Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity
NCT ID: NCT06153810
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2023-11-17
2025-11-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Delayed stimulation
Biofeedback treatment is started after three weeks of observation
Biofeedback stimulation
Delivery of the vibratory biofeedback stimulus
Early stimulation
Biofeedback treatment is started after two weeks of observation
Biofeedback stimulation
Delivery of the vibratory biofeedback stimulus
Interventions
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Biofeedback stimulation
Delivery of the vibratory biofeedback stimulus
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Aesyra SA
INDUSTRY
Responsible Party
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Principal Investigators
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Marcello Maddalone
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS San Gerardo dei Tintori
Locations
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Fondazione Irccs San Gerardo Dei Tintori
Monza, Monza E Brianza, Italy
Countries
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Other Identifiers
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ABA020-CIP-001
Identifier Type: -
Identifier Source: org_study_id