MRI of the TMJ in Patients With DJD

NCT ID: NCT07008690

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-17
• Study Completion Date: 2027-11-28

Brief 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 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.

Conditions

Degenerative Joint Disease; Control Subjects

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

MRI

Intervention Type: DIAGNOSTIC_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.

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.

Magnetic Resonance Imaging

Intervention Type: DIAGNOSTIC_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.

Interventions

MRI

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.

Intervention Type: DIAGNOSTIC_TEST

Magnetic Resonance Imaging

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. 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
• 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

2. 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:

1. Ferromagnetic implants

2. History of shrapnel or shot gun injury

3. Too large to fit in the magnet (body mass index >= 40, approx.)

4. Cardiac pacemakers

5. Severe claustrophobia

6. Large tattoos

7. History of metalwork

• Are non-English speaking
• Could be pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Orofacial MRI Center at UMN

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

University of Minnesota - DJD

Identifier Type: -

Identifier Source: org_study_id