Breakage-Related Remanufacture of Mandibular Advancement Devices in Patients With Obstructive Sleep Apnea: A Retrospective Study of 219 Patients

Introduction: Mandibular advancement devices (MADs) are used for obstructive sleep apnea (OSA), but the frequency of new-device fabrication following breakage during treatment is uncertain.Methods: We analyzed 219 patients treated with a custom-made fixed-type MAD at a single center.The endpoint was the first documented new-device fabrication due to device breakage, across successive appliances if necessary, measured from the initial recorded fabrication date.The record term "repair" denoted new-device fabrication, whereas adjustment of an existing device was not an event.Dentaltreatment and loss-related replacements did not end patient-level observation.For patients without a documented breakage event, absence of a return visit was assumed to mean no recorded event through March 31, 2025.Results: Fifty-eight of 219 patients (26.5%) had a first breakage-related remanufacture; 161 were administratively censored.Two patients had an intervening new device for a non-device reason: one later had a breakage event and one did not.Median analytic observation time was 45.9 months (IQR 18.4-77.3;range 0.3-180.7).Estimated event-free survival at one and three years was 91.6% (95% CI 87.0-94.6)and 81.1% (95% CI 74.8-86.0),respectively.Actual last-contact dates and loss to clinical follow-up could not be determined.Conclusion: Breakage-related new-device fabrication was documented during MAD treatment.These patient-level estimates depend on an unverified assumption that patients who did not return had no recorded event; they do not describe the physical lifespan of a single appliance or treatment efficacy.