INNOVATIVE BENEFITS OF A 4D VIRTUAL SIMULATOR
ConditionTemporomandibular Disorders (TMD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nice
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
digital jaw impressions and Modjaw® records
Other intervention* 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
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: MODJAW®Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
presence of a step in reducible disc displacement (length)
the length between the curves, which will be examined to determine their ability to distinguish between DTM1 and MRI (in mm)
Time frame
at inclusion2
presence of a step in reducible disc displacement (vertical spacing)
the vertical spacing between the curves, which will be examined to determine their ability to distinguish between DTM1 and MRI (in mm)
Time frame
at inclusionSponsors and contacts
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Source ClinicalTrials.gov