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RECRUITING
NCT06999005
NA

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

Sponsor: University of Nove de Julho

View on ClinicalTrials.gov

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.

Official title: Longitudinal Evaluation of Minimally Invasive Protocols for the Prevention and Control of Dental Caries in Brazilian Schoolchildren: A Multicenter Study Protocol

Key Details

Gender

All

Age Range

6 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

2500

Start Date

2026-02-28

Completion Date

2028-12

Last Updated

2026-05-15

Healthy Volunteers

Yes

Conditions

Interventions

PROCEDURE

Fluoride Varnish Application (Preventive Protocol)

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

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.

Locations (1)

Universidade Metropolitana de Santos - UNIMES

Santos, São Paulo, Brazil