Clinical Research Directory
Browse clinical research sites, groups, and studies.
Clinical Evaluation of Botulinum Toxin a in the Management of Temporomandibular Myofascial Pain
Sponsor: Riphah International University
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
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
118
Start Date
2026-08-15
Completion Date
2026-12-15
Last Updated
2026-09-29
Healthy Volunteers
No
Conditions
Interventions
Botulinum Toxin Type A (BoNT-A)
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)
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.
Locations (1)
Islamic International Dental Hospital
Islamabad, Pakistan