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临床试验/NCT07012850
NCT07012850Enrolling By Invitation不适用

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

Harald Essig1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
60
试验地点
1
主要终点
qualitative imaging parameters

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

qualitative imaging parameters

时间窗: From enrollment to the end of treatment at week 5

Primary Outcome Measures: 1. Qualitative Assessment of Imaging Quality Description: Image quality will be evaluated using a standardized 5-point Likert scale for the following parameters: overall image quality, artifact severity, fracture visibility, and bone-to-soft-tissue contrast. Each parameter will be scored independently. Unit of Measure: Score on a 5-point Likert scale (1 = poor, 5 = excellent)

Quantitative Assessment of Fracture Dimensions

时间窗: From enrollment to the end of treatment at week 5

Fracture length, width, and depth will be measured in millimeters across axial, sagittal, and coronal planes using standardized digital radiologic tools. Measurements will be taken by two blinded radiologists and averaged. Unit of Measure: Millimeters (mm).

次要结局

未报告次要终点

研究者

发起方
Harald Essig
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Harald Essig

Prof. Dr. med. Dr. med. dent.

University of Zurich

研究点 (1)

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