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Clinical Evaluation of Botulinum Toxin a in the Management of Temporomandibular Myofascial Pain

RecruitingPhase 2Ages 18 Years - 60 YearsAllRiphah International University
NCT07847541 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effectiveness of botulinum toxin type A (BoNT-A) in patients with temporomandibular myofascial pain who have not improved after at least 3 months of conservative treatment. Eligible patients aged 18-60 years will be randomly assigned to one of two groups: * Intervention group: Intramuscular injection of 100 U BoNT-A into the bilateral masseter and temporalis muscles. * Control group: Intramuscular injection of 0.9% normal saline (placebo) using the same technique. The primary outcomes will be: * Pain intensity, measured using a 0-10 pain scale (VAS/NRS). * Maximum mouth opening (maximal interincisal distance), measured in millimetres. Assessments will be performed before treatment (baseline) and at 1 week, 1 month, and 3 months after injection. The study will also monitor adverse eve

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📋 Eligibility rules (as published)
Inclusion Criteria: * History of TMD, no relief with conservative therapy after at least three months. * Clinical diagnosis of bilateral arthrogenous disorder and myalgia. * Moreover, TMD can be confirmed by diagnosis through MRI and CT examinations * Pregnancy or lactation. * Previous mandible or significant facial trauma. * History of prior TMD treatment or cosmetic treatments of the face with BoNT/A. * Any contraindication to BoNT/A as outlined in the XEOMIN package insert. Exclusion Criteria: \-
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What it tests

  • Botulinum Toxin Type A (BoNT-A)
  • 0.9% Normal Saline (Placebo)
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Where

1 site
Islamic International Dental Hospital
Islamabad, Pakistan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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