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临床试验/NCT04274569
NCT04274569Unknown不适用

Are Calcium- and Phosphate-containing Fluoride Varnishes More Effective Than Conventional Fluoride Varnish in Preventing Early Childhood Caries? A Randomized Clinical Trial.

The University of Hong Kong2 个研究点 分布在 1 个国家目标入组 570 人开始时间: 2019年3月13日最近更新:
适应症

试验速览

阶段
不适用
入组人数
570
试验地点
2
主要终点
Proportion of children with new caries and new dmfs.

研究概览

简要总结

This study evaluates and compares the effect of two types of calcium- and phosphate-containing fluoride varnishes to conventional fluoride varnishes in preventing early childhood caries.

详细描述

Fluoride vanish is the most commonly used professionally applied topical agent. Traditional fluoride vanish application has been reported to exhibit significant caries inhibiting effect in both permanent teeth and primary teeth. The greatest advantage of fluoride vanish is its ability to adhere to tooth tissues for a longer period of time that enables improved fluoride uptake. It allows continuous release of fluoride ions into enamel, dentine, plaque, and saliva.The main action of topical fluoride is to retard demineralization and promote remineralization of enamel by the uptake of calcium and phosphates from saliva. The proposed mechanism of action of topical fluoride is the formation of intraoral calcium fluoride reservoirs, which are retained on enamel and slowly released to inhibit mineral loss during demineralization.

However, the formation of the intraoral calcium fluoride reservoirs is limited by the availability of intraoral calcium and fluoride ions. Low concentration of salivary calcium and phosphate ions leads to mineral deposition only at the surface of enamel as a result of low ion concentration gradient. Deposition of minerals at the surface of enamel alone may not improve the structural properties of the deep part of the incipient carious lesions. Hence, many manufacturers have modified fluoride vanish to include calcium and phosphate ions in an attempt to further improve efficacy of fluoride varnishes.

The in vitro remineralizing effects of calcium- and phosphate-containing fluoride vanishes are encouraging and scientifically sound, a longitudinal, high quality clinical study is needed to verify the laboratory findings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 4 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Generally healthy children age between 3-4 of age with unremarkable medical history and at high caries risk with at least one carious lesion (precavitated or cavitated) (Agouropoulos et al 2014). The high caries risk children are chosen because it is anticipated that they will benefit more from the topical fluoride varnish application than the low caries risk children.

排除标准

  • Patients who had received professional fluoride application in the past 6 months
  • Patients with underlying medical history or special health care needs
  • Patient who are uncooperative or refuse the treatment
  • Patient who are allergic to milk protein (as MI VarnishTM contains "casein, a milk protein)
  • Patient with contraindication for fluoride varnish e.g. hypersensitivity to colophony and/or any other constituents
  • Patient who have primary teeth with enamel hypoplasia

结局指标

主要结局

Proportion of children with new caries and new dmfs.

时间窗: 24 months

次要结局

  • MS growth(12 months and 24 months)

研究者

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

Professor Cynthia Kar-Yung Yiu

Clinical Professor in Paediatric Dentistry

The University of Hong Kong

研究点 (2)

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