Clinicians at UTHealth Houston School of Dentistry have published new research examining changes in adverse event reports associated with oral appliances used to treat obstructive sleep apnea and snoring.
The article, “Increasing Reports and Shifting Categorical Trends in Adverse Event Reports for Oral Appliances,” was published online in the Journal of Clinical Sleep Medicine by Aaron Glick, DDS, and Sue Ellen Richardson, DDS, faculty in the Department of General Practice and Dental Public Health.
Mandibular advancement devices are a well-established treatment for obstructive sleep apnea and are recommended by the American Academy of Sleep Medicine and the American Academy of Dental Sleep Medicine as custom, titratable devices provided with ongoing clinical follow-up. As newer delivery models have emerged in recent years, including direct-to-consumer options, the researchers sought to better understand how reported adverse events have changed over time.
The study analyzed reports submitted to the U.S. Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database involving mandibular advancement devices from January 2020 through December 2025. Comparing data from 2020-23 with 2024-25, the researchers found that the average number of reports submitted to the FDA increased from 42 per year to 423.5 per year, a more than tenfold increase.
The study also identified a shift in the types of reported events. During 2020-23, allergy or biocompatibility reactions accounted for 78% of reported complaints. During 2024-25, broken or fractured devices represented 91.6% of reported events.
“Our findings highlight the importance of continued evaluation of oral appliance safety trends and delivery models as dental sleep medicine continues to evolve,” Glick said.
The researchers found that most of the increase in reports was associated with a single manufacturer and that many reports involved fractures of an anchor or hinge component without patient injury. They also identified a small but growing number of reports involving direct-to-consumer delivery models, an emerging trend they say warrants additional investigation.
The authors emphasize that the MAUDE database is a passive reporting system and does not measure how often adverse events occur among all oral appliance users. As a result, an increase in reported events should not be interpreted as an increase in the overall incidence of device failures.
“Oral appliance therapy remains an effective treatment option for obstructive sleep apnea,” Richardson said. “This research underscores the need for appropriate patient evaluation, device selection, and ongoing clinical follow-up consistent with professional guidelines.”
The authors conclude that their findings support continued evaluation of mechanical device failures and evolving delivery methods, contributing to ongoing efforts to improve patient safety and advance the field of dental sleep medicine.