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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preventive Varnish Application (Protocol 1) | Experimental | Children with erupting or erupted permanent first molars and incisors will receive preventive application of Duraphat® fluoride varnish (Colgate®). The varnish will be applied after surface cleaning and drying, with quarterly maintenance applications during follow-up. |
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| Active White Spot Lesion Treatment (Protocol 2) | Experimental | Children diagnosed with active non-cavitated enamel lesions (ICDAS 1 to 2) will receive Duraphat® fluoride varnish (Colgate®) in four weekly sessions to promote lesion arrest and remineralization, followed by quarterly maintenance applications during follow-up. |
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| ART Sealant Application (Protocol 3) | Experimental | Children with occlusal carious lesions classified as ICDAS 3 on first permanent molars will receive ART sealants using high-viscosity glass ionomer cement. The protocol includes surface cleaning, relative isolation, placement of the material using finger pressure technique, and fluoride varnish application. Quarterly evaluations and maintenance applications will be performed during follow-up. |
|
| Atraumatic Restorative Treatment (Protocol 4) | Experimental | Children with dentin carious lesions classified as ICDAS 4 to 6 and preserved pulp vitality will receive atraumatic restorative treatment (ART) using hand instruments and high-viscosity glass ionomer cement. PapacarieDUO® may be optionally used to facilitate selective caries removal according to clinical indication. Fluoride varnish will be applied after treatment, with quarterly follow-up evaluations throughout the study period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride Varnish Application (Preventive Protocol) | Procedure | Preventive application of Duraphat® fluoride varnish on permanent molars and incisors, with quarterly maintenance applications. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3, 6, 9, 12, 15, 18, 21, and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3, 6, 9, 12, 15, 18, 21, and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandra K Bussadori | Contact | +55 11 3385-9241 | sandra.skb@gmail.com | |
| Elaine M Santos | Contact | +55 13 3228-3400 |
| Name | Affiliation | Role |
|---|---|---|
| Sandra K Bussadori | Universidade Metropolitana de Santos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Metropolitana de Santos - UNIMES | Recruiting | Santos | São Paulo | 11045-002 | Brazil |
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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.
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This is an open-label study due to the visible and procedural nature of the dental interventions performed.
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| Fluoride Varnish for Active Enamel Lesions | Procedure | Four weekly fluoride varnish applications for active white spot lesions, followed by quarterly maintenance applications. |
|
| Atraumatic Restorative Treatment (ART) Sealant | Procedure | 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 | Atraumatic restorative treatment with high-viscosity glass ionomer cement for ICDAS 4-6 lesions, with optional use of PapacarieDUO® and quarterly fluoride varnish applications. |
|
| Inactivation of Active White Spot Lesions | Assessment of the inactivation of active white spot lesions following fluoride varnish applications during follow-up evaluations. | 3, 6, 9, 12, 15, 18, 21, and 24 months |
| 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. | 3, 6, 9, 12, 15, 18, 21, and 24 months |
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D057087 | Dental Atraumatic Restorative Treatment |
| ID | Term |
|---|---|
| D003813 | Dentistry |
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