An Overview of Oral Appliances and their Clinical Indications David C. Stanton M.D., D.M.D., F.A.C.S. Associate Professor of Oral & Maxillofacial Surgery Residency Program Director University of Pennsylvania Functional Classification of Oral Appliances Categorized by Modes of Action Soft Palate Lifters Tongue Retainers Mandibular Repositioners Functional Classification of Oral Appliances Adjustable Soft Palate Lifter Tongue Retaining Device Page 1
Mandibular Repositioning Devices Sleep and Nocturnal Apnea Reducer (SNOAR) SnoreGuard Mandibular Repositioning Devices Oasys Klearway Nocturnal Airway Patency Appliance (NAPA) Herbst Appliance Somnomed Mandibular Advancement Splint Anatomy of Sleep Apnea Mandibular Repositioning Appliance The appliance is set in the neutral position. The appliance is adjusted to provide ~ 70% of the maximum mandibular advancement Picture of the airway corresponding to the neutral setting. Picture of the airway corresponding to the 70% setting. Page 2
Mandibular Repositioning Appliance Design Variations Method of Retention Flexibility of Material Adjustability Vertical Opening Freedom of Jaw Movement Lab vs. Office Fabrication Functional Classification of Oral Appliances Google Sleep apnea appliances 301,000 entries Pub Med search Sleep apnea appliances 1202 entries FDA website - over 71 types of devices listed Premarket Notification (510K)» 66 Appliances with Regulation Number: 872.5570(Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.) http://www.fda.gov/cdrh/ode/guidance/1378.html http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm FDA Product Classification Database: Product Code - LRK (Device, Antisnoring) Regulation Number: 872.5570 (Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.) Device Applicant 510(k) Decision Date Approval Statement somnofit strategic counsel sa K060795 12/18/2006 Snoring, OSA laimad steven lamberg, d.d. K062333 12/14/2006 Snoring tap iii anti-snoring airway management in K062951 12/12/2006 Snoring, OSA anti-snoring / sleep tomed dr. toussaint K061688 09/08/2006 Snoring, OSA tap-t airway management in K061732 07/12/2006 Snoring, OSA o'brien mpa (mandibu o'brien dental lab, K060744 06/02/2006 Snoring, OSA sleep splint nakagawa dental clin K060122 05/19/2006 Snoring, OSA tap ii anti-snoring airway management in K060388 05/17/2006 Snoring, OSA silent partner serie dreamwrx dental labo K051014 08/09/2005 Snoring, OSA somnomed mas rxa somnomed ltd K050592 07/12/2005 Snoring, OSA nti tension suppress nti-tss, inc. K041184 05/03/2005 Snoring, OSA anti-snoring/sleep a rj & vk bird pty ltd K042161 10/27/2004 Snoring, OSA restful nights, ist- ottawa dental labora K021569 03/15/2004 Snoring, OSA respironics custom i respironics, inc. K033822 02/06/2004 Snoring, OSA respironics custom i respironics, inc. K033823 02/06/2004 Snoring oasys-oral airway sy mark abramson, d.d.s K030440 08/26/2003 Snoring, OSA the suad device strong dental inc. K023836 07/08/2003 Snoring, OSA the breathe ez anti- d&s redhage K022891 02/19/2003 Snoring, bruxism FDA Product Classification Database: Product Code - LRK (Device, Antisnoring) Regulation Number: 872.5570 (Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.) Device Applicant 510(k) Decision Date Approval Statement snore-aid max dental imagineers, l K022284 12/10/2002 Snoring, OSA, bruxism nose breathe mouthpi steven k. sue K013687 05/28/2002 Snoring norad nocturnal oral dennis r. bailey, dd K020893 05/28/2002 Snoring, OSA sleepbite dental imagineers, l K013808 01/30/2002 Snoring, bruxism norad, nocturnal ora dennis r. bailey, dd K013049 11/29/2001 Snoring the quiet sleeper precision dental lab K012142 10/04/2001 Snoring, OSA tongue stabilizer de university of otago K993381 12/21/1999 Snoring oral sleep disorder perl-rad rad sleep disor K991209 09/22/1999 Snoring dr. b's mouthpiece, snore - ezzer K991948 09/02/1999 Snoring, bruxism snore-aid plus dental imagineers, l K991449 07/22/1999 Snoring, OSA, bruxism the snore peace the snore peace grou K981923 08/24/1998 Snoring snore-cure anti-snor ortho-tain, tain, inc. K980952 06/01/1998 Snoring snore-ezzer ezzer snore - ezzer K974531 02/12/1998 Snoring snoring control devi kenneth hilsen K963591 01/09/1998 Snoring elastic mandibular a frantz design, inc. K973884 01/09/1998 Snoring, OSA adjustable therasnor distar, inc. K973038 11/12/1997 Snoring elastic mandibular a frantz design, inc. K971794 09/29/1997 Snoring, OSA silentnite glidewell laboratori K972424 09/18/1997 Snoring Page 3
FDA Product Classification Database: Product Code - LRK (Device, Antisnoring) Regulation Number: 872.5570 (Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.) Device Applicant 510(k) Decision Date Approval Statement toa w. keith thornton, d K972061 08/21/1997 Snoring, OSA snore tec marketing technologi K963063 04/14/1997 Statement not available tap nellcor puritan benn K964516 01/24/1997 Snoring, OSA tap anti-snoring dev nellcor puritan benn K962516 09/10/1996 Snoring removable herbst app univ. dental assoc. K955822 03/20/1996 Statement not available snorefree scott feldman dds & K955336 01/04/1996 Statement not available the silencer silent knights ventu K954530 10/30/1995 Statement not available snor-x x mouth guard snorex, inc. K954324 10/17/1995 Statement not available snoremaster d d s, inc. K954128 10/02/1995 Statement not available lowe klearway dr. alan a. lowe, in K950763 05/25/1995 Statement not available therasnore dr. thomas e. meade K926382 07/08/1993 Statement not available orthodontic bite american orthodontic K922984 03/31/1993 Statement not available adjustable soft pala ortho publications, K895189 02/09/1990 Statement not available h&m anti-snoring dev hays & meade, inc. K882303 04/14/1989 Statement not available dental anti-snoring ortho publications, K874416 10/18/1988 Statement not available FDA Product Classification Database: Product Code - LQZ (Device, Jaw Repositioning) Regulation Number: 872.5570 (Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.) Device Applicant 510(k) Decision Date Approval Statement full breath sleep ap bryan keropian dds K061228 05/26/2006 Snoring, OSA full breath sleep ap bryan keropian dds K053065 01/03/2006 Snoring, OSA full breath sleep ap bryan keropian dds K052862 12/30/2005 Snoring, OSA snorenti james p boyd K032410 02/28/2005 OSA snorex snorex (nz) ltd. K971818 12/18/1997 Snoring osap snorefree, inc. K960673 05/09/1996 Statement not available adjustable pm positi jonathan a. parker, K955503 02/08/1996 Statement not available pm positioner jonathan a. parker, K953293 09/15/1995 Statement not available desra d.s.r.a., inc. K945820 06/15/1995 Statement not available elastomeric sleep ap village park orthodo K946112 06/14/1995 Statement not available snoremaster snore re the snoremaster co. K932932 02/10/1995 Statement not available snore-no-more great lakes orthodon K922818 02/09/1994 Statement not available napa g-ortho lab K902790 09/19/1990 Statement not available snoar(tm) open airwa kent j. toone, d.d.s K880956 05/11/1988 Statement not available the equalizer airway sleep renewal, inc. K870501 03/04/1987 Statement not available American Academy of Sleep Medicine What is the efficacy of OA in the treatment of snoring & obstructive sleep apnea in the short & long term? By what mechanism do OA improve snoring & obstructive sleep apnea? Do patients use OA in the treatment of snoring & obstructive sleep apnea in the short & long term? What short- & long-term side effects, adverse effects of complications occur with the use of OA in the treatment of snoring & obstructive sleep apnea How do OAs compare to nasal CPAP, surgery & other therapies for the treatment of snoring & obstructive sleep apnea in terms of efficacy, treatment adherence, and preference? What device selection & procedures are best for implementing OA in the treatment of snoring & obstructive sleep apnea? American Academy of Sleep Medicine Review of literature since 1995, produced 87 articles with published results of original research. 15 Randomized trials 72 case series, nonrandomized historical cohort studies, or nonrandomized controlled or concurrent cohort studies Number of subjects ranged from 8-257. 80% of studies had between 11 & 50 patients Page 4
American Academy of Sleep Medicine What is the efficacy of OA in the treatment of snoring & obstructive sleep apnea in the short & long term? 8 studies of MRA therapy with success as AHI < 5: success rate = 42% 30 studies of MRA therapy with success as AHI <10: success rate = 52% 10 studies of MRA therapy with success as AHI reduced by 50%: success rate = 65% Improvement in minimum O 2 sat ranged from 1-11%, but not always clinically significant Snoring: improved in intensity & frequency by bed partner reporting. Also reduced in all but 1 study using objective measures, but better objective evaluation needed. EDS: Most often self-report. Many studies showed Epworth improvement, but not always statistically significant. Need better objective assessment in future research. American Academy of Sleep Medicine What is the efficacy of OA in the treatment of snoring & obstructive sleep apnea in the short & long term? Variables affecting OA efficacy Severity of the OSA: 9 studies analyzed success of treatment by severity of OSA mild-moderate OSA success rates: 57-81% severe OSA success rates 14-61% Amount of mandibular protrusion: <10 studies. OSA improves with more advancement. Possible increased occlusal changes with increased protrusion. Presence of positional sleep apnea: 3 studies showed greater success rates of OA with positional apnea. 2 studies found no relationship. BMI: Several studies, but not all, showed inverse relationship between BMI & OA success. Klearway Appliance Klearway Appliance Lowe A, Sjoholm T, Ryan C, Fleetham J, Ferguson K, Remmers J: Treatment, Airway and Compliance Effects of A Titratable Oral Appliance. Sleep 23 Suppl 4: S172-8 June 2000 Page 5
Materials and Methods 134 consecutive patients from 1993-19981998 80 patients completed the post-insertion PSG and follow-up appointments All appliances adjusted to achieve approximately 50-75% of normal protrusion and increase vertical dimension 2-5 mm Post-therapy therapy study done at 3 months with the appliance both in and out while sleeping Success = RDI < 20 or a reduction in RDI > 50% Results No significant weight changes Decreased RDI Less frequent oxygen desaturation Decreased Snoring Effect of CPAP and Dental Appliance Therapy on Patients with Sleep Apnea 40 30 20 10 0 36 12.7 RDI 7.7 Pre-appliance CPAP Post-appliance A Retrospective Study of a Mandibular Advancement Device, the Klearway Appliance, for the Treatment of Sleep Apnea David Stanton D.M.D., M.D., Paul Madlock D.M.D., M.D., Douglas Ditty D.M.D., M.D., and Joli Chou D.M.D., M.D. Initial patient pool: 348 patients treated with the Klearway appliance from 1/1/95 to 2/1/2004. Exclusion criteria: Lack of pre- and post- insertion polysomnography studies at Hospital of University of Pennsylvania. Co-morbidities affecting the sleep study. An initial RDI < 5 without the appliance. Surgery for sleep apnea between studies. Polysomnography studies with and without the appliance greater than 6 months apart. Weight change of greater than 10% of body mass between polysomnography studies. 64 subjects were identified that had full records of pre- and post- appliance insertion at HUP. Of the 64 subjects, 41 patients met the inclusion criteria, of which 7 had multiple Polysomnography studies. Snoring was evaluated as snoring or no snoring by patient report. Partial responses or reductions in snoring were not included in the questionnaire. A two tailed paired T test was used to analyze the data. Page 6
A Retrospective Study of a Mandibular Advancement Device, the Klearway Appliance for the Treatment of Sleep Apnea Paul Madlock D.M.D., M.D., David Stanton D.M.D., M.D., Douglas Ditty D.M.D., M.D., and Joli Chou D.M.D., M.D. RDI 90 80 70 60 50 40 30 20 10 0 Sleep Apnea RDI 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 Patient Number Pre-appliance RDI Post-appliance RDI A Retrospective Study of a Mandibular Advancement Device, the Klearway Appliance for the Treatment of Sleep Apnea David Stanton D.M.D., M.D., Paul Madlock D.M.D., M.D., Douglas Ditty D.M.D., M.D., and Joli Chou D.M.D., M.D. Mild & Moderate Mean RDI Pretreatment 14.2 8.36 Moderate 20.1 10.8 Severe 48.9 20.7 All subjects 26.1 12.6 Mean RDI Posttreatment No significant improvement in oxyhemoglobin nadir AASM (American Academy of Sleep Medicine) By what mechanism do OA improve snoring & obstructive sleep apnea? Several studies using upright cephalometry have shown increases in PAS or reductions in the MPH A few studies utilizing Ct or MRI Imaging have also demonstrated increases in the pharyngeal airway size and volume. Cephalometrics Page 7
Cephalometrics Cephalometrics AASM (American Academy of Sleep Medicine) Do patients use OA in the treatment of snoring & obstructive sleep apnea in the short & long term? Not well studied. Generally relies on self-reporting. Ranges from 100% to 25% for MRA AASM (American Academy of Sleep Medicine) What short- & long-term side effects, adverse effects of complications occur with the use of OA in the treatment of snoring & obstructive sleep apnea Page 8
Mandibular Repositioning Device Side effects and Complications Oral Appliance Therapy Side effects and Complications Minor and Temporary Effects: Excessive Salivation Transient discomfort - teeth, TMJ, muscles of mastication Dry mouth Soft tissue irritation Temporary, minor bite disharmonies (morning-after occlusal changes) Moderate to Severe and Continuous: Significant TMJ discomfort / dysfunction Myofascial pain Tongue pain (tongue devices only) Gagging(mostly soft palate lifters) Dry mouth and salivation Permanent occlusal changes Oral Appliance Therapy Side effects and Complications Occlusal Changes Oral Appliance Therapy Side effects and Complications Occlusal Changes Page 9
Oral Appliance Therapy Side effects and Complications Occlusal Changes Oral Appliance Therapy Side effects and Complications Occlusal Changes Oral Appliance Therapy Side effects and Complications Occlusal Changes AASM (American Academy of Sleep Medicine) How do OAs compare to nasal CPAP, surgery & other therapies for the treatment of snoring & obstructive sleep apnea in terms of efficacy, treatment adherence, and preference? Page 10
SnoreGuard Randomized Crossover Study Ferguson et al. Chest 1996; 109: 1269-75 SnoreGuard Randomized Crossover Study Ferguson et al. Chest 1996; 109: 1269-75 SnoreGuard compared to CPAP in 27 patients with mild to moderate OSA. Patients had 4 months of therapy with one modality and crossed-over over to 4 months of therapy with the other. 2 drop-outs: outs: 25 patients completed the study Snoring was eliminated by CPAP in all but remained in 6 SG patients (24%) CPAP more effective in reducing EDS Reported compliance was the same. Significant side effects were more common with CPAP SnoreGuard Randomized Crossover Study Ferguson et al. Chest 1996; 109: 1269-75 Treatment Success (RDI <10) Compliance Failure (unable/unwilling) Treatment Failure (RDI >10 or symptoms) SnoreGuard CPAP 12 (48%) 13 (62%) 6(24%) 8(38%) 7(28%) 0 AASM (American Academy of Sleep Medicine) What device selection & procedures are best for implementing OA in the treatment of snoring & obstructive sleep apnea? Page 11
Practice Parameters for the Treatment of Snoring & Obstructive Sleep Apnea with Oral Appliances: An Update for 2005 Kushida,CA, Morgenthaler, TI, Litner, MR, et. Al. SLEEP, 2006, 29(2); 240-243 Diagnosis Appliance Fitting Treatment Follow-up An American Academy of Sleep Medicine Report Practice Parameters for the Treatment of Snoring & Obstructive Sleep Apnea with Oral Appliances: An Update for 2005 Kushida,CA, Morgenthaler, TI, Litner, MR, et. Al. SLEEP, 2006, 29(2); 240-243 Diagnosis An American Academy of Sleep Medicine Report 3.1.1 The presence or absence of OSA must be determined before initiating treatment with oral appliances to identify those patients at risk due to complications of sleep apnea and to provide a baseline to establish the effectiveness of subsequent treatment. Detailed diagnostic criteria for OSA are available and include clinical signs, symptoms and the findings identified by polysomnography. The severity of sleep related respiratory problems must be established in order to make an appropriate treatment decision. (Standard) Definition of Dental Sleep Medicine & Dental Scope of Practice Protocol American Academy of Dental Sleep Medicine: Dialogue, Issue 3, 2006, page 7 The diagnosis of SDB, particularly the potentially life-threatening medical disorder, OSA, as well as the differential diagnosis of narcolepsy, periodic limb movements of sleep, insufficient sleep syndrome, and other medical conditions that also exhibit EDS, must be determined by sleep physicians. Scope of Practice Statement American Academy of Dental Sleep Medicine: Dialogue, Issue 3, 2006, page 6 Although most state dental practice acts allow us to care for the oral cavity and surrounding structures which could be construed to include the upper airway, none go so far as to directly allow for the diagnosis of sleep-disordered breathing. As such, in a court of law, a dentist would easily be shown to be outside of his scope of license and in breach of the standard of care in sleep medicine. American Dental Association Definition of Dentistry Dentistry is defined as the evaluation, diagnosis, prevention and/or treatment (nonsurgical, surgical or related procedures) of diseases, disorders and/or conditions of the oral cavity, maxillofacial area and/or the adjacent and associated structures and their impact on the human body; provided by a dentist, within the scope of his/her education, training and experience, in accordance with the ethics of the profession and applicable law. (As adopted by the 1997 ADA House of Delegates) Scope of Practice Dental Practice Act Commonwealth of Pennsylvania Definition of Dentistry Medical Practice Act Commonwealth of Pennsylvania Page 12
Practice Parameters for the Treatment of Snoring & Obstructive Sleep Apnea with Oral Appliances: An Update for 2005 An American Academy of Sleep Medicine Report Kushida,CA, Morgenthaler, TI, Litner, MR, et. Al. SLEEP, 2006, 29(2); 240-243 Appliance Fitting 3.2.1 Oral appliances should be fitted by qualified dental personnel who are trained and experienced in the overall care of oral health, the temporomandibular joint, dental occlusion and associated oral structures. Dental management of patients with OAs should be overseen by practitioners who have undertaken serious training in sleep medicine and/or sleep related breathing disorders with focused emphasis on the proper protocol for diagnosis, treatment, and follow-up. (Option)* 3.2.2 Although cephalometric evaluation is not always required for patients who will use an oral appliance, appropriately trained professional should perform these examinations when they are deemed necessary. (Option) Klearway Appliance GEORGE GAUGE Great Lakes Orthodontics, Ltd. Tonawanda, NY 1-800-828-7626 Klearway Appliance Great Lakes Orthodontics, Ltd. Tonawanda, NY 1-800-828-7626 Practice Parameters for the Treatment of Snoring & Obstructive Sleep Apnea with Oral Appliances: An Update for 2005 An American Academy of Sleep Medicine Report Kushida,CA, Morgenthaler, TI, Litner, MR, et. Al. SLEEP, 2006, 29(2); 240-243 Treatment Treatment Objectives 3.3.1.1 For patients with primary snoring without features of OSA or upper airway resistance syndrome, the treatment objective is to reduce the snoring to a subjectively acceptable level. (Standard) 3.3.1.2 For patients with OSA, the desired outcome of treatment includes the resolution of the clinical signs and symptoms of OSA and the normalization of the apnea-hypopnea index and oxyhemoglobin saturation. (Standard) 3.3.2 Oral appliances are appropriate for use in patients with primary snoring who do not respond to or are not appropriate candidates for treatment with behavioral measures such as weight loss or sleep position change. (Guideline)* 3.3.3 Although not as efficacious as CPAP, oral appliances are indicated for use in patients with mild to moderate OSA who prefer OAs to CPAP, or who fail treatment attempts with CPAP or treatment with behavioral measures such as weight loss or sleepposition change. (Guideline)* 3.3.4 Patients with severe OSA should have an initial trial of nasal CPAP because greater effectiveness has been shown with this intervention that with the use of oral appliances. Upper airway surgery (including tonsillectomy and adenoidectomy, craniofacial operation and tracheostomy) may also supercede use of oral appliances in patients for whom these operations are predicted to be highly effective in treating sleep apnea. (Guideline)* Page 13
Practice Parameters for the Treatment of Snoring & Obstructive Sleep Apnea with Oral Appliances: An Update for 2005 An American Academy of Sleep Medicine Report Kushida,CA, Morgenthaler, TI, Litner, MR, et. Al. SLEEP, 2006, 29(2); 240-243 Follow-up 3.4.1 Follow-up sleep testing is not indicated for patients with primary snoring. (Guideline) 3.4.2 To ensure satisfactory therapeutic benefit from OAs, patients with OSA should undergo polysomnography or an attended cardiorespiratory (Type 3) sleep study with the oral appliance in place after final adjustments of fit have been performed. (Guideline)* 3.4.3 Patients with OSA who are treated with oral appliances should return for follow-up office visits with the dental specialist. Once optimal fit is obtained and efficacy shown, dental specialist follow-up at every 6 months is recommended for the first year, and at least annually thereafter. The purpose of follow-up is to monitor patient adherence, evaluate device deterioration or maladjustment, evaluate the health of the oral structures and integrity of the occlusion, and assess the patient for sign and symptoms of worsening OSA. Intolerance and improper use of the device are potential problems for patients using oral appliances, which require patient effort to use properly. Oral appliances may aggravate temporomandibular joint disease and may cause dental misalignment and discomfort that are unique to each device. In addition, oral appliances can be rendered ineffective by patient alteration of the device. (Option)* 3.4.4 Patients with OSA who are treated with oral appliances should return for periodic follow-up office visits with the referring clinician. The purpose of follow-up is to assess the patient for signs and symptoms of worsening OSA. Close communication with the dental specialist is most conducive to good patient care. An objective reevaluation of respiration during sleep is indicated is sign or symptoms of OSA worsen or reoccur. (Option)* Protocol for Oral Appliance Therapy Evaluation of appliance for 2-3 months Repeat polysomnography Repeat evaluation by both pulmonologist and Dentist/OMFS Summary Ferguson, KA, Cartwright, R, Rogers, R, et.al. Oral Appliances for Snoring & Obstructive Sleep Overall, those with mild to severe OSA have a 52% chance of being able to control apnea using an appliance Oral appliances (OA) are on the whole less effective than CPAP but may be better accepted by patients OA are not recommended as a first line treatment in patients with severe OSA (AHI>40) Patients with severe OSA might consider an OA of they have failed CPAP or upper airway surgery, recognizing that the results of OA therapy in severe OSA are unpredictable. What is the best Appliance? One that works, and that the patient will use. Mandibular Repositioning Appliances Design Variations Adjustability Method of Retention Flexibility of Material Freedom of Jaw Movement Lab vs. Office Fabrication Vertical Opening Page 14
Future Directions Titration of amount of jaw protrusion at sleep center Home PSG monitoring to assess efficacy of advancement?use in children & adolescents probable effect on facial growth. Page 15