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Can botox beat ibuprofen for jaw pain from teeth grinding?

NCT ID NCT07732751

Symptom relief Sponsor: NEW Cyprus Health and Social Sciences University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This trial compares Botox injections with ibuprofen pills to see which better eases jaw muscle pain and improves quality of life in people with sleep bruxism (teeth grinding). Forty adults with jaw pain are randomly assigned to receive either Botox injections into the masseter and temporalis muscles or a one-week course of oral ibuprofen. Researchers track pain levels, oral health-related quality of life, muscle tenderness, and jaw function over 20 weeks.

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) injections into the jaw muscles
What this could lead to
If Botox proves better than ibuprofen, it could offer a longer-lasting treatment option for chronic jaw pain from teeth grinding.
What could go wrong
This is a small, early-phase trial with only 40 participants. Botox injections carry risks like temporary muscle weakness or bruising, and the results may not apply to everyone with bruxism.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

40 people

The number who actually took part.

Started

Feb 2026

Finished

Jun 2026

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 65 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: * Adults aged 18 years or older. * Clinical diagnosis of sleep bruxism. * Presence of jaw muscle pain. * Ability to provide written informed consent. Exclusion Criteria: * Pregnancy or breastfeeding. * Previous botulinum toxin treatment within 6 months. * Neuromuscular disorders. * Allergy to botulinum toxin or ibuprofen. * Use of medications affecting neuromuscular function.

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Conditions

The condition(s) this trial relates to.

bruxism myofascial pain syndrome parasomnia, sleep bruxism type

As listed by the trial registrant

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

Bruxism Myofascial pain

Contacts and locations

Locations

  • New Cyprus Health and Social Sciences University

    Güzelyurt (Morphou), Northern Cyprus, 99750, Cyprus

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