Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity (NCT06153810) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity
Italy26 participantsStarted 2023-11-17
Plain-language summary
The overall objective of the clinical investigation is to evaluate whether the use of the AesyBite Active reduces the bruxism activity.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.