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NOT YET RECRUITING
NCT06999005
NA

Minimally Invasive Protocols for the Treatment and Control of Caries Lesions in Children and Adolescents

Sponsor: University of Nove de Julho

View on ClinicalTrials.gov

Summary

This multicenter longitudinal interventional study aims to evaluate the effectiveness of four minimally invasive protocols for the prevention and control of dental caries in children and adolescents. In the first phase, approximately 50,000 children aged 6 to 12 years from five Brazilian cities will undergo dental screening and receive preventive oral health interventions. In the second phase, 2,500 children diagnosed with active caries will be treated with different interventions, depending on lesion severity. All participants will be followed up every three months for 24 months.

Official title: Minimally Invasive Protocols for the Treatment and Control of Caries Lesions in Children and Adolescents:A Multicenter Longitudinal Interventional Study

Key Details

Gender

All

Age Range

6 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

2500

Start Date

2026-02

Completion Date

2027-12

Last Updated

2026-01-27

Healthy Volunteers

Yes

Conditions

Interventions

PROCEDURE

Fluoride Varnish Application (Preventive Protocol)

Single application of Duraphat® fluoride varnish on permanent molars and incisors, repeated every 3 months.

PROCEDURE

Fluoride Varnish for Active Enamel Lesions

Weekly fluoride varnish applications for 4 weeks, followed by quarterly maintenance applications.

PROCEDURE

Atraumatic Restorative Treatment (ART) Sealant

Sealant placement with high-viscosity glass ionomer using the ART technique, with quarterly fluoride varnish.

PROCEDURE

Atraumatic Restorative Treatment (ART)

Manual caries removal and cavity restoration with glass ionomer cement, followed by fluoride varnish every 3 months.