跳至主要内容
临床试验/NCT06276959
NCT06276959招募中不适用

Comparison of Near-infrared Imaging With Cone Beam Computed Tomography for Proximal Caries Detection in Permanent Dentition: An in Vivo Study.

West China College of Stomatology1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
positive percent agreement

研究概览

简要总结

As a new emerging technology for the diagnosis of dental caries, near-infrared imaging requires further research and validation to determine its effectiveness. This study aims to compare near-infrared imaging with cone-beam computed tomography (CBCT) to validate the efficiency of near-infrared imaging in diagnosing proximal caries using large-scale clinical data through retrospective cross-sectional studies.

研究设计

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

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Permanent dentition
  • Participants aged 12 and above
  • Patients who have undergone iTero Element 5D oral scanning, as well as CBCT imaging, intraoral photography, and clinical oral examination within 1 week
  • CBCT or iTero Element 5D oral scanning indicating proximal caries

排除标准

  • The following teeth were excluded:
  • Third molars
  • Teeth with gross loss of tooth structure (cavitated carious lesions extending to the occlusal or buccal/lingual surfaces)
  • Teeth with amalgam fillings and their adjacent teeth
  • Teeth with crown restorations and their adjacent teeth

结局指标

主要结局

positive percent agreement

时间窗: After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.

Using CBCT as the reference test, positive percent agreement of NIRI, UVE, and a combination of the two index tests in parallel (PAR) for the detection of proximal caries at different depths and in different tooth locations was evaluated.

overall percent agreement

时间窗: After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.

Using CBCT as the reference test, overall percent agreement of NIRI, UVE, and a combination of the two index tests in parallel (PAR) for the detection of proximal caries at different depths and in different tooth locations was evaluated.

negative percent agreement

时间窗: After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.

Using CBCT as the reference test, negative percent agreement of NIRI, UVE, and a combination of the two index tests in parallel (PAR) for the detection of proximal caries at different depths and in different tooth locations was evaluated.

次要结局

  • Proximal caries positive site diagnosed by near-infrared imaging (NIRI)(Immediately following NIRI image interpretation.)
  • Proximal caries positive site diagnosed by CBCT(Immediately following CBCT image interpretation.)
  • Proximal caries positive site diagnosed by unaided visual examination (UVE)(Immediately following clinical oral examination.)

研究者

发起方
West China College of Stomatology
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xia Kai

Attending physician

West China College of Stomatology

研究点 (1)

Loading locations...

相似试验