Ready-Made Versus Custom-Made Mandibular Repositioning Devices in Sleep Apnea: A Randomized Clinical Trial.

STUDY OBJECTIVES: To compare the effectiveness of a custom-made (MRDc) versus ready-made (MRDr) mandibular repositioning devices (MRD) in the management of obstructive sleep apnea (OSA). METHODS: A randomized crossover trial design was adopted in which patients with a confirmed diagnosis of OSA were randomly allocated to receive either a 3-month period of ready-made or custom-made MRD, with an intervening washout period of 2 weeks, prior to crossover. Treatment outcomes included both objective sleep monitoring and patient-centered measures (daytime sleepiness, partner snoring and quality of life). RESULTS: Twenty-five patients, with a mild degree of OSA (apnea-hypopnea index of 13.3 [10.9-25] events/h) and daytime sleepiness (Epworth Sleepiness Scale of 11 [6-16]), completed both arms of the trial. The MRDc achieved a complete treatment response in 64% of participants, compared with 24% with the MRDr (p < 0.001). A significant difference was observed in treatment failures, when comparing the MRDr (36%) with the MRDc (4%). Excessive daytime sleepiness (Epworth Sleepiness Scale >/= 10) persisted in 33% (MRDc) and 66% (MRDr) of OSA subjects, following treatment. A statistically significant improvement was observed in quality of life scales following MRDc therapy only. Significant differences were observed in relation to both the number of nights per week (p = 0.004) and hours per night (p = 0.006) between the two different designs of device. CONCLUSIONS: The study demonstrates the significant clinical effectiveness of a custom-made mandibular repositioning device, particularly in terms of patient compliance and tolerance, in the treatment of OSA.