Arresting Early Childhood Caries with Silver Diamine Fluoride Gel Among Preschool Children: Protocol for a Randomised Clinical Trial.

ABSTRACT: Background: The World Health Organisation (WHO) included silver diamine fluoride (SDF) in the WHO Model List of Essential Medicines for the management of early childhood caries. SDF is typically available as a 38% aqueous solution, which is watery to apply. A 38% SDF gel has recently been developed, but its caries-arrest effectiveness remains unsubstantiated. The objective of this study is to determine whether the efficacy of a 38% SDF gel is non-inferior to a 38% SDF solution in arresting early childhood caries. Methods: This is a 30-month, randomised, active-controlled, parallel-group non-inferiority pragmatic clinical trial with two arms. The hypothesis is that the 38% SDF gel is not worse than the 38% SDF solution by a non-inferiority margin of 10% caries-arrest rate when

SUBMITTER: Cheng AY 

PROVIDER: S-EPMC11674657 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature