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

Dental Caries in Children Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05025163
• Other study ID #: NCNCD
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: December 28, 2018

Study information

• Verified date: November 2021
• Source: National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1083
• Est. completion date: December 28, 2018
• Est. primary completion date: October 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 4 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean number of decayed,missing and filled teeth at baseline,12 months and 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	24 months
Primary	The mean number of decayed,missing and filled teeth surfaces at baseline,12 months and 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	24 months
Primary	The change of mean number of decayed,missing and filled teeth at baseline,12 months and 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	24 months
Primary	The change of mean number of decayed,missing and filled teeth surfaces at baseline,12 months and 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	24 months
Secondary	The mean cost per caries avoided after 12 months and 24 months	The mean cost per caries avoided in fluoride foam group and fluoride varnish group after 12 months and 24 months	24 months