Dental CrowdingNCT06948162
Exploration of the Utility of Dental-dedicated MRI for Dentistry
An observational study of Dental Crowding and Dental Occlusion, Traumatic, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Crowding, Dental Occlusion, Traumatic, Endodontic Disease
- What is being tested?
- dental-dedicated MRI (ddMRI)
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2025to 31 Aug 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 exposed to metal particles and have the potential for such particles to be embedded within them.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Orofacial MRI Center(OMRIC), University of Minnesota, School of Dentistry, Malcolm Moos Health Sciences Tower, 515 Delaware St. SE,
Minneapolis, Minnesota, 55455
Rania Nuwailati, BDS, MS, PhD, 612-626-8431, Nuwai003@umn.edu
Sara Duffy, BS, 612-626-1025, ohcrc@umn.edu
About this study
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.
Read the 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.
- Conditions
- Dental Crowding, Dental Occlusion, Traumatic, Endodontic Disease, Orthodontic Treatment, Endodontic Lesions, PeriodontalConditions
- Being tested
- dental-dedicated MRI (ddMRI)
- Keywords
- Diagnosis, Magnetic resonance imaging, Spatial Behavior, Malocclusion, Behavior, Tooth Diseases, Stomatognathic Diseases, Facial Pain, Neurologic Manifestations, Pain, Pathological Conditions, Signs and Symptoms, Dental Occlusion, Traumatic, Crowding, Dental Pulp Diseases, Tooth extraction, Periodontitis, Histopathalogy, Local anesthesia
- Medical subject headings
- Crowding, Dental Occlusion, Traumatic, Dental Pulp Diseases, Periodontal Diseases, Disease, Spatial Behavior, Malocclusion, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental-dedicated MRI (ddMRI)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Dental patients | Dental patients receiving care that have imaging a part of routine care Receives: Device: dental-dedicated MRI (ddMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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.
Measured: 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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start17 Mar 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CrowdingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply North America LLC, Siemens Medical Solutions USA Inc. (Siemens Healthineers), American Association for Endodontics Foundation
- Responsible party
- Sponsor
- Investigators
- Kristin Artinger, PhD, Principal investigator, University of MinneostaLaurance Gaalaas, DDS, MS, Study director, University of Minneosta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948162
- Sponsor's protocol ID
- University of Minnesota
- Other IDs
- Dentsply Sirona
- Status last verified
- Aug 2026
- First submitted
- 28 Mar 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No