History of Oral Appliances for Sleep Breathing Disorders. History - Continued. The EQUALIZER 4/12/18

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1 Splints vs Oral Appliance Therapy Make the Correct One the First Time Introduction & Update Where Are We Going Things to Consider History of Oral Appliances for Sleep Breathing Disorders Repositioning of the Mandible and Tongue to Open the Airway During Sleep is Not New 1903: Infants with Micrognathia Derived a Benefit when Tongue is Sutured to Lower Lip 1930: Chinstraps & Helmets Used to Reposition Mandible Forward 1934: Pierre Robin Reports First Use of Oral Appliance to Reposition the Mandible History - Continued The EQUALIZER 1970s: Surgery for Sleep Apnea and Snoring Developed 1979: Surgical Advancement of the Mandible to Open the Airway 1982: Cartwright & Sammelson Report on the Tongue Retaining Device 1980s: A Variety of Oral Appliances are Introduced 1990s into the 2000s: Oral Appliances with More Mandibular Mobility and Two Piece Design Current Status: More refinements compliance now an issue NAPA NAPA 1

2 Adjustable Soft Palate Lifter SNOAR Hilsen Adjustable Appliance PRACTICE PARAMETERS An Update for 2005 From: American Academy of Sleep Medicine February 1, 2006 SLEEP: Vol 29, No 2 p & p Indications for Oral Appliances Primary Snoring Mild to Moderate Sleep Apnea CPAP Intolerant Surgical Failures Substitutive Therapy Most Currently Clinical Prac6ce Guideline Joint statement from the AASM and AADSM as an update from 2006 Prac6ce Parameters Con6nues to reinforce the indica6on for oral appliance use for Sleep Apnea & Snoring What about a Sleep Breathing Disorder? Limita&ons exist From: J Clin Sleep Med 2015;11(7):

3 OA is compared to CPAP Craniofacial Changes After 2 Years of Nasal CPAP Use in Patients with OSA CPAP use can alter craniofacial form: reduce maxillary / mandibular prominence Can alter dental arch relationships From: CHEST (4): Oral Appliances for Snoring and Obstructive Sleep Apnea: A Review An Evidence Based Review since 1995 Determine: Efficacy Mechanism of Action Short & Long Term Side Effects OAs compared to CPAP Device Selection & Procedures Best for Implementation Practice Parameters Follow-up Follow-up sleep testing / Sleep Study after appliance adjusted / titrated Follow-up with the Dentist after 6 months the first year and annually thereafter Follow-up care with the referring Clinician Periodically to assess for worsening OSA CONTRAINDICATIONS Central Sleep Apnea Significant TMJ Disorders Inadequate Dental Status Unmotivated Patient Design Variations Method of Retention Flexibility of Material Adjustability Vertical Opening Freedom of Jaw Movement Lab vs Office Construction 3

4 Potential Adverse Effects Side Effects Common Increased Salivation Transient Discomfort Soft Tissue Irritation Dry Mouth Temporary Bite Changes Uncommon Long Term Discomfort Permanent Occlusal Changes Criteria for Optimum Oral Airway Dilator Appliance Therapy Titrateable Adjustable Posterior Support Full Coverage Jaw (Mandibular) Mobility Adequate Lip Seal Able to Nose Breathe Adequate tongue space - keep lingual open FDA Guidelines Class II Medical Devices In Columbus, Ohio Radio ad for an alternate therapy to CPAP Got 9,000 calls Patients did not want to return to the sleep physician who pushed CPAP Not interested in another sleep study Patients not interested in CPAP do not believe they have anything else to offer them OAs are good alternative to CPAP The Tongue Retainer 4

5 The Tongue Stabilizer MPowRx from Great Lakes The Silent Night by Glidewell The HERBST Appliance PM POSITIONER Fixed and Adjustable EMA Appliance (Elastic Mandibular Advancement) 5

6 The KLEARWAY The SILENCER TAP Appliance The TAP Appliance SomnoDent MAS by SomnoMed OASYS 6

7 Good Air Oral Airway Dilator Other Less Well Known Oral Appliances Dorsal Full Breath Solution Zquiet Lamberg Sleep-Well Silent Sleep Respire The Moses DNA Appliance The Snorkel Narval CC ZQuiet Respire Blue Series The Moses DNA Appliance 7

8 Narval CC from ResMed Trial Appliances The THERASNORE by Distar Therasnore SnoreGuard Snore Silencer Norad EMA First Step SUAD TSA And others The Snore Guard The Modern Snore Guard 8

9 SnoreGuard EMA First Step TSA (Trial SUAD) 9

10 SnoreRx Results of Preliminary Study at Kaiser in Fontana, CA 100% posi6ve predic6ve value for pre-fab oral appliance (ApneaRX) for outcome of custom more durable oral appliance ApneaRX use n=227 but n=117 (65%) returned for custom appliance (SomnoDent) Response was based on AHI < 15 & 50% decrease Pre-fab AHI vs. Custom MAD AHI 31.6 Diagnos6c Pre-fab Custom MAD AHI Pa6ent Number 10.4% 8.2% AHI Supine AHI Non-supine AHI ODI T90% 10

11 VitalSleep MyTAP trial appliance Comparison of Custom Appliance to Thermoplastic 35 patient study 4 Months of treatment AHI only reduced with custom appliance Custom device reduced snoring to a greater extent Total failure rate with thermoplastic device is 60% (poor retention) Do not use thermoplastic device as trial Ref: Am J Resp Crit Care Med 2008 Vol178 p Side effects of boil and bite oral appliance therapy in sleep apnea patients Over 80% had improved snoring, daytime sleepiness and apnea > 60% were satisfied with OA therapy Poor fit main cause of D/C use Sleep & Breathing (2010) 14(3): Tsuda H, Almeida FR,Masumi S Lowe AA, The Bite / Jaw Position Most Difficult Step in OA Therapy Criteria for the bite? Much Confusion varies with manufacturer / lab / OA No standard method or guideline Initial Bite Recommendations Effects of an oral appliance with different mandibular positions at a constant vertical dimension on OSA 17 patients - constant vertical with random advancement ( %) of maximum protrusion 25% advanced significant improvement in AHI At 50 & 75% even more improvement Side effects greater at 50% or more Recom: give up some improvement to reduce side effects - start at 50% advanced From: Clin Oral Investig 2009 June 18 11

12 Cone Beam Imaging With Oral No Appliance Appliance Cone Beam Imaging No Appliance With Oral Appliance Star6ng Treatment with Something Other Than the Standard Oral Appliance Criteria & Guidelines A Different Approach to Trea6ng Sleep Disordered Breathing Indica6ons Limited ROM Par6cularly mandibular advancement TMJ findings OFP SB (not sure of response to OA that has more of a locking effect) What Does the Star6ng Oral Appliance Look Like Two Flat Planes opposing one another Trea6ng Both SBD and SB Use of class II elas6cs op6onal Need to combine this with other management op6ons: Physical Therapy Myofunc6onal Therapy What The Appliance Looks Like 12

13 Two Flat Planes Side View Intra-oral View Side View The Plan Start off with the flat plane class II appliance Focus is more on ver6cal Monitor over 6-12 month period Once ini6al symptoms resolved ROM improved - move into more defini6ve oral appliance This is different than a trial appliance What is The Next Appliance Consider one that con6nues to have posterior support Re-evalua6on may be needed Do HST or PSG Evaluate the 4 Components Looking for presence of SB If results good Why do the next appliance? Consider a Trial Appliance? 13

14 Give the OA Time Progressive snorers disease Leg inflammation a factor Limited ROM Overall improved inflammation Co-morbid conditions: Insomnia, PLMs, Bruxism, Narcolepsy Long Term Outcome Aner 1.5 years significant improvement in UARS pa6ents (30 people into 2 groups) Reduc6on in many ways: Improved RDI Arousal index lower Improved sleep quality and sustained apen6on Decreased severity of depression Reduced sleep fragmenta6on Sleep 2017 vol 40;No 12 Side Effects Bite changes Tooth Movement Opening Contacts TMJ / TMD Myofascial (muscle) pain Management of Bite Changes Leaf Gauge Tooth Movement Opening Contacts Mostly associated with bite change anterior teeth hit More likely with soft elastomeric design 14

15 Jaw pain - TMJ/TMD Myofascial Pain Most jaw pain is muscular No evidence that MRA causes TMJ/TMD actually improves symptoms and findings Myofascial pain and pain referral Cardiovascular and Sleep-Related Consequences of TMJ Disorders NHLBI Workshop December 3-4, 2001 Co-morbid complaints such as problems with sleep, blood pressure and breathing not uncommon for this group of TMD patients Educa6on is a progressive discovery of our ignorance James Howard Univ. of Washington Literature Review Some ar6cles to consider For your pleasure and inves6ga6on Health Outcomes of CPAP vs Oral Appliance Treatment for OSA Phillips CL, Grunstein RR, et al AJRCCM 2013 Vol187, Issue 8, p Conclusion: Important health outcomes were similar aner 1 month of op6mal oral appliance (OA) and CPAP treatment in pa6ents with moderate to severe OSA. Greater efficacy of CPAP is offset by inferior compliance rela6ve to OA. This resulted in similar effec6veness. 15

16 A systematic review of the efficacy of oral appliance design in the management of OSA All MADs improved PSG outcomes No one type of MAD was most effective Effect depends on: severity of OSA material and method of fabrication Monobloc vs twin bloc Degree of protrusion (advancement & vertical) From: Eur J Orthod June 2011;33(3): Does Propulsion Mechanism Influence the Longterm Side Effects of Oral Appliances in the the Treatment of SDB? Do different designs have different outcomes? Looked at Traction based vs Compression based designs?? Traction - propels the mandible Compression - pulls / forces mandible AHI at < 5 occurred in 28% with traction devices and 24% with compression devices Both types produced similar results From: CHEST Nov (5): Titrated mandibular advancement vs positive airway pressure for sleep apnea MAD effective therapy in moderately sleepy + overweight people Less effective than CPAP - Successfully titrated MAD was very effective in reducing AHI and higher compliance Both improved functional outcomes!! One night titration had a low negative predictive value for treatment success Subjective efficacy of oral appliance design features in the management of OSA: A systematic review Looked at 14 studies as the basis of the study No 1 MAD design that is most effective Future studies needed - especailly related to Bibloc vs Monobloc and advancement vs vertical From: Eur Respir J 2009;34: From: Am J Ortho Orthoped Vol 138(5): Oral Appliance Treatment of OSA: An Update Robust evidence of the efficacy of oral appliances for improving PSG indices and modifying the health risk associated with OSA Outcomes similar to CPAP Curr Opin Pulm Med 2009;16(6): A. Chan and P. Cistulli Efficacy of Oral Appliances OA significantly improve subjec6ve and objec6ve measures of sleepiness, quality of life and 24 hour blood pressure measurement Subjec6vely and objec6vely OAs decrease sleepiness to the same degree as CPAP & improve quality of life and neuropsychological func6on Con6nued next slide 16

17 More on OAs Five studies OAs preferred over CPAP With respect to improvements in symptoms: Compliance with and acceptance of OAs similar to CPAP From DCNA April2012 Vol56 No 2 p Oral & Maxillofacial Surgery Clinics Nov 2009 Adherence using Oral Appliance Extent to which the pa6ent will follow the recommended treatment by the provider Adherence not as good with CPAP Adherence excels with OA DCNA April 2012 Pliska & Almeida p Copy: pliska@den6stry.ubc.ca Effect of Oral Appliance Therapy on Sleep Apnea and Hypertension Oral Appliances Reduce BP In OSA Patients Followed 102 Patients with OSA 38 with average BP 149/93 AHI with average BP 123/76 AHI 17.8 Post-OA Treatment Hypertensive Group average BP 137/84 Non-Hypertensive Group average BP 122/75 Increased Oxygen Levels 50% Decrease in RDI In 4 Weeks: Decreased BP = To CPAP Sleep 2004;27(5): Abstract IADR March 12, 2004 Other Articles on OA and OSA OA vs CPAP in OSA Syndrome: A 2-year Follow-up SLEEP 2013;36(9) Both CPAP and OA effective treating mild-moderate OSA. CPAP better with severe patients Preferred Treatment by Schmidt-Nowara in J Clin Sleep Med Patients should have a say in the choice of OA vs CPAP but may not be informed Another Advance in OA Therapy by Pat Strollo. Called 68% of max protrusion quite low using RCMP?? Dentist who is adequately trained in dental sleep medicine need to be ID d SLEEP 36(10) 17