HealthyARTEMISNCT06070558
ChAracterization of Normal and Pathological moRphological Variations of the TEMporomandibular Joint by Real-time magnetIc reSonance Imaging
A study testing MRI with Real Time MRI Rapid Flash sequence in people with Healthy and Temporomandibular Joint Disorders, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The Real Time MRI Rapid Flash sequence is particularly interesting for the study of moving organs and joints. This sequence will make it possible to characterize normal and pathological temporomandibular joint movements by MRI. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Temporomandibular Joint Disorders
- What is being tested?
- MRI with Real Time MRI Rapid Flash sequence
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2023to 12 Dec 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult: age ≥ 18 years old;
- Person with the capacity to understand the instructions given;
- Person affiliated to a social security scheme or beneficiary of such a scheme;
- Person having received complete information on the organization of the Clinical Investigation and having signed informed consent.
Who cannot join
- Person with large-scale metallic dental reconstructions;
- Edentulism more than 5 teeth;
- Claustrophobia;
- Contraindication to performing an MRI examination
- Persons referred to in Articles 64, 65 and 66 of European Regulation 2017/745 on Medical Devices (RDM) and in L. 1121-5 to L1121-8 of the French Public Health Code
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gabriela Hossu, PhD contact
France1 site, 1 recruiting
- Recruiting
CHRU de Nancy
Nancy, 54000
Guillaume DROUOT, PhD, +33383157666 ext. +33, g.drouot@chru-nancy.fr
About this study
The Real Time MRI Rapid Flash sequence is particularly interesting for the study of moving organs and joints.
This sequence will make it possible to characterize normal and pathological temporomandibular joint movements by MRI.
- Conditions
- Healthy, Temporomandibular Joint Disorders
- Being tested
- MRI with Real Time MRI Rapid Flash sequence
- 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.
MRI with Real Time MRI Rapid Flash sequenceDevice
MRI examination of temporomandibular joint with Real Time MRI Rapid Flash sequence
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Other | Healthy volunteers Receives: Device: MRI with Real Time MRI Rapid Flash sequence |
| Temporomandibular Joint Disorders | Other | Patients with Temporomandibular Joint Disorders Receives: Device: MRI with Real Time MRI Rapid Flash sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Curve representing the difference between displacement of condyles during Temporo Mandibular Joint (TMJ) movements in healthy subjects and in subjects with known Temporo Mandibular Disorder (TMD).
Measured: Baseline (day 0)
Secondary outcomes (3)
Curve representing the displacement of the articular discs during TMJ movements
Measured: Baseline (day 0)
Curve representing the difference between displacement of joint discs during TMJ movements in healthy subjects and in subjects with known TMD
Measured: Baseline (day 0)
Characterization of the volume in mm3 of the main masticatory muscles during movement by MRI in healthy and pathological subjects.
Measured: Baseline (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start12 Dec 2023
- Primary completion12 Dec 2026 (estimated)
- Study completion12 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro TEIXEIRA-GONDIM, MD, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070558
- Sponsor's protocol ID
- 2021-A02648-33
- Acronym
- ARTEMIS
- Status last verified
- Jun 2026
- First submitted
- 10 Jul 2023
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ChAracterization of Normal and Pathological moRphological Variations of the TEMporomandibular Joint by Real-time magnetIc reSonance Imaging
- ClinicalTrials.gov ID
- NCT06070558
- Acronym / sponsor ID
- ARTEMIS / 2021-A02648-33
- Conditions
- Healthy, Temporomandibular Joint Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 6 Oct 2023 (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.
The Real Time MRI Rapid Flash sequence is particularly interesting for the study of moving organs and joints.
This sequence will make it possible to characterize normal and pathological temporomandibular joint movements by MRI.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | Other | Device: MRI with Real Time MRI Rapid Flash sequenceHealthy volunteers |
| Temporomandibular Joint Disorders | Other | Device: MRI with Real Time MRI Rapid Flash sequencePatients with Temporomandibular Joint Disorders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult: age ≥ 18 years old;
- Person with the capacity to understand the instructions given;
- Person affiliated to a social security scheme or beneficiary of such a scheme;
- Person having received complete information on the organization of the Clinical Investigation and having signed informed consent.
Key exclusion criteria (5 listed)
- Person with large-scale metallic dental reconstructions;
- Edentulism more than 5 teeth;
- Claustrophobia;
- Contraindication to performing an MRI examination
- Persons referred to in Articles 64, 65 and 66 of European Regulation 2017/745 on Medical Devices (RDM) and in L. 1121-5 to L1121-8 of the French Public Health Code
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 |
|---|---|---|
| MRI with Real Time MRI Rapid Flash sequenceMRI examination of temporomandibular joint with Real Time MRI Rapid Flash sequence | Device | Healthy, Temporomandibular Joint Disorders |
Primary outcome
Curve representing the difference between displacement of condyles during Temporo Mandibular Joint (TMJ) movements in healthy subjects and in subjects with known Temporo Mandibular Disorder (TMD).
Time frame: Baseline (day 0)
3 secondary outcomes
Curve representing the displacement of the articular discs during TMJ movements
Time frame: Baseline (day 0)
Curve representing the difference between displacement of joint discs during TMJ movements in healthy subjects and in subjects with known TMD
Time frame: Baseline (day 0)
Characterization of the volume in mm3 of the main masticatory muscles during movement by MRI in healthy and pathological subjects.
Time frame: Baseline (day 0)
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 17 Jun 2026.
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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.
Gabriela Hossu, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI with Real Time MRI Rapid Flash sequence in people with Healthy and Temporomandibular Joint Disorders, run by Central Hospital, Nancy, France 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 4 inclusion and 5 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 17 Jun 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 Pedro Augusto GONDIM TEIXEIRA, MD, PhD (0033 3 83 85 21 61, p.teixeira@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Curve representing the difference between displacement of condyles during Temporo Mandibular Joint (TMJ) movements in healthy subjects and in subjects with known Temporo Mandibular Disorder (TMD). (time frame: Baseline (day 0)). 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 17 Jun 2026.