Status:
COMPLETED
Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity
Lead Sponsor:
Aesyra SA
Conditions:
Sleep Bruxism
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The overall objective of the clinical investigation is to evaluate whether the use of the AesyBite Active reduces the bruxism activity.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2025
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06153810
Start Date
November 17 2023
End Date
November 7 2025
Last Update
December 23 2025
Active Locations (1)
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1
Fondazione Irccs San Gerardo Dei Tintori
Monza, Monza E Brianza, Italy, 20900