INNOVATIVE BENEFITS OF A 4D VIRTUAL SIMULATOR

NCT07499869 | Not Yet Recruiting

• 1 other identifier: 24-AOIP-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Temporomandibular Disorders (TMD)

Outcome Measures

Primary Outcomes (2)

• 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)

  at inclusion

• 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)

  at inclusion

Study Arms (1)

MODJAW®

EXPERIMENTAL

Modjaw® record

Other: digital jaw impressions and Modjaw® records

Interventions

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

MODJAW®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Nice University Hospital

Nice, 06000, France

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Central Study Contacts

Elodie EHRMANN

CONTACT

33492033270; ehrmann.e@chu-nice.fr

Carole CHARAVET

CONTACT

33492033270; charavet.c@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)