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

Not Applicable

Not yet recruiting

• Conditions: Temporomandibular Joint Disorders; Healthy
• Interventions: Device: MRI with Real Time MRI Rapid Flash sequence

• Registration Number: NCT06070558
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-10
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-30
• Last Update Submitted: 2023-09-30
• Study First Posted: 2023-10-06
• Last Update Posted: 2023-10-06
• Study Start: 2023-11-01
• Primary Completion: 2026-07-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy	MRI with Real Time MRI Rapid Flash sequence	Healthy volunteers
Temporomandibular Joint Disorders	MRI with Real Time MRI Rapid Flash sequence	Patients with Temporomandibular Joint Disorders

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Characterization of the volume in mm3 of the main masticatory muscles during movement by MRI in healthy and pathological subjects.	Baseline (day 0)
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)

Trial Locations

Locations (1)

CHRU de Nancy; 🇫🇷 Nancy, France