Assessment and Comparison of Diagnostic Technologies for the Detection of Dental Caries in Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of technologies for detection of dental caries
研究概览
简要总结
This study aims to evaluate and compare different digital diagnostic technologies used for the detection of dental caries in clinical practice. The study focuses on assessing the diagnostic accuracy of various methods, including visual examination and digital diagnostic tools, in identifying dental caries in patients. The results will contribute to improving early detection and diagnostic strategies in dentistry.
详细描述
Dental caries remains one of the most prevalent oral diseases worldwide. Early and accurate detection is essential for effective treatment and prevention of disease progression. This observational study aims to assess and compare the effectiveness of different diagnostic technologies used in routine dental practice.
Participants undergoing dental examination will be evaluated using conventional diagnostic methods and selected digital diagnostic technologies. The diagnostic performance of each method will be analyzed and compared based on their ability to detect carious lesions.
The study will be conducted in clinical settings, including university hospital and private dental clinic environments. The results are expected to provide insights into the advantages and limitations of modern diagnostic technologies in dentistry and support their appropriate use in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years
- •Presence of permanent dentition only
- •Presence of primary or secondary carious lesions
- •Presence of all teeth in the lateral segment (teeth 4-7) in both maxilla and mandible
- •Signed informed consent including agreement with photodocumentation, bitewing radiographs, and use of AI-based diagnostic methods (including DIAGNOcam)
排除标准
- •Age under 18 or over 65 years
- •Extensive crown destruction affecting more than two-thirds of the tooth
- •Carious lesions reaching the dental pulp or threatening pulp vitality
- •Inability or refusal to undergo radiographic examination (bitewing radiographs)
- •Teeth with fixed prosthetic restorations in the examined area Refusal to participate or to use AI-based diagnostic methods (including DIAGNOcam)
研究组 & 干预措施
Single diagnostic arm
All participants undergo diagnostic assessment of dental caries using digital technologies (e.g., intraoral imaging, radiographic methods, and/or AI-based analysis, transillumination Diagnocam), followed by clinical verification through operative intervention (cavity opening).
干预措施: Diagnostic methods for dental caries (Diagnostic Test)
结局指标
主要结局
Diagnostic accuracy of technologies for detection of dental caries
时间窗: Baseline/ Day 1
Assessment of sensitivity and specificity of diagnostic methods (including visual examination, intraoral imaging, radiographic methods (Bitewings), AI -based analysis and transillumination) compared to clinical references standard (cavity opening).
次要结局
未报告次要终点