INNOVATIVE BENEFITS OF A 4D VIRTUAL SIMULATOR (DiagDTM)

March 24, 2026 updated by: Centre Hospitalier Universitaire de Nice

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Nice, France, 06000
        • Nice University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elodie EHRMANN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MODJAW®
Modjaw® record
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-AOIP-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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