CARies DEtection in Children-Pelotas (CARDEC-PEL): Comparison of Two Methods of Caries Risk Assessment in Children

What this Trial Is About

Researchers are comparing two methods for assessing the risk of dental caries (tooth decay) in children aged 7 to 11 years. The study aims to evaluate whether an elaborate, individualized risk assessment using the International Caries Classification and Management System (ICCMS) provides better guidance for treatment and follow-up than a simpler method based only on past dental caries experience. This is a randomized, double-blind clinical trial conducted over two years at the Pediatric Dentistry Clinic of the Federal University of Pelotas. Participants will be randomly assigned to one of two groups: one group will receive dental caries treatment and maintenance guided by the multivariate ICCMS risk assessment, while the other group will be treated based on their caries experience alone using WHO criteria. Treatments and follow-up intervals will be tailored according to the initial risk assessment method assigned. The study includes evaluations at baseline, 12 months, and 24 months. During the study, parents will complete questionnaires about their child's diet, general and oral health quality of life, and medical history. Children will undergo clinical exams to assess caries presence and activity using the simplified ICDAS system. Researchers will track new caries lesions requiring operative intervention as the primary outcome and will also assess quality of life changes from baseline to the end of treatment. Data will be analyzed to compare the two risk assessment approaches over the 24-month period.

CARDEC-PEL: Comparison of Two Methods of Caries Risk Assessment in Children