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
This trial accepts healthy volunteersQualifiers
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
Sequential
Treatments tested in this trial
Fluoride Varnish Application (Preventive Protocol)
Procedure/SurgeryPreventive application of Duraphat® fluoride varnish on permanent molars and incisors, with quarterly maintenance applications.
Fluoride Varnish for Active Enamel Lesions
Procedure/SurgeryFour weekly fluoride varnish applications for active white spot lesions, followed by quarterly maintenance applications.
Atraumatic Restorative Treatment (ART) Sealant
Procedure/SurgeryPlacement of ART sealants with high-viscosity glass ionomer cement for ICDAS 3 lesions, followed by quarterly fluoride varnish applications.
Atraumatic Restorative Treatment (ART)
Procedure/SurgeryAtraumatic restorative treatment with high-viscosity glass ionomer cement for ICDAS 4-6 lesions, with optional use of PapacarieDUO® and quarterly fluoride varnish applications.
Treatment groups
Trial outcomes
Primary outcomes
Control of Caries Activity
Assessment of caries activity control using International Caries Detection and Assessment System (ICDAS) criteria during longitudinal follow-up. Control of caries activity will be defined according to the absence of lesion progression, reduction in lesion activity, or maintenance/arrest of carious lesions over time.
Secondary outcomes
Survival and Integrity of ART Sealants and Restorations
Assessment of the clinical survival and integrity of ART sealants and restorations according to the criteria proposed by Amorim et al. (2014), including evaluation of marginal defects, fractures, retention, and restoration failure over follow-up.
Inactivation of Active White Spot Lesions
Assessment of the inactivation of active white spot lesions following fluoride varnish applications during follow-up evaluations.
Adherence to Preventive Oral Health Measures
Assessment of adherence to supervised toothbrushing, use of fluoridated toothpaste, and attendance at scheduled follow-up visits throughout the study period.
Sponsors and contacts
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