Diagnostic Accuracy of Near Infrared Transillumination in Combination With a Dye in the Cavitation Detection
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
Remineralization
干预措施: Radiographic examination (Device)
Remineralization
干预措施: Scanning with DIAGNOcam (Device)
Remineralization
干预措施: Scan with DIAGNOcam and Indocyanine (Device)
Remineralization
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
Santiago Miguel de Vega Calleja
Principal investigator
Universidad Rey Juan Carlos
