Longitudinal Evaluation of Minimally Invasive Protocols for Dental Caries in Brazilian Schoolchildren
Longitudinal Evaluation of Minimally Invasive Protocols for the Prevention and Control of Dental Caries in Brazilian Schoolchildren: A Multicenter Study Protocol
University of Nove de Julho
2,500 participants
Feb 28, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- Children aged between 6 and 12 years at the time of enrollment
- Presence of at least one erupted permanent first molar
- Diagnosis of active caries lesions classified according to ICDAS (scores 1 to 6)
- Written informed consent signed by a legal guardian and assent signed by the child
- Ability to attend quarterly follow-up visits over a 24-month period
Exclusion Criteria4
- Children requiring endodontic treatment or presenting extensive pulpal involvement
- Presence of systemic diseases or medical conditions that contraindicate dental care
- Known allergy to any material used in the study (fluoride varnish, high-viscosity glass ionomer cement)
- Participation in other clinical dental studies that could interfere with the outcomes
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Interventions
Preventive application of Duraphat® fluoride varnish on permanent molars and incisors, with quarterly maintenance applications.
Four weekly fluoride varnish applications for active white spot lesions, followed by quarterly maintenance applications.
Placement of ART sealants with high-viscosity glass ionomer cement for ICDAS 3 lesions, followed by quarterly fluoride varnish applications.
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)
View Full Details on ClinicalTrials.gov
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NCT06999005