Trial Outcomes & Findings for Comparative Effectiveness of School-based Caries Prevention (NCT NCT03442309)
NCT ID: NCT03442309
Last Updated: 2025-02-26
Results Overview
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).
COMPLETED
NA
7418 participants
Two years
2025-02-26
Participant Flow
Unit of analysis: Schools
Participant milestones
| Measure |
Experimental Condition
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.
Silver Diamine Fluoride: Silver diamine fluoride (SDF)
Fluoride Varnishes: Fluoride varnish (FV)
|
Active Control
Pits and fissures on all bicuspids and molar teeth will be sealed with glass ionomer sealants (GC Fuji IX). Glass ionomer sealants (atraumatic 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.
Fluoride Varnishes: Fluoride varnish (FV)
Glass Ionomer: Glass Ionomer Sealants (GC Fuji IX) and atraumatic restorations
|
|---|---|---|
|
Overall Study
STARTED
|
3739 22
|
3679 24
|
|
Overall Study
COMPLETED
|
2063 20
|
2037 22
|
|
Overall Study
NOT COMPLETED
|
1676 2
|
1642 2
|
Reasons for withdrawal
| Measure |
Experimental Condition
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.
Silver Diamine Fluoride: Silver diamine fluoride (SDF)
Fluoride Varnishes: Fluoride varnish (FV)
|
Active Control
Pits and fissures on all bicuspids and molar teeth will be sealed with glass ionomer sealants (GC Fuji IX). Glass ionomer sealants (atraumatic 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.
Fluoride Varnishes: Fluoride varnish (FV)
Glass Ionomer: Glass Ionomer Sealants (GC Fuji IX) and atraumatic restorations
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1676
|
1642
|
Baseline Characteristics
Comparative Effectiveness of School-based Caries Prevention
Baseline characteristics by cohort
| Measure |
Experimental Condition
n=3739 Participants
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.
Silver Diamine Fluoride: Silver diamine fluoride (SDF)
Fluoride Varnishes: Fluoride varnish (FV)
|
Active Control
n=3679 Participants
Pits and fissures on all bicuspids and molar teeth will be sealed with glass ionomer sealants (GC Fuji IX). Glass ionomer sealants (atraumatic 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.
Fluoride Varnishes: Fluoride varnish (FV)
Glass Ionomer: Glass Ionomer Sealants (GC Fuji IX) and atraumatic restorations
|
Total
n=7418 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.5 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
7.6 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
7.6 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1954 Participants
n=5 Participants
|
2052 Participants
n=7 Participants
|
4006 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1785 Participants
n=5 Participants
|
1627 Participants
n=7 Participants
|
3412 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
88 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
650 Participants
n=5 Participants
|
596 Participants
n=7 Participants
|
1246 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1766 Participants
n=5 Participants
|
1882 Participants
n=7 Participants
|
3648 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
86 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
67 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
56 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unreported
|
1026 Participants
n=5 Participants
|
1016 Participants
n=7 Participants
|
2042 Participants
n=5 Participants
|
|
Number of participants with untreated tooth decay
|
1016 Participants
n=5 Participants
|
964 Participants
n=7 Participants
|
1980 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Two yearsPopulation: The study was suspended after initial enrollment and treatment in response to COVID-19. The number of subjects for this outcome subsequently reflects only those enrolled before COVID-19 suspensions and successfully completed a follow-up procedure two years later.
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).
Outcome measures
| Measure |
Experimental Condition
n=193 Participants
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.
Silver Diamine Fluoride: Silver diamine fluoride (SDF)
Fluoride Varnishes: Fluoride varnish (FV)
|
Active Control
n=220 Participants
Pits and fissures on all bicuspids and molar teeth will be sealed with glass ionomer sealants (GC Fuji IX). Glass ionomer sealants (atraumatic 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.
Fluoride Varnishes: Fluoride varnish (FV)
Glass Ionomer: Glass Ionomer Sealants (GC Fuji IX) and atraumatic restorations
|
Non-treated Schools
Schools that were eligible for the study but not enrolled or randomized
|
|---|---|---|---|
|
Proportion of Subjects With All Caries Arrested
|
108 Participants
|
101 Participants
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental Condition
n=2063 Participants
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.
Silver Diamine Fluoride: Silver diamine fluoride (SDF)
Fluoride Varnishes: Fluoride varnish (FV)
|
Active Control
n=2037 Participants
Pits and fissures on all bicuspids and molar teeth will be sealed with glass ionomer sealants (GC Fuji IX). Glass ionomer sealants (atraumatic 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.
Fluoride Varnishes: Fluoride varnish (FV)
Glass Ionomer: Glass Ionomer Sealants (GC Fuji IX) and atraumatic restorations
|
Non-treated Schools
Schools that were eligible for the study but not enrolled or randomized
|
|---|---|---|---|
|
Prevalence of Dental Caries as Measured by a Clinical Oral Examination
|
10.2 # of caries per 1000 tooth years
|
9.8 # of caries per 1000 tooth years
|
—
|
SECONDARY outcome
Timeframe: Six months after initial treatment.Population: The study was suspended after initial enrollment and treatment in response to COVID-19. The number of subjects for this outcome subsequently reflects only those enrolled until initial suspension and randomly selected to complete the COHIP-SF scale.
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.
Outcome measures
| Measure |
Experimental Condition
n=111 Participants
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.
Silver Diamine Fluoride: Silver diamine fluoride (SDF)
Fluoride Varnishes: Fluoride varnish (FV)
|
Active Control
n=49 Participants
Pits and fissures on all bicuspids and molar teeth will be sealed with glass ionomer sealants (GC Fuji IX). Glass ionomer sealants (atraumatic 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.
Fluoride Varnishes: Fluoride varnish (FV)
Glass Ionomer: Glass Ionomer Sealants (GC Fuji IX) and atraumatic restorations
|
Non-treated Schools
Schools that were eligible for the study but not enrolled or randomized
|
|---|---|---|---|
|
Oral Health-Related Quality of Life
|
14.62 Total COHIP-SF score
Standard Deviation 11.90
|
16.47 Total COHIP-SF score
Standard Deviation 11.09
|
—
|
SECONDARY outcome
Timeframe: 4 years after initial baseline observationPopulation: For this outcome schools were assessed for attendance, individual level data was not collected.
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.
Outcome measures
| Measure |
Experimental Condition
n=18 Schools
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.
Silver Diamine Fluoride: Silver diamine fluoride (SDF)
Fluoride Varnishes: Fluoride varnish (FV)
|
Active Control
n=19 Schools
Pits and fissures on all bicuspids and molar teeth will be sealed with glass ionomer sealants (GC Fuji IX). Glass ionomer sealants (atraumatic 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.
Fluoride Varnishes: Fluoride varnish (FV)
Glass Ionomer: Glass Ionomer Sealants (GC Fuji IX) and atraumatic restorations
|
Non-treated Schools
n=15 Schools
Schools that were eligible for the study but not enrolled or randomized
|
|---|---|---|---|
|
School Attendance
|
-.037 Beta coefficient comparing exp to ctl
Interval -0.062 to -0.011
|
-.037 Beta coefficient comparing exp to ctl
Interval -0.062 to -0.011
|
0 Beta coefficient comparing exp to ctl
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 4 years after initial baseline observationPopulation: Data were not available to be collected due to COVID-19
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.
Outcome measures
Outcome data not reported
Adverse Events
Experimental Condition
Active Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place