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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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 events associated with the injections. The aim is to determine whether BoNT-A provides greater pain relief and improved mouth opening compared with placebo in patients with temporomandibular myofascial pain. The findings may help support the use of BoNT-A as a treatment option for patients who do not respond to conventional therapy and provide valuable evidence for clinical practice in Pakista
Trial Details
NCT Number NCT07847541
Lead Sponsor Riphah International University
Conditions
(from sponsor)
Temporomandibular Disorder
Related terms Temporomandibular Joint Disorders
Enrollment 118 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov