ChAracterization of Normal and Pathological moRphological Variations of the TEMporomandibular Joint by Real-time magnetIc reSonance Imaging
ARTEMIS
1 other identifier
interventional
60
1 country
1
Brief Summary
The Real Time MRI Rapid Flash sequence is particularly interesting for the study of moving organs and joints. This sequence will make it possible to characterize normal and pathological temporomandibular joint movements by MRI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Nov 2023
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2023
CompletedFirst Posted
Study publicly available on registry
October 6, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
October 6, 2023
September 1, 2023
2.7 years
July 10, 2023
September 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Curve representing the difference between displacement of condyles during Temporo Mandibular Joint (TMJ) movements in healthy subjects and in subjects with known Temporo Mandibular Disorder (TMD).
Baseline (day 0)
Secondary Outcomes (3)
Curve representing the displacement of the articular discs during TMJ movements
Baseline (day 0)
Curve representing the difference between displacement of joint discs during TMJ movements in healthy subjects and in subjects with known TMD
Baseline (day 0)
Characterization of the volume in mm3 of the main masticatory muscles during movement by MRI in healthy and pathological subjects.
Baseline (day 0)
Study Arms (2)
Healthy
OTHERHealthy volunteers
Temporomandibular Joint Disorders
OTHERPatients with Temporomandibular Joint Disorders
Interventions
MRI examination of temporomandibular joint with Real Time MRI Rapid Flash sequence
Eligibility Criteria
You may qualify if:
- Adult: age ≥ 18 years old;
- Person with the capacity to understand the instructions given;
- Person affiliated to a social security scheme or beneficiary of such a scheme;
- Person having received complete information on the organization of the Clinical Investigation and having signed informed consent.
You may not qualify if:
- Person with large-scale metallic dental reconstructions;
- Edentulism more than 5 teeth;
- Claustrophobia;
- Contraindication to performing an MRI examination
- Persons referred to in Articles 64, 65 and 66 of European Regulation 2017/745 on Medical Devices (RDM) and in L. 1121-5 to L1121-8 of the French Public Health Code
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU de Nancy
Nancy, 54000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 10, 2023
First Posted
October 6, 2023
Study Start
November 1, 2023
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
October 6, 2023
Record last verified: 2023-09