Dental Caries
Conditions
Brief 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.
Detailed description
This is a pragmatic, multicenter, non-randomized, longitudinal interventional study coordinated by the Brazilian Association of Pediatric Dentistry (ABOPED) in five Brazilian cities: Santos, Ponta Grossa, Brasília, Fortaleza, and Belém. The study aims to evaluate the longitudinal clinical behaviour of carious lesions and the performance of minimally invasive oral health strategies under routine school-based public health conditions. In the first phase, 50,000 children aged 6-12 years enrolled in public schools will undergo dental screening using the International Caries Detection and Assessment System (ICDAS). All participants will receive preventive and educational measures, including oral health counselling, supervised toothbrushing with fluoridated toothpaste (1100 ppm F), toothbrushes, toothpaste, and application of Duraphat® fluoride varnish to permanent molars and incisors. Children identified with active carious lesions classified as ICDAS 1-6 and meeting the eligibility criteria will enter the longitudinal minimally invasive treatment phase. A total of 2,500 participants will be managed according to ICDAS-based treatment protocols: Protocol 1: preventive fluoride varnish application; Protocol 2: fluoride varnish applications for active white spot lesions; Protocol 3: ART sealants with high-viscosity glass ionomer cement for ICDAS 3 lesions; Protocol 4: atraumatic restorative treatment with high-viscosity glass ionomer cement for ICDAS 4-6 lesions, with optional use of PapacarieDUO® during selective caries removal. Participants will be followed every three months for up to 24 months.
Interventions
Atraumatic restorative treatment with high-viscosity glass ionomer cement for ICDAS 4-6 lesions, with optional use of PapacarieDUO® and quarterly fluoride varnish applications.
PROCEDUREAtraumatic Restorative Treatment (ART) Sealant
Placement of ART sealants with high-viscosity glass ionomer cement for ICDAS 3 lesions, followed by quarterly fluoride varnish applications.
PROCEDUREFluoride Varnish Application (Preventive Protocol)
Preventive application of Duraphat® fluoride varnish on permanent molars and incisors, with quarterly maintenance applications.
PROCEDUREFluoride Varnish for Active Enamel Lesions
Four weekly fluoride varnish applications for active white spot lesions, followed by quarterly maintenance applications.
Sponsors
University of Nove de Julho
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Masking description
This is an open-label study due to the visible and procedural nature of the dental interventions performed.
Intervention model description
Participants will not be randomized. After screening of 50,000 children aged 6 to 12 years, 2,500 children diagnosed with active dental caries lesions will enter the longitudinal minimally invasive treatment phase and will be managed according to ICDAS-based treatment protocols defined by lesion severity and clinical indication. Participants will receive the clinically appropriate minimally invasive protocol and will be followed every three months for up to 24 months.
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Control of Caries Activity | Baseline, 3, 6, 9, 12, 15, 18, 21, and 24 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Survival and Integrity of ART Sealants and Restorations | 3, 6, 9, 12, 15, 18, 21, and 24 months | 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 | 3, 6, 9, 12, 15, 18, 21, and 24 months | Assessment of the inactivation of active white spot lesions following fluoride varnish applications during follow-up evaluations. |
| Adherence to Preventive Oral Health Measures | 3, 6, 9, 12, 15, 18, 21, and 24 months | Assessment of adherence to supervised toothbrushing, use of fluoridated toothpaste, and attendance at scheduled follow-up visits throughout the study period. |
Countries
Brazil
Contacts
CONTACTSandra K Bussadori
CONTACTElaine M Santos
PRINCIPAL_INVESTIGATORSandra K Bussadori
Universidade Metropolitana de Santos
Outcome results
None listed