Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT06999005
Brief 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: São Paulo, Curitiba, 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.
Study:
NCT06999005
Study Brief:
Protocol Section:
NCT06999005