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Could a simple mouthguard silence your ringing ears?

NCT ID NCT07211711

Symptom relief Sponsor: University of Sao Paulo General Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a stabilizing occlusal splint (a type of mouthguard) can reduce tinnitus (ringing in the ears) in people who also have temporomandibular joint (TMJ) disorder. Researchers will compare the real splint to a placebo splint in 63 adults over 4 months, measuring changes in tinnitus distress and quality of life.

What this could mean

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

Active substance
stabilizing occlusal splint
What this could lead to
If it works, this could provide a simple, non-drug treatment option for people whose tinnitus is linked to jaw joint problems.
What could go wrong
This is a small, early-stage trial with only 63 participants. The splint may not improve tinnitus more than a placebo, and results may not apply to everyone with tinnitus.

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 63 people

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

Started

Aug 2023

Expected to finish

Jun 2026

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

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: * Patients over 18 years old; * Sufferers of somatosensory tinnitus and TMD for more than 6 months; * Dentition in good health, with at least minimal occlusion up to the second premolars on both sides; * Availability for at least 4 months of follow-up; * Able to speak and read the Portuguese language. Exclusion Criteria: Pregnant patients; Treatment for TMD in the last 3 months; Treatment for tinnitus in the last 3 months; Use of total or partial removable prostheses Presence of orofacial pain disorders not related to TMD; Medical contraindication to treatment; Reluctance to accept any designated treatment; Unable or unwilling to give informed consent; Language barrier or delay in neuropsychomotor development.

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Conditions

The condition(s) this trial relates to.

temporomandibular joint disorder temporomandibular joint dysfunction syndrome tinnitus

As listed by the trial registrant

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

Temporomandibular disorders (TMD) Tinnitus TMJ

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

  • University of São Paulo Faculty of Medicine Clinics Hospital

    RECRUITING

    São Paulo, São Paulo, 05.403-905, Brazil

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