EVALUATION OF AN ALTERNATIVE TECHNIQUE FOR THE APPLICATION OF SODIUM FLUOROPHOSPHATE: A 2-YEARS DOUBLE-BLIND RCT
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Caries incidence reduction
研究概览
简要总结
he study was designed as a double-blind three-parallel-group randomized controlled trial, in which the evaluators and a researcher, not involved in the evaluation process, was responsible for the randomization process, were masked to the group assignment.
The study will be carried out at 2 schools of the Metropolitan Area of Buenos Aires where school programs are developed by the Department of Preventive and Community Dentistry of the University of Buenos Aires, and that present homogeneous characteristics in terms of social risk. The children (n=244) attending those primary schools will be the population object of the trial.
Clinical examinations
Each child will go under a clinical examination to determine dental status according to the ICDAS II criteria (Pitts, 2005) and the Caries Treatment Need Index (CTNI).
Intervention
Children will be divided into three different groups according to the mode of treatment:
- NaF varnish group (NaFV) Professional application of 5% NaF varnish twice a year pH 7 (ClinPro White Varnish®) according to manufacturer's instructions.
- APF in tray Group (APFt) Professional application of APF 1.23% twice a year pH 3.5 (Klepp®) with tray according to manufacturer's instructions
- APF in toothbrush group (APFtbru) Professional application of APF 1.23% twice a year pH 3.5 (Klepp®) with toothbrush 2 minutes brushing according to manufacturer's instructions.
Dental examination and Monitoring
Observations and clinical examinations will be conducted at schools. After 12 and 24 months, the clinical examination will be repeated to assess the dental status of schoolchildren following the same criteria described. The presence of new caries lesions will be taken as a dependent variable. So sound surfaces on baseline will be observed for 24 months.
详细描述
The study was designed as a double-blind three-parallel-group randomized controlled trial, in which the evaluators and a researcher, not involved in the evaluation process, was responsible for the randomization process, were masked to the group assignment.
The study will be carried out at 2 schools of the Metropolitan Area of Buenos Aires where school programs are developed by the Department of Preventive and Community Dentistry of the University of Buenos Aires, and that present homogeneous characteristics in terms of social risk. The children (n=244) attending those primary schools will be the population object of the trial.
All parents/caregivers of the children will receive a leaflet requesting the approval to enroll their children; for those families that decide not to be included into the trial, the children will receive the dental treatment needed but their data will not be evaluated.
The inclusion criteria were children between 4 and 11 years old attending the selected schools. Exclusion criteria: Children with systemic diseases or systemic disease treatments, motor disorders and children receiving preventive measures in other public, private, or social security dental services.
Clinical examinations
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 6 Years 至 8 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Schoolchildren
排除标准
- 未提供
研究组 & 干预措施
Varnish
干预措施: Fluoride (Combination Product)
FFA gel
干预措施: Fluoride (Combination Product)
FFA toothbrush
干预措施: Fluoride (Combination Product)
结局指标
主要结局
Caries incidence reduction
时间窗: 24 months
次要结局
未报告次要终点
研究者
ALDO SQUASSI
Chairman Dept. Preventive and Community Dentistry
University of Buenos Aires
