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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06070558
Collaborator
(none)
60
1
2
38
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: MRI with Real Time MRI Rapid Flash sequence
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
ChAracterization of Normal and Pathological moRphological Variations of the TEMporomandibular Joint by Real-time magnetIc reSonance Imaging
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2026
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. Curve representing the displacement of the articular discs during TMJ movements [Baseline (day 0)]

  2. Curve representing the difference between displacement of joint discs during TMJ movements in healthy subjects and in subjects with known TMD [Baseline (day 0)]

  3. Characterization of the volume in mm3 of the main masticatory muscles during movement by MRI in healthy and pathological subjects. [Baseline (day 0)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHRU de Nancy Nancy France 54000

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pedro TEIXEIRA-GONDIM, MD, Principal Investigator, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT06070558
Other Study ID Numbers:
  • 2021-A02648-33
First Posted:
Oct 6, 2023
Last Update Posted:
Oct 6, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2023