Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity

NCT06153810 | Completed

• 1 other identifier: ABA020-CIP-001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Bruxism

Outcome Measures

Primary Outcomes (1)

• Reduction of the bruxism activity

  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.

  1 month

Secondary Outcomes (8)

• Reduction of the bruxism index

  1 month

• Reduction of the mean duration of sleep bruxism episode

  1 month

• Relative change in average intensity of bruxism episodes

  1 month

• Change in self-reported sleep quality marked on a visual analogue scale

  1 month

• Change in self-reported pain marked on a visual analogue scale

  1 month

Study Arms (2)

Early stimulation

EXPERIMENTAL

Biofeedback treatment is started after two weeks of observation

Device: Biofeedback stimulation

Delayed stimulation

EXPERIMENTAL

Biofeedback treatment is started after three weeks of observation

Device: Biofeedback stimulation

Interventions

Biofeedback stimulation DEVICE

Delivery of the vibratory biofeedback stimulus

Delayed stimulation; Early stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aesyra SA: lead

Study Sites (1)

Fondazione Irccs San Gerardo Dei Tintori

Monza, Monza E Brianza, 20900, Italy

Location

MeSH Terms

Conditions

Sleep Bruxism

Condition Hierarchy (Ancestors)

Bruxism; Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Marcello Maddalone

  Fondazione IRCCS San Gerardo dei Tintori

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: December 1, 2023
• Study Start: November 17, 2023
• Primary Completion: November 7, 2025
• Study Completion: November 7, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-01

Locations

IT (1)