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Botulinum Toxin A for Jaw Dystonia .

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07792798
Acronym
OMD _ BTX-A
Enrollment
20
Registered
2026-08-28
Start date
2022-09-13
Completion date
2024-10-17
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electromyography, Oromandibular Dystonia

Keywords

oromandibular dystonia, electromyography, botulinum toxin.

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.

Interventions

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

Sana'a University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

20

Eligibility

Sex/Gender
ALL
Age
31 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Oromandibular Dystonia Symptoms Following EMG-Guided Botulinum Toxin Type A InjectionBaseline (immediately before BTX-A injection), 1 week, 3 months, and 6 months after injectionThe 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.

Countries

Yemen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026