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临床试验/NCT05441423
NCT05441423Unknown不适用

Accuracy and Reliability of Ultra Low Dose CBCT Versus CBCT Imaging in Semi-automated Segmentation of the Mandibular Condyle (A Diagnostic Accuracy Study)

Cairo University0 个研究点目标入组 29 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
29
主要终点
Linear Measurements

研究概览

简要总结

The objective of this study will be evaluation of accuracy and reliability of CBCT imaging versus Ultra low dose CBCT imaging in semi-automated mandibular condyle segmentation (linear and volumetric assessment of the condyles), in cases requiring condylar and mandibular reconstruction. Dry human skulls and dry human mandibles will be recruited from Anatomy Department, Faculty of Medicine, Cairo University. The following radiographic examination will be done in Oral and Maxillofacial Radiology Department, Faculty Dentistry, Cairo University. they include Radiographic imaging by CBCT machine & Data acquisition and analysis. then semiautomated segmentation will be performed for the mandibular condyles and then after the assessment will be done as both linear and volumetric for each condyle.

详细描述

The objective of this study will be evaluation of accuracy and reliability of CBCT imaging versus Ultra low dose CBCT imaging in semi-automated mandibular condyle segmentation (linear and volumetric assessment of the condyles), in cases requiring condylar and mandibular reconstruction. Dry human skulls and dry human mandibles will be recruited from Anatomy Department, Faculty of Medicine, Cairo University. The following radiographic examination will be done in Oral and Maxillofacial Radiology Department, Faculty Dentistry, Cairo University. they include Radiographic imaging by CBCT machine & Data acquisition and analysis. then semiautomated segmentation will be performed for the mandibular condyles and then after the assessment will be done as both linear and volumetric for each condyle.

R (Reference standard): Physical real linear measurements of the condyles will be considered as reference standard, where distances will be measured by digital caliper on the dry human in millimeters as supported by García-Sanz et al. (2017) & (Kim et al., 2020).

Volumetric measurements form the dry human condyles will be considered as reference standard where water displacement method will be used (according to Archimedes' principle), by immersion of the condyle under investigation in a water filled graduated transparent glass container, after being hangered from a L-shaped metal hanger by using a rope, till the complete immersion of the condylar volume (which was demarcated by using the gutta percha points) under the water level, this will provide more standardization. Then, the displaced amount of water, will be observed and then aspirated by a graduated pipette to calculate its volume in cubic millimeters. This technique was supported by García-Sanz et al. (2017).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Blinding

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •mandibles with sound condyles
  • •skulls with sound glenoid fossa.

排除标准

  • •skulls with fractured glenoid fossa,
  • •glenoid fossa with developmental deformities,
  • •mandibles with fractured condylar neck or head,
  • •presence of pathological lesions,
  • •developmental deformities in the condyle.

结局指标

主要结局

Linear Measurements

时间窗: 1 year

Linear assessment will be done by applying the same landmarks on the both segmented condyles (yielded rom Conventional and Ultralow dose CBCT imaging), Distances will be measured on the segmented condyles from the segmentation software in millimeters. The linear distances according to García-Sanz et al. (2017) will be as follows: * Line 1: Condylar width measured as the distance between lateral and medial landmarks. * Line 2: Condylar length measured as distance between anterior and posterior landmarks. * Line 3: Condylar height measured as distance of the perpendicular line traced from superior point to line 1.

次要结局

  • Volumetric measurements(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marina Salib

PhD Candidate

Cairo University

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