MedTrace Logo

Botulinum Toxin A for Jaw Dystonia .

NCT07792798 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-28

No results posted yet for this study

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.

Conditions

  • Oromandibular Dystonia
  • Electromyography

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.

Sponsors & Collaborators

  • Sana'a University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
31 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-13
Primary Completion
2024-10-17
Completion
2024-10-17

Countries

  • Yemen

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07792798 on ClinicalTrials.gov