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临床试验/NCT03090061
NCT03090061Unknown不适用

Reliability of Light Induced Fluorescence Intraoral Camera Versus Visual-Tactile Method in Assessment of Marginal Integrity of Resin Composite Restorations: Diagnostic Invivo Study

Cairo University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2017年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
29
试验地点
1
主要终点
Repeatability for both diagnostic methods

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 FDI criteria in clinical evaluation the margins of resin composite restorations

详细描述

Each patient should have at least one resin composite restoration. The restoration will be evaluated by two diagnostic methods.

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, FDI probe under good illumination condition, while the fluorescent-aided identification method will be performed by light induced fluorescence intraoral camera then the reliability of each diagnostic tool will be assessed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

盲法说明

The assessors will not be blind about the type of intervention/control assessment methods. However it will not be allowed amongst the examiners to exchange any information throughout the entire study period

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients should be over 18 years of age.
  • •Patients should have an acceptable oral hygiene level.
  • •Patients must have at least one posterior resin composite restoration.

排除标准

  • •Patients with a compromised medical history.
  • •Severe or active periodontal disease.
  • •Heavy bruxism or a traumatic occlusion.

研究组 & 干预措施

Light induced fluorescence intraoral camera

Experimental

干预措施: Light induced fluorescence intraoral camera (Diagnostic Test)

Visual-tactile assessment method according to FDI criteria

Active Comparator

干预措施: Visual-tactile assessment method according to FDI criteria (Diagnostic Test)

结局指标

主要结局

Repeatability for both diagnostic methods

时间窗: 20 minutes

Three examiners will record the dental findings of 29 resin composte restorations using both the intervention and control assessment methods. Each method will be repeated twice to calculate the repeatability. The intra-operator agreement will be evaluated using the kappa statistics.

Reproducibility for both diagnostic methods

时间窗: 1 week

Three examiners will record the dental findings of 29 resin composite restorations using both the intervention and control assessment methods. Each method will be repeated after one week interval to calculate the reproducibility. The inter-operator agreement will be evaluated using the kappa statistics.

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

Aya Mohamed Adly

internal resident

Cairo University

研究点 (1)

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