INNOVATIVE BENEFITS OF A 4D VIRTUAL SIMULATOR

NCT07499869 · tracked via the Priya Life Science France tracker

Sponsor

Centre Hospitalier Universitaire de Nice

Phase

Not applicable

Started

2026-09-17

Last updated

2026-09-22

Condition(s) studied

Temporomandibular Disorders (TMD)

Investigational drug(s) / intervention(s)

digital jaw impressions and Modjaw® records

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

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

presence of a step in reducible disc displacement (length) — at inclusion
the length between the curves, which will be examined to determine their ability to distinguish between DTM1 and MRI (in mm)
presence of a step in reducible disc displacement (vertical spacing) — at inclusion
the vertical spacing between the curves, which will be examined to determine their ability to distinguish between DTM1 and MRI (in mm)

Trial sites (1)

Facility	City	Region	Status
Nice University Hospital	Nice	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07499869 on ClinicalTrials.gov ↗ ← All trials in France