Botulinum Toxin A for Jaw Dystonia .

Sana'a University20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Oromandibular Dystonia Electromyography

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.

Eligibility

Sex: ALLMin age: 31 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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