Botulinum Toxin A for Jaw Dystonia .

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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Key information

Conditions

Oromandibular Dystonia Electromyography

Age range

31 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sana'a university faculty of dentistry

Sanaa, Yemen

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Change in Oromandibular Dystonia Symptoms Following EMG-Guided Botulinum Toxin Type A Injection

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sana'a University

Other

Registry information

Official study title

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

Acronym: OMD _ BTX-A

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Aug 28, 2026
Registry last updated: Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed