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临床试验/CTRI/2023/02/050056
CTRI/2023/02/050056已完成不适用

Comparative evaluation between fluoride varnish and fluoride containing mouth rinse amongst 12yrs old school going children of Lucknow city:field trial

dr pratisha mishra1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2023年2月27日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
230
试验地点
1
主要终点
The fluoride varnish and fluoride containing mouth rinse will act as preventive agent for dental caries which will arrest the caries progression and would prevent further tooth decay.fluoride containing mouth rinse would be costeffective.however, fluoride varnish will be more effective in comparison to mouth rinse.

研究概览

简要总结

“Heath is a state of complete physical, mental, social well being and not merely the absence of disease and infirmity†by WHO. The oral disorder can have a negative impact on the functional social and psychological well-being of children and their families.

Dental caries is considered a public health problem worldwide due to the high prevalence, economic impact, and the possibility of prevention. In India dental caries afflicts more than 50% of the subjects in all subjects groups varing from 51.9% to 85% and the mean prevalence rate of dental caries was found to be 48% in 12 years old children.1,2

Targeting preventive strategies for preventing dental caries in school set up will go in long way to decrease the future burden of the disease and to improve oral and general health related quality of life in school going children.2

School can provide an effective platform for promoting oral health because they reach 1 billion worldwide.3 Fluoride has been used as a powerful tool time and again to prevent and control dental caries. Fluoride varnish provides an opportunity to offer professionally applied topical applied in schools. Numerous studies have quoted that Biannually application of Fluoride varnish is effective in preventing dental caries in permanent dentition.4 School based fluoride mouth rinse program have been considered as important low cost strategy to prevent caries among school children.5

The efficacy of fluoride varnish that varies from 25-80% whereas that of fluoride mouth rinse was 30%.2 both have been shown effective in community as well as individual basis.

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
12.00 Year(s) 至 13.00 Year(s)(—)
性别
All

入选标准

  • Study subjects aged 12 years with the highest risk of developing caries (WHO basic classification for dental caries scale for assessing occlusal surfaces of teeth not more than D2)6 .
  • Study subjects whose parents will give consent.
  • Study subjects willing to participate.

排除标准

  • •Subjects complaining of pain and sensitivity due to deep carious lesion.
  • •Subjects with orthodontic bands or under any other dental treatment.

结局指标

主要结局

The fluoride varnish and fluoride containing mouth rinse will act as preventive agent for dental caries which will arrest the caries progression and would prevent further tooth decay.fluoride containing mouth rinse would be costeffective.however, fluoride varnish will be more effective in comparison to mouth rinse.

时间窗: The fluoride varnish and fluoride containing mouth rinse will be applied at base line and it would act as preventive agent for dental caries at 3months, 6months and 9months respectively which will arrest the caries progression and would prevent further tooth decay.

次要结局

  • To recommend any of the above methods for caries prevention in 12 years old school going children at 3months, 6months and 9months(To recommend any of the above methods for caries prevention in 12 years old school at the end of 9months going children.)

研究者

发起方
dr pratisha mishra
申办方类型
Other [self]

研究点 (1)

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