Exploration of the Utility of Dental-dedicated MRI for Dentistry

August 23, 2026 updated by: University of Minnesota
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients of record will be 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Kelli Trauger, MS, DH, RF
  • Phone Number: 612-624-2231
  • Email: ohcrc@umn.edu

Study Contact Backup

  • Name: Sara Duffy, BS,
  • Phone Number: 612-626-1025
  • Email: ohcrc@umn.edu

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • Orofacial MRI Center(OMRIC), University of Minnesota, School of Dentistry, Malcolm Moos Health Sciences Tower, 515 Delaware St. SE,
        • Contact:
          • Rania Nuwailati, BDS, MS, PhD
          • Phone Number: 612-626-8431
          • Email: Nuwai003@umn.edu
        • Contact:
        • Principal Investigator:
          • Kristin Artinger, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Univeristy of Minnesota School of Dentistry School patients age 18 and older that are able to provide informed consent for themselves who are established patients and being treated in a specialty clinic, such as Endodontics, Orthodontics, Periodontics, Oral Surgery, or the TMD Oral/Facial Pain Clinic for routine dental care where diagnostic imaging is current within the last 3-5 years.

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 exposed to metal particles and have the potential for such particles to be embedded within them.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnostic Quality Assessment of ddMRI in Dental Patients
Time Frame: 1 year
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
Time Frame: 3 years
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
Feasibility and Safety Assessment of ddMRI in Dental Patients
Time Frame: 1 year
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 discomfort 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dentsply North America LLC
Siemens Medical Solutions USA Inc. (Siemens Healthineers)
American Association for Endodontics Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Laurance Gaalaas, DDS, MS, University of Minneosta
  • Principal Investigator: Kristin Artinger, PhD, University of Minneosta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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