Dental Sleep Practice Fall 2021

My CPAP Can Harm Me. What Can You Do?

by Steve Carstensen, DDS, D.ABDSM

Effectively Simple One Appliance's Journey Through Time

FALL 2021 | dentalsleeppractice.com

Special Section DSM Education

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by John Viviano, DDS, D.ABDSM, and John Bouzis, DDS

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INTRODUCTION

Divergence, Convergence, and Agency

W

hat’s next? What’s around the corner? Where do we go from here?

These are questions we ask ourselves as a global community, a nation, as a profession, and as individuals.

Sometimes this can be something banal.

Other times, it can be massive and monumental.

As a country, the United States is at a convergence. Or is it a divergence? The reckoning with past transgressions and charting new paths to a brighter future. Through dialogue.

Through space (literally – just ask Bezos, Branson, and Musk). The Delta variant, vaccination holdouts, COVID breakthrough cases. The Capitol insurrection fallout. Where do we go from here?

As a profession, Dental Sleep Medicine is also at a crossroads. There are more dentists participating in dental sleep medicine educational courses than ever before. The number of people that may benefit from OAT is higher than any other time in history due to increasing obesity numbers, the Philips CPAP recall, the AHRQ draft report, and growing public awareness about dentistry’s indispensable role in addressing sleep disordered breathing.

Nonetheless, we are nowhere near an inflection point. We cast aspersions about other companies’ appliances and chuck muck at medical colleagues and peers whose crimes are being uninformed, ill-informed, or more successful than us. There is a lot of work to do, collaborative relationships to form, research to conduct, technologies to harness, and dammit, there are millions of people to help.

I’ve been hearing about the looming dental sleep medicine tipping point for fifteen years.

Yes, we’ve seen growth, increased adoption, and improvements to the landscape.

Most medical payors reimburse for treatment, respected professional organizations such as the ADA and AADSM have provided explicit guidance highlighting the importance of DSM, and the list goes on Jason Tierney with a litany of micro-wins.

But what happens next? Do we continue to take 3 steps forward and 2 steps back until we reach the proverbial promised land?

What is our moonshot and who will manage mission control?

That’s up to you. Each of us possesses agency. We choose our path. We may not be able to change the world, but we can change ourselves. If you do that, someone else will see it and they’ll influence another, and another, ad infinitum. It is through these singular changes that movements are born. If you want to change dental sleep medicine – if you desire to see more medical referrals, more sensible insurance payments, more meaningful regulatory changes, then start with changing your own practice.

The weight of the world is on your shoulders. Now. But others will see you and come to your aid. The yoke will lighten, and the world will be elevated.

Dental Sleep Medicine should be commonplace – writing this next chapter is a collaborative project. Make it happen.

Dental Sleep Practice subscribers are able to earn 2 hours of AGD PACE CE in this issue by completing the online quiz after reading the article “Physician-Dentist Collaboration: A Call to Arms for Allied Troops” by Drs. John Viviano and John Bouzis which starts on page 30.

DentalSleepPractice.com

1

CONTENTS

12

Cover Story

Effectively Simple – One Appliance’s Journey Through Time

Don Frantz, DDS, and the EMA® device are stalwarts of the Dental Sleep Medicine field. How did they get here and where are they headed? Inquiring minds want to know.

8

Bigger Picture

My CPAP Can Harm Me. What Can You Do?

by Steve Carstensen, DDS, D.ABDSM The recent CPAP recall has shone a light on the critical gap provisional appliances can fill.

Read how this therapy can be used now and in the future.

58

Practice Management

You Can’t Buy Your Way to Dental Sleep Success

by Brett Brocki Can you subscribe to success or pay for practice perfection? A growing number of companies claim they hold all the secrets. Separate fact from fakery, and focus on what matters.

Continuing Education

30

Physician-Dentist Collaboration: A Call to Arms for Allied Troops

by John Viviano, DDS, D.ABDSM, and John Bouzis, DDS Recent events are tarnishing PAP’s gold standard luster. What does this mean for collaborative sleep medicine, OAT, and patient wellness?

2 CE CREDITS

45 2 DSP | Fall 2021

Special Section

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CONTENTS

6

Publisher’s Perspective

Off the Roller Coaster – A Positive Outlook, Fresh Goals, and Renewed Focus on Success

by Lisa Moler, Founder/CEO, MedMark Media

18 Expert View

In Your Own Words We asked some of the most prolific dental sleep practices for tips and techniques to increase case presentation.

Read it in their own words.

24 Clinical Focus

Do Occlusal Guards Cause or Worsen Apnea?

by Barry Glassman, DMD, and Don Malizia, DDS Everyone knows that occlusal splints worsen sleep apnea. But is everyone wrong? The literature will shock you.

27 Product Spotlight

How Do We Measure Success?

by Mark T. Murphy, DDS, D.ABDSM What KPIs are you using to determine which devices are working for your patients? If it’s just AHI, you might be striking out.

28 Billing Blocks Home Sleep Tests: To Bill or Not to Bill

by Randy Curran Can you monetize Home Sleep Testing in your practice? The medical billing oracle shares the ins and outs, dos and don’ts so you do what’s right by your patients, your practice, and the law.

4 DSP | Fall 2021

38 Technology & Innovation

4 Reasons a Dedicated Dental Sleep Medicine Health Record Will Benefit You

by Rose Nierman and Courtney Snow Do you really need a dental sleep software? Here are 4 solid reasons that will remove any doubt.

41 Product Spotlight

Now Is the Time to Get SnoreHooked

by James P. Boyd, DDS What do you do when you need an appliance today? Or a backup device?

That’s PDAC-approved for under $100?

The answer is the same for all these questions.

42 Medical Insight

Inspire: Every Breath You Take

by Asim Roy, MD and Brandon Canfield, DDS You’ve heard the radio and TV ads, but what is Inspire therapy? Who’s it for and why does this matter to dentists?

54 Practical Tips Oral Appliances and Tooth Movement; Caveat Emptor

by John Viviano, DDS, D.ABDSM Tooth movement is among one of DSM’s most dreaded side-effects. Which appliances are the culprits and does it really matter?

60 Clinical Focus

Healthy Cells, Healthy Brain: Nose Breathing is Fundamental

by Steve Carstensen, DDS, D.ABDSM, and Karen Davidson, DHA, MSA, MEd, MSN, RN Nasal breathing is vitally important – but why? Your patients’ health depends on it.

64 Seek and Sleep

DSP Crossout

Fall 2021 Publisher | Lisa Moler lmoler@medmarkmedia.com Editor in Chief | Jason Tierney jason@medmarkmedia.com Managing Editor | Lou Shuman, DMD, CAGS lou@medmarkmedia.com Editorial Advisors Jagdeep Bijwadia, MD Randy Clare Scott Craig Randy Curran Barry Glassman, DMD Elias Kalantzis Steve Lamberg, DDS, D.ABDSM Mayoor Patel, DDS, MS, RPSGT, D.ABDSM Mark Murphy, DDS John Viviano, DDS

Director of Operations Don Gardner | don@medmarkmedia.com Manager – Client Services/Sales Adrienne Good | agood@medmarkmedia.com Creative Director/Production Manager Amanda Culver | amanda@medmarkmedia.com Marketing & Digital Strategy Amzi Koury | amzi@medmarkmedia.com eMedia Coordinator Michelle Britzius | emedia@medmarkmedia.com Social Media & PR Manager April Gutierrez | medmarkmedia@medmarkmedia.com Webmaster Mike Campbell | webmaster@medmarkmedia.com Front Office Administrator Melissa Minnick | melissa@medmarkmedia.com MedMark, LLC 15720 N. Greenway-Hayden Loop #9 Scottsdale, AZ 85260 Tel: (480) 621-8955 Toll-free: (866) 579-9496 www.DentalSleepPractice.com Subscription Rates 1 year (4 issues) $149 | 3 years (12 issues) $399 ©MedMark, LLC 2021. 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.

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PUBLISHER’Sperspective

Off the Roller Coaster – A Positive Outlook, Fresh Goals, and Renewed Focus on Success

I

n looking back, most of us felt that last year was a roller coaster ride.

We got shoved into that buggy, fastened our seat belts, and hung on.

Dentists hurtled around all of the new rules and regulations that were unveiled each day. You skidded around corners that held unknown aerosol dangers, careened past roadblocks to business operations, and avoided the twists and turns of offering emergency care to patients when the definition of emergency care was still evolving. It was a white-knuckle ride, for sure.

But through the highs and lows and learning curves, we emerged definitely wiser and more resilient.

Lisa Moler Founder/CEO, MedMark Media

Here at MedMark, even at the height of the pandemic, we brought you the most up-to-date information on how to protect your patients and staff and prepare for reopening. We anticipated and tracked the new trends and technologies that patients would be expecting. We checked on our readers and authors through emails, texts, and Zooms. We saw you calmly focus on keeping in touch with patients through teledentistry, informative texts, and website updates. You prepared protective equipment to be able to provide emergency care, consulting, and treatment plans for when the crisis was over.

Now, we are joyfully hearing about your safe returns to business. And our articles reflect our goal of helping you flourish in the future. Our CE, Physician-Dentist Collaboration: A Call to Arms for Allied Troops, by Drs. John Viviano and Jon Bouzis, reviews recent events that have the potential to significantly alter the face of sleep medicine and discusses the Physician-Dentist Collaboration model. Our

cover story is a conversation between Dr. Don Frantz the inventor of EMA® dental sleep appliances and me. Dr. Frantz creates oral appliances for sleep apnea with a focus on simplicity, ease of use, affordability, and value. Don’t forget to check out our Special Section on Education. There, you will find nine companies that can help expand or start your dental sleep practice.

Each one is differentiated by its offerings, materials, perspectives, and educators.

These educational opportunities can help you find the tools to be successful in the field of DSM. With this fall issue, the new view from the top is exciting. We are thrilled to be able to say that we made it. We’re no longer anticipating what is coming around each bend. And we are ready to take a new plunge — into the future. I’m proud and amazed at the perseverance and courage that we all saw in the dental profession.

With a positive outlook, fresh goals, and renewed focus on success — the MedMark team is bracing for new adventures!

Do you like what you are reading in DSP? Do you have ideas you want to share about what works in your practice? Our editor Jason Tierney is happy to consider essays from any reader! Contact him at jason@medmarkmedia.com.

6 DSP | Fall 2021

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My CPAP Can Harm Me. What Can You Do?

by Steve Carstensen, DDS, D.ABDSM

“S

top using your CPAP device and contact your physician or DME provider for next steps.“ On June 14, 2021, Philips issued a safety recall for most of their CPAP/BiPAP line based on breakdown of internal parts that could release particulates and certain chemicals into the airstream.

“Stop using your CPAP device and contact your physician or DME provider for next steps.”

This represents a tremendous opportunity for dentists to help.

8 DSP | Fall 2021

Stop using the machine that people put up with because it significantly improves their quality of life and/or addresses a vital medical problem? Philips had no suggestion for what to put in place other than ‘work with your physician.’

This represents a tremendous opportunity for dentists to help patients breathe better the first night without CPAP. Why dentists? Why not switch to a safer brand of PAP? Since Philips is one of two major PAP manufacturers, and since this recall came as a surprise to the industry, the other companies had to quickly pivot and ramp up their production and supply. However, in the American Academy of Sleep Medicine’s webinar on June 21, 2021, they stated, “CPAP supply is nearly exhausted. Prioritize severe sleep apnea and complex patients.”

Philips has put millions of PAP devices into people’s homes over decades. That many calls to sleep docs and DME providers alone would overwhelm the system. There’s no answer for most people demanding a solution to their risky sleep related breathing disorder.

Into that gap steps the dentist trained in fitting mandibular advancement devices.

We have at our disposal professional interim devices we can fit tonight and assure our patients their airway will be supported. We can order custom oral appliances from our manufacturing partners to address airway collapse in the long term, sans harmful particulates or ‘certain chemicals.’

How do we become the saviors of the day? Let’s step back a bit and examine how

patient flow works in your dental practice.

The ADA has suggested every dentist, all 199,486 (as of 2018), screen their patients for sleep related breathing disorders (SRBD).

If you’ve not started that yet, please look into how simple it is to add a few questions to your health history. You can ask: • Do you snore or has anyone told you that you do?

• Have you ever been diagnosed with a sleep breathing problem and been prescribed CPAP? • Do you feel sleepier in the day than you think you should?

• Has anyone ever mentioned you stop breathing during sleep, or observed you choke or gasp?

• In the morning, do you ever feel you’re not rested, despite enough time in bed?

• Do you get up more than once during the night to use the restroom?

Dentists are using questions like these, along with validated tools such as STOPBANG or Epworth Sleepiness Scale, to identify people at risk for SRBD and sending them for further evaluation by a sleep physician.

That’s excellent practice, but there is more to be done.

Ken Berley, DDS, JD, uses a ‘Snore +’ method of understanding his patient’s status. If they report snoring plus one other ‘comorbidity’ such as hypertension, anxiety, diabetes, GERD, or one of another 18 signs, symptoms, or reported history, it generates a heightened sense of urgency to make sure patients are safe while they pursue additional evaluation.

What if your patient reports enough factors that you are worried for their safety – they are afraid they would be sleepy driving, for example. If they say they are afraid to go to sleep without their Philips CPAP because they fear stroke, heart attack, or not waking in the morning? If they enjoy sleeping in their master bedroom instead of the guest

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room down the hall? Are you going to simply assure them and help them make an appointment to see the sleep doc, even if that’s weeks or months away? Is that your best doctor behavior?

Professional interim mandibular advancement devices, made in the office by your trained team, give your patients the solution they seek, tonight.

There are choices – Amazon lists ‘over 1,000 results for anti-snoring.’2 There are many professional devices such as Apnea Guard (Advanced Brain Monitoring), Alpha (SomnoMed), Moses Express (Moses Appliances), Silent Nite (Glidewell), SnoreHook (ChairsideSplintStore. com), and myTAP by Airway Management (www.tapintosleep.com).

The myTAP has advantages other devices don’t have: a silicone mouth shield to promote nasal breathing and vertical shims to vary the tongue space to fine tune airway support. The thin arch forms are shaped over the teeth and can be refitted an unlimited number of times by reheating. The device can be relined in a simple process, ensuring excellent retention. Dialing in the patient’s mandibular protrusion and vertical jaw position while improving nasal breathing allows the astute clinician to address patient’s SRBD with precision. Immediately, tonight.

If your dental practice is like most, you have 1000, 1500, 2500 patients in your care.

Statistics indicate over 25% of them have some form of SRBD, and many probably have history of CPAP use. Reaching out to your patient base with a message of support and an offer to take action today is a powerful value statement of your commitment to health.

Steve Carstensen, DDS, has treated sleep apnea and snoring in Bellevue, WA since 1998. He’s the Consultant to the ADA for sleep related breathing disorders, has trained at UCLA’s Mini-Residency in Sleep and is a Diplomate of the American Board of Dental Sleep Medicine. He lectures internationally, directs sleep education at Airway Technologies and the Pankey Institute and is a guest lecturer at Spear Education and Louisiana State Dental School, in addition to advising several other sleep-related manufacturers. From 2014 – 2019 he was Editor of Dental Sleep Practice magazine. In 2019, Quintessence published A Clinician’s Handbook for Dental Sleep Medicine, written with a co-author.

10 DSP | Fall 2021

Another excellent feature of professional interim devices is they require no doctor time to fabricate – the dentist simply needs to order them. Trained team members take over and heat, shape, fit and counsel the patients about their use. In my practice experience, this energizes the team, provides new education, opportunities to help patients, and reinforces the values of the office.

If you provide myTAP or another device for undiagnosed patients while waiting for additional medical evaluation, or if your patient cannot use their CPAP, there is currently no medical or dental benefit coverage for the devices, coded E0485 in insurance terms.

These are cash-pay services, simplifying your collection systems.

The Philips CPAP recall provides the ethical dentist with many marketing opportunities. First, to your patients who need help tonight. How will you do that? Email blast?

Social media posts? Automated text or voice messages? Can your software help?

To your medical colleagues – offer to help the physicians who diagnose SRBD and prescribe CPAP – keep in mind, they don’t have other brands to turn to. Give them a face-saving solution, and you will build loyalty.

To physicians, dentists, and health care professionals not directly involved in sleep care: they might not have thought of your office when discussing sleep issues with their patients. Providing your expertise, fact sheets, and giving them answers to FAQ will enhance your reputation as the go-to in your community.

What about the general public? Do you, the dentist, offer services directly when the recall announcement says, “Consult your physician and DME Provider?” Of the millions of Philips CPAPs delivered to patients, more than half are unused.3 Your message might prompt those diagnosed, untreated people to consider an alternative that appeals to them. Make yourself known and give them hope.

We want every breath, every night, to be the best possible for every patient.

The Philips recall is another reminder that no part of health care has all the answers.

Trained dentists have been and will always be part of the solution. Do your part. Help people, today.

1.

2.

3.

https://www.usa.philips.com/healthcare/e/sleep/communications/src-update Online accessed 07/01/2021 https://www.usa.philips.com/c-e/smartsleep/campaign/worldsleep-day.html

Dental Sleep Education That Fits Your Schedule Dental Sleep Education that fits your schedule The Academy of Clinical Sleep Disorders Disciplines is the only organization offering a fully online and on-demand certificate in Dental Sleep Medicine.

Study theonly lectures and course materials at your own The Academy of Clinical Sleep Disorder Disciplines is the organization offering a fully online pace, then when you are ready, take theSleep exam.Medicine.

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The Academy of Clinical Sleep Disorders Disciplines (ACSDD) is an ADA CERP Recognized Provider.

ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education. ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry.

The Academy of Clinical Sleep Disorders Disciplines (ACSDD) is an ADA CERP Recognized Provider.

This program has been submitted for approval by the ACSDD for a maximum of 13 credits as meeting general dental requirements.

ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education. ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry. Concerns or complaints about a CE provider may be directed to the provider at info@acsdd.org or to ADA CERP at www.ada.org/goto/cerp.

COVERstory

Effectively Simple One Appliance's Journey Through Time

D

on Frantz, DDS, has a lot on his mind, and he wants to share it with the Dental Sleep Medicine (DSM) profession. Dr. Frantz is the inventor of the EMA® dental sleep appliances, and his passion for sleep drives him to continually innovate, work, and invent. He practiced as an orthodontist for 60 years before entering the field of sleep medicine.

His company, Frantz Design Incorporated, owns more than 50 foreign and domestic patents which his team plans to leverage to continue improving the Dental Sleep Medicine landscape. MedMark Media’s CEO, Lisa Moler recently sat down with Dr. Frantz to learn how his past drives DSM’s future.

Take us back. What prompted you to create the EMA?

To be honest, I was tired of getting kicked in the middle of the night! Whenever I stopped breathing in my sleep, my wife would give me a good kick. My son,

12 DSP | Fall 2021

COVERstory Michael, had a dental lab and we began to tinker with an oral appliance that might help treat my sleep apnea. As you know, that’s actually how a lot of sleep practitioners enter the field – as a way to treat themselves.

And that led to the EMA?

Yep. We developed the first EMA prototype in 1993. It was important to me that any product we created checked three boxes.

The appliance had to be simple, inexpensive, and be readily accessible to patients. We still operate under this philosophy.

How did you break into the oral appliance market with the EMA?

It wasn’t easy. As an orthodontist, I first approached a sleep lab in Houston and told them I had created a device that would really help with sleep apnea, I’m not sure they took me seriously.

After some persistence, they eventually gave me a study of eight to ten patients. Little did I know at the time, the study included some moderate to severe sleep apnea cases.

Through the course of treating those patients and tweaking the design, we saw great results. At the end of the study, one patient went from an AHI of 110 all the way down to 10. The results of that study are what landed us an NIH grant.

That’s what really launched us. Fortunately, the sleep doctors’ treatment philosophy and mine were the same – do what’s right for the patient. I learned a lot on those long nights, at the sleep lab, observing patients and titrating EMAs during sleep studies. Buy me a drink sometime and I can tell you some interesting stories about anesthetized patients and MRIs!

Surely you had people in your corner.

Did you have mentors or colleagues that supported you during that time?

Oh yeah. We were fortunate to have some really smart friends in sleep medicine. If we ran into a problem or a stumbling block, we’d meet to compare clinical notes and figure it out. We had a great think tank. We learned a lot by getting dentists’ perspectives at the annual AADSM meetings and then venturing over to the AASM meetings for the physicians’ insights.

It wasn’t always flattering to dentists, but we learned a lot. I can tell you there is an incredible opportunity for dentists in dental sleep medicine.

Well, you’ve come a long way. The EMA has great market share. What keeps the EMA competitive?

As dental sleep appliance developers, we need to make products that position a dentist for success without a lot of complexity, cost, or confusion. Usually, dentists’ first patients are either themselves, family members, or a staff member. It’s frustrating for me because there is a lot of need and I know what this simple oral appliance can do.

The removable safety handles allows the trays to be easily heated for a semi-custom fit and also provides a visible strap length indicator for a simple EMA Advancement Strap length selection.

How did the medical field receive the EMA?

I was having success with patients and my local sleep physicians, but on a national scale, dentists were having a difficult time developing relationships with physicians.

They frequently don’t see them as equals.

I remember, this one time, in the beginning, we were at a medical conference in New Orleans. A doctor nearby said, loud enough for everyone to hear, “Who let the snake oil salesmen in”? Luckily, a physician at our booth shouted, “Yeah, the earth is flat too!”

These images are renderings of Frantz Designs new EMA NOW™ temporary oral appliance that is indicated for treatment of mild to moderate snoring and OSA.

DentalSleepPractice.com

13

COVERstory The more people we can reach with this product, the more people we can help, the more lives we can save. Unfortunately, not all dentists understood the correlation between dentistry and sleep apnea. Oral appliances have been rumored to move teeth, and there were some that did. You must treat teeth as a single unit. Trying to move the jaw alone will end up moving teeth. As an orthodontist, I was accustomed to creating retainers. The design of the EMA is based on a retainer with an appropriate amount of tension.

The EMA is comfortable. It doesn’t cause TMJ issues, and it works. Simplicity works.

We never stop working on research and development. I always say, if you begin to think you know it all, you don’t. We feel there are always improvements that can be made to improve the comfort and function of the EMA. Things like straps, buttons, milling and 3D printing. We continue to focus on simplicity, ease of use, affordability, and value. It works for us, for our doctors, and for their patients.

“We continue to focus on simplicity, ease of use, affordability, and value. It works for us, for our doctors, and for their patients.” What’s your take on the current state of oral appliance therapy?

Personally, I still think it’s too slow, especially when so many people suffer from this very treatable sleep condition. Dentists take an oath when they graduate – the commitment to do what’s in the best interest of their patients. But I don’t think many dentists realize that sleep medicine is in their job description. With a simple oral device, dentists have access to an effective solution for many patients suffering from OSA. It’s their job, their oath, and their responsibility to educate themselves on oral appliances and how they can benefit their patients.

Occlusal pads have been lengthened to extend over the bicuspids and molars for added TMJ comfort.

14 DSP | Fall 2021

Patent Pending dual temperature material utilized for an easily adaptable semi-custom fit. Rigid arch frame maintains structural integrity making the heat-to-fit process user friendly.

Do you think it is a problem with the experience level of the dentist? Is there a learning curve when it comes to sleep medicine?

This is a simple case of obligation, part of the job. For years, there was no mention of sleep in the dental school curriculum. Fortunately, that is changing and will likely continue to move in the right direction. Still, we need more communication between physicians and dentists on the issue – to bridge the gap between dentistry and medicine. We’ve made some progress, but we can’t rest on our laurels.

To dentists, I say, make sure you’re on top of what’s available for your patients. Partner with a quality lab that produces dental sleep medicine oral appliances and products. Be part of the solution.

Compare the gratification you felt in orthodontics with what you feel in sleep medicine.

I enjoyed orthodontics for so many years, but sleep medicine is particularly rewarding. I used to run into orthodontic patients and they would thank me for giving them a great smile. A sleep patient will say, “Doctor Frantz, YOU SAVED MY LIFE!” That’s pretty great. Talk about gratification…it’s not even close. There is no comparison.

Years ago, I had a patient whose sleep condition was so advanced, his family thought he had Alzheimer’s. They took his car keys and everything. When he came to me, I gave him the EMA. Next time I saw him, he picked me up off the ground and said, “You don’t know how much I love you!”

Now, this was a family that had dirt floors in their home. They couldn’t pay me. His wife said she would pray for me and that was my payment. The money comes and that’s great, but those prayers mean far more to me than any amount of money. My wish for dentists is for each and every one of them to experience this themselves. But stories like this make it all worth it. Access to care is so important to me, the ability to create a product that is simple and available to everyone.

That does sound gratifying. You’ve been retired now for five years. Are you enjoying it?

I hate it! I’m a better dentist and designer

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COVERstory than I am a fisherman. I wish I could be seeing patients, but I had a heart attack and reluctantly retired in 2016. Since that time, I’ve been able to focus on the design aspect of the EMA, which I really enjoy. I have a great team that fills in the gaps. There are things that I don’t want to do, or that I’m not so good at. Most of the time, it’s much more of a passion than a job.

You’re the busiest retired person I know, but you can’t do this alone. Who’s the dream team behind the EMA?

“Affordability should never be the reason patients don’t have access to quality care and restorative sleep.”

I have an incredible engineer named Dane Kitchen. He’s a mechanical engineer that designs injection-formed toolings for different medical devices. He also handles processing and manufacturing of the current EMA model and is really talented. My son, Joe Frantz, is Chief of Operations of Frantz Designs and runs the business. We’ve partnered with Sonnie Bocala, who owns Apex Dental Sleep Lab. He manufactures custom-made dental appliances like the EMA. Together with Myerson, our global distributor, we have this cohesive think tank that just blows me away. We all have our areas of specialty, but we all learn from each other. Kind of a checks-and-balances system. This makes us all better, keeps work exciting, and creates exponential growth. The passion and contribution of every member of the team gives me so much confidence in where we are going.

When everyone has this level of skill and passion, it doesn’t feel like work at all.

That leads me to my next question.

Where do you see the EMA in ten years?

That’s a big question. No matter what, the three points of our philosophy will still be at the center of what we do. Simplicity, affordability, and accessibility.

We just launched the EMA-NOW™, an immediate, temporary oral appliance for sleep apnea. This product was designed to be affordable, accessible, and fast. Patients can see their dentist and walk away with treatment that same day which is badly needed today due to the recent CPAP recall.

One seismic change I see in the industry is digitization. We’ve been watching the digital advancements in this field for years but have intentionally sat on the sidelines.

We didn’t feel the technology was there yet.

I always say, just because you can, doesn’t mean you should. We didn’t feel that digitization had evolved to the point where it would align with our three main goals, but we see that changing.

These days, 3D printing is incredibly accurate, more accurate than traditional production. We’re not jumping on the bandwagon just yet though, because the technology isn’t quite ready for prime time. It’s almost there, and we’re moving in that direction. We’ve already begun 3D production designs. Like I said, our main goal is to keep it simple, keep it cost effective, and keep it accessible to everyone who needs care. When we can check these three boxes, we’re ready to digitize.

Will the 3D designed product differ much from the current EMA?

Dr. Frantz…living in the present and enjoying his other passions.

16 DSP | Fall 2021

Not much will change with the basic design – because it works. We’re improving the strap and making the unit more comfortable, with smaller, lower profile buttons.

We’ll have to make small alterations to make the design more digital-friendly, but it won’t look much different than the product patients are used to.

I’ll tell you what won’t change – the price.

The reason we’ve held off on digitization is because 3D products are often double the cost to produce. We’re close to a production margin that will keep the EMA in an affordable price range for patients. That is very important to us. Affordability should never be the reason patients don’t have access to quality care and restorative sleep.

SLEEP... IT’S WHAT WE DO

@apexdentalsleeplab

EXPERT view

In Your Own Words

S

ome call it “case presentation.” Others refer to it as “presenting treatment”, and there are even a few that use the 4 letter “S” word – SELL. No matter how beneficial oral appliance therapy (OAT) might be for a patient, the onus is on you to tap into what matters to your patient, highlight the value of treatment, and help them see a better future in exchange for payment. If you can’t help them see this light, it’s likely those prescriptions will remain blank.

In each issue of Dental Sleep Practice we ask experienced subject matter experts the same 3 questions. Here are their insights about improving case presentation… in Your Own Words.

1. What is the most common objection & how do you overcome it?

2. What 2 case presentation tips would you give to a DSM practitioner?

3. What is one aspect of OAT case presentation you changed, why, and how did it make a positive impact?

Jerry Hu, DDS

1. There are 2 equally common objections my practice faces. The first relates to the patients’ knowledge and awareness of how serious untreated OSA and UARS can be. The solution is always to communicate thoroughly. Digging into their health history, connecting the dots to their co-morbidities and systemic illnesses, reviewing their sleep test results and screening data from equipment, plus allowing your team to do their roles are all essential. Engaging with the patient’s bed partner is also critical, and allotting proper time is key to developing exceptional care and follow up. The second objection is financial, but once the first objection is overcome, the second is overcome rather naturally because the patient sees the value, benefit, and level of care you provide.

2. In my practice, we are equipment lovers. When it comes to case closures, take the time to measure and collect baseline data, involve the patient with doing something “physical” such as using the Eccovision and other activities like the cottle test. These are priceless steps that guide patients to engage, accept, and want to progress with additional screening and treatment. It’s like getting an EKG and a

18 DSP | Fall 2021

printout report; these are very powerful tools to use to help patients co-discover their health condition and problems.

3. New technology and innovations aiming toward OAT precision and comfort have allowed my office to enhance our presentation and reputation. Using equipment to measure for patients’ unique “sweet spot” for the initial position of the OAT allows my practice to save time by having minimal to no calibration need. In my state of Alaska, some patients travel quite far to see us. Decreasing the number of appointments needed and respecting precision and comfort, allow for better compliance and overall effectiveness outcomes. These all matter for achieving long term success. Time is money.

Mark Murphy, DDS, D.ABDSM

1. The most common objection is in our own dental thinking paradigm, where we set up systems to protect our practice from NOT getting paid. That construct is important with dental “insurance” (which is NOT real insurance taking on risk against a catastrophic loss) but NOT with medical. Virtually NO one ever discusses or asks how much it will cost in a medical practice, or had patients sign financial agreements or make down payments before treatment. Act like you are practicing medicine when doing sleep and you will do more.

2. Assume the patient is moving forward with testing and/or treatment because it is a medically necessary treatment….and covered by medical insurance…and then stay out of their way. Just make it easy to do business with you and talk way less about money and how much it costs.

You may get burned (rarely) but you will close many more cases - the math works.

I worked with an office that moved from under 25% to 80% closure rates with minimal nonpayment. The results were HUGE! 3. There is a study about the medical patient pathway that describes three questions that patients want answers to; Do I have

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EXPERT view this? Is it serious? And can you treat this?

Keeping these three points in mind helps you construct a talk track that pre-answers these three things while education the patient during the consultation and treatment presentation.

Lesia Crawford 1. This is no surprise – out of pocket cost or “I don’t mind paying for it but how do I know it will it work for me?” When cost is a challenge, I let the patient know that we do not turn anyone away who needs treatment. Whatever it takes to make it affordable we are willing to help. We offer CareCredit, custom payment plans, and emphasize maximizing their insurance coverage.

When it comes to treatment efficacy, I let them know we can never guarantee it will work 100%. I warmly tell them that we have helped patients who have severe apnea with 70 to 90 episodes per hour and brought them down to 2 or 3. We have also had patients where no matter what we do, it just does not work. We will do all we can if you are willing to give it a 100% effort to make it work for you, we will as well.

2. Spend more time listening to your patient and their concerns and goals. You have two ears and one mouth. Listen more.

Talk less. Ask why they are there. What do they want to accomplish? How is their sleep apnea affecting their life?

Personalize their solutions. If they sleep with 2 cats, they do NOT care about snoring. If they are relegated to the couch by an agitated bed partner, they DO care about snoring. Get them excited about restorative sleep, feeling better, and moving forward to a solution to their health or social problems.

3. This is my favorite question. During the first couple of years in the dental office, I was afraid to offer the option of moving forward with sleep apnea treatment until we had an approval from the insurance company. The patient was in the office, excited to get started, and I put the brakes on and said, “We will call you when your insurance approves the services.” Now, we start right away and do not make

20 DSP | Fall 2021

the patients wait. We schedule them out three weeks for delivery and that is plenty of time to get an approval. If it denied and we have to appeal, or we are working on a GAP and it takes longer, we simply move the appointment out a week or two.

Our acceptance rate went from less than 50% to greater than 85% overnight.

Jennifer Le, DMD, D.ABDSM, CPCC 1. The most common objection to oral appliance therapy is concern with changes in dentition. Being direct with the patient through open communication and education on the pros and cons of various treatment options tremendously helps with case acceptance and minimizes misunderstandings. Take the time to reassure the patients that you are available for questions and concerns throughout their treatment. Give patients literature and recommendations for video demonstrations of exercises. All therapy options have risks. Educate yourself on them so that you can answer patient’s questions in order to help them arrive at a therapy option that best fits their needs.

2. Patient Education – Many patients will arrive in your chair not understanding what OSA or AHI means. Take the time to help patients understand their diagnosis. Help them appreciate the importance of compliance on their overall health. Go beyond “you’ll feel better” and discuss mind and body health. Discuss importance of each sleep cycle and why uninterrupted sleep is imperative to facilitating regenerative sleep on a systemic level.

Pre-treatment baseline – Make sure to have clinical documentation of dentition, pre-treatment sleep studies, dental clearance. Models, digital scans, and intraoral documentation of pre-treatment dentition will allow better assessment of rate of change or any concerns of dental changes as treatment progresses.

Discuss reasonable expectations of various types of appliances based on your clinical findings of the patient’s self-reported parafunctions and anatomical variations.

3. I am 100% involved in the patient’s OAT case presentation from start to finish. This

EXPERT view helps to establish confidence in OAT therapy because patients are able to ask questions and establish rapport. This has tremendously reduced miscommunication and increased case acceptance and referrals.

Jay Neuhaus, DDS, D.ABDSM

1. My practice is limited to DSM, and most of my patients are referrals from MDs, Cardiologists, ENTs, and other dentists. Because most of my patients are “pre-qualified”, the main objection I get is “Why do I have to wait so long (3-4 weeks) to receive my appliance?” My quick response is always “Why did you wait so many years to begin treatment?”

And then I offer them an interim temporary appliance at an additional fee.

2. First, I’d say focus on the patient’s specific chief complaint (snoring, excessive daytime sleepiness, etc.) as it relates to their specific comorbidities (hypertension, stroke, afib, cognitive deficiencies, etc.).

Make sure they understand that sleep apnea can markedly shorten their life expectancy.

Secondly, I’d suggest they under-promise & over-deliver! Never make the false claim that you can cure everything with your appliance! Assure them that you will do everything in your power to help them live with their very serious disease. And then DO SO! 3. When I still ran a very successful dental practice, I quickly learned not to mix in my “sleep” case presentations into my regular schedule. You really must be in a different mindset. Put on your “medical hat” and get out of your “dental mentality hat.” Never do the presentation in a dental operatory. Don’t wear your typical dental scrubs or gowns! Talk like a

“real doctor” while you’re discussing a real life-threatening medical condition.

I found the best way to do this was to set aside a half-day each week specifically for sleep case presentations.

Patti Staniorski

1. It’s very common for the patient to come in for the consultation and not understand what Obstructive Sleep Apnea (OSA) is because it was never explained to them.

They were just told, “You have OSA and you’re getting a CPAP.” When that happens, the patient doesn’t usually believe they have a life-threatening condition, and so we explain what OSA is and how it can take its toll on the entire body.

2. When a clinician or staff member has gone through the entire process, from diagnosis to treatment, they can better relate to the patient and vice versa. This can make all the difference in the world for their successful treatment.

If the patient is still hesitant, I explain they have four options: 1) wear a CPAP (which they won’t do), 2) try the oral device, 3) have surgery, or 4) do nothing.

If you do nothing, then you have a 92% chance of having a stroke or heart attack.

3. We require that the patient’s spouse or bed partner be present at the consultation. The reason for this is so that they can listen and learn along with the patient.

This minimizes any miscommunication when the patient goes home to discuss what happened at the consultation. The patient is the one sleeping, not the bed partner. The bed partner is the one hearing the snoring, lying awake fearful when the partner stops breathing. They usually have many more questions. Once we implemented this protocol, our case acceptance rate climbed 82%.

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22 DSP | Fall 2021

CLINICALfocus

Do Occlusal Guards Cause or Worsen Apnea?

by Barry Glassman, DMD, and Don Malizia, DDS

O

ral appliances used in the treatment of primary snoring and obstructive sleep apnea (OSA) have been shown to be potentially as effective in mean disease alleviation as CPAP therapy.1,2 The active mechanism these oral appliances utilize is mandibular protrusion. Mandibular protrusion has been shown to increase the muscle tone of the pharyngeal dilators during sleep, thereby counteracting the tendency to have the sleep-induced loss of muscle tone contribute to pharyngeal collapse. It is also noted that mandibular protrusion also tends to stabilize the hyoid bone, which, in the human as opposed to other mammals, is a floating bone that does not articulate with the styloid process of the petrous temporal bone. Mandibular protrusion with hyoid stabilization stabilizes the anterior pharyngeal wall.

80-90% of those who have some degree of sleep disturbed breathing are undiagnosed.3 Consequently, patients who are treated in dental offices may indeed be among those who remain undiagnosed with OSA. Misconceptions that only overweight men suffer from apnea or that it is possible to identify apneics in a clinical examination must be dispelled if we are to properly diagnose more patients more effectively. Proper screening should be performed.4 Over 3 million occlusal splints to manage sleep bruxism and TMD are annually prescribed by dentists in the US.5 It was theorized by Gagnon, et al that these appliances, by the very nature of the interocclusal acrylic, would have several consequences, including a retruded mandible and decreased tongue space. The authors then hypothesized that “the use of a single maxillary oral splint may aggravate respiratory disturbance in sleep apneic patients.”6 The potential relevance of this hypothesis is noteworthy. The severity of OSA is associated with the significant cardiovascular disorders of hypertension, stroke, heart failure, and is potentially associated with sudden death.7 Other significant disorders associated with OSA include diabetes and migraine. Recent studies have noted a possible association with Alzheimer’s disease. OSA is often a major contributing factor to excessive daytime sleepiness, and thus can contribute to the cause of motor vehicle accidents and work mishaps.7 With the use of maxillary splints, could dentistry have a long history of inadvertently contributing to increasing the likelihood of these serious untoward consequences?

Sleep medicine is a young science. The potential effectiveness of oral appliances combined with the issues of compliance associated with positive airway pressure – the “gold standard” of OSA care – have made dental sleep medicine continuing education among the most popular courses available. After the publication of the 2004 Gagnon, et al study many es-

24 DSP | Fall 2021

teemed lecturers authoritatively decreed from the podium that dentistry has been responsible for making OSA worse by using “night guards.”

Accusations included the charge that anyone who uses a night guard or occlusal splint without testing their patient for OSA is committing malpractice. Further assumptions claimed that if a maxillary occlusal appliance can Increase the disease in patients with apnea, it most likely can create apnea in the non-apneic patient.

Let’s review the 2004 Gagnon, et al study to uncover what it really shows and maybe more importantly, what it doesn’t show.

Methods of the 2004 Gagnon Study

Ten patients (3 women and 7 men) who had reported snoring and, after a single night study, were determined to have an AHI greater than 5, were the subjects of this study. It is noteworthy that three of the patients were taking anti-depressive anxiolytic medication.

All ten patients were fitted with a maxillary occlusal splint. They were given two weeks to adapt to the occlusal night guard. They then removed the oral splint for three weeks and participated in a “baseline” study without the appliance. The ten subjects were then instructed to wear the oral appliance for a week when they returned for the third study, this one with the splint in place.

Results of the 2004 Gagnon Study

The variables that were compared in the two studies included but were not limited to the apnea hypopnea index (AHI), the respiratory disturbance index (RDI), the Epworth Sleepiness Scale (ESS), upper airway resistance, percent of time with snoring sounds, and percent of time in the supine position.

Interestingly, it was reported that “there was no statistically significant difference in any of the sleep variables between the baseline and splint nights.” Yet it was noted that six subjects experienced an increase in AHI with the splint. This resulted in changes in the diagnostic classification of sleep apnea with one patient getting better (from moderate to mild) but four patients getting worse (two went from mild to moderate, and two went from moder-

CLINICALfocus ate to severe). The RDI was increased in six patients as well. Eight patients had an increase in snoring time with the splint in place.6

Comments on the results

Night to night variability and postural effect The small sample clearly limits the power of the study. Differences in amount of time spent in the supine position alone can result in an altered AHI beyond the normal night to night variability. In the discussion the authors comment that future studies should be done with a larger sample size using double blind rather than single blind methodology.

Does snoring time alone indicate the validity of increased snoring as a diagnostic tool?

Eight patients had increased snoring time with the appliance in place. There was no reference to the thresholds to determine snoring or any discussion of decibel levels. There was also no discussion as to what that increased time was or if that time was within the limits of night-to-night variability or related to increased time supine.

Clinical relevance of the potential change in sleep disturbed breathing Those who have taken the results of this study and admonished dentistry over the use of a maxillary splint for bruxism and/or TMD have leaned on the study’s report of increased AHI with the appliance in place. The AHI increase has been emphasized even though it has since been shown that there is no direct relationship between AHI and the associated disease states.8 This lack of a direct relationship puts into question any suggestion that a percentage of increase of AHI is clinically relevant The percentage the AHI is increased can be statistically significant without being clinically significant, especially in the lower AHI ranges.

Could the use of the medications in the patient sample possibly have confounded the study?

In the 2004 Gagnon, et al study it was reported that three of the ten subjects were taking anti-depressive or anxiolytic medications and that the use of the medications was not interrupted.

Neither the specific medication nor which patients were taking that medication was identified. The use of SSRIs, for example, can have a profound effect on sleep and can increase bruxism and negatively affect sleep quality.9,10 It should be noted that the Kuwashima, et al 2019

study that refuted the results of increased AHI with maxillary or mandibular splints excluded any patients taking any medication that could influence sleep.11 Can the use of a maxillary splint cause apnea in a non-apneic patient?

With the results of the Gagnon, et al study in hand, self-anointed gurus have unjustifiably pronounced that ‘night guards’ “...many esteemed or ‘bite splints’ will worsen AHI in pa- lecturers tients or cause sleep apnea when it didn’t previously exist. In 2019 Kuwashima, et authoritatively al completed double blind randomized decreed from control study with 26 patients who were diagnosed with TMD.11 Subjects with an the podium that elevated Epworth Sleepiness Scale score or dentistry has been those that tested positive on the validated STOP-BANG screener were excluded from responsible for the study. Those patients who required ap- making OSA worse pliance therapy for bruxism as determined by the AASM classification of movement by using ‘night disorders12 were randomly given either a guards.’” maxillary or mandibular splint. A baseline home study was taken before and after the appliance insertion, and it was noted that the AHI tended to decrease in both appliance groups. It was concluded that neither the increased vertical dimension nor the decreased tongue space resulted in an increased AHI. Have the study results been reproduced or refuted?

In 2011, Nikolopoulou, et al study utilized a sample group of eighteen patients with OSA.13 They underwent full polysomnograms

Barry Glassman, DMD, has earned Diplomate status with the American Board of Craniofacial Pain, the American Academy of Pain Management, and the American Board of Dental Sleep Medicine. He is also a Fellow of the International College of Craniomandibular Disorders. Among his recent publications are The Effect of Regional Anesthetic Sphenopalatine Ganglion Block on Self-Reported Pain in Patients with Status Migrainosus in Headache, and The Curious History of Occlusion in Dentistry in Dentaltown. He teaches and lectures internationally on orofacial pain, joint dysfunction, and sleep disorders.

Don Malizia, DDS, limits his practice to upper-quarter chronic pain and sleep disturbed breathing at the Allentown Pain & Sleep Center in Wilkes-Barre, Pennsylvania.

DentalSleepPractice.com

25

CLINICALfocus

NTI-tss device (Glidewell Dental)

and were then provided mandibular advancement devices that consisted of a maxillary and mandibular units which increased the vertical dimension in the anterior segment by six millimeters. The appliance was not advanced, and afterward a follow-up study was completed.

“No significant difference in AHI was noted between the baseline night and the 0 % MAD night.” There were, however, two patients whose AHI increase was significant. The conclusion made in this pilot study was that it is possible that some patients may be at risk for aggravation of their OSA with appliance therapy.

With the pilot study behind them, in 2013, Nikolopoulou, et al, attempted to access the influence of occlusal stabilization splints on patients with OSA.14 Ten patients underwent three polysomnogram recordings with their maxillary “stabilization” appliances in place and three without their appliances in a crossover design. The study confirmed that the increased AHI with the appliance in place was small, and that there was no change in the subject’s Epworth Sleepiness Score. With that small increase, clinical significance was deemed unlikely.

The 2019, Kuwashima, et al study demonstrated in their double-blind controlled study that the increased vertical dimension with the use of either a maxillary or mandibular appliance tended to decrease the AHI of patients who were given an appliance for treatment of their TMD.11

Summary

Six of the ten 2004 Gagnon, et al subjects were shown to have increased AHI with the appliance in place, but the difference was not statistically significant.

In the discussion, the astute authors noted the potential confounding issues of altered posture from night to night that were not taken into consideration. They also noted that longer observational periods could have affected the results. It was observed that the study was not double-blinded and potentially affected by bias. Another stated limitation was that nightto-night variability could have contributed significantly to the results.

The Gagnon, et al study was an excellent pilot study that encouraged further work.

The real concern is not with the study, but with the response of the dental sleep community that has ignored the limitations, the

26 DSP | Fall 2021

actual data, and irresponsibly developed conclusions purportedly confirming the tendency of splints to aggravate patient’s OSA. The misconception was further exaggerated to the assumption that a maxillary splint could cause OSA in non-apneic patients. These assumptions continue to pervade the dental community despite the subsequent, well-designed studies that have questioned the direct relationship between a maxillary appliance for TMD and/or bruxism and the aggravation of a patient’s OSA. Therefore, the concern for use of a maxillary appliance may not be valid.

It’s also important to note that no studies have shown worsening of AHI with an NTI-tss device (Glidewell Dental, Newport Beach, CA) or other anterior segmented splints (Figure 1).

As clinicians, we are responsible for critically evaluating research before making clinical decisions, and the onus is on opinion leaders to responsibly share information from the rostrum. Dentistry has been charged with screening all patients for obstructive sleep apnea with the use of a validated screening tool. Comprehensive screening and referral to sleep physicians when indicated would prevent any inadvertent increase in OSA with any dental procedure.

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

Anandam, A., et al., Cardiovascular mortality in obstructive sleep apnoea treated with continuous positive airway pressure or oral appliance: An observational study. Respirology, 2013. 18(8): p. 1184-1190.

Phillips, C.L., et al., Health Outcomes of Continuous Positive Airway Pressure versus Oral Appliance Treatment for Obstructive Sleep Apnea.

American Journal of Respiratory and Critical Care Medicine, 2013.

187(8): p. 879-887.

Finkel, K.J., et al., Prevalence of undiagnosed obstructive sleep apnea among adult surgical patients in an academic medical center. Sleep Med, 2009. 10(7): p. 753-8.

Jonas, D.E., et al., Screening for obstructive sleep apnea in adults: evidence report and systematic review for the US Preventive Services Task Force. Jama, 2017. 317(4): p. 415-433.

Pierce, C., et al., Dental splint prescription patterns: a survey. J Am Dent Assoc, 1995. 126(2): p. 248-254.

Gagnon, Y., et al., Aggravation of respiratory disturbances by the use of an occlusal splint in apneic patients: a pilot study. International Journal of Prosthodontics, 2004. 17(4).

Knauert, M., et al., Clinical consequences and economic costs of untreated obstructive sleep apnea syndrome. World Journal of Otorhinolaryngology-Head and Neck Surgery, 2015. 1(1): p. 17-27.

Malhotra, A., et al., Metrics of Sleep Apnea Severity: Beyond the AHI. Sleep, 2021.

Garrett, A.R. and J.S. Hawley, SSRI-associated bruxism: A systematic review of published case reports. Neurology. Clinical practice, 2018.

8(2): p. 135-141.

Medscape, SSRIs Disrupt Sleep in the Elderly, May Contribute to Dementia. Medscape, 2016.

Kuwashima, A., A. Virk, and R. Merrill, Respiratory effect associated with use of occlusal orthotics in temporomandibular disorder patients.

International Journal of Oral-Medical Sciences, 2019. 18(1): p. 101109.

American Academy of Sleep Medicine International Classification of Sleep Disorders Third Edition. 2014, Darien, IL: American Academy of Sleep Medicine.

Nikolopoulou, M., et al., The effect of raising the bite without mandibular protrusion on obstructive sleep apnoea. J Oral Rehabil, 2011.

38(9): p. 643-647.

Nikolopoulou, M., et al., Effects of Occlusal Stabilization Splints on Obstructive Sleep Apnea: A Randomized Controlled Trial. J Orofac Pain, 2013. 27(3): p. 199-205.

PRODUCTspotlight

How Do We Measure Success?

by Mark T. Murphy, DDS, D.ABDSM

D

ental Sleep Medicine stakeholders argue that focusing on a single metric to define success could be a costly mistake.

Patient preference of treatment, quality of life, and satisfaction may be as, if not – more important – than a simple numerical reduction of AHI scores. The Agency for Healthcare Research and Quality (AHRQ) was asked by the Center for Medicare Services to investigate the efficacy and effectiveness of CPAP therapy. Along with challenging efficacy, their draft also concluded that, “insufficient evidence exists to assess the validity of AHI as a surrogate or intermediate outcome for long-term clinical outcomes”.

In the movie, Moneyball (based on Michael Lewis’s book of the same name), Brad Pitt harnessed the power of previously ignored statistics to build a world series team on a shoestring budget. No longer were the scouting reports and traditional triple crown data sets (batting average, homeruns, and RBIs) the norm. Instead, subtle yet important metrics guided player selection. On base percentage, total bases, and other arcane data were used.

They made it to the World Series. Perhaps it is time to apply “Moneyball” principles to DSM. Let’s evaluate other key performance indicators that, if managed better, could win the world series for DSM and our patients.

Patient Satisfaction

Patient preference of OAT over PAP speaks to the PICO questions (patient population, intervention, comparison and outcomes) in the AASM/AADSM joint guidelines. Furthermore, a recent poster and abstract published by the AASM demonstrated patient preference of ProSomnus’ EVO over predicate devices designed for comfort (soft liners and printed nylon) as well as PAP therapy. It should be noted, these same patients liked their predicate devices but 96% strongly preferred EVO.

Quality of Life

A lower AHI/ODI score in the absence of improved QOL may also fall

A Multi-Center Preference study of a Novel Oral Appliance Design and Material for Better Provider, Physician, Patient and Payer Acceptance Drs., Erin Elliott1, Jason Ehtessabian2, P.I. Mark Murphy3, Jeffrey Rein and Neal Seltzer4, David Schwartz5, Srujal Shah6, Kent Smith7 1

Sleep Better Northwest; 2 Refresh Sleep and Snoring Center, 3Funktional Sleep, 4Long Island Dental Sleep Medicine, 5Sleep Better Chicago, 6Spark Sleep Solutions, 7Sleep Dallas

Introduction

Materials and Methods

It has been said that PAP therapy is nearly 100% efficacious but chases adherence. The latest generation of CAD CAM oral appliances to the contrary, has excellent compliance and chases efficacy. The third recommendation of the AASM/AADSM joint guidelines recommends physicians prescribe OAT for patients who prefer it (mild and moderate OSA diagnosis or failed PAP therapy). Thus, it is essential for providers to select a device that patients prefer over CPAP and satisfies important clinical performance factors such as acceptable efficacy, precision, strength, size, ease of delivery and cleanability. In this way, all four of the major stakeholders in OSA treatment will be better satisfied, Patients, Providers, Physicians and Payers. This study tested the quality of patient and dentists’ preferences of EVO, a novel iterative advancement device (NIAD), manufactured using artificial intelligent design, robotic manufacturing and the most advanced medical grade materials ever, from ProSomnus Sleep Technologies over legacy devices and PAP therapy.

Devices were manufactured from digital records of U/L impressions and bite registrations. 31 Patients (all with previous, some multiple OAs and 20 previous CPAP users) and 7 dentists were surveyed regarding a range of preferences about the NIAD material and device using a 010 scale. Samples were analyzed for stainability by mustard at 37C for 10 days against representative predicates using colorimetry. The NIAD device has specific features that were tested as shown below.

Results (continued)

NIAD: The ProSomnus EVO Sleep and Snore device

Conclusions

Both doctors and patients were surveyed on their experience with the NIAD device.

Patient Survey Results Survey Question

Response %

Preferred NIAD over CPAP

100%

Reported NIAD easier to keep clean than CPAP

100%

Would wear NIAD more than CPAP

100%

Preferred NIAD over the previous appliance(s) they had worn*

100%

*(21 various soft liner devices with fulcrum straps, advancement tubes, screws, or anterior hook devices and 15 printed nylon appliances) Survey Question

Score

NIAD comfortable at delivery

9.2

NIAD smaller than other appliances I have worn

9.4

Contours more natural feeling

9.5

Easier to close my lips together

8.8

Confident device will not break if I grind

9.1

Confident in durability over time

9.1

Doctor Survey Results Survey Question

• Test patient preference for the NIAD against previously used oral appliances • Test patient preference for the NIAD against CPAP • Rate performance of the device for comfort based on features of the NIAD • Determine material performance against other device materials • Validate key design features with patients

Specific Features to test • • • • • •

Monolithic MG6™ material vs acrylic with liner True anatomical design (from patient’s anatomy) Flex and fit of MG6 material vs hard acrylic, nylon and acrylic with liner Dual 90 degree post comfort MG6 flexibility in reference to ease of delivery, fit, and ease of removal

Results Overall all acceptance of NIAD feature set 4.56 +/-0.43 Scored 0-5, 5 being most favorable

Dentists reported that easy delivery and excellent retention, with no or very limited adjustments was accomplished. 100% added that they would use this device again, on a wider variety of patients (bruxers and multiple restorations) and would recommend to their colleagues.

Contact Response %

No adjustment interventions for fit at delivery,

Objectives

Patients preferred NIAD over CPAP and all other devices similarly designed for comfortable easy fit and delivery (soft liners and printed nylon) without compromising the comfort, cleanability or strength. Liner less milled devices outperform all other devices with less staining. The NIAD is similar to a current well studied (good efficacy, less side effects, precision, smallest, comfortable and compliant) iterative advancement device design from the same manufacturer with the addition of the new medical grade material application to enhance the patient, physician and payer experience.

81%

Would prescribe NIAD again

100%

Would recommend NIAD to their friends and colleagues

100%

Felt the precision is important

100%

* Average adjustment time was 3.1 min

Survey Question

Score

NIAD was easier to deliver than other devices

9.1

Retention was just right at delivery

8.7

Would use NIAD for patients with Bruxism

97

NIAD is safe for patients with Crowns and Veneers*

9.3

Would use NIAD on wider range of patients

9.8

NIAD would be easy to keep clean

9.8

*No crowns or veneers were removed or damaged during delivery

The NIAD MG6 material demonstrated less uptake of mustard resulting in a lower Delta E than all other devices with a soft lining or printed nylon, due to the low porosity of the surface structure

Samples had their color measured using a colorimeter capturing the E value, baseline values were subtracted from 10 day mustard soak value to calculate the Delta E, the color difference before and after staining

Dr. Mark Murphy – mtmurphydds@gmail.com

References

1.“AADSM Guidelines” Ramar K, Dort LC, Katz SG, Lettieri CJ, Harrod CG, Thomas SM, Chervin RD. Clinical practice guideline for the treatment of Obstructive Sleep Apnea and snoring with oral appliance therapy: an update for 2015. Journal of Dental Sleep Medicine 2015;2(3):71–125.

2.“Evaluation of a New Oral Appliance with Objective Compliance Recording Capability: A Feasibility Study” By Jerry Hu, DDS, Jerry Hu Family Dentistry, Soldotna, Alaska; Len Liptak, MBA, ProSomnus Sleep Technologies, Pleasanton, California; Journal of Dental Sleep Medicine (Vol. 5, No. 2, 2018).

3.“Efficacy and Effectiveness of the ProSomnus® [IA] Sleep Device for the Treatment of Obstructive Sleep Apnea – The EFFECTS Study” By Jordan Stern, MD, Kiwon Lee, DDS, David Kuhns, PhD, Stephanie Zhu, Poster presented at AADSM Annual Meeting (June 2018).

4.“Oral Appliance Therapy Awareness and Perceptions Survey” By Sree Roy. Sleep Review. January 2016.

5.“Assessment of Potential Tooth Movement and Bite Changes with a Hard-Acrylic Sleep Appliance: A 2-Year Clinical Study” Journal of Dental Sleep Medicine: Vol. 6, No.2 2019.

6.“Say No to Bio-Gunk!” By Michael Gelb, DDS; DSM Insider (March 2018).

7.ProSomnus Company Data on File.

8.“ACP Positioning Statement - Role of Oral Devices in Managing Sleep-disordered Breathing Patients” https://www.prosthodontics.org/assets/1/7/16.Role_of_Oral_Devices_in_Managing_Sleepdisordered_Breathing_Patients.pdf 9.“A Feedback-Controlled Mandibular Positioner Identifies Individuals with Sleep Apnea Who Will Respond to Oral Appliance Therapy” By John E. Remmers, MD; Zbigniew Topor, PhD; Joshua Grosse, MMath; Nikola Vranjes, DDS; Erin V. Mosca, PhD; Rollin Brant, PhD; Sabina Bruehlmann, PhD; Shouresh Charkhandeh, DDS; Seyed Abdolali Zareian Jahromi, PhD; Journal of Clinical Sleep Medicine (Vol. 13, No. 7, 2017).

10.“Using a Precision Milled, Continuous Advancement, Oral Appliance with Symmetric Titration to Treat All Severity Levels of Obstructive Sleep Apnea” By Neal Seltzer, DMD, FAGD, D.AADSM, D.ACSDD, D.ASBA; Jeffrey S. Rein, DDS, FAGD, D.AADSM, D.ACSDD, D.ASBA; and Gina Pepitone-Mattiello RDH, C.ACSDD; Dental Sleep Practice (Spring 2019).

11.“A Collaborative Quest for Better OAT Devices and Outcomes” By Mark T. Murphy, DDS, FAGD; Dental Sleep Practice (Summer 2018).

12.“Preventing Side Effects Undesirable Jaw Pain” By Dr. Mark T. Murphy, DDS; DSM Insider (May 2018).

13.“Minimizing Side Effects: A Retrospective Case Series Analysis of Tooth Movement in Oral Appliance Therapy”

By Jerry Hu, DDS, DABDSM, DASBA, MICOI, FICOI, AFAAID, LVIF, FIAPA, FIADFE; Dental Sleep Practice (December 2017).

14.“Patient Centric Design Helps Collaborate with Medicine” By Reza Radmand, DMD, FAAOM; Dental Sleep Practice (December 2017).

15.“Utilizing A Fully Digital Clinical Workflow for Oral Appliance Therapy with an Auto-Titrating Mandibular Positioner (AMP): A Feasibility Study” By S. Charkhandeh, DDS; N. Vranjes, DDS; D. Kuhns, PhD; E. Mosca, PhD; S. Kim, BS; Bruehlmann, PhD; Poster presented at World Sleep Congress in Prague, Czech Republic (October 2017).

16.“A Fully Digital Workflow and Device Manufacturing for Mandibular Repositioning Devices for the Treatment of Obstructive Sleep Apnea; A Feasibility Study” By Shouresh Charkhandeh, DDS; David Kuhns, PhD; Sung Kim, BS; Journal of Dental Sleep Medicine (July 2017).

17.“Objectively Recorded Compliance with a Novel Oral Appliance for the Treatment of Obstructive Sleep Apnea”

By Jerry Hu, DDS, DABDSM, MICOI, FICOI, LVIF, AFAAID, FIADFE; Mark T. Murphy, DDS, FAGD; David Kuhns, PhD; Len Liptak, MBA; Journal of Dental Sleep Medicine (2017).

18.“Patient Treatment Success with Comfort and Tongue Space of the MicrO2®” By Michael Gelb, DDS, MD and Edlir Dume, DDS; Dental Sleep Medicine (August 2016).

19.“A New Oral Appliance Titration Protocol Using the MicrO2® Sleep Device and Mandibular Positioning Home Sleep Test” By John Remmers, MD and Nikola Vranjes, DDS; Presented at AADSM (June 2016).

20.“Is Selecting the Appropriate Sleep Device for You and Your Patient Important?” By David Carlton, DDS; Dental Sleep Practice (Summer 2016).

21.“What Do You See?” By Mark T. Murphy, DDS; Dental Sleep Practice, Educational Spotlight (Spring 2016).

22.“Innovations Spotlight: MicrO2® Sleep & Snore Device” By David Kuhns, PhD; Dental Sleep Medicine (Mar 2016).

23.“4th Generation Oral Appliances” By Mark T. Murphy, DDS; Dental Sleep Medicine, Insider (Feb 2016).

RESEARCH POSTER PRESENTATION DESIGN © 2015

www.PosterPresentations.com

short of meaningful deliverables. Patients do not present with complaints of SPO2 desaturations or low nadir. They complain of poor sleep, snoring, and other QOL issues. Ignoring how the patient feels subjectively can undermine clnical success.

Side Effects

A recent AADSM poster discussed the reduced ‘dose’ of mandibular advancement required by ProSomnus EVO. Less advancement dose may result in less TMD pain, muscle challenges, and easier morning realignment. Older legacy devices may function similary by advancing the mandible to open the airway but they do so in a different manner with greater risks. You can drive from New York to LA in a 10 year old subcompact or a luxury SUV. The goal is the same, but how you feel will be very different.

Efficacy and Compliance Mark T. Murphy, DDS, D.ABDSM, is an American Board of Dental Sleep Medicine Diplomate and has practiced in the Rochester area for over 35 years. He is the Lead Faculty for Clinical Education at ProSomnus Sleep Technologies, Principal of Funktional Sleep, serves on the Guest Faculty at the University of Detroit Mercy School of Dentistry and as a Regular Presenter at the Pankey Institute. He has served on the Boards of Directors of the Pankey Institute, National Association of Dental Laboratories, the Identalloy Council, the Foundation for Dental Laboratory Technology, St. Vincent DePaul’s Dental Center and the Dental Advisor. He lectures internationally on Leadership, Dental Sleep Medicine, TMD, Treatment Planning, and Occlusion.

Efficacy and compliance combine to produce effectiveness. The AADSM poster and abstract on minimal therapuetic dose also tracked and evaluated compliance and potential discontinuation of use. Every patient in the trial was still wearing the device ~7 hours per night, 7 nights per week.

OAT adherence is the trump card against the better efficacy of PAP therapy.

The ProSomnus AI designs and robotic manufacturing advantages produce better outcomes that advance the mission of improved patient care.

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BILLINGblocks

Home Sleep Tests: To Bill or Not to Bill

by Randy Curran

I

n 1860, Ralph Waldo Emerson wrote “The first wealth is health.” This dictum is still true today. Nonetheless, the medical insurance behemoth has put patients and practitioners in a position where health is seemingly dictated by wealth. There is currently an imbalance. As dental sleep professionals, we must strike a balance – producing profits by providing for people.

What’s the best way to achieve this ever-elusive balance as it relates to home sleep testing (HST)? How can you provide optimal patient care while driving direct revenue now and in the future? Which of the most common sleep testing avenues is best for you, your practice, and your patients?

1. Collaborate with a local sleep physician with the aim of building a reciprocal referral relationship?

2. Coordinate with a national HST company that will ship devices directly to your patients, assign a sleep physician to interpret the study, and prescribe the appliance when appropriate?

3. Purchase or lease HST devices to send them home with the patient from your practice?

The ideal option is to build a relationship with local sleep physicians and MDs. This is the preferred path, but it usually takes a couple years to get beyond the trailhead. Based on my newsfeed, we don’t live in an ideal world, so let’s focus on the other options enumerated above.

When purchasing your own HST unit, there are a couple variables to consider. One

28 DSP | Fall 2021

commonly asked question – can it be billed to the patient’s medical insurance? Secondly, what insurance carriers allow dentists to send this home with a patient and subsequently receive reimbursement?

The devil is in the details, and this can get a little tricky. Allow me to break it down by the major carriers to help you determine whether the HST should be billed or be given to the patient on a cash pay basis.

• Medicare: Hard “NO!” If you are a Medicare provider, their policy does not allow the DME provider to be involved in any aspect of sleep testing.

This includes dispensing the device to a patient on behalf of a medical doctor. This is a conflict of interest in Medicare’s eyes. Do not do it.

• Aetna and United Healthcare: Yes, billing the HST to these insurance carriers can be advantageous for a dental practice. Aetna does not require a pre-authorization for home sleep testing and the dentist’s taxonomy number should cross over to the home sleep testing CPT code.

• Cigna and BCBS: It’s not worth billing to either, as almost every plan will require pre-authorization from a medical doctor prior to a 95800 or 95806 being a covered benefit. Also, most BCBS plans will not match the taxonomy code for a dental practice to either of the CPT codes mentioned above.

Of the four major private insurance carriers and Medicare, only two might make

BILLINGblocks sense for a dentist to bill. Now, let’s consider another compounding aspect – Billable vs.

Payable.

Most dental practices treating sleep apnea are out of network with medical insurance carriers, and most patients have out of network deductibles above the average allowable for home sleep testing. This combination means that although some insurance carriers may approve coverage for HST, it’s unlikely it will be payable.

With this in mind, let’s examine the options dental practices may have to make this as easy as possible.

If the dental practice is contracted with United Healthcare or Aetna, then, yes, it would be worthwhile billing for home sleep testing. If the dental practice is not contracted with the aforementioned insurance carriers, the dental practice should then simplify this by using a cash pay model for all home sleep testing devices, with the exception of Medicare which should always be referred to a sleep physician or national sleep testing company to ensure compliance with federal rules. This is important enough that I want to reiterate – As a DME provider, your dental practice cannot provide HST to Medicare patients. Period. End of sentence. Full stop.

Approximately half of Pristine Medical Billing’s clients have their own sleep testing devices and use a cash pay model so they can send units home with patients the same day. A successful method deployed by many practices is to charge the patient $95 - $150 for the sleep test and sleep physician interpretation, and then let the patient know that if they move forward with treatment, you will apply this payment as credit toward their treatment cost. There is a proverbial asterisk here though – United Healthcare patients will still need a consultation with a medical doctor boarded in sleep medicine to meet the medical policy for the appliance.

This model works well in many practices.

Still, there are situations when patients are insistent their insurance cover the cost of the sleep study. If you are still working to identify a local sleep physician relationship, national sleep testing companies are a great solution in these instances.

At Pristine, we work with a couple of these companies to help dental practices with their sleep testing. These companies can bill the medical insurance carrier as in

network providers for not only for the sleep study, but also for the patient’s telemedicine consultation to help reduce the patients out of pocket cost for the treatment.

There are several options for dental practices to get patients sleep tested: collaborate with a local medical doctor, purchase or lease sleep testing devices and use them in a cash pay model, or use a national sleep testing service to coordinate the telemedicine visit and ship the device directly to the patient’s home (while also achieving some of the requirements for insurance …the medical coverage for the oral appliance, includ- insurance behemoth ing Medicare).

There is still another option that may has put patients and yield positive results – a hybrid of these practitioners in methods. In this situation, Medicare and United Healthcare patients go to a local a position where sleep MD or a national sleep testing com- health is seemingly pany, as they will meet the requirements of consultations with medical doctors dictated by wealth. prior to treatment for UHC and testing for Medicare. And for other patients, you can send the patient home with your own HST as a cash pay.

One last tangentially related item to pass on from practices that we’ve seen succeed in Dental Sleep Medicine – some patients will be resistant to a sleep study due to finances. Regardless of which model you’re using, send the patient home with a pulse oximeter at no charge. The aim is that the patient will understand that this is not about a financial reward for the dental practice but about their health and the possible longterm effects of untreated OSA. Pulse oximeters are very affordable, and they can effectively demonstrate for reluctant patients that they really do have an oxygen desaturation problem. Then, Emerson’s words will underscore the importance of the heart rate over the inflation rate.

Randy Curran is the founder and CEO of Pristine Medical Billing. During the past 12 years, Randy has committed his life to helping those with sleep related breathing disorders obtain prior authorizations for coverage while ensuring providers receive fair compensation for care. Randy has been involved in the treatment of more than 38,000 patients while collecting over $85,000,000 for providers from insurance carriers through both contracting and claim submissions.

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CONTINUING education

Physician-Dentist Collaboration: A Call to Arms for Allied Troops

by John Viviano, DDS, D.ABDSM, and John Bouzis, DDS

B

roken. This one word describes the current model for identifying, diagnosing, and treating sleep disordered breathing patients. Recognizing the need for change, the American Academy of Sleep Medicine (AASM) sponsored the “Sleep Medicine Disruptors 2021” contest to stimulate creative thinking and to encourage constructive dialogue. Despite the American Dental Association’s (ADA) guidance on dental management of SDB,1 few dentists have followed the guidance, and those that have, struggle mightily due to a strong bias for use of Continuous Positive Airway Pressure (CPAP). Unfortunately, CPAP therapy is hindered by poor patient adherence,2 leaving many patients either sub-optimally or totally unmanaged.

This article reviews recent events that have the potential to significantly alter the face of sleep medicine and discusses the Physician-Dentist Collaboration model.

The Status Quo

More than 85% of the adult SDB population remain undiagnosed and children are mostly ignored.3 In diagnosed adults, approximately 85% are prescribed Positive Airway Pressure (PAP),4 for which adherence is 50% at 6

months5 and 17% at 5 years.6 Most non-adherent PAP patients simply remain unmanaged because the patient was advised that CPAP is “Gold Standard” and the only effective therapy.

Globally, the number of people affected by sleep apnea approaches 1 billion,3 contributing to the economic burden associated with unhealthy sleep, with health costs alone, approaching $700 billion per annum.7 In the United States, a 2015 report commissioned by the AASM found that sleep disorders are responsible for approximately $150 billion in workplace and motor vehicle accidents, lost productivity, and comorbid diseases.8 The American Board of Sleep Medicine (ABSM) website documents that there are approximately 7,500 board-certified sleep specialists serving a population of approximately 325 million people in the United States.9 Further exacerbating this obvious problem is the uneven geographic distribution of sleep specialists creating an accessibility imbalance throughout the United States.

What Is the AASM Looking for?

Educational Aims This self-instructional course aims to discuss a “Physician-Dentist Collaboration” concept for the management of Sleep Disordered Breathing, providing both literature evidence and details on an existing working model of this approach.

Expected Outcomes

Dental Sleep Practice subscribers can answer the CE questions online at dentalsleeppractice.com/ce-articles to earn 2 hours of CE from reading the article. Correctly answering the questions will exhibit the reader will: 1. Learn about how uniquely positioned dentistry is to help manage Sleep Disordered Breathing 2. Identify how OAT compares to PAP therapy 3. Realize the current short comings in Sleep Medicine Research 4. Understand current events as opportunities for OAT 5. View patient care with OAT from an Physician-Dentist Collaborative viewpoint

30 DSP | Fall 2021

In an AASM podcast entitled Sleep Innovation (Podcast S3E9), the chairperson of the AASM Sleep Disruptors contest, Dr. Azizi Seixas, was interviewed by Dr. Seema Koshla, who stated the following, “I feel like we are all over-worked and that we are perpetually in survival mode”.

Dr. Seixas responded with, “We’ve got to re-imagine health care in terms of education, in terms of clinical care, in terms of research, in terms of venture...”, and “In order for us to do this we need an entire army.” He continued, “There aren’t enough sleep clinics out there to serve the great need we have in the community... we need to turn everything on its head and say how do we reach these individuals” and finally, “Develop new solutions of care and workflow so that we can better reach our people and that is the key!”

CONTINUING education A recent article penned by the Board of Directors of the AASM discussing the future of Sleep Medicine stated, “…the future of sleep medicine lies in its ability to provide the workforce to care for sleep disorders across the population, from the cradle to the grave.”10 The article considered leveraging technology such as telemedicine and smartphone apps to improve efficiency, increase patient satisfaction, and reduce cost of care.

These technological advances have already surfaced, and as you read on, you will also see how the confluence of current events may accelerate the acceptance of oral appliance therapy (OAT).

also acknowledged that AHI is a less than optimum surrogate of outcome,13 and that CPAP has a “Dose Response.”14,15 A direct quote from the AASM letter, “CPAP is an imperfect therapy, and like most treatments, adherence is variable. We propose at least two more appropriate approaches for examining a dose-response relationship between changes in AHI and any clinical outcome be considered.” The first involves examining the extent to which CPAP alleviates AHI, taking into consideration CPAP usage as a proportion of total sleep time; mean disease alleviation index16 and the effective AHI.17,18 The second involves examining the relationship between hours of CPAP use and improvements in clinical outcomes.19,20 The letter proceeded to discuss the ethical and practical reasons that randomized controlled trials are difficult to conduct when it comes to sleepy patients, pointing out that non-sleepy patients are typically less adherent in the long-term and as such, the conclusions regarding endpoints may not apply to sleepy patients that would be more likely to remain adherent.21

AHRQ Draft Report; A Gold Standard Tarnished

A Paradigm Shift: From Gold Standard to Optimized Care

Recently, the Agency for Healthcare Research and Quality (AHRQ) published a draft report that was commissioned by the Center for Medicare and Medicaid Services to answer the following two questions:11 1. What is the efficacy and comparative effectiveness of CPAP to improve clinical outcomes?

2. What’s the evidence that apnea hypopnea index (AHI) is a valid surrogate of clinically significant outcomes?

The report found a low strength of evidence that hypertension, cardiovascular disease, heart attacks, stroke, diabetes, depression, and quality of life indices were improved with CPAP use. It is important to note that there is no literature demonstrating that OAT has a different impact on long-term healthcare outcomes.

The AASM Responds

In conjunction with over a dozen other organizations, the AASM penned a detailed response12 to the AHRQ providing several insights and suggestions which will hopefully be incorporated into the final report. The AASM wrote, “AHRQ conclusions do not reflect the totality of available evidence, and misinterpretation of the draft report could have detrimental repercussions for the millions of Americans with OSA.” The letter pointed out that the AHRQ report did not look at measures of excessive sleepiness or blood pressure reduction to be clinically significant outcomes, and that it ignored the considerable level of evidence that CPAP use reduces motor vehicle accidents. The letter

It is interesting that the AASM is now recommending alternative metrics when evaluating outcomes for establishing CPAP effectiveness; one that considers adherence, and nightly hours of use, rather than reduction in AHI. The SomnoMed Effectiveness Equation (SomnoMed, Plano, TX) is a software product that compares OAT and CPAP based on these exact variables with

Dr. Viviano obtained his credentials from the University of Toronto in 1983. His clinic is limited to managing sleep-disordered breathing and sleep-related bruxism. He is a Credentialed Diplomate of the American Board of Dental Sleep Medicine and has lectured internationally, conducted original research, and authored original articles on the management of sleep-disordered breathing. His clinic is the first Canadian facility accredited by the American Academy of Dental Sleep Medicine and he is Clinical Director of the Sleep Disorders Dentistry Research and Learning Centre. Dr. Viviano also hosts the SleepDisordersDentistry LinkedIn Discussion Group and conducts dental sleep medicine CE programs for various levels of experience, including a 4-day mini residency. Dr. Viviano’s Class and Cloud Based CE programs can be found on SDDacademy.com, and he can be reached at (905) 212-7732 or via the website sleepdisordersdentistry.com.

John Bouzis, DDS, is a member of the American Dental Association, the Natrona County Dental Society, the Wyoming Dental Association, the Academy of General Dentistry, the Association for the Study of Headache, Fellow in the International College of Cranio Mandibular Orthopedics, and the American Academy of Dental Sleep Medicine. His education and affiliations allow him to be an asset to those seeking information and treatment for sleep apnea. Dr. Bouzis has hundreds of hours of continuing education devoted to the treatment of TMJ, Jaw Disorders, Headaches and Migraines and, most recently, Sleep Medicine and the Treatment of Obstructive Sleep Apnea. When Dr. Bouzis isn't treating patients at his office in Casper, WY, he enjoys racing bicycles, racquet ball, golf, sports conditioning, and technology – especially the technical aspects of modern dentistry and its impact on patient care and comfort.

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CONTINUING education the intention of establishing a more realistic understanding of how much benefit a patient is receiving from both therapies. It enables clinicians to consider the impact treatment adherence can have on OAT outcomes which can be comparable or even superior to CPAP, even though the OAT resulted in residual AHI (Figure I).

The AHRQ report could be considered a “call to action” for myriad issues: 1. Ensure better research 2. Use more meaningful markers than AHI 3. Consider adherence, hours of nightly use and actual effectiveness in the field 4. Evaluate treatment alternatives that patients are more likely to comply with 5. Collaborate with other care providers to optimize patient outcomes

Philips Recall and Physician-Dentist Collaboration

Currently, the world is dealing with the recall of an estimated 3-4 million bi-level PAP, CPAP, and mechanical ventilator devices manufactured by Philips.22 The recall is in response to potential health risks associated with the sound abatement foam component used in these devices. This foam may break down, resulting in particulate matter and volatile organic compounds (VOC) that can then circulate through the CPAP tubing. Philips has announced that potential risks to patients include skin, eye and respiratory tract irritation, inflammation, headache, asthma, adverse effects to other organs, and toxic carcinogenic effects.23 The U.S. Food and Drug Administration (FDA) has classified the recall of Philips’s breathing devices and ventilators as Class 1, the most serious type of recall, stating that use of these devices may cause serious injuries or death.24

Figure I: Examples of SomnoMed Effectiveness Equation demonstrating Real World effectiveness of CPAP and OAT after taking into consideration actual hours used

32 DSP | Fall 2021

For those patients affected by the Philips recall, the FDA recommends talking to your health care provider regarding a suitable treatment for your condition, which may include:25 • Stopping use of your device • Using another similar device that is not part of the recall • Utilizing alternative treatments for sleep apnea, such as positional therapy or oral appliances, which fit like a sports mouth guard or an orthodontic retainer.

• Initiating long term therapies for sleep apnea, such as losing weight, avoiding alcohol, stopping smoking, or, for moderate to severe sleep apnea, considering surgical options.

• Continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification.

Philips is now discouraging the use of ozone-related cleaning products due to concerns regarding the potential degradation of the sound abatement foam.22 In an effort to find a solution for patients in need of immediate therapy where replacement devices are not available in a timely manner, a trained dentist can provide an interim oral appliance such as a myTAP (Airway Management, Inc., Farmers Branch, TX). (See Figure II) Once the patient receives their replacement device, this oral appliance could continue to be useful as back-up therapy. However, for some patients, a wellchosen, long-term custom appliance may be preferred therapeutic modality. This current situation could uncover those semi-adherent CPAP patients that may benefit from the opportunity to trial OAT. For those patients that experience residual apnea with their appliance, a well-trained dentist will be able to navigate the patient through various adjunctive therapies. These include sleep position,26 head elevation,27 weight loss28 myofunctional therapy29 and increasing fitness levels,30 all of which have the potential to further normalize the AHI. Dan Levendowski recently introduced software which was designed based on research findings to select the optimum therapy alternative for patients impacted by the Philips recall.31 The software allows input of a 3-night sleep study evaluation. Night one is a baseline study. Night two is a study with use

CONTINUING education

Figure II: myTAP appliance available to provide immediate relief for patient in need of replacement for recall impacted device

of a trial appliance such as the ApneaGuard (Advanced Brain Monitoring, Carlsbad, CA), and the third night is a study with use of positional therapy such as the NightShift (Advanced Brain Monitoring Carlsbad CA). The software automatically analyzes the input data and determines if patient care would be optimized by use of OAT, combining OAT and positional therapy, positional therapy alone, or PAP therapy alone. (See Figure III) Considering the current shortage of replacement devices, it would be beneficial to pre-determine exactly which patient will respond exclusively to PAP therapy, allowing for efficient and reliable use of the heavily restricted PAP inventory.

COVID-19 and CPAP Mask Leaks

The COVID-19 pandemic has brought to light the fact that even well-fitting CPAP masks leak, leading to concerns of spreading infection throughout the household for those that are infected with COVID-19. AASM guidance recommends that COVID-19 positive CPAP patients speak to their physician about assessing the risks and benefits of continuing CPAP use.32 AADSM guidance currently recommends that OAT could be considered an effective alternative to CPAP for these patients. They underscore that OAT does not share any of the aerosol concerns and is also much easier to disinfect daily, and recommends that under the supervision of a physician, OAT should be prescribed as a first-line therapy for sleep apnea during the COVID-19 pandemic.33

What Dentistry Has to Offer

In the United States there are 7,500 board-certified sleep specialists.9 In contrast, the ADA website reports that in 2020 there were 201,117 dentists working in the United States,34 However, only 800 dentists currently meet the requirements as a Diplomate of the ABDSM.35 The AADSM provides a “Qualified

Figure III: Advanced Brain Monitoring software is designed to be used with any HST that measures supine and non-supine AHI, trial OA, and PT device. The WatchPat HST, ApneaGuard OA, and Nightshift PT device are shown above. Treatment distributions in Figure III were based on 170 patients intolerant of CPAP using the Apnea Guard to determine OAT effectiveness.31

Dentist” designation, which requires dentists to successfully complete the AADSM’s Mastery Course I.36 This designation is for any dentist that would like an official credential demonstrating basic competency in dental sleep medicine and also provides a stepping-stone for those dentists interested in becoming a Diplomate of the ABDSM. The AADSM reports a total of 1,775 Diplomates and Qualified Dentists as of the writing of this article; a small fraction of the total number of dentists in the U.S. Clearly, dentistry has a massive workforce to offer, but more motivation is required to attract dentists to this field. Establishing a more collaborative workflow between physicians and dentists is necessary to improve access to care.

Working in collaboration with a physician, a well-trained dentist is ideally positioned to have a significant impact on all levels; screening, management, and follow-up. 80% of Americans have a dentist of record37 and 79% of Americans visit their dentist every 2-3 years.34 Patients are accustomed to regularly visiting their dentists for follow-up appointments and a Physician-Dentist Collaboration could help fill the current need expressed by Doctors Seixas and Koshla and provide the required “army” they alluded to.

In 2017, the ADA published guidance mandating that dental offices screen their adult and pediatric patients for airway disorders, establishing both referral and management standards of practice.1 Dentistry provides direct professional access to patients, with the ability to screen, offer therapy, and the necessary follow-up resources. Active screening of each patient could reduce undiagnosed levels of SDB dramatically. Dr. Seixas states that the AASM is looking for “new solutions of care and workflow.” The AADSM is an evidence-based professional organization that has published guidance DentalSleepPractice.com

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CONTINUING education that many dental licensing bodies follow. Oral appliance therapy has been demonstrated to be an effective, highly successful, conservative therapy.

Physician-Dentist Collaboration could provide the PAP non-adherent patients easy access to OAT and also aid in uncovering the many undiagnosed sufferers, guiding them to appropriate physician-supervised collaborative therapy. (See Figure IV) Mobilizing the entire dental workforce to conform to the 2017 ADA guidance would exponentially improve access to care.; to provide screening, referral, OAT (when appropriate and by physician prescription), and follow-up. In fact, regular dental visits help to facilitate these crucial follow-up appointments.

Despite the 2017 ADA guidance,1 California-based Glidewell Dental Lab, reported by Frost and Sullivan4 to be the largest provider of oral appliances for snoring and sleep apnea in the United States, indicates that 20% of their customers treated a snoring and sleep apnea patient in 2019. This number grew by 25% year over year from 2018, spurred by significant clinical education initiatives. However, even with the large number of cases that were shipped, less than 1% of accounts prescribed 10 appliances or more for the year, signifying an underserved need when compared to the estimated number of patients suffering from some form of SDB.

Is Dentistry Adequately Trained?

A study of SDB education in 49 US dental schools published in 2012 found the mean time spent teaching SDB to be 0.5 h for first year, 0.64 h for second year, 1.81 h for third year and 0.97 h for fourth year in the 37 schools that actually provided some curriculum.38 Nearly a decade later, the level of SDB education dentists have acquired upon graduating dental school has not materially increased. A personal survey of recent University of Toronto, Managing 100% of Patients 100% of the Time Dental Patient Base Screen 100% If Negative Monitored Yearly

If Positive Refer to MD & Continuously Followed Refer to MD with possiblity of participating in care

Behavior Therapy

Monitor 100% for change in status

PAP

OAT

Surgery

Combo or Other

Remain Untreated

Continuously follow up to monitor continued efficacy, adherence to therapy and encouracge untreated to consider therapy

Entire patient base on either "Continual Yearly Screening" or "Continual Follow-up" status: • Screening for suspicion of disorder for undiagnosed patient • Follow-up for deterioration of outcome for treated patient • Follow-up for non-adherence to treatment for treated patient • Follow-up for opportunity to discuss initiating treatment for previously diagnosed patient Figure IV: This figure demonstrates how recruiting the entire dental workforce to implement active screening would impact on the number of undiagnosed sleep apnea patients remarkably.

34 DSP | Fall 2021

Canada dental school graduates found that they completed their degree requirements with only approximately 1 hour of education regarding SDB. Dentists who opt to practice DSM should first obtain adequate post-dental school training to achieve competency. It is unnerving that the 2017 ADA guidance was not more impactful. Lives could have been saved if more clinicians followed this guidance. However, the DSM world is full of obstacles such as Medicare rules, insurance coverage criteria, clinical competency, internal team buy-in, and the strong physician bias for CPAP. All of these make entry into DSM more challenging. However, physician resistance to OAT may shift due to the AHRQ draft and the Philips recall. It is likely that abiding ADA guidance will become easier to entertain for a dentist new to DSM once the wall of physician bias has been dismantled, thus attracting more dentists to enlist in the army to battle SDB.

Are Dentistry and OAT Worthy?

Clearly, PAP is superior at reducing AHI.39 However, when comparing adherence, OAT is superior.2 This results in an unexpected phenomenon. Although the following is rarely stated or even acknowledged by physicians, there is overwhelming evidence that health outcomes with OAT compare very favorably to those of PAP. This is found to be the case for objective measures of health outcomes,40 measures of functional outcomes,41 hypertension outcomes,42 and cardiovascular mortality outcomes.43 This may be in part explained by the “Dose Response” relationship observed with PAP use. One study documented that the number of hours PAP is worn nightly is related to both cerebrovascular events and development of hypertension.14 Along these same lines, various measures of sleepiness as documented by the Functional Outcomes of Sleep Questionnaire, Epworth Sleepiness Score, and the Multiple Latency Score have also been shown to be related to hours of nightly CPAP use.15 When considering side effects, the frequency and intensity of OAT side effects are similar to reports of PAP side effects.44 A crossover comparison study between PAP and OAT documented that patients preferred OAT in all aspects evaluated.45 In fact, multiple studies have revealed that patients prefer OAT to PAP,46

CONTINUING education and it is this preference that may translate to more hours of oral appliance use. It is not always possible for patients to get the recommended amount of sleep, however, OAT is most therapeutically effective when patients sleep 7 hours or more,46 so qualified dentists must educate the patient on the importance of obtaining sufficient sleep nightly. Objectively documented OAT adherence studies have found OAT adherence to be 86.1%47 and 91.2%.48 A recent systematic review and meta-analysis of the literature evaluating factors that influence OAT adherence found a weak relationship between objective adherence and patient and disease characteristics, such as age, sex, obesity, apnea hypopnea index, and daytime sleepiness. However, non-adherent patients reported more side effects with OAT than adherent users and tended to discontinue the treatment within the first 3 months. Additionally, custom fabricated oral appliances were preferred, and had increased adherence in comparison with non-custom appliances.49 As mentioned above, ADA guidance recommends that we screen both our adult and pedo patients for SDB and then through collaborative efforts with physicians, surgeons, and other appropriate specialists, participate in the care and follow-up of those patients.1 For patients that screen positive for SDB, a referral to a medical specialist is required for evaluation and diagnosis. In Canada, the prevalence of adults with, or at high risk of having sleep apnea is approximately 26.8%, approximately ¼ of the adult patient base.50 We will review the potential management of this group under the following scenarios: • Dental Diagnostic Testing Allowed • Dental Diagnostic Testing Not Allowed • Previously Diagnosed Patients • Immediate Need and Delay to Treatment.

Dental Diagnostic Testing Allowed

A dentist can order or dispense a multiple night Home Sleep Test (HST) with interpretation by a board-certified sleep physician. A multiple night study is important to account for night-to-night variability.51,52 HST devices such as the NightOwl (Ectosense, Belgium) facilitate multi-night sleep testing, but no data is provided regarding body position, airflow, or breathing effort. Level III HST devices like the WatchPAT (Itamar Medical Limited, Israel)

and NOX T3 (NOX Medical, Iceland) can be used to obtain multiple night studies and they do provide position, airflow, and breathing effort data. A well-trained dentist should be able to discuss the various treatment options recommended by the board-certified sleep physician that interpreted the sleep study and provided the diagnosis. Whichever therapy implemented, the dental office should monitor adherence to treatment and regularly report to the prescribing physician.

Dental Diagnostic Testing Not Allowed

A patient who has screened positive for sleep apnea should be referred to a board-certified sleep physician. In some jurisdictions, this will require an intermediary referral to their primary care physician. They will arrange the appropriate sleep testing and complete the interpretation and provide the diagnosis and appropriate prescription. The physician then meets with the patient to discuss treatment options.

Previously Diagnosed Patients

Dental follow-up appointments should review and confirm the patient’s continued adherence to treatment. Patients are commonly considered CPAP adherent if they wear their device 4 hours/night, 5 nights/week. However, they should be coached to wear their CPAP a minimum of 5-6 hours/night which is closer to the levels required to improve measures of sleepiness and hypertension.14,15 For patients unable to establish this level of CPAP adherence, a conversation should focus on efforts to increase adherence, and/or the possibility of adding adjunctive therapies that may increase CPAP adherence, or alternative therapies such as OAT that the patient may find easier to comply with. When one considers that approximately 83% of patients have dropped out of CPAP use by year five,6 it is easy to imagine that regular dental screening would uncover a sizable group of non-adherent former CPAP patients.

Immediate Need & Delay to Treatment

The uneven distribution of board-certified sleep physicians sometimes results in lengthy waiting periods to initiate treatment. Although controversial, and outside the scope of current guidelines, these patients may benefit from an interim treatment, or “provisional” device while awaiting access to a board-certified sleep physician. A knowledgeable dentist could dispense a HST and while awaiting a diagnosis and treatment recommendations proceed with an interim oral appliance such as a myTAP temporary appliance.

It is important to acknowledge that this need is very real for a segment of the general population, and that it is important to have this discussion rather than pretend the issue does not exist. However, to solve this problem together, one first needs to be liberated of the concept that dentistry is a Trojan Horse. Instead, it must be viewed as an army of allied troops ready, willing, and able to help.

A Vision for the Future: Alberta, Canada Model of Care

Guidance for the Alberta, Canada model of care, published in 2019, is the result of all stakeholders coming together to establish a standard for dentists who provide SDB treatment to adult and pediatric patients.53 This guidance clearly indicates that dentists providing OAT to manage SDB must be properly trained and that SDB can only be diagnosed by a sleep medicine physician. They discuss a multidisciplinary collaborative approach in which a physician and dentist work collaboratively to provide an effective workflow, where patients with undiagnosed SDB can be screened, diagnosed, and treated with appropriate treatment modalities.

DentalSleepPractice.com

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CONTINUING education In Alberta, a qualifying dentist can order, request, prescribe, own and dispense equipment for sleep testing for oral appliance calibration, and for submission to a physician for screening and diagnosis of SDB. Before providing OAT, a dentist must first complete comprehensive record taking, obtain informed consent and inform the patient about OAT and associated side effects, CPAP therapy and associated side effects, surgical alternatives, sleep behavioral therapy and all alternative and appropriate adjunctive therapies. A written prescription from a physician is required prior to proceeding with OAT, and therapy should involve a custom, titratable appliance. The Alberta guidance specifically states that “Use of non-custom or temporary mandibular repositioning devices as a diagnostic tool is not recommended.”

Ongoing monitoring, follow-up testing, and evaluation of treatment for adults and pediatric patients is mandated, and pediatric treatment requires appropriate screening and confirmative diagnosis and involvement of the pediatric sleep team, including a sleep medicine physician.

No Trojan Horse Here!

All this bears well for the future of oral appliance therapy. The calls to action resulting from the AHRQ draft report illuminate CPAP adherence issues, thus challenging the Gold Standard moniker and polarized therapy approach.

All parties acknowledging the need for better research, the shortcomings of using AHI as an outcome marker, the importance of considering treatment adherence, and the evaluation of treatment alternatives that patients are more likely to comply with bodes very well for OAT as a viable treatment alternative.

The Physician-Dentist Collaboration has been exemplified by how dentistry has positioned itself to help patients during the COVID-19 pandemic and PAP recall. The Alberta, Canada model stands as an example of Physician-Dentist Collaboration at work. Finally, regarding that army Dr. Seixas rallied for in his podcast... Here We Are – Together We’re Stronger!

Acknowledgement: The authors would like to thank Dr. Shouresh Charkhandeh for critically reviewing this article prior to publication.

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American Dental Association [ADA]. Policy statement on the role of dentistry in the treatment of sleep-related breathing disorders. Adopted by 2017 House of Delegates [Internet]. Chicago, IL: ADA; 2017. Available from: https://www.ada.org/~/media/ ADA/Member%20Center/FIles/The-Role-of-Dentistry-in-Sleep-Related-Breathing-Disorders.pdf?la=en Sutherland K, Phillips CL, Cistulli PA. Efficacy vs. effectiveness in the treatment of OSA: CPAP and oral appliances. Journal of Dental Sleep Medicine 2015;2(4):175–181 Benjafield AV, et al., Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature- based analysis.

The Lancet Respiratory Medicine. 2019 Aug 1;7(8):687-98.

Frost & Sullivan. The price of a good night’s sleep: Insights into the US oral appliance market [Internet]. Darien, IL: American Academy of Sleep Medicine; 2017. Available from: https://www.columbussleepcenter. com/assets/docs/frost-and-sullivan.pdf Bartlett D, Wong K, Richards D, et al. Increasing adherence to obstructive sleep apnea treatment with a group social cognitive therapy treatment intervention: a randomized trial. Sleep 2013;36:1647–54.

Weaver TE, Sawyer A. Management of obstructive sleep apnea by continuous positive airway pressure. Oral Maxillofac Surg Clin North Am 2009;21:403–12.

Vijay Kumar Chattu et al., Insufficient Sleep Syndrome: Is it time to classify it as a major noncommunicable disease? Sleep Sci Mar-Apr 2018;11(2):56-64. doi: 10.5935/1984-0063.20180013.

Frost & Sullivan. “Vital Signs, The Price of a Good Night’s Sleep: Insights into the US Oral Appliance Market” Commissioned by the AASM. January 2015 ABSM.org website Watson NF, Rosen IM, Chervin RD, Board of Directors of the American Academy of Sleep Medicine. The past is prologue: the future of sleep medicine. J Clin Sleep Med. 2017;13(1):127–135.

AHRQ DRAFT Report: Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea 2021 AASM Letter RE: Draft Technology Assessment – “Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea.

April 23, 2021 Malhotra A, Ayappa I, Ayas N, et al. Metrics of Sleep Apnea Severity: Beyond the AHI. Sleep. 2021.

Navarro-Soriano et al., Long-term Effect of CPAP Treatment on Cardiovascular Events in Patients With Resistant Hypertension and Sleep Apnea. Data From the HIPARCO-2 Study Arch Bronconeumol. 2020 https://doi.org/10.1016/j.arbres.2019.12.006 Weaver TE; Maislin G; Dinges DF et al. Relationship between hours of CPAP use and achieving normal levels of sleepiness and daily functioning. SLEEP 2007;30(6):711-719 Grote L, et al. Therapy with nCPAP: incomplete elimination of Sleep Related Breathing Disorder. Eur Respir J. 2000;16(5):921-7.

Bakker JP, et al. Adherence to CPAP: What Should We Be Aiming For, and How Can We Get There? Chest. 2019;155(6):127287.

Bianchi MT, Alameddine Y, Mojica J. Apnea burden: efficacy versus effectiveness in patients using positive airway pressure.

Sleep Med. 2014;15(12):1579-81.

Antic NA, Catcheside P, Buchan C, et al. The effect of CPAP in normalizing daytime sleepiness, quality of life, and neurocognitive function in patients with moderate to severe OSA. Sleep. 2011;34(1):111-9.

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20. Weaver TE, Maislin G, Dinges DF, et al. Relationship between hours of CPAP use and achieving normal levels of sleepiness and daily functioning. Sleep. 2007;30(6):711-9.

21. Cistulli PA, Armitstead J, Pepin JL, et al. Short-term CPAP adherence in obstructive sleep apnea: a big data analysis using real world data. Sleep Med. 2019;59:114-16.

22. Masse, JF. On the Philips recall and the professionalism of dental sleep medicine. J Dent Sleep Med. 2021;8(3) 23. Najib T. et al., Position Statement from the Canadian Thoracic Society, Canadian Sleep Society and the Canadian Society of Respiratory Therapists Philips Respironics Device Recall Version 1.0 – July 9, 2021.

Emailed July 19, 2021 at 11:23 am EST 24. Reuters Website. FDA classifies Philips ventilator recall as most serious. https://www.reuters.com/business/healthcare-pharmaceuticals/fda-classifies-philips-ventilator-recall-most-serious-2021-07-22/ 25. FDA Website. Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. https://www.fda.gov/medical-devices/safety-communications/ certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health-risks 26. Takaesu Y, Tsuiki S, Kobayashi M, Komada Y, Nakayama H, Inoue Y. Mandibular advancement device as a comparable treatment to nasal continuous positive airway pressure for positional obstructive sleep apnea. J Clin Sleep Med 2016;12(8):1113–1119.

27. Souza et al., The influence of head-of-bed elevation in patients with obstructive sleep apnea. Sleep Breath. June 24, 2017; DOI 10.1007/ s11325-017-1524-3 28. PE Peppard et al, Longitudinal Study of Moderate Weight Change and Sleep-Disordered Breathing. JAMA December 20, 2000. Vol 284 No 23 29. Camacho M, Certal V, Abdullatif J, Zaghi S, Ruoff CM, Capasso R, Kushida CA. Myofunctional therapy to treat obstructive sleep apnea: a systematic review and meta-analysis. SLEEP 2015;38(5):669–675.

30. Maciel Dias de Andrade and Pedrosa, The role of physical exercise in obstructive sleep apnea. J Bras Pneumol. 2016 Nov-Dec; 42(6): 457–464 31. Levendowski DJ, et al. Criteria for oral appliance and/or supine avoidance therapy selection criteria based on outcome optimization and cost-effectiveness. J Med Economics 2021; 24(1) 32. AASM.org website 33. Schwartz D, Addy N, Levine M, Smith H. Oral appliance therapy should be prescribed as a first-line therapy for OSA during the COVID-19 pandemic. Journal of Dental Sleep Medicine. 2020 May;7(3):1.

34. ADA Website 35. ABDSM.org website 36. AADSM.org website 37. 2019 NADP Dental Benefits Report 38. Simmons MS., Pullinger A., Education in sleep disorders in US dental schools DDS programs. Sleep Breath (2012) 16:383–392 39. Schwartz, M. et al. Effects of CPAP and mandibular advancement device treatment in OSA patients: a systematic review and meta-analysis. Sleep Breath 2018: 22, 555–568 40. Philips, Gozal & Malhotra, What is the Future of Sleep Medicine in the United States AJRCCM 2015: 192(8), 915-917 41. Gagnadoux et al., Titrated Mandibular Advancement vs. Positive Airway Pressure for Sleep Apnea. European Respiratory Journal, 2009: 34(4), 914-920 42. Bratton et al., CPAP vs Mandibular Advancement Devices and Blood Pressure in Patients With OSA: A Systematic Review and Meta-analysis.

JAMA. 2015;314(21):2280-2293 43. Anandam et al., Cardiovascular mortality in obstructive sleep apnoea treated with continuous positive airway pressure or oral appliance: An observational study. Respirology, 2013: 18(8),pp1184-1190 44. Gagnadoux et al. Titrated mandibular advancement versus positive airway pressure for sleep apnoea Eur Respir J 2009; 34: 914–920 45. Yamamoto et al., Crossover comparison between CPAP and mandibular advancement device with adherence monitor about the effects on endothelial function, blood pressure and symptoms in patients with obstructive sleep apnea Heart Vessels 2019: 34, 1692–1702 46. Sutherland K, Phillips CL, Cistulli PA. Efficacy vs. effectiveness in the treatment of OSA: CPAP and oral appliances. Journal of Dental Sleep Medicine 2015;2(4):175–181 47. Dieltjens M, Braem MJ, Vroegop AVMT, et al. Objectively measured vs self-reported compliance during oral appliance therapy for sleep-disordered breathing. Chest. 2013;144(5):1495-1502. doi:10.1378/ CHEST.13-0613 48. Vanderveken OM, et al. Objective measurement of compliance during oral appliance therapy for sleep-disordered breathing. Thorax.

2013;68(1):91-96. doi:10.1136/thoraxjnl-2012-201900 49. Tallamaraju H, Newton JT, Fleming PS, Johal A. Factors influencing adherence to oral appliance therapy in adults with obstructive sleep apnea: a systematic review and meta-analysis. J Clin Sleep Med. 2021;17(7):1485–1498.

50. Jessica Evans, et al. The Prevalence Rate and Risk of Obstructive Sleep Apnea in Canada. Slide Presentations: Sunday, October 31, 2010 | October 2010 Chest. 2010;138(4_MeetingAbstracts):702A. doi:10.1378/ chest.10037 51. Daniel Levendowski, et al. The impact of obstructive sleep apnea variability measured in-lab versus in-home on sample size calculations. International Archives of Medicine. 2009, 2:2 doi:10.1186/1755-7682-2-2 52. Prasad B., et al. Short-term variability in apnea-hypopnea index during extended home portable monitoring. J Clin Sleep Med 2016;12(6):855– 863.

53. Alberta Dental Association and College. Standard of Practice: Non-surgical Management for Sleep Disordered Breathing. 2019

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Physician-Dentist Collaboration: A Call to Arms for Allied Troops

by John Viviano, DDS, D.ABDSM, and John Bouzis, DDS

1. CPAP adherence has been shown to be _____% at 6 months & declines to ____% at 5 years. a. 85% & 50% b. 50% & 17% c. 75% & 35% d. None of the above 2. Approximately ________ board-certified sleep physicians are currently in the United States? a. 50,000 b. 25,000 c. 10,952 d. 7,500

d. 6 hours/night, 7 nights/week 6. Oral appliance therapy has been shown to be most effective when patients wear the device ________. a. 3 hours or more b. 5 hours or more c. 7 hours or more d. None of the above 7. The 2017 ADA guidance on SDB states that dentists should not provide home sleep tests. a. True b. False

3. The AHRQ Draft Report found a high strength of evidence that hypertension, cardiovascular disease, heart attacks, stroke, diabetes, depression, and quality of life indices were improved with CPAP use. a. True b. False

8. ____% of Americans have a dentist of record. a. 60% b. 70% c. 80% d. 90% e. None of the above

4. In 2021, 3-4 million PAP and ventilators were recalled due to _____________. a. Agreement that OAT is the most efficacious treatment b. Potential health risks associated with the sound abatement foam component used in some devices c. Documented evidence of maxilla retrusion when using PAP d. All of the above

9. ____% of adults diagnosed with OSA are prescribed PAP therapy? a. 65% b. 75% c. 85% d. 105%

5. Patients are commonly considered CPAP adherent if they wear their device __________. a. 4 hours/night, 5 nights/week b. 6 hours/night, 5 nights/week c. 8 hours/night, 5 nights/week

10. The American Academy of Dental Sleep Medicine (AADSM) currently lists approximately _______ Diplomates in the United States. a. 800 b. 2,000 c. 5,000 d. 12,000 DentalSleepPractice.com

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TECHNOLOGY&innovation

4 Reasons a Dedicated Dental Sleep Medicine Health Record Will Benefit You

by Rose Nierman and Courtney Snow

E

very dental practice that embarks on the journey of implementing Dental Sleep Medicine (DSM) faces an essential decision early on. Do you try to document and bill this treatment with workarounds in your current dental practice management software, or utilize a new system focused on the medical model?

While it may be tempting to consider using the current dental practice management software system to avoid the additional costs and learning curves of a new system, many practices have found that to be detrimental to the implementation and the efficiency of activities in a DSM practice. In There are specific… day-to-day short: it may cost you far more in the long elements needed run – not only dollars but also time and team frustration. The fact is that your averfor practices to get age dental software program is designed to paid by medical prove that a procedure is a dental necessity, but not a medical necessity! Successful insurance, and dental practices implementing DSM and dental practice medical billing adopt the “medical model” by using a dedicated DSM health remanagement cord. Years of observing, educating, and software simply supporting the most successful DSM dental practices have confirmed that using a doesn’t address dedicated DSM and medical billing syssome key elements tem or application helps practices reach the intended goals. Here are four reasons of this process. you, too, should follow the lead of the leading practices who are billing medical insurance and effectively communicating with medical community.

1. Medical Coding & Billing is Different than Dental

Medical insurance pre-authorization requests and claims require different code sets than dental insurance billing. The claim form itself is different as well. Instead of using the ADA dental claim form, dentists must use the CMS1500 claim form. For the codes on the claim form, instead of using the CDT coding set, you must use medical coding sets ICD (di-

38 DSP | Fall 2021

agnosis), CPT (procedure), and HCPCS (equipment/supply).

Even if the dental practice management software is equipped with the medical codes, a common complaint is the process of setting up and using the medical codes in dental software is complicated and convoluted. You may find trying to bill medical from dental software an arduous chore. Busy offices then relegate it to the dreaded backburner pile. A system designed specifically for dental practices who work with patients’ medical insurance will eliminate this pain point.

The dedicated system should simplify medical model documentation, coding, and communication with both referral sources and medical insurers. For example, the DentalWriter software by Nierman Practice Management (NPM) has been used by dental practices working with their patients’ medical insurance for over two decades. A long-time DentalWriter user who built a successful DSM-focused practice stated, “Getting involved with DSM and using the DentalWriter software are two of the best practice decisions I ever made.” NPM has done the work and figured this out so you don’t have to.

2. Medical Documentation is Different than Dental

DSP (Summer 2021) featured several DSM influencers answering the question, “What would you have done differently when transitioning to a DSM practice?” A common thread was setting up systems, software, and front office flow. One influencer commented, “Without the right person in the front office and the right systems, you will fail.” Another reflected, “The second thing I would have done differently is taken a high-intensity crash course in medical billing,” while another stated, “Assign a team member SOLELY responsible for overseeing the DSM portion of the practice.”

There are specific notes and elements needed for dental practices to get paid by medical insurance, and dental practice management software simply doesn’t address some key ele-

TECHNOLOGY&innovation ments of this process. So, how do you focus on the medical model? Medical documentation starts with gathering the chief complaints, pertinent medical history, airway evaluation, and key exam items related to oral appliances for OSA. This medical model style of documenting your patients’ care in the SOAP format demonstrates medical necessity. SOAP notes include Subjective (complaints and history).

Objective (sleep study results, dentist’s exam findings), Assessment (diagnosis), and the Plan (treatment, referrals). For example, the DentalWriter software segments this into a 4-step process where the patient can complete the subjective portion using online questionnaires. The clinical team easily documents the objective, assessment, and plan portions. This 4-step process results in a customizable SOAP report built specifically for DSM treatment and the medical claim generated with the right codes.

In DSM, we commonly see situations in which the medical insurer denies a pre-authorization request or claim indicating “not medically necessary” or “medical necessity is not supported.” For example, did you know that to meet coverage criteria for medical coverage for patients suffering from mild Obstructive Sleep Apnea (OSA) that most medical insurers require at least one of the common comorbidities of OSA be present in their medical history? These common comorbidities typically include excessive daytime sleepiness, hypertension, impaired cognition, mood disorders, insomnia, ischemic heart disease, or a history of stroke. The health record system should ask these types of questions on the front end, so you’re not scrambling to obtain the information when the denial inevitably shows up because that information was not provided. For example, the DentalWriter software by NPM asks these questions on the front end during the first step – the online patient questionnaire.

3. Dental Notes Can Derail a Medical Pre-authorization or Claim

4. Separate Business Entities Simplify a Future Transition to a DSM-dedicated Practice

We’ve seen too many unfortunate situations where a dental practice attempts to send clinical notes stored in their dental practice management software to the medical insurer, only to find later that the pre-authorization request or claim was either denied as dental in nature rather than medical in nature, was lacking the necessary information to prove that the patient meets criteria to support medical necessity or was mistakenly rerouted to the dental insurance department.

Courtney Snow is the VP of Nierman Practice Management (NPM) and a CE faculty member for NPM’s CrossCoding: Medical Billing in Dentistry seminars. She is well-known in the industry for her dedication to client success and knowledge of medical billing in dentistry including Dental Sleep Medicine, TMJ disorders and oral surgeries.

As founder & CEO of Nierman Practice Management, Rose Nierman is a pioneer and icon in establishing systems, education, and training for dentists. For 33 years, Nierman’s Crosscoding; Medical Billing in Dentistry courses, DentalWriter Software, and billing services have helped thousands of dentists implement Dental Sleep Medicine, TMD, and medical billing. For more information: contactus@dentalwriter.com or 800-879-6468.

40 DSP | Fall 2021

Many dentists aspire to grow the volume of sleep patients enough that the practice can be focused entirely on DSM. There are multiple ways to do this: sell the general dentistry practice and focus entirely on sleep or delegate restorative patient care to one or more associates while you focus exclusively on sleep patients.

Whichever route a practitioner takes, having the dedicated DSM health records separate from the dental records is a piece of the puzzle that will save you time, money, and hassle when getting a practice valuation. That’s not conjecture. That’s factual. If your decision is to set up a separate business entity for your sleep practice (different business name/tax ID, NPI, logos, etc.) keeping your DSM health records separate is certainly a no-brainer.

There are myriad other reasons practices should use a dedicated DSM software, but these 4 reasons alone should suffice. We encourage you to “pull the trigger” and get started now with your dedicated DSM health records. If you’ve already taken the leap – kudos to you.

We hope this article helps reinforce that you made an excellent decision! If you haven’t, we’d love to learn more about you and your practice and discuss how NPM can help you successfully implement the medical model and integrate into your medical community. In short – we’d love to help you make it EASY!

PRODUCTspotlight

Now Is the Time to Get SnoreHooked

by James P. Boyd, DDS

T

he recent Philips PAP recall has rendered potentially millions of patients without their necessary therapy. Additionally, the AHRQ draft report calls into question the actual effectiveness of PAP therapy. These are prime examples of why prepared clinicians always have a few Snorehook kits in their office.

The Snorehook is: • FDA cleared custom oral appliance for the treatment of snoring and sleep apnea • Medicare PDAC-approved • Fabricated chairside in under 15 minutes • Durable for long-term use • Ideal as a back-up, provisional, or trial device • Infinitely adjustable • Under $90 per device What do you do when: • Your favorite patient has lost their device, and is leaving tomorrow on vacation?

• It’s the end of year and your lab can’t get their device to you before the insurance benefit cut-off?

• You’d like to provide a ”second set of keys” in addition to your primary device without incurring another huge lab bill?

• You have future restorations planned so you need infinite adjustability?

• You need no lab bill to help the “cash pay” patient?

• You appreciate and expect life-time free replacement on any part or component?

I’ll give you a hint. The answer is the same to every question. It’s “SnoreHook”, the only appliance for every every patient. Request Free Samples at www.SnoreHook.com

DentalSleepPractice.com

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MEDICALinsight

Inspire: Every Breath You Take

by Asim Roy, MD and Brandon Canfield, DDS

D

ue to savvy marketing, ubiquitous multimedia ads, and efficacious treatment to support the buzz, Inspire is fast becoming synonymous with sleep apnea treatment in many households. Lack of detailed information and far worse – misinformation – abound about the procedure in some professional circles. Inspire isn’t a competing therapy that aims to cannibalize the therapeutic market. It is an innovative and wildly effective treatment that is only for a select patient profile.

With this article, we aim to explain what Inspire is, who the prospective patient population is (and isn’t), and how dentists and Inspire doctors can collaborate to ensure that all patients get the treatment that’s best for them.

What Is It & How Does It Work?

A major determining factor of upper airway patency during sleep is the activity of the genioglossus muscle (tongue muscle).

Activation of this muscle via stimulation of the hypoglossal nerve is a creative new approach for treatment of obstructive sleep apnea (OSA). Hypoglossal nerve stimulation therapy is commonly referred to as Inspire, a reference to the name of the company – Inspire Medical Systems – that developed the treatment, which was approved by the Food and Drug Administration in 2014. Inspire therapy is an implantable treatment option for people with OSA who are unable to use or get consistent benefit from continuous positive airway pressure (CPAP). It’s a small implant that is inserted through two (previously three) small incisions during a same day outpatient procedure. When they go to sleep each night, Inspire patients turn the device on with their Inspire sleep remote.

Two leads are connected to the generator (battery). One lead senses when the patient

42 DSP | Fall 2021

inhales. The other sensor sits on the nerve that controls tongue movement and delivers mild stimulation that nudges the tongue forward, preventing the collapse that blocks the airway. This happens throughout the night – the system continues to keep the airway open, giving the patient a restful night’s sleep. The generator is expected to last 11 years before it needs to be replaced.

While the patient is sleeping, Inspire monitors every breath they take. Based on their unique breathing patterns, the system delivers mild stimulation to the hypoglossal nerve, which controls the movement of the tongue and other key airway muscles. By stimulating these muscles, the airway remains open during sleep. Inspire is controlled by a small handheld remote. The remote allows the patient to turn Inspire therapy on before bed and off when they wake up, adjust stimulation strength, and pause during the night if needed. Patients have full control over the device.

It is essentially a pacemaker for the tongue.

Patient Criteria

Criteria for Inspire patient candidacy include: • Moderate to severe obstructive sleep apnea (AHI of 15-65).

• Unable to use or get consistent benefit from CPAP. • Not significantly overweight (ideally BMI < 35) • Over the age of 18.

• Favorable airway by DISE (drug induced sleep endoscopy). DISE is a procedure that looks at a person’s airway under conditions that mimic sleep.

Does it Really Work?

The pivotal study of hypoglossal nerve stimulation was the Stimulation Therapy for

MEDICALinsight Apnea Reduction (STAR) trial, which was authored by Patrick J. Strollo Jr., MD, et al and appeared in The New England Journal of Medicine in 2014. The trial included 126 patients with OSA who had difficulty initiating or maintaining continuous positive airway pressure (CPAP) therapy.

The stimulator was associated with a 68 percent reduction in the apnea-hypopnea index (AHI), from 29.3 events an hour to 9.0 events an hour at 12 months. Sixty-six percent of subjects achieved a reduction of at least 50 percent and an AHI of less than 20 events an hour. The AHI reduction was accompanied by improvements in daytime sleepiness and functional outcomes of sleep. The rate of serious adverse events was less than 2 percent.

Non-serious side effects included temporary pain at incision sites, transient tongue weakness, and tongue soreness. Tongue soreness improved over time with acclimatization, device reprogramming, or both.

Maintenance of upper airway stimulation therapy efficacy at three and five years in the STAR cohort has subsequently been reported. There is also the ADHERE registry which has over 2,100 patients enrolled in a cohort study sponsored by Inspire.

In total, over 8,000 patients have currently been implanted with the Inspire device.

The growth has been tremendous. Nearly 150 new centers began offering Inspire therapy in 2020 which increases the total number of centers to more than 470 centers.

Additionally, Inspire recently conducted market research which revealed that most

physicians did not believe Inspire therapy was covered by medical insurance. It is covered by most major providers – 64 total commercial insurance plans that provide coverage for 262 million members.

Alternatives to Inspire

People are not good candidates if they don’t meet the previously mentioned criteria.

Asim Roy, MD, is the medical director of the Ohio Sleep Medicine Institute. Board certified in sleep medicine and neurology, he works in close collaboration with health care providers to deliver continuous and coordinated sleep medicine care to adult and pediatric patients. He is the author of various articles, chapters, and books, covering sleep and neurological disorders, restless legs syndrome, idiopathic hypersomnia, cataplexy, and REM sleep behavior disorder. Dr. Roy is a member of the American Academy of Sleep Medicine, American Academy of Neurology, American Medical Association, and Columbus Medical Association.

After receiving his bachelor’s degree from The Ohio State University, Brandon Canfield, DDS, continued his studies at OSU earning his Doctor of Dental Surgery degree from The Ohio State University College of Dentistry.

Dr. Canfield’s interest in sleep dentistry was sparked by his own suffering of sleep apnea that was relieved by wearing an oral appliance. He is a member of the Academy of Dental Sleep Medicine and is a Diplomate of the American Board of Dental Sleep Medicine. Dr Canfield is currently an Adjunct Assistant Professor in the Division of Restorative and Prosthetic Dentistry at The Ohio State University College of Dentistry.

DentalSleepPractice.com

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MEDICALinsight

Some Inspire patients can have their voltage reduced or be better treated at their current voltage with OAT combination therapy.

As you can deduce, this means many patients are not good candidates for Inspire. However, we still need to treat their sleep apnea.

There are many viable alternatives to CPAP or Inspire for these patients. Something many Dental Sleep Practice (DSP) readers are familiar with is oral appliance therapy (OAT) that uses a mandibular advancement device (MAD) to advance the jaw forward to achieve airway patency. There are other surgical solutions that can be helpful such as maxillomandibular advancement (MMA) and uvulopalatopharyngoplasty (UPPP).

Recently pharmacotherapy has been shown to be effective using two medications in combination that affect the upper airway (atomoxetine and oxybutynin). Recent technological developments of devices called iNAP (Somnics, Inc. Taiwan) and exciteOSA (Signifier Medical Technologies, London) both received FDA approval within the last year and can be effective in treating sleep apnea in certain cases. Conservative measures such as positional therapy and weight loss can also be effective. The key to this is not ignoring the disease but working in a multidisciplinary approach to treat the disease.

Inspire & Dental Sleep Medicine

Dentists have a vital role in this multidisciplinary approach in numerous ways. As mentioned above, dentists can treat patients who are not candidates for Inspire or CPAP with oral appliance therapy. As highlighted

by Dr. John Viviano in the Summer edition of DSP, OAT has been shown to be as effective as CPAP in a recent meta-analysis.

Additionally, some patients may be noncompliant with their PAP due to their need for high pressure settings. These patients can have a MAD fabricated to wear in conjunction with their PAP to reduce the pressure setting and make them more compliant with their PAP therapy. In this same vein, some Inspire patients can have their voltage reduced or be better treated at their current voltage with OAT combination therapy. Keeping a lower voltage is more comfortable for patients and leads to less nighttime awakenings.

Dentists can also contribute to patient care by treating a minor but common side effect of Inspire therapy. Due to the tongue thrusts inherently caused by the hypoglossal nerve stimulator, some patients complain of tongue irritation from sliding along uneven

44 DSP | Fall 2021

edges of the patient’s teeth. To protect the tongues of these patients, a dentist can fabricate a vacuum-formed matrix to fit comfortably over the patient’s teeth to wear while sleeping. This eliminates the discomfort that can result from the tongue thrust against sharp, uneven lower incisors.

Dental practices play a crucial role in screening for sleep apnea. The American Dental Association released a policy statement which states assessing a patient’s risk for sleep related breathing disorders (SRBD) is part of a comprehensive medical and dental history for all patients. Once patients screen positive for SRBD, the dentists can refer to a physician for testing, diagnosis, and subsequent therapy thus increasing the dentist’s role in this multidisciplinary approach.

Dentists encounter patients that may be disqualified as OAT candidates for multitudinous reasons (e.g. severe periodontal disease, upper and lower dentures, acute TMD).

These patients can be referred back to their physician to consider Inspire as a treatment alternative.

Likewise, many Inspire providers refer patients that are precluded from Inspire treatment to dentists for OAT. If a patient is not an Inspire candidate and does not respond to CPAP or OAT, we often consider pharmacotherapy. The iNAP device (negative pressure) or exciteOSA (daytime tongue stimulator) can be considered as adjunctive therapies. Occasionally supplemental oxygen can be beneficial. Other surgical options can be considered to reduce the burden of disease and the DISE often is helpful to make those decisions.

Patient Wellness is Our Shared Goal

Properly treating sleep apnea requires a multidisciplinary approach to patient care.

Collaboration between ENTs and dentists is crucial for successful sleep apnea treatment plans for many patients. We share the primary goal of patient wellness. We must move away from the algorithmic, cookie cutter approach that considers the full swath of treatment options only after patients have first tried and failed PAP therapy. We need better phenotyping of these patients so we can administer optimal therapy sooner than later. Inspire should be considered for many of these patients as it has been proven to be highly effective for patients with moderate to severe sleep apnea that previously had limited options.

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Airway Collaborative What is the greatest challenge dentists face in DSM and how will your course help attendees overcome it?

ensuring optimal development of the facial skeleton is fundamental to allowing good airflow. Repairing distorted or damaged structures through growth enhancement is critical to airway health.

• Improving the resiliency of the airway and reducing its tendency to collapse by optimizing physiologic functions keeps the airway open, day and night.

• Most importantly, since many of the chronic maladies of the airway occur as downstream results of behaviors and habits that have been adopted as compensations for a modern environment that is full of chronic stressors, changing the behaviors that lead to collapse of the airway is fundamental to airway health. This includes breathing, tongue posture, oral functions, body posture and more. If the behaviors don’t change, the outcomes cannot be permanently changed.

At the Airway Collaborative, we teach how to address function, structure, and behavior in a way that is clinically meaningful and leads to successful patient outcomes.

Visit Our Website for Course Listings

and additional information: https://airwaycollaborative.com/

DentalSleepPractice.com

EDUCATION

For the most part, “sleep” dentists have been relegated to an ancillary role to the physician in the treatment of obstructive sleep apnea (OSA). But as we learn more about the significance of developmental anatomy, airway flow limitation, and soft tissue dysfunction as risk factors, we see that OSA is not the main problem at all. OSA is but the end-stage symptom of a lifetime of poor development, poor function, and poor daytime and nighttime breathing.

All these latter issues are within the purview of the airway-focused dentist and orthodontist. According to the ADA policy on the Role of Dentists in Sleep Related Breathing Disorders, we are responsible for helping children “develop an optimal physiologic airway and breathing pattern.” In collaboration with other healthcare professionals and interdisciplinary protocols, dentistry has the ability to obviate the upper airway flow limitation and prevent the occurrence of OSA. Certainly medicine can manage the problem, but it lacks the tools and understanding of craniofacial development that dental professionals possess.

The challenge is getting dentists to see that the precursors to airway flow limitation begin at birth and that we have the ability to address distortions in structure, hampered function, and sub-optimal behaviors at all stages and ages of life. Our allopathic training has been focused largely on signs and symptoms management. Our methods have become somewhat mechanical and yet that is not how human physiology works. Instead, we must address etiology/root cause and prevent the downstream co-morbidities.

This approach is not included in most dental training. Dentists must come to understand that the science and evidence is overwhelming in supporting a systems approach to breathing and sleep problems. Striving for optimal wellness and not just symptom reduction is a hallmark of airway dentistry.

Here are some principles we teach: • Since the jaws form the housing for the nasal and pharyngeal airways,

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Ben-Pat Institute

EDUCATION

What differentiates your curriculum from other dental sleep educational offerings?

Our curriculum not only covers dental sleep issues but also includes a good temporomandibular joint disorder (TMD) presentation that may help the practitioner in diagnosing jaw issues. We offer an extensive hands-on experience which includes a comprehensive examination of the oral cavity and supporting musculature as well as a TMD evaluation. Our teaching style invites dentist participation with questions and then group discussions during the lectures.

Additionally, our methods encompass a case-based didactic learning style. This allows participants to appreciate the thoughts behind the clinical cause that they may encounter. We chose this learning style because it will help you have a clear understanding of the examination and diagnosis process as well as the treatment plan. Everything is intertwined and we want to make sure you understand it all.

How will attendees be different after experiencing your educational event(s)?

After experiencing our educational events, attendees will have the basis of knowledge of dental sleep medicine and

Visit Our Website for Course Lisitngs

and additional information: https://benpatinstitute.com/

46 DSP | Fall 2021

TMD. They will also recognize that there is a substantial crossover of these patients with their symptoms. Our goal is to give them the basic skills in TMD to recognize, refer or even treat these patients.

It is our goal to help attendees build confidence in their diagnostic skills as well as with preparing and understanding treatment plans. Through our hands-on components, we can provide all attendees with the skills needed to successfully implement these concepts while also understanding the flow for their individual clinical practices.

There is an abundance of DSM CE available – Why should a dentist attend yours?

We present the broadest materials of the two disciplines – obstructive sleep apnea and TMD – and then show how to implement this into your practice. We want each dentist who takes the class to be able to go out immediately after each session and be able to implement what they learned on Monday.

How will your course(s) make my practice better?

The subjects we teach will give each dentist a different perspective with their existing patients. We teach that as dentists, airway will trump many issues related to failed restorative care in some cases. One should always take the airway into consideration when planning their care.

What do your events teach about DSM and how will it help attendees actually treat more patients?

We bring in different medical doctors and adjunctive healthcare providers to talk about their specialties – sleep doctor, pediatric neurologist, physical therapist – and try to give the best overall perspective for the learning experiences of all dentists involved.

Combined with the hands-on portions of the mini residency, this gives the dentist the tools they need to be successful. Combined, our two presenters, have more than 50 years of knowledge in treating TMD and obstructive sleep apnea patients.

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DS3 What is the top question you are asked and how would you answer it?

“How do I get paid for dental sleep medicine?” Every office is different, and we help provide a custom billing model that meets each practice’s needs. This custom approach ensures patient and practice satisfaction compared to a “one size fits all” approach.

What differentiates your curriculum from other dental sleep educational offerings?

What is one actionable step you want every participant to walk away with?

All our educational experiences achieve the same goal; preparing dentists to treat OSA patients. We want every attendee to get started treating their sleep disordered breathing patients. With the knowledge and support we provide, dentists can rapidly start bringing this rewarding service to their practices.

Our team has decades of hands-on experience treating thousands of DSM patients.

We’ve learned what works and we’ve developed simple steps for DSM Success. Our training focuses on providing efficient systems for the 4 Pillars of DSM: Screening, Testing, Treating, and Billing. Helping dentists succeed in dental sleep is what we do all day every day!

What changes should we expect in DSM over the next 3 years?

We believe the industry will grow exponentially. Changes in HSAT, telemedicine, digital devices, and FastTrack calibrations will further streamline the DSM process. Public awareness is at an all-time high and CPAP challenges with effectiveness and other issues have become more prevalent. All of this adds up to a greater awareness and need for DSM.

How will your course(s) make my practice better?

Your team will learn a new way to help patients which can be rewarding for their career while your practice grows financially. We teach proven simple systems for DSM implementation. Our programs will empower you to help more patients breathe better, sleep better, and live longer!

Use Code DSP21 and Attend a Course on Us!

Scan the code below or visit https://ds3sleep.com/DS3Complete

How will attendees be different after experiencing your educational event(s)?

They’ll look at airway, bruxism, and dentistry from a new perspective. Understanding the airway connection in addition to their patient’s dentition can make their restorative practices much more enjoyable, predictable, and they’ll realize they can save lives!

DentalSleepPractice.com

EDUCATION

We offer a comprehensive Dental Sleep Medicine (DSM) curriculum taught by DSM experts. We were founded by successful DSM dentists who bring over 40 years of DSM experience and over a decade of teaching streamlined systems for patient care.

Our curriculum focuses on simplifying the processes with practical solutions to DSM challenges with an emphasis on screening, testing, treating, and billing. We offer a wide variety of educational opportunities including but not limited to: • On demand/live interactive coaching • Nationwide webinar series • DSM virtual educational continuum • Hands-on courses • In-person consulting and shadowing opportunities

There is an abundance of DSM CE available – Why should a dentist attend yours?

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Kettenbach

EDUCATION

Does Kettenbach offer any CE courses that relate to their products?

For over 70 years, we’ve been focused on progress. We strive to improve the lives of clinicians and your patients – it’s that simple! Sometimes we do this through our groundbreaking products and materials. Other times we achieve this goal through education.

Kettenbach is proud to align with some of the most exceptional educators in Dental Sleep Medicine. They use our products, have benefited from their predictability, ease of use, and accuracy. Dentists like Dr. John Tucker share their real-world experiences with us and with clinicians around the world. This creates a feedback loop that helps dentists save time and money while also empowering Kettenbach with the knowledge to continually innovate.

What upcoming educational opportunities do you have scheduled?

We will definitely be at the Greater New York Dental Meeting, sponsoring Dr. John Tucker’s sleep course along with Dental Sleep Practice.

Get 15% Off Your Next Order

Mention this code KEBA-SLEEP15 – and get 15% off your next order. (Limit to 1 order.) 30-day risk-free trial. Love it or your money back! Call Kettenbach Direct 877-532-2123.

48 DSP | Fall 2021

If you can’t make it to GNYDM, be sure to catch Kettenbach at the AAPMD (9/239/25) or the ADA SmileCon (10/11-10/13) at booth B3417. See a full list of events on our schedule: https://www.kettenbachusa.com/ downloads.aspx

What if someone can’t make it out to a course or trade show? How can they learn about your products and how to maximize their benefits?

We’re really thankful that the U.S. has turned a corner, and we can all spend time together in social educational settings again.

Even if you can’t travel to one of the excellent meetings on our schedule, we also offer regional seminars with more personal instruction through our sales representatives.

Connect with a local representative and take advantage of these invaluable educational opportunities: https://www.kettenbach-dental. us/contact/ 877-532-2123 We’re also ecstatic to announce our free on-demand product related courses featured on our partner platform with Catapult Education (https://www.catapulteducation.com/ kettenbach). This platform provides a wealth of useful information that will improve efficiency, maximize your output, and save time.

Of course, time is money.

A free CE webinar titled “Bite Registration for Oral Appliances to Treat Sleep-Related Breathing Disorders” hosted by Dr. Tucker is available now on the Dental Sleep Practice website. From impression techniques to improve OAT fit to predictable bite registrations to minimize titration, Dr. Tucker covered it here: https://bit.ly/2WbkFrB

What makes Kettenbach unique?

Besides impression materials, snore screeners, mandibular simulators, and titration keys, we also carry a full line of restorative products, including temporary, core build up and adhesive cement. Our worldclass customer service team is available for you to provide education and assistance every step. You’ll also save 30-40% since you will be buying directly from the manufacturer.

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N3Sleep & DreamSleep What is the main difference between the DreamSleep program and other dental sleep education programs?

N3Sleep, the consulting division of DreamSleep, combines a robust online curriculum with hands-on, in-office training for your whole team, not just the dentist or sleep coordinator. We believe that whole team training is critical to success in sleep. Everyone must know their part and be invested in the health of the patient. Each element of our program is tailored to the specific needs of your practice. We integrate your procedures and the tools you have chosen into a custom protocol for each member of your team.

Another meaningful differentiator is that we include a minimum of 6 months follow-up coaching with your team. We don’t just give you information and leave it up to you to implement. We help you get the program moving, train your team, and work through the issues along the way.

The N3Sleep program is focused on the whole team. Your team will complete the program knowing not only what they need to do but more importantly how to work together. We know it’s busy running a dental practice, which is why our program is built to make integrating sleep easy. We work with your team to create protocols and systems that work for your practice. Our ongoing coaching program helps ensure that you overcome any obstacles that pop up.

What is the greatest challenge dentists face in DSM & how will your course help attendees overcome it?

Sleep medicine is a team effort, and everyone needs to understand their role. Whole team training ensures that each team member understands their contribution to patient care. To learn more, visit https://n3sleep. com/.

Free 20 Minute Sleep Program Consultation

Scan this code to schedule a free 20 minute sleep program consultation or visit https://bookme.name/n3sleep/sleep-program-consult

Effective training for the team is the biggest challenge facing dental practices adding sleep. It’s a lot of work training your whole team, especially when running a busy practice. It can quickly become the thing that gets dropped. That is why it’s essential to have a dedicated partner who can give each member of your team the attention they need.

DentalSleepPractice.com

EDUCATION

How will attendees be different after N3Sleep training?

How will your course(s) make my practice better?

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Pristine Medical Billing When educating a practice on the amount to collect from the patient for the oral appliance therapy, what factors come in to play?

EDUCATION

Randy Curran

For out-of-network providers, it is difficult to pinpoint the exact payment without a contracted rate. If you’ve curated a history of allowable rates for the codes being billed to the carrier or you use a third-party billing service, you can do the math from the benefit check. However, that gets challenging since you’re unsure if the gap is going to be approved. We recommend using the history of allowable rates for your state, get the gap/pre-auth approval first and then present the financials to the patient. Otherwise, you may present the financials on assumptions of gap approval and get it wrong. While this might take a couple weeks, it gives patients an accurate estimate and confidence that treatment has been approved. This will also boost your financial coordinator’s confidence which will be felt by your patients.

What advice does Pristine give during webinars about the initial insurance coverage, when the patient asks about the cost?

We recommend that you do not make the mistake of saying “Yes, your insurance

Schedule a Demo

Contact us at www.PristineMedicalBilling.com to schedule a demo and review our new EMR system that is included with the Pristine membership

50 DSP | Fall 2021

covers the treatment.” This seemingly innocuous statement can lead patients to believe the insurance pays for most of treatment and perhaps, they just need to pay a copay like a doctor’s appointment or an ER visit. We recommend that our practices inform patients that “Yes, your insurance should cover a good portion of the treatment depending on your plan coverage. We ‘ll have a better understanding once we complete the benefit check and pre-authorization for the treatment.”

This creates clear expectations, so everyone is on the same page.

Does Pristine advise attendees at courses to bill for morning aligners or impression material?

This is an area that dental practices need to be very careful about as there are entities that will recommend oral surgery codes like 21110 or 21085 for these items. This could be considered insurance fraud. If a practice wants to bill out a morning aligner, the only code we would recommend is the E1399 Misc. DME code, but that isn’t usually worth the hassle.

Does Pristine coach dental practices to go in-network or stay out-of-network with medical insurance carriers?

That depends on the area in which you practice. If there is an in-network dental sleep medicine provider within 20-30 miles of your practice, it would probably be best to go in-network as the insurance carrier will likely default to send the patient to the other provider during the pre-authorization process. It will also be challenging to obtain a gap approval to use the patient’s lower in-network deductible. The insurance carriers are now contracting with general dentists, so that is currently an option for many practices.

If there are not any in-network practices within a 30-mile radius, then the practice can remain out-of-network and obtain gap approvals to realize the best of both worlds.

Whatever decision you make, you’re strongly encouraged to coordinate with an experienced medical billing company that helps coach you to success. We can help.

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Sleep Group Solutions What differentiates your curriculum from other dental sleep educational offerings?

At Sleep Group Solutions, our curriculum focuses on full-service, end-to-end solutions for dental sleep medicine. There are many programs out there covering practice management protocols, appliances, sleep testing options, and other individual pieces of the dental sleep medicine puzzle. SGS is the only one with a comprehensive, 360 degree solution including hands-on clinical training for your team. We are proud to present a clinical program that provides objective predictable results for appliance therapy with a process that may eliminate the need for future titrations/adjustments.

How will attendees be different after experiencing your educational event(s)?

What is the greatest challenge dentists face in DSM and how will your course help attendees overcome it?

What changes should we expect in DSM over the next 3 years?

Oral appliances are the most patient preferred, non-invasive treatment option for the management of sleep apnea. As awareness, physician acceptance, and referrals increase, dentists will find themselves in a prime position to take advantage of this market growth.

The time to establish yourself as the “go-to” provider for this therapy in your area is now.

How will your course(s) make my practice better?

DSM will mean two things for your practice: Doing the right thing for your patients and growing your business. You don’t get to choose if you see sleep apnea patients, every single person reading this, saw sleep patients today so the choice is simple: Are you going to help them? Or are you going to overlook the airway problems you see every day? Join us on a journey to a clinically and financially successful sleep business today!

Contact Us for a Free In-office Consultation https://go.sleepgroupsolutions.com/DSP2021

There are numerous challenges in Dental Sleep Medicine but our program helps to address all of them. Most often, there are miscommunications with patients that result in an over-reliance on insurance. Our mission is helping to improve how practices engage and educate patients regarding their sleep disorders. With SGS’s system, guesswork is eliminated, giving you confidence knowing that the bite you take for your patient’s sleep appliance is precisely positioned. The costly

DentalSleepPractice.com

EDUCATION

Whether you are already practicing dental sleep medicine or you are brand new and have never made a sleep appliance, our program provides attendees with the protocols to establish or grow a dental sleep medicine business. After the SGS sleep course, you will possess a new or enhanced understanding of sleep and breathing and how it connects with daily dental complications you encounter. Just today, 1 in 4 of the patients you saw had a diagnosable sleep-related breathing disorder and odds are, you missed 99% of them – this will change after the SGS sleep course!

process of advancing devices an arbitrary amount for a bite and then testing, adjusting, re-testing, and adjusting again, is gone.

In addition to this predictable, time-saving clinical protocol, we teach systems to ensure successful medical insurance billing & reimbursement.

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Vivos Billing Intelligence Service What is the top question you are asked, and how would you answer it?

“How can I get medical insurance to help pay for my patient’s treatment?” The answer lies in having an integrated workflow leading to both a successful clinical and financial outcome. The only thing preventing dentists from accessing medical benefits is fear or lack of knowledge – and the fear comes from the lack of knowledge!

EDUCATION

Chris Farrugia, DDS

What differentiates your curriculum from other dental sleep educational offerings, and why should dentists attend yours?

We start with the end goal in mind: successful clinical AND financial outcomes.

With that in mind, dentists can benefit from “reverse engineering” their clinical protocols and avoid embedding obstacles for payment into their workflow.

Our curriculum is different in two important ways: 1. This course gives equal weight to the clinical and financial aspects of treating sleep patients. Many dental sleep courses incorrectly focus on the clinical aspect of treating sleep patients and present the financial aspect as an afterthought. Due to this, dentists who want to treat these patients are often prepared clinically but fail financially, eventually becoming discouraged and giving up.

Attend Dr. Farrugia’s Online Course “Beyond MAD” Sign up by calling 720-414-3485 or by visiting www.vivosbis.com

Oral appliance therapy beyond mandibular advancement

52 DSP | Fall 2021

2. It provides the ability to recognize, treat, and be paid for a variety of treatment modalities, such as craniofacial appliances that address the underlying structural problems. Other dental sleep courses focus on treatment by mandibular advancement; however, MADs are only one tool in the dentist’s “toolbox.”

What do you mean by “Beyond MAD”?

In their earliest exposure to DSM, dentists are taught that mandibular advancement is a therapeutic solution for OSA. In fact, it is only a management tool and not a solution.

Dentists must be prepared to recognize and treat the full spectrum of clinical presentations and be paid for such valuable service.

What’s the funniest thing that’s ever happened at one of your events?

A dentist got up in the middle of a course, left the room to go outside, and started screaming: “Now I get it!” over and over again. Then he came back into the room and sat down as if nothing had happened. It was the embodiment of the power of an “Aha!” moment!

What is the greatest challenge dentists face in DSM, and how will your course help attendees overcome it?

The greatest challenge dentists face is case acceptance and being paid properly for their services. Knowledge is power. Knowing what is needed for payment and incorporating that knowledge into clinical protocols helps them overcome that challenge.

What changes should we expect in DSM over the next three years?

Technology will simplify the identification and diagnosis of OSA and accelerate public awareness of this widespread problem. Focus will shift to the underlying reasons people have OSA and how it can be reversed in adults and avoided by early screening and intervention in our younger population. This will create a huge demand for dentists prepared to treat and be paid for a full range of treatment options – especially craniofacial dental sleep medicine.

SPECIALfeature

The Vivos Institute What is the top question you are asked and how would you answer it?

Why was The Vivos Institute established?

We wanted to build a space for post-graduate education across a variety of needs that we know are prevalent in dentistry. We teach on dental practice management, leadership skills, medical billing, orthodontic treatment, myofunctional therapies, sleep test use and understanding, and a variety of modalities that include oral appliance therapies to treat SDB, including mild-to-moderate OSA and dentofacial underdevelopment.

What differentiates your curriculum from other dental sleep educational offerings?

What is one actionable step you want every participant to walk away with?

When attendees leave our trainings, they immediately go back to the office with a list of patients they now recognize as candidates for a more thorough screening that will include sleep questionnaires, home sleep tests, etc. This alone will hugely impact patient health.

How will attendees be different after experiencing your educational event(s)?

Our post-graduate CE includes state-of-the-art equipment, hands on opportunities, and will train the entire office team their crucial role to establish a sleep and airway focus in their practice.

Beyond amazing educators, The Vivos Institute support team and the overall experience are designed to assure a high-level experience for every attendee.

What is the greatest challenge dentists face in DSM and how will your course help attendees overcome it?

The challenge, as we see it, is just not knowing what they don’t know. Through the learning at The Vivos Institute, attendees realize their critical role and step-by-step methodologies for implementing successfully.

EDUCATION

We know this is a multi-disciplinary issue that impacts everyone uniquely. We incorporate all the latest modalities to give our attendees a comprehensive understanding of what to look for, what to ask patients, intake procedures and forms to incorporate, how to become effective and, most importantly – the enormous impact dentists and their teams can have on the overall health and wellness of their patients.

There is an abundance of DSM CE available – Why should a dentist attend yours?

What do your events teach about DSM and how will it help attendees actually treat more patients?

It all starts with screening – using new technologies, such as the VivoScore by SleepImage, which is low cost and easy to use, dental practices will have an easy-toimplement patient flow to quickly address this critical area of overall health.

To Learn More About the Vivos Institute Visit https://thevivosinstitute.com/

Our attendees leave with the ability to visually recognize common facial, oral, and health history conditions that are indicators that better questions should be asked. They are motivated to look beyond the teeth and be concerned for the overall health of each patient they see. They know that these common symptoms are anything but normal.

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PRACTICALtips

Oral Appliances and Tooth Movement; Caveat Emptor

by John Viviano, DDS, D.ABDSM

I

am not aware of anyone that has died from a bite change. I’ve studied the literature. I’ve asked my colleagues. Nothing! Many of you have heard that before, but this debate still rages in the minds of some referrers, a few patients, and many of our dentist colleagues. The potential for bite changes is oft cited as rationale to preclude someone in need from receiving Oral Appliance Therapy (OAT).

When it comes to OAT, there should be no question about if teeth will move. It’s as if any recollection of ORTHO 101 has been erased from our minds. Let’s have a quick refresher. We learned many surprising things in first year ortho class: 1. Teeth move 2. Teeth can be moved by placing a subtle force on them 3. Any level of force will eventually move teeth There, you have just reviewed the basics of orthodontic therapy, and now you can schedule your first clear aligner case!

There are manifold examples in general dentistry of subtle forces leading to tooth movement, such as those associated with tongue thrusting, thumb sucking, and mouth breathing.

All these lead to not only tooth movement but also dental arch malformation. We all know this. However, we expect to use OAT and not experience any tooth movement, with some oral appliance manufacturers even claiming that their appliance design does not move teeth at all! How can I put this politely, “BALDERDASH!” We can’t cheat physics. These dental changes are all explained by Newton’s Third Law of Motion which states, “For every action, there is an equal and opposite reaction.” If you sit in a chair, your body exerts

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a downward force on the chair and the chair exerts an upward force on your body.

So, two forces result from this interaction: a force on the chair (the action) and a force on your body (the reaction). The “force size” equals the size of the reaction force, and the direction of the reaction force is opposite to the direction of the applied force. In summary, forces always come in equal and opposite, “action-reaction” force pairs. Yet, some would have us believe that the Laws of Physics simply do not apply in the oral cavity by making claims that their oral appliances do not move teeth.

OAT enforces a particular mandibular posture by engaging the upper and lower jaw by the teeth and maintaining a specific position. In accordance with the discussion above, forces such as those applied by gravity (which vary depending on sleep position) and bruxism (which vary depending on intensity and frequency) will result in equal and opposite “action-reaction” force pairs, that will in accordance with ORTHO 101 impact on tooth movement. Rather than claiming that a particular appliance design does not move teeth, perhaps a more meaningful approach could be, “How can we minimize the consequences of “action-reaction” force pairs associated with sleep apnea oral appliance wear?”

Now we ask the question, “Will the consequences of these forces be the same on everyone’s dentition?” We can posit that the

PRACTICALtips consequences will not be the same. Appliance design is a major contributing factor; does the appliance push or pull the lower jaw forward, are forces oblique or horizontal to the occlusal plane and does the appliance allow for movement or does it fix the jaws in a specific position? Another major contributing factor is the level of force, which can be influenced by sleep position and the level of bruxism. Finally, there are patient-specific contributing factors to consider; periodontal status (bone levels), edentulous areas, degree of mandibular advancement, and hours of appliance wear.

The literature robustly supports the notion that OAT creates bite changes.1 However, as discussed above, tooth movement is influenced by a number of factors aside from the actual oral appliance, some of which are difficult to control. Consequently, studies in this area must be scrutinized carefully, and without a body of evidence to support a particular finding, generalizations regarding tooth movement and prevention of tooth movement may be difficult to substantiate.

Norrhem et al.2 conducted a tooth movement study of bite changes associated with a rigid Dorsal-style acrylic appliance that contacted all of the mandibular teeth, to those associated with a flexible nylon appliance that limited mandibular tooth contact from the cuspids distally, with no anterior tooth contact. Significant anterior crowding was documented with the appliance that did not contact the anterior teeth. The authors found that the posterior teeth, which were engaged by the appliance moved mesially “en bloc”, while the anterior teeth which were not engaged by the appliance, and thus not subjected to forces, simply crowded. Some have chosen to refer to this as evidence that an appliance that engages the entire dentition

does not move teeth. Is this really the case?

Or is the movement more uniform and less obvious? Or will it simply take longer for the movement to become statistically significant? Considering Newton’s Third Law, actually setting a standard that defies the Laws of Physics is not a responsible use of literature findings; potentially setting both patients and referrers up for disappointment.

The nylon appliance studied by Norrhem et al. was the Narval appliance (Resmed, San Diego, CA). With a similar design to the aforementioned Narval, the D-SAD (Panthera, Quebec City, Canada) has been modified to incorporate what we’ve learned from the research (Figure 1). Panthera now recommends that the lower arch be a full plateau and that the anterior band be placed on the lingual and wrap over the incisal, all making the lower arch of the D-SAD more rigid. In addition, Panthera now also makes the anterior band thicker and places it a mere 0.2 mm away from the dentition, further adding to rigidity and minimizing the likelihood of anterior crowding. These design modifica-

When it comes to OAT, there should be no question about if teeth will move.

Figure I: To minimize tooth movement Panthera recommends a full plateau for the lower arch with the anterior band situated on the lingual, wrapping over the incisal edge and 0.2 mm away from the dentition.

Dr. Viviano obtained his credentials from the University of Toronto in 1983. His clinic is limited to managing sleep-disordered breathing and sleep-related bruxism. He is a Credentialed Diplomate of the American Board of Dental Sleep Medicine and has lectured internationally, conducted original research, and authored original articles on the management of sleep-disordered breathing. His clinic is the first Canadian facility accredited by the American Academy of Dental Sleep Medicine and he is Clinical Director of the Sleep Disorders Dentistry Research and Learning Centre. Dr. Viviano also hosts the SleepDisordersDentistry LinkedIn Discussion Group and conducts dental sleep medicine CE programs for various levels of experience, including a 4-day mini residency. Dr. Viviano’s Class and Cloud Based CE programs can be found on SDDacademy.com, and he can be reached at (905) 212-7732 or via the website sleepdisordersdentistry.com.

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Figure 2: The forces exerted by a Herbst-like appliance on the dentition have been shown to result in an intrusive with distal inclination tooth movement of the maxillary posterior teeth and an intrusive with anterior inclination tooth movement of the mandibular anterior teeth.

...the literature documents tooth movement from CPAP wear as well.

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tions are an example of responsible use of literature findings; improvement of appliance design in an effort to reduce tooth movement associated with OAT. Another study evaluating tooth movement further demonstrates how bite changes are appliance-design specific. This study documented bite changes associated with a Herbstlike appliance whose design uses downward and forward, oblique compression forces (Figure 2). These investigators found an intrusive with distal inclination tooth movement of the maxillary posterior teeth and an intrusive with anterior inclination tooth movement of the mandibular anterior teeth.3 How do these findings differ from those expected based on basic orthodontic principles?

It appears that tooth movement varies depending on appliance design. With more strictly controlled studies, perhaps we will be better able to determine which designs minimize this eventuality. However, no appliance can cheat physics. When it comes to claims of preventing tooth movement in the absence of a body of evidence, “caveat emptor.” I advise my patients that their teeth naturally move throughout their lifetime and that the appliance will likely contribute to this tooth movement in an appliance specific manner. Not only are these expectations less likely to result in disappointment, advising a patient that a particular appliance will prevent bite changes all together simply defies both physics and logic.

We have now shed some light on the “IF” and “WHY” OAT causes tooth movement.

However, there is another elephant in the room – “jaw posture.” Our mandible is suspended in a muscular sling from the maxillae, and daytime jaw posture can sometimes change over time as influenced by wearing a sleep apnea oral appliance. This change can be influenced by factors such as the degree of mandibular advancement and the effort a patient is willing to put into reclaiming their habitual bite every morning. In consideration of this phenomenon, the American Academy of Dental Sleep Medicine (AADSM) has published an alternate definition of habitual occlusion for us to consider. “The position of closure between the dental arches in which the patient feels the teeth fit most comfortably with minimal feeling of stress in the muscles and joints.” This further complicates the monitoring of bite changes caused by a specific appliance, and I would suggest, even speaks to just how insignificant these bite changes are. Finally, for those wondering if CPAP would be a better option to minimize these bite changes, the literature documents tooth movement from CPAP wear as well.4,5 OSA is a life-threatening disorder that reduces both quality and longevity of life.

Studies show that most patients are not even aware of their oral appliance-related bite change until it is pointed out to them by a dental professional.1,6 According to Gordon Christensen, “Occlusion is a constantly changing, dynamic state that is almost never the same from day to day.”7 As clinicians, we really need to focus on our patients’ overall health and keep our unhealthy obsession with occlusion in check. Remember, no one has ever died of a bite change!

1.

2.

3.

4.

5.

6.

7.

Sheats et al., Management of side effects of oral appliance therapy for sleep-disordered breathing. Journal of Dental Sleep Medicine. 2017;4(4):111–125 Norrhem et al. Changes in lower incisor irregularity during treatment with oral sleep apnea appliances. Sleep Breath; Published On-line JAN 23 2017 DOI 10.1007/s11325-016-1456-3 Cohen-Levy, J., Pételle, B., Pinguet, J. et al. Forces created by mandibular advancement devices in OSAS patients. Sleep Breath 17, 781–789 (2013). https://doi.org/10.1007/s11325012-0765-4 Pliska BT, Almeida FR. Tooth movement associated with CPAP therapy. J Clin Sleep Med. 2018;14(4):701–702.

Tsuda et al. Craniofacial changes after 2 years of nasal continuous positive airway pressure use in patients with obstructive sleep apnea. Chest 2010 Oct;138(4):870-4 Tsuda et al. Practical considerations for effective oral appliance use in the treatment of obstructive sleep apnea: a clinical review. Sleep Science and Practice (2017) 1:12 Christensen G. What causes changes in occlusion? Dental Economics July 15, 2013

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PRACTICEmanagement

You Can’t Buy Your Way to Dental Sleep Success

by Brett Brocki

T

o quote Jack Nicholson’s character, Col. Nathan R. Jessep, in the 1992 movie, A Few Good Men, “You can’t handle the truth!” This is an unpopular opinion, especially amongst those selling services and products in the dental sleep medicine, but it is the truth. You cannot now, in the past, nor probably will you ever be able to buy your way to Dental Sleep Medicine success.

There is no magic bullet, no miracle cure that turns on the firehose of patients and reimbursement checks from medical insurance companies. You cannot purchase a title or degree that is a substitute for the experience you gain from hands-on patient care. Sleep lab owners and physicians will tell you that they have met clinicians with an alphabet of post-nominal titles that do not take proper bite registrations, fail to follow professional organizations’ guidelines, and lack consistent communication or predictable patient management protocols needed to provide the highest level of care. Don’t be that dental sleep practice.

Certainly, there are tools that can improve your sleep practice and make it easier for you and your team to be effective, but the simple truth is that there is no replacement for hard

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work, experience, and good coaching. If you want your practice to succeed, you need to put in the work. This is a mindset that you must adopt if you want to succeed.

What kind of effort do you need to put forth and where do you need to focus? Here are some places to start:

Educate yourself and your team on the science and medicine of sleep

Properly treating sleep patients with oral appliance therapy (OAT) requires effective communication and genuine collaboration between dentists and physicians. That means you need to speak their language and understand their needs. The same is true on the other side; to effectively communicate with patients your whole team needs to understand what is at stake and why you are doing this. Coach your team to help people. They need to understand the effects sleep apnea has on every system in the body; on lifespan, quality of life, productivity, mood, weight, and more. When the focus is on helping people instead of fitting an appliance their sincerity will transform your sleep practice. It’s important to also understand the benefits and the limits of oral appliance therapy. Not everyone is an ideal candidate for OAT and referring out

PRACTICEmanagement to a physician who can get them help can transform lives.

Training for yourself and your team on the systems, processes, and procedures

Sleep medicine is definitely not traditional restorative dentistry. There are innumerable moving parts. Collaboration with physicians is key. You’ll need to understand how each one of them prefers to communicate.

You will need to cross every ‘T’ and dot every “I” when navigating arcane, Byzantine processes and procedures to comply with the requirements of different medical insurance companies. Your team will need to know what is required from the different labs. I’m often amazed at the new ways practices can develop to create barriers for patients or obstacles for medical reimbursement. It needn’t be that way. Get yourself a coach and a mentor to help guide you on this journey. Learn from their experiences. Many practices follow well-worn paths to success created by coaches.

Measure your results in meaningful ways, not just production

Track all your important stats that contribute to a successful practice like number of screenings, number of home sleep tests, and number of referrals. Not everyone is an ideal candidate for oral appliance therapy but to reach every ideal candidate you need to cast a wide net. If you are going to improve your operation you need to know where the snags are. Start keeping track of your patient funnel. How many screenings do you do before a patient agrees to testing? How many tests do you schedule before a patient agrees to treatment? Knowing these numbers can help you identify gaps in your process and problems with your patient communications.

A simple change in wording can affect your screening and consult rates, but if you aren’t tracking these you won’t know.

Commit to incremental improvements Success does not come overnight, but if you keep taking baby steps you’ll get there.

One foot in front of the other. Repeat. Keep an eye on your key performance indicators,

and commit to making small improvements every week. This is a marathon, not a sprint.

Your team did not learn about OSA in school.

It will take time to internalize these processes, integrate them into your dental program, and fine-tune your execution.

Adapt

The key skill to success is adaptability. Success in dental sleep medicine is a moving target: the technologies are changing constantly. Medical insurance will continue to move the goal posts and your team needs to be prepared to adapt and update protocols as necessary. Listen to your team members. Listen to your patients. And listen to physicians you are working with. Continually solicit their feedback to help you improve your protocols, efficiency, and patient care.

Repeat

I’m often amazed at the new ways practices can develop to create barriers for patients or obstacles for medical reimbursement.

Stay current with your education and training. As your team grows in experience, get them educated, and certified in their roles. This will increase their confidence and make them better at adapting as needed.

Stick with the plan and keep measuring your progress. Evaluate. Adapt. Repeat.

As you cycle through this process, you may see equipment, programs, or opportunities that you can acquire. Your experiences will inform your choice to buy or not buy into these things. They may help you on your journey in dental sleep medicine. One thing is certain though, no program or equipment will help you find success if you are not doing the “work”.

Brett Brocki is the Founder and Chief Executive Officer of DreamSleep and N3Sleep. Brett has been in the dental industry since birth. His mother was the former head dental assistant at Fort Bragg, and Brett has seen the inside of thousands of dental practices – including civilian, military and hospital practices. His expertise in business, finance and dental have given him exposure and unrivaled capabilities to truly bring the right picture together for overall health and wellness. Working closely with many practices to achieve the optimum sleep practice with the most thorough care, Brett has truly developed a multidisciplinary team with the tools to connect the Medical and Dental professionals into one cohesive business unit.

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CLINICALfocus

Healthy Cells, Healthy Brain: Nose Breathing is Fundamental

by Steve Carstensen, DDS, D.ABDSM, and Karen Davidson, DHA, MSA, MEd, MSN, RN

T

o prepare yourself to read this article, take a breath. In, then out. Did it feel like every other breath – did you notice anything? Nothing? That is to be expected. It’s normal, and that breath was probably not as good for you as it could have been.

This is true for most people. And not just when their airway collapses during sleep and we label them ‘patient’ with a disease that requires our help. Pick up Breath by Nestor and The Breathing Cure by McKeown to learn more. Read on to learn what to say about where it all begins: the nose and how we make it work for or against our best health.

Oxygen is abundant: at sea level, about 21% of inhaled air, 16% exhaled after we’ve extracted all we need.

But oxygen is only one of three critical gases related to nose breathing.

60 DSP | Fall 2021

Carbon dioxide is 0.04% of the air we breathe but 4% of what we exhale – it is a byproduct of energy production in our cells.

CO2 levels also control respiration rate and affect oxygen uptake in the blood.1 Hypocapnia results in less oxygen available for mitochondria to make energy.

Tanaka et al., found that end-tidal-CO2 concentrations were higher during nose breathing than during oral breathing. A group of healthy volunteers had an average CO2 of about 43.7 mm Hg for nose breathing and only around 40.6 mm Hg for oral breathing.

The immediate negative biochemical effects of mouth-breathing related to CO2 are: Hypocapnia, reduced oxygenation to the body and vital organs, mental health conditions including anxiety, addictive behavior, and negative emotions. The emotional aspect can lead to stress and add to sleeping problems.2 Hypocapnia also leads to central sleep apnea and probably has a role in obstructive sleep apnea.3 Our noses are no mere portals for gas flow. If we want to make sure our bodies can get oxygen to the cells, an exchange and transport process must take place. Healthy lung tissues are coated with a special surfactant – without it, the alveoli cannot stay open in the deepest part of the lungs. Transfer molecules responsible for moving oxygen from

CLINICALfocus air to blood and CO2 into air are blocked when the tissues are hard, inflexible, and dry.

A key ingredient that allows surfactant to be produced in the lungs is nitric oxide, NO. Hummmmm. Do it with me – hum while you breathe through your nose and read this paragraph. A 2002 study measured nitric oxide in nasal- and mouth-breathing, with and without humming. The differences are startling: Mouth-breathing produced 104nl/ min – humming had no effect. Switching to nose breathing resulted in 189nl/min NO production. Add humming: 2818 nl/min – a 15-fold increase.4 Nitric oxide is produced in the sinuses and drawn into the lungs during nasal inspiration. In clinic, suggest humming during breathing exercises to slow exhalations. Nestor’s and McKeown’s books are replete with helpful exercises you can promote to your patients.

Clear sinuses and 100% nasal breathing provide enough nitric oxide (Molecule of the Year in 1992, according to Science magazine) for proper lung function. Nitric oxide has antibacterial and antiviral properties. While studies are ongoing for effects on COVID-19, NO was studied during SARS outbreaks and found to limit infections. People who breathe through their noses were found to have fewer rhinovirus infections – colds and flu.5 There are many great properties of NO but getting people’s attention only needs a couple of key points, and these days, ‘antiviral’ is enough.

Let’s go deeper. You know that Cranial Nerve 1, Olfactory, has specialized receptor neurons that allow our cortex to assess our environment for threat or reward by sniffing volumes of air into the upper reaches of our nose, around the superior turbinate. What is less well understood are the mechanoreceptor cilia connected to axons of CN1 that travel to the limbic system. In a landmark study,6 rare patients with epilepsy who had electrodes implanted in their brains were led through a series of breathing exercises. Neuronal activity in the piriform complex, amygdala, and hippocampus tracked along with nasal breathing but not when the subjects breathed through their mouths. While full conclusions of the physiologic importance of this synchrony are still being considered, the authors note “behavioral data in healthy subjects suggest that breathing phase systematically influences cognitive tasks related to amygdala and hippocampal functions.” Oth-

er experiments cited in this paper show nasal breathing serves as a common “clock” to organize spatiotemporal excitability (a sense of space and time) broadly throughout the brain. Nasal breathing helps your patients be calmer, smarter, and more graceful in moving through their environment.

Is there an objective way to know if patients can breathe well through their nose?

Over a hundred years ago, Dr. Glatzel promoted a cold mirror inscribed with lines – by holding the mirror under the nose, fogging on the cold mirror would reveal differences between left and right nasal passages. Not quantifiable, but helpful to show patients.

Rhinomanometry is a non-invasive, 4minute test that provides real-time objective data about nasal airway resistance and the

While studies are ongoing for effects on COVID-19, NO was studied during SARS outbreaks and found to limit infections.

Figure 1: Glatzel Mirror showing equivalent nasal flow

Steve Carstensen, DDS, has treated sleep apnea and snoring in Bellevue, WA since 1998. He’s the Consultant to the ADA for sleep related breathing disorders, has trained at UCLA’s Mini-Residency in Sleep and is a Diplomate of the American Board of Dental Sleep Medicine. He lectures internationally, directs sleep education at Airway Technologies and the Pankey Institute and is a guest lecturer at Spear Education and Louisiana State Dental School, in addition to advising several other sleep-related manufacturers. From 2014 – 2019 he was Editor of Dental Sleep Practice magazine. In 2019, Quintessence published A Clinician’s Handbook for Dental Sleep Medicine, written with a co-author.

Karen Davidson, DHA, MSA, MEd., MSN, RN, has held many positions in the medical device industry over the past 25 years, specifically in the ENT and Sleep markets, in addition to 29 years of clinical experience to include service as a Flight Nurse in the United States Air Force Reserves. Dr. Davidson serves as the Vice President at GM Instruments, Ltd. with a special interest in the technology of objective nasal measurements, nasal physiology, clinical application, reimbursement, health economics, and health policy.

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CLINICALfocus

Patient testing with rhinomanometry

Patient testing with acoustic rhinometry

patency of the nose. It measures the pressure and flow for left and right nasal passages during normal inspiration and expiration. It can independently measure one nostril at a time with active anterior rhinomanometry to provide a graphic illustration of airflow, or both nostrils simultaneously with active posterior rhinomanometry, but it does not tell the clinician where the site of obstruction lies. Interventions such as decongestants and rinses can be used and results measured with this device for short-term comparisons, patient education, and treatment progress.

Since the nose undergoes normal cycling, which changes the shape of the turbinates and thickness of the mucosa on a 2 – 3-hour timeframe, in addition to other variables such as gender, age, testing position (sitting vs. supine) and time of day, to name a few, using rhinomanometry for clinical decision-making may be imprecise, yet a valuable assessment tool across many specialties. Studies show a profound relationship between nasal resistance, posture, and treatment options for sleep disordered breathing.

What about using rhinomanometry to see if children have normal airflow? Hosseini et 1.

2.

3.

4.

5.

6.

7.

al, recently published “the correlations identified between anatomic data and pressure gradient have clinical implications in pediatric rhinology, suggesting that certain aspects of airway anatomy in infants and children can be predicted through the measurement of intranasal pressure gradient measured with rhinomanometry.”7 Acoustic rhinometry provides, using a sound wave, an accurate picture of nasal airway anatomy. This can show with precision where the airflow is most restricted.

Otorhinolaryngologists have found nasal endoscopy more useful for diagnosis. Using the camera while the patient is sedated is called Drug Induced Sleep Endoscopy, or DISE. There is much more to understand about how the nose works and the myriad benefits of nasal breathing. While the first breath of life is by necessity through the mouth, every breath after that one is best done through the organ designed for it – the nose. When you can influence your patients at every stage of life to breathe through their mouth as often as they eat through their nose, you are on the right track. Are you thinking about your own breathing? Feel anything different?

Hlastala MP, Woodson RD. Saturation dependency of the Bohr effect: interactions among H-+, CO2, and DPG. J Appl Physiol. 1975 Jun;38(6):1126-31. doi: 10.1152/jappl.1975.38.6.1126.

PMID: 237871.

Tanaka, Y., Morikawa, T., & Honda, Y. (1988, Oct. 1). An assessment of nasal functions in control of breathing. Journal of Applied Physiology, 65(4), 1520-1524. https://doi.org/10.1152/ jappl.1988.65.4.1520 Badr MS, Dingell JD, Javaheri S. Central Sleep Apnea: a Brief Review. Curr Pulmonol Rep. 2019 Mar;8(1):14-21. doi: 10.1007/s13665-019-0221-z. Epub 2019 Mar 13. PMID: 31788413; PMCID: PMC6883649.

Weitzberg, E., Lundberg, J.: Humming Greatly Increases Nasal Nitric Oxide. Am J Respir Crit Care Med 166(2):144-145, 2002.

Fabio Lisi, Alexander N. Zelikin, Rona Chandrawati: Nitric Oxide to Fight Viral Infections Adv Sci (Weinh) 2021 Apr; 8(7): 2003895. Published online 2021 Feb 9.

Zelano et al. • Human Limbic Respiratory Oscillations J. Neurosci., December 7, 2016 • 36(49):12448 –12467 Hosseini, S. Schuman, T. A. & Golshahi, L. (2021, June). correlations to estimate the key anatomical dimensions of pediatric nasal airways using minimally invasive measurements of intranasal pressure gradient. Journal of Aerosol Medicine and Pulmonary Drug Delivery, 34(3), 171-180. http://doi.org/10.1089/jamp.2019.1586

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Accu-Fit Dorsal®

Accu-Fit Herbst®

The DynaFlex® exclusive Accu-Fit™ material provides superior retention, exceptional patient comfort and is fully re-adaptable after dental restorations. DynaFlex® is the only US manufacturer offering a full line of FDA Cleared sleep devices with the Accu-Fit™ Material.

800.489.4020 | www.dynaflex.com 041321 © 2021 DynaFlex® , St. Louis, MO 63074. Printed in U.S.A. All rights reserved. *PATENT 10085877B2

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