Dental Caries, Quality of Life
Conditions
Keywords
dental caries, caries arrest, caries prevention, quality of life, silver diamine fluoride, sealants, interim therapeutic restorations, student achievement, school attendance
Brief summary
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.
Detailed description
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.
Interventions
DEVICESilver Diamine Fluoride
Silver diamine fluoride (SDF)
DEVICEFluoride Varnishes
Fluoride varnish (FV)
DEVICEGlass Ionomer
Glass Ionomer Sealants (GC Fuji IX)
Sponsors
Patient-Centered Outcomes Research Institute
Boston University
New York City Department of Health and Mental Hygiene
NYU College of Dentistry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The investigators responsible for analyzing the data for primary outcomes will be masked.
Intervention model description
Two-arm, parallel, non-inferiority cluster randomized trial
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
Yes
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 3,739 |
| 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 | 3,679 |
| Total | 7,418 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1,676 | 1,642 |
Baseline characteristics
| Characteristic | Experimental Condition | Active Control | Total |
|---|---|---|---|
| Age, Continuous | 7.5 years STANDARD_DEVIATION 1.9 | 7.6 years STANDARD_DEVIATION 1.9 | 7.6 years STANDARD_DEVIATION 1.9 |
| Number of participants with untreated tooth decay | 1016 Participants | 964 Participants | 1980 Participants |
| Race/Ethnicity, Customized Asian | 88 Participants | 37 Participants | 125 Participants |
| Race/Ethnicity, Customized Black | 650 Participants | 596 Participants | 1246 Participants |
| Race/Ethnicity, Customized Hispanic | 1766 Participants | 1882 Participants | 3648 Participants |
| Race/Ethnicity, Customized Multiple | 67 Participants | 47 Participants | 114 Participants |
| Race/Ethnicity, Customized Other | 56 Participants | 34 Participants | 90 Participants |
| Race/Ethnicity, Customized Unreported | 1026 Participants | 1016 Participants | 2042 Participants |
| Race/Ethnicity, Customized White | 86 Participants | 67 Participants | 153 Participants |
| Sex: Female, Male Female | 1954 Participants | 2052 Participants | 4006 Participants |
| Sex: Female, Male Male | 1785 Participants | 1627 Participants | 3412 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3,739 | 0 / 3,679 |
| other Total, other adverse events | 0 / 3,739 | 0 / 3,679 |
| serious Total, serious adverse events | 0 / 3,739 | 0 / 3,679 |
Outcome results
Primary
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental Condition | Prevalence of Dental Caries as Measured by a Clinical Oral Examination | 10.2 # of caries per 1000 tooth years |
| Active Control | Prevalence of Dental Caries as Measured by a Clinical Oral Examination | 9.8 # of caries per 1000 tooth years |
90% CI: [0.82, 1.08]
Primary
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
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 before COVID-19 suspensions and successfully completed a follow-up procedure two years later.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Condition | Proportion of Subjects With All Caries Arrested | 108 Participants |
| Active Control | Proportion of Subjects With All Caries Arrested | 101 Participants |
95% CI: [-0.22, 0.01]
Secondary
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
Population: Data were not available to be collected due to COVID-19
Secondary
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.
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Condition | Oral Health-Related Quality of Life | 14.62 Total COHIP-SF score | Standard Deviation 11.9 |
| Active Control | Oral Health-Related Quality of Life | 16.47 Total COHIP-SF score | Standard Deviation 11.09 |
Secondary
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
Population: For this outcome schools were assessed for attendance, individual level data was not collected.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental Condition | School Attendance | -.037 Beta coefficient comparing exp to ctl |
| Active Control | School Attendance | -.037 Beta coefficient comparing exp to ctl |
| Non-treated Schools | School Attendance | 0 Beta coefficient comparing exp to ctl |