Intramuscular Injections of Botulinum Toxin in Lateral Pterygoid Muscle in the Treatment of Temporomandibular Dysfunctions: Studying the Interest of MRI Guidance and Ultrasound Guidance
Not Applicable
- Conditions
- Mandibular Dysfunction
- Registration Number
- NCT04900324
- Lead Sponsor
- Centre Hospitalier Universitaire de Besancon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 48
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pain improvement 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHu de Besançon
🇫🇷Besançon, France
CHu de Besançon🇫🇷Besançon, France