Skip to main content
OpenTrials
Completed

NCT Number: NCT06153810

Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Irccs San Gerardo Dei Tintori

Monza, Monza E Brianza, 20900, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biofeedback stimulation

Device

Delivery of the vibratory biofeedback stimulus

Primary outcomes

  1. Reduction of the bruxism activity

    Time frame: 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 outcomes

  1. Reduction of the bruxism index

    Time frame: 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).

  2. Reduction of the mean duration of sleep bruxism episode

    Time frame: 1 month

    Evaluation of the efficacy of AesyBite Active in reducing the mean duration of sleep bruxism episodes (sec/episode).

  3. Relative change in average intensity of bruxism episodes

    Time frame: 1 month

    A measure of the average bite strength exerted during the bruxism episodes.

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

    Time frame: 1 month

    Change in self-reported sleep quality assessed using a visual analogue scale (VAS) with a sleep quality scale from 0 to 10.

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

    Time frame: 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.

  6. Change in self-reported comfort marked on a visual analogue scale

    Time frame: 1 month

    Change in self-reported comfort assessed using a visual analogue scale (VAS) with a comfort severity scale from 0 to 10.

  7. Change in self-reported retention marked on a visual analogue scale

    Time frame: 1 month

    Change in self-reported retention assessed using a visual analogue scale (VAS) with a retention severity scale from 0 to 10.

  8. Change in self-reported ease of breathing marked on a visual analogue scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aesyra SA

Industry

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 1, 2023
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.