Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity

Launched by AESYRA SA · Nov 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a device called AesyBite Active in reducing sleep bruxism, which is the habit of grinding or clenching teeth during sleep. The goal is to see if this device can help people who experience this issue, which can lead to tooth damage and discomfort.

To participate in the trial, you need to be between 18 and 70 years old and generally healthy. You should have experienced tooth grinding sounds at night or noticeable muscle changes in your jaw. You also need to have some signs of tooth wear or feel discomfort in your jaw when you wake up. If you qualify, you will be asked to use the AesyBite Active and complete some questionnaires about your experience. It's important to note that certain conditions, like allergies to specific materials or ongoing orthodontic treatments, may exclude you from participating. If you're interested, this could be a helpful way to address bruxism and improve your sleep quality!

Gender

ALL

Eligibility 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.