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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-13

Study Completion Date

2024-02-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Mandibular Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MRI guidance

Injections of botulinum toxin performed using MRI guidance

Group Type EXPERIMENTAL

MRI guidance

Intervention Type DEVICE

Injections of botulinum toxin performed using MRI guidance

Ultrasound guidance

Injections of botulinum toxin performed using ultrasound guidance

Group Type EXPERIMENTAL

Ultrasound guidance

Intervention Type DEVICE

Injections of botulinum toxin performed using ultrasound guidance

Interventions

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MRI guidance

Injections of botulinum toxin performed using MRI guidance

Intervention Type DEVICE

Ultrasound guidance

Injections of botulinum toxin performed using ultrasound guidance

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No