Oral Appliances and their Clinical Applications

Transcription

1 Oral Appliances and their Clinical Applications Peter Cistulli MBBS, PhD, MBA, FRACP Professor of Respiratory Medicine & Head of Discipline of Sleep Medicine University of Sydney Director, Centre for Sleep Health & Research, Royal North Shore Hospital Sleep & Circadian Group, Woolcock Institute of Medical Research University of Sydney Royal North Shore Hospital

2 Conflict of Interest Disclosures Competitive Research Funding: NHMRC of Australia Victorian Neurtrauma Initiative Industry Support: SomnoMed Ltd ResMed Inc

3 Outline Types of Oral Appliances Efficacy of Mandibular Advancement Splints in OSA Comparison of Mandibular Advancement Splints to CPAP Comparison of Mandibular Advancement Splints to Tongue Stabilising Devices Clinical Indications for Oral Appliances Orofacial Orthopedics for OSA

4 Types of Oral Appliances Mandibular Advancement Splints (MAS) Tongue Stabilising Devices Orofacial Orthopedics (eg. Rapid Maxillary Expansion)

5 Mandibular Advancement Splints (MAS) Also known as Mandibular Advancement Device (MAD) or Mandibular Repositioning Appliance (MRA) Many designs one-piece vs two-piece Customized vs non-customized Adjustable vs non-adjustable Different coupling mechanisms, materials, vertical opening, lateral movement

6 Examples of MAS Designs One-piece (monobloc) Two-piece (duobloc)

7 Medical Outcomes in Oral Appliance Research Physiology Symptoms (subjective) Objective Outcomes AHI SaO 2 indices Arousal index Sleep architecture Snoring Sleepiness Mood Neurocognitive function Quality of life Treatment adherence & side effects Snoring Sleepiness Psychomotor function Driving performance Cardiovascular outcomes Treatment adherence & side effects

8 Efficacy of MAS Definition of Success No. of studies Average Success Rate (%) AHI < 5/hour AHI<10/hour AHI<50% compared to baseline Ferguson et al, Sleep, 2006

9 Sleep Architecture Mehta et al, AJRCCM, 2001

10 Efficacy: RCTs of CPAP vs MAS

11 Symptomatic Outcomes Outcome Snoring 1 Sleepiness 2,3 Neurocognitive function 2,3 Quality of Life 2,3 Mood 2 Effect of MAS, compared to CPAP Very high subjective response rate. Objective reductions in snoring intensity and frequency Improved ESS. No difference between MAS and CPAP Placebo effect. Inconsistent results. No clear evidence of differential effect of MAS or CPAP Improved QOL. No difference in FOSQ, and SF-36 between MAS and CPAP. Few studies. Improved POMS, BDI, and HADS scores. Inconsistent differences between MAS and CPAP 1. Schmidt-Nowara et al, Sleep Engleman et al, AJRCCM, 2002; Barnes et al, AJRCCM, 2004; Naismith et al, J Clin Sleep Med Gagnadoux et al, ERJ, 2009

12 Aug 08 Update Compared to: Inactive oral appliances (6) CPAP (10) Surgery (1) N=831 Mild to moderate OSA Mostly middle aged men

13 Cochrane Review on Oral Appliances for OSA CPAP appears to be more effective in improving sleep disordered breathing than OA. The difference in symptomatic response between these two treatments is NOT significant Lim et al, Cochrane Database of Systematic Reviews, 2006

14 Objective Health Outcomes with MAS Outcome Objective Sleepiness 1 Psychomotor speed 2 Driving simulator performance 3 24 hr blood pressure 4 Endothelial function & oxidative stress 5 Effect of MAS Improved MSLT at 1 mth. No difference between MAS and CPAP effect on MWT. Similar improvement in Osler. Improved psychomotor speed at 1 mth Improved driving performance (reduced attention lapses) at 2-3mths. No difference between MAS and CPAP. Reduced mean blood pressure at 4 & 12 wks Improved at 1 yr 1. Gotsopoulos et al, AJRCCM 2002; Engleman et al, AJRCCM, 2002; Barnes et al, AJRCCM, 2004; Gagnadoux, ERJ, Naismith et al, J Clin Sleep Med Hoekema et al, Sleep Breath, Gotsopoulos et al, Sleep, 2004; Barnes et al, AJRCCM, Itzhaki et al, Chest 2007

15 Long-term Effectiveness Continued long term benefit at 5 years 90% still using treatment Continued symptom control Continued PSG efficacy (82% AHI<10/hr), even in those with severe OSA at baseline Need for appliance replacement (32%) Regular medical & dental follow-up required Marklund et al, Chest 2001

16 Adherence High self-reported nightly compliance (6.7hrs) (Gotsopoulos et al, AJRCCM 2002) Average adherence of 77% at 1 year (Ferguson et al, Sleep 2006) 90% continued use at 5 years in short-term responders (Marklund et al, Chest 2001) Relapse usually due to weight gain or appliance deterioration (Marklund et al, Chest 2004) Compared with CPAP adherence 46-83% patients are nonadherent (ie. use CPAP 4hrs per night) (Weaver & Grunstein, PATS 2008)

17 Adherence Titrated mandibular advancement vs CPAP Cross-over study with 8 weeks intervention N=59 Subjective compliance - MAS 7.0 hrs (6-8), 98% nights - CPAP 6.0 hrs (4-7), 90% nights Objective CPAP compliance hrs ( ) Treatment preference: 71% MAS, 8.5% CPAP, 21.5% no preference Gagnadouz et al,erj,2009

18 Treatment Preference

19 Acute Side Effects Compared to control: Jaw discomfort Tooth tenderness Excessive salivation Generally mild 99% expressed desire to continue MAS treatment High self-reported compliance (6.7hrs) Gotsopoulos et al AJRCCM 2002

20 Acute Side-effects: MAS vs CPAP Scoring system for quantifying and comparing sideeffects for CPAP and MAS (0,1,2,3) CPAP nasal congestion, drippy, irritated, skin lesion, eye iritation, dry mouth MAS jaw pain, tooth pain, muscle stiffness, dry mouth, hypersalivation, occlusal change Similar symptom scores (3.2 vs 3.2) Gagnadouz et al,erj,2009

21 Long-Term Side Effects Retroclination of the maxillary incisors Distal tipping of the maxillary molars Proclination of the mandibular incisors Mesial tipping of the mandibular molars 2001 Courtesy: Prof Alan Lowe, UBC

22 Suggested Criteria for Assessing Performance of Any Treatment for OSA Cost PSG Parameters Convenience Symptom control Acceptance Health Outcomes Patient tolerance Adherence

23 Comparison of Treatment Performance: MAS vs CPAP PSG efficacy Affordability Symptom control Convenience Health benefits Patient & partner acceptance Chan & Cistulli, Cur Opin Pulmon Med, 2009 Tolerance Adherence CPAP MAS

24 AASM Practice Parameters 2005 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 do not respond to CPAP, are not appropriate candidates for CPAP, or who fail treatment attempts with CPAP or treatment with behavioral measures such as weight loss or sleep position change. (Guideline) Kushida et al, Sleep, 2006

25 Clinical Protocol Multidisciplinary approach Physician (OSA diagnosis, dental referral, evaluation of treatment response, medical follow-up) Dentist (suitability for and choice of OA, supervise titration, monitor response and side-effects, dental follow-up) Titration Protocol Initial advancement to 50-60% of maximum Incremental advancement over weeks or months Appropriate end-point of titration?

26 Contraindications Temporomandibular joint dysfunction Insufficient teeth (need 8-10 in each arch) Periodontal disease / tooth mobility Need for rapid control of OSA Central sleep apnea / hypoventilation syndromes

27 Predictors of Treatment Response Anthropomorphic Younger age Female gender Lower BMI Smaller neck circumference Smaller overjet Imaging Nasopharyngoscopy CT/MRI Cephalometric Polysomnographic Lower baseline AHI Supine-dependent OSA (Oropharyngeal collapse) Awake Physiological Measures Flow-volume loops Nasal resistance Liu Y et al. Am J Orthod Dentofacial Orthop 2001 Marklund M et al. Chest 1998 Mehta A et al. AJRCCM 2001 Ng AT et al. Sleep 2006 Zeng et al, AJRCCM, 2007 Zeng et al, Sleep, 2008

28 Combination with other Therapy? Weight loss Nasal decongestants Surgery CPAP

29 MAS vs Tongue Stabilizing Device N=27 Mean age: 49.4±11 (SD) yrs Mean AHI: 27.0±17.2 /hr Mean min SaO 2 : 84.3±6.5 % Post-treatment AHI: MAS 12±9 vs TSD 13±11 / hr Deane et al, Sleep, 2009

30 MAS vs TSD % of patients Figure 4. Comparison of compliance frequency reported by patients using MAS and TSD. Deane et al, Sleep, 2009

31 Orofacial Orthopedics Rapid Maxillary Expansion (RME) Functional appliance for promoting mandibular growth Prevention of OSA in Children? Reverse-Pull Headgear for promoting maxillary growth