Validity of Fluorescence-Based Devices Versus Visual-Tactile Method in Detection of Secondary Caries Around Resin Composite Restorations: Invivo Diagnostic Accuracy Study
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Validity of Fluorescence-based Devices versus Visual-tactile method
研究概览
简要总结
This study will be conducted to evaluate the clinical performance and validity of both light-induced fluorescence intraoral camera and laser-induced fluorescence device in comparison to visual-tactile assessment method in detection of secondary caries around margins of resin composite restorations.
详细描述
Each patient should have at least one resin composite restoration. The restoration will be evaluated by all diagnostic methods. Each examiner will independently record the dental findings using all methods, the visual- tactile assessment method and both fluorescent-aided identification methods. The visual-tactile assessment method includes the use of mirror, probe under good illumination condition, while the fluorescent-aided identification methods will be performed by both light-induced fluorescence intraoral camera and laser-induced fluorescence device. Then Diagnostic performance for caries detection was evaluated, assessing the validity of each diagnostic method in diagnosing secondary caries around margins of resin composite restorations
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 (Outcomes Assessor)
盲法说明
The assessors will not be blind about the type of intervention/control assessment methods. However it will not be allowed amongst the examiners to exchange any information throughout the entire study period
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients should be over 18 years of age.
- •Patients should have an acceptable oral hygiene level.
- •Patients should have at least one resin composite restoration.
排除标准
- •Patients with a compromised medical history.
- •Patients with active severe periodontal disease.
研究组 & 干预措施
Light induced fluorescence intraoral camera
干预措施: Light induced fluorescence intraoral camera (Diagnostic Test)
Laser-induced fluorescence device
干预措施: Laser-induced fluorescence device (Diagnostic Test)
Visual-tactile assessment method according to FDI criteria
干预措施: Visual-tactile assessment method according to FDI criteria (Diagnostic Test)
结局指标
主要结局
Validity of Fluorescence-based Devices versus Visual-tactile method
时间窗: Through study completion, an average of 5 months
Diagnostic performance for caries detection was evaluated, assessing the validity of each diagnostic method in diagnosing secondary caries around margins of resin composite restorations in terms of sensitivity and specificity.
次要结局
未报告次要终点
研究者
Aya Mohamed Adly
Principal Investigator
Cairo University