Clinical- and Cost-Effectiveness of a Mandibular Advancement Device Versus Continuous Positive Airway Pressure in Moderate Obstructive Sleep Apnea.

STUDY OBJECTIVES: Limited evidence exists on the cost-effectiveness of mandibular advancement device (MAD) compared to continuous positive airway pressure (CPAP) therapy in moderate obstructive sleep apnea (OSA). Therefore, this study compares the clinical and cost-effectiveness of MAD therapy with CPAP therapy in moderate OSA. METHODS: In a multicentre randomized controlled trial, patients with an apnea-hypopnea index (AHI) of 15 to 30 events/h were randomized to either MAD or CPAP. Incremental cost-effectiveness and cost-utility ratios (ICER/ICUR, in terms of AHI reduction and quality-adjusted life-years [QALYs, based on the EuroQol Five-Dimension Quality of Life questionnaire]) were calculated after 12 months, all from a societal perspective. RESULTS: In the 85 randomized patients (n = 42 CPAP, n = 43 MAD), AHI reduction was significantly greater with CPAP (median reduction AHI 18.3 [14.8-22.6] events/h) than with MAD therapy (median reduction AHI 13.5 [8.5-18.4] events/h) after 12 months. Societal costs after 12 months were higher for MAD than for CPAP (mean difference €2.156). MAD was less cost-effective than CPAP after 12 months (ICER -€305 [-€3.003 to €1.572] per AHI point improvement). However, in terms of QALY, MAD performed better than CPAP after 12 months (€33.701 [-€191.106 to €562.271] per QALY gained). CONCLUSIONS: CPAP was more clinically effective (in terms of AHI reduction) and cost-effective than MAD. However, costs per QALY was better with MAD as compared to CPAP. Therefore, CPAP is the first-choice treatment option in moderate OSA and MAD may be a good alternative. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Identifier: NCT01588275.

Oral appliance for Obstructive Sleep Apnea: Prototyping and Optimization of the Mandibular Protrusion Device.

Obstructive Sleep apnea is a public health problem. This disease is associated with daytime sleepiness, increased motor vehicle accidents, heart failure and stroke. Treatment options include weight loss, positive airway pressure, pharyngeal and orthognatic surgery. However, selected patients have good response to oral appliances devices that intended to protrude and stabilize the mandible mechanically during the night in order to reduce the collapsibility of the upper airway. Selection of patients includes primary snoring, mild, moderate and positional apnea. The perfect mandibular advance device has not yet been designed. For these reasons, the objective of this paper is to present a new thermoadjustable chair-side oral appliance. Device integrates the best characteristics of custom made and boils and bite previous designs and minimizes inconveniences and possible side effects. The device is a titratable mandibular advancement appliance. It consists of two independent prefabricated trays adaptable to the shape of adult dental arch and linked to each other by a protrusion mechanism. Each tray contains a hard outer shell and a soft thermoplastic resin inner body. The position of the jaw can be adjusted by moving an aluminum rack into, or out from, the guide so the ratchet may get locked into a certain position ensuring the length of the mechanism. The protrusion mechanism is fixed to the splint using small rings that are articulated over a "t" button. Our prototype satisfies the requirements of an effective oral appliance, in terms of retention, comfort, safety and efficacy. It is easy to fit, durable, low cost, quickly titratable, not bulky and easy cleaning. Thermoplastic appliances are specially used like a predictor of treatment response in apnea patients. The device described is a cost-effective introduction to mandibular advancement technology. A qualified dentist or trained sleep doctor could mitigate dental side effects and reduce their incidence.

Clinical effectiveness and cost-effectiveness results from the randomised controlled Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea-hypopnoea (TOMADO) and long-term economic analysis of oral devices and continuous positive airway pressure.

BACKGROUND: Obstructive sleep apnoea-hypopnoea (OSAH) causes excessive daytime sleepiness (EDS), impairs quality of life (QoL) and increases cardiovascular disease and road traffic accident risks. Continuous positive airway pressure (CPAP) treatment is clinically effective but undermined by intolerance, and its cost-effectiveness is borderline in milder cases. Mandibular advancement devices (MADs) are another option, but evidence is lacking regarding their clinical effectiveness and cost-effectiveness in milder disease. OBJECTIVES: (1) Conduct a randomised controlled trial (RCT) examining the clinical effectiveness and cost-effectiveness of MADs against no treatment in mild to moderate OSAH. (2) Update systematic reviews and an existing health economic decision model with data from the Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea-hypopnoea (TOMADO) and newly published results to better inform long-term clinical effectiveness and cost-effectiveness of MADs and CPAP in mild to moderate OSAH. TOMADO: A crossover RCT comparing clinical effectiveness and cost-effectiveness of three MADs: self-moulded [SleepPro 1™ (SP1); Meditas Ltd, Winchester, UK]; semibespoke [SleepPro 2™ (SP2); Meditas Ltd, Winchester, UK]; and fully bespoke [bespoke MAD (bMAD); NHS Oral-Maxillofacial Laboratory, Addenbrooke's Hospital, Cambridge, UK] against no treatment, in 90 adults with mild to moderate OSAH. All devices improved primary outcome [apnoea-hypopnoea index (AHI)] compared with no treatment: relative risk 0.74 [95% confidence interval (CI) 0.62 to 0.89] for SP1; relative risk 0.67 (95% CI 0.59 to 0.76) for SP2; and relative risk 0.64 (95% CI 0.55 to 0.76) for bMAD (p < 0.001). Differences between MADs were not significant. Sleepiness [as measured by the Epworth Sleepiness Scale (ESS)] was scored 1.51 [95% CI 0.73 to 2.29 (SP1)] to 2.37 [95% CI 1.53 to 3.22 (bMAD)] lower than no treatment (p < 0.001), with SP2 and bMAD significantly better than SP1. All MADs improved disease-specific QoL. Compliance was lower for SP1, which was unpopular at trial exit. At 4 weeks, all devices were cost-effective at £20,000/quality-adjusted life-year (QALY), with SP2 the best value below £39,800/QALY. META-ANALYSIS: A MEDLINE, EMBASE and Science Citation Index search updating two existing systematic reviews (one from November 2006 and the other from June 2008) to August 2013 identified 77 RCTs in adult OSAH patients comparing MAD with conservative management (CM), MADs with CPAP or CPAP with CM. MADs and CPAP significantly improved AHI [MAD -9.3/hour (p < 0.001); CPAP -25.4/hour (p < 0.001)]. Effect difference between CPAP and MADs was 7.0/hour (p < 0.001), favouring CPAP. No trials compared CPAP with MADs in mild OSAH. MAD and CPAP reduced the ESS score similarly [MAD 1.6 (p < 0.001); CPAP 1.6 (p < 0.001)]. LONG-TERM COST-EFFECTIVENESS: An existing model assessed lifetime cost-utility of MAD and CPAP in mild to moderate OSAH, using the revised meta-analysis to update input values. The TOMADO provided utility estimates, mapping ESS score to European Quality of Life-5 Dimensions three-level version for device cost-utility. Using SP2 as the standard device, MADs produced higher mean costs and mean QALYs than CM [incremental cost-effectiveness ratio (ICER) £6687/QALY]. From a willingness to pay (WTP) of £15,367/QALY, CPAP is cost-effective, although the likelihood of MADs (p = 0.48) and CPAP (p = 0.49) being cost-effective is very similar. Both were better than CM, but there was much uncertainty in the choice between CPAP and MAD (at a WTP £20,000/QALY, the probability of being the most cost-effective was 47% for MAD and 52% for CPAP). When SP2 lifespan increased to 18 months, the ICER for CPAP compared with MAD became £44,066. The ICER for SP1 compared with CM was £1552, and for bMAD compared with CM the ICER was £13,836. The ICER for CPAP compared with SP1 was £89,182, but CPAP produced lower mean costs and higher mean QALYs than bMAD. Differential compliance rates for CPAP reduces cost-effectiveness so MADs become less costly and more clinically effective with CPAP compliance 90% of SP2. CONCLUSIONS: Mandibular advancement devices are clinically effective and cost-effective in mild to moderate OSAH. A semi-bespoke MAD is the appropriate first choice in most patients in the short term. Future work should explore whether or not adjustable MADs give additional clinical and cost benefits. Further data on longer-term cardiovascular risk and its risk factors would reduce uncertainty in the health economic model and improve precision of effectiveness estimates. TRIAL REGISTRATION: This trial is registered as ISRCTN02309506. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 67. See the NIHR Journals Library website for further project information.

A crossover randomised controlled trial of oral mandibular advancement devices for obstructive sleep apnoea-hypopnoea (TOMADO).

RATIONALE: Mandibular advancement devices (MADs) are used to treat obstructive sleep apnoea-hypopnoea syndrome (OSAHS) but evidence is lacking regarding their clinical and cost-effectiveness in less severe disease. OBJECTIVES: To compare clinical- and cost-effectiveness of a range of MADs against no treatment in mild to moderate OSAHS. MEASUREMENTS AND METHODS: This open-label, randomised, controlled, crossover trial was undertaken at a UK sleep centre. Adults with Apnoea-Hypopnoea Index (AHI) 5-<30/h and Epworth Sleepiness Scale (ESS) score ≥9 underwent 6 weeks of treatment with three non-adjustable MADs: self-moulded (SleepPro 1; SP1); semi-bespoke (SleepPro 2; SP2); fully-bespoke MAD (bMAD); and 4 weeks no treatment. Primary outcome was AHI scored by a polysomnographer blinded to treatment. Secondary outcomes included ESS, quality of life, resource use and cost. MAIN RESULTS: 90 patients were randomised and 83 were analysed. All devices reduced AHI compared with no treatment by 26% (95% CI 11% to 38%, p=0.001) for SP1, 33% (95% CI 24% to 41%) for SP2 and 36% (95% CI 24% to 45%, p<0.001) for bMAD. ESS was 1.51 (95% CI 0.73 to 2.29, p<0.001, SP1) to 2.37 (95% CI 1.53 to 3.22, p<0.001, bMAD) lower than no treatment (p<0.001 for all). Compliance was lower for SP1, which was the least preferred treatment at trial exit. All devices were cost-effective compared with no treatment at a £20,000/quality-adjusted life year (QALY) threshold. SP2 was the most cost-effective up to £39,800/QALY. CONCLUSIONS: Non-adjustable MADs achieve clinically important improvements in mild to moderate OSAHS and are cost-effective. Of those trialled, the semi-bespoke MAD is an appropriate first choice. TRIAL REGISTRATION NUMBER: ISRCTN02309506.

[Trends in prevalence of continuous positive airway pressure treatment for adults from 2006 to 2010]. / Évolution de 2006 à 2010 du nombre d'adultes traités par pression positive continue.

INTRODUCTION: The aim of this study was to evaluate the evolution from 2006 to 2010 of the prevalence of continuous positive airway pressure treatment for the beneficiaries of two regional health care insurance funds (17 and 43). METHODS: One million forty-eight thousand four hundred and thirty beneficiary-years were analyzed from 2006 to 2010. The prevalence of continuous positive airway pressure treatment was tested with regard to the effect of the year of delivery. A logit regression was used to adjust for potentially confounding differences in age and gender, which were included as covariates. The prevalence of alternative treatments and of controls of reimbursement benefits implemented by the funds are evaluated too during the same period. RESULTS: Continuous positive airway pressure treatment annual prevalence was 6.34/1000. A significant annual increase of prevalence from 2006 to 2008 was followed by a slowing of the rate of growth starting from 2008. In the same time for fund 43, obesity surgery rose from 41.85/100,000 to 55.44/100,000 and mandibular osteotomy surgery rose from 0.97/100,000 to 4.78/100,000. For fund 17 mandibular advancement devices rose from 10.72/100,000 to 21,08/100,000. The two funds started a reinforced inspections of reimbursement benefits for continuous positive airway pressure treatment in 2008. CONCLUSIONS: The dynamics of continuous positive airway pressure treatment have to be considered in the context of policies introduced and trends in the application of alternative treatments in each fund.

Skeletal stability in bimaxillary orthognathic surgery: P(L/DL)LA-resorbable versus titanium osteofixation.

BACKGROUND: One-year skeletal stability following bimaxillary orthognathic surgery was assessed by comparing poly(L-lactide-co-DL-lactide) to titanium osteofixation. METHODS: Thirty patients underwent osteofixation with poly(L-lactide-co-DL-lactide) copolymer and 30 had 2.0-mm titanium-miniplate osteosyntheses. Lateral cephalograms were analyzed preoperatively, postoperatively, and at 1-year follow-up. Average +/- SD values were as follows in resorbable plate-osteosyntheses (number of cases/titanium controls): for maxillary advancement, 3.5 +/- 4.1 mm (n = 19)/5.4 +/- 3.5 mm (n = 21); setback, 2.8 +/- 3.7 mm (n = 9)/1.9 +/- 1.8 mm (n = 8); elongation, 4.2 +/- 3.6 mm (n = 18)/3.7 +/- 5.2 mm (n = 14); and intrusion, 1.9 +/- 1.7 mm (n = 12)/3.3 +/- 2.7 mm (n = 13); for mandibular advancement, 4.6 +/- 3.6 mm (n = 10)/6.3 +/- 8.8 mm (n = 18); setback, 7.5 +/- 8.3 mm (n = 20)/7.2 +/- 3.2 mm (n = 12); enlargement of the mandibular angle, 11.8 +/- 9.9 degrees (n = 19)/7.9 +/- 6.6 degrees (n = 21); and reduction, 4.5 +/- 3.2 degrees (n = 9)/6.3 +/- 6.6 degrees (n = 9). RESULTS: Preoperative to postoperative landmark positions within the study and control groups differed highly significantly (p = 0.008, paired t test), yet the amount of operative movement was comparable between the study and control groups (p = 0.5, two-sided t test). Absolute instability at the advanced A-point was (study group/controls) 2.3 +/- 1.8/2.4 +/- 2 mm, setback was 2.3 +/- 1.9 mm/2.5 +/- 1.7 mm, elongation at the anterior nasal spine was 3.8 +/- 3.1 mm/3.1 +/- 3.6 mm, intrusion was 2.1 +/- 1.9 mm/2.2 +/- 1.5 mm, advancement instability at the B-point was 4.9 +/- 4.3 mm/5.1 +/- 8.2 mm, setback was 3.0 +/- 2 mm/1.7 +/- 2 mm, mandibular angle enlargement instability was 6.7 +/- 8.9 degrees/8.2 +/- 9.6 degrees, and angle narrowing was 6.8 +/- 5.2 degrees/4.2 +/- 5.9 degrees. Absolute postoperative instability did not differ significantly between the study and control groups (p = 0.6). CONCLUSIONS: Resorbable osteofixation as tested proved to be as reliable as titanium, but as the study and control groups were not matched, the results have to be interpreted as preliminary. Resorbable materials permitted clinically faster occlusal and condylar settling than standard titanium osteosyntheses, as bone segments showed slight clinical mobility up to 6 weeks postoperatively.

Outcome of treatment of Class II malocclusion by intraoral mandibular distraction.

Our aim was to find out long-term results of treatment in patients treated orthodontically and by mandibular distraction osteogenesis. Data on duration of treatment, costs, and results of 26 patients (13 girls and 13 boys) with a mean age of 15 years were analysed. The preoperative cephalograms were compared with those taken at the last follow-up visit. There was a significant reduction in duration of treatment when patients were treated without a first phase that included functional appliances. The differences in costs of orthodontic treatment were not significant. The costs of the operation for distraction were significantly higher compared to BSSO, mainly because of the costs of the distraction devices. Comparison of the cephalograms showed a significant increase in SNB angle, Wits value, ANB angle, overjet, and overbite. The Y-axis, MP/S, and SpP/MP angle increased. Orthodontic treatment and distraction of the mandible was a successful, but more expensive, treatment.