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COMPLETED
NCT07792798
PHASE1

Botulinum Toxin A for Jaw Dystonia .

Sponsor: Sana'a University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

31 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2022-09-13

Completion Date

2024-10-17

Last Updated

2026-08-28

Healthy Volunteers

No

Interventions

DRUG

Botulinum Toxin Type A (BOTOX) Injection

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.

Locations (1)

Sana'a university faculty of dentistry

Sanaa, Yemen