Comparison of the Effectiveness and Feasibility of Two Fluoride Therapies for Caries Management in Early Childhood: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 814
- 试验地点
- 3
- 主要终点
- one-year proportion of children with new cavities and mean number of new cavities (preventive effect)
研究概览
简要总结
The aim of this study is to compare the effectiveness and feasibility of using silver diamine fluoride solution (SDF) vs. sodium fluoride varnish (NaF) for caries management in children from Bogotá (and its suburban areas) and Cartagena, in terms of: 1. Preventive effect: number of carious dental surfaces (cavitated); 2. Arrest effect: number of arrested carious tooth surfaces (cavitated); 3. Presence and number of adverse effects in soft/hard oral tissues.
Null hypothesis: Effectiveness and feasibility of silver diamine fluoride is superior to the sodium fluoride for caries management:
Alternative hypothesis: Effectiveness and feasibility of silver diamine fluoride is not superior to the sodium fluoride for caries management.
This Randomize Clinical Trial included 752 3-4 year-old medically healthy children from Bogotá and Cartagena. Participants were randomized equality distributed per city to receive either SDF (38%) or NaF (5%) biannually. Primary outcomes: cavity prevention and arresting effect. Secondary: feasibility (adherence, fidelity), dental-care parental satisfaction/acceptance and adverse effects. Data were analysed using t-tests, Chi-square, and Generalized estimating equations -GEE (0.05 statistical significance).
详细描述
Ethical approval obtained from the Ethics Board at Universidad El Bosque (UEB 2022-11045).
It corresponds to a double-blind randomised controlled clinical trial following the Consolidated Standards of Reporting and Trials Checklist (CONSORT) 2010.
Population: 3-4-year-old children from (Bogotá and Cartagena) with good self-reported general health.
Sample size was calculated according to the protocols of Gao et al. and Chu et al. [20,21] (using Program-Sample-Size®, version 1.1), considering type-I error: 0.05; type-II error: 0.10; standard deviation: 0.87; expected average group-1: 0.47, group-2: 0.70. The determined sample size was of n=601, increasing due to possible losses by 25% (n=151) for a total sample size of n=752, equally divided in n=376 per arm (Bogotá/Cartagena).
Once the informed consent is signed by the parents, a comprehensive examination will be performed, including:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •3-4-year-old children (from Bogotá/Cartagena)
- •Informed consent signed.
- •Self-reported good general health (parents)
排除标准
- •Intention to move in the next 12 months
- •Systemic disease, physical/mental disability
- •Regularly medication intake
- •Non-cooperative children
结局指标
主要结局
one-year proportion of children with new cavities and mean number of new cavities (preventive effect)
时间窗: 12 months
The one-year proportion of children with new cavities and the mean number of new cavities reflect the preventive effect of the intervention. These measures help assess how effective the dental treatments (NaF or SDF) were in preventing the development of new carious lesions over the course of the year. Proportion of children with new cavities: This refers to the percentage of children who developed new carious lesions (cavities) after one year, compared to the total number of children initially assessed. A lower proportion suggests that the intervention was effective in preventing new cavities. Mean number of new cavities: This refers to the average number of new cavities per child in the intervention group. A lower mean number of new cavities indicates a stronger preventive effect, showing that fewer cavities developed over the year in the group that received the intervention.
one-year proportion of children with inactive cavities and mean number of inactive cavities (arresting effect)
时间窗: 12 months
The one-year proportion of children with inactive cavities and the mean number of inactive cavities reflect the "arresting effect" of the intervention. These metrics assess how effective the treatment (NaF or SDF) was in halting the progression of existing carious lesions, potentially leading to arrested or inactive cavities. Proportion of children with inactive cavities: This refers to the percentage of children who had cavities that became inactive (arrested) after one year. Inactive cavities are characterized by hard, shiny surfaces, indicating that the decay process has stopped. A higher proportion suggests that the intervention was effective in arresting caries progression. Mean number of inactive cavities: This refers to the average number of cavities per child that became inactive over the course of one year. A higher mean number of inactive cavities indicates that a greater number of cavities were successfully arrested in the intervention group.
次要结局
- Feasibility at one year, in terms of adherence (number of participants recruited and retained)(12 months)
- Feasibility at one year, in terms of fidelity (number of participants not receiving a different intervention)(12 months)
- Number of participants with adverse oral soft tissue effects (one day after the first intervention and after one year)(1 day and 12 months)
- Satisfaction/acceptance of parents' children with caries care after the first intervention(12 months)
- Child's self-reported pain(After the dental intervention)
- Child's behaviour (during the procedure)(During the dental intervention)
研究者
Stefania Martignon
Principal Investigator
Universidad El Bosque, Bogotá