Back to resultsIntramuscular Injections of Botulinum Toxin in Lateral Pterygoid Muscle in the Treatment of Temporomandibular Dysfunctions: Studying the Interest of MRI Guidance and Ultrasound Guidance (MAUSBOT)
Primary Purpose
Mandibular Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI guidance
Ultrasound guidance
Sponsored by
About this trial
This is an interventional treatment trial for Mandibular Dysfunction
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
MRI guidance
Ultrasound guidance
Arm Description
Injections of botulinum toxin performed using MRI guidance
Injections of botulinum toxin performed using ultrasound guidance
Outcomes
Primary Outcome Measures
Pain improvement
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04900324
First Posted
May 19, 2021
Last Updated
May 20, 2021
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT04900324
Brief Title
Intramuscular Injections of Botulinum Toxin in Lateral Pterygoid Muscle in the Treatment of Temporomandibular Dysfunctions: Studying the Interest of MRI Guidance and Ultrasound Guidance
Acronym
MAUSBOT
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandibular Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MRI guidance
Arm Type
Experimental
Arm Description
Injections of botulinum toxin performed using MRI guidance
Arm Title
Ultrasound guidance
Arm Type
Experimental
Arm Description
Injections of botulinum toxin performed using ultrasound guidance
Intervention Type
Device
Intervention Name(s)
MRI guidance
Intervention Description
Injections of botulinum toxin performed using MRI guidance
Intervention Type
Device
Intervention Name(s)
Ultrasound guidance
Intervention Description
Injections of botulinum toxin performed using ultrasound guidance
Primary Outcome Measure Information:
Title
Pain improvement
Description
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
Time Frame
Month 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mélanie PONS, Int
Email
mpons@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe MEYER, Md PhD
Organizational Affiliation
CHU de Besançon
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Intramuscular Injections of Botulinum Toxin in Lateral Pterygoid Muscle in the Treatment of Temporomandibular Dysfunctions: Studying the Interest of MRI Guidance and Ultrasound Guidance
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