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
• Interventions: Device: Ultrasound guidance; Device: MRI guidance

• 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

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-20
• Last Update Submitted: 2021-05-20
• Study First Posted: 2021-05-25
• Last Update Posted: 2021-05-25
• Study Start: 2021-06
• Primary Completion: 2022-08
• Study Completion: 2023-02

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

Arm && Interventions

Group	Intervention	Description
Ultrasound guidance	Ultrasound guidance	Injections of botulinum toxin performed using ultrasound guidance
MRI guidance	MRI guidance	Injections of botulinum toxin performed using MRI guidance

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

Trial Locations

Locations (1)

CHu de Besançon; 🇫🇷 Besançon, France