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3/19/2014 Oral Appliance Therapy for the management of Sleep‐Related Breathing Disorders Dental Sleep Medicine Dental sleep medicine focuses on the management of sleep‐related breathing disorders (SRBD), which includes snoring and obstructive sleep apnea (OSA), with oral appliance therapy (OAT) and upper airway surgery. OAT involves the customized selection, fabrication, fitting, adjustments, and long‐term follow‐up care of specially designed oral devices, worn during sleep, which reposition the lower jaw and tongue base forward to maintain a more open upper airway. American Academy of Dental Sleep Medicine. www.aadsm.org; c2013 [updated 2013; cited 2013 Mar 22]. Available from: http://www.aadsm.org Historical Perspective of Oral Appliance Therapy 1903: Micrognathic infants benefit when the tongue is sutured forward to the lower lip 1923: Pierre Robin reports the first use of an oral appliance to reposition the mandible 1930: Helmets and chinstraps were used to reposition the mandible forward 1979: Mandible surgically advanced to open the airway 1982: Cartwright & Samelson describe the tongue retaining device1 1986: Meier‐Ewert presents published report on the use of oral appliance therapy for OSA2 1Cartwright RD, Samelson CF. The effects of a nonsurgical treatment for obstructive sleep apnea. The tongue‐retaining device. JAMA. 1982 Aug 13;248(6):705‐9. 2[Therapy of obstructive sleep apnea syndrome]. Kloss W, Meier‐Ewert K, Schäfer H. Fortschr Neurol Psychiatr. 1986 Aug;54(8):267‐71. German. PMID: 3530925 [PubMed ‐ indexed for MEDLINE] 1 3/19/2014 Historical Perspective of Oral Appliance Therapy cont. 1995: American Academy of Sleep Medicine (AASM) publishes first “Practice Parameters for the Treatment of Snoring and Obstructive Sleep Apnea with Oral Appliances”1 2006: AASM publishes “Practice Parameters for the Treatment of Snoring and Obstructive Sleep Apnea with Oral Appliances: An Update for 2005”2 1Thorpy M, Chesson A, et al. Practice Parameters For The Treatment Of Snoring And Obstructive Sleep Apnea With Oral Appliances. Sleep 1995;18(6):511‐513. 2 Kushida CA; Morgenthaler TI; Littner MR et al. Practice Parameters for the Treatment of Snoring and Obstructive Sleep Apnea with Oral Appliances: An Update for 2005. SLEEP 2006;29(2): 240‐243. Practice Parameters for Oral Appliance Therapy • Published by the American Academy of Sleep Medicine • Describe recommendations based on available evidence • Stipulate that oral appliances should be fitted by a trained dentist • Guide physicians and dentists in use of oral appliances for treatment of sleep‐related breathing disorders Kushida CA; Morgenthaler TI; Littner MR et al. Practice Parameters for the Treatment of Snoring and Obstructive Sleep Apnea with Oral Appliances: An Update for 2005. SLEEP 2006;29(2): 240‐243. Practice Parameters: Patient Selection • Oral appliances (OAs) are appropriate for patients: o o o with mild to moderate OSA who prefer OAs to CPAP who do not respond to, are not appropriate candidates for, or who fail treatment attempts with CPAP or treatment with behavioral measures such as weight loss or sleep‐ position change with primary snoring without features of OSA or upper‐airway resistance syndrome • Evidence lacking to support use of oral appliances in severe OSA patients. o o Trial of CPAP should be attempted Other treatment modalities including surgery may be indicated Kushida CA; Morgenthaler TI; Littner MR et al. Practice Parameters for the Treatment of Snoring and Obstructive Sleep Apnea with Oral Appliances: An Update for 2005. SLEEP 2006;29(2): 240‐243. 2 3/19/2014 Practice Parameters: Treatment Objectives • For patients with OSA: o o o Resolve clinical signs and symptoms of OSA Normalize AHI (Apnea Hypopnea Index) Normalize oxyhemoglobin saturation • For patients with snoring (without OSA or Upper Airway Resistance Syndrome) o Reduce snoring to a subjectively acceptable level Kushida CA; Morgenthaler TI; Littner MR et al. Practice Parameters for the Treatment of Snoring and Obstructive Sleep Apnea with Oral Appliances: An Update for 2005. SLEEP 2006;29(2): 240‐243. Oral Appliance Treatment Protocol • Developed by the American Academy of Dental Sleep Medicine for dentists • Describes clinical guidelines for providing oral appliances to patients with sleep‐related breathing disorders • Supported by best evidence available American Academy of Dental Sleep Medicine. aadsm.org; c2013 [updated 2013; cited 2013 June 24]. AADSM Treatment Protocol: Oral Appliance Therapy for Sleep Disordered Breathing: An Update for 2013. Available from: http://www.aadsm.org/treatmentprotocol.aspx Role of Dentistry in the Treatment of Snoring & Obstructive Sleep Apnea with Oral Appliance Therapy 3 3/19/2014 Physician/Dentist Collaboration • Therapies for OSA, including positive airway pressure (PAP) and oral appliance therapy (OAT), must be prescribed by a qualified physician trained in sleep medicine. • Oral appliances should be fit by a qualified dentist with training and experience in the temporomandibular joint, dental occlusion, and associated oral structures. American Academy of Dental Sleep Medicine. aadsm.org; c2012 [updated 2012; cited 2013 Mar 19]. AADSM/AASM Joint Policy Statement. Available from: http://www.aadsm.org/articles.aspx?id=3426 Guidelines for the Treating Dentist • Ensure the patient has been properly diagnosed by a treating physician according to AASM Clinical Practice Guidelines • Understand the pathophysiology of OSA • Choose cases appropriately • Provide a variety of oral appliance therapy options • Manage the side effects of oral appliance therapy • Evaluate patients on regular basis • Facilitate follow‐up with referring physician to ensure efficacy of oral appliance Dental Consultation 4 3/19/2014 Dental Sleep Medicine History Potential questions: • Is there a family history of sleep disorders? • Do they have any past history of a sleep disorder? • Have they ever had a sleep study? Used CPAP? Used an oral appliance? Had surgical intervention? Dental Sleep Medicine History (cont.) • • • • • • • • • • Snoring Witnessed apneas Choking arousals Frequent nocturnal awakening Excessive daytime sleepiness Unrefreshed sleep Effect on daily activities Cognitive impairment Recent change in weight Epworth Sleepiness Scale Dental Examination • • • • • • BMI Neck circumference Mallampati Classification Jaw relationship Evaluation of oropharyngeal hard and soft tissue structures Nasal patency Epstein LJ; Kristo D; Strollo PJ; Friedman N; Malhotra A; Patil SP; Ramar K; Rogers R; Schwab RJ; Weaver EM; Weinstein MD. Clinical guideline for the evaluation, management and long‐term care of obstructive sleep apnea in adults. J Clin Sleep Med 2009;5(3):263‐276. 5 3/19/2014 Dental Examination (cont). • TMJ Evaluation • Muscle Palpation • Jaw Range of Motion Jaw Relationships Retrognathic mandibles are often associated with obstructive sleep apnea Photo courtesy of Rose Sheats, DMD Arch Forms Broad • Broad or square arch forms may accommodate the tongue without impinging on the airway • Narrow or tapered forms suggest less room to accommodate the tongue and potential risk for obstruction of posterior airway Tapered Photos courtesy of Jay A. Nelson, DMD, FAGD 6 3/19/2014 Scalloping of the Tongue Scalloping of the edges of the tongue are signs of a large tongue and that the patient should be evaluated or queried for possible OSA Photos courtesy of Nancy Addy, DDS Evaluating the Oropharyngeal Area 1. Uvula 2. Soft Palate 3. Palatalglossal Arch 4. Palatine Tonsil 5 2 5. Supratonsillar Fossa 6. Palatalpharyngeal Arch 7. Posterior wall of Airway 3 1 4 4 7 6 Photo courtesy of Leslie Dort, DDS Imaging • Panoramic / Intra‐oral series To evaluate health of dentition and suitability for an OAT • Cephalometric measurements Provide information on AP dimension of the airway May be used to assess changes in the dentition May be used to measure changes in the AP dimensions of the jaw as a result of treatment • Photographs Valuable for the dentist in documenting occlusal changes 7 3/19/2014 Oral Appliance Therapy Oral Appliance Definition • Developed by AADSM in order to be universally applied in both the field of dental sleep medicine and clinical research settings • Crafted by using a modified RAND Appropriateness Method process • Delineates the purpose, physical features, and function of an oral appliance • Published in AADSM’s Journal of Dental Sleep Medicine American Academy of Dental Sleep Medicine. aadsm.org; c2013 [cited 2013 Aug 2]. Definition of an Effective Oral Appliance. Available from: http://www.jdsm.org/AcceptedPapers/JD‐01‐01.pdf FDA Market 510(k) Approved Oral Appliances Cumulative # appliances 120 100 80 60 Cumulative # appliances 40 20 0 1985 1990 1995 2000 2005 2010 2015 YEAR U.S. Food and Drug Administration. fda.gov; c2013 [updated 2013; cited 2013 Mar 22]. Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. FDA product codes: LQZ and LRK 8 3/19/2014 Functional Classification of Oral Appliances Permission for image provided by Strong Dental • Mandibular Advancement Devices • Tongue Retention Devices Photo courtesy of KD Night Laboratory • Hybrid Therapy: oral appliance and a PAP interface Function of an Oral Appliance The function of an oral appliance is to protrude and help stabilize the mandible in order to maintain a patent upper airway during sleep. American Academy of Dental Sleep Medicine. aadsm.org; c2013 [cited 2013 Aug 2]. Definition of an Effective Oral Appliance. Available from: http://www.jdsm.org/AcceptedPapers/JD‐01‐01.pdf Airway Changes WITH APPLIANCE BEFORE Posterior View KEY Red=Tongue White=Mandible Blue=Airway Photo courtesy of Alan Lowe, DMD, PhD, FRCD(C) Superior View Increases airway caliber in lateral dimension1 Increases airway size at level of velopharynx (retropalatal) 2 1Sutherland K; Deane SA; Chan ASL; Schwab RJ; Ng AT; Darendeliler MA; Cistulli PA. Comparative effects of two oral appliances on upper airway structure in obstructive sleep apnea. SLEEP 2011;34(4):469‐477. 2Ryan, C.F., et al., Mandibular advancement oral appliance therapy for obstructive sleep apnoea: effect on awake calibre of the velopharynx. Thorax, 1999. 54(11): p. 972‐7. 9 3/19/2014 Oral Appliance Therapy Oral Appliance Therapy Oral Appliance Therapy 10 3/19/2014 Oral Appliance Therapy Oral Appliance Design Features • Method of Retention • Vertical Opening • Freedom of Jaw Movement • Flexibility of Material • Adjustability Oral Appliance Design Features Somnodent Thornton Anterior Positioner (TAP) Permission for images provided by, from clockwise: Somnomed, Great Lakes Ortho, Myerson Tooth, Airway Management Herbst Elastic Mandibular Advancement (EMA) 11 3/19/2014 Oral Appliance Design Features Narval CAD/CAM Klearway Permission for image provided by ResMed Permission for image provided by Alan Lowe, DMD, PhD Oral Appliance Design Features SUAD Permission for images provided by Strong Dental Tongue Retention Devices Photo courtesy of B. Gail Demko, DMD 12 3/19/2014 Indications For Tongue Retention Devices • Lack of sufficient tooth support • Edentulous patients • Active TMJ symptoms (pain/dysfunction) • Habitual snorers • Mild OSA • OSA worse in prone position Photo courtesy of KD Night Laboratory • Macroglossia Tongue Retention Devices: Outcomes Mandibular advancement devices are more effective than tongue retention devices. Deane SA, Cistulli PA, Ng AT, Zeng B, Petocz P, Darendeliler MA. Comparison of mandibular advancement splint and tongue stabilizing device in obstructive sleep apnea: a randomized controlled trial. Sleep 2009;32:648‐53. Sutherland K, Deane SA, Chan AS, Schwab RJ, Ng AT, Darendeliler MA, Cistulli PA. Comparative effects of two oral appliances on upper airway structure in obstructive sleep apnea. Sleep. 2011 Apr 1;34(4):469‐77. Hybrid Therapy Photo courtesy of Leila Chahine, DMD 13 3/19/2014 Hybrid Therapy A treatment that physically combines the use of an oral appliance and a PAP interface in a single delivery system. Combination Therapy The simultaneous use of both an oral appliance and a complete PAP delivery system. Oral Appliance Therapy Follow‐up Protocol Calibration (Titration) • Obtain objective data to verify effectiveness • Further adjustments if necessary • Medical evaluation and assessment 14 3/19/2014 Calibration (Titration) cont. Discuss the adjunctive therapies to increase therapeutic benefit, such as: • positional therapy • timing of food consumption • avoidance of alcohol and sedatives • relief of nasal congestion • weight loss • exercise Follow‐up Checklist Evaluate • • • • • Integrity of appliance Fit of appliance Occlusion TMJ / muscle function Side effects Update progress • Adherence with appliance • Change in symptoms • Change in Epworth scale Schedule next follow‐up visit Short‐term Follow‐up 1‐3 days post‐delivery: contact patient to assess acclimation to OAT 4 week follow‐up: face‐to‐face appointment is offered Every 1‐12 weeks thereafter: follow‐up appointments as needed to optimize subjective and objective resolution of symptoms When optimum resolution of symptoms has been achieved, refer patient back to referring physician for follow‐up evaluation 15 3/19/2014 Long‐term Follow‐up 6 month follow‐up: face‐to‐face appointment is offered Annually thereafter: face‐to‐face appointment is offered Information to Send Referring Physician • Appliance type • Date of insertion • Has the oral appliance been calibrated to optimize signs and symptoms • Has a home monitoring device been used during the calibration process • Pre‐ and post‐ESS scores • Change in symptoms • Side effects Side Effects The patient is informed of potential side effects and complications prior to beginning treatment. 16 3/19/2014 Short‐term Side Effects TMJ and Myofascial Pain, excess salivation, and tenderness in teeth and gums are: • Common during the adaptation phase of oral appliance therapy • Usually resolve on their own • Easily managed by adjustments of the oral appliance Long‐term Side Effects Occlusal and Skeletal Changes Changes in bite Doff, Finnema et al. (2012), in a two year study of 51 patients, found that the oral appliance group had small but significant changes compared to the CPAP group, although both groups showed a significant decrease in the number of occlusal contact points in the premolar region. Matinez‐Gomis et al (2010) additionally observed a significant reduction in occlusal contacts after two years or oral appliance wear, but that this tendency reversed during the two to five year period of oral appliance wear. Chen, Lowe, et al (2008) concluded that occlusal and skeletal changes are most often adapted to and accepted by patients compared with the consequences of untreated OSA. It is believed that daily jaw exercises may be a potential method to help minimize occlusal changes in predisposed patients (Ueda, Almeida et al. 2009) Summary • Increasing number of dentists trained in dental sleep medicine • Their expertise includes the identification of appropriate candidates for OAT after referral from a physician, selection and fabrication of a customized appliance, and the management of the fit, adjustment, and side effects of the appliance • Oral appliances have been demonstrated by a convincing body of evidence to be as effective as CPAP in treating appropriately selected patients with sleep‐related breathing disorders1, 2, 3 1Phillips CL, et al. Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: a randomized controlled trial. Am J Respir Crit Care Med. 2013 Apr 15;187(8):879‐87. 2Aarab G, Lobbezoo F, Hamburger HL, Naeije M. Oral appliance therapy versus nasal continuous positive airway pressure in obstructive sleep apnea: a randomized, placebo‐controlled trial. Respiration. 2011;81(5):411‐9. 3Holley AB, Lettieri CJ, Shah AA. Efficacy of an adjustable oral appliance and comparison with continuous positive airway pressure for the treatment of obstructive sleep apnea syndrome. CHEST 2011; 140(6):1511–1516. 17 3/19/2014 Summary Dentists and sleep physicians can forge a strong collaboration to provide the best treatment option for each patient with sleep‐ related breathing disorders. 18