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临床试验/NCT04748913
NCT04748913已完成不适用

Diagnostic Accuracy of Near Infrared Transillumination in Combination With a Dye in the Cavitation Detection

Universidad Rey Juan Carlos1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2020年11月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
153
试验地点
1
主要终点
Near infrared transillumination

研究概览

简要总结

The aim of the study will be to make a comparison in vivo of the following techniques:

DIAGNOcam, DIAGNOcam in combination with indocyanine and bitewing radiography, analyzing the ability to detect cavitation in initial proximal caries in posterior teeth using visual separation with tactile exploration as a gold standard.

Methodology:

During a period of 2 years, patients with initial proximal caries will be evaluated in the facilities of the clinic belonging to the Fundación de la Clínica Universitaria of the Rey Juan Carlos University (Madrid, Spain). Those subjects where a minimum of a proximal carious lesion (E1, E2 or D1) is diagnosed in posterior teeth will be candidates for the study. The exploration of proximal caries will be carried out in four phases: radiographic exploration, exploration with DIAGNOcam, exploration with DIAGNOcam and Indocyanine and visual-tactile exploration with separation. Once the visual-tactile examination with separation has been completed, the caries lesions will be treated. Depending on whether the lesion is cavitated or not, a non-invasive procedure or an operative treatment will be chosen.

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 (Investigator)

入排标准

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

入选标准

  • •E1, E2 and D1 proximal carious lesions in permanent posterior teeth (E1: outer half of enamel; E2: inner half of enamel; D1: outer half of dentin)

排除标准

  • •estructural abnormalities
  • •visible clinical cavitation
  • •restorations on the proximal surfaces
  • •open contact points
  • •overlapping structures on the X-ray that prevent a clear view of the proximal area

研究组 & 干预措施

No intervention

No Intervention

Remineralization

Other

干预措施: Radiographic examination (Device)

Remineralization

Other

干预措施: Scanning with DIAGNOcam (Device)

Remineralization

Other

干预措施: Scan with DIAGNOcam and Indocyanine (Device)

Remineralization

Other

干预措施: Visual-tactile exploration with separation (Diagnostic Test)

结局指标

主要结局

Near infrared transillumination

时间窗: 2 years

Ability to detect cavitation in initial proximal caries of DIAGNOcam in combination with indocyanine

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

Santiago Miguel de Vega Calleja

Principal investigator

Universidad Rey Juan Carlos

研究点 (1)

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