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New device zaps teeth grinding with vibrations

NCT ID NCT06153810

Disease control Sponsor: Aesyra SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed trial tested a device called AesyBite Active, which uses gentle vibrations to reduce teeth grinding (sleep bruxism) during the night. 26 adults who grind their teeth wore the device while sleeping. The main goal was to see if it could cut grinding activity by at least 60% compared to no stimulation. The approach is non-invasive and aims to provide a drug-free option for managing bruxism.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AesyBite Active device (vibratory biofeedback stimulation)
What this could lead to
If it works, this could offer a non-drug, non-invasive way to reduce teeth grinding during sleep, potentially preventing dental damage and jaw pain.
What could go wrong
This is a small, early-stage trial with only 26 people. The device may not work for everyone, and long-term benefits or side effects are not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

26 people

The number who actually took part.

Started

Nov 2023

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

bruxism parasomnia, sleep bruxism type Sleep Bruxism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sleep bruxism

Contacts and locations

Locations

  • Fondazione Irccs San Gerardo Dei Tintori

    Monza, Monza E Brianza, 20900, Italy

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