NCT04810429

Comparison of Temporomandibular Joint Arthroscopy With Botulinum Toxin Injection Versus Placebo

Comparison of Temporomandibular Joint Arthroscopy With Botulinum Toxin Injection Versus Placebo: a Randomized Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Instituto Portugues da Face · Academic / Other
• Sex: All
• Age: 12 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study Objective: To investigate the potential performance of incobotulinumtoxin-A (BTXA) in patients submitted to TMJ surgical arthroscopy. Besides the acceptable good outcomes of TMJ arthroscopy, the authors believe that using a single injection of BTXA into the temporalis and masseter muscles could reduce joint loading and pain, improving TMJ arthroscopy results. The proposed explanation for this study: TMJ arthroscopy is a minimal invasive surgical technique for different types of temporomandibular joint (TMJ) internal derangements. Besides the acceptable outcomes of TMJ arthroscopy, the authors believe that adding to this treatment a single injection of BTXA into the temporalis and masseter muscles could reduce joint loading, improving TMJ arthroscopic results.

Conditions

• Temporomandibular Joint Disorders

Interventions

Type	Name	Description
DRUG	Incobotulinumoxin A	XEOMIN® (incobotulinumtoxinA) is an approved medication that inhibits the release of acetylcholine and muscle blockage. Xeomin is indicated for the symptomatic treatment of blepharospasm and hemifacial spasm, cervical dystonia of a predominantly rotational type (spasmodic torticollis), spasticity of the upper limbs and chronic sialorrhea due to neurological changes. Xeomin comes as a white powder for solution for injection. When dissolved Xeomin is a clear, colorless solution that does not contain particles. Xeomin is reconstituted before use with sterile sodium chloride 9 mg / ml (0.9%) solution, without preservatives, for injections. The active substance is Clostridium botulinum type A neurotoxin (150 kD), without complexing proteins. The other components are human albumin and sucrose.
PROCEDURE	TMJ surgical arthroscopy	TMJ arthroscopy is a minimal invasive surgical technique for different types of temporomandibular joint (TMJ) internal derangements. Besides the acceptable outcomes of TMJ arthroscopy, the authors believe that adding to this treatment a single injection of BTXA into the temporalis and masseter muscles could reduce joint loading, improving TMJ arthroscopic results.

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-12-31
• Completion: 2022-06-01
• First posted: 2021-03-23
• Last updated: 2022-10-21

Locations

1 site across 1 country: Portugal