Botulinum Toxin A for Jaw Dystonia .

NCT07792798 | Completed Phase 1

• 1 other identifier: OMFS:07/09/2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

oromandibular dystonia, electromyography, botulinum toxin.

Outcome Measures

Primary Outcomes (1)

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

  Baseline (immediately before BTX-A injection), 1 week, 3 months, and 6 months after injection

Study Arms (2)

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

Interventions

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.

Botulinum Toxin Type A .; Electromyography guided botulinum toxin _A Injection Group .

Eligibility Criteria

• Age: 31 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sana'a University: lead

Study Sites (1)

Sana'a university faculty of dentistry

Sanaa, Yemen

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 20
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer, Department of oral and maxillofacial surgery

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start: September 13, 2022
• Primary Completion: October 17, 2024
• Study Completion: October 17, 2024
• Last Updated: August 28, 2026

Record last verified: 2026-07

Locations

YE (1)