Using AesyBite Active to reduce sleep bruxism
Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity
This study is testing if a new device called AesyBite Active can help people aged 18 to 70 reduce tooth grinding while they sleep.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Aesyra SA Industry-sponsored |
| Locations | 1 site (Monza, Monza E Brianza) |
| Trial ID | NCT06153810 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to evaluate the effectiveness of AesyBite Active, a biofeedback device, in reducing the activity of sleep bruxism. Participants will be monitored for signs of tooth grinding during sleep, and the device will provide feedback to help manage this condition. The study will include individuals aged 18 to 70 who have reported symptoms of bruxism and have previously used a night splint. The primary goal is to determine if the AesyBite Active can significantly decrease bruxism activity compared to baseline measurements.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 who experience symptoms of sleep bruxism and have previously used a night splint.
Not a fit: Patients with major neurological or psychiatric disorders or those currently undergoing orthodontic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to a reduction in tooth grinding, potentially alleviating associated dental damage and discomfort.
How similar studies have performed: While there is limited information on the specific use of biofeedback devices for bruxism, similar approaches in managing other conditions have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 to 70 years, in good general health. * Presence of at least one of the following: * sleeping partner's report of tooth grinding sounds during sleep for at least three nights per week within the last 6 months, * hypertrophy of the masseter muscle upon digital palpation. * Presence of at least one of the following: * signs of tooth attrition or shiny spots on dental restorations, * self-report of masticatory muscle fatigue or pain at awakening. * Previous prescription of a night splint for bruxism. * Able to understand and follow the protocol and complete the self-administered paper questionnaires. * Able to provide written informed consent to study participation and storage and processing of study data Exclusion Criteria: * Allergic to Ethylene-Vinyl Acetate (EVA) copolymer. * With more than two missing molars (excluding third molars). * Ongoing orthodontic treatment (e.g. teeth alignment). * With major neurological or psychiatric disorders including substance dependence. * Using a removable dental prosthesis. * Using a medication with known effects on sleep or motor behavior. * Suffering from periodontal disease. * With occlusal or jaw abnormalities that prevent the wearing of a normal dental splint. * Participants with pacemakers.
Where this trial is running
Monza, Monza E Brianza
- Fondazione Irccs San Gerardo Dei Tintori — Monza, Monza E Brianza, Italy (Recruiting)
Study contacts
- Principal investigator: Marcello Maddalone — Fondazione IRCCS San Gerardo dei Tintori
- Study coordinator: Marco Letizia
- Email: marco.letizia@aesyra.com
- Phone: +390282396887
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.