Comparative Effectiveness of School-based Caries Prevention

Dental caries is the most prevalent childhood disease in the world and can lead to infection,
pain, reduced quality of life, and negative educational outcomes. Multiple prevention agents
are available to arrest and prevent dental caries, however little is known of the comparative
effectiveness of combined treatments in pragmatic settings. The aim of the presented study is
to compare the benefit of silver diamine fluoride and fluoride varnish versus fluoride
varnish and glass ionomer therapeutic sealants in the arrest and prevention of dental caries.

This is a longitudinal, pragmatic, cluster randomized, single-blind, non-inferiority trial to
be conducted in low-income minority children enrolled in public elementary schools in New
York City, New York, United States, from 2018-2023. The primary objective is to assess the
non-inferiority of alternative agents in the arrest and prevention of dental caries.
Secondary objectives are to assess oral health-related quality of life and educational
outcomes. Caries arrest will be evaluated after two 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.

Notably, the standard of care for dental caries is office-based surgery, which presents
multiple barriers to care including cost, fear, and geographic isolation. The simplicity and
affordability of silver diamine fluoride may be a viable alternative for the arrest and
prevention of dental caries in high-risk children.

Inclusion Criteria:

- Any primary school in New York City with a Hispanic/Latino student population greater
than 50% and,

- A low-income population (defined as a student receiving free or reduced price lunch)
of at least 80%.

- Within participating schools, all children are eligible to participate in the study.

Exclusion Criteria:

- Schools that already have a pre-existing school-based dental health program.

- Within participating schools, exclusion criteria for children include those without
informed consent or those with consent but without assent.