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Not yet recruiting NCT07499869

INNOVATIVE BENEFITS OF A 4D VIRTUAL SIMULATOR

No phase Interventional Temporomandibular Disorders (TMD)

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: digital jaw impressions and Modjaw® records.
Who it may be relevant to
Registry conditions: Temporomandibular Disorders (TMD). 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 →

Official title

INNOVATIVE CONTRIBUTIONS OF A 4D VIRTUAL SIMULATOR (Modjaw®) IN THE MANAGEMENT OF TEMPOROMANDIBULAR JOINT DISORDERS

Overview

Temporomandibular disorders (TMD) encompass all temporomandibular muscular and osteoarticular conditions. TMD affects 31% of the adult population, with chronic, debilitating pain in 10% of cases. Clinical diagnosis remains complex, and patients are underdiagnosed, whereas early management of these disorders can prevent worsening and significant public health expenditure. The Modjaw device, which is integrated into modern digital workflows in dental surgery-particularly for the manufacture of prostheses-could enable systematic joint diagnosis through the automatic interpretation of tracings. The validity of interpreting condylar tracings obtained via axiography (compared to MRI, considered the gold standard) for diagnosing disc displacement in the TMJ has been demonstrated. The team recently demonstrated the reproducibility of Modjaw® condylar recordings from healthy patients, as well as the reliability of the recordings. However, to date, the evaluation of this device has not focused on its added potential in terms of assisting the clinician in diagnosing disc displacement.

Interventions

  • Other digital jaw impressions and Modjaw® records
    * digital impressions (optical scanner available in the department); * Modjaw® recording (system available in the department) by an investigator who is unaware of the MRI results; * entry of MRI and Modjaw® data

Primary outcome measures

  • presence of a step in reducible disc displacement (length) [Time frame: at inclusion]
  • presence of a step in reducible disc displacement (vertical spacing) [Time frame: at inclusion]

Eligibility criteria

Inclusion criteria

  • adults;
  • positive result on the validated questionnaire for the screening of disc displacement;
  • referral for an MRI scan of the TMJs for diagnostic confirmation
  • signed informed consent form
  • membership of a social security scheme

Exclusion criteria

  • Patients who do not speak or understand French;
  • Pregnant women;
  • Patients who have refused an MRI scan or for whom an MRI scan is contraindicated.
  • Vulnerable patients, minors, patients under guardianship or trusteeship, or those protected by law.

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

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Nice University Hospital — Nice

Identifiers

NCT: NCT07499869 · 24-AOIP-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗