跳至主要内容
临床试验/NCT05127356
NCT05127356已完成不适用

Diagnostic Accuracy of DIAGNOdent Compared to ICDAS II in Detection of Incipient White Spot Lesions: An In-vivo Evaluation

Cairo University1 个研究点 分布在 1 个国家目标入组 193 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
193
试验地点
1
主要终点
Diagnostic accuracy

研究概览

简要总结

There is a paradigm shift in conservative dentistry by substituting the surgical model with the medical model of treatment. Early detection of initial carious lesions will aid in clinical decision making during management ; either no care advised, preventive care advised or operative care advised. According to recent systematic reviews meticulous visual examination using ICDAS II presented a substantial level of reproducibility and accuracy for assessment of carious lesions and was considered the reference for clinical visual assessment . However, visual examination is subjective and is highly dependent on the dentist's skills and experience, with high specificity and low sensitivity. New devices have been developed to detect and quantify incipient demineralization. Besides visual detection systems, laser fluorescence assessment can be considered a suitable method. In vitro data suggested that the visual examination and fluorescence method have similar accuracy to detect initial carious lesions.

详细描述

This study will be conducted to evaluate the diagnostic accuracy of laser fluorescence device (DIAGNOdent) compared to to visual examination (ICDAS II) in detection of incipient carious lesions for decision making during caries management

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Non cavitated white spot lesions.
  • Patient compliance

排除标准

  • Cavitated lesions.
  • Medically compromised patients.
  • Enrollment in another clinical trials.

结局指标

主要结局

Diagnostic accuracy

时间窗: Immediate (cross-sectional)

Assessing the validity of both methods in detecting initial carious lesions in terms of sensitivity and specificity.

次要结局

未报告次要终点

研究者

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

Omar Osama Shaalan

Lecturer, Conservative Dentistry Department, Faculty of Dentistry

Cairo University

研究点 (1)

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