Clinical trial NCT06948162: Exploration of the Utility of Dental-dedicated MRI for Dentistry
Official title: Exploration of the Utility of Dental-dedicated MRI for Dentistry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dental Crowding
Dental Occlusion, Traumatic
Dental Pain
TMD/Orofacial Pain
TMD
Orthodontics
Endodontic Disease
Orthodontic Treatment
Keywords: Diagnosis
Magnetic resounance imaging
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Dentsply Sirona Implants and Consumables
name: Siemens Healthineers USA
First posted: 2025-04-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dental patients age 18 and older that are able to provide informed consent for themselves, being seen at the School of Dentistry at the UMN for routine dental care where diagnostic imaging is indicated.

Brief summary: This description observational research is comparative in design, that is comparing existing standard clinical dental images, not obtained in this study, to test (i.e., ddMRI) images. The standard clinical dental images consist of radiographs, such as bitewings, periapical, panoramic, cone-beam CT, and medical CT, as well medical MRIs of the temporomandibular joints (TMJ).The conceptualization of research questions, study designing, and interpretation of imaging data has and will involve content expertise in all ddMRI research.

Detailed description: Patients recruited from dental clinics at the University of Minnesota School of Dentistry will be screened for eligibility and asked to complete an MRI safety screening questionnaire. Eligible individuals will be invited to participate in at least one study visit, during which an MRI scan will be performed. At the end of the session, participants will complete a short questionnaire about their experience during the scan.

Eligibility criteria: Inclusion Criteria:

1. Patient Age: 18 years old or older
2. Receiving imaging for routine dental care
3. Does not have a serious medical condition
4. Is not pregnant or is not potentially pregnant
5. Is willing and able to give consent in English
6. Has the ability to manage their own calendar and schedule appointments
7. Willing to have a separate 2-hour appointment to have an MRI

Exclusion Criteria:

1. Unable to consent to participant in English
2. Serious health condition, which includes but not limited to renal failure/on dialysis, unstable heart disease (uncontrolled arrhythmia, cardiomyopathy and/or unable to lay flat, within 1 month of cardiac catheterization or myocardial infarction), unstable cerebral vascular disease (within 1 month of stroke and/or stent placement), diabetes (type I or II) not controlled by medication or diet, uncontrolled seizures, uncontrolled hyperthyroidism, non-allergic bronchospasm (chronic obstructive pulmonary disease and emphysema), uncontrolled movement disorder, and liver failure
3. Pregnant and/or intending to become pregnant,
4. Prisoner and/or not able to manage their own scheduling
5. Screen positive on MR safety questionnaire, specifically including people that have worked with or otherwise been exposure to metal particles and have the potential for such particles to be embed within them.

Primary outcomes:
measure: Feasibility and Safety Assessment of ddMRI in Dental Patients
timeFrame: 1 year
measure: Diagnostic Quality Assessment of ddMRI in Dental Patients
timeFrame: 1 year
measure: Anatomical landmark identification and inflammation detection
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Orofacial MRI Center at UMN
state: Minnesota
Study officials:
affiliation: University of Minneosta
name: Donald R Nixdorf, DDS, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minneosta
name: Laurance Gaalaas, DDS, MS
role: STUDY_DIRECTOR
References: