Remineralizing Effect of Nano-eggshell, Casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP), and Sodium Fluoride on Initial Enamel Caries: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in remineralization of initial enamel caries
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate and compare the remineralizing effect of nano-eggshell varnish, CPP-ACP paste (GC Tooth Mousse), and sodium fluoride varnish on initial enamel caries among adolescents aged 15-20 years.
Participants will be randomly allocated into three groups. Remineralization and caries activity will be assessed using DIAGNOdent readings, International Caries Classification and Management System (ICCMS) criteria, and the decayed, missed, and filled surfaces (DMFS) index over a 12-month follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Masking will be applied at the level of the outcome assessor. The examiner responsible for evaluating caries activity and remineralization outcomes (using DIAGNOdent and ICCMS criteria) will be blinded to group allocation. Participants and operators cannot be blinded due to the different nature of the interventions.
入排标准
- 年龄范围
- 15 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients' ages should be 15-20 years. Patients should have at least three to four teeth with ICDAS II scores of 1-
- •Patients should have moderate-to-high caries risk.
排除标准
- •Known hypersensitivity to one of the components of the material under study. Systemic disorders or medication interfering with normal salivary flow.
结局指标
主要结局
Change in remineralization of initial enamel caries
时间窗: Baseline to 12 months
Change in remineralization of initial enamel caries measured by DIAGNOdent readings from baseline to 12 months. When the DIAGNOdent reading decreases, it means good remineralization ability.
Change in DIAGNOdent readings
时间窗: Baseline, 3, 6, 9, and 12 months
The DIAGNOdent device will be used to quantify changes in enamel demineralization and remineralization over time. Measurements will be recorded at different follow-up intervals
次要结局
- Caries activity assessment using ICCMS criteria(Baseline, 3, 6, 9, and 12 months)
- Change in the Decayed, Missing, and Filled Surfaces (DMFS) index(baseline, after 6 and 12 months)