Temporomandibular Disorders (TMD)DiagDTMNCT07499869
INNOVATIVE BENEFITS OF A 4D VIRTUAL SIMULATOR
A study testing digital jaw impressions and Modjaw® records in people with Temporomandibular Disorders (TMD), run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorders (TMD)
- What is being tested?
- digital jaw impressions and Modjaw® records
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nice University Hospital
Nice, 06000
Elodie EHRMANN, 33492033270, ehrmann.e@chu-nice.fr
Carole CHARAVET, 33492033270, charavet.c@chu-nice.fr
About this study
Official title: 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.
- Conditions
- Temporomandibular Disorders (TMD)
- Being tested
- digital jaw impressions and Modjaw® records
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital jaw impressions and Modjaw® recordsOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| MODJAW® | Experimental | Modjaw® record Receives: Other: digital jaw impressions and Modjaw® records |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start17 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499869
- Sponsor's protocol ID
- 24-AOIP-01
- Acronym
- DiagDTM
- Status last verified
- Sep 2026
- First submitted
- 24 Mar 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INNOVATIVE CONTRIBUTIONS OF A 4D VIRTUAL SIMULATOR (Modjaw®) IN THE MANAGEMENT OF TEMPOROMANDIBULAR JOINT DISORDERS
- ClinicalTrials.gov ID
- NCT07499869
- Acronym / sponsor ID
- DiagDTM / 24-AOIP-01
- Conditions
- Temporomandibular Disorders (TMD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 17 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MODJAW® | Experimental | Other: digital jaw impressions and Modjaw® recordsModjaw® record |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | MODJAW® |
Primary outcome
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital jaw impressions and Modjaw® records in people with Temporomandibular Disorders (TMD), run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elodie EHRMANN (33492033270, ehrmann.e@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of a step in reducible disc displacement (length) (time frame: at inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.