RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Riphah International University • ClinicalTrials.gov ID: NCT07847541

Registry updated: 2026-09-29

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Description

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

Interventions

Botulinum Toxin Type A (BoNT-A) (Drug)
Participants will receive a total dose of 100 units of Botulinum Toxin Type A (BoNT-A) administered by intramuscular injection into the bilateral masseter and temporalis muscles (25 U per side in each muscle). The injections will be performed using a 31G × 12 mm needle. Participants will be followed at 1 week, 1 month, and 3 months to assess pain intensity and maximal interincisal mouth opening.
0.9% Normal Saline (Placebo) (Drug)
Participants will receive 0.9% normal saline by intramuscular injection into the bilateral masseter and temporalis muscles using the same injection technique, volume, and follow-up schedule as the experimental group. The placebo is used to maintain blinding and serve as the comparator.

Eligibility criteria

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: \-

Conditions

Temporomandibular Disorder

Locations

Islamic International Dental Hospital — Islamabad, Pakistan

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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