Cost-effectiveness of Topical Fluoride in Preventing Deciduous Dental Caries in Preschool Children

Sponsor
National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC (Other)
Overall Status
Completed
CT.gov ID
NCT05025163
Collaborator
(none)
1,083
3
29.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 1.23% fluoride foam application
  • Drug: 2.26% fluoride varnish application
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1083 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Cost-effectiveness Analysis of Fluoride Foam and Fluoride Varnish in Preventing Dental Caries in the Primary Teeth of Preschool Children With High Caries Risk
Actual Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Oct 16, 2018
Actual Study Completion Date :
Dec 28, 2018

Arms and Interventions

Arm Intervention/Treatment
No Intervention: control group

no intervention in the control group

Experimental: fluoride foam group

intervention; fluoride foam application (with 1.23% fluoride foam application on teeth )

Drug: 1.23% fluoride foam application
topical application of fluoride foam every 6 months
Other Names:
  • fluoride foam
  • Experimental: fluoride varnish group

    intervention; fluoride varnish application (with 2.26% fluoride varnish application on teeth)

    Drug: 2.26% fluoride varnish application
    topical application of fluoride varnish every 6 months
    Other Names:
  • Duraphat (Colgate)
  • Outcome Measures

    Primary Outcome Measures

    1. The mean number of decayed,missing and filled teeth at baseline,12 months and 24 months [24 months]

      The mean number of decayed,missing and filled teeth in fluoride foam group,fluoride varnish group and control group at baseline,12 months and 24 months

    2. The mean number of decayed,missing and filled teeth surfaces at baseline,12 months and 24 months [24 months]

      The mean number of decayed,missing and filled teeth surfaces in fluoride foam group,fluoride varnish group and control group at baseline,12 months and 24 months

    3. The change of mean number of decayed,missing and filled teeth at baseline,12 months and 24 months [24 months]

      The change of mean number of decayed,missing and filled teeth in fluoride foam group,fluoride varnish group and control group at baseline,12 months and 24 months

    4. The change of mean number of decayed,missing and filled teeth surfaces at baseline,12 months and 24 months [24 months]

      The change of mean number of decayed,missing and filled teeth surfaces in fluoride foam group,fluoride varnish group and control group at baseline,12 months and 24 months

    Secondary Outcome Measures

    1. The mean cost per caries avoided after 12 months and 24 months [24 months]

      The mean cost per caries avoided in fluoride foam group and fluoride varnish group after 12 months and 24 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 4 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Kindergartens Inclusion Criteria:
    • Kindergartens which are all located in Harbin, Heilongjiang Province, China;

    • 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 Inclusion Criteria:
    • 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 who are unable to cooperate or have a strong vomiting reflex;

    • Children with a history of asthma or allergies;

    • Children with other contraindications specified in the product manual.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC

    Investigators

    • Study Director: Chunxiao Wang, National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC
    ClinicalTrials.gov Identifier:
    NCT05025163
    Other Study ID Numbers:
    • NCNCD
    First Posted:
    Aug 27, 2021
    Last Update Posted:
    Nov 12, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 12, 2021