Longitudinal Minimally Invasive Dental Caries Protocols in Brazilian Schoolchildren
Official title: Longitudinal Evaluation of Minimally Invasive Protocols for the Prevention and Control of Dental Caries in Brazilian Schoolchildren: A Multicenter Study Protocol
Run by University of Nove de Julho · NCT06999005 · Data updated 2026-11-12
This study tests minimally invasive dental treatments for active caries in 6–12 year-olds in Brazilian public schools to see if these approaches prevent progression over 24 months.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 12 Years |
| Sex | All |
| Enrollment | 2500 (estimated) |
| Sponsor | University of Nove de Julho Academic / other |
| Locations | 1 site (Santos, São Paulo) |
| Status | Recruiting |
| Started | February 28, 2026 |
| Main results expected | February 2028 |
| Study ends | December 2028 |
| Registry record updated | May 15, 2026 |
| Trial ID | NCT06999005 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6–12 with at least one erupted permanent first molar and active caries (ICDAS 1–6) who can attend quarterly visits for 24 months.
✕Probably not a fit
Children without active caries or those unable to attend regular follow-ups may not experience benefit from the treatment protocols.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, pragmatic interventional study in five Brazilian cities evaluates minimally invasive protocols for prevention and management of dental caries among schoolchildren in routine public health settings. In phase one, 50,000 children receive screening with ICDAS and receive preventive measures and education, including fluoride varnish and supervised brushing. In phase two, 2,500 children with active caries are treated using ICDAS-based approaches such as fluoride varnish, ART sealants, and ART restorations, with quarterly follow-ups for up to two years. The study is non-randomized and coordinated by ABOPED with lead involvement from the University of Nove de Julho, aiming to observe lesion behavior and protocol performance in real-world school health programs.
Why it matters
Potential benefit: If successful, the protocols could reduce caries progression and improve oral health outcomes for schoolchildren in public health settings.
How similar studies have gone: Prior studies have shown potential for minimally invasive approaches in caries management, but this study is conducted in routine public-school settings and is broader in scope.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Universidade Metropolitana de Santos - UNIMES
Santos, São Paulo, Brazil Recruiting
Study contacts
- Principal investigator: Sandra K Bussadori — Universidade Metropolitana de Santos
- Study coordinator: Sandra K Bussadori
- Email: sandra.skb@gmail.com
- Phone: +55 11 3385-9241
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.