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Assessment of the Variations in the Root Canal System of the Permanent Mandibular First and Second Molars Among Egyptian Population Using Cone Beam Computed Tomography

2018年5月8日 更新者:Farid Medhat、Cairo University

Assessment of the Variations in the Number of Roots and the Root Canal System of the Permanent Mandibular First and Second Molars in a Sample of Egyptian Population Using Cone Beam Computed Tomography

A cross-sectional study to estimate Variations in the Number of Roots and the Root Canal System of the Permanent Mandibular First and Second Molars in a Sample of Egyptian Population using cone beam computed tomography through retrospective data analysis

研究概览

地位

未知

详细说明

Setting and Location:

The data collection will be obtained from the data base available at the department of oral and maxillofacial radiology, faculty of dentistry, Cairo university, Cairo, Egypt.

cone beam images will be obtained from Egyptian patients who had cone beam computed tomography examination as part of their dental examination, diagnosis or treatment planning .

Participants:

A total sample of 384 mandibular first and second permanent molars belonging to Egyptian individuals will be included.

Images of the first and second mandibular permanent molars are selected according to the following criteria:

Inclusion criteria:

  • Fully maturated and erupted mandibular permanent first and second molars of Egyptian patients, males or females .
  • Intact roots without fractures or cracks .
  • Molars without posts or previous root canal treatment .
  • cone beam scans of mandibular first and second molars using different fields of view, and different voxel resolutions .

Exclusion criteria:

  • Evidence of apicectomy or periapical surgery .
  • Mandibular molars with developmental anomalies .
  • External or Internal Root resorption .
  • Root Canal Calcification .
  • Previous Root Canal treatment .
  • Post restorations .
  • Root caries specially reaching the bifurcation area .
  • Tomographic images of poor quality or artifacts interfering with the detection of root canals .

Variables:

  1. Number of roots of mandibular first and second molars .
  2. Number of root canals of mandibular first and second molars .

Data Sources / Measurements:

  • Retrospective Data Analysis will be performed after the Cone beam images are pooled from the computer database.
  • All the cone beam computed tomography examinations will be scanned using CBCT Software (Planmeca Romexis Viewer) .
  • cone beam computed tomography images will be analysed in the 3 planes; first the sagittal and coronal sections will be oriented parallel to the long axis of the root, and then sections will be obtained on the axial plane for detection of the number of roots and root canals.
  • cone beam computed tomography images will be interpreted by three oral radiologists independently; blinded from demographic data of the patients and from the results of each other.
  • Each one will evaluate the images separately twice with a period of two weeks between the two reading sessions.
  • Then inter-observational and intra-observational variability between the observers will be evaluated.

Bias:

No source of bias.

Study Size:

To detect variations in number of roots and root canals in permanent mandibular first and second molars in the Egyptian population. The investigators are going to apply convenient consecutive sampling.Using a precision of 5, a design effect set at 1 with 95% CI (confidence interval), a total sample size of 384 will be sufficient. The sample size was calculated by Epi info.

sampling strategy: The sample will be collected by simple random sampling .

Quantitative Variables:

The number of cone beam computed tomography scans of Egyptian individuals with extra roots and accessory root canals in mandibular first and second permanent molars will be counted to estimate the variations in the Egyptian population.

Statistical methods:

Data will be analysed using IBM SPSS advanced statistics (Statistical Package for Social Sciences), version 21 (SPSS Inc., Chicago, IL). Numerical data will be described as mean and standard deviation or median and range. Categorical data will be described as numbers and percentages. Comparisons between male and females for normally distributed numeric variables will be done using the Student's t-test while for non-normally distributed numeric variables will be done by Mann-Whitney test. Comparisons between categorical variables will be performed using the chi square test. A p-value less than or equal to 0.05 will be considered statistically significant. All tests will be two tailed.

研究类型

观察性的

注册 (预期的)

384

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

15年 及以上 (孩子、成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

Egyptian population

描述

Inclusion Criteria:

  • Fully maturated and erupted mandibular permanent first and second molars of Egyptian patients, males or females .
  • Intact roots without fractures or cracks .
  • Molars without posts or previous root canal treatment .
  • CBCT scans of mandibular first and second molars using different fields of view, and different voxel resolutions .

Exclusion Criteria:

  • Evidence of apicectomy or periapical surgery .
  • Mandibular molars with developmental anomalies .
  • External or Internal Root resorption .
  • Root Canal Calcification .
  • Previous Root Canal treatment .
  • Post restorations .

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Extra root in the first and second mandibular permanent molars
大体时间:six months
by Percentage
six months

次要结果测量

结果测量
措施说明
大体时间
Extra root canals in the first and second mandibular permanent molars
大体时间:six months
by percentage
six months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2018年6月1日

初级完成 (预期的)

2018年9月1日

研究完成 (预期的)

2018年10月1日

研究注册日期

首次提交

2018年4月2日

首先提交符合 QC 标准的

2018年5月8日

首次发布 (实际的)

2018年5月21日

研究记录更新

最后更新发布 (实际的)

2018年5月21日

上次提交的符合 QC 标准的更新

2018年5月8日

最后验证

2018年5月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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