Clinical trial NCT07008690: MRI of the TMJ in Patients With DJD
Official title: Magnetic Resonance Imaging of the Temporomandibular Joint in Patients With Degenerative Joint Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Degenerative Joint Disease
Control Subjects
Keywords: Degenerative joint disease
TMJ
MRI
Controls
Healthy controls
Magnetic resounance imaging
Diagnosis
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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
3. 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

Primary outcomes:
measure: Assess the change in qMRI measures in degenerative changes of the TMJ over time
timeFrame: 1.5 year
Secondary outcomes:
measure: Build a rich MRI data set
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Orofacial MRI Center at UMN
state: Minnesota
Study officials:
References: