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临床试验/NCT03227172
NCT03227172已完成不适用

The Accuracy of Magnetic Resonance Imaging in Diagnosing Endodontic Periapical Lesion

University of Bologna0 个研究点目标入组 34 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
主要终点
The diagnostic accuracy of the resonance magnetic imaging, calculated in comparison with the pathologists' diagnosis with a ROC analysis

研究概览

简要总结

The radiolucent periapical jaw lesions of 34 patients, which were surgically enucleated, were investigated by two radiologists using MRI, based on the same six criteria, to categorize the lesions as granulomas or radicular cysts. After apicoectomies, two oral pathologists (blinded to the radiologist's diagnoses) analyzed all specimens by referring to seven specific parameters and diagnosed the specimens as granulomas or radicular cysts. The inter-rater agreements between the radiologists and pathologists in terms of MRI and histological diagnoses, respectively, along with the discriminant power of the adopted criteria and the accuracy of the MRI assessments compared with the histopathologic results, were calculated.

A strong inter-rater reliability was observed between the two radiologists (k-statistic = 0.86, p = 0.0001) and the two pathologists (k-statistic = 0.88, p = 0.0001). Reliability was higher for the radiological (Guttmann's lambda lower bound > 0.6) than histopathological criteria. The accuracy (true positives plus true negatives) of the radiologists was higher than that of the pathologists based on receiver operator characteristic analysis (area under the curve = 0.87 and 0.91, respectively). MRI reliability and accuracy were high and comparable to histopathological reliability, highlighting the usefulness of this non-invasive exam as a pre-treatment diagnostic method for periapical endodontic lesions.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient age ≥ 18 years
  • the diameter of the lesion ≥ 5 mm, assessed based on periapical x-ray,
  • an acceptable endodontic treatment for the involved tooth.

排除标准

  • general medical contraindications for classification of the patient as level III or higher according to the American Society of Anesthesiologists,
  • teeth involved in the lesion, the function of which could not be salvaged after enucleation of the lesion and apicoectomy. The radiological exclusion criteria were
  • contraindication undergoing magnetic resonance: presence of a pacemaker or any metallic devices that could interfere with the magnetic field;
  • severe claustrophobia,
  • weight ≥ 130 kg
  • intolerance to gadolinium-DTPA as a contrast agent;

结局指标

主要结局

The diagnostic accuracy of the resonance magnetic imaging, calculated in comparison with the pathologists' diagnosis with a ROC analysis

时间窗: 5 years

To determine the diagnostic accuracy of the radiologists compared with the pathologists (considered the gold standard), receiver operator characteristic (ROC) analysis was performed assuming that the diagnostic test is dichotomous. This method for computing the area under curve (AUC) and its error is in agreement with fitting procedures used for diagnostic tests.

次要结局

  • inter-pathologist diagnoses , inter-radiologist diagnoses and internal consistency of the items used for the differential diagnosis by radiologists and pathologists.(5 years)

研究者

发起方
University of Bologna
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giuseppe Lizio

research assistant

University of Bologna

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