ChAracterization of Normal and Pathological moRphological Variations of the TEMporomandibular Joint by Real-time magnetIc reSonance Imaging (ARTEMIS)

September 30, 2023 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

Not yet 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

Study Contact Backup

  • Name: Gabriela Hossu, PhD
  • Phone Number: 0033 3 83 15 50 96

Study Locations

  • France
      • Nancy, France, 54000
        • CHRU de NANCY

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
Device: MRI with Real Time MRI Rapid Flash sequence
MRI examination of temporomandibular joint with Real Time MRI Rapid Flash sequence
Other: Temporomandibular Joint Disorders
Patients with Temporomandibular Joint Disorders
Device: MRI with Real Time MRI Rapid Flash sequence
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

Central Hospital, Nancy, France

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 (Estimated)

November 1, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 31, 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)

October 6, 2023

Last Update Submitted That Met QC Criteria

September 30, 2023

Last Verified

September 1, 2023

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.

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