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New splint aims to diagnose teeth grinding accurately

NCT ID NCT03363204

Diagnosis Sponsor: Hospices Civils de Lyon 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new device called the BRUXENSE occlusal splint to see if it can help diagnose sleep bruxism (teeth grinding). Seven adults with bruxism tried wearing the splint for 10 nights. The goal was to see if they could use it comfortably and if it collected enough data for a diagnosis.

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

7 people

The number who actually took part.

Started

Feb 2018

Finished

Dec 2018

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * adult from 18-70 * patients diagnosed with bruxism according to the following criteria: * positive question at one of the following question: * are you aware of your grinding? * does your partner hear you grinding? * are you aware that you are frequently tighten your jaws during the day and/or the night? * are you tired and/or do experience jaws 'muscular pain in the morning. * presence of at least one criteria: * abnormal tooth wear or tooth prosthesis damages * Hypertrophy of the masseter muscles * patients agreeing to participate * patient able to understand and follow the protocol * patient with health insurance Exclusion Criteria: * patients with more than 2 missing tooth * Severe troubles to correctly close the mouth. * neurological disorder (Parkinson, Alzheimer) or psychiatric disorder * Sleep disorder (insomnia, narcolepsy, sleep apnea, restless leg disorder) * use of drugs that potentially impair sleep (benzodiazepines, neuroleptics, tricyclic antidepressants) alcohol or narcotics. * complete or partial removal dental prosthesis or orthodontic device * Patient under legal protection * pregnant women * Patients deprived of their freedom by a judicial or administrative decision

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Conditions

The condition(s) this trial relates to.

bruxism Sleep Bruxism

As listed by the trial registrant

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

Bruxism, sleep-related

Contacts and locations

Locations

  • Service de Consultations et de Traitements Dentaires, Hospices Civils de Lyon

    Lyon, France, 69007, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.