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NCT07847541
Clinical Evaluation of Botulinum Toxin a in the Management of Temporomandibular Myofascial Pain
Conditions: Temporomandibular Disorder
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 118
Sponsor: Riphah International University
Location: Islamic International Dental Hospital Islamabad
Summary
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
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:
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Source: ClinicalTrials.gov (NCT07847541). StuddyBuddy aggregates publicly available trial information.