Comparative Effectiveness of Treatments to Prevent Dental Caries

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 children enrolled in public elementary schools in New Hampshire
from 2017-2023. The primary objective is to assess the non-inferiority of alternative agents
in the arrest and prevention of dental caries. Caries arrest will be evaluated after two
years, and caries prevention 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 with a previously employed caries prevention program operating in
rural areas, with official Title 1 status, and located in a health professional
shortage area. Within participating schools, all children are eligible to participate
in the study. Those with informed consent and assent will receive care.

Exclusion Criteria:

- Children without informed consent or those with consent but without assent.