- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06070558
ChAracterization of Normal and Pathological moRphological Variations of the TEMporomandibular Joint by Real-time magnetIc reSonance Imaging (ARTEMIS)
June 16, 2026 updated by: Pedro TEIXEIRA-GONDIM, MD, Central Hospital, Nancy, France
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pedro Augusto GONDIM TEIXEIRA, MD, PhD
- Phone Number: 0033 3 83 85 21 61
- Email: p.teixeira@chru-nancy.fr
Study Contact Backup
- Name: Gabriela Hossu, PhD
- Phone Number: 0033 3 83 15 50 96
Study Locations
-
-
-
Nancy, France, 54000
- Recruiting
- CHRU de Nancy
-
Contact:
- Guillaume DROUOT, PhD
- Phone Number: +33 +33383157666
- Email: g.drouot@chru-nancy.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Healthy
Healthy volunteers
|
MRI examination of temporomandibular joint with Real Time MRI Rapid Flash sequence
|
|
Other: Temporomandibular Joint Disorders
Patients with Temporomandibular Joint Disorders
|
MRI examination of temporomandibular joint with Real Time MRI Rapid Flash sequence
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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).
Time Frame: Baseline (day 0)
|
Baseline (day 0)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Curve representing the displacement of the articular discs during TMJ movements
Time Frame: Baseline (day 0)
|
Baseline (day 0)
|
|
Curve representing the difference between displacement of joint discs during TMJ movements in healthy subjects and in subjects with known TMD
Time Frame: Baseline (day 0)
|
Baseline (day 0)
|
|
Characterization of the volume in mm3 of the main masticatory muscles during movement by MRI in healthy and pathological subjects.
Time Frame: Baseline (day 0)
|
Baseline (day 0)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 12, 2023
Primary Completion (Estimated)
December 12, 2026
Study Completion (Estimated)
December 12, 2026
Study Registration Dates
First Submitted
July 10, 2023
First Submitted That Met QC Criteria
September 30, 2023
First Posted (Actual)
October 6, 2023
Study Record Updates
Last Update Posted (Actual)
June 17, 2026
Last Update Submitted That Met QC Criteria
June 16, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-A02648-33
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.