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Botox vs. splints: which stops teeth grinding best for denture wearers?

NCT ID NCT07361900

Symptom relief Sponsor: Delta University for Science and Technology 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested three ways to manage sleep bruxism (teeth grinding) in 48 people with implant-supported dentures. One group got Botox injections into the jaw muscles, another used a custom mouth splint at night, and a third simply removed their dentures at night (control). Researchers measured muscle activity and denture retention over 12 months to see which approach worked best.

What this could mean

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

Active substance
Botulinum toxin type A (Botox)
What this could lead to
If Botox works better than splints or no treatment, it could offer a simple injection to reduce teeth grinding and improve denture fit.
What could go wrong
This is a small, early-phase study with only 48 people. Botox may not work for everyone, and effects are temporary, requiring repeat injections.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

48 people

The number who actually took part.

Started

Mar 2024

Finished

Aug 2025

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

50 to 75 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: * a confirmed diagnosis of definite sleep bruxism (SB) * retention of natural dentition in the maxillary dental arch, without missing a single tooth of 6 anterior teeth, with no more than one or two missing premolar or molar teeth per quadrant * existing implant-retained single overdentures (OD) that had been functionally loaded for at least one year prior to study initiation Exclusion Criteria: * had undergone any previous therapeutic interventions for bruxism * exhibited medical conditions with known impacts on temporomandibular joint (TMJ) function, including (but not restricted to) post-radiation effects, osteoarthritis, or trauma-related pathologies. * Any contraindication for BTX-A injection such as, allergy, pregnancy, and lactation.

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Conditions

The condition(s) this trial relates to.

bruxism parasomnia, sleep bruxism type

As listed by the trial registrant

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

Bruxism

Contacts and locations

Locations

  • Delta University for Science and Technology

    Gamasa, Egypt

More trials for these conditions

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