Not Yet RecruitingNot Applicable

Minimally Invasive Protocols for the Treatment and Control of Caries Lesions in Children and Adolescents

2,500 participantsStarted 2026-02

Plain-language summary

This multicenter longitudinal interventional study aims to evaluate the effectiveness of four minimally invasive protocols for the prevention and control of dental caries in children and adolescents. In the first phase, approximately 50,000 children aged 6 to 12 years from five Brazilian cities will undergo dental screening and receive preventive oral health interventions. In the second phase, 2,500 children diagnosed with active caries will be treated with different interventions, depending on lesion severity. All participants will be followed up every three months for 24 months.

Who can participate

Age range6 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Caries Lesion Progression

Timeframe: Baseline, 3, 6, 9, 12, 15, 18, 21, and 24 months

Trial details

NCT IDNCT06999005

SponsorUniversity of Nove de Julho

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12