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临床试验/CTRI/2018/04/013389
CTRI/2018/04/013389已完成不适用

Effect of Chlorhexidine-Fluoride gel and fluoride varnish on active caries among 9-12 year old children in Bangalore city: A comparative study

Sourabha K G1 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2010年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
163
试验地点
1
主要终点
Progression of active caries lesions

研究概览

简要总结

A Randomized controlled trial was done to assessthe effect of Chlorhexidine-Fluoride gel and Fluoride varnish on active cariesamong 9-12 year old school children from 8 schools of Bangalore city. Childrenwere randomly allocated to 3groups i.e Chlorhexidine-fluoride gel group,profluoride varnish group and control group. Children who fulfilled theeligibility criteria were chosen. At the baseline, the children underwent oralprophylaxis and cavitated lesions were restored with Type II GIC as needed. Activeenamel caries were recorded using Nyvad’s Colleagues criteria (1999).Supervised tooth brushing was performed weekly thrice forChlorhexidine-Fluoride gel group. Profluoride Varnish application was done atBaseline, 6th month and 12th month and No interventionwas done for control group. The effect of chlorhexidine-fluoirde varnish wasevaluated at 6, 12 and 15 months.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
9.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • •Children of age 9-12 years Children free of any systemic diseases Children whose parents give consent for the procedures School children with active intact caries according to nyvad criteria.

排除标准

  • •Children with multiple lesions on the same tooth Children with any systemic diseases and who were taking medication for any illness.

结局指标

主要结局

Progression of active caries lesions

时间窗: 6th month, 12th month and 15th month

次要结局

  • Not applicable(Not applicable)

研究者

发起方
Sourabha K G
申办方类型
Other [self]

研究点 (1)

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