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

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.

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.

cavity (d) prevention effect.

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).

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.

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.