NCT04900324

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 13, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.4 years

First QC Date

May 19, 2021

Last Update Submit

September 5, 2024

Conditions

Mandibular Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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

    Month 2

Study Arms (2)

MRI guidance

EXPERIMENTAL

Injections of botulinum toxin performed using MRI guidance

Device: MRI guidance

Ultrasound guidance

EXPERIMENTAL

Injections of botulinum toxin performed using ultrasound guidance

Device: Ultrasound guidance

Interventions

MRI guidanceDEVICE

Injections of botulinum toxin performed using MRI guidance

MRI guidance
Ultrasound guidanceDEVICE

Injections of botulinum toxin performed using ultrasound guidance

Ultrasound guidance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHu de Besançon

Besançon, France

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Christophe MEYER, Md PhD

    CHU de Besançon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 25, 2021

Study Start

September 13, 2021

Primary Completion

February 16, 2024

Study Completion

February 16, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

FR(1)