Randomized Efficacy Trial of MySmileBuddy, a Family-centered Behavioral Intervention to Reduce Early Childhood Caries
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Proportion of Participants with Early Childhood Caries Progression
研究概览
简要总结
This study seeks to evaluate the best way to encourage a healthy diet and proper fluoride use in children at greatest risk for tooth decay. To do so, this study will evaluate whether or not a family focused intervention, MySmileBuddy, is able to reduce tooth decay progression in Hispanic preschoolers at high risk of this disease.
详细描述
Tooth decay in young children has traditionally been treated through surgical dental repair, an approach that does not address the oral hygiene and dietary behaviors that cause the disease. Professionals agree that behavioral strategies to prevent tooth decay are needed, but they have not been well studied in Hispanic children in the United States that have disproportionately high rates of this disease. Use of fluoridated toothpaste twice a day and consumption of a healthy diet can both prevent tooth decay and stop it from progressing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 24 Months 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 24 to 71 months of age, have a minimum of 12 teeth present, and have early childhood caries (ECC)
- •Will reside in the New York City (NYC) metropolitan for the following 12 months
- •Parents must be 18 years or older and must report having a cell phone with texting capabilities
排除标准
- •Children with developmental delays or medical conditions that would impede oral dietary intake, at-home oral hygiene practices, or receipt of oral exams
- •Children with parents who are under the age of 18 years of age, do not report having a mobile phone, do not plan to reside in the New York City (NYC) metropolitan area for the following 12 months
- •Children of parents who do not provide consent to participate.
研究组 & 干预措施
MySmileBuddy
Children, aged 24-71 months of age, who have tooth decay will be enrolled, along with their caregiver, and will receive a family-focused intervention called MySmileBuddy.
干预措施: MySmileBuddy (MSB) (Behavioral)
Control
Children, aged 24-71 months of age, who have tooth decay will be enrolled, along with their caregiver, and will not receive any intervention.
结局指标
主要结局
Proportion of Participants with Early Childhood Caries Progression
时间窗: 12 months post-randomization
The number of decayed, missing, or filled teeth (dmft)/decayed filled surfaces (dfs) as a count variable will be measured to determine the proportion of participants who have a positive change in the number of dmft/dfs post-intervention.
Change in Number of Decayed, Missing, or Filled Teeth or Surfaces
时间窗: 12 months post-randomization
Early childhood caries status will be determined by visual examination, assisted by an examination light, mirror, and probe with caries experience defined by number of teeth (t) and surfaces (s) that either have decay (d), are missing due to decay (m), or have had a dental filling (f) due to a cavity.
次要结局
- Change in Twice Daily Fluoridated Toothpaste Use(12 months post-randomization)
- Change in Consumption of a Low Cariogenic Diet(12 months post-randomization)
研究者
Carol Kunzel
Professor of Dental Community Health, Dental Medicine
Columbia University