About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
dental-dedicated MRI (ddMRI)
DeviceThis 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Sponsors and contacts
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University of Minnesota
Lead sponsor
Dentsply North America LLC
Collaborator
Siemens Medical Solutions USA Inc. (Siemens Healthineers)
Collaborator
American Association for Endodontics Foundation
Collaborator