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Recruiting NCT06948162

Exploration of the Utility of Dental-dedicated MRI for Dentistry

Observational Dental Crowding Dental Occlusion, Traumatic Dental Pain TMD/Orofacial Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: dental-dedicated MRI (ddMRI).
Who it may be relevant to
Registry conditions: Dental Crowding, Dental Occlusion, Traumatic, Dental Pain, TMD/Orofacial Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Feasibility and Safety Assessment of ddMRI in Dental Patients [Time frame: 1 year]
  • Diagnostic Quality Assessment of ddMRI in Dental Patients [Time frame: 1 year]
  • Anatomical landmark identification and inflammation detection [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Orofacial MRI Center at UMN — Minneapolis

Identifiers

NCT: NCT06948162 · University of Minnesota · Dentsply Sirona

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗