Dental Caries
Conditions
Keywords
dental caries, caries arrest, caries prevention, silver diamine fluoride, sealants, interim therapeutic restorations
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 Hampshire.
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 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.
Interventions
DEVICESilver Diamine Fluoride
Silver diamine fluoride (SDF)
DEVICEFluoride Varnishes
Fluoride varnish (FV)
DEVICEGlass Ionomer
Glass Ionomer Sealants (GC Fuji IX)
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Arrested Dental Caries, Assessed Using a Clinical Oral Examination | Two years | For any participants with untreated dental caries on teeth at baseline treated with SDF/FV or Glass ionomer atraumatic restorative treatment (ART)/FV to arrest (control) the infection, what is the proportion of participants that stayed arrested |
| Caries Prevention | Five years | For teeth without carious lesions (sound teeth) treated with SDF/FV or Glass ionomer/FV, how many teeth developed caries over the course of observation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Simple Prevention 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) | 1,558 |
| Complex Prevention 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/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) | 1,787 |
| Total | 3,345 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 229 | 258 |
Baseline characteristics
| Characteristic | Simple Prevention | Complex Prevention | Total |
|---|---|---|---|
| Age, Continuous | 7.0 years STANDARD_DEVIATION 1.8 | 7.3 years STANDARD_DEVIATION 1.8 | 7.2 years STANDARD_DEVIATION 1.8 |
| Baseline untreated decay | 221 Participants | 276 Participants | 497 Participants |
| Race/Ethnicity, Customized Asian | 10 Participants | 19 Participants | 29 Participants |
| Race/Ethnicity, Customized Black | 16 Participants | 14 Participants | 30 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 13 Participants | 23 Participants | 36 Participants |
| Race/Ethnicity, Customized Multiple | 10 Participants | 9 Participants | 19 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 9 Participants | 10 Participants |
| Race/Ethnicity, Customized Unreported | 1162 Participants | 1191 Participants | 2353 Participants |
| Race/Ethnicity, Customized White | 346 Participants | 522 Participants | 868 Participants |
| Sex: Female, Male Female | 784 Participants | 808 Participants | 1592 Participants |
| Sex: Female, Male Male | 774 Participants | 979 Participants | 1753 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,558 | 0 / 1,787 |
| other Total, other adverse events | 0 / 1,558 | 0 / 1,787 |
| serious Total, serious adverse events | 0 / 1,558 | 0 / 1,787 |
Outcome results
Primary
Caries Prevention
For teeth without carious lesions (sound teeth) treated with SDF/FV or Glass ionomer/FV, how many teeth developed caries over the course of observation
Time frame: Five years
Population: The analysis population includes the total number of teeth in each participant in each group. Thus, the overall number of units analyzed will be greater than the number in participant flow (participant flow reflects individuals participating in the study).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Simple Prevention | Caries Prevention | 210 teeth |
| Complex Prevention | Caries Prevention | 179 teeth |
Primary
Number of Participants With Arrested Dental Caries, Assessed Using a Clinical Oral Examination
For any participants with untreated dental caries on teeth at baseline treated with SDF/FV or Glass ionomer atraumatic restorative treatment (ART)/FV to arrest (control) the infection, what is the proportion of participants that stayed arrested
Time frame: Two years
Population: The analysis population are those participants who completed the study and had dental caries at baseline. This population is a subset of the full study population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Simple Prevention | Number of Participants With Arrested Dental Caries, Assessed Using a Clinical Oral Examination | 48 Participants |
| Complex Prevention | Number of Participants With Arrested Dental Caries, Assessed Using a Clinical Oral Examination | 53 Participants |