Exploration of the Utility of Dental-dedicated MRI for Dentistry

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.

Study Overview

• Status: Recruiting
• Conditions: Endodontic Disease; Dental Pain; Orthodontics; TMD; Orthodontic Treatment; Dental Occlusion, Traumatic; Dental Crowding; TMD/Orofacial Pain
• Intervention / Treatment: Device: dental-dedicated MRI (ddMRI)

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Rania Nuwailati, BDS, MS, PhD; Phone Number: 612-626-8431; Email: Nuwai003@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • Orofacial MRI Center at UMN
      • Contact: Rania Nuwailati, BDS, MS, PhD; Phone Number: 612-626-8431; Email: Nuwai003@umn.edu
      • Contact: Phone Number: 612-626-9521

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dental patients; Dental patients receiving care that have imaging a part of routine care	Device: dental-dedicated MRI (ddMRI); This descriptive 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and Safety Assessment of ddMRI in Dental Patients	Evaluate the feasibility and safety of dental-dedicated MRI (ddMRI) in dental patients by assessing their experiences immediately following each scan. This will be done using an exit questionnaire designed to capture any sensations or discomforts that may have occurred during the scan. Participants will be asked to report the presence of various sensations, including but not limited to: nervousness, double vision, sleepiness, vertigo, lightheadedness, metallic taste, and feelings of warmth or cold. The collected responses will help determine the overall tolerability of ddMRI in this patient population.	1 year
Diagnostic Quality Assessment of ddMRI in Dental Patients	The diagnostic quality of dental-dedicated MRI (ddMRI) in dental patients will be evaluated through subjective ratings of its ability to identify various dentoalveolar anatomical structures. These ratings will be compared to those obtained from existing standard dental imaging modalities. Additionally, intra- and inter-rater reliability analyses will be conducted to assess the consistency of the ddMRI interpretations and their agreement with conventional dental imaging.	1 year
Anatomical landmark identification and inflammation detection	Compare the diagnostic efficacy of ddMRI versus existing clinical imaging (e.g., plain film, CT, MRI) in terms of identifying anatomical landmarks and detecting the presence of inflammation, as rated by dental specialist examiners.	3 years

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: Dentsply Sirona Implants and Consumables; Siemens Healthineers USA
• Investigators: Principal Investigator: Donald R Nixdorf, DDS, MS, University of Minneosta; Study Director: Laurance Gaalaas, DDS, MS, University of Minneosta

Publications and helpful links

Helpful Links

• The Orofacial Magnetic Resonance Imaging Center (OMRIC) facility at the UMN: a state-of-the-art research facility -1st in the nation- that supports oral and craniofacial imaging studies, particularly those involving MRI.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Diagnosis; Magnetic resounance imaging
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Pathologic Processes; Tooth Diseases; Malocclusion; Facial Pain; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Spatial Behavior; Disease; Dental Pulp Diseases; Toothache; Dental Occlusion, Traumatic; Crowding
• Other Study ID Numbers: University of Minnesota; Dentsply Sirona (Other Identifier: Dentsply Sirona)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No