Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,060
- 试验地点
- 2
- 主要终点
- Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline
研究概览
简要总结
An intensive intervention of specially trained paraprofessionals, called community oral health specialists (COHS), administering on a quarterly basis for 2 years fluoride varnish and oral health promotion education, compared to usual care, will reduce decayed, missing, and filled tooth surface measures at 2 years for children in American Indian Head Start Programs.
详细描述
The study design will be a clustered randomized design. Fifty-two head start classes in a Southwest American Indian Reservation will be randomized, 26 to the intervention program and 26 to usual care. The intervention will be comprised of specially trained paraprofessionals, called community oral health specialists (COHS), administering fluoride varnish and oral health promotion education quarterly for 2 years. Baseline and annual measures of decayed, missing, and filled tooth surfaces (dmfs) of the children, and surveys of their caregivers' dental knowledge, attitudes, and behaviors will be completed. The study will be a 5-year study, with 2 years for intake/accrual, and 3 years of follow-up.
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)
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children ages 3-5 enrolled in Head Start Centers on a Southwest Indian Reservation and having a primary caregiver (preferably mother, or the child's legal guardian as documented by the HSC)
- •American Indian, as defined by the tribe, or
- •Children of other racial/ethnic groups who are in the Head Start classes on the Reservation
- •Parent/caregiver able to read, understand, and sign the study consent form, and
- •Willing and able to follow the study procedures and instructions
排除标准
- •Allergy to any of the components of the fluoride varnish
- •Ulcerative gingivitis
- •Stomatitis
- •Other conditions resulting in disrupted or irritated oral mucosa
- •Any other conditions or findings that, in the opinion of the investigators, would interfere with or preclude participation in the study.
结局指标
主要结局
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline
时间窗: Baseline
The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries.
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 1
时间窗: 1 Year
The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries.
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2
时间窗: 2 Years
The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries.
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3
时间窗: 3 Years
The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries.
次要结局
- Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children(Over 3 years)
- Evaluation of Caries Patterns(Over 3 years)
- Comparison of Utilization and Costs of Dental Care(Up to 3 years after randomization)
- Acquisition of Dental Knowledge of the Caregivers of the Children(Over 3 years)