INNOVATIVE BENEFITS OF A 4D VIRTUAL SIMULATOR

NCT07499869 — Not applicable, Recruiting, 20 participants, Centre Hospitalier Universitaire de Nice

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

Registry	NCT07499869, acronym DiagDTM
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, other
Enrollment	20 (Estimated)
Sponsor	Centre Hospitalier Universitaire de Nice (Other)
Conditions	Temporomandibular Disorders (TMD)
Interventions	digital jaw impressions and Modjaw® records (Other)
Dates	start 2026-09-17 (estimated), primary completion 2027-09-01 (estimated), completion 2028-09-01 (estimated), first posted 2026-03-30, last updated 2026-09-22
Locations	1 site in France

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
MODJAW®	Experimental	Other: digital jaw impressions and Modjaw® records	Modjaw® record

digital jaw impressions and Modjaw® records (Other): * 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

+Outcome measures

Primary outcomes

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)

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Nice University Hospital	Nice	France	Recruiting