Mandibular DysfunctionMAUSBOTNCT04900324
Intramuscular Injections of Botulinum Toxin in Lateral Pterygoid Muscle in the Treatment of Temporomandibular Dysfunctions: Studying the Interest of MRI Guidance and Ultrasound Guidance
A study testing MRI guidance and Ultrasound guidance in people with Mandibular Dysfunction, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mandibular Dysfunction
- What is being tested?
- MRI guidance and Ultrasound guidance
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 13 Sep 2021to 16 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Mandibular Dysfunction
- Being tested
- MRI guidance, Ultrasound guidance
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI guidanceDevice
Injections of botulinum toxin performed using MRI guidance
Ultrasound guidanceDevice
Injections of botulinum toxin performed using ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| MRI guidance | Experimental | Injections of botulinum toxin performed using MRI guidance Receives: Device: MRI guidance |
| Ultrasound guidance | Experimental | Injections of botulinum toxin performed using ultrasound guidance Receives: Device: Ultrasound guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start13 Sep 2021
- Primary completion16 Feb 2024
- Study completion16 Feb 2024
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular DysfunctionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe MEYER, Md PhD, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900324
- Sponsor's protocol ID
- 2020/554
- Acronym
- MAUSBOT
- Status last verified
- Sep 2024
- First submitted
- 19 May 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04900324
- Acronym / sponsor ID
- MAUSBOT / 2020/554
- Conditions
- Mandibular Dysfunction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI guidance | Experimental | Device: MRI guidanceInjections of botulinum toxin performed using MRI guidance |
| Ultrasound guidance | Experimental | Device: Ultrasound guidanceInjections of botulinum toxin performed using ultrasound guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI guidanceInjections of botulinum toxin performed using MRI guidance | Device | MRI guidance |
| Ultrasound guidanceInjections of botulinum toxin performed using ultrasound guidance | Device | Ultrasound guidance |
Primary outcome
Pain improvement
Time frame: 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
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe MEYER, Md PhD principal investigator
CHU de Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI guidance and Ultrasound guidance in people with Mandibular Dysfunction, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain improvement (time frame: Month 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.