Dental Applications Guide - Zephyr Sleep Technologies · Oral appliances that reposition the...

Dental Applications Guide

Table of Contents

2 Introduction

Welcome to MATRx™

Message to Dental Professionals

Acknowledgements

7 OSA Co-Morbidities

Prevalence of Sleep Apnea

Consequences of Untreated Sleep Apnea

Risk Factors and Clinical Features of Sleep Apnea

11 The MATRx™ System

Predicting Success with Oral Appliance Therapy

What is MATRx and How Does it Work?

MATRx Hardware

MATRx Software

OATRx™ – Scientifically-Validated, Proprietary Technology

15 MATRx™ Benefits

The Importance of MATRx in Dental Sleep Medicine

Oral Appliance Therapy – Without MATRx

Oral Appliance Therapy – With MATRx

MATRx Study Results

The Target Protrusive Position

What Dentists Are Saying About MATRx

19 Patient Selection and Tray Fitting

Who’s Right for a MATRx Study?

Fitting the MATRx Titration Trays

31 Using the MATRx™ Target Protrusive Position

Bite Registration and Appliance Fabrication

Appliance Fitting and Titration

Using the MATRx OAT Protocol

Decrease Chair Time and Fast-Track Titration to Target

Decrease Dental Costs

Follow-up Testing and Dental Assessment

37 Dental Case Studies

54 References

56 Customer Support

Information in this document is subject to change without notice.

Manufactured by: Zephyr Sleep Technologies Inc.610A – 70th Ave. S.E. Calgary, Alberta, Canada. T2H 2J6 1.877.341.8814www.zephyrsleep.com

OATRx™ and MATRx™ are trademarks of Zephyr Sleep Technologies Inc. All other trademarks are property of their respective holders. This product ismanufactured and sold under one or more of U.S. Patent No. 5,826,579 andother U.S. and foreign patents pending.

©2013 Zephyr Sleep Technologies Inc.

TM

3Introduction2 Introduction

Introduction

Soon after the recognition and understanding of sleep apnea, Colin Sullivan and co-workers discovered a miraculous therapy, nasal continuous positive airway pressure (CPAP).1 This uniformly efficacious and benign intervention allowed effective management of life-threatening disease. Unfortunately, the sleep-disturbing features of a competent facial interface, a tethering hose and air pressure distending the upper airway have proved distressing for many obstructive sleep apnea (OSA) patients, and poor adherence to therapy has limited the overall effectiveness of CPAP.2 One of the most important challenges presently facing the field of sleep medicine is finding satisfactory alternative therapies for OSA, which is now recognized to be one of the most prevalent diseases in industrialized countries.

Oral appliances that reposition the mandible constitute one of the most promising of known treatment alternatives for OSA. Protrusion of the mandible enlarges both the oropharynx and velopharynx by passive mechanisms (i.e. stretching soft tissues that attach to the pharyngeal walls).3 This mandibular movement can be readily accomplished by a dental appliance that applies a ventral force to the lower teeth and a dorsal force to the upper teeth, and such appliances have been found to successfully treat OSA. Lacking the cumbersome aspects of a CPAP apparatus and internally applied air pressure, oral appliances are often preferred by patients over nasal CPAP therapy, and adherence does not appear to be a major obstacle to therapeutic effectiveness.

Despite these advantages, oral appliance therapy (OAT) has not received widespread acceptance in sleep medicine and this can be attributed in large part to the uncertainty regarding efficaciousness in any particular patient (i.e. OAT reduces the apnea hypopnea index, AHI, to normal values in approximately 50 percent of cases).4 Apparently, the stretching of buccal and pharyngeal soft tissues does not always develop enough force on the pharyngeal walls to overcome the anatomical problem causing the obstruction. Clinical features (e.g. apnea hypopnea index, body mass index, airway anatomy by acoustic reflectance) and bony imaging (e.g. cephalometrics or CT scan) have not been shown to accurately predict success with OAT. Presumably, this is because these methods do not assess the underlying pharyngeal anatomic problem that causes the obstruction during sleep. This lack of uniform efficacy, from both a therapeutic and diagnostic perspective, highlights the need for a viable method to identify OSA patients who will be successfully treated by an appliance that protrudes the mandible. MATRx is a product that is designed to do exactly this; MATRx will, for the first time, allow sleep physicians to reliably predict the efficacy of mandibular advancement therapy in OSA patients and will provide a target protrusive position for this therapy.

Dr. John Remmers is a world renowned expert in the field of snoring and sleep apnea, being the first researcher to elucidate the pathogenesis of sleep apnea and to demonstrate that sleep apnea is caused by an anatomical narrowing of the pharynx.

As the Chief Medical Officer at Zephyr Sleep Technologies, Dr. Remmers leads the research, design and development for innovative products used in the diagnosis and treatment of obstructive sleep apnea. He is a pulmonologist and clinical professor of internal medicine at the University of Calgary and also has an active sleep practice in the sleep lab at the Foothills Medical Centre in Calgary, Canada which he founded in 1984.

Being a recognized pioneer and innovator in sleep medicine, Dr. Remmers has invented products ranging from portable diagnostic sleep monitors to auto-titrating CPAP devices and MATRx. Most notably, Dr. Remmers invented the first electronically controlled CPAP device, which was licensed to Healthdyne prior to its acquisition by Philips Respironics in 1997. In addition, Dr. Remmers’ long-standing relationship with Philips Respironics led to the development of many commercialized CPAP technologies, in particular the REMstar® Auto CPAP device, which uses a proactive algorithm to automatically adjust CPAP pressure based on patient need.

Dr. Remmers served two terms as the Editor-in-Chief of the Journal of Applied Physiology and has presented honorary research lectures to the American Thoracic Society, the American Physiological Society and American College of Chest Physicians. His research interests relate to the neurobiology of respiratory rhythmogenesis, chemoreception, and the pathophysiology of the control of breathing. Dr. Remmers has published over one hundred peer reviewed publications in the area of respiratory physiology.

John E. Remmers, MDChief Medical OfficerZephyr Sleep Technologies Inc.

5Introduction4 Introduction

Message to Dental Professionals

Dental Sleep Medicine is one of the fastest growing areas of dentistry with many dental practices now focusing on their patients’ overall health and wellness as well as their dental health and hygiene. Instead of being “tooth-focused” dentists, we are becoming “oral health” physicians.

The pioneers in dental sleep medicine have completed a substantial amount of work over the last 20 years, making valuable contributions to the ever growing body of scientific research supporting oral appliance therapy (OAT) for the treatment of obstructive sleep apnea (OSA). This has allowed us to build meaningful partnerships with sleep physicians and further demonstrate that OAT is an efficacious treatment option for our patients. Today, OAT is only being used in roughly 5% of the OSA population but research and AASM supported data shows that 50% of all OSA patients may be appropriate oral appliance candidates. Clearly we are well positioned to be a larger part of the OSA management team and to provide the benefits of OAT to our patients.

Historically, the most common concern or “hesitation” from the medical community regarding OAT is the uncertainty regarding therapeutic outcomes. In addition, the lack of a scientifically-validated OAT assessment process, that generates objective data, is preventing our AASM colleagues from supporting OAT as a viable alternative to CPAP and thereby limiting the growth of this therapy. Therefore, the OSA population today is predominantly a CPAP user community. As expected, CPAP reduces the number of apneas more effectively, especially in those patients with severe OSA, however we know that mandibular repositioning devices are sometimes tolerated better and self-reported compliance rates appear to be higher. Therefore given the trade-offs between efficacy and compliance, some researchers looking at the health outcomes of CPAP versus OAT are now recommending that both treatment modalities should be considered as acceptable first-line treatments, even in those suffering from severe OSA.

Given the increased interest in OAT as a viable treatment alternative to CPAP and as first-line treatment, the MATRx technology is well positioned to change how we approach OSA diagnosis and treatment – a critical step in the continued development of dental sleep medicine and the AASM Practice Parameters for OAT. Not only does MATRx enable us to confirm OAT candidacy in a single night, but it accurately identifies an effective target protrusion allowing us to quickly and efficiently provide therapy to our patients. I invite you to examine MATRx with your referring physician and consider how this tool can help meet the need for OAT within the OSA population.

Dr. Shouresh Charkhandeh is an advocate and practitioner of dental sleep medicine, which relies on the collaboration of a multidisciplinary team of Sleep Physicians, Sleep Dentists and many other healthcare professionals. He received his Doctor of Dental Surgery and Bachelor of Medical Sciences from the University of Alberta, Canada and earned his Fellowship from the Las Vegas Institute for Advanced Dental Studies.

As the Chief Dental Officer at Zephyr Sleep Technologies, Dr. Charkhandeh is a valuable member of the R&D team, dedicating research efforts to improving therapeutic outcomes with OAT by defining methods that can predict which patients will be successfully treated with an oral appliance. He has been instrumental in the research, development and release of the revolutionary product MATRx.

Dr. Charkhandeh is actively involved in research and improving practice parameters in his field. In 2012, being recognized by the American Academy of Dental Sleep Medicine (AADSM) for his outstanding research efforts, he received the Clinical Research Award. As a clinical instructor for the SomnoMed Academy and the Aurum Group, Dr. Charkhandeh presents dental sleep medicine courses throughout North America.He is a valued educator in his field and has lectured at AADSM Annual Meetings as well as those for the AASM and the IAO.

Currently, Dr. Charkhandeh maintains a group of private practices in Edmonton and Calgary, Alberta specializing in Dental Sleep Medicine, Temporomandibular Disorders (TMD) and advanced occlusal reconstructive cases. He is the Clinical Director at The Snore Centre, in Calgary, Canada whose multidisciplinary team offers personalized diagnostic and treatment services for snoring, obstructive sleep apnea and other sleep disorders.

Shouresh Charkhandeh, BMedSC, DDS, LVIFChief Dental OfficerZephyr Sleep Technologies Inc.

6 IntroductionOSA Co-M

orbidities

OSA Co-Morbidities

Acknowledgements

The MATRx system is available for use due to the collaborative efforts of Zephyr Sleep Technologies Inc. and the University of Calgary.

Zephyr Sleep Technologies Inc. would like to acknowledge the following individuals for the time they have contributed to the creation of this guide. We thank this professional team for their commitment to research and education and for their clinical expertise as it relates to the use and application of MATRx in the field of dental sleep medicine.

Shouresh Charkhandeh BMedSc, DDS, LVIF, Chief Dental Officer

Brenda Pettigrew RRT, Manager, Customer Support & Communications

John Remmers MD, Chief Medical Officer

7OSA Co-Morbidities

* male subjects only

Prevalence of Sleep Apnea*

Sleep apnea affects a significant portion of the population and it is estimated that 75-85% of sleep apnea sufferers remain undiagnosed.5 If not treated, they have a greater chance of being ill or being involved in traffic or work related accidents.

Prevalence of Sleep Apnea (in middle-aged adults) 5,6

• Non-symptomatic: 9% women, 24% men

• Symptomatic: 2% women, 4% men

• 1 in 15 have at least moderate sleep apnea

• 1 in 5 have at least mild sleep apnea

Prevalence of Sleep Apnea in Comorbidities 7-14

9OSA Co-Morbidities8 OSA Co-Morbidities

Risk Factors and Clinical Features of Sleep Apnea

Common misconceptions are the sleep apnea is a “male disease” and that only obese people suffer from sleep apnea. Although the stereotypical sleep apnea patient is middle-aged, overweight and male, anyone can suffer from this condition.

Given the increased prevalence of untreated sleep apnea and the associated comorbidities and health risks, dental sleep medicine professionals need to take an active role in screening their patient population for sleep apnea and referring these patients to a sleep lab for diagnosis.

Risk Factors

The risk factors for sleep apnea are very similar to those for hypertension and diabetes. If someone has more than one of the following risk factors, the likelihood of sleep apnea increases:

• Male gender

• Being older

• Smoking

• Family history of sleep apnea

• Anatomic abnormalities of the upper airway

• Excess weight

• Increased neck circumference

• Alcohol or sedative use

• Endocrine and metabolic disorders (e.g. diabetes, metabolic syndrome)

Clinical Features

Patients who present with some of the following symptoms or conditions and have some of the risk factors above have a higher chance of having sleep apnea:

Consequences of Untreated Sleep Apnea

Hypertension

• Sleep apnea is an independent risk factor for hypertension 15, 16

• Odds of developing hypertension increases with increased severity of OSA 17

• 43% of patients with mild OSA and 69% of patients with severe OSA have hypertension 18

Stroke and Cardiovascular Disease

• 65% of stroke patients have sleep-disordered breathing (SDB) 19

•Note:OSAaccountsforapproximately75%ofallSDBpatients

• Moderate to severe sleep apnea triples stroke risk in men 20

• 40-50% of strokes occur during the night or within one hour of waking 21

• 42% of deaths in people who had severe sleep apnea were caused by cardiovascular disease or stroke 22

• 76% of patients with congestive heart failure (CHF) have OSA 9

Type 2 Diabetes

• 48% of type 2 diabetic patients suffer from sleep apnea 12

• 86% of obese patients with type 2 diabetes have OSA 23

• OSA is associated with insulin resistance, independent of obesity 24

• OSA is independently associated with type 2 diabetes; as the severity of OSA increases, the risk of type 2 diabetes increases 25

• Increasing OSA severity is independently associated with poorer glucose control 26

Healthcare Utilization and Costs

• Prior to diagnosis, untreated sleep apnea patients utilized 23-50% more medical resources 27

• Undiagnosed moderate to severe sleep apnea may cause $3.4 billion in additional medical costs in the US 28

Motor Vehicle Accidents

Untreated sleep apnea patients are:

• 15 fold increase of being involved in a motor vehicle accident 29

• Treating drivers with sleep apnea would save $11.1 billion in collision costs and save 980 lives annually 30

• Excessive daytime sleepiness

• Snoring

• Nighttime gasping, choking, coughing

• Witnessed apneas

• Morning headaches

• Depression and irritability

• Short-term memory loss

• Difficulty concentrating

• Hypertension

• Type 2 diabetes

• Frequent nocturnal urination

• Impotence

10 OSA Co-Morbidities

The MATRx™ System

The MATRx System

11The MATRx System

Predicting Success with Oral Appliance Therapy

What is MATRx and How Does it Work?

MATRx is a medical device that combines the expertise of a sleep physician and a sleep dentist to accurately identify and successfully treat OSA patients with efficacious oral appliance therapy (OAT).

The MATRx system is used by the sleep tech, in a polysomnographic setting, to conduct a mandibular titration study on a patient diagnosed with OSA. The MATRx study is similar to the industry standard CPAP titration study, except the sleep tech monitors and manipulates mandibular position rather than CPAP pressure and mask fit. To begin, the sleep tech enters the patient’s OATRx Scale readings provided by the sleep dentist into the MATRx system. This ensures mandibular titration will be performed within the patient’s protrusive range. The patient’s MATRx Titration trays are then attached to the remotely controlled Mandibular Positioner which allows the sleep tech to titrate the position of the patient’s mandible, while they sleep, until the patient’s respiratory events (i.e. apneas and hypopneas) are eliminated.

The sleep physician evaluates the patient’s MATRx study results and is able to:

Confirm whether the patient will experience therapeutic success with a custom- fitted oral appliance.

Accurately determine the patient’s Target Protrusive Position (TPP), also known as the OATRx Number.

Refer all successful candidates to the sleep dentist with a prescription for OAT which includes their effective TPP.

1

2

3

13The MATRx System12 The MATRx System

MATRx™ Hardware

The MATRx System Components

• A Controller

• A remotely controlled Mandibular Positioner (MP) Note:TheMPandcablearelight,weighingalittlelessthan90grams(3oz)

• Set of MATRx Titration TraysNote:Traysareavailablein2sizes–mediumandlarge

The MATRx Titration Trays

Generally, a MATRx study lasts about 8 hours therefore it is important that the trays and impressions:

• Fit the patient comfortably

• Move easily within the patient’s range of motion

• Maintain adequate retention

Note:TheMATRxTitrationTraysareproprietaryimpressiontraysforusewiththeMATRxsystemandarenottobe used for any other purpose. The trays are designed for single patient multi-use for one study only.

MATRx™ Software

OATRx™ - Scientifically-Validated, Proprietary Technology

MATRx mandibular titration software, known as OATRx Titration Software (OATRx TS) is the ONLY scientifically-validated, proprietary, technology used by sleep physicians & dentists to accurately select OSA patients who will be responders to OAT. OATRx also determines the target protrusive position allowing dentists to treat their OSA patients efficiently and effectively with an oral appliance. The OATRx’s ingenuity is fully integrated into the software, driving the remote-controlled mandibular positioner, MATRx and all of Zephyr’s oral appliance titration products.

OATRx Technology, pioneered and developed by Dr. John Remmers and Zephyr’s research and development team, is based on 30 years clinical research, experience in the field of sleep medicine and an in-depth understanding of mandibular advancement and its impact on sleep architecture, during both REM and Non-REM sleep. Three prospective studies 31-33 have validated the MATRx technology and demonstrate that mandibular titration during sleep accurately predicts the efficacy of OAT, similar to that of CPAP titration. The knowledge gained from these studies has been invaluable in the refinement and improvement of the OATRx Technology.

Figure 1: The MATRx System

Figure 2: MATRx Titration Trays with impressionsFigure 3: MATRx Titration Trays placed for the patient’s MATRx Study

Figure 4: The OATRx Scale of the MATRx Titration TraysThe OATRx Scale is used by the sleep dentist to determine the mandibular measurements needed to conduct a MATRx study (i.e. Resting Position and Maximal Voluntary Protrusion).

14 The MATRx SystemM

ATRx ™ Benefits

MATRx™ Benefits

15MATRx™ Benefits

The Importance of MATRx™ in Dental Sleep Medicine

Oral Appliance Therapy - Without MATRx

Following the AASM guidelines for patient selection, the traditional approach for providing OAT has required regular visits to the sleep dentist’s office for appliance fitting and titration. Some of these patients will be effectively treated with the oral appliance, but up to 50% of patients will not 4. As a result the amount of time spent with each patient varies, however the more difficult cases can easily cost the dentist several hours of chair time over a 3-8 month period and require a follow-up study.

Oral Appliance Therapy - With MATRx

MATRx simplifies the process for both the patient and their dentist. Following a patient’s MATRx study, they return to the sleep dentist for appliance fitting and titration. Given the high predictive accuracy of MATRx, most (if not all) of these patients will be successful with therapy. In addition, knowing the patient’s TPP allows for immediate titration to this therapeutic position with effective therapy being achieved in as little as 30 days.

With MATRx you know that every oral appliance referralwill be successful with therapy.

• Have confidence in treatment outcomes

• Reduce multiple visits and chair time by starting at the MATRx TPP

• Eliminate appliance failures

• Prevent under and over-protrusion

• Improve patient satisfaction and compliance with treatment

• Expand your practice by offering a new therapy to improve patient health

MATRx provides you with an effective target protrusive position (TPP) for every patient allowing you to treat more patients, more effectively, and in less time.

17MATRx™ Benefits16 MATRx™ Benefits

The MATRx™ Study Results

For the first time in history of Dental Sleep Medicine, the sleep physician and the sleep dentist will be able to objectively record and evaluate each patient’s unique physiological response to mandibular protrusion and confirm if the patient’s OSA eliminates the patient’s airway obstruction, thereby treating the sleep apnea.

The MATRx Target Protrusive Position is the mandibular protrusive position that eliminates the patient’s airway obstruction, thereby treating the sleep apnea..

The sleep physician determines the patient’s target protrusive position (TPP), also known as the OATRx Number, when performing the MATRx study interpretation.

The OATRx Number will be used by the sleep dentist to fabricate the patient’s custom oral appliance to their therapeutic position.

What Dentists Are Saying About MATRx™

Figure 5: Hypnogram generated from a MATRx studyThe red highlighted area displays the mandibular titration performed during the MATRx study. The study output is known as the OATRx Number and generated from the OATRx titration software.

I have recently helped my local hospital’s Sleep Center implement the MATRx System for OAT evaluation. So called “non-responders” can be found before investing the time, money and energy into fabricating an appliance. Thank you Zephyr!

Dr. Rob Burwell Burwell Center for Better Sleep, Greater Los Angeles Area

When I ask sleep physicians why they prescribe C-PAP first when an oral appliance would be suitable I usually hear, “Because we don’t know if it will be therapeutic”, “because C-PAP is the gold standard,” “because, because, because.” An important part of Dental Sleep Medicine is working with the medical community. The MATRx affords a good relationship with a lab that puts the patient’s best interest and preferences at the forefront by providing confidence in the treatment of choice.

Dr. Erin Elliot DentalSleepMedicineSpecialistatSleepBetterNorthwest,Spokane,WashingtonArea

The MATRx study offers a clear advantage for patients and doctors by eliminating guess work in treating OSA with MRDs. We can quickly and efficiently determine optimal treatment parameters with the MATRx as part of our standard treatment protocol. Its use is imperative for anyone seeking a high quality treatment model.

Dr. Srujal Shah Bay Area Dental Surgery Center, San Francisco Bay Area

The MATRx system resolves one of the primary differences between PAP therapy and oral appliances.NolongerdoIhavetotellpatientsthatCPAPissuperiorduetotheabilitytotitrateinthelab....(MATRx)givesmemoresecurityandconfidencewhenIneedtoclosethegapbetweenthetwo best therapies in treating sleep disordered breathing.

Dr. Kent Smith Clinical Instructor at Six Month Smiles, Dallas/Fort Worth Area

MATRx has taken the guesswork out of the calibration process! We now know the exact position for efficacious oral appliance therapy! It is my professional opinion that incorporating the MATRx device into treatment protocol is the future of oral appliance therapy! It is a win-win for all involved with patient management! The sleep physician, dentist and patient can be confident that the disease has been properly managed!

Dr. John Tucker Partner at Tucker Dental Excellence LLC, Erie, Pennsylvania Area

“”

“”

“”

“

”

“

”

18 MATRx™ BenefitsPatient Selection

Patient Selection and Tray Fitting

19Patient Selection

Who’s Right for a MATRx™ Study?

Considering that oral appliances are often preferred over CPAP and compliance rates appears to be higher, 4 OAT only accounts for approximately 5% of the total OSA therapy. This is largely due to our inability to identify individuals within our patient population that will be effectively treated with an oral appliance and the uncertainty regarding the efficacy of OAT. MATRx removes these barriers to OAT acceptance and use therefore many sleep dental professionals are asking:

“How can I fit MATRx into my practice to better treat my OSA patients?”

There are many situations when a MATRx study would be applicable for OSA patients sourced from your own patient population or the sleep lab.

21Patient Selection20 Patient Selection

Considerations for MATRx Testing

Patient Preference for OAT

Ask your patients if they have a treatment preference. Now you can confidently support your patient’s choice for OAT, knowing that the results from the MATRx study will confirm whether the patient will be successfully treated with the oral appliance. In many cases, OAT can be considered as first-line treatment.

Global Fees for Reimbursement

In January 2012, Medicare established a global reimbursement fee for dentists treating OSA. Global fees paid by Medicare and other major payors necessitate an efficient protocol for selecting patients and titrating to optimal efficacy. Therefore the ability to expedite effective OAT in fewer patient visits will become increasingly more important to the dentist and their patient. The MATRx study ensures that the dentist is only treating patients that will be successful with OAT therefore preventing OAT failures and the associated follow-up costs. In addition, MATRx provides an effective target protrusive position for each OAT patient resulting in decreased chair time for OA titration when compared to traditional titration practices.

MATRx Contraindications

The MATRx device is contraindicated for use in patients who:

• Have central sleep apnea

• Have severe respiratory disorders

• Have loose teeth or advanced periodontal disease

• Have full dentures or dental implants

• Are under the age of 18

AHI & BMI as Predictors of OAT Efficacy

In a review of the literature, 4 the success rates for OAT in patients with mild to moderate OSA were better than those classified as severe. However, comparison between these studies was difficult due to variations in the definition of success and in overall study design. A higher BMI was associated with lower OAT efficacy however this was not seen in all studies. We can conclude that AHI and BMI are not reliable predictors of OAT efficacy. In the most recent MATRx clinical trial, 33 baseline AHI, BMI and positional dependence of AHI did not predict therapeutic outcome (see results in Figure 6). Therefore, it may be reasonable to consider most OSA patients for OAT unless there are known contraindications to MATRx testing.

OAT Candidacy

The sleep dentist should review the patient’s medical history and/or referral information when determining the suitability of a patient for OAT. Oral appliances are contraindicated in patients who have:

• Limitations that will affect their ability to care for and use an oral appliance

• Limited range of motion

• Active, uncontrolled temporal mandibular joint (TMJ) disease

• Short teeth or insufficient number of teeth per arch and quadrant (if tray retention will be effected)

• Faulty or poor restorations that may become worse with tray use

• Allergies to metals or plastics

• Insufficient undercuts to retain the oral appliance

Figure 6: Results from the MATRx clinical trial, SLEEP 2013. The effect of OAT at the final protrusive position for each subject in relation to their BMI. The shaded area denotes the generalized guidelines for OAT based on a patient’s baseline AHI and BMI.


Fitting the MATRx™ Titration Trays Recording the Tray’s Reference Number

The tray’s edge-to-edge position is known as the Reference Number.

The Reference Number is determined by accurate alignment of the incisal grooves on the mandibular and maxillary trays. Once aligned, the reference number is the OATRx Scale reading at that position.

The Reference Number will assist the sleep dentist when converting the patient’s prescribed TPP (OATRx Number) to a protrusive setting for appliance fabrication (see page 31).

It is important to record the tray’s Reference Number before trimming the trays or taking impressions.

Figure 9: Confirming the Titration Tray’s Reference NumberIn this example, the tray’s Reference Number is 10mm.

Selecting the Proper Tray Size

The patient’s tray size should be determined before taking impressions.

Trays are available in 2 sizes, medium and large, and each set consists of an upper tray and a lower tray.

The size and orientation of each tray is indicated by a label located on the distal end of each tray. For example, a MU indicates a medium upper tray; a LL indicates a large lower tray.

Figure 7: A medium lower tray Figure 8: Correct tray size

Select the smallest tray that:

• Fits well around the teeth, without binding or fitting loosely

• Minimizes encroachment of the lingual space

• Prevents any discomfort from gingival or soft tissue impingement

• Allows the patient to comfortably achieve maximum protrusion

1

2

3

In cases where the sleep dentist trains a dental assistant or healthcare professional to fit the MATRx Titration Trays, the patient must complete a pre-screening questionnaire and consent form to rule out any conditions that may:

Preclude the trained professional from fitting the trays

Impact the ability of the patient to use the trays and

Prevent the patient from being effectively treated with an oral appliance.

If any of these conditions exist, the patient must be referred to the sleep dentist for assessment and tray fitting.

PleasevisitZephyr’sYouTubesiteforinstructionalvideosonMATRxTitrationTrayusewww.youtube.com/zephyrsleep.


Adjusting Tray Length

• In each quadrant, the ends of each tray should not extend beyond the last half of the most posterior tooth.

• For trays that are too long (i.e. extending behind the last half of the most posterior tooth), use scissors (e.g. crown & bridge) or a scalpel to trim the molar ends to the correct length.

Figure 10: Correct tray length

Each tray should be assessed for adjustments that may be required in length and width.

Figure 11: Trim Lines

• Trim lines on the trays will help to guide trimming.

• After trimming is complete, ensure any sharp edges have been removed before placing the trays back in the patient’s mouth.

Adjusting Tray Width

• A heat torch can be used to soften the tray material to allow for easy bending and adjustment of the tray.

• By applying heat directly to the retention grooves located on the proximal end of each tray, they can be widened or narrowed as desired

• Place the trays on a flat surface after all adjustments have been made to ensure they are not bent or distorted as this will interfere with proper tray movement during MATRx titration

Before taking impressions, place the tray back into the patient’s mouth to ensure optimal patient comfort and tray fit.

Figure 12: Heat torch being used to soften tray material

In cases where the trays are too wide or narrow to fit the patient’s dental arch, the width of each tray can be adjusted.


Impression Procedure

Take the Maxillary Impression First

• Fill the upper tray with impression material and place onto the maxilla

• Ensure the incisors are positioned midline and deep within the tray’s Incisal Groove

• Push the tray firmly around the teeth

• Place your fingers on the cuspid region when applying force to the tray. This will prevent “over-tilting” of the tray in the posterior region and ensure proper tray positioning.

• Allow the impression material to set (i.e. 30 seconds) and then slowly remove the upper tray, verifying adequate retention

Trim the Upper Impression

• Trim and polish excess impression material from the upper tray

Check Fit and Comfort

• Connect the upper tray, with trimmed impressions, to the lower tray and ensure both trays slide back and forth easily

• Place both trays in the patient’s mouth to confirm tray fit and patient comfort

• Ask the patient to gently bite into the lower tray to ensure the proper placement of the lower anterior teeth within the tray’s Incisal Groove

• Remove both trays from patient’s mouth, verifying adequate retention of the upper tray

Figure 13: Henry Schein®Blu-Bite Fast Set

Figure 14: Incisal Groove on upper tray

Figure 15a 15b: Taking the maxillary impression

Figure 16a 16b: Trimmingupper tray impression

Figure 17: Trimmed upper tray impression

Figure 18: Trimmed upper tray connectedto lower tray

Figure 19: Checking fit of trimmed upper tray

Figure 20a 20b: Taking the mandibular impression

Take the Mandibular Impression

• With the trays connected, fill the lower tray with impression

material to prepare for taking the mandibular impression

• Place the upper tray first

• Ask the patient to gently bite into the lower tray (now filled with impression material). This will ensure the maxillary- mandibular relationship is correct and the lower teeth are properly positioned in the Incisal Groove while minimizing any unwanted mandibular torque.

• Allow the impression material to set (i.e. 30 seconds) and then slowly remove the trays, verifying adequate retention

Trim and Polish Both Impressions

• Trim and polish excess impression material from the lower tray

• After trimming is complete, connect the upper tray to the lower tray and ensure both trays slide back and forth easily and all surfaces are smooth

Check Fit, Comfort, Function and Retention

• Place the trimmed trays back into the patient’s mouth to check patient comfort, tray fit, ease of tray movement and retention. If the trays do not fit properly or the patient complains of discomfort check for the following:

• Excess impression material on the trays

• Sharp tray surfaces from tray trimming

• Teeth undercuts that may be in the way

Figure 21: Trimmed and polished tray impressions

Figure 22: Checking function of trimmed trays and impressions

Figure 23: Checking tray midlines

Figure 24: Checking tray fit

1

2

3

4

5

6


Impression Tips

• Use only Henry Schein® Blu-Bite HP Fast Set impression material

• Always take the maxillary impression first

• When placing the trays in the patient’s mouth, ensure the flat surface of the tray is parallel to the Camper’s plane, using the ala-tragus line as a reference. This will ensure proper tray fit and allow for easy mandibular movements during MATRx titration.

• Use the tray’s Incisal Grooves to:

• Position the patient’s upper and lower incisors in the center of the trays

• Aid in midline positioning

• Ensure adequate bite depth (i.e. incisors should be touching the flat surface of the Incisal Groove’s gap)

• Correct midline positioning will prevent improper protrusion of the patient’s mandible during the MATRx study (caused by misalignment), ensure accurate MATRx study results and optimize patient comfort. In regards to midline positioning:

• Ensure the tray midline matches the patient’s facial midline, especially in patients with craniofacial abnormalities

• Place the patient’s upper and lower dental midlines in the position that will be used to fabricate the patient’s oral appliance. This must be determined by the dentist based on their clinical knowledge and bite-technique, the patient’s craniofacial characteristics and oral appliance. TMJ health, and any other relevant factors.

• Since the duration of the MATRx study can be up to 8 hours, proper trimming and polishing of the trays and impression material will:

• Maximize space for the tongue

• Ensure the trays will slide back and forth easily

• Maximize tray comfort

• Prevent tissue impingement and ensure maximum protrusion

• Prevent injury and discomfort from sharp edges

• In regards to trimming of the impression material:

• Do not over-trim material from the retention grooves

• Trimming of the vestibular edges is generally not required since this excess impression material should make the trays more comfortable

• Ensure the back of the impression is trimmed flush with the molar ends of the tray

Figure 25:Resting Position is 13mm

Measurement #1: Resting Position

• Ask the patient to establish their most comfortable bite or resting position. Once comfortable, record the measurement from the OATRx Scale.

Measurement #2: Maximum Voluntary Protrusion

• Ask the patient to protrude their mandible as far as possible and record the measurement from the OATRx Scale

• In cases when the measurement (e.g. 22mm) is greater than the last number on the OATRx Scale, which is 20mm, record 20 for the patient’s Maximum Voluntary Protrusion

Figure 26: Maximal Voluntary Protrusion is 19mm

1

2

Taking the OATRx™ Scale Readings

The OATRx Scale readings are mandibular measurements recorded from the tray’s OATRx Scale. These measurements ensure the patient’s MATRx titration starts at a comfortable position and is conducted within their maximum protrusive range.

• Place the trays and impressions back into the patient’s mouth

• Instruct the patient to relax their jaw muscles by performing range of motion exercises with the lower mandible

• Have the patient repeat the procedure a few times to ensure maximum protrusion has been reached and the measurements are reproducible

• Record these readings in the patient’s dental chart and on the Patient Assessment Card, which will be given to the sleep lab

Note:Athirdmeasurement(i.e.FullRetrusion),canbetakentocomparethepatient’srangeof motion recorded with the OATRx Scale to that recorded with a bite registration device. If there is a difference, it is likely that the trays have not been trimmed adequately and the extra material is interfering with the patient’s ability to maximally protrude and/or retrude. Therefore, check the trays, refit and repeat the patient’s measurements.

Figure 27a 27b: Preparing the trays for the Sleep Lab

3 Prepare the Trays for the Sleep Lab

• Rinse the trays under tap water, dry the trays and place them in the tray case

• Place the tray case in the box along with the patient’s Assessment Card

30 Patient SelectionUsing M

ATRx ™ Results

Using The Matrx™ Target Protrusive Position

31Using MATRx™ Results

Bite Registration and Appliance Fabrication

After receiving the patient’s oral appliance prescription, including the OATRx Number (i.e. target protrusive position), you will need to use this number, representing a mandibular position (in millimeters) to determine a bite registration for fabrication of the custom-fitted oral appliance.. Each patient’s target protrusive distance is unique which means you will need to determine the best management strategy for each patient based on their OATRx Number.

Option #1 - Using the MATRx Trays for the Bite Registration

MATRx titration trays can be used for the bite registration provided they have been approved by a sleep dentist prior to fabrication of your patient’s oral appliance. Simply provide the manufacturer with the patient’s MATRx trays and their prescribed OATRx Number. This is the preferred approach as it minimizes chair time and patient visits.

Option #2 - Using a Bite Registration Device

Some sleep dentist’s may prefer to use a bite registration device (e.g. George Gauge, Andra Gauge) to determine their patient’s bite. In this approach, the patient’s prescribed OATRx Number must be converted to a target protrusion for appliance fabrication.

Use one of the following conversion methods:

1

2

33Using MATRx™ Results32 Using MATRx™ Results

Appliance Fitting and Titration

The Problem

With OAT reimbursement being guided by stricter CMS guidelines, in-network contracts and global fee schedules, there is significant pressure on sleep dentists to provide effective OAT in less time and with less economic benefit. So it is more important now, than ever before, to ensure sleep dentists are treating the right OSA patients with OAT in order to minimize treatment failures and lengthy titration periods.

Current estimates of patient success with OAT suggest that 20-40% of OAT patients will experience difficulty with OA titration and will not achieve therapeutic success. This patient group is generally unsatisfied with treatment and cause the chair times associated with OA titration to be higher than needed. The titration process can stretch on for months and negatively impact the perception of OAT efficacy with patients, primary care physicians and sleep physicians.

The Solution

Using MATRx, every referral from the sleep physician will be a successful OAT candidate and the prescribed TPP will ensure OAT can be provided efficiently and effectively. With this objective data, dentists providing OAT should realize increased economic benefits.

Using the MATRx OAT Protocol

One of the major dental benefits of MATRx is knowing each patient’s TPP prior to appliance fabrication and fitting. Based on the patient’s history and degree of mandibular protrusion needed to treat their OSA, the sleep dentist will decide how quickly the patient can be titrated to their TPP. In many cases, the patient’s mandible can be moved immediately to the prescribed TPP. In cases when the patient’s TPP is approaching their maximum protrusive position, the sleep dentist may choose to fit the appliance 2-3mm behind (i.e. more retrusive) the TPP and gradually move to the prescribed TPP over a few visits. Ensure the patient is aware that becoming accustomed to their appliance may take time and this is normal.

When determining the best strategy for titration, consider the following:

• Prescribed TPP relative to maximum voluntary protrusion

• Patient comfort

• Complicating factors (e.g. history of TMD, muscle pain, etc.)

• Relevant medical history and urgency in achieving efficacious OAT

• Medical and dental side effects or complications if titration to TPP is delayed (e.g.xx)

• Patient/sleep physician expectations regarding OAT and timeline

• Your preferred method of practice

To better understand the therapeutic and economic benefits MATRx provides to dental sleep medicine professionals and OSA patients, let’s compare use of the Traditional OAT Protocol (without MATRx) with the MATRx OAT Protocols (Figure 28, Figure 29).

35Using MATRx™ Results34 Using MATRx™ Results

Decrease Chair Time and Fast-Track Titration to Target

In this comparison, sleep dentists using a MATRx OAT Protocol are able to decrease the time needed to provide effective OAT to their OSA patients by up to 50%. In addition, the patient will be treated at their therapeutic position sooner (in as little as 30 days).

Figure 28: A comparison of the Traditional OAT Protocol and the MATRx OAT Protocols. The MATRx OAT Protocols vary as a result of the professional performing the MATRx Titration Tray fitting (sleep dentist or non-dentist).

Decrease Dental Costs

In this comparison, sleep dentists using a MATRx OAT Protocol are able to decrease the costs associated with providing oral appliance therapy to their OSA patients. The revenue generated per OA fitting will vary depending on the reimbursement model being used.

Figure 29– Table of economic costs associated with the provision of OAT. These are estimates only. The chair time cost is calculated using a fee of $300/hour.

36 Using MATRx™ Results

Follow-up Testing and Dental Assessment

The desired outcome of OAT includes the resolution of the clinical signs and symptoms of OSA and the normalization of the apnea-hypopnea index (AHI) and blood oxygen level.

When follow-up testing is determined to be appropriate, a polysomnographic study is the gold standard. When a polysomnographic study is not available, a portable sleep recorder can be used. In these situations, we recommend using an AASM compliant sleep recorder with the oxygen desaturation percentage set to the same desaturation percentage recommended in the hypopnea rule used for scoring.

• For hypopnea scoring using Rule 4-A (recommended), use a sleep recorder with the oxygen desaturation percentage set at 4%.

• For hypopnea scoring using Rule 4-B, use a sleep recorder with the oxygen desaturation percentage set at 3%.

Once OA efficacy has been shown, the patient should return to the sleep dentist every 6 months for the first year and at least annually thereafter. The purpose of dental follow-up is to:

• Monitor therapy compliance

• Evaluate the Integrity of the appliance

• Evaluate the patient’s dental/oral health

• Assess and monitor the patient for any signs/symptoms of TMD, tooth movement or other side effects

• Assess the patient for signs and symptoms of ineffective OAT (i.e. excessive daytime sleepiness, reports of snoring, high blood pressure, etc.)

Dental Case Studies

Dental Case Studies

37Case Studies

Case Studies

The cases presented in this section represent a typical OSA demographic (i.e. mild to severe OSA with a wide range of BMIs). Each case review includes the following:

• Patient Profile

• Dental Assessment

• MATRx Study Analysis

• Mandibular Titration Summary

• MATRx Study Interpretation

• Therapeutic Outcome

Each case demonstrates the clinical utility of the MATRx study and confirms that the clinical features traditionally used to predict OAT success or failure (i.e. low BMI, high AHI, airway anatomy) may not always be reliable indicators.

The cases also demonstrate application of the MATRx Interpretive Criteria considering the patient’s sleep state and body position.

Hypnogram Legend

Each case study hypnogram is marked with a variety of color-coded windows to clearly identify and differentiate periods of time, during the MATRx titration study, when the patient’s degree of mandibular protrusion is effective or ineffective in reducing or eliminating apneas and/or hypopneas. In addition, each color-coded window also identifies the patient’s sleep state and body position during this same period.

The following colors and textures build the components of the hypnogram legend:

• Sleep state—REM (green) or NREM (orange)

• Body position—supine (solid texture) or lateral (hatched texture)

• Mandibular protrusion—effective (green border) or ineffective (red border)

Effective Protrusion

REM supine

REM lateral

NREM supine

NREM lateral

Ineffective Protrusion

REM supine

REM lateral

NREM supine

NREM lateral

38 Case Studies

Predicted Successes

Predicted Successes

39Case Studies

√ Predicted Success

A MATRx study is considered to be a predicted success when:

• Protrusion of the patient’s mandible, during REM sleep, results in the reduction or elimination of apneas and/or hypopneas, as specified in the MATRx Interpretive Criteria

41Case Studies40 Case Studies

Case 1 - Underweight Patient with Severe OSA

This case reveals that some patients with severe sleep apnea can be successfully treated with OAT, in combination with postural therapy, and that only modest mandibular protrusion may be required.

Patient Profile

• 56 year old female

• Pre-study AHI = 34.4

• BMI = 18.3

• Confirmed side sleeper

MATRx Study Analysis During the study, the patient slept reasonably well (sleep efficiency = 77.5%) but displayed little REM sleep (5.2%). No REM supine was sampled despite sleeping supine most of the night. Two REM cycles were observed in the lateral position. The arousal index was 22.4. Arterial oxyhemoglobin saturation was normal throughout the study, except for periods of mild desaturation during REM sleep. No periodic limb movements were observed. Effective mandibular protrusion was observed in both REM lateral periods (Intervals 2 and 4) and the NREM supine period (Interval 3).

Mandibular Titration Summary

Interval 1

NREM cycle; 30 minutes

SUPINE position

Ineffective protrusion » mandibular position 11.8–12.2mm

Interval 2

REM cycle; 12.5 minutes

LATERAL position

Effective protrusion » mandibular position 12.2–12.6mm

MATRx Study Interpretation

• Prediction: Patient is a predicted success in the lateral position

• OATRx Number (Target Protrusive Position): 15.0mm

Therapeutic Outcome

The patient was fitted with a SomnoDent® oral appliance adjusted immediately to the target protrusive position (80% protrusion). A therapeutic outcome study, with the appliance set at this position, revealed a decrease in the AHI to 7.8 with no reported side-effects or discomfort associated with appliance use.

Dental Assessment (OATRxscalereadingsfortitrationstudy)

• Lower Limit (Resting Position) = 10.0mm

• Upper Limit (Maximum Protrusion) = 16.0mm

Interval 3


SUPINE position


Interval 4

REM cycle; 3 minutes

LATERAL position

Effective protrusion » mandibular position 15.6mm

Upper Limit (Maximum Protrusion)Lower Limit (Resting Position)


Case 2 - Obese Patient with Severe OSA

This case reveals that in the presence of both obesity and severe sleep apnea, each thought to impede the response to mandibular protrusion, some patients can achieve an excellent response to a mandibular advancement device. Moreover, such a response can occur well short of the patient’s upper limit for mandibular protrusion.

Patient Profile



• BMI = 32.3

MATRx Study Analysis During the study, the patient slept reasonably well (sleep efficiency = 82%) and displayed fairly normal sleep architecture with three REM cycles observed; two in the supine position. The arousal index was 20.3. Arterial oxyhemoglobin saturation was normal throughout the study. One 40 minute episode of periodic limb movements was observed. Effective mandibular protrusion was observed in the NREM lateral period (Interval 1) and both REM supine periods (Intervals 3 and 4).


Interval 1


LATERAL position


Interval 2


LATERAL position

Ineffective protrusion » mandibular position 12.4mm


• Prediction: Patient is a predicted success in the supine position


Therapeutic Outcome

The patient was fitted with a SomnoDent® oral appliance adjusted immediately to the target protrusive position (65% protrusion). A therapeutic outcome study, with the appliance set at this position, revealed a decrease of the AHI to a normal value of 4.0 with no reported side-effects or discomfort associated with appliance use.




Interval 3


SUPINE position


Interval 4


SUPINE position




Case 3 - Obese Patient with Moderate OSA

This case reveals that in some OSA patients, sleeping in the supine position can dramatically increase airway collapsibility and the occurrence of apneas and hypopneas. In addition, this case demonstrates the utility of the OATRx number in confirming that minimal mandibular protrusion can result in efficacious OAT. This patient was successfully treated by simply stabilizing the mandible at a position 2 mm greater than (i.e. more protrusive) than the patient’s resting position. Without this knowledge, OAT may have been initiated at a position that resulted in overprotrusion.

Patient Profile



• BMI = 34.3

• Confirmed side sleeper

MATRx Study Analysis During the study, the patient slept predominately in the lateral position. She slept reasonably well (sleep efficiency = 76.9%) and displayed a somewhat disordered sleep architecture with two REM cycles observed. One full REM cycle was observed near the end of the study; no REM supine was observed. Arterial oxyhemoglobin saturation was normal throughout the study, except for periods of mild desaturation during REM sleep. The arousal index was 15.0. A two hour period of periodic limb movements was observed during the first half of the night. Effective mandibular protrusion was observed in the NREM lateral period (Interval 1) and the REM lateral period (Interval 2). In Interval 3, we can clearly see the effect of body position on airway collapsibility, despite titrating to the patient’s upper limit (i.e. maximum protrusion).



• Prediction: Patient is a predicted success in the lateral position with minimal protrusion


Therapeutic Outcome

The patient was fitted with a SomnoDent® oral appliance adjusted immediately to the target protrusive position (20% protrusion).. A therapeutic outcome study, with the appliance set at this position, revealed a decrease in the AHI to 5.2. The patient reported slight discomfort in the right temporomandibular joint (TMJ) which was managed by morning repositioning exercises. The TMJ discomfort resolved in 6 weeks.




Interval 1


LATERAL position

Effective protrusion » mandibular position 15.0mm (Lower Limit)

Interval 2


LATERAL position


Interval 3


SUPINE position

Ineffective protrusion » mandibular position 17.2–21.0mm (Upper Limit)


46 Case Studies

Predicted Failures

Predicted Failures

47Case Studies

Predicted Failure

A MATRx study is considered to be a predicted failure when:

• The patient’s upper limit (i.e. maximum protrusion) has been reached and apneas and/or hypopneas continue at a rate greater than specified in the MATRx Interpretive Criteria

• Central events are observed and continue despite mandibular retrusion

X


Case 4 - Obese Patient with Moderate OSA

This case reveals that some patients with moderate sleep apnea can fail to experience an efficacious response to OAT, despite protruding the mandible to the patient’s upper limit (i.e. maximum protrusion).

Patient Profile

• 76 year old male


• BMI = 32.0

MATRx Study Analysis During the study, the patient slept reasonably well (sleep efficiency = 83.8%) but had a high arousal index (48.1). Three REM cycles were observed; one in the supine position. Arterial oxyhemoglobin saturation was normal throughout the study, except for periods of mild desaturation during REM sleep. Numerous periodic limb movements were recorded during the night, including during REM sleep. Effective mandibular protrusion was not achieved in REM supine (Interval 3), despite titrating to the patient’s upper limit (i.e. maximum protrusion). Effective mandibular protrusion was only observed in NREM periods in the supine position (Interval 2) and the lateral position (Interval 4).



• Prediction: Patient is a predicted failure

Therapeutic Outcome

The patient was fitted with a SomnoDent® oral appliance adjusted to 70% of the patient’s full protrusive position. A therapeutic outcome study, with the appliance set at this position, revealed an increase in AHI to 20.8 compared to a pre-study AHI of 17.9. A repeat therapeutic outcome study, at maximum protrusion failed to further reduce the patient’s AHI.




Interval 1


LATERAL position

Ineffective protrusion » mandibular position 12.4–15.0mm

Interval 2


SUPINE position

Effective protrusion » mandibular position 19.0mm (Upper Limit)

Interval 3


SUPINE position

Ineffective protrusion » mandibular position 19.0mm (Upper Limit)

Interval 4


LATERAL position

Effective protrusion » mandibular position 14.9mm–16.5mm

Interval 5


LATERAL position

Ineffective protrusion » mandibular position 16.5–19.0mm (Upper Limit)



Case 5 - Overweight Patient with Moderate OSA

This case reveals that some patients with moderate sleep apnea, who are known supine sleepers, can fail to experience an efficacious response to OAT despite protruding the mandible to the patient’s upper limit (i.e. maximum protrusion). In this case, the patient was unwilling to sleep in the lateral position and slept supine all night.

Patient Profile

• 55 year old male


• BMI = 27.1

MATRx Study Analysis During the study, the patient slept well (sleep efficiency = 87.2%), but had a somewhat elevated arousal index (30.0). The patient slept in the supine position all night with only two REM cycles observed. Arterial oxyhemoglobin saturation was normal throughout the study, except for periods of mild desaturation during REM sleep. No periodic limb movements were recorded. Effective mandibular protrusion was not achieved in either period of REM supine (Intervals 1 and 2), despite titrating to the patient’s upper limit (i.e. maximum protrusion).


Interval 1


SUPINE position

Ineffective protrusion » mandibular position 13.9mm–16.1mm


• Prediction: Patient is a predicted failure

Therapeutic Outcome

The patient was fitted with a SomnoDent® oral appliance adjusted to 70% of the patient’s full protrusive position. A therapeutic outcome study, with the appliance set at this position, revealed a reduction of the AHI to 14.6. A repeat therapeutic outcome study, at maximum protrusion failed to reduce the patient’s AHI significantly.




Interval 2


SUPINE position

Ineffective protrusion » mandibular position 16.0mm–18.0mm (Upper Limit)



Case 6 - Obese Patient with Mild OSA

This case reveals that in some OSA patients, mandibular protrusion may paradoxically increase airway collapsibility and promote the occurrence of apneas and hypopneas. In this patient with mild sleep apnea, titration to maximum protrusion resulted in an increased number of observed apneas and hypopneas.

Patient Profile



• BMI = 30.5

MATRx Study Analysis During the study, the patient slept reasonably well (sleep efficiency = 70.8%), but had an elevated arousal index (37.3). Three REM cycles were observed; two occurring near the end of the study in the supine position. Arterial oxyhemoglobin saturation was normal throughout the study, except for periods of mild desaturation during REM sleep. No periodic limb movements were recorded. Effective mandibular protrusion was not achieved in REM supine (Interval 3), despite titrating to the patient’s upper limit (i.e. maximum protrusion). Effective mandibular protrusion was only observed in a period of NREM lateral (Interval 1) and in a brief period of REM lateral (Interval 2).



Prediction: Patient is a predicted failure

Therapeutic Outcome

The patient was fitted with a SomnoDent® oral appliance adjusted to 70% of the patient’s full protrusive position. A therapeutic outcome study, with the appliance set at this position, revealed an increase in AHI to 24 compared to a pre-study AHI of 11.5.




Interval 1


LATERAL position


Interval 2


LATERAL position


Interval 3


SUPINE position

Ineffective protrusion » mandibular position 12.0mm (Upper Limit)


55References54 References54

References

1. Sullivan CE, Issa FG, Berthon-Jones M, Eves L. Reversal of obstructive sleep apnea by continuous positive airway pressure applied through the nares. Lancet 1981; 1 (8225): 862-5.

2. McArdle N, Devereux G, Hassan H, Engelman HM, Mackay TW, Douglas NJ. Long-term use of CPAP therapy for sleep apnea/hypopnea syndrome. Am J Respir Crit Care Med 1999; 159: 1108-14.

3. Isono S, Tanaka A, Sho Y, Konno A, Nishino T. Advancement of the mandible Improves velopharyngeal airway patency. J Appl Physiol 1995; 79(6): 2132-8.

4. Ferguson KA, Cartwright R, Rogers R, Schmidt-Nowara W. Oral appliances for snoring and obstructive sleep apnea: A review. SLEEP 2006; 29(2); 244-62.

5. Young T et al. Risk factors for obstructive sleep apnea in adults. J Am Med Assoc 2004; 291 (16): 2013-16 and Young T et al. Estimation of the clinically diagnosed proportion of sleep apnea syndrome in middle-aged men and women. Sleep 1997; 29(9): 705-6.

6. Young T et al. The occurrence of sleep-disordered breathing among middle-aged adults. New Engl J Med 1993; 328(17): 1230-5.

7. Logan AG et al. High prevalence of unrecognized sleep apnea in drug-resistant hypertension. J Hypertens 2001; 19(12): 2271-7.

8. O’Keeffe T, Patterson EJ. Evidence supporting routine polysomnography before bariatric surgery. Obes Surg 2004; 14: 23-36.

9. Oldenburg O et al. Sleep-disordered breathing in patients with symptomatic heart failure: A contemporary study of prevalence in and characteristics of 700 patients. Eur J Heart Fail 2007; 9: 251-7.

10. Garrigue et al. High prevalence of sleep apnea syndrome in patients with long-term pacing. Circulation 2007; 115: 1697.

11. Gami AS et al. Association of atrial fibrillation and obstructive sleep apnea. Circulation 2004; 110: 364-7.

12. Einhorn D et al. Prevalence of sleep apnea in a population of adults with type 2 diabetes mellitus. Endocr Pract 2007; 13(4): 355-62.

13. Sjostrom C et al. Prevalence of sleep apnoea and snoring in hypertensive men: A population based study. Thorax 2002; 57: 602-7.

14. Schafer H et al. Obstructive sleep apnea as a risk marker in coronary artery disease. Cardiology 1999; 92(2): 79-84.

15. 15. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC&). NIH Publication No. 04-5230. August 2004.

16. Nieto FJ et al. Association of sleep-disordered breathing, sleep apnea, and hypertension in a large community-based study. J Am Med Assoc 2000: 283(14): 1829-36.

17. Peppard P et al. Prospective study of the association between sleep-disordered breathing and hypertension. New Engl J Med 2000; 342: 1378-84.

18. Young et al. Sleep disordered breathing and mortality: Eighteen year follow-up of the Wisconsin Sleep Cohort. SLEEP 2008: Vol 31 No 8.

19. Lloyd-Jones D et al. Heart disease and stroke statistics – 2010 update: A report from the American Heart Association. Circulation 2010; 121: e46-e215.

20. Redline et al. Obstructive sleep apnea-hypopnea and incident stroke: the Sleep Heart Health Study. Am J Resp Crit Care Med 2010: 182; 269-77.

21. Dyken M et al. Investigating the relationship between stroke and obstructive sleep apnea. Stroke 1996; 27(3): 401-7.

22. Logan AG et al. High prevalence of unrecognized sleep apnea in drug-resistant hypertension. J Hypertens 2001; 19(12): 2271-77.

23. Foster GD et al. Obstructive sleep apnea among obese patients with type 2 diabetes. Diabetes Care 2009; 32 (6); 1017-19.

24. Punjabi NM et al. SDB and insulin resistance in middle-aged and overweight men. Am J Respir Crit Care Med 2002; 165: 677-82.

25. Botros N et al. OSA as a risk factor for type 2 diabetes. Am J Med 2009; 122: 1122-27.

26. Aronsohn RS et al. Impact of untreated obstructive sleep apnea on glucose control in type 2 diabetes. Am J Respir Crit Care Med 2010; 181: 507-13.

27. Smith et al. What are the obstructive sleep apnea patients being treated for prior to this diagnosis? Chest 2002: Jan; 121(1); 164-72.

28. Kapur V et al. The medical cost of undiagnosed sleep apnea. Sleep 1999; 22(6): 749-55.

29. Horstmann S. et al. Sleepiness-related accidents in sleep apnea patients. Sleep 2000; 23(3): 383-89.

30. Cistulli P et al. Treatment of snoring and OSA with mandibular repositioning appliances. Sleep Med Reviews 2004, Vol 8, Issue 6: 427-99.

31. Tsai WH, Vazquez JC, Oshima T, Dort L, Roycroft B, Lowe AA, Hadjuk E, Remmers JE. Remotely controlled mandibular positioner predicts efficacy of oral appliances in sleep apnea. Am J Respir Crit Care Med 2004; 170: 366-70.

32. Dort LC, Hadjuk E, Remmers JE. Mandibular advancement and obstructive sleep apnoea: A method for determining effective mandibular protrusion. Eur Respir J 2006; 27: 1003-9.

33. Remmers J, Charkhandeh S, Grosse J, Topor Z, Brant R, Santosham P, Bruehlmann S. Remotely controlled mandibular protrusion during sleep predicts therapeutic success with oral appliances in patients with obstructive sleep apnea. SLEEP 2013; 36 (10): 1517-25.

56 Customer Support

Customer Support

Technical Support: 1.877.227.9832

Email: [email protected]

Customer Sales: 1.877.341.8814

Email: [email protected]

610A - 70th Ave. S.E. Calgary, Alberta, Canada. T2H 2J6 | 1.877.341.8814 | www.zephyrsleep.com

CDC-0000008-00/V1

Dental Applications Guide - Zephyr Sleep Technologies · Oral appliances that reposition the...

Documents

Transcript of Dental Applications Guide - Zephyr Sleep Technologies · Oral appliances that reposition the...