Effect of Fluoride and Casein Phosphopeptide-amorphous Calcium Phosphate on Remineralization of Early Caries Lesions in Primary Teeth: an in Vivo Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Change in remineralization of white spot lesions using Quantitative Light-induced Fluorescence (QLF) machine
研究概览
简要总结
This study is a randomized controlled trial involving 118 children ages between 4 and 5 years to assess the remineralization effect of Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) on white spot lesions in primary teeth using Quantitative Light-induced Fluorescence (QLF) system, and compare that with fluoride alone or combined use of fluoride and CPP-ACP.
详细描述
Aim: To assess the remineralization effect of CPP-ACP on white spot lesions in primary teeth using QLF system, and compare that with fluoride alone or combined use of fluoride and CPP-ACP.
Materials and Methods:
o Study design:
The present study is a randomized control trial (RCT).
- Study setting: The present study will be conducted at Kindergartens, Irbid, Jordan. A list of schools will be obtained from the development sector, schools will be invited to be participate in the study. Children will be randomly allocated into groups.
- Study procedure:
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
- None
入排标准
- 年龄范围
- 4 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy 4-5 years old children, with primary dentition, and early white spot lesions
排除标准
- •Lack of cooperation in the oral examination.
- •Allergies to milk protein.
- •Have received a fluoride supplement or professional topical fluoride application at least 3 months before or during the study period.
- •Medically compromised patient.
研究组 & 干预措施
Fluoride toothpaste
Fluoride toothpaste
干预措施: Fluoride toothpaste (Other)
CPP-ACP paste
Casein phosphopeptide amorphous calcium phosphate is a product that contains calcium, phosphate, protein and casein.
干预措施: CPP-ACP paste (Other)
Both (Fluoride and CPP-ACP)
Fluoride toothpaste and CPP-ACP paste
干预措施: Both (Fluoride and CPP-ACP) (Other)
结局指标
主要结局
Change in remineralization of white spot lesions using Quantitative Light-induced Fluorescence (QLF) machine
时间窗: 3 and 6 months
Change in remineralization of white spot lesions as indicated by changes in fluorescence levels detected by QLF after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.
次要结局
- Changes in caries using the decayed, missing due to caries, filled, deciduous teeth (dmft) index.(3 and 6 months)
- Changes in caries using the decayed, missing due to caries, filled, deciduous tooth surfaces (dmfs) index.(3 and 6 months)
- Changes in caries using the International Caries Detection and Assessment System (ICDAS) scores.(3 and 6 months)