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NCT Number: NCT07499869

INNOVATIVE BENEFITS OF A 4D VIRTUAL SIMULATOR

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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Key information

Conditions

Temporomandibular Disorders (TMD) Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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)

  2. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Carole CHARAVET

CONTACT

[email protected]

33492033270

Elodie EHRMANN

CONTACT

[email protected]

33492033270

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: DiagDTM

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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