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Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders

NCT06941636 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-04-24

No results posted yet for this study

Summary

Both patients and remitters ask for treatment with Botulinumtoxin A (BTX) with the hope that it will be an effective aid for pain, but little is known regarding if the effect is dose dependent.

The aim of this project is to investigate if injections with BTX in the masseter- and temporal muscle is an efficient treatment in patient with myogenous temporomandibular disorders (TMD) and if the effect of BTX is dose dependent.

Conditions

  • Temporomandibular Disorder

Interventions

DRUG

5U/0,1 ml Botulinum toxin A

Botox® 100 U (AbbVie) will be dissolved in 2 milliliters of room-temperature sterile isotonic saline, resulting in a solution concentration of 5 U/0.1 mL. Each patient will receive a total dose of 50 U, administered bilaterally into the masseter and temporalis muscles.

DRUG

10U/0,1 ml Botulinum toxin A

Botox® 100 U (AbbVie) will be dissolved in 1 milliliters of room-temperature sterile isotonic saline, resulting in a solution concentration of 10 U/0.1 mL. Each patient will receive a total dose of 100 U, administered bilaterally into the masseter and temporalis muscles.

Sponsors & Collaborators

  • Region Stockholm

    lead OTHER_GOV

Principal Investigators

  • Veronica de Flon · Region Stockholm

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-12-01
Completion
2026-12-01

Countries

  • Sweden

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 NCT06941636 on ClinicalTrials.gov