Effectiveness of a Novel Nano-Silver Fluoride with Green Tea Extract Compared with Silver Diamine Fluoride: A Randomized, Controlled, Non-Inferiority Trial

The aim of this study wasto evaluate whether the cariostatic efficacy of a biologically synthesized novel Nano-Silver Fluoride with green tea extract (NSF-GTE) is non-inferior to Silver Diamine Fluoride (SDF) 38% in deciduous teeth in preschool children. This study was a randomized, single-blinded, non-inferiority clinical trial. Sixty-three preschoolers with a total of 164 active lesions were selected and randomly assigned into two groups (A: 32 children with 83 lesions treated with NSF-GTE - B:31 children with 81 lesions treated with SDF). Clinical evaluation was performed at 21 days,3 and 6 months after treatment using International Caries Detection and Assessment System (ICDAS II) criteria to assess carious lesions activity. Non- Inferiority margin was set at 15%. At six months, Total arrest rate was 67.4% and 79.6% for NSF-GTE and SDF respectively (P> 0.05). Furthermore, 95% confidence interval of the Relative Risk for (group A) at the three follow-up periods lies entirely below the predefined margin in comparison to (group B). Also, it was observed that anterior teeth and single surface lesions had higher arrest rates as compared to posterior teeth and multiple surface lesions (P<0.05). Non-Inferiority was demonstrated, and both SDF and NSF-GTE presented cariostatic efficacy in primary teeth.