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

Centre Hospitalier Universitaire de Besancon

Status: Terminated

Conditions: Mandibular Dysfunction

Treatments: Device: Ultrasound guidance; Device: MRI guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT04900324

2020/554

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

MRI guidance

Experimental group

Description:

Injections of botulinum toxin performed using MRI guidance

Treatment:

Device: MRI guidance

Ultrasound guidance

Experimental group

Description:

Injections of botulinum toxin performed using ultrasound guidance

Treatment:

Device: Ultrasound guidance