Dental Applications Guide

Transcription

1 Dental Applications Guide

2 Table of Contents TM 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 2J OATRx and MATRx are trademarks of Zephyr Sleep Technologies Inc. All other trademarks are property of their respective holders. This product is manufactured and sold under one or more of U.S. Patent No. 5,826,579 and other U.S. and foreign patents pending Zephyr Sleep Technologies Inc. 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

3 2 Introduction Introduction 3 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. John E. Remmers, MD Chief Medical Officer Zephyr Sleep Technologies Inc. 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 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 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.

4 4 Introduction Introduction 5 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 firstline 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. Shouresh Charkhandeh, BMedSC, DDS, LVIF Chief Dental Officer Zephyr Sleep Technologies Inc. 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.

5 6 Introduction 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 OSA Co-Morbidities

6 OSA Co-Morbidities 7 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 * male subjects only

7 8 OSA Co-Morbidities OSA Co-Morbidities 9 Consequences of Untreated Sleep Apnea Risk Factors and Clinical Features of Sleep Apnea Hypertension 15, 16 Sleep apnea is an independent risk factor for hypertension 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: OSA accounts for approximately 75% of all SDB patients Moderate to severe sleep apnea triples stroke risk in men % 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 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: 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

8 10 OSA Co-Morbidities The MATRx System The MATRx System

9 The MATRx System 11 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 customfitted 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.

10 12 The MATRx System The MATRx System 13 MATRx Hardware 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. Figure 1: The MATRx System The MATRx System Components A Controller A remotely controlled Mandibular Positioner (MP) Note: The MP and cable are light, weighing a little less than 90 grams (3 oz) Set of MATRx Titration Trays Note: Trays are available in 2 sizes medium and large 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 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 3: MATRx Titration Trays placed for the patient s MATRx Study Figure 2: MATRx Titration Trays with impressions 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: The MATRx Titration Trays are proprietary impression trays for use with the MATRx system and are not to be used for any other purpose. The trays are designed for single patient multi-use for one study only. Figure 4: The OATRx Scale of the MATRx Titration Trays The 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).

11 14 The MATRx System MATRx Benefits MATRx Benefits

12 MATRx Benefits 15 The Importance of MATRx in Dental Sleep Medicine With MATRx you know that every oral appliance referral will be successful with therapy. 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. 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 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.

13 16 MATRx Benefits MATRx Benefits 17 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 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 Dental Sleep Medicine Specialist at Sleep Better Northwest, Spokane, Washington Area 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. No longer do I have to tell patients that CPAP is superior due to the ability to titrate in the lab....(matrx) gives me more security and confidence when I need to close the gap between the two best therapies in treating sleep disordered breathing. Dr. Kent Smith Clinical Instructor at Six Month Smiles, Dallas/Fort Worth Area Figure 5: Hypnogram generated from a MATRx study The 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. 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

14 18 MATRx Benefits Patient Selection and Tray Fitting Patient Selection

15 Patient Selection 19 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.

16 20 Patient Selection Patient Selection 21 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. 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. 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 Figure 6: Results from the MATRx clinical trial, SLEEP 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. 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

17 22 Patient Selection Patient Selection 23 Fitting the MATRx Titration Trays Recording the Tray s Reference Number Please visit Zephyr s You Tube site for instructional videos on MATRx Titration Tray use Selecting the Proper Tray Size Figure 7: A medium lower tray Figure 8: Correct 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. 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 Figure 9: Confirming the Titration Tray s Reference Number In this example, the tray s Reference Number is 10mm. 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). 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: It is important to record the tray s Reference Number before trimming the trays or taking impressions 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.

18 24 Patient Selection Patient Selection 25 Adjusting Tray Length Adjusting Tray Width Each tray should be assessed for adjustments that may be required in length and width. 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. Figure 10: Correct tray length Figure 11: Trim Lines 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. 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. Figure 12: Heat torch being used to soften tray material 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.

19 26 Patient Selection Patient Selection 27 Impression Procedure 1 Take the Maxillary Impression First 4 Take the Mandibular Impression Fill the upper tray with impression material and place onto the maxilla With the trays connected, fill the lower tray with impression material to prepare for taking the mandibular impression Figure 13: Henry Schein Blu-Bite Fast Set Figure 15a 15b: Taking the maxillary impression Figure 14: Incisal Groove on upper tray 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 Figure 20a 20b: 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 maxillarymandibular 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 2 Trim the Upper Impression 5 Trim and Polish Both Impressions Trim and polish excess impression material from the upper tray Trim and polish excess impression material from the lower tray Figure 16a 16b: Trimming upper tray impression Figure 17: Trimmed upper tray impression Figure 21: Trimmed and polished tray impressions Figure 22: Checking function of trimmed trays and impressions 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 3 Check Fit and Comfort 6 Check Fit, Comfort, Function and Retention Figure 18: Trimmed upper tray connected to lower tray Figure 19: Checking fit of trimmed upper tray 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 23: Checking tray midlines Figure 24: Checking tray fit 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

20 28 Patient Selection Patient Selection 29 Impression Tips Taking the OATRx Scale Readings 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 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 1 2 Figure 25: Resting Position is 13mm Figure 26: Maximal Voluntary Protrusion is 19mm 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 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: A third measurement (i.e. Full Retrusion), can be taken to compare the patient s range of 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. 3 Prepare the Trays for the Sleep Lab Figure 27a 27b: Preparing 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

21 30 Patient Selection Using The Matrx Target Protrusive Position Using MATRx Results

22 Using MATRx Results 31 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. 1 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. 2 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:

23 32 Using MATRx Results Using MATRx Results 33 Appliance Fitting and Titration Using the MATRx OAT Protocol 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. 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).

24 34 Using MATRx Results Using MATRx Results 35 Decrease Chair Time and Fast-Track Titration to Target Decrease Dental Costs 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). 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 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). 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.

25 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 Dental Case Studies 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

26 Case Studies 37 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

27 38 Case Studies Predicted Successes Predicted Successes

28 Case Studies 39 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

29 40 Case Studies Case Studies 41 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 Dental Assessment (OATRx scale readings for titration study) Lower Limit (Resting Position) = 10.0mm Upper Limit (Maximum Protrusion) = 16.0mm 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 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 mm Interval 2 REM cycle; 12.5 minutes LATERAL position Effective protrusion» mandibular position mm Interval 3 NREM cycle; 50 minutes SUPINE position Effective protrusion» mandibular position mm Interval 4 REM cycle; 3 minutes LATERAL position Effective protrusion» mandibular position 15.6mm 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. Upper Limit (Maximum Protrusion) Lower Limit (Resting Position)

30 42 Case Studies Case Studies 43 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 42 year old female Pre-study AHI = 41.4 BMI = 32.3 Dental Assessment (OATRx scale readings for titration study) Lower Limit (Resting Position) = 10.0mm Upper Limit (Maximum Protrusion) = 17.0mm 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 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). Mandibular Titration Summary Interval 1 NREM cycle; 30 minutes LATERAL position Effective protrusion» mandibular position mm Interval 2 REM cycle; 5 minutes LATERAL position Ineffective protrusion» mandibular position 12.4mm Interval 3 REM cycle; 25 minutes SUPINE position Effective protrusion» mandibular position mm Interval 4 REM cycle; 25 minutes SUPINE position Effective protrusion» mandibular position mm MATRx Study Interpretation Prediction: Patient is a predicted success in the supine position OATRx Number (Target Protrusive Position): 14.5mm 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. Upper Limit (Maximum Protrusion) Lower Limit (Resting Position)