Comparison of Temporomandibular Joint Arthroscopy With Botulinum Toxin Injection Versus Placebo

PHASE4CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

January 1, 2021

Primary Completion Date

December 31, 2021

Study Completion Date

June 1, 2022

Conditions
Temporomandibular Joint Disorders
Interventions
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.

Trial Locations (1)

1050-227

Instituto Português da Face, Lisbon

All Listed Sponsors
lead

Instituto Portugues da Face

OTHER

NCT04810429 - Comparison of Temporomandibular Joint Arthroscopy With Botulinum Toxin Injection Versus Placebo | Biotech Hunter | Biotech Hunter