NCT06999005

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,500 (estimated)
• Sponsor: University of Nove de Julho · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is a multicenter longitudinal interventional trial coordinated by the Brazilian Society of Pediatric Dentistry (ABOPED) in five Brazilian cities: Santos, Ponta Grossa, Brasília, Fortaleza, and Belém. The aim is to assess the effectiveness of four evidence-based minimally invasive protocols for preventing and managing dental caries in children and adolescents, and to propose a replicable public health model for pediatric oral care. In the first phase, approximately 50,000 children aged 6-12 years will undergo dental screening using the International Caries Detection and Assessment System (ICDAS). All children will receive health literacy activities, oral hygiene instructions, toothbrushes, fluoride toothpaste (1,100 ppm), and a single application of fluoride varnish (Duraphat®) to permanent molars and incisors. Children identified with active caries lesions (ICDAS 1-6) will be considered for the second phase. A total of 2,500 participants will be selected and allocated to one of the following four intervention protocols based on clinical diagnosis: Protocol 1: Single application of fluoride varnish for prevention. Protocol 2: Four weekly applications of fluoride varnish for active white spot lesions, followed by quarterly applications. Protocol 3: High-viscosity glass ionomer ART sealants (for ICDAS 3), with quarterly fluoride varnish. Protocol 4: Conventional atraumatic restorative treatment (ART) with glass ionomer (for ICDAS 4-6), plus quarterly fluoride varnish. Participants will be followed up every three months over a 24-month period.

Conditions

• Dental Caries

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2025-05-31
• Last updated: 2026-01-27