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First page of Cavity-management effectiveness and feasibility of SDF solution and NaF varnish in children: One-year follow-up non-inferiority RCT

Introduction: The prevalence of caries experience among 5-year-old children in Colombia remains high (62%). The National Health System supports the use of NaF varnish (FV) from age one. Considering the inclusion of SDF solution (SDF) by the WHO and the FDI to control caries burden by 2030, the aim of this non-inferiority randomised controlled trial (RCT) was to compare after one year the effectiveness and feasibility of biannual applications of SDF or FV for the control of cavities in young children from Bogotá and Cartagena, Colombia. Methods: This non-inferiority RCT included 752 3-4 year-old medically healthy children from Bogotá and Cartagena. Participants in each city were randomised to receive either SDF (38%) or FV (5%) biannually. Primary outcome: cavity (d) prevention effect. Secondary outcomes: active-cavity (active-d) arresting effect, feasibility (study adherence, received-treatment fidelity), dental-care parental satisfaction/acceptance, child-procedure behaviour and pain, and adverse effects. Data were analysed using t-tests, Chi-square tests, and generalised-estimating-equation (GEE) (0.05 statistical significance). Results: 611 children (75.1%) completed the one-year follow-up. At baseline, overall prevalence of caries experience (dmf) was of 32% (prevalence of d: 27%), increasing to over 75% when including Initial and Moderate caries lesions (assessed without air-drying, Epi) (ICDAS-merged Epi dmf). Corresponding mean number of tooth surfaces with ICDAS-merged Epi dmf was >5.9, of which cavities/d: >1.1. Most reported a high daily intake of free sugars (FV: 82.8%; SDF: 79.9%), and use of fluoridated toothpaste was not generalised (FV: 60.3%; SDF: 57.8%). After one year, mean number of new-cavity tooth surfaces showed no inferiority for SDF vs. FV (FV: 0.61±1.86; SDF: 0.40±1.13, p=0.22). Arresting active cavities was achieved in 49.4% (FV) and 72.2% (SDF) of children (p>0.05). Feasibility was high: study adherence (FV: 76.1%; SDF: 74.0%); received-treatment fidelity (FV: 92.9%; SDF: 91.4%) (p>0.05). Most parents were satisfied-very-satisfied (FV: 93.2%; SDF: 96.0%) (p>0.05). Only one case of adverse effects appeared after the first fluoride application (SDF) and resolved uneventfully. Conclusion: After one year, a biannual application of SDF versus FV was not inferior in preventing new cavities, with high feasibility in community settings. This study supports the use of these fluoride therapies for young children in similar socioeconomic contexts, recommending increasing fluoridated toothpaste affordability and including behaviour change strategies to improve oral-health practices.

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S. Karger AG, Basel
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2025
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