MRI of the TMJ in Patients With DJD

Active, not recruiting

• Conditions: Degenerative Joint Disease; Control Subjects

• Registration Number: NCT07008690
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study Start: 2025-04-17
• Status Verified: 2025-05
• Study First Submitted: 2025-05-28
• Study First Submitted QC: 2025-05-28
• Last Update Submitted: 2025-05-28
• Study First Posted: 2025-06-06
• Last Update Posted: 2025-06-06
• Primary Completion: 2027-05-31
• Study Completion: 2027-11-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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:

• Contraindications to MRI. Exclusion criteria for MRI are:

  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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the change in qMRI measures in degenerative changes of the TMJ over time	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

Secondary Outcome Measures

Name	Time	Method
Build a rich MRI data set	1.5 years	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.

Trial Locations

Locations (1)

Orofacial MRI Center at UMN; 🇺🇸 Minneapolis, Minnesota, United States