Overview
The overall objective of the clinical investigation is to evaluate whether the use of the AesyBite Active reduces the bruxism activity.
Eligibility
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.