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

Ryan Richard Ruff, Richard Niederman, Ryan Richard Ruff, Richard Niederman

Abstract

Background: Dental 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/design: A 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.

Discussion: The 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 registration: U.S. National Library of Medicine, www.clinicaltrials.gov , ID: NCT03442309 . Registered on 22 February 2018.

Keywords: Caries arrest; Caries prevention; Dental caries; Education; Interim therapeutic restorations; Quality of life; Sealants; Silver diamine fluoride.

Conflict of interest statement

Ethics approval and consent to participate

This study received approval from the New York University School of Medicine Institutional Review Board (approved 3 October 2017; #i17–00578). All students in participating schools will be invited to participate and parents will sign a consent form after reviewing written information about the study.

Consent for publication

All authors consent to publication of this article.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study design, enrollment, and data collection
Fig. 2
Fig. 2
Schedule of enrollment, interventions, and assessments

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