Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity

Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity

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

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.