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Botox for jaw pain: a shot at rewiring pain signals?

NCT ID NCT05720065

Disease control Sponsor: Karolinska Institutet 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This study tests whether botulinum toxin (Botox) injections into the jaw muscle can reduce pain and alter pain-related gene activity in people with painful jaw disorders. Half of the 100 participants receive Botox, the other half a placebo (saline). Researchers compare pain levels and muscle tissue samples before and after treatment to see if Botox changes how pain signals are processed.

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
What this could lead to
If it works, this could point toward a new way to treat jaw muscle pain by targeting pain signals at the source.
What could go wrong
This is a mid-stage trial, so results may not hold up in larger studies. Botulinum toxin injections can cause temporary muscle weakness or discomfort.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

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

Started

Nov 2023

Expected to finish

Aug 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

20 to 45 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 diagnosis of TMDM myalgia or myofascial pain according to the DC/TMD criteria * females with adequate contraceptives and a negative pregnancy test * pain upon digital palpation of at least one of the masseter muscle * a characteristic pain intensity of \> 40/100 * a negative pregnancy test at the day of treatment Exclusion Criteria: * difficulties understanding the Swedish language * systemic inflammatory connective tissue diseases * widespread pain * neuromuscular disorders * diagnosed or severe psychiatric disease * neuropathic pain * pain of dental origin * history of trauma to the face, head or neck * pregnancy or nursing * known allergy to botulinum toxin or antibiotics * use of muscle relaxants, antidepressant, neuropsychiatric, anticoagulant drugs, or aminoglycoside antibiotics * previous treatment with botulinum toxin during the last 12 months * use of analgesic or anti-inflammatory medication during the 48 hours preceding biopsy * skin infection over injection/biopsy site

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Conditions

The condition(s) this trial relates to.

Myalgia Pain temporomandibular joint disorder

As listed by the trial registrant

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

Temporomandibular disorders

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

  • Department of Dental Medicine, Karolinska Institutet

    RECRUITING

    Huddinge, Stockholm County, SE14104, Sweden

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