A multi-centric split-mouth randomized clinical trial published in Caries Research assessed the effectiveness of 2 types of resin-based sealants with and without fluoride in a population with high caries risk.
The study assessed sealant effectiveness in preventing carious International Caries Detection and Assessment System (ICDAS) 3–6 lesions within a 2-year follow-up, along with retention rates and the cries risk factors related to their outcomes.
The study included 663 tooth pairs in 400 children (aged 5 to 15 years) considered to be at high individual caries risk (ICR) and presenting permanent molars free of caries or affected by ICDAS 1–2 lesions.
In the first randomization, molars were either randomized to the treatment group receiving a dental sealant or the control group (nontreatment). In the second randomization, the sealant material to be used in the intervention group was selected. Uni- and multivariate Cox proportional hazard models were employed.
At the 2-year follow-up, 483 tooth pairs were assessed. Sealed molars had 83% (adjusted HR = 0.17; 95% CI: 0.15 to 0.20) less risk of developing ICDAS 3–6 lesions than molars without sealant. The magnitude of the protective effect was lower among teeth with ICDAS 1–2 lesions or with occlusal deep fissures than without. If the total retention rate of sealants was 70% at 2 years, sealant loss was not associated with the risk of caries (HR = 1.29, 95% CI: 0.92 to 1.79, p = 0.14).
The study found that sealants allow the prevention of new ICDAS 3–6 lesions or progression of noncavitated carious lesions in children at high ICR, and the effect of the sealant was similar regardless of whether it contained fluoride or not. (Source: Caries Research, March 1, 2018.)
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