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Fluoride Caries-control Effectiveness/Feasibility in Children

NCT06690008 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 814

Last updated 2025-04-15

No results posted yet for this study

Summary

The aim of this study is to compare the effectiveness and feasibility of using silver diamine fluoride solution (SDF) vs. sodium fluoride varnish (NaF) for caries management in children from Bogotá (and its suburban areas) and Cartagena, in terms of: 1. Preventive effect: number of carious dental surfaces (cavitated); 2. Arrest effect: number of arrested carious tooth surfaces (cavitated); 3. Presence and number of adverse effects in soft/hard oral tissues.

Null hypothesis: Effectiveness and feasibility of silver diamine fluoride is superior to the sodium fluoride for caries management:

Alternative hypothesis: Effectiveness and feasibility of silver diamine fluoride is not superior to the sodium fluoride for caries management.

This Randomize Clinical Trial included 752 3-4 year-old medically healthy children from Bogotá and Cartagena. Participants were randomized equality distributed per city to receive either SDF (38%) or NaF (5%) biannually. Primary outcomes: cavity prevention and arresting effect. Secondary: feasibility (adherence, fidelity), dental-care parental satisfaction/acceptance and adverse effects. Data were analysed using t-tests, Chi-square, and Generalized estimating equations -GEE (0.05 statistical significance).

Conditions

  • Caries,Dental

Interventions

PROCEDURE

Experimental group

SDF application

Sponsors & Collaborators

  • Corporacion Universitaria Rafael Nunez

    collaborator OTHER

  • Cooperative University of Colombia

    collaborator OTHER

  • Universidad El Bosque, Bogotá

    lead OTHER

Principal Investigators

  • Stefania Martignon, PhD · Universidad El Bosq

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-22
Primary Completion
2023-04-30
Completion
2024-04-30

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06690008 on ClinicalTrials.gov