Effectiveness of Different Remineralizing Strategies on the Management of Early Carious Lesions in Primary Teeth (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Assessing the remineralization of early carious lesions in primary teeth
研究概览
简要总结
the primary aim of the study is remineralization of early carious lesions in primary teeth using different remineralizing agents of different remineralizing strategies when applied in an intensive mode. The secondary aim of the study is to compare their antibacterial effect against streptococcus mutans and their effect on reducing the size of the lesions.
详细描述
The primary aim of the study is to compare the effect of curodont repair fluoride plus (self-assembling peptide p11-4 with 0.5% sodium fluoride) with MI varnish (casein phosphopeptide amorphous calcium phosphate fluoride) and Colgate fluoride varnish (5% sodium fluoride) in remineralization of early carious lesions in primary anterior teeth. The study sample is consisted of 66 patients aged 3-6 years old with at least 2 white spot lesions in their primary anterior teeth who are assigned into control group (n=22): colgate fluoride varnish, test group 1(n=22): MI varnish and test group 2 (n=22) :curodont repair fluoride plus. Each material is applied once every 2 weeks for 3 times (intensive mode of application). The secondary aim of the study is to determine the antibacterial effect of each material against streptococcus mutans is compared by obtaining a plaque sample at baseline then after application by 48 hours, 1 months and 3 months and culturing using disk diffusion method for determining the log count of streptococcus mutans at each time point. Another secondary aim is to determine the change in lesion size at baseline and after 6 months and 12 months using standardized photographs with a digital camera.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy children
- •age range 3-6
- •at least 2 early carious lesions
排除标准
- •Children presenting with special health care needs or undergoing medical treatment for chronic or acute diseases.
- •Application of fluoride varnish less than 3 months prior to study treatment.
- •Any metabolic disorders affecting bone turnover.
- •Concurrent participation in another clinical trial.
- •Patients receiving any antibiotic within 1 month prior to plaque sample collection
研究组 & 干预措施
curodont repair fluoride plus
self-assembling peptide (p11-4) with 0.05% sodium fluoride
干预措施: self assmbling peptide p11-4 combined with 0.05% fluoride (Drug)
CPP-ACPF varnish
casein phoshphopeptide amorphous calcium phosphate fluoride (CPP-ACPF )
干预措施: Casein phosphopeptide amorphous calcium phosphate (Drug)
5 % sodium fluoride varnish
5% sodium fluoride varnish
干预措施: 5% sodium fluoride varnish (Drug)
结局指标
主要结局
Assessing the remineralization of early carious lesions in primary teeth
时间窗: 3,6,9 and12 months
comparing the remineralization effect of different remineralizing agents both qualitatively by comparing the change in ICDAS -11 criteria and quantitatively by using laser fluorescence scores using kavo DIAGNOdent classic after intensive mode of application of the different remineralizing agents
次要结局
- comparing the antibacterial effect of different remineralizing agents against streptococcus mutans(3 months)
- comparing the change in esthetic appearance of early carious lesion before and after treatment(12 months)
研究者
Sarah Khairy
assistant lecturer
Alexandria University
