MRI of the TMJ in Patients With DJD

NCT07008690 | Active Not Recruiting FDA Device

• 1 other identifier: University of Minnesota - DJD
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Joint Disease; Control Subjects

Keywords

Degenerative joint disease; TMJ; MRI; Controls; Healthy controls; Magnetic resounance imaging; Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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

  1.5 year

Secondary Outcomes (1)

• Build a rich MRI data set

  1.5 years

Study Arms (2)

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.

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.

Diagnostic Test: Magnetic Resonance Imaging

Interventions

MRI 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.

DJD

Magnetic Resonance Imaging 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.

Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• 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

You may not qualify if:

• Participants will be excluded if they:
• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Orofacial MRI Center at UMN

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Joint Diseases; Disease

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 6, 2025
• Study Start: April 17, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): November 28, 2027
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)