Effectiveness of Different Fluoride Varnishes on Salivary Bacteria Levels in Children With Early Childhood Caries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 主要终点
- Effect of fluoride varnishes on saliva Mutans streptococci (MS) and Lactobacilli (LB) levels were evaluated as colony forming units (CFU).
研究概览
简要总结
The study was carried out in 88 children with severe early childhood caries (dmfs≥age +1) who were referred to the investigators' clinic. Patients who completed dental treatment under general anesthesia in a single session, were included to the study.
Patients were divided randomly into 4 groups and after dental treatment one of the fluoride varnish listed below was applied to each child. The groups were as follows;
- Duraphat varnish containing 5% Sodium Fluoride (Colgate) (n = 22),
- Clinpro ™ White Varnish containing 5% of Sodium Fluoride tricalcium phosphate (3M ESPE) (n = 22),
- Embrace ™ Varnish containing 5% Sodium Fluoride with CXP ™ (Pulpdent) (n = 22),
- MI Varnish containing 5% Sodium Fluoride casein phosphopeptide amorphous calcium phosphate varnish (GC) (n = 22).
Saliva Mutans streptococci (MS) and Lactobacilli (LB) levels, were evaluated by taking saliva samples before general anaesthesia; one month after treatment and three months after treatment.
详细描述
Duraphat (Colgate), which we used as a positive control group in our study, contains only 5% sodium fluoride. It has been reported in studies that Duraphat is effective in remineralization.
Clinpro ™ White Varnish, another topical varnish in this study,was reported to be effective for caries prevention in pre-school children.
One of the varnishes we evaluate in the study, Embrace™ Varnish, contains 5% sodium fluoride with xylitol-coated calcium and phosphate. According to the manufacturer, the xylitol coating prevents the calcium and phosphate salts from reacting until they come in contact with saliva. Saliva dissolves the xylitol and releases the calcium and phosphate ions, which react with the fluoride ions in saliva to form protective fluorapatite on the teeth19 MI Varnish, in the fourth group containing 5% sodium fluoride with casein phosphopeptide amorphous calcium phosphate (CPP-ACP) had a high release of calcium and fluoride ions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 36 Months 至 72 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •clinical diagnosis of healthy children with severe early childhood caries,
- •younger than 6 years in the primary dentition
排除标准
- •history of any chronic disease,
- •use of any drugs that reduce salivary flow or antibiotics in the last 4 weeks,
- •use of systemic fluoride tablets
研究组 & 干预措施
Sodium Fluoride
Varnish containing 5% Sodium Fluoride, was applied to all remaining teeth of each child after dental treatment under general anaesthesia.
干预措施: Sodium Fluoride (Drug)
Sodium Fluoride with TCP
Varnish containing 5% Sodium Fluoride with tricalcium phosphate (TCP) ,varnish was applied to all remaining teeth of each child after dental treatment under general anaesthesia.
干预措施: Sodium Fluoride with TCP (Drug)
Sodium Fluoride with CXP
Varnish containing 5% Sodium Fluoride with Xylitol-coated Calcium and Phosphate (CXP) ,varnish was applied to all remaining teeth of each child after dental treatment under general anaesthesia.
干预措施: Sodium Fluoride with CXP (Drug)
Sodium Fluoride with CPP-ACP
Varnish containing 5% Sodium Fluoride with casein phosphopeptide amorphous calcium phosphate (CPP-ACP), varnish was applied to all remaining teeth of each child after dental treatment under general anaesthesia.
干预措施: Sodium Fluoride with CPP-ACP (Drug)
结局指标
主要结局
Effect of fluoride varnishes on saliva Mutans streptococci (MS) and Lactobacilli (LB) levels were evaluated as colony forming units (CFU).
时间窗: 3 months
Saliva Mutans streptococci (MS) and Lactobacilli (LB) levels, were evaluated by taking saliva samples using CRT Bacteria (Caries Risk Test, Ivoclar Vivadent)
次要结局
未报告次要终点
研究者
Merve Erkmen Almaz
assist prof
Kırıkkale University