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

RecruitingNAAges 6 Years - 12 YearsAllUniversity of Nove de Julho
NCT06999005 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • Fluoride Varnish Application (Preventive Protocol)
  • Fluoride Varnish for Active Enamel Lesions
  • Atraumatic Restorative Treatment (ART) Sealant
  • Atraumatic Restorative Treatment (ART)
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Where

1 site
Universidade Metropolitana de Santos - UNIMES
Santos, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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