Silver Diamine Fluoride Versus Therapeutic Sealants for the Arrest and Prevention of Dental Caries in Low-income Minority Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,418
- 试验地点
- 2
- 主要终点
- Proportion of Subjects With All Caries Arrested
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The investigators responsible for analyzing the data for primary outcomes will be masked.
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Proportion of Subjects With All Caries Arrested
时间窗: 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
时间窗: 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.
次要结局
- Oral Health-Related Quality of Life(Six months after initial treatment.)
- School Attendance(4 years after initial baseline observation)
- Academic Performance(4 years after initial baseline observation)
研究者
Richard Niederman
Professor
NYU College of Dentistry