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Outcome of Treatment With Botulinum toxinA in Patients With Temporomandibular Myofascial Pain

NCT07668375 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2026-06-25

No results posted yet for this study

Summary

Purpose: The aim of this study is to investigate the effectiveness and patient reported outcomes (interincisal distance and temporomandibular myofascial pain) of treatment with intramuscularly administered BTX-A vs N/S in patients with temporomandibular myofascial pain. OBJECTIVES: To determine the outcome of treatment with botulinum toxin-A vs N/S in patients with temporomandibular myofascial pain.

Conditions

  • Myofascial Pain - Dysfunction Syndrome of TMJ

Interventions

DRUG

Botulinum Toxin-A (Botulax - letibotulinumtoxinA)

In this study, intramuscular injection of Botulinum Toxin-A (50-100 units) would be administered to the patient using a 1 mL insulin syringe with a 26G needle at a dilution of 10 U/mL in normal saline. Injections would be given at 5 sites: 3 in the masseter muscle and 2 in the temporalis muscle, based on the patient's side of complaint (unilateral or bilateral). Topical lidocaine 5% cream would be applied before injection. The injection aims to reduce jaw muscle pain and increase interincisal mouth opening, allowing patients to resume normal daily activities without delay.

DRUG

Normal Saline

Intramuscular injection of normal saline (N/S) 1 mL would be administered at the same sites (masseter and temporalis muscles) as a placebo comparator. Normal saline injection would not be expected to significantly reduce pain intensity or increase interincisal mouth opening compared to BTX-A.

Sponsors & Collaborators

  • PAEC General Hospital, Islamabad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-02
Primary Completion
2026-04-01
Completion
2026-04-01
FDA Drug
Yes

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07668375 on ClinicalTrials.gov