An interventional study of Silver Diamine Fluoride and Fluoride Varnishes in Dental Caries and Quality of Life, sponsored by NYU College of Dentistry. Completed at 1 site in United States. Open to participants aged 5 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by NYU College of Dentistry · Not applicable, Interventional, and Prevention
Dental caries (tooth decay) is the most prevalent childhood disease in the world. Multiple interventions are available to treat and prevent caries. The aim of the proposed study is to compare the benefit of silver diamine fluoride (SDF) and fluoride varnish versus fluoride varnish and glass ionomer sealants. This study is a five-year, cluster randomized, pragmatic controlled trial conducted in public elementary schools in New York City.
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.
1,138 studies on the registry are indexed under Dental Caries; 201 are open to participants now.
This study's enrollment of 7,418 is above the median of 60 across 936 interventional studies indexed under Dental Caries.
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Exclusion Criteria:
One drop (0.05 ml) of silver diamine fluoride (Advantage ArrestTM) solution at 38% concentration (2.24 F-ion mg/dose) will be dispensed per child. Posterior tooth surfaces to be treated will be dried, after which the SDF will be applied with a micro-brush to all asymptomatic carious lesions and to all pits and fissures on bicuspids and molar teeth for thirty seconds. Fluoride varnishes (5% NaF) will then be applied to all teeth. Dosage frequency will be twice-yearly.
Device: Silver Diamine Fluoride · Device: Fluoride Varnishes
Pits and fissures on all bicuspids and molar teeth will be sealed with glass ionomer sealants (GC Fuji IX). Glass ionomer sealants (interim therapeutic restorations) will also be placed on all frank asymptomatic carious lesions. Fluoride varnishes (5% NaF) will then be applied to all teeth. Dosage frequency will be twice-yearly.
Device: Fluoride Varnishes · Device: Glass Ionomer
Silver diamine fluoride (SDF)
Also known as: Advantage Arrest
Fluoride varnish (FV)
Glass Ionomer Sealants (GC Fuji IX)
Proportion of Subjects With All Caries Arrested
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).
Time frame: Two years
Prevalence of Dental Caries as Measured by a Clinical Oral Examination
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.
Time frame: Participants were evaluated biannually over a total of four years or until lost to follow-up, whichever occurred first.
Oral Health-Related Quality of Life
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.
Time frame: Six months after initial treatment.
School Attendance
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.
Time frame: 4 years after initial baseline observation
Academic Performance
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.
Time frame: 4 years after initial baseline observation
| Milestone | Experimental Condition | Active Control |
|---|---|---|
| Started | 3739 | 3679 |
| Completed | 2063 | 2037 |
| Not completed | 1676 | 1642 |
| Withdrew: Lost to follow-up | 1676 | 1642 |
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).
| Participants | Experimental Condition | Active Control |
|---|---|---|
| Proportion of Subjects With All Caries Arrested | 108 | 101 |
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.
| # of caries per 1000 tooth years | Experimental Condition | Active Control |
|---|---|---|
| Prevalence of Dental Caries as Measured by a Clinical Oral Examination | 10.2 | 9.8 |
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.
| Total COHIP-SF score | Experimental Condition | Active Control |
|---|---|---|
| Oral Health-Related Quality of Life | 14.62 ± 11.90 | 16.47 ± 11.09 |
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.
| Beta coefficient comparing exp to ctl | Experimental Condition | Active Control | Non-treated Schools |
|---|---|---|---|
| School Attendance | -.037 (-0.062 to -0.011) | -.037 (-0.062 to -0.011) | 0 (0 to 0) |
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.
No measurements were reported for this outcome.
Collected over Maximum of 4 years of follow-up observation, post-baseline. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental Condition | 0/3,739 (0%) | 0/3,739 (0%) | 0/3,739 (0%) |
| Active Control | 0/3,679 (0%) | 0/3,679 (0%) | 0/3,679 (0%) |
| Age, Continuous(years) | Experimental Condition | Active Control | Total |
|---|---|---|---|
| Mean | 7.5 ± 1.9 | 7.6 ± 1.9 | 7.6 ± 1.9 |
| Sex: Female, Male(Participants) | Experimental Condition | Active Control | Total |
|---|---|---|---|
| Female | 1954 | 2052 | 4006 |
| Male | 1785 | 1627 | 3412 |
| Race/Ethnicity, Customized(Participants) | Experimental Condition | Active Control | Total |
|---|---|---|---|
| Asian | 88 | 37 | 125 |
| Black | 650 | 596 | 1246 |
| Hispanic | 1766 | 1882 | 3648 |
| White | 86 | 67 | 153 |
| Multiple | 67 | 47 | 114 |
| Other | 56 | 34 | 90 |
| Unreported | 1026 | 1016 | 2042 |
| Number of participants with untreated tooth decay(Participants) | Experimental Condition | Active Control | Total |
|---|---|---|---|
| Count of participants | 1016 | 964 | 1980 |
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Plan to share: Undecided — Individual participant data could be shared with proper approval from participating organizations for relevant and appropriate requests.
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NYU College of Dentistry