Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity

Not Applicable

Recruiting

• Conditions: Sleep Bruxism
• Interventions: Device: Biofeedback stimulation

• Registration Number: NCT06153810
• Lead Sponsor: Aesyra SA

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-16
• Study Start: 2023-11-17
• Study First Submitted QC: 2023-11-30
• Study First Posted: 2023-12-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed stimulation	Biofeedback stimulation	Biofeedback treatment is started after three weeks of observation
Early stimulation	Biofeedback stimulation	Biofeedback treatment is started after two weeks of observation

Primary Outcome Measures

Name	Time	Method
Reduction of the bruxism activity	1 month	Evaluation of the efficacy of AesyBite Active in reducing the bruxism activity expressed as total sleep bruxism duration per hour (TDPH, sec/hour) by at least 60% in the stimulation phase compared with baseline with a 10% non-inferiority margin.

Secondary Outcome Measures

Name	Time	Method
Change in self-reported comfort marked on a visual analogue scale	1 month	Change in self-reported comfort assessed using a visual analogue scale (VAS) with a comfort severity scale from 0 to 10.
Relative change in average intensity of bruxism episodes	1 month	A measure of the average bite strength exerted during the bruxism episodes.
Change in self-reported sleep quality marked on a visual analogue scale	1 month	Change in self-reported sleep quality assessed using a visual analogue scale (VAS) with a sleep quality scale from 0 to 10.
Reduction of the bruxism index	1 month	Evaluation of the efficacy of AesyBite Active in reducing the bruxism index expressed as number of sleep bruxism episodes per hour (episodes/hour).
Reduction of the mean duration of sleep bruxism episode	1 month	Evaluation of the efficacy of AesyBite Active in reducing the mean duration of sleep bruxism episodes (sec/episode).
Change in self-reported retention marked on a visual analogue scale	1 month	Change in self-reported retention assessed using a visual analogue scale (VAS) with a retention severity scale from 0 to 10.
Change in self-reported ease of breathing marked on a visual analogue scale	1 month	Change in self-reported ease of breathing assessed using a visual analogue scale (VAS) with a ease of breathing severity scale from 0 to 10.
Change in self-reported pain marked on a visual analogue scale	1 month	Change in self-reported pain (facial pain, myofascial headache) assessed using a visual analogue scale (VAS) with a pain severity scale from 0 to 10.

Trial Locations

Locations (1)

Fondazione Irccs San Gerardo Dei Tintori; 🇮🇹 Monza, Monza E Brianza, Italy