Cost-effectiveness of Topical Fluoride in Preventing Deciduous Dental Caries in Preschool Children
NCT ID: NCT05025163
Last Updated: 2021-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1083 participants
INTERVENTIONAL
2016-07-01
2018-12-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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control group
no intervention in the control group
No interventions assigned to this group
fluoride foam group
intervention; fluoride foam application (with 1.23% fluoride foam application on teeth )
1.23% fluoride foam application
topical application of fluoride foam every 6 months
fluoride varnish group
intervention; fluoride varnish application (with 2.26% fluoride varnish application on teeth)
2.26% fluoride varnish application
topical application of fluoride varnish every 6 months
Interventions
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1.23% fluoride foam application
topical application of fluoride foam every 6 months
2.26% fluoride varnish application
topical application of fluoride varnish every 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Kindergartens which are basically the same in terms of school scale, student source structure, economic level and sanitary conditions;
* Kindergartens with the same source of domestic water, or with the same fluoride concentration in water , and the fluoride concentration in water less than 1.0mg/L.
* Children aged over 3-year and under 4-year at the time of the survey;
* Children in good health;
* Children with a certain degree of understanding and good compliance;
* Children whose parents sign the informed consent form.
Exclusion Criteria
* Children with a history of asthma or allergies;
* Children with other contraindications specified in the product manual.
3 Years
4 Years
ALL
No
Sponsors
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National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC
OTHER
Responsible Party
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Principal Investigators
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Chunxiao Wang
Role: STUDY_DIRECTOR
National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC
Other Identifiers
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NCNCD
Identifier Type: -
Identifier Source: org_study_id