Exploration of the Utility of Dental-dedicated MRI for Dentistry
2 other identifiers
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 17, 2025
CompletedFirst Submitted
Initial submission to the registry
March 28, 2025
CompletedFirst Posted
Study publicly available on registry
April 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2028
April 29, 2025
April 1, 2025
2.8 years
March 28, 2025
April 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (1)
Dental patients
Dental patients receiving care that have imaging a part of routine care
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Patient Age: 18 years old or older
- Receiving imaging for routine dental care
- Does not have a serious medical condition
- Is not pregnant or is not potentially pregnant
- Is willing and able to give consent in English
- Has the ability to manage their own calendar and schedule appointments
- Willing to have a separate 2-hour appointment to have an MRI
You may not qualify if:
- Unable to consent to participant in English
- 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
- Pregnant and/or intending to become pregnant,
- Prisoner and/or not able to manage their own scheduling
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Donald Nixdorflead
- Dentsply Sirona Implants and Consumablescollaborator
- Siemens Healthineers USAcollaborator
Study Sites (1)
Orofacial MRI Center at UMN
Minneapolis, Minnesota, 55455, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donald R Nixdorf, DDS, MS
University of Minneosta
- STUDY DIRECTOR
Laurance Gaalaas, DDS, MS
University of Minneosta
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 28, 2025
First Posted
April 29, 2025
Study Start
March 17, 2025
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
July 31, 2028
Last Updated
April 29, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share