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.

• Silver Diamine Fluoride (Device), also known as Advantage Arrest: Silver diamine fluoride (SDF)
• Fluoride Varnishes (Device): Fluoride varnish (FV)
• Glass Ionomer (Device): Glass Ionomer Sealants (GC Fuji IX)

Primary outcomes

• Proportion of Subjects With All Caries Arrested [Two years]: For any participants with any untreated dental caries on teeth at baseline treated with SDF/FV or Glass ionomer/FV to arrest (control) the infection, what is the proportion of subjects that stayed arrested. Differences were compared to the pre-established non-inferiority margin (10%). NOTE: this analysis conducted after COVID-19 suspensions, thus patient enrollment for this outcome is a subset of the total enrollment reported in Participant Flow. It reflects the total enrollment prior to COVID-19 suspensions (N=1398).
• Prevalence of Dental Caries as Measured by a Clinical Oral Examination [Participants were evaluated biannually over a total of four years or until lost to follow-up, whichever occurred first.]: We assessed the prevalence of dental caries through up to four years of follow-up using generalized mixed effects models, with predictors included for time and treatment. Outcomes were assessed comparing the odds of dental caries in participants receiving the active control to those receiving the experimental condition and compared to the pre-established non-inferiority margin.

Secondary outcomes

• Oral Health-Related Quality of Life [Six months after initial treatment.]: A subset of participants in each treatment group were randomly selected to complete an oral health-related quality of life (OHRQoL) instrument (name: Child Oral Health Impact Profile - Short Form, COHIP-SF19) to compare quality of life pre/post treatment and between treatment groups. Here the differences in COHIP-SF scales are reported six months after initial treatment. After this, COVID-19 suspensions removed any further follow-up for this outcome, which is also why the same sizes are not the same for the full trial. In this analysis, higher scores indicate worse OHRQoL. The COHIP-SF scale consists of 19 items. Each item on the scale was scored between 0-3, for a total scale range of 0 to 57.
• School Attendance [4 years after initial baseline observation]: Annual school attendance (chronic absenteeism) at the school level as recorded by the New York City Department of Education. In evaluating this outcome, we assessed school-level data on the proportion of students who were absent. Additionally, we obtained data from an additional 15 schools which met inclusion criteria but did not participate in the trial as a non-randomized comparison group. This allowed us to compare schools in the experimental group to those in the active control, as well as to a non-randomized untreated group of schools.
• Academic Performance [4 years after initial baseline observation]: Children participating in schools assigned to each arm of the trial that received care were to have their academic performance evaluated. This outcome was to use academic performance data collected by the school, not investigators.

Sex: All, ages: 5 Years to 12 Years, accepts healthy volunteers

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.

Participant flow

Outcome results

• Proportion of Subjects With All Caries Arrested (Primary), Count of participants, Participants: Experimental Condition 108; Active Control 101
• Prevalence of Dental Caries as Measured by a Clinical Oral Examination (Primary), Number, # of caries per 1000 tooth years: Experimental Condition 10.2; Active Control 9.8
• Oral Health-Related Quality of Life (Secondary), Mean, Total COHIP-SF score: Experimental Condition 14.62 +/- 11.90; Active Control 16.47 +/- 11.09
• School Attendance (Secondary), Number, Beta coefficient comparing exp to ctl: Experimental Condition -.037 (-0.062 to -0.011); Active Control -.037 (-0.062 to -0.011); Non-treated Schools 0 (0 to 0)
• Academic Performance (Secondary)

Adverse events

Time frame: Maximum of 4 years of follow-up observation, post-baseline

• Results publication: Ruff RR, Gawande AA, Xu Q, Barry Godin T. Silver Diamine Fluoride vs Atraumatic Restoration for Managing Dental Caries in Schools: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2513826. doi: 10.1001/jamanetworkopen.2025.13826. PMID 40489112
• Results publication: Ruff RR, Barry Godin TJ, Niederman R. Noninferiority of Silver Diamine Fluoride vs Sealants for Reducing Dental Caries Prevalence and Incidence: A Randomized Clinical Trial. JAMA Pediatr. 2024 Apr 1;178(4):354-361. doi: 10.1001/jamapediatrics.2023.6770. PMID 38436947
• Results publication: Ruff RR, Habib R, Godin TB, Niederman R. School-based caries prevention and the impact on acute and chronic student absenteeism. J Am Dent Assoc. 2023 Aug;154(8):753-759. doi: 10.1016/j.adaj.2023.05.007. PMID 37500236
• Results publication: Ruff RR, Barry-Godin T, Niederman R. Effect of Silver Diamine Fluoride on Caries Arrest and Prevention: The CariedAway School-Based Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2255458. doi: 10.1001/jamanetworkopen.2022.55458. PMID 36757696
• Results publication: Ruff RR, Niederman R. 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. Trials. 2018 Sep 26;19(1):523. doi: 10.1186/s13063-018-2891-1. PMID 30257696

• Study Protocol and Statistical Analysis Plan (PDF, 2022-07-27)
• Informed Consent Form: Recruitment and Informed Consent (PDF, 2018-02-15)

• Richard Niederman, DMD, Principal investigator, NYU Langone Health
• Ryan R Ruff, PhD, Principal investigator, NYU Langone Health