Degenerative Joint DiseaseNCT07008690
MRI of the TMJ in Patients With DJD
An observational study of Degenerative Joint Disease and Control Subjects, run by University of Minnesota at 1 site in United States.
Trial summary
This observational research is comparative in design, that is assessing the change in qMRI measures in degenerative changes of the TMJ in patients diagnosed with DJD. These patients will be imaged multiple times over the course of 18 months, using clinical 3T MRI scanners located at the Center for Magnetic Resonance… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Degenerative Joint Disease, Control Subjects
- What is being tested?
- MRI and Magnetic Resonance Imaging
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2025to 28 Nov 2027
- Phase
- Observational
- 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
Study population: Participants with DJD will be recruited during routine examinations at the TMD clinic located at the School of Dentistry, UMN. If eligible and interested, participants will undergo approximately 90 minutes of qMRI scans. Additional follow-up scans may occur over 18 months, while control participants will have two scans 1-4 weeks apart.
Who may be able to join
- To participate in this study, patients (with DJD) must:
- Be 18 years or older
- Provide written informed consent in English
- State willingness to comply with all study procedures and be available for the duration of the study
- Have clinically confirmed DJD diagnoses based on CT and/or radiographs, and /or traditional MRI scan obtained by their clinician.
- Willing to have a separate approximately 2-hour appointment to have an MRI at the CMRR
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- Has the ability to manage their own calendar and schedule appointments
- Does not have a serious medical condition
- Is not pregnant or is not potentially pregnant
- To participate in this study, controls (participants without DJD) must:
- Be 18 years or older
- Provide written informed consent in English
- State willingness to comply with all study procedures and be available for the duration of the study
- Confirm the absence of any pre-existing TMJ disease
- Willing to have a separate approximately 2-hour appointment to have an MRI at the CMRR
- Has the ability to manage their own calendar and schedule appointments
- Does not have a serious medical condition
- Is not pregnant or is not potentially pregnant
- Exclusion Criteria:
- Participants will be excluded if they:
- Contraindications to MRI. Exclusion criteria for MRI are:
- Ferromagnetic implants
- History of shrapnel or shot gun injury
- Too large to fit in the magnet (body mass index >= 40, approx.)
- Cardiac pacemakers
- Severe claustrophobia
- Large tattoos
- History of metalwork
- Are non-English speaking
- Could be pregnant
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orofacial MRI Center at UMN
Minneapolis, Minnesota, 55455
About this study
Official title: Magnetic Resonance Imaging of the Temporomandibular Joint in Patients With Degenerative Joint Disease
This observational research is comparative in design, that is assessing the change in qMRI measures in degenerative changes of the TMJ in patients diagnosed with DJD. These patients will be imaged multiple times over the course of 18 months, using clinical 3T MRI scanners located at the Center for Magnetic Resonance Research (CMRR), and their findings will be compared to controls; individuals who are not diagnosed with DJD. No investigational agents or MRI contrast agents will be used.
Read the detailed description
Participants with DJD will be recruited during routine examinations at the TMD clinic located at the School of Dentistry, UMN. They will be approached by their clinicians for potential enrollment in an MRI study. Eligibility will be assessed based on prior imaging and medical history. If eligible and interested, participants will complete a consent process and a CMRR questionnaire which is a safety screening questionnaire, followed by scheduling for a 2-hour MRI session at the CMRR. During the visit, participants will undergo approximately 90 minutes of qMRI scans using a 15-channel face coil. Afterward, they'll complete an exit questionnaire. Additional follow-up scans may occur over 18 months, following the same procedures, while control participants will have two scans 1-4 weeks apart.
- Conditions
- Degenerative Joint Disease, Control Subjects
- Being tested
- MRI, Magnetic Resonance Imaging
- Keywords
- Degenerative joint disease, TMJ, MRI, Controls, Healthy controls, Magnetic resounance imaging, Diagnosis
- Medical subject headings
- Joint Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
This exploratory study will longitudinally image patients diagnosed with DJD, capturing multiple bilateral TMJ MRI scan images over the course of 18 months using 3T MRI.
Magnetic Resonance ImagingDiagnostic test
For comparison, this exploratory study will image patients that are not diagnosed with DJD, capturing multiple bilateral TMJ MRI scan images over the course of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| DJD | Participants must be 18 years or older, who can attend a 2-hour MRI appointment at the CMRR. They must have a clinically confirmed diagnosis of degenerative joint disease (DJD) based on CT, radiographs, or traditional MRI. Receives: Diagnostic Test: MRI | |
| Controls | Participants must be 18 years or older who can attend a 2-hour MRI appointment at the CMRR. They must confirm the absence of any pre-existing temporomandibular joint (TMJ) disease. Receives: Diagnostic Test: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the change in qMRI measures in degenerative changes of the TMJ over time
We will assess these changes between baseline MRI and multiple MRI scanning session over the course of 18 months. We will group patients who do (case group) and do not (control group) have clinical progression of DJD based on their existing CT scans and/or radiograph imaging acquired by their clinician to confirm their diagnosis. These findings will be evaluated through subjective observations and the ability to identify various anatomical structures. Additionally, intra- and inter-rater reliability analyses will be conducted to assess the consistency of the MRI interpretations
Measured: 1.5 year
Secondary outcomes (1)
Build a rich MRI data set
This exploratory study is designed to provide useful data regardless of the outcomes. This study will begin to build a rich MRI data set that will lay the groundwork for future, larger studies to more fully evaluate the quantitative MRI techniques and address important clinical questions.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start17 Apr 2025
- Primary completion31 May 2027 (estimated)
- Study completion28 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Joint DiseaseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008690
- Sponsor's protocol ID
- University of Minnesota - DJD
- Status last verified
- Jun 2026
- First submitted
- 28 May 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging of the Temporomandibular Joint in Patients With Degenerative Joint Disease
- ClinicalTrials.gov ID
- NCT07008690
- Acronym / sponsor ID
- University of Minnesota - DJD
- Conditions
- Degenerative Joint Disease, Control Subjects
- Keywords
- Degenerative joint disease, TMJ, MRI, Controls, Healthy controls, Magnetic resounance imaging, Diagnosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 28 Nov 2027 (estimated)
- First posted
- 6 Jun 2025 (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.
This observational research is comparative in design, that is assessing the change in qMRI measures in degenerative changes of the TMJ in patients diagnosed with DJD. These patients will be imaged multiple times over the course of 18 months, using clinical 3T MRI scanners located at the Center for Magnetic Resonance Research (CMRR), and their findings will be compared to controls; individuals who are not diagnosed with DJD. No investigational agents or MRI contrast agents will be used.
Detailed description
Participants with DJD will be recruited during routine examinations at the TMD clinic located at the School of Dentistry, UMN. They will be approached by their clinicians for potential enrollment in an MRI study. Eligibility will be assessed based on prior imaging and medical history. If eligible and interested, participants will complete a consent process and a CMRR questionnaire which is a safety screening questionnaire, followed by scheduling for a 2-hour MRI session at the CMRR. During the visit, participants will undergo approximately 90 minutes of qMRI scans using a 15-channel face coil. Afterward, they'll complete an exit questionnaire. Additional follow-up scans may occur over 18 months, following the same procedures, while control participants will have two scans 1-4 weeks apart.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DJD | – | Diagnostic Test: MRIParticipants must be 18 years or older, who can attend a 2-hour MRI appointment at the CMRR. They must have a clinically confirmed diagnosis of degenerative joint disease (DJD) based on CT, radiographs, or traditional MRI. |
| Controls | – | Diagnostic Test: Magnetic Resonance ImagingParticipants must be 18 years or older who can attend a 2-hour MRI appointment at the CMRR. They must confirm the absence of any pre-existing temporomandibular joint (TMJ) disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with DJD will be recruited during routine examinations at the TMD clinic located at the School of Dentistry, UMN. If eligible and interested, participants will undergo approximately 90 minutes of qMRI scans. Additional follow-up scans may occur over 18 months, while control participants will have two scans 1-4 weeks apart.
Key inclusion criteria (30 listed)
- To participate in this study, patients (with DJD) must:
- To participate in this study, controls (participants without DJD) must:
- Exclusion Criteria:
- Contraindications to MRI. Exclusion criteria for MRI are:
- Are non-English speaking
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MRIThis exploratory study will longitudinally image patients diagnosed with DJD, capturing multiple bilateral TMJ MRI scan images over the course of 18 months using 3T MRI. | Diagnostic test | DJD |
| Magnetic Resonance ImagingFor comparison, this exploratory study will image patients that are not diagnosed with DJD, capturing multiple bilateral TMJ MRI scan images over the course of 4 weeks. | Diagnostic test | Controls |
Primary outcome
Assess the change in qMRI measures in degenerative changes of the TMJ over time
Time frame: 1.5 year
We will assess these changes between baseline MRI and multiple MRI scanning session over the course of 18 months. We will group patients who do (case group) and do not (control group) have clinical progression of DJD based on their existing CT scans and/or radiograph imaging acquired by their clinician to confirm their diagnosis. These findings will be evaluated through subjective observations and the ability to identify various anatomical structures. Additionally, intra- and inter-rater reliability analyses will be conducted to assess the consistency of the MRI interpretations
1 secondary outcome
Build a rich MRI data set
Time frame: 1.5 years
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 18 Jun 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Joint Disease and Control Subjects, run by University of Minnesota at 1 site in United States.
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 30 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 18 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the change in qMRI measures in degenerative changes of the TMJ over time (time frame: 1.5 year). 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 18 Jun 2026.