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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries in Children
• Intervention / Treatment: Drug: 1.23% fluoride foam application; Drug: 2.26% fluoride varnish application

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 Type: Interventional
• Enrollment (Actual): 1083
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): October 16, 2018
• Study Completion (Actual): December 28, 2018

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): November 12, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: clinical trial; cost effectiveness; fluoride varnish; dental caries; fluoride foam
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Fluorides, Topical
• Other Study ID Numbers: NCNCD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No