Fluoride Caries-control Effectiveness/Feasibility in Children

NCT06690008 | Completed

• 1 other identifier: PCI-2022-11045
• Study Type: interventional
• Target: 814
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Dental caries; Fluorides; Diamine silver fluoride; Sodium fluoride; Prevention; Control

Outcome Measures

Primary Outcomes (2)

• one-year proportion of children with new cavities and mean number of new cavities (preventive effect)

  The one-year proportion of children with new cavities and the mean number of new cavities reflect the preventive effect of the intervention. These measures help assess how effective the dental treatments (NaF or SDF) were in preventing the development of new carious lesions over the course of the year. Proportion of children with new cavities: This refers to the percentage of children who developed new carious lesions (cavities) after one year, compared to the total number of children initially assessed. A lower proportion suggests that the intervention was effective in preventing new cavities. Mean number of new cavities: This refers to the average number of new cavities per child in the intervention group. A lower mean number of new cavities indicates a stronger preventive effect, showing that fewer cavities developed over the year in the group that received the intervention.

  12 months

• one-year proportion of children with inactive cavities and mean number of inactive cavities (arresting effect)

  The one-year proportion of children with inactive cavities and the mean number of inactive cavities reflect the "arresting effect" of the intervention. These metrics assess how effective the treatment (NaF or SDF) was in halting the progression of existing carious lesions, potentially leading to arrested or inactive cavities. Proportion of children with inactive cavities: This refers to the percentage of children who had cavities that became inactive (arrested) after one year. Inactive cavities are characterized by hard, shiny surfaces, indicating that the decay process has stopped. A higher proportion suggests that the intervention was effective in arresting caries progression. Mean number of inactive cavities: This refers to the average number of cavities per child that became inactive over the course of one year. A higher mean number of inactive cavities indicates that a greater number of cavities were successfully arrested in the intervention group.

  12 months

Secondary Outcomes (6)

• Feasibility at one year, in terms of adherence (number of participants recruited and retained)

  12 months

• Feasibility at one year, in terms of fidelity (number of participants not receiving a different intervention)

  12 months

• Number of participants with adverse oral soft tissue effects (one day after the first intervention and after one year)

  1 day and 12 months

• Satisfaction/acceptance of parents' children with caries care after the first intervention

  12 months

• Child's self-reported pain

  After the dental intervention

Study Arms (2)

Experimental group (SDF group)

EXPERIMENTAL

SDF application: -Vaseline will be used to isolate and protect the soft tissues (gums and lips); -Then, SDF will be dispensed on paraffin paper according to the dosage guide; - SDF will be applied on dental surfaces and rubbed with a micro-applicator (1'); -Patients will be asked not to eat/drink/rinse (30').

Procedure: Experimental group

Control group NaF group)

ACTIVE COMPARATOR

NaF application: - NaF will be dispensed according to the dosage guide; -all tooth surfaces will be brushed with NaF; -The patient will close his/her mouth until NaF get hard; -Patients will be asked not to eat/drink/rinse (30') Do not brush teeth that day.

Procedure: Experimental group

Interventions

Experimental group PROCEDURE

SDF application

Control group NaF group); Experimental group (SDF group)

Eligibility Criteria

• Age: 3 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• year-old children (from Bogotá/Cartagena)
• Informed consent signed.
• Self-reported good general health (parents)

You may not qualify if:

• Intention to move in the next 12 months
• Systemic disease, physical/mental disability
• Regularly medication intake
• Non-cooperative children

Sponsors & Collaborators

• Universidad El Bosque, Bogotá: lead
• Corporacion Universitaria Rafael Nunez: collaborator
• Cooperative University of Colombia: collaborator

Study Sites (2)

Universidad El Bosque

Bogotá, Bogotá DC, 110121, Colombia

Location

Corporación Universitaria Rafael Núñez

Cartagena, Departamento de Bolívar, Colombia

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Stefania Martignon, PhD

  Universidad El Bosq

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are assigned to two groups in parallel for the duration of the study

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: November 15, 2024
• Study Start: August 22, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2024
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CO (2)