel VV, Cheng A, Refaat MM, Ruskin JN, Heist EK. 8. Metabolic syndrome is associated with gastroesophageal reflux disease based on a 24-hour ambulatory pH monitoring.Kallel L1, Bibani N, Fekih M, Matri S, Karoui S, Mustapha NB, Serghini M, Zouiten L, Feki M, Zouari B, Boubaker J, Kaabachi N, Filali A. 9. Obstructive sleep apnea, gestational hypertension and preeclampsia: a review of the literature. Pengo MF1, Rossi GP, Steier J.

42 DSP | Winter 2015

Discover the Narval difference Known for innovation and excellence in sleep-disordered breathing for more than 25 years, ResMed has revolutionized oral appliance therapy for the treatment of obstructive sleep apnea (OSA). Discover how you can deliver a great fit for each patient with Narval CCâ&#x20AC;&#x2122;s advanced CAD/CAM precision technology, the unrivaled alternative to thermoform and acrylic.

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PRODUCTspotlight

Narval CC: Delivering on Innovation for the Treatment of Obstructive Sleep Apnea by Tom Barman

ince introducing Narval CC into the North American market a few years ago, ResMed has continued charging forward in its quest to change millions of lives by increasing awareness of the adverse health effects of sleep disordered breathing, as well as by engaging the medical and dental communities to help strengthen collaborative efforts along the continuum of care.

ResMed global headquarters in San Diego, CA

44 DSP | Winter 2015

In so doing, ResMed has taken a balanced and meticulous approach to the evolution of its proprietary Narval CC CAD/CAMdesigned mandibular repositioning device (MRD) amidst the spectrum of more traditional oral appliances that the dental community has been accustomed to prescribing for the treatment of obstructive sleep apnea (OSA). Along these lines, ResMed has set the bar high in its adherence to various standards of excellence that have touched all aspects of Narval CC’s evolution – from continued innovation to evidence-based medical research to rigorous quality standards – facets that have collectively validated the clinical value and utility of Narval CC. At the center of Narval CC’s approach to innovation has been a patient-centric design philosophy that fosters ongoing feedback from ResMed’s customers, including dentists, sleep physicians and other stakeholders in the medical community. Such insights provide clinical and practical perspectives that form the basis for driving new innovations and continuous improvements for the portfolio.

ResMed’s Narval CC

With multiple design variations that address a diversity of clinical needs, there are many intricacies that have been factored into Narval CC’s ongoing evolution (patient comfort, optimal retention, clinical efficacy). And when it comes to new product development, an agile approach – driven by prototyping, continuous testing and granular customer feedback – is employed to ensure that such innovations are optimized for market introduction. And it is precisely this approach that ResMed has taken for its new Narval CC design variation that contacts the anterior teeth – slated for commercial release this winter. When it comes to clinical performance, Narval’s evolution has and continues to be benchmarked through evidence-based medical research. The ORCADES study, by ResMed, is an ongoing five-year, prospective multi-center study that is monitoring the efficacy of Narval in real-life conditions. Interim results published to-date have been positive, with significant reductions in Apnea Hypopnea Index (AHI) reported, high levels of subjective compliance, beneficial effects on cardiovascular parameters including reduction of blood pressure in patients with hypertension, and improved quality of life. Additional data and results from ORCADES will continue to be published over

PRODUCTspotlight

time. It is intended that this rigorous evidence will raise the bar for oral appliance therapy while increasing attention from sleep physicians. Behind the scenes, ResMed’s philosophy of continuous improvement is also leveraged for Narval CC and its proprietary CAD/CAM technology, as such improvements enable product innovations to be executed with absolute precision and operational efficiency. Just as companies like Apple and Microsoft continually improve and upgrade their software and operating systems, so, too, does ResMed in its effort to keep Narval current and progressive as the market continues to adopt digital technologies in the dental field. As a worldwide leader in developing innovative devices and treatments for sleepdisordered breathing, ResMed’s adherence to extremely rigorous quality and regulatory standards are also engrained into its culture. From minor design modifications to new design variations to CAD/CAM technology upgrades, a multitude of quality and design controls are followed to ensure that the final product consistently meets expectations. Risk analysis, software validation and verification, biocompatibility and materials testing, regulatory compliance, and various other checks and balances are routinely employed, and

these essentials remain contributing factors to the ongoing success of Narval. ResMed has pioneered and innovated Narval CC’s proprietary CAD/CAM technology in the North American market. Through concerted efforts focused on product innovation, evidence-based medical research, and rigorous quality and regulatory standards, Narval CC has increasingly earned the trust and confidence of multidisciplinary teams including dentists, sleep physicians and other healthcare professionals as a preferred treatment option for their patients with OSA, further delivering on ResMed’s mission of changing lives with every breath. For more information on Narval and ResMed, visit www.resmed.com/narval.

Tom Barman joined ResMed in early 2015 as Senior Product Manager, where he currently manages ResMed’s Dental Sleep business for the Americas. With a diverse business and marketing background, he brings more than 10 years of expertise from leading companies in the dental, medical device and biotechnology sectors.

DentalSleepPractice.com

ORTHO connection

Moving Teeth and Moving Air Two Systems, Great Results by Mark Abramson, DDS

he OASYS™ is one of the most versatile appliances on the market. Besides packing the punch of three different distinctive actions in one simple device, it has versatility in use in many special situations. We all know that the OASYS™ is the only sleep device cleared by the ENT division of the FDA to treat nasal resistance with it’s patented nasal dilators but did you know that it’s special design makes it the preferred appliance to use in many other situations you will commonly encounter?

OASYS™ and Invisalign

Patients with airway problems commonly present with craniofacial and dental discrepancies that require orthodontic treatment in addition to their airway treatment or they simply wish to have orthodontic care for their aesthetics or crowding. The OASYS™ is the perfect appliance to use to combine Invisalign orthodontic treatment and airway therapy with oral appliances. We all see a number of cases in which the patient presents with a retrognathic mandible and in the process of mandibular repositioning the mandible became stable in a more protrusive posture. Many of these cases were

46 DSP | Winter 2015

The upper Invisalign aligner is used as the upper component of the OASYS.

class II div I or post orthodontic treatment in which they were treated with extractions or headgear. These cases required orthodontics to procline the central incisors and sometimes to correct deep bites and crowding. It is possible to treat the patient with Invisalign using the OASYS™ system due to enhanced design features. Whether the patient is already being treated for sleep apnea, wishes to have orthodontic treatment and needs to be able to continue their OSA therapy or the patient is in appliance therapy for sleep apnea and we see the need to add orthodontic care to the treatment plan, these clinical choices can be easily coordinated. The process begins with the patient workup using traditional orthodontic records and treatment planning. If the treatment can be

ORTHOconnection

The lower base of the OASYS constructed to accommodate the full series of aligners on a new OASYS or is opened up to allow the base to fit over the series in a previously made OASYS. The PVS is changed every three aligners by removing the old and impressing new PVS over the next aligner.

OASYS appliance with dentures.

performed using Invisalign and OASYS™ appliance, the treatment is started by ordering the Invisalign aligners. The upper Invisalign aligners becomes the upper cushion component of the OASYS™ appliance - the system has the functional unit attached only to the mandibular arch and an “upper cushion” very similar to clear aligners. Used together, the upper arch aligners require no modifications to work as the upper component. For the lower arch the base of the OASYS™ will need to fit over the aligners in place and provide room for the changes desired over the course of treatment. If the patient is not currently using a sleep device, it is best that the impressions for the MAD be taken when the Invisalign is delivered and the buttons have been placed. The impressions are taken with the first aligners in place to approximate the spacing needed for future aligners and movement. A layer of PVS inner liner will provide

retention of the OASYS™ during treatment. If the patient already has a device, the base of the appliance is ground out to allow space for the aligner and future movement though the full course of treatment. At delivery, I insert the first aligners and place PVS impression material into the inner base and position the OASYS™ over the lower arch to mold the PVS around the aligner. The base may need a mechanical lock to hold it in as PVS does not adhere to the acrylic of the base. Cutting into the inner base or adding acrylic to form undercuts to the lower edges of the base in a couple of areas is usually enough mechanical lock. As the Invisalign treatment progresses, I will see the patient every six weeks or 3 aligners, pulling out the old PVS material and adding new material into the lower base. This takes very little time and is usually done by my dental assistant. These simple steps will allow you to partner with your patient to give them two good results. The small amount of extra work is a good investment for customizing your service! Join the rapidly growing number of doctors using the OASYS™ for combination of airway and orthodontic treatment.

OASYS™ and Upper Denture

After considering the OASYS™ device over aligners, it’s easy to see how it can also be used directly over an upper denture without any modifications. The denture is the upper element; by taking your typical lower impression, with your usual bite registration, you have it! Full denture cases still require implant support on the lower arch.

Dr. Mark Abramson is a TMJ and Sleep Apnea dentist, serving patients in Redwood City, in the San Francisco Bay Area. He attended the University of Maryland School of Dentistry where he graduated in 1975. Upon graduation he came to California to do a general practice residence at the Palo Alto Veterans Hospital. After his residency, he limited his dental practice to treating the special needs of those suffering with TMJ and headache and facial pain. Dr. Abramson is a Diplomat, American Academy of Orofacial Pain; Diplomat, Academy of Pain Management; Diplomat, American Academy of Dental Sleep Medicine; and a Fellow, Dr. Abramson is the driver for Dr. William American Academy of Craniofacial Pain Management. He is a member of the American Dental Dement, the ‘Father of Sleep Medicine’ Association, California Dental Association, American Academy of Dental Sleep Medicine where on the “Sleep and Dreams Shuttle” to his he is on the program committee, American Academy of Craiofacial Pain Management, Cranial class at Stanford University Academy and his dental license is extended to include acupuncture treatment. Dr. Abramson developed the O2 OASYS Oral/Nasal Airway System™ and in 2004 received FDA approval for this device. Dr. Abramson directs Stanford University’s Mindfulness Based Stress Reduction Clinic and teaches ongoing classes on this program through Stanford University School of Medicine. Dr. Abramson is a staff physician at Stanford University Hospital.

48 DSP | Winter 2015

COMBINATIONtherapy

Positional Therapy

A complementary tool to improve patient outcomes by Shad Morris, DMD

s pioneers in a unique branch of dentistry, you and I understand the complex nature of sleep disordered breathing. Not only are we dealing with a spectrum of breathing disorders and disease states, but treatments can often overlap. This complexity requires a thorough approach and gives us opportunities to seek out, educate, and work with other healthcare providers to deliver the most effective patient care. In my 13 years as a sleep dentist, I have seen oral appliances change thousands of lives. I have also worked on some particularly tough cases where oral therapy improved the patient’s situation but fell short of the desired results. That’s why I started studying and discovered the power of positional therapy when used as a supplemental treatment. I’m not alone – “Positional therapy makes oral appliance therapy more effective for my patients. It may seem simple, but it keeps them in the best position for a peaceful night’s rest.” says Dr. Steve Carstensen, sleep dentist. Here’s why it works: Body position can dramatically impact a patient’s ability to breathe and increase the severity of their snoring. Sleeping flat on the back causes the throat to relax and block the airway, which aggravates sleep disorders. Positional therapy is a simple behavioral strategy to keep patients on their side so breathing can return to normal. Anxious to improve patient success, I searched for an effective positional therapy device. Unable to find an adequate product that was affordable for patients, I made the commitment to develop Slumberbump. The Slumberbump is a lightweight, breathable sleep belt that trains individuals to sleep comfortably on their side. Our development team worked diligently to meet the following criteria so you and I can easily incorporate the Slumberbump into our current treatment methods: • Durable, lifetime satisfaction guarantee

• Simple, patients will actually use the device • Affordable, $49.95 patient cost To date, we have seen a 90% compliance and 80% success rate on positional sleep disorders. The sleep dental field will undoubtedly continue to grow through advancing research and technology, allowing our role as dentists to morph and expand. I know a multidisciplinary approach to patient care is absolutely necessary to get the results we desire for our patients. Oral appliance and positional therapy are a winning combination.

Position Your Patients for Sounder Sleep

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DentalSleepPractice.com

INSIDEtheLAB

Oral Sleep Appliance Management, Simplified! The DynaFlex Dorsal速 Accu-Fit Appliance by Stephen Tracey, DDS, MS

ould your sleep practice keep up with 500% growth? According to the American Sleep Apnea Association, 22 million Americans suffer from sleep apnea with the vast majority remaining undiagnosed. Frost & Sullivan, a leading consulting and market research firm, anticipate the market for oral appliances will double by the year 2020, with custom oral appliance revenues increasing five-fold during that time period. Appliance Selection

Along with the increase in numbers of patients seeking OAT, there has been a surge in the number and variety of oral sleep appliances available to practitioners of dental sleep medicine. With over 140 FDA approved oral sleep appliances currently available, dentists are often frustrated and confused when it comes to determining which appliances are most effective in treating obstructive sleep apnea (OSA), which appliances are most comfortable for their patients, and which appliances are the easiest to deliver, adjust and manage. As both a practitioner of dental sleep medicine and beneficiary of oral appliance therapy for many years, I have personally used nearly a dozen different appliances over the past decade. During that time I have determined seven key criteria that I

50 DSP | Winter 2015

INSIDEtheLAB believe to be absolutely essential in an oral sleep appliance. First, it must be FDA-approved for treatment of OSA. Second, it must be extremely durable and of high quality construction such that it will provide the patient many years of nightly use. I personally prefer to avoid vacuum-formed appliances and plastic inter-arch straps that tend to deteriorate both physically and esthetically quite rapidly. Third, it must be comfortable for the patient. This means as little acrylic and as few moving parts as possible. Fourth, it must be constructed of two separate parts (maxillary and mandibular) that allow for opening, sipping of water, and casual conversation with a bed partner. Appliances that are fabricated as a single unit, or even two separate parts that are locked together in the anterior are not tolerated as well by some patients, and in some cases even create a sense of claustrophobia. Fifth, it must maximize tongue space in the palate and between the anterior teeth. While most practitioners understand the importance of mandibular advancement in the treatment of OSA, creation of increased tongue space is often overlooked. Sixth, it must be adjustable in small increments. I have often found an adjustment of as little as 0.25 mm is all it takes to achieve a successful outcome while minimizing the possibility of long-term bite changes. And seventh, it must be easy to fit and adjust to the patientâ&#x20AC;&#x2122;s dentition. With this in mind, the oral sleep appliance I feel best satisfies these criteria at this time is a thermallyfitted dorsal appliance made by DynaFlex laboratory in St. Ann, Missouri.

DynaFlex DorsalÂŽ Accu-Fit Appliance

The appliance (figure 1) is a two-part mandibular advancement device that utilizes the time-tested dorsal design to guide and hold the mandible into the desired protrusive position. Adjustments of as little as 0.1 mm are possible with the adjustable screws embedded in the upper part of the appliance. Typically I use 6-8 mm of anterior opening for the fabrication of my appliances in order to reduce the amount of mandibular protrusion required and accommodate an anterior opening between the upper and lower parts of the appliance to allow for tongue space.

Figure 1: DynaFlex Dorsalr Accu-Fit

The body of the appliance is made of dense, durable, lab-processed acrylic, while retention is provided by an inner lining of thermal acrylic (figure 2). It is this unique feature that allows the appliance to be fit easily and comfortably each and every time with a minimal amount of adjustment and chair time. Another benefit of using thermal acrylic for retention is that it may be reformed in the event a patient requires future dental work that might otherwise render the appliance obsolete.

Figure 2: Accu-Fit Thermal Acrylic

Appliance Delivery

After years of using appliances that required time-consuming adjustments of acrylic and ball clasps at the delivery appointment,

Dr. Stephen Tracey is a native of Southern California and a graduate of Loma Linda University with a B.S. Degree in Human Biology, a D.D.S. Degree, and a M.S. Degree in Orthodontics. He is a member of the American Dental Association, the American Association of Orthodontists, the World Federation of Orthodontists and the American Academy of Dental Sleep Medicine, and has been appointed a Distinguished Fellow of the American College of Dental Science. As a pioneer in the application and use of soft tissue lasers in orthodontics, Dr. Tracey is also a member of the Academy of Laser Dentistry with proficiency certification in both diode and Er:YAG lasers. Formerly Orthodontic Instructor of the Year at Loma Linda University in 1995, he now serves as Visiting Professor of Orthodontics at the University of Ferrara in Ferrara, Italy.

DentalSleepPractice.com

INSIDEtheLAB

Figure 3: Cuisinart Electric Kettle

Figure 4: Heating Accu-Fit Thermal Acrylic

I absolutely love the ease and simplicity of fitting this appliance. Although the appliance comes fit-ready on digitally printed models of the patient’s dentition, we further customize it by heating the thermal acrylic liner material in hot water. Per instructions from DynaFlex, we heat water to a precise 160 degrees using an inexpensive electric kettle that can be programmed for the desired temperature (figure 3) and then pour the water into a disposable paper cup. The appliances are then placed in the heated water for 3-5 seconds to slightly soften the thermal acrylic prior to fitting them in the patient’s mouth (figure 4). Once seated, the appliances are cooled with a few short bursts of air from an air/water syringe and then removed for further cooling in cold water. Following this procedure ensures a perfect fit in a matter of minutes each and every time.

Confirmation of Airway Increase with CBCT

Although all patients undergo a period of titration, using a combination of methods such as audio sleep recordings with smart phone apps such as SnoreLab (iOS and Android), Observer Sleep Scale forms, and changes in Epworth Sleepiness Scale scores, we have found documenting airway volume changes (as well as condylar positions and bite changes) with CBCT scans extremely valuable. Utilizing low dose scans from our i-CAT FLX CBCT we are able to visualize paranasal sinus abnormalities as well as identify and measure airway restrictions. However, it is important to note that an awake, vertical airway is not the same as a sleeping, horizontal airway. Consequently, CBCT volume changes seen with mandibular advancement therapy should only be considered a small part of the total sleep disorder picture. In every case, once titration seems to have accomplished the intended outcome, follow-up PSGs or HSTs are always the final determinate of success.

Summary

Figure 5: Airway Increase with MAD

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Whether you’re considering entering the rewarding field of dental sleep medicine, or just reevaluating the sleep appliances you presently use, I highly recommend the DynaFlex Dorsal® Accu-Fit Appliance for your practice.

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510(k) Cleared Medical Devices

Phone: 800.489.4020 | Fax: 314.429.7575 | www.dynaflex.com *PATENT PENDING 090415 © 2015 DynaFlex® , St. Louis, MO 63074. Printed in U.S.A. All rights reserved. It is a violation of copyright law to reproduce all or part of this material, including photography, without the permission of DynaFlex®. Introductory offer not valid with any other discounts, promotions, or incentive pricing. No Cash Value. Offer Expires 12/31/16.

NEWideas

by Simon Ash, FDS, MSc, MOrth, BDS

reat Britain’s National Health Service probably doesn’t bring to your mind cutting-edge, problem-solving, longterm health focus. Maybe it’s time to rethink that view. Read on to learn how a passionate English orthodontist set out to help his patients, and his practice. In the early 90’s Dr. Simon Ash, a Consultant & Specialist Orthodontist, joined with Chest Medicine and ENT Consultants to create a multidisciplinary approach to treating sleep related breathing disorders, snoring and obstructive sleep apnea, within the National Health Service (NHS). The service was overwhelmed with patient demand. The patient experience and compliance when treated with plastic mandibular advancement devices was unpredictable. Patients complained of device bulk, failure, breakages, a dry mouth, device hygiene and limited device longevity. It was quickly realised that there just were not the time available to repeatedly see pa-

54 DSP | Winter 2015

tients with these problems and to remake and replace devices regularly. Unlike dental and orthodontic conditions, sleep related breathing disorders worsen with age and are chronic long-term diseases. The search was on to find a minimum bulk, long term resilient, robust, hygienic, sterilisable, ultra comfortable, adjustable, easy to wear mandibular advancement device that would withstand the rigours of the mouth and last fairly indefinitely. Indeed a tall order. Simon resorted to his partial denture prosthetic dentistry training and made cast chrome cobalt tooth supported frameworks, leaving off the prosthetic teeth. To this frame he added heat- cured acrylic inclined blocks, creating cast chrome cobalt twin-blocks devices. This was published in the Journal of Orthodontics 2004. Whilst this was an advance on the all-plastic devices, patients still had bulk, tooth movement and hygiene issues. The acrylic blocks were then replaced by the piston rod Herbst mechanisms. The challenge

NEWideas was to devise a means of joining the piston rods to the cast chrome cobalt frameworks. Most Herbst devices rely on screw attachments and this raised health risks to patients should the screws detach. Simon then invented the “Olympic Stud” which is an attachment included in the metal casting onto which the Herbst piston rods form a locking key. This simple, highly effective device has replaced the screws, reduced device bulk and given added strength to the fixing parts. The active protrusion element in the device is the Herbst piston rod. Currently, they are prone to distortion, fracture and have limited adjustment capabilities. Simon then invented the “Ash Adjuster” which has metal injected moulded high strength end fixing parts to match the Olympic studs. The Ash Adjuster has a longer range of adjustment and the rods carry millimeter markings so that jaw advancements can be accurately titrated and measured. It was apparent that device bulk and encroachment into tongue space was critically important for patient comfort. If the oral cavity and in particular the oral vault is filled, the tongue is forced backward, aggravating the breathing problem. The Somnowell major connector is located in the labio-mental sulcus to minimize oral vault encroachment and to take advantage of the inner fibres of the mentalis muscle, which on stretching would, via the Somnowell labial bar, provide a counterforce to the forward force vector of the Herbst. Many patients with these sleep related breathing disorders have bruxism and jaw parafunction. To minimize damaging effects to the patient and the devices, all Somnowell Chrome devices are mounted on a semi adjustable articulator using a facebow transfer system. The opposing frameworks include occlusally balanced platforms. As the patient closes the jaws, the balanced metal platforms meet and distribute the load over all of the teeth. The dentist using all-metal devices also gains long-term orthodontic retention and periodontal tooth splinting. Sadly the NHS could not support the service expansion or research and development to find answers to the problems created by all-acrylic devices, so Simon turned to his own resources. Somnowell Ltd started in the front parlour and garage. Family members, neighbours and friends joined in to get the company

Patient with Somnowell device in place

underway. Somnowell now occupies a fully staffed purpose built laboratory and offices. In 2015 Somnowell achieved FDA approval and has established Somnowell Inc. to commence marketing the Somnowell in the USA. Somnowell Inc is launching a Promoted Practitioner marketing program using the same digital marketing expertise that has propelled them to become the U.K. market leader within 3 years. They will run localised campaigns that exclusively promote one practitioner in each area. To learn more and to apply please visit www.somnowell.com/ en-us/promoted-practitioners. The Somnowell Chrome devices are low bulk, tooth borne, very strong comfortable appliances. They can be autoclaved and cleaned in a dishwasher. They are robust and easily maintained. Think of the concerns you, your staff, and your patients have had about some of the devices you’ve provided over the years. Do some of these innovative features address those needs? Would you have saved a lot of office time (read: $$) if you had not had to work through those problems? Somnowell’s innovative design has received awards Beyond just supporting the airway, it is truly changing lives within and without the dental sleep office.

Dr. Ash placing a Somnowell device on LondonLife TV

Simon Ash, FDS, MSc, MOrth, BDS, is a Consultant and Specialist Orthodontist with over 30 years clinical experience, with a special interest in sleep related breathing disorders, TMJD, and bruxism. He currently works in Harley Street London and two private hospitals in London as part of a multi-disciplinary team managing snoring and sleep apnea, and is Visiting Professor of Orthodontics at the BPP University. He is a Fellow of the Royal College of Surgeons of England and an accredited Consultant and Fellow at the Royal College of Surgeons of Edinburgh. Furthermore, for many years Dr. Ash served as the Regional Dental and Speciality Orthodontic adviser (North Thames) to the Royal College of Surgeons of England.

DentalSleepPractice.com

CHOOSINGappliances

Getting

MAD Right Choosing Oral Appliances “It doesn’t matter if the guy is perfect or if the girl is perfect, as long as they are perfect for each other.” – Matt Damon “Good Will Hunting”

by Steve Carstensen, DDS, DABDSM Keep that quote in mind as you sit with your patient and decide which of the over 100 FDA cleared mandibular advancement devices (MAD) is the right one to open the airway. There is no universal appliance, just like there is no ‘standard’ patient! So how do we go about this decision? Dr. Pankey taught us a philosophy that includes the relevant parts: “Know Your Patient, Know Your Work, and Apply Your Knowledge.” Let’s see how this applies to Oral Appliance Therapy.

Know Your Patient

Your patient comes with a history critical for you to understand. There is a different way to approach people who have never used any sort of acrylic device on their teeth than there is for someone who has worn a bruxism guard every night for years. For the inexperienced patient, assurance of safety and custom fit of your recommended MAD would be paramount; for those with plenty of experience, the similarities can be emphasized to make them more comfortable with the next step. The first patient has to trust they can adapt to something completely new; the latter, just something different.

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CHOOSINGappliances

Dentists have been coaching people for years – use those skills

Part of the CAD CAM Narval process

58 DSP | Winter 2015

History also includes psychological information. Some patients will express great reluctance to use any device that holds their mouth closed; often accompanied by reports of ‘claustrophobia.’ In my experience, I have often found these patients to have a history of abuse that lies not far below the surface. Assuring them of choosing a device with plenty of freedom of movement is one way to avoid triggering emotions that may block successful use of even the best MAD. Most people do not want to share with me details of these memories, and I do not want or need to know, either, but I do want them to feel safe. Nearly all custom MAD are adjustable; your patient may be expected to advance the device until subjective symptoms are resolved. Devices vary in the simplicity of adjustment, some require small tools to be used in tiny holes; some are clearly marked and some patients must refer to printed instructions to see what to do. No matter which one you have made, you must be sure your patient is capable of performing the specific task required. Have them demonstrate competency in your office where they can be coached. Your dental team has been coaching people on how to take care of themselves for years – these skills can be easily adapted. Does your patient have a significant bruxism history? Many people have poor (admitted) awareness of this movement disorder despite extensive physical evidence of the effects of it. If they have comorbid OSA, you can assure them your device will ‘treat both problems’ without making them admit they brux. It is still not valid to assure these people

that bruxism will cease with an open airway, so choose wisely – some devices can withstand the extra muscle activity of sleep bruxism more than others. Again, they feel safe.

Know Your Work – Apply Your Knowledge

What about physical characteristics? If your patient has significantly limited range of motion or, on the other hand, has excessive mandibular mobility, each of these limits your choices. A small opening may require a small device with separate units for maxillary and mandibular arches. Someone with excessively wide opening may have trouble with retention for devices connected with buccal hinges. ROM has implications for TMJ health, so the sleep dentist must be well informed about the relevant anatomy, physiology, and pathology of these complex body parts. Patients have unique features such as exostoses, crowded nasal airways, asymmetric protrusive pathways, and widely divergent tooth axial inclinations that influence design choices. One common finding is narrow, restricted arch forms that leave little room for the tongue. Further encroachment on the lingual side of the arch may crowd the tongue further into the airway. Choose a device with as a little lingual presence as possible. Conversely, some patients have significant hyperkeratosis along the occlusal plane in the buccal tissue. Placing the adjustment mechanism buccal to the teeth is asking for trouble as your device competes for limited space. Are you sure your patient will respond to the MAD with an open airway? Not likely – and some patients are reluctant to invest in a full custom MAD without some ‘proof.’ Thankfully, we can now choose among several professional-level ‘temporary’ MAD that give those patients (and you!) some ability to know whether this is the right therapy for them. The MATRx system is employed in several sleep labs to identify MAD responders before the custom device is chosen. Materials used in device construction are important for a select subset of your patients. Many people are allergic to nickel, removing stainless steel from the possibility list. Others react to plastic; have examples on your desk to show them, and make sure you ask again the questions from the medical history, as they might not think to make the connection between reactions to “cheap jewelry” and your professional device. There are appli-

CHOOSINGappliances ances that are entirely hypoallergenic. Some devices have multiple layers of different materials, possibly leaving gaps that are difficult to clean or provide failure points. The easiest aspect for dentists to master is deciding whether there is sufficient anchorage available to hold the mandible forward. There are designs that work for the edentulous maxilla, but the lower arch requires stable teeth or implants to be useful. Some appliance designs stabilize mostly on anterior teeth, others posterior. Be aware of where the forces from advancement are concentrated by the hinge mechanism. Obviously, the right choice must be made here to have any hope of success. Should cost be a factor? There is a wide range of lab cost between the simplest and most complex or robust devices. Even those with similar designs come with different costs – like many things in life, often one gets what one pays for. Be careful saving money on lab expense if it costs in terms of device reliability or longevity. Never lose sight of the fact that our patients, and our medical colleagues, have little understanding of device therapy and expect them to work ‘as promised’ so early failure will not go over well. Most people think of these devices as ‘expensive’ anyway – if you need a slightly higher fee to support a top-quality lab cost, the extra amount will fade in memory as the device serves for years without problems, especially as you remind them of this happy result. No one with a failed device will thank you for saving them a few bucks on the front end. Scientific research has rarely been designed to differentiate between individual appliances; most published studies use a chosen MAD to compare to PAP therapy. This doesn’t give us a great way to use science to establish one device as ‘better’ than another. What the informed dentist can do is notice which appliances have been used in many of these studies; those documented results are useful when discussing oral appliance therapy with medical colleagues. Pain and dysfunction accompany sleep disruption, TMD, and joint instability. Should you shy away from treating patients with such complications? You choose, based on your training and comfort levels as well as the examination details you determine. Every dentist comfortable with sleep therapy will have skills with acrylic devices – find similarities among the variety of MAD available and

translate those skills to the wider scope of therapy required to open the airway. Claim your expertise! With the variety of device choices and an entirely unique population of patients, every dentist who treats sleep disordered breathing must master several appliances and be adept at a few others. Thankfully, there is no reason to use each of the 100+ on the market; but don’t limit yourself to one or a few, either. You are the matchmaker – look for that perfect device to achieve success!

D. A: Sleep Herbst. B: MicrO2. C: TAP3. D: SomnoDent

DentalSleepPractice.com

PATIENTeducation

f you treat obstructive sleep apnea with mandibular advancement devices and you use more than one type of device, there may be some confusion regarding the best method of caring for the appliance. Should you soak the appliance in water? Should you use toothpaste or mild soap or nothing at all to clean it? Is it safe to use a denture cleaner? If yes, how often and for how long?

It would seem that the purpose of cleaning the appliance is two fold. Compliance in wearing the device is always important when it comes to oral appliance therapy. Odor and cleanliness would influence this greatly. Cleanliness is also important with the devices that require access to small parts to assist with titration. A cleaner that is both a deodorizer and a germicide is vital in hav-

Before

60 DSP | Winter 2015

After

ing a positive impact on patient usage and compliance. But what about the appliance itself? Some appliances are made of a polymer material; others are made of hard acrylic. Some appliances have metal parts, while others do not. As you may have guessed, the cleaning instructions differ based upon the material from which the appliance is fabricated. A quick overview of four commonly used appliances will further illustrate how the materials impact the prescribed cleaning methods. The SomnoDent Fusion is comprised of a soft polymer molecularly bonded to an acrylic. The care instructions for this appliance include using a soft toothbrush with mild soap to clean it after use. After thoroughly rinsing the appliance, it is recommended to soak the appliance in clean water ensuring it is fully submerged. This is done to keep the microbi-

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Send case to (or request shipping label from): Gergen’s Sleep Appliance Lab | 1745 W. Deer Valley Road | Bldg. 1, Suite 112 Phoenix, AZ 85027 | 866-437-4361 | info@gergensortho.com

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PATIENTeducation

Before

After

al count down and so that the soft liner material will not become desiccated. Soaking will also help to prevent crack corrosion and possible discoloration to the metal components caused by a build up of salts and saliva. Once a week, it is recommended to soak your SomnoDent in a partial denture cleaner for five minutes, then rinse and store in water. Some denture cleaning tablets containing active oxygen may damage the SomnoDent. Ensure that you use a partial denture cleaner. A Narval appliance is made up of a biocompatible polymer material and is metal free and flexible. The most important care instruction regarding this appliance is to use a soft toothbrush whose only designated use is to clean the Narval appliance. Each morning, use the designated toothbrush to clean and remove the saliva film using warm water. This device is stored dry. Do not use toothpaste or liquid soap as the Narval appliance is fabricated from an extremely porous material that will trap cleaning materials with in the appliance and may cause an allergic reaction. Two times per week, use the sonic cleaner that comes with the appliance. You may also use denture tablets that have an effervescent quality to soak the Narval in for 10 minutes at a time. The TAP appliance is made of a polycarbonate material with a soft liner. Because of the bilaminate nature of this appliance, you must be careful using certain harsh cleaners because they may destroy the soft liner with extended use. When cleaning the TAP appliDr. Christina Cairns has been a general dentist for more than 14 years and has limited her practice in Colorado Springs, Colorado to treating patients with sleep disorders. Dr. Cairns is a graduate of Creighton University and the UCLA Residency in Dental Sleep Medicine/Sleep Apnea. She is an active member of the AADSM.

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ance daily, it is recommended to use hand soap or regular toothpaste with a soft toothbrush to clean the appliance. It is strongly recommended to avoid whitening or tartar control toothpastes as they are too abrasive for use on the soft liner. After cleaning, simply rinse off the appliance and store in an open, dry container to avoid an increase in microbial growth. The Herbst Sleep Appliance is comprised of hard acrylic with two metal telescopic mechanisms on each side. For this appliance, it is consistently and strongly recommended to use DentaSOAK due to the diverse nature of the two materials- acrylic and metal. DentaSOAK is mixed up once a week in a sealed container. After waking, it is recommended to soak the Herbst Sleep Appliance in the solution for 15 minutes. A soft bristled toothbrush may also be used to remove debris or build up. After a thorough rinse, this appliance is also stored in a dry container. Regarding the different types of cleaners, there are some items of which to be aware. Some cleaners may damage or weaken acrylic. Other cleaners may harm the metal components. The cleaners used for sleep apnea appliances need to be both germicidal and deodorizing in nature. It is important to consider that a segment of your patient population may be sensitive to the chemicals within the cleaning product that you recommend. It is best practice to recommend that patients try a small sample first to make certain they do not experience any adverse reactions. For example, some cleaners contain persulfates, a known allergen. This process may also include your dental team. For example, at subsequent follow up appointments, we place their appliances in the ultrasonic cleaner with a tartar-removal cleaner. Because patients do not have access to this equipment, itâ&#x20AC;&#x2122;s a nice service to compliment their home care routine. So that your patients will have the highest possible levels of satisfaction with their appliances, the dentist, dental team and the patient must be committed to keeping their devices clean and fresh. Knowing your appliance and the cleaners you recommend will allow you to match the right chemicals to the device, ensuring optimum outcomes!

CASEreport

Allergic to PAP!

Solving this Patient’s Dilemma by Ronald S. Prehn, DDS

his is an interesting case where the patient was allergic to the silicone in the soft liner that is the interface of the CPAP mask to the face and also allergic to the neoprene straps of the CPAP mask. This middle aged woman has been trying to use the CPAP for 8 years off and on. She states that she cannot tolerate CPAP due to “allergy to neoprene,” which makes her face and nose red and itchy every morning (upon testing it was determined that it was actually the silicone as well that was the source of the allergic response). Since all CPAP masks use silicone, her options were very limited. This case will demonstrate that a Dentist trained in Combination Therapy can give people like this more options because the materials used in fabrication of custom masks do not include silicone. Combination Therapy (CBT) is combining CPAP (continuous positive airway pressure) therapy and OAT (oral appliance therapy) to resolve Obstructive Sleep Apnea (OSA). 64 DSP | Winter 2015

Chief Complaint

A 56 year old woman with a body mass index (BMI) of 26 presents with intolerance to CPAP mask. She has a rare genetic craniofacial disorder called Treacher Collins Syndrome, which in her case results in an under developed zygoma and mandible (a challenge for a CPAP mask fit). Her chief sleep complaint is fatigue with falling asleep at inappropriate times. Her Epworth Sleepiness Scale (ESS) is 16 with the CPAP machine. She had a recent split night PSG with an AHI of 86, PSO2 87% (moderate OSA, but extremely fragmented sleep). CPAP with nasal pillow was started with a setting of 8cm H20. But she states that she cannot tolerate the nasal pillow due to allergy to the material, which makes her face and nose red and itchy every morning (just like the mask did in the past). She wears it for a few days and then has to stop for a week to allow the redness to subside while she deals with the extreme fatigue.

Sleep-related dental problems such as GERD and bruxism can pose serious health risks for your patients. TAP Sleep

myTAPTM

TAP CUSTOM

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TAP PAPâ&#x201E;˘ CS

CASEreport Clinical Findings

“Thank you seems so inadequate for the gift of sleep that you have given me.”

Her blood pressure was 142/84 and her neck circumference was 15 inches. Palpation of the TM Joints revealed tenderness in both joints indicating capsulitis of the joints. The temporalis, deep masseter, and lateral pterygoid muscles were tender on both sides. Her mandibular range of motion (ROM) was only 28mm with pain. Because of her Treacher Collins Syndrome, she has a significant retrognathic skeletal relationship. Oral examination indicated that she has many signs and symptoms of clenching at night including scalloping of the tongue, linea alba, high vaulted palate, narrow dental arches, mandibular tori and significant wear facets on her teeth. She also has an anterior open bite secondary to her retrognathia, but also because of her tongue thrust at night. Because of the degenerative changes in the left condyle, her mandibular midline was 1mm left of facial midline. The cone-beam x-ray (i-CAT) indicated that she has concha bullosa of the left middle turbinate and slight degenerative changes in the left TM joint (with a subcondyral cyst). And as expected based on physical exam, she also has an extremely small airway.

may have restricted nasal airflow. With her significant number of arousals, hypoxemia, and cardiovascular concerns, it was my judgment to proceed directly to combination therapy to stabilize her airway to see if we can demonstrate the resolution of all her symptoms before we consider mandibular advancement splint (MAS). When the MAS is considered in her case, there will be many challenges. First she has arthritic TM joints (especially the left) with pain. Then she has retrognathia which will make advancing the mandible to a significant degree a challenge. The open bite is also challenging as the MAS has a tendency to make that situation worse. As a result, overall the fact that she has TMJ symptoms, it was my judgment that entering right into the mandibular advancement splint would aggravate her TMJ condition and basically make her overall sleep worse. So the rational to move right into Combination Therapy (CBT) is based on first demonstrating resolution of symptoms (mainly fatigue) with a stable airway. If the airway is stable, and the sleep structure restored to normal and the

Clinical Considerations

It was obvious by her continuing fatigue and nocturnal clenching/bruxing that the CPAP machine that she has been using has not adequately resolved her OSA. She still had many compensatory mechanisms in place because the airway was not stable. These compensatory mechanisms include clenching and bruxing at night, which causes fragmentation of her sleep and the fatigue that she is dealing with. The allergies that she had from the silicone may be contributory to her fragmented sleep and the concha bullosa

TAP-PAP™ CS with the TAP3™ as the base for the oral aspect of the device. Post attached to the TAP mechanism and nasal pillows attached to the post. CPAP hose is then attached to the nasal pillows via the collet.

Dr. Ronald S. Prehn, a third generation Dentist, focuses his practice on the cusp between medicine and dentistry, providing care for patients with sleep related breathing disturbances as well as headaches and TMJ. He is a board certified Diplomate of both the American Board of Orofacial Pain and the American Board of Dental Sleep Medicine (belonging to both sister academies). He currently sits on the Board of Directors of the American Board of Dental Sleep Medicine. He earned his DDS at the Marquette School of Dentistry in 1981. His postgraduate work was accomplished at the Parker Mahan Facial Pain Center at the University of Florida in 1993 and at the L.D.Pankey Institute. His limited practice, Restore TMJ & Sleep Therapy, PA is in The Woodlands, Texas (www.tmjtexas.com). He is well published in the Journal of Sleep and others and is involved in numerous sleep research projects. Dr. Prehn is also adjunct professor at the University of Texas Dental Branch in Houston, as well as a sought out speaker for many seminars and conferences to other Dentists, Physicians and health care professionals around the state and nation.

66 DSP | Winter 2015

CASEreport fatigue is gone, then a transition to a MAS can be attempted with the best possible outcome. But if the airway is stable and she still has fatigue, then other reasons for the fragmented sleep will have to be explored.

Treatment Outcome

A TAP-PAP™ CS (with nasal pillows) was attempted first to see if she could tolerate the nasal pillows. This device is designed to attach nasal pillows to a post that is screwed directly onto a TAP3™ mechanism. Then the CPAP hose is clipped into the nasal pillows. The result is that there are no straps and nothing touching her face except the nasal pillows in her nose. There is no movement and the mandible is stable with the mouth closed with the TAP3™ upper and lower glued together with Thermocryle™. Even with this set up, she had leakage of air through her oral cavity at night and she explains that the nasal pillows (which came from the Fischer Paykel Opus™ mask) also cause redness around her nose (they were made of silicone). This indicated to me that she not only had a neoprene problem, but also an allergy to silicone. A piece of neoprene, silicone and acrylic was taped to her arm for three days to determine which material would give her an allergic response. The result was that she had a wheal and flare allergic skin response to the silicone and the neoprene, but not the Biocryl™ acrylic (Great Lakes Orthodontics). Therefore, face impression was taken for a TAP-PAP™ CM (Custom Mask), to be made from Biocryl. The TAP-PAP® CM was fabricated for her. Her mandible was stable with a 3 mm protrusion to augment the CPAP. There was no leakage and she was able to take it off and on with no struggles. It was very quiet and stable. She explained that she has had the best night sleep that she has ever had. She was sent to her daughter who is a local sleep physician for a re-titration of her CPAP machine. The pressures were reduced to 7 cm H20. As a result her ROM increased, her TM Joint pain resolved and her fatigue levels were significantly reduced (ESS 9), although not totally. She wants to remain in the Custom Mask for at least a year before considering a MAS.

Patient Comments

“Thank you seems so inadequate for the gift of sleep that you have given me. I would have never thought I would have seen

such the differences I have. Initially, my goal was just get rid of the neoprene headgear, I never expected it would also be the great improvement in the quality of sleep that I would experience. I cannot remember when I ever (and I do mean ever) woke up feeling refreshed like I had a great night sleep until the introduction of the TAP-PAP into my life. Again, thank you.”

Summary

As a Dentist who treats conditions related to Sleep Disordered Breathing (SDB), there are many aspects of the profession that can be applied to treatment options. The knowledge of materials that can be used to treat these conditions and conditions that effect the facial structures are well known to a Dentist. This case challenged both aspects of care. The joy of treating these SDB conditions is realized when the lives of our patients are improved and the SDB condition is resolved.

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1/12/15 12:52 PM

MEASURE

Why Measure for Parafunctional EMG During Sleep? by Jeff Wyscarver, RPSGT

o you have patients with worn teeth? Do you know what to say to them? A growing set of patients with tooth damage can be helped as a result of a new class of Electromyographic (EMG) testing. Surface EMG testing has been available for many years but it records only a portion of the problem. Other critical variables must be measured in conjunction with the surface EMG to capture data the dentist needs to accurately triage and treat patients who present with puzzling conditions.

Fig. 1: Swallow — EMG activity in conjunction with a “shelf” in the flow signal and flattened respiratory effort.

68 DSP | Winter 2015

Parafunctional EMG (PEMG) should include surface EMG of the masseter measured while the patient sleeps and also include a detailed evaluation of the airway on a single time axis which establishes not only the presence of the PEMG activity but also the context in which these damaging events occur. A growing set of patients with tooth damage can be helped as a result of this new class PEMG testing. Adding to the PEMG landscape is calibrating the signal for the purpose of quantifying the amount of energy exerted by the masseter muscles. Knowing the frequency of the PEMG events as well

and the strength and magnitude of the PEMG events is the final component we believe will enable the clinician to more effectively treat patients with damaging bruxism. Bio-mechanical measuring technology has advanced to the extent that we can routinely collect PEMG and airway data on a single time axis to create invaluable information when used by trained individuals. The implication is with updated training and the ability to create the PEMG landscape the dentist can improve long term treatment and rehabilitation outcomes on patients which often seemed hopeless in the past.

MEASURE First let’s talk about EMG. The masseter muscles are particularly busy muscle Fig. 2: Rhythmic Masticatory Muscle Activity participating in many essential tasks, especially during sleep. Swallowing and yawning and a variety of other relatively normal and mundane activities are accompanied by lessor-known activities (Figs. 1-2), such as Rhythmic Masticatory Muscle Activity, (RMMA — essentially twitches during sleep), associated with arousals and changes in sleep stages. To summarize the challenge there are several types of EMG waveforms we measure many of which are of little or no concern. Distinguishing those from the more clinically significant waveforms such as those generated during a clench or a grind can prove challenging. Further complicating the effective assessment of parafunctional EMG activity is the lack of information on the strength or magnitude of the clinically significant waveforms Fig. 3: Audio channel recoding tooth contact during a clench seen during clenches in particular. There are a number of occlusal mappers which can identify mal-occlu- The task of sions and highlight the damaging contact points but these tests quantifying damaging are typically performed while awake sitting in a dental chair parafunctional activity and not while the patient sleeps. One of the specific technology is challenging but advancements which has facil- not insurmountable. itated the assessment of parafunctional activity is the ability to record the audio and convert Fig. 4: Bio-Calibration: Five strong clenches while awake the audio recording to a waveform. By identifying the distinctive sound of tooth to tooth contact, we can determine which muscle activities are significant and which are not. Many of us know this unique sound and find it difficult to listen to. For the same reason it is easy to identify in the audio Fig. 5 recording (Fig. 3). So the task of quantifying damaging parafunctional activity is challenging but not insurmountable. By creating specific algorithms to detect normal activity, ignore Jeff Wyscarver is a registered polysomnographic techartifacts and quantify the remaining signifinologist (RPSGT) and president of DDME (www.ddme cant parafunctional activity, we have made online.com • 1-800-513-9337), a company that the first step to measure bruxism effectively. brings sleep lab technology and services to the dental To quantify bruxism we need to calibrate community. the surface EMG signal. This establishes a baseline energy unit by performing a waking “clench”. We ask our patients to bite down as hard as the can five times (Fig. 4). DentalSleepPractice.com

MEASURE

Fig. 6: OSA followed by audible clench

Fig. 7: Mouth Breathing and intermittent clenches

Fig. 8: Normal breathing then a parafunctional event

70 DSP | Winter 2015

These clenches are accurately measured and used to create the patient’s “Energy Unit (eU).” Through this process the total energy expended by the masseter is quantified as well as the total clench energy (Fig. 5). It is important that this is custom-generated by each patient, rather than comparing their test results to some population-generated ‘normal values.’ The other major challenge is to cast the bruxism data in the proper context of what else is going on while the patient sleeps. By comparing timing of airway events and muscle activity, we can draw some conclusions about correlation of these events. The goal is to accurately quantify the significant bruxism in the context in which they occur. The first example most of us think of is a clench occurring after an obstructive apnea or hypopnea which I call Post Arousal Clench, (PACL). In the example below we suspect tooth contact due to the audible signal detected timed with the clench (Figs. 6-8). The value of this assessment technique is the ability of the dentist, armed with more specific information, to plan for a more tailored treatment or rehabilitation. Bruxism has been an enigma since the first time anyone noticed a worn tooth. Showing what appears to be a compromised airway correlation may unlock a bit of the mystery and put more previously ‘difficult’ cases on an effective treatment path. It’s difficult to say but many patients in the dental chair may not be receiving the most effective protection against bruxism. For example should a patient be fitted for a night guard which has been shown to introduce risk to the airway or an appliance which takes into account the patient airway condition? So to answer the question: “Why Measure for Parafunctional EMG Activity?” Provide vital information to the treating dentists to more accurately categorize their patient’s condition, thus allowing them to choose the best therapy, and thereby improve outcome. Isn’t that the goal of all medicine?

A NEW WAY TO EFFECTIVELY MANAGE BRUXISM Whip Mix in partnership with DDME brings dental professionals a system to provide objective measurements for assessing and treating bruxism while not compromising the airway. Dentists, while observing damaged teeth, can be the first to notice the signs and symptoms related to bruxism and associated airway conditions. As the next step, utilize the Bruxism and Sleep monitor with unique software which provides the Bruxism Episodes Index (BEI), Apnea-Hypopnea Index (AHI), and Upper Airway Resistant Syndrome (UARS), producing a comprehensive dental report.

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TEAMfocus

Promote positive airway management

Use educational tools

5 Ways

to Promote

Apply positive persuasion

Provide goodie bags to promote therapy

Oral Appliance Therapy

by Glennine Varga, AAS, RDA, CTA

n this issue of DSP we dive into oral appliances and look at different aspects of the actual devices. These powerful little custom-made mouthpieces are created to reduce the amount of collapsibility of the airway during sleep, a service that clinical research is showing to be more and more important. Here are five ways to promote oral appliance therapy with the help of positive persuasion. 1. Promote positive airway management

When patients have an issue breathing during sleep it’s best to promote positive airway management. Some patients we talk to will need a sleep study and others will have a previous diagnosis of OSA. Both types of patients will need positive reinforcement to act on complying with getting a test or doing therapy. Any therapy. This could be PAP therapy, surgery, lifestyle changes, and oral appliance therapy. It’s best to keep your focus on the main goal, which is to help patients breathe better during sleep no matter which way they choose to do it.

2. Use educational tools

Create, purchase or borrow pictures, diagrams and videos to illustrate to patients

72 DSP | Winter 2015

what happens with airway anatomy during sleep. Visual aids are a great way to communicate with patients. Some patients just need a little explanation to fully understand obstructed breathing during sleep. Great Lakes Orthodontics lab has some great educational tools such as the OSA Demonstrator. Visit http://www.greatlakesortho.com/commerce/ detail/?nPID=1920&returnTo=http://www. greatlakesortho.com/commerce/category/ index.cfm?cid=138&lvl=2 to check it out. You can also download and print color diagrams (see image below) for your treatment rooms from my website www.dsmbootcamp. com. This is my gift to you for reading the team column! My suggestion is to laminate them so you can wipe them down between patients.

3. Apply positive persuasion

Based off a recent study published by the National Center for Biotechnology Information. Ref: http://www.ncbi.nlm.nih.gov/ pubmed/24417326 The study explains that with some patients when they think they had a good night’s sleep it can improve cognitive function! Let your patients know you are excited to see their sleep improve and see symptoms get better. It’s never a good idea to promise any therapy is going to work 100% or guarantee success as bodies respond differently. However, we can promote how ex-

TEAMfocus instructor in Irving TX, has a great free app about sleep hygiene. It’s called Best Sleep Hygiene. Once your patients start oral appliance therapy give them a goodie bag to reinforce good sleep hygiene. Include things like Chamomile tea, eye masks, ear plugs, nose cones or strips, white noise apps, sleep tracker app, sleep diary, coffee mug and a denture brush to clean the appliance. You can get creative with this. Make it game to see who can come up with the best goodies for the least amount of cost.

5. Supply patient surveys

cited we are about therapy outcomes and patient success. Talk about how other patients were nervous to start therapy but after they got used to it, the success was tremendous. Never share patient names or personal information but keep track of patient success. A simple spreadsheet of before and after symptoms, AHI/RDI/O2 outcomes or Epworth scores will be beneficial. Patients look to the team for answers; they pick up on our body language, tone and inflection in our voice. Let’s promote how great our therapy works!

4. Provide goodie bags to promote therapy

Who doesn’t love an gift? Your patients will love something to take home when they are first being introduced to sleep like a brochure, newsletter, or app. Dr. Kent Smith, a dental sleep medicine dentist and

According to Forbes magazine it’s best customer service when you are surveying your clients – in our case our patients. Once patients are stable with their therapy ask them to rate their experience with you. If they are rating you top notch you can use that for marketing and promotional purposes, and even better, if they don’t give you a high rating it’s a great opportunity to find out why and improve your processes. As we focus on oral appliances in this issue as a team we need to focus on the overall positive effects of oral appliance therapy and promote it to our patients. Always remember our therapy is reversible, non-surgical and non-pharmaceutical. However, it can be used in conjunction with surgery or medication if needed. We have a solid dental solution to a medical issue, it’s time we promote this to all patients and promote our positive patient outcomes! 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: editor@ DentalSleepPractice.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 is certified in radiology, electrodiagnostics, expanded duties dental assistant in the treatment of temporomandibular disorders. She 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. She has trained and assisted hundreds of dental offices on practice management, TMD/Sleep Apnea concepts, medical billing and team training. For more information visit www.dsmbootcamp.com or email g@dsmbootcamp.com.

74 DSP | Winter 2015

LEGALledger

Are You Guilty? Part II by Ken Berley, DDS, JD, DABDSM

76 DSP | Winter 2015

LEGALledger

n the last edition, I explored the issue of insurance fraud in Dental Sleep Medicine and the response has been enthusiastic, as anticipated. While I am aware that insurance audits and inspections in dentistry have been rare, it is my personal opinion that this may change in the near future as more and more dentists are filing Medical Insurance and Medicare. Additionally, medical billing services are flourishing in DSM. Unfortunately, some of the medical insurance billing services do not seem to know the law or have chosen to ignore state and federal regulations. These billing companies have an obvious conflict of interest with an incentive to over-bill for services. Dental sleep practices frequently are encouraged by their billing service to overcharge for Oral Appliance Therapy and waive co-payments and deductibles, creating an obvious area of potential liability. Waiving deductibles and co-payments could ultimately result in audits by medical insurance companies and visits from the FBI. In the dental arena, risk management typically addresses negligent conduct that breaches the standard of care and results in an injury to our patients. A ruling of negligence results in monetary damages. Insurance fraud and abuse is a criminal offense if a prosecutor can prove that you intentionally conspired to receive a payment that you were not entitled to. If the prosecutor can prove fraud you could go to prison. If you are suspected of Medicare fraud or abuse, the FBI will show up at your office with a search warrant. The warrant will list the items of equipment and documents that the searching officers have the legal right to confiscate. Obviously, computers and patient records are frequently on the list. If you are suspected of Medical insurance fraud, an insurance auditor will show up at your office and set up shop for an extended period of time until he is satisfied that he has accessed and evaluated all patient records in question. Sadly, it is not uncommon for insurance auditors to stretch their authority and request records that they have no legal right to access. With the possibility of audits on the horizon, here are some steps a dental practitioner should take if FBI agents or auditors show up at your front desk with a search warrant. Please save this copy of DSP in case you ever find yourself confronted with this scenario. Once the FBI Officers or Medical Insurance Auditors have presented themselves: 1. Call your attorney immediately and donâ&#x20AC;&#x2122;t let your staff talk to the invaders:

You should inform the officers and auditors conducting the search that you would like them to wait for your attorney to arrive before the inspection or audit begins. Insurance fraud is a criminal offense and you have a consti- It is not uncommon tutional right to have legal counsel. If your attorney does not have the for insurance auditors necessary criminal law expertise to stretch their authority to advise you how to proceed, you should contact an attorney with that and request records that expertise. It is absolutely imperative they have no legal right that this be done immediately. You should be aware that the officers do to access. not have to wait for your attorney to arrive. They have the legal right to go ahead and begin the search but get an attorney to assist you as soon as possible. Additionally, do not allow your staff to be questioned without legal counsel present. Inform your staff members that nothing is to be gained by talking to the FBI Agents or the Auditors. They are

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, Attorneysâ&#x20AC;&#x2122; 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.Â

DentalSleepPractice.com

LEGALledger not your friends. If the officers refuse to wait until counsel arrives, you and your employees have the right to refuse to be questioned and the right to invoke the Fifth Amendment. 2. The Search Warrant will list the items and areas the officers can search and equipment or documents that can be All DSM practitioners confiscated: Federal Rules of Criminal Procedure require that the officers or should review their auditors must provide you with a copy office insurance of the search warrant which must specifically describe the premises to be procedures to be sure searched and the documents or items they are compliant with to be seized. They are not authorized to search any premises or property not federal and state law. specifically described in the warrant. They have the right to take what’s listed on the search warrant. It is imperative that you know what is being removed from your office. 3. Assign a staff member to create a list of all documents or items being removed from your office. Although the Federal Rules require that the officers conducting the search prepare and provide a written inventory, they are often uninformative, non-specific and never clearly identify what items have been seized. You, or someone on your staff, should make your own inventory or itemized list of records this should include sufficient detail to enable you and your attorney to know exactly what has been taken. 4. Be ready with great backups: The question that everyone wants to know is; “Can they really take my computers?” The short answer is “Yes!” However, it is reasonable for your attorney to insist on getting a backup of your system before it is taken. As always a reasonable precaution is to have a good backup of your systems at all times. 5. Be nice, be polite, remain calm and cooperative, but use your smart phone to record the entire search: Do not verbally or physically make any attempt to prevent or hinder the officers during the search. At the same time do not volunteer information. Indicate to the officers that you do wish to cooperate with them. However, do not HELP them. You do not have to assist them during their search. If you are polite, calm and cooperative, the officers are more likely to honor any requests that you make with regard to inventories of the

78 DSP | Winter 2015

property. Be courteous and professional at all times. Photos or video recordings of items and documents seized are an extremely helpful addition to any written inventory that you have made with regard to the items. This information could be vital in recovering your documents. Additionally, video or photographic evidence of the conduct of the officers conducting the search may be helpful at a suppression hearing should your attorney be attempting to suppress the search for the reason that it violated your privacy rights or the warrant’s limited scope. Being confronted with a “surprise” federal investigation can be a very disturbing and frightening experience. While it is unlikely that an FBI agent will show up with a search warrant, the fact remains that these types of medical fraud investigations are likely to increase in DSM in the near future. As stated earlier, keep a copy of this article in an accessible place. Plan an office meeting with your staff to discuss the contents of this article. Being prepared is always a great approach. Try to schedule a local attorney who has experience in this area of law to do a lunch and learn. Make sure each of your staff members understands what they should and should not do in the event of an FBI search or Medical Insurance audit. Prevention is always the best strategy. An insurance audit or an FBI surprise search will only occur if you are consistently abusing or defrauding Medicare or commercial insurance carriers. All Dental Sleep Medicine practitioners should review their office insurance procedures to be sure they are compliant with federal and state law. Remember that auditors don’t show up for an audit unless they are certain you are violating the law. If you are unsure if a billing practice is legal, call your attorney for their opinion. Laws vary from state to state. If a billing service is filing your insurance claims be aware that they are acting as your agent and you will be responsible for any claims filed on your behalf. Don’t let your billing service cause you to be found guilty of Medicare Fraud or Medical Insurance Fraud. In the next issue of Dental Sleep Practice, I will discuss possible consequences and penalties which could be imposed if you were found guilty of Medical Insurance Fraud or Medicare Fraud.

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