Clinical Evaluation of Botulinum Toxin a in the Management of Temporomandibular Myofascial Pain
- Temporomandibular Disorder
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Riphah International University
- Enrolment target
- 118
- Started
- 15 August 2026
- Main results due
- 15 December 2026
- Study sites
- 1
- Registry updated
- 29 September 2026
Can you take part?
- Ages 18 years to 60 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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: \-
What this study is about
In the sponsor’s own words, from the registry.
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
Study sites(1)
Islamic International Dental Hospital
Islamabad, Pakistan
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07847541. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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