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Can a simple mouth splint tame nighttime teeth grinding? new study aims to find out

NCT ID NCT07611643

Knowledge-focused Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 will track jaw muscle activity in 42 adults with chronic jaw pain and teeth grinding (bruxism) who use a custom mouth splint at night. Participants will wear a portable device for 24 hours to measure muscle activity before starting the splint, two weeks later, and after two months. The goal is to see how the splint affects grinding and clenching, and compare results to healthy people without jaw pain.

What this could mean

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

Active substance
gnathological occlusal splint
What this could lead to
If successful, this study could clarify how occlusal splints reduce jaw muscle activity and pain, leading to better treatment guidelines for bruxism and TMD.
What could go wrong
This is a small, early-stage study with only 42 participants, so results may not apply to everyone. It focuses on measurement, not a new treatment, so no direct health benefit is guaranteed.

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

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jan 2027

An estimate. End dates often move.

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 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 subjects aged ≥ 18 years * Subjects willing to provide written informed consent * Patients with temporomandibular disorders who have an indication for treatment with a gnathological occlusal splint Exclusion Criteria: * Patients who change their pharmacological regimen during the monitoring period, as drug therapy may affect facial pain and/or muscle activity.

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Conditions

The condition(s) this trial relates to.

bruxism insomnia myofascial pain syndrome Sleep Bruxism temporomandibular joint disorder

As listed by the trial registrant

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

Bruxism Bruxism, sleep-related Sleep quality

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinica Odontostomatologica - Fondazione Policlinico IRCSS A. Gemelli

    RECRUITING

    Roma, Roma, 00168, Italy

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