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临床试验/NCT03731403
NCT03731403已完成不适用

Remineralization Potential of MI Varnish(CPP-ACP and Fluoride) Versus Fluoride Varnish in Controlling White Spot Lesions in Maxillary Primary Incisors: A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Caries activity

研究概览

简要总结

Remineralization effect of CPP-ACP and Fluoride (MI varnish) versus Fluoride varnish on white spot lesions in maxillary primary incisors

详细描述

Early childhood caries (ECC) is a very common and consequential chronic disease affecting young children ( Çolak et al., 2013). The prevalence of ECC in Egypt is high, it is about (78%) according to the last Egyptian Report, 2014.

ECC begins with white-spot lesions, and caries can progress continuously, leading to complete destruction of the crown. Calcium and phosphate ions are more readily lost for children because lower mineralization of deciduous enamel. The disease usually develops very quickly and causes many childhood health problems, such as caries-related toothache and infection.

Demineralization and remineralization are dynamic processes in caries initiation, progression, and reversal. Therefore, regulation of the demineralization- remineralization balance is a key to caries prevention and treatment. The ideal method of increasing remineralization is reconstructing the depleted tissues with hydroxyapatite, which is the same inorganic component as the enamel.

Fluoride varnishes have been the standard practice for the professional application of fluoride.

Casien PhosphoPeptide (CPP) is a sticky protein that binds and stabilizes calcium and phosphate ions in an amorphous state. CPP-ACP has been shown to adhere to teeth surfaces.

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)

入排标准

年龄范围
3 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with white spot lesions on their incisors.
  • Age ranging 3-5 years.
  • Good general health.

排除标准

  • Chronic use of medications or antibiotics
  • lack of cooperation in the oral examination
  • Allergies to milk protein or benzoate preservatives
  • Presence of oral soft-tissue lesions or enamel hypoplasia at baseline examination,
  • Children who have received a fluoride supplement or professional topical fluoride application at least 3 months before or during the study period.

结局指标

主要结局

Caries activity

时间窗: Change from base line, after application at 3, 6, 9 last follow up 12 months

Measured by ICDAS II

次要结局

  • Remineralization(Change from base line, after application at 3, 6, 9 last follow up 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samaa Sayed

Assistant lecturer

Cairo University

研究点 (1)

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