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

NCT05025163 | Completed

• 1 other identifier: NCNCD
• Study Type: interventional
• Target: 1,083
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Caries in Children

Keywords

cost effectiveness; fluoride foam; fluoride varnish; dental caries; clinical trial

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• The mean cost per caries avoided after 12 months and 24 months

  24 months

Study Arms (3)

control group

NO INTERVENTION

no intervention in the control group

fluoride foam group

EXPERIMENTAL

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

Drug: 1.23% fluoride foam application

fluoride varnish group

EXPERIMENTAL

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

Drug: 2.26% fluoride varnish application

Interventions

1.23% fluoride foam application DRUG

topical application of fluoride foam every 6 months

Also known as: fluoride foam

fluoride foam group

2.26% fluoride varnish application DRUG

topical application of fluoride varnish every 6 months

Also known as: Duraphat (Colgate)

fluoride varnish group

Eligibility Criteria

• Age: 3 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Dental Caries

Interventions

sodium fluoride topical preparation; Sodium Fluoride

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Chunxiao Wang

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 27, 2021
• Study Start: July 1, 2016
• Primary Completion: October 16, 2018
• Study Completion: December 28, 2018
• Last Updated: November 12, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share