Exploration of the Utility of Dental-dedicated MRI for Dentistry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Minnesota

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Dental patients1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year
2

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.

Time frame
1 year
3

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.

Time frame
3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Dentsply North America LLC

Collaborator

Siemens Medical Solutions USA Inc. (Siemens Healthineers)

Collaborator

American Association for Endodontics Foundation

Collaborator