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临床试验/NCT04438252
NCT04438252Unknown不适用

Evaluation of Reliability of Impedance Spectroscopy (CarieScan PRO) in Comparison With Digital Radiograph and ICDAS-II in Detection of Occlusal Carious Lesions: Diagnostic Accuracy Study.

Cairo University1 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2020年9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
166
试验地点
1
主要终点
Dental Caries

研究概览

简要总结

The aim of this study is to evaluate the Clinical performance of alternating current impedance spectroscopy (CarieScan PRO) in comparison with digital radiograph and ICDAS-II in detection of occlusal carious lesions.

详细描述

The visual examination is routinely used for detecting caries in dental clinics and was also used in recent studies comparing the efficacy of various visual aids. It has the benefit that it is quick and easy to perform, does not need expensive equipment, and can be completed without unnecessary radiation or fluorescence (Ismail, et al., 2007). In the current study, ICDAS-II was set as "gold standard" due to validated relationship between its codes and the histological depth of a carious lesion as in many other studies. In addition, several studies have shown good reproducibility and accuracy of ICDAS-II for caries detection in permanent teeth especially caries lesions in the outer half of the enamel (Gugnani, et al., 2010). Bitewing radiographs are used to determine the depth of caries involvement. Most often, bitewing examination is affiliated with the diagnosis of interproximal caries. It is strongly recommended that these radiographs be used in the diagnosis of occlusal caries into dentin (Pitts NB et al., 1991).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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
是

入选标准

  • •Posterior teeth with dark shadow on occlusal surface.
  • •Vital upper or lower posterior teeth with no signs of irreversible pulpitis.
  • •Intact contact with opposing teeth.
  • •Teeth with no previous restorations in other surfaces.

排除标准

  • •of the teeth:
  • •Periapical pathology or signs of pulpal pathology.
  • •Tooth hypersensitivity.
  • •Possible prosthodontic restoration of teeth.
  • •Heavy occlusion and occlusal contacts or history of bruxism.
  • •Severe periodontal affection.

研究组 & 干预措施

Cariescan pro

Experimental

device for early caries detection

干预措施: CariScan Pro (Device)

Cariescan pro

Experimental

device for early caries detection

干预措施: Digital Radiograpgy (Radiation)

ICDAS II

Experimental

Index for caries detection

干预措施: ICDAS II (Diagnostic Test)

结局指标

主要结局

Dental Caries

时间窗: slow study completion in average of 1 year

primary occlusal caries

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

Amr Ramadan Abdelkader

Assistant Lecturer

Cairo University

研究点 (1)

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