Using ICDAS II and KaVo DIAGNOdent Pen Detecting Tooth Pit and Fissure Level Incipent Caries Progression
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in Decayed Surfaces (DS) of Different Fissure Sealants
研究概览
简要总结
The study was to monitor effectiveness of glass ionomer sealant and resin-based sealant in ICDAS, and to evaluat the correlation between ICDAS and DIAGNOdent over 24 months. Over 200 8-year-old children with at least 2 permanent molar with the International Caries Detection and Assessment System (ICDAS) scores 0-4 were placed glass ionomer sealant and resin-based sealant split-mouthed randomly, and examined with ICDAS and DIAGNOdent before sealents placement and 6, 12 and 24 months after.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 7 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects provided written informed consent;
- •They were 7 to 9 years old;
- •They have at least 2 permanent molar with the International Caries Detection and Assessment System (ICDAS) scores 0-4;
- •They were generally heallthy
排除标准
- •They were allergic to the constituents in pit and fissure sealants
结局指标
主要结局
Change in Decayed Surfaces (DS) of Different Fissure Sealants
时间窗: Baseline, 6 months, 12 months and 24 months
Count of DS in different ICDAS cut-off( including D1-6S, D1-2S, D3-6S, D4-6S and D5-6S) in the baseline and 6-month, 12-month and 24-month follow-up.
Change in Repaired Sealants by the baseline ICDAS
时间窗: 6 months, 12 months and 24 months
Evaluation the numbers of tooth surface in which the fissure sealants were in the status partially retained or completely lost, and ICDAS score were increasing from the baseline to the 3 follow-ups.
Change in DIAGNOdent Score
时间窗: Baseline, 6 months, 12 months and 24 months
The peak value of DIAGNOdent was recorded after repeating it 3 times in the baseline and 3 follow-ups
次要结局
未报告次要终点
研究者
Sheng-Chao Wang
Director, Preventive Dentistry Department, Clinical Professor
Air Force Military Medical University, China