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

Primary Purpose

Healthy, Temporomandibular Joint Disorders

Status

Not yet recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

MRI with Real Time MRI Rapid Flash sequence

About this trial

This is an interventional other trial for Healthy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

CHRU de Nancy

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Healthy

Temporomandibular Joint Disorders

Arm Description

Healthy volunteers

Patients with Temporomandibular Joint Disorders

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Curve representing the displacement of the articular discs during TMJ movements

Curve representing the difference between displacement of joint discs during TMJ movements in healthy subjects and in subjects with known TMD

Characterization of the volume in mm3 of the main masticatory muscles during movement by MRI in healthy and pathological subjects.

Full Information

NCT ID

NCT06070558

First Posted

July 10, 2023

Last Updated

September 30, 2023

Sponsor

Central Hospital, Nancy, France

1. Study Identification

Unique Protocol Identification Number

NCT06070558

Brief Title

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

Acronym

ARTEMIS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 1, 2023 (Anticipated)

Primary Completion Date

July 1, 2026 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Temporomandibular Joint Disorders

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy

Arm Type

Other

Arm Description

Healthy volunteers

Arm Title

Temporomandibular Joint Disorders

Arm Type

Other

Arm Description

Patients with Temporomandibular Joint Disorders

Intervention Type

Device

Intervention Name(s)

MRI with Real Time MRI Rapid Flash sequence

Intervention Description

MRI examination of temporomandibular joint with Real Time MRI Rapid Flash sequence

Primary Outcome Measure Information:

Title

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)

Secondary Outcome Measure Information:

Title

Curve representing the displacement of the articular discs during TMJ movements

Time Frame

Baseline (day 0)

Title

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)

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pedro Augusto GONDIM TEIXEIRA, MD, PhD

Phone

0033 3 83 85 21 61

p.teixeira@chru-nancy.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Gabriela Hossu, PhD

Phone

0033 3 83 15 50 96

Facility Information:

Facility Name

CHRU de Nancy

City

Nancy

ZIP/Postal Code

54000

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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