Intramuscular Injections of Botulinum Toxin in Lateral Pterygoid Muscle in the Treatment of Temporomandibular Dysfunctions: Studying the Interest of MRI Guidance and Ultrasound Guidance

Centre Hospitalier Universitaire de Besancon1 site in 1 country48 target enrollmentJune 2021

ConditionsMandibular Dysfunction

Overview

Phase: N/A
Intervention: Not specified
Conditions: Mandibular Dysfunction
Sponsor: Centre Hospitalier Universitaire de Besancon
Enrollment: 48
Locations: 1
Primary Endpoint: Pain improvement
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main hypothesis is that a significant pain improve (measured with Visual Analogic Scale [VAS]) can be observed after injection of botulinum toxin A, meaning the success of the guidance device.

Registry

clinicaltrials.gov

Start Date

June 2021

End Date

February 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Besancon

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•patients suffering from muscular TemporoMandibular Dysfunctions (TMD) with clinical diagnosis: myofascial pain, limited opening of the mouth, articular noise.
•\>= 18 years old
•with signed informed consent form

Exclusion Criteria

•articular TMD: arthritis or other inflammatory disease of temporomandibular joint, arthrosis, bone deformation, previous fracture of condylar area ;
•electromyographic hypoactivity, pure muscular diseases ;
•oro-mandibular dystonia ;
•botulinum toxin allergy,
•risk of bleeding
•recent or active infection
•intercurrent antibiotic treatment (drug interaction) ;
•vaccination during the 15 days preceding the injection.

Outcomes

Primary Outcomes

Pain improvement

Time Frame: Month 2

Significant improvement of the pain measured with VAS (0 to 10), corresponding to at least 30% decrease of the pain after injection of botulinum toxin A