Botulinum toxin for jaw myofascial pain in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2 trial evaluating botulinum toxin type A for adults with temporomandibular myofascial pain after at least three months of unsuccessful conservative treatment. Participants receive either 100 units of BoNT-A injected into the masseter and temporalis muscles or placebo injections with the same technique. Primary outcomes are pain intensity on a 0-10 scale and maximal mouth opening, measured at baseline, 1 week, 1 month, and 3 months. Safety monitoring for injection-related adverse events is included. The study aims to determine if BoNT-A provides greater pain relief and functional improvement compared with placebo.

Why it matters

Who can join: the full rules

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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Where it's running

• Islamic International Dental Hospital
  Islamabad, Pakistan Recruiting

Study contacts

• Principal investigator: Uzair Luqman, FCPS — Riphah International University
• Study coordinator: Muhammad Sohaib Arshad
• Email: muhammadsohaibarshad542@gmail.com
• Phone: +923345635938

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.