Exploration of the Utility of Dental-dedicated MRI for Dentistry

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Orofacial MRI Center at UMN — Minneapolis

Идентификаторы

NCT: NCT06948162 · University of Minnesota · Dentsply Sirona

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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