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| ID | Type | Description | Link |
|---|---|---|---|
| Dentsply Sirona | Other Identifier | Dentsply Sirona |
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| Name | Class |
|---|---|
| Dentsply Sirona Implants and Consumables | INDUSTRY |
| Siemens Healthineers USA | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dental patients | Dental patients receiving care that have imaging a part of routine care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 discomforts 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. | 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. | 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. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Dental patients age 18 and older that are able to provide informed consent for themselves, being seen at the School of Dentistry at the UMN for routine dental care where diagnostic imaging is indicated.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rania Nuwailati, BDS, MS, PhD | Contact | 612-626-8431 | Nuwai003@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Donald R Nixdorf, DDS, MS | University of Minneosta | Principal Investigator |
| Laurance Gaalaas, DDS, MS | University of Minneosta | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orofacial MRI Center at UMN | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| Label | URL |
|---|---|
| The Orofacial Magnetic Resonance Imaging Center (OMRIC) facility at the UMN: a state-of-the-art research facility -1st in the nation- that supports oral and craniofacial imaging studies, particularly those involving MRI. | View source |
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| ID | Term |
|---|---|
| D003441 | Crowding |
| D003769 | Dental Occlusion, Traumatic |
| D014098 | Toothache |
| D003788 | Dental Pulp Diseases |
| D004194 | Disease |
| ID | Term |
|---|---|
| D013037 | Spatial Behavior |
| D001519 | Behavior |
| D008310 | Malocclusion |
| D014076 | Tooth Diseases |
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| D009057 |
| Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |