Status:
TERMINATED
Intramuscular Injections of Botulinum Toxin in Lateral Pterygoid Muscle in the Treatment of Temporomandibular Dysfunctions: Studying the Interest of MRI Guidance and Ultrasound Guidance
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Conditions:
Mandibular Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2024
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04900324
Start Date
September 13 2021
End Date
February 16 2024
Last Update
September 19 2024
Active Locations (1)
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1
CHu de Besançon
Besançon, France