Overview

Comparison of Temporomandibular Joint Arthroscopy With Botulinum Toxin Injection Versus Placebo

Status:
Recruiting

Trial end date:
2021-12-31

Target enrollment:
0

Participant gender:
All

Summary

There are several studies that have considered Botulinum toxin A (BoNT-A) injections are effective in treating symptoms for Temporomandibular Joint (TMJ) disorders. BoNT-A injections improve the hyper-tonicity of mandibular muscles and its consequent joint load reduction. Also injections of BoNT-A, for patients with articular disc displacement, resulted in pain relief and return of the normal movements of the mandible. The main goal of this study is to test the beneficial impact of BoNT-A injections in the masticatory muscles of patients submitted to TMJ surgical arthroscopy.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Instituto Portugues da Face

Criteria

Inclusion Criteria:

- Patients with TMJ with indication for arthroscopy

- Age between 12-60 years old

- Minimum level of pain for inclusion should be 5/10 (on a 0-10 VAS scale)

Exclusion Criteria:

- Previous treatment to TMD

- Previous use of facial Botulinum Toxin

- Any contraindication for the use of BTXA according to XEOMIN SmPC