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Cost-effectiveness Analysis of Fluoride Foam and Fluoride Varnish in Preventing Dental Caries in the Primary Teeth of Preschool Children With High Caries Risk
Fluoride foam and fluoride varnish are effectiveness in prevention deciduous dental caries. However, the relative clinical efficacy and cost-effectiveness of these two interventions are uncertain. This study aims to evaluate the relative clinical effectiveness and cost-effectiveness of fluoride foam and fluoride varnish in preventing dental caries in the primary teeth of preschool children with high caries risk.
This 24-month randomized clinical trial aims to compare the clinical efficacy and cost-effectiveness of topical fluoride application of fluoride foam and fluoride varnish in preventing dental caries in the primary teeth of preschool children with high caries risk in Harbin,Heilongjiang Province,China. Preschool children (3-4 years) with high caries risk will be invited to participant in this study. An invitation letter will be sent to the parents explaining the purpose and procedures of this study.Parental concent will be sought. The children will be randomly divided into three groups: the control group-no intervention; the intervention group 1 - applications of 1.23% fluoride foam every 6 months; the intervention group 2- applications of 2.26% fluoride varnish every 6 months. Dental clinical examination of the children will be performed at the beginning of the study,12 months and 24 months later.The dental examiners will receive unified training and consistency test of dental caries survey.Only when the Kappa value reached 0.8 can oral examiners participate in the oral examination.Dental caries condition will be recorded. Approximately 5% of children will be re-examined to determine the reliability of the results. The status of any possible side/adverse effects will be recorded in the follow-up examinations. The data of the study will be analysed by SPSS Statistical Analysis Software.The differences among the groups will be calculated and compared. And p\<0.05 will be considered statistically significant.
Age
3 - 4 years
Sex
ALL
Healthy Volunteers
No
Start Date
July 1, 2016
Primary Completion Date
October 16, 2018
Completion Date
December 28, 2018
Last Updated
November 12, 2021
1,083
ACTUAL participants
1.23% fluoride foam application
DRUG
2.26% fluoride varnish application
DRUG
Lead Sponsor
National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC
NCT07009015
NCT06558955
Data Source & Attribution
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