Mandibular Dysfunction
Conditions
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.
Interventions
DEVICEMRI guidance
Injections of botulinum toxin performed using MRI guidance
DEVICEUltrasound guidance
Injections of botulinum toxin performed using ultrasound guidance
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed