UTHealth Houston Researchers Report Rising Adverse Events from Sleep Apnea Oral Appliances

Reports of adverse events linked to oral appliances used for obstructive sleep apnea are rising in the U.S. Food and Drug Administration database, according to a research letter published in the Journal of Clinical Sleep Medicine. Aaron Glick and Sue Ellen Richardson of the University of Texas Health Science Center at Houston School of Dentistry examined the Manufacturer and User Facility Device Experience database to chart how problems associated with the devices have changed over time. Their analysis reveals both a growing volume of incident reports and a shift in the categories of reported patient harm.

Database Analysis Shows Rising Reports and Shifting Harms

The FDA database serves as a passive surveillance system where manufacturers, importers, and user facilities must submit device-related deaths, serious injuries, and malfunctions. Healthcare professionals and the public may also file voluntary reports. Glick and Richardson used this repository to track adverse event trends across the reporting period for sleep-disordered breathing devices. The researchers found that the total number of reports is increasing and the types of reported problems are changing.

Oral appliances commonly rely on mandibular advancement devices, which are two-arch dental appliances that hold the lower jaw forward during sleep. This mechanical positioning tightens the upper airway to reduce the tissue collapse that drives apneic events. Clinical practice guidelines from the American Academy of Sleep Medicine and the American Academy of Dental Sleep Medicine endorse this therapy for obstructive sleep apnea patients, especially those who cannot tolerate continuous positive airway pressure machines or prefer another treatment.

Oral Appliance Therapy Reduces Hypoxic Burden but Causes Side Effects

Recent research highlights why oral appliance therapy has gained wider clinical acceptance. A 2025 analysis found that these devices effectively reduce sleep apnea-specific hypoxic burden, a metric linked to cardiovascular morbidity and mortality. A 2026 study comparing long-term outcomes of mandibular advancement devices with continuous positive airway pressure demonstrated meaningful therapeutic efficacy.

However, the mechanical action that makes the appliances effective—protruding the mandible night after night—also generates well-documented side effects. The dental sleep medicine literature has long catalogued temporomandibular joint discomfort, myofascial pain, dental pain, and occlusal changes where the bite shifts as teeth move under sustained force. Other recognized side effects include dry mouth, hypersalivation, and gum irritation. A 2025 systematic review and meta-analysis confirmed that these side effects are common and vary by device design across the market’s range of custom, semi-custom, and over-the-counter products. The American Academy of Dental Sleep Medicine recommends careful monitoring and follow-up as integral parts of managing these effects.

Multiple Factors Influence the Rise in Adverse Event Reports

The rising volume of adverse event reports in the FDA database carries important context, as passive reporting systems reflect multiple influencing factors beyond true injury incidence. Report counts respond to the size of the exposed population, growing awareness among clinicians and patients that reporting is possible, expanded device marketing, and the rise of teledentistry pathways. Glick and Richardson noted that the growth of teledentistry in dental sleep medicine requires safeguards because remote care models alter how side effects are detected, managed, and reported. Changes in the categorical mix of reports over time further suggest that the nature of device use, new device designs, or the evolving patient population receiving appliances may be altering real-world safety outcomes.

Oral appliances emerged as a visible alternative to CPAP machines for millions of snorers and apnea patients.