Can botox calm the jaw and face muscles that Won't relax?
NCT ID NCT07792798
First seen Aug 28, 2026 · Last updated Aug 28, 2026
Summary
This trial tests whether botulinum toxin type A, commonly known as Botox, can ease the involuntary muscle contractions of oromandibular dystonia, a condition that affects the jaw, tongue, and face. Researchers inject the toxin into specific muscles using electromyography (EMG) to guide the needle precisely. Twenty patients with different subtypes of the condition will be followed for six months to see if chewing, speech, and discomfort improve, and to track any side effects.
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) injected into specific jaw and face muscles, guided by electromyography (EMG) to target the overactive muscles.
- What this could lead to
- If it works, this could offer a more precise, effective treatment for oromandibular dystonia, improving chewing, speaking, and swallowing for people with this condition.
- What could go wrong
- This is a small, early-phase trial with only 20 patients, so results may not apply to everyone. Botulinum toxin injections can cause side effects like temporary muscle weakness or difficulty swallowing.
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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
-
20 people
The number who actually took part.
- Started
-
Sep 2022
- Finished
-
Oct 2024
- 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
-
31 to 60 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 Hide 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: i) Patients with a confirmed diagnosis of OMD based on clinical evaluation. ii) Patients who have been referred to the maxillofacial departments at the Faculty of Dentistry, Sana'a University, specifically for the treatment of OMD. iii) Commitment to follow-up visits Exclusion Criteria: i) The presence of pathological findings at the site of injection, such as fibrous dysplasia, tumors, or cysts. ii) Patients who have known contraindications or allergies to botulinum toxin or its components. iii) Patients who are unlikely to be available for the required follow-up visits or have limited accessibility to the study site. iv) Previously treated with BTX-A within 6 months. v) Pregnant woman.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Sana'a university faculty of dentistry
Sanaa, Yemen
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