Arresting early childhood caries using silver and fluoride products - A randomised trial

Objective: The aim of this randomised non-inferiority clinical trial was to compare the effectiveness of semi-annual (every six months) applications of 25 % silver nitrate (AgNO3) solution followed by 5 % sodium fluoride (NaF) varnish to semi-annual applications of 38 % silver diamine fluoride (SDF) solution in arresting early childhood caries (ECC). Methods: Three-year-old children with active cavitated carious lesions were recruited and randomly assigned to two intervention groups. Children in Group A received semi-annual applications of 25 % AgNO3 solution followed by 5 % NaF varnish on carious lesions. Children in Group B received semi-annual applications of 38 % SDF solution followed by a placebo varnish. One trained dentist assessed ECC status at baseline and in all follow-up examinations. An independent operator performed the interventions. The dentist, the children, and their care takers were blinded to the intervention allocation. Data were analysed using a non-inferiority test. Group A's non-inferiority would be accepted if the lower limit of the 95 % confidence interval (CI) for the difference in the mean number of arrested decayed surfaces (ds) was greater than -0.5. Results: At baseline, 1,070 children were recruited, and 535 children were assigned to each group. After 30 months, the mean arrested ds in Groups A (n = 447) and B (n = 433) were 3.7 +/- 3.6 and 3.6 +/- 3.7, respectively (p = 0.694). The difference in the mean arrested ds between the two groups was 0.088 (95 % CI: -0.351 to 0.526). Conclusion: Semi-annual application of 25 % AgNO3 followed by 5 % NaF is at least as effective as the semi-annual application of 38 % SDF in arresting ECC. Clinical significance: Silver and fluoride products are effective in arresting caries. As a simple, non-invasive, and inexpensive strategy, it can be used in young children, elderly adults, and people with special needs.