Aesyra SA, a Swiss medtech company developing digital therapeutics for dental and sleep-related disorders, today announced the successful completion of its clinical investigation evaluating the efficacy and safety of AesyBite Active, a smart mouthguard that uses biofeedback to treat and prevent sleep bruxism, or teeth grinding.
The device, which also incorporates sensors for tracking sleep bruxism, is designed to gently vibrate and help stop teeth grinding without waking up the user.
The company said the clinical investigation demonstrated that AesyBite Active achieved a statistically significant and clinically meaningful reduction in sleep bruxism activity, exceeding the predefined performance target.
Aesyra said the device reduced number of bruxism episodes per hour, shortened bruxism episode duration, lowered intensity of bruxism episodes, and demonstrated no negative impact on sleep duration.
The therapeutic effect was consistent regardless of baseline bruxism severity and independent of the timing of biofeedback activation.
No adverse events were reported during the investigation. Patient-reported outcomes showed progressive improvements in orofacial pain, as well as improved comfort and acceptance of the device over time, supporting its suitability for long-term nightly use.
