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临床试验/NCT03586713
NCT03586713Unknown不适用

Accuracy Of Sopro-Life Camera In Comparison With ICDAS II For Detection Of Initial Caries In Adult Patients With Non Cavitated Pits And Fissure Discoloration: Diagnostic Accuracy Study

Cairo University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
reliability and reproducibility of intra oral light fluorescence camera using kappa strength

研究概览

简要总结

This study will be conducted to assess diagnostic predictive values of a light induced fluorescence intraoral camera versus those of the visual-tactile assessment method according to modified ICDAS-II criteria in clinical

详细描述

volunteers patients will be assigned in this study. Each patient should have at least one posterior tooth with pits and fissure discoloration and maximum 4 teeth. The teeth will be evaluated by two diagnostic methods (D), where D1 represents visual-tactile assessment method (ICDAS-II) and D2 represents light induced fluorescence intraoral camera.Three operators, the researcher and the 2 supervisors, from the Conservative Dentistry Department, Faculty of Dentistry, Cairo University, will be the examiners in this study. Each examiner will record the dental findings using both the visual- tactile assessment method and the fluorescent-aided identification method. The visual-tactile assessment method includes the use of mirror, probe under good illumination condition, while the fluorescent-aided identification method will be performed by light induced fluorescence intraoral camera.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
15 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged from 15 to 50 years.
  • No gender restriction.
  • Patients should have an acceptable oral hygiene level.
  • Patients must have at least one posterior with fissure discoloration

排除标准

  • • Patients with a compromised medical history.
  • Severe or active periodontal disease.
  • Heavy bruxism or a traumatic occlusion.
  • Acute or chronic dental infection.
  • Pregnant or breastfeeding women.
  • Patients with posterior restorations on molars or premolars.

研究组 & 干预措施

ICDAS-II

Other

According to the international caries detection and assessment system (ICDAS-II). The visual examination was performed using the ICDAS-II criteria, which provides a standardized method of lesion detection. The ICDAS-II detection codes for coronal categories the score will be 0 =surface not restored or sealant then according to caries categories range from 0 to 6 depending on the severity of the lesion with the corresponding clinical views.

干预措施: light induced fluorescence camera (Diagnostic Test)

结局指标

主要结局

reliability and reproducibility of intra oral light fluorescence camera using kappa strength

时间窗: 6 month

in primary caries diagnosis

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

Noura alzayyat

assistant lecturer

Cairo University

研究点 (2)

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