Silver diamine fluoride versus therapeutic sealants for the arrest and prevention of dental caries in low-income minority children: study protocol for a cluster randomized controlled trial

Abstract

BackgroundDental caries is the most prominent childhood disease in the world. In the United States, more than 50% of children have experienced caries. Untreated caries can have negative impacts on quality of life, academic performance, and school attendance. To reduce oral health disparities, multiple organizations recommend school-based caries prevention.Methods/designA longitudinal, cluster randomized, non-inferiority trial will be conducted in low-income children from primarily Hispanic/Latino backgrounds currently enrolled in public elementary schools in New York City, New York, United States, from 2018 to 2023. The primary objective is to compare the non-inferiority of silver diamine fluoride and fluoride varnish versus glass ionomer therapeutic sealants and fluoride varnish in the arrest and prevention of dental caries. Secondary objectives are to evaluate differences in effectiveness when care is provided by nurses versus dental hygienists and assess the impact of prevention on oral health-related quality of life and educational outcomes. Caries arrest will be evaluated after 2 years, and caries prevention and secondary outcomes will be assessed at the completion of the study. Data analysis will follow intent-to-treat, and statistical analyses will be conducted using a two-sided significance level of 0.05.DiscussionThe comparative effectiveness of alternative caries prevention delivery models is considered to be one of the highest research priorities in the United States. Many treatments are currently available to prevent and arrest dental caries. The simplicity and affordability of silver diamine fluoride may be a viable alternative for the prevention of dental caries in high-risk children.Trial registrationU.S. National Library of Medicine, www.clinicaltrials.gov, ID: NCT03442309. Registered on 22 February 2018.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2891-1) contains supplementary material, which is available to authorized users.

Microbial population shift and metabolic characterization of silver diamine fluoride treatment failure on dental caries

“…Children most at risk for oral diseases face profound health inequalities and often lack access to oral health services [10][11][12][13][14]. To address this unmet need, several clinical trials on the pragmatic use of non-surgical methods for caries management are currently in progress [15,16].…”

Dentists’ Adoption of Silver Diamine Fluoride among 1- to 5-Year-Old Children in North Carolina

“…Our results paint an important picture for public health and school-based program planning. When considering the primary preventive effects of SDF when compared with placebo or fluoride varnish (Oliveira et al 2019), these results suggest a place for SDF utilization in school-based prevention programs targeted toward provision gaps (Ruff and Niederman 2018).…”

School-based caries prevention and longitudinal trends in untreated decay: an updated analysis with Markov chains

“…The combination of treatments can form a comprehensive prevention program that treats existing infection and prevents the spread or incidence of caries; however, the additional time and costs required is a consideration for any school-based program. Alternative agents such as silver diamine fluoride (SDF) can be safely and efficiently used at a fraction of the cost and time of ITRs, however research in large pragmatic settings is ongoing [23,24].…”