Dental Crowding, Dental Occlusion, Traumatic, Endodontic Disease, Endodontic Histopathology, Endodontic Lesions, Local Anesthesia, Oral Surgery Conditions, Orthodontics, Orthodontic Treatment, PeriodontalConditions, Periodontal Diseases, TMJ, Tooth Extractions, Traumatic Dental Pain
Conditions
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
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.
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.
Interventions
DEVICEdental-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.
Sponsors
University of Minnesota
Dentsply North America LLC
Siemens Medical Solutions USA Inc. (Siemens Healthineers)
American Association for Endodontics Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patient Age: 18 years old or older 2. Receiving imaging for routine dental care 3. Does not have a serious medical condition 4. Is not pregnant or is not potentially pregnant 5. Is willing and able to give consent in English 6. Has the ability to manage their own calendar and schedule appointments 7. Willing to have a separate 2-hour appointment to have an MRI
Exclusion criteria
1. Unable to consent to participant in English 2. 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 3. Pregnant and/or intending to become pregnant, 4. Prisoner and/or not able to manage their own scheduling 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and Safety Assessment of ddMRI in Dental Patients | 1 year | 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 | 1 year | 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 | 3 years | 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. |
Countries
United States
Contacts
CONTACTKelli Trauger, MS, DH, RF
CONTACTSara Duffy, BS,
PRINCIPAL_INVESTIGATORKristin Artinger, PhD
University of Minneosta
STUDY_DIRECTORLaurance Gaalaas, DDS, MS
University of Minneosta
Outcome results
None listed