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

Healthy Clinical Trial

— ARTEMIS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06070558
• Other study ID #: 2021-A02648-33
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: September 2023
• Source: Central Hospital, Nancy, France
• Contact: Pedro Augusto GONDIM TEIXEIRA, MD, PhD
• Phone: 0033 3 83 85 21 61
• Email: p.teixeira[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Device:
• MRI with Real Time MRI Rapid Flash sequence
MRI examination of temporomandibular joint with Real Time MRI Rapid Flash sequence

Locations

Country	Name	City	State
France	CHRU de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Curve representing the displacement of the articular discs during TMJ movements		Baseline (day 0)
Secondary	Curve representing the difference between displacement of joint discs during TMJ movements in healthy subjects and in subjects with known TMD		Baseline (day 0)
Secondary	Characterization of the volume in mm3 of the main masticatory muscles during movement by MRI in healthy and pathological subjects.		Baseline (day 0)