Cavity Management Effectiveness and Feasibility of Silver Diamine Fluoride Solution and Sodium Fluoride Varnish in Children: One-Year Follow-Up Non-Inferiority Randomised Controlled Trial.

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 1 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 seven hundred fifty-two 3- to 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, χ2 tests, and generalised estimating equation (0.05 statistical significance). Results: A total of 611 children (75.1%) completed the 1-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 1 year, mean number of new cavity tooth surfaces showed no inferiority for SDF versus 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 1 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 socio-economic contexts, recommending increasing fluoridated toothpaste affordability and including behaviour change strategies to improve oral health practices. Plain Language Summary: In Colombia, still too many children at age 5 years have cavities (decay) (62%). As a preventive measure, the National Health System promotes the use of a well-known fluoride varnish from age one. Recently, world agencies related to oral health and the profession (WHO and FDI) are also supporting the use of a fluoride solution (SDF) to control caries. So, this study intended to assess in a controlled manner if after 1 year of two semi-annual applications on young children teeth of either of these fluorides, the fluoride solution was not inferior to the fluoride varnish in preventing the appearance of new cavities. It was approved by the Ethical Board and children's parents who accepted signed informed consent. The trial was conducted by applying by chance either fluoride to half of 752 children aged 3 to 4 years in Bogotá and Cartagena, Colombia, repeating the same application after 6 months. The study also measured if these fluorides had any adverse effects and its feasibility, by assessing if children left the trial before its end or went for a different dental treatment, as well as if during fluoride applications children were uneasy or felt pain, and if parents liked the fluoride treatments. Results after 1 year showed that fluoride solution was not inferior to fluoride varnish, both preventing new cavities in over 80% of children. The study showed feasibility (>75% of children finished, <9% had a different treatment). In general, there were no children's uneasiness/pain issues and parents were satisfied. [ABSTRACT FROM AUTHOR]