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

ConditionDental Caries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorUniversity of Nove de Julho

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

2,500 Participants
are divided into 4 treatment groups

Sponsors and collaborators