TY - JOUR
T1 - Silver diamine fluoride versus therapeutic sealants for the arrest and prevention of dental caries in low-income minority children
T2 - Study protocol for a cluster randomized controlled trial
AU - Ruff, Ryan Richard
AU - Niederman, Richard
N1 - Funding Information:
Research reported in this publication was funded through a Patient-Centered Outcomes Research Institute (PCORI) award (PCS-1609-36824; Niederman and Ruff, principal investigators). The views presented in this publication are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or the Methodology Committee.
Publisher Copyright:
© The Author(s).
PY - 2018
Y1 - 2018
N2 - 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.
AB - 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.
KW - Caries arrest
KW - Caries prevention
KW - Dental caries
KW - Education
KW - Interim therapeutic restorations
KW - Quality of life
KW - Sealants
KW - Silver diamine fluoride
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U2 - 10.1186/s13063-018-2891-1
DO - 10.1186/s13063-018-2891-1
M3 - Article
C2 - 30257696
AN - SCOPUS:85065563518
SN - 1745-6215
VL - 19
JO - Trials
JF - Trials
IS - 1
M1 - 523
ER -