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临床试验/NCT05919576
NCT05919576已完成不适用

The Effectiveness of an Intraoral Scanner With Near-infrared Imaging (Transillumination) Technology for the Detection of Proximal Caries

Marmara University1 个研究点 分布在 1 个国家目标入组 639 人开始时间: 2022年8月8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
639
试验地点
1
主要终点
Panoramic Radiography

研究概览

简要总结

This study aims to determine the effectiveness of an intraoral scanner with near-infrared imaging (NIRI) for the diagnosis of proximal caries.

详细描述

A total of 639 proximal surfaces (mesial-distal) of 22 volunteers without restoration of premolars and molars were examined. Results were scored for 4 different examination methods; intraoral examination by visual-tactile method (VTM), bitewing radiography (BWR), panoramic radiography (PR) and near-infrared imaging (NIRI). Scoring was made according to the type of lesion (0:no caries, 1:early enamel lesion(EEL), 2:lesion involving the dentin-enamel-junction (DEJ). Data were analyzed with IBM-SPSS-V23. McNemar-Test was used for comparison between the methods. The Kappa Test was used to examine the agreement between two methods in categorical data, and the Fleiss-Kappa Test was used to assess the agreement between more than two methods. The analysis results are presented as frequency(percentage).The significance level was considered p<0.05.

研究设计

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

入排标准

年龄范围
14 Years 至 45 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Panoramic Radiography

时间窗: 08.08.2022-22.08.2022

Surface codes: Sound surface (0), Enamel lesion (1), Lesions involving DEJ (2). A total of at least 150 surfaces are expected to be examined

VTM GROUP (Visual-tactile examination)

时间窗: 08.08.2022 - 22.08.2022

Surface codes: Sound surface (0), Enamel lesion (1), Lesions involving DEJ (2). A total of at least 150 surfaces are expected to be examined

Bitewing Radiography

时间窗: 08.08.2022-22.08.2022

Surface codes: Sound surface (0), Enamel lesion (1), Lesions involving DEJ (2). A total of at least 150 surfaces are expected to be examined

NIRI (Near infrared Imaging Technology)

时间窗: 08.08.2022-22.08.2022

Surface codes: Sound surface (0), Enamel lesion (1), Lesions involving DEJ (2). A total of at least 150 surfaces are expected to be examined

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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