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Longitudinal Evaluation of Minimally Invasive Protocols for Dental Caries in Brazilian Schoolchildren

NCT06999005 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2500

Last updated 2026-05-15

No results posted yet for this study

Summary

This multicenter longitudinal interventional study aims to evaluate minimally invasive protocols for the prevention and control of dental caries in Brazilian schoolchildren under routine public health conditions. In the first phase, 50,000 children aged 6 to 12 years from public schools in five Brazilian cities will undergo dental screening using ICDAS criteria and receive preventive and educational oral health measures. In the longitudinal treatment phase, 2,500 children diagnosed with active carious lesions will be managed according to ICDAS-based minimally invasive treatment protocols. Participants will be followed every three months for up to 24 months.

Conditions

  • Dental Caries

Interventions

PROCEDURE

Fluoride Varnish for Active Enamel Lesions

Four weekly fluoride varnish applications for active white spot lesions, followed by quarterly maintenance applications.

PROCEDURE

Atraumatic Restorative Treatment (ART) Sealant

Placement of ART sealants with high-viscosity glass ionomer cement for ICDAS 3 lesions, followed by quarterly fluoride varnish applications.

PROCEDURE

Atraumatic Restorative Treatment (ART)

Atraumatic restorative treatment with high-viscosity glass ionomer cement for ICDAS 4-6 lesions, with optional use of PapacarieDUO® and quarterly fluoride varnish applications.

PROCEDURE

Fluoride Varnish Application (Preventive Protocol)

Preventive application of Duraphat® fluoride varnish on permanent molars and incisors, with quarterly maintenance applications.

Sponsors & Collaborators

  • University of Nove de Julho

    lead OTHER

Principal Investigators

  • Sandra K Bussadori · Universidade Metropolitana de Santos

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2028-02-29
Completion
2028-12-31

Countries

  • Brazil

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 NCT06999005 on ClinicalTrials.gov