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Набор по приглашению NCT07012850

Advanced Magnetic Resonance Imaging for Perioperative Evaluation of Dental, Oral and Maxillofacial Trauma

— Наблюдательное Traumatology Maxillofacial Trauma Maxillofacial Injuries

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Magnetic Resonance Imaging.
Кому может быть актуально
Состояния в реестре: Traumatology, Maxillofacial Trauma, Maxillofacial Injuries. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Dental, oral, and maxillofacial trauma represents a significant public health concern, with most cases resulting from accidents and occurring frequently in young adults. Diagnosis relies on clinical examination and imaging modalities like computed tomography (CT) and cone-beam computed tomography (CBCT), which are standard for hard tissue assessment but expose patients to ionizing radiation. To reduce radiation exposure while simultaneously allowing for the visualization of soft tissues, newer imaging methods, including magnetic resonance imaging (MRI), as well as Black Bone and CT-like MRI protocols (ZTE, UTE), are being explored. These MRI techniques offer high-resolution, non-ionizing alternatives, showing promise for diagnosing soft tissue injuries and fractures without radiation risks, especially beneficial for younger patients. This study aims to assess MRI's diagnostic capabilities for maxillofacial trauma, focusing on early diagnosis, artifact reduction, and comparison to conventional X-ray-based imaging, within a minimal-risk study framework. This study aims to evaluate the diagnostic efficacy of MRI compared to X-ray-based imaging modalities (CT/CBCT) for detecting dental, oral, and maxillofacial fractures, with a specific focus on Black Bone and CT-like MRI techniques. Additionally, it investigates MRI's potential to reduce artifacts around osteosynthesis plates, enhancing postoperative imaging quality in the presence of metal hardware.

Вмешательства

  • Диагностический тест Magnetic Resonance Imaging
    To reduce radiation exposure while simultaneously allowing for the visualization of soft tissues, newer imaging methods, including magnetic resonance imaging (MRI), as well as Black Bone and CT-like MRI protocols (ZTE, UTE), are being explored. These MRI techniques offer high-resolution, non-ionizing alternatives, showing promise for diagnosing soft tissue injuries and fractures without radiation risks.

Первичные конечные точки

  • qualitative imaging parameters [Срок оценки: From enrollment to the end of treatment at week 5]
  • Quantitative Assessment of Fracture Dimensions [Срок оценки: From enrollment to the end of treatment at week 5]

Критерии участия

Критерии включения

  • Patients presenting with acute dental, oral and maxillofacial trauma
  • Age: 18 years and older
  • Able to give informed consent (documented by signature)
  • No prior radiation-based imaging for the current trauma episode

Критерии исключения

  • Pregnant or lactating individuals
  • Known contraindications to MRI (e.g., pacemakers, certain implants)
  • Clinically significant concomitant diseases affecting imaging quality (e.g., severe neurocognitive disorders)
  • Inability to comply with MRI procedures or study protocol (e.g., due to language barriers, psychological disorders, or dementia)
  • Participation in other clinical trials that may interfere with the imaging study

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швейцария · 1 центр
  • Department of Cranio-Maxillofacial and Oral Surgery, University Hospital Zurich — Zurich

Публикации

  • Al-Haj Husain A, Sandhu S, Burian E, Precht MM, Sommer S, Frauenfelder T, Wagner MEH, Essig H. Intraoperative C-arm CBCT versus early postoperative MRI for the assessment of fracture reduction and osteosynthesis material positioning in cranio-maxillofacial trauma surgery. Oral Maxillofac Surg. 2026 Jun 26;30(1):101. doi: 10.1007/s10006-026-01588-8. PMID 42360559
  • Al-Haj Husain A, Kessler P, Lie SAN, Sandhu S, Wagner MEH, Burian E, Zedler D, Precht MM, Sommer S, Frauenfelder T, Essig H. Comparative evaluation of MRI-based bone-targeted sequences and computed tomography for preoperative assessment of midfacial trauma. Sci Rep. 2026 Feb 18;16(1):9700. doi: 10.1038/s41598-026-40252-9. PMID 41708704
  • Al-Haj Husain A, Sandhu S, Wagner MEH, Burian E, Lie SAN, Precht MM, Zedler D, Frauenfelder T, Hotker AM, Stadlinger B, Sommer S, Kessler P, Essig H. Diagnostic performance of CT and MRI in mandibular trauma assessment - a prospective comparative study. Oral Maxillofac Surg. 2025 Dec 27;30(1):12. doi: 10.1007/s10006-025-01496-3. PMID 41454981

Идентификаторы

NCT: NCT07012850 · 2024-02307

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗