Antimicrobial Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Streptococcus Mutans in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Changes in Streptococcus mutans levels (Colony Forming Units/CFU) using Saliva Check Mutans kits ( GC, Asia)
研究概览
简要总结
This study is a randomized controlled trial involving 127 children ages between 4 and 5 years to investigate the efficacy of Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) in reducing Streptococcus mutans (S. mutans) bacteria, and compare that with fluoride alone, or combined use of fluoride and CPP-ACP over a 6 month period using Saliva Check Mutans kits to detect Mutans Streptococci (MS). It is expected that all used anti-cariogenic agents will have the ability to reduce the S. mutans level in different values.
详细描述
Aim: The aim of this study is to investigate the efficacy of CPP-ACP in reducing S. mutans, and compare that with fluoride alone, or combined use of fluoride and CPP-ACP.
Materials and methods
This study is a randomized controlled trial involving 127 children ages between 4 and 5 years. They will be examined and chosen randomly for the study. One hundred and twenty seven children will be divided equally into three groups: Group 1 will use CPP-ACP twice daily, Group 2 will apply fluoride toothpaste twice daily, Group 3 will apply fluoridated toothpaste and CPP-ACP twice daily. Oral swabs will be collected from children to measure S. mutans levels in terms of Colony forming units (CFU) using Saliva Check Mutans kits (GC© , Asia) for this purpose. Samples will be analyzed for S. mutans colonization before antibacterial agent application (baseline) and at 3, and 6 month intervals.
Expected results: it is expected that all used anti-cariogenic agents will have the ability to reduce the S. mutans levels in different levels.
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 childhood caries/high risk caries
排除标准
- •Milk protein (casein) sensitivity
- •Patient who has taken antibiotics in the last month
- •Lack in cooperation in oral examination
- •Medically compromised children
- •Children that have received fluoride supplement or professional topical fluoride application at least three months before or during the study period.
研究组 & 干预措施
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)
Fluoride toothpaste
Fluoride toothpaste
干预措施: Fluoride toothpaste (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
Changes in Streptococcus mutans levels (Colony Forming Units/CFU) using Saliva Check Mutans kits ( GC, Asia)
时间窗: 3 and 6 months
Changes in Streptococcus mutans after use of CPP-ACP, Fluoride or both Saliva Check Mutans kits ( GC, Asia)
次要结局
- 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)
- Changes in caries using the decayed, missing due to caries, filled, deciduous teeth (dmft index)(3 and 6 months)