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Recruiting NCT06070558

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

No phase Interventional Healthy Temporomandibular Joint Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI with Real Time MRI Rapid Flash sequence.
Who it may be relevant to
Registry conditions: Healthy, Temporomandibular Joint Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

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). [Time frame: Baseline (day 0)]
Secondary outcome measures (3)
  • Curve representing the displacement of the articular discs during TMJ movements [Time frame: 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)]
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHRU de Nancy — Nancy

Identifiers

NCT: NCT06070558 · 2021-A02648-33

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗