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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Fluoride Varnish Application (Preventive Protocol)

    Procedure/Surgery

    Preventive application of Duraphat® fluoride varnish on permanent molars and incisors, with quarterly maintenance applications.

  • Fluoride Varnish for Active Enamel Lesions

    Procedure/Surgery

    Four weekly fluoride varnish applications for active white spot lesions, followed by quarterly maintenance applications.

  • Atraumatic Restorative Treatment (ART) Sealant

    Procedure/Surgery

    Placement of ART sealants with high-viscosity glass ionomer cement for ICDAS 3 lesions, followed by quarterly fluoride varnish applications.

  • Atraumatic Restorative Treatment (ART)

    Procedure/Surgery

    Atraumatic 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

2,500 Participants
are divided into 4 treatment groups
Group A: Preventive Varnish Application (Protocol 1)Experimental treatment 1 intervention
Group B: Active White Spot Lesion Treatment (Protocol 2)Experimental treatment 1 intervention
Group C: ART Sealant Application (Protocol 3)Experimental treatment 1 intervention
Group D: Atraumatic Restorative Treatment (Protocol 4)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 3, 6, 9, 12, 15, 18, 21, and 24 months

Secondary outcomes

1

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.

Time frame
3, 6, 9, 12, 15, 18, 21, and 24 months
2

Inactivation of Active White Spot Lesions

Assessment of the inactivation of active white spot lesions following fluoride varnish applications during follow-up evaluations.

Time frame
3, 6, 9, 12, 15, 18, 21, and 24 months
3

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.

Time frame
3, 6, 9, 12, 15, 18, 21, and 24 months

Other outcomes

Sponsors and contacts

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