Botulinum Toxin A for Jaw Dystonia .

NCT07792798 — Phase 1, Completed, 20 participants, Sana'a University

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The Effectiveness of Botulinum Toxin A in the Treatment of Oromandibular Dystonia in a Sample of Yemeni Patients

Registry	NCT07792798, acronym OMD _ BTX-A
Status	Completed
Phase	Phase 1
Study type	Interventional; non randomized, single group, masking: none, treatment
Enrollment	20 (Actual)
Sponsor	Sana'a University (Other)
Conditions	Oromandibular Dystonia, Electromyography
Interventions	Botulinum Toxin Type A (BOTOX) Injection (Drug)
Dates	start 2022-09-13, primary completion 2024-10-17, completion 2024-10-17, first posted 2026-08-28, last updated 2026-08-28
Locations	1 site in Yemen

-Summary

This study evaluates the effectiveness and safety of Electromyography (EMG)-guided Botulinum Toxin type A (BTX-A) injections in treating oromandibular dystonia (OMD) among a sample of Yemeni patients. Oromandibular dystonia is a neurological movement disorder characterized by involuntary contractions of the jaw, tongue, and face muscles, which severely interferes with essential daily functions such as chewing, speaking, and swallowing.

A prospective clinical trial was conducted on 20 patients diagnosed with different clinical subtypes of OMD (jaw closing, jaw opening, and jaw deviation). Targeted muscles were injected with BTX-A using EMG guidance to ensure precise placement. Patients were evaluated over a 6-month follow-up period to measure improvements in mastication ability, speech, and functional discomfort, as well as to document any adverse side effects.

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+Arms and interventions

Arm	Type	Interventions	Description
Botulinum Toxin Type A .	Experimental	Drug: Botulinum Toxin Type A (BOTOX) Injection
Electromyography guided botulinum toxin _A Injection Group .	Experimental	Drug: Botulinum Toxin Type A (BOTOX) Injection

Botulinum Toxin Type A (BOTOX) Injection (Drug): Electromyography (EMG)-guided intramuscular injections into specific affected masticatory and lower facial muscles. Dosing is tailored to the specific oromandibular dystonia subtype (e.g., jaw closing, jaw opening, or mixed) and targeted muscles (such as the Masseter, Temporal, Medial Pterygoid, Lateral Pterygoid, or Digastric muscles). The injections are administered using an EMG device (e.g., Dantec Clavis) to ensure precise localization of the hyperactive muscles prior to injection.

+Outcome measures

Primary outcomes

Change in Oromandibular Dystonia Symptoms Following EMG-Guided Botulinum Toxin Type A Injection [Baseline (immediately before BTX-A injection), 1 week, 3 months, and 6 months after injection]: The primary outcome was the change in the severity of the main symptoms of oromandibular dystonia following electromyography-guided botulinum toxin type A (BTX-A) injection. The symptoms assessed were mastication ability, discomfort, speech, and pain. Each symptom was evaluated using a 5-point ordinal rating scale ranging from 0 (normal/no symptoms) to 4 (severe impairment). Changes from baseline were assessed during follow-up visits at 1 week, 3 months, and 6 months after BTX-A injection.

+Eligibility

Sex: All, ages: 31 Years to 60 Years

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.

+Locations (1)

Facility	City	Country	Status
Sana'a university faculty of dentistry	Sanaa	Yemen

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