Effect of Therapeutic Measures in Dental Caries Reduction in Children With Primary Dentition From Metropolitan Area Sorrounded Medellín City. A Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 主要终点
- Dental Caries reduction as if the patient has or not new dental caries.
研究概览
简要总结
The propouse of this study is to evaluate some combined preventive measures, of easy application in children under 6 years old as education, brush teeth, fluoride free tooth paste,fluoridated tooth paste, professional cleaning and fluoride varnish application, to determine between three groups of differents combined preventive measures, wich one is better in reduting dental caries appearance.
Hypothesis:
- Ho: Dental caries reduction percentage is larger or equal in the group with only prevention education and Professional cleaning, than in the groups intercepted with fluoride varnish or fluoride toothpaste.
- Ha: Dental caries reduction percentage is less in the group with only prevention education and Professional cleaning, than in the groups intercepted with fluoride varnish or fluoride toothpaste.
详细描述
Dental caries is a public health problem in any society. Even though caries prevalence has decreased in many industrialized countries, dental caries in the early infancy still has high prevalence in non developing countries. In Colombia as well Medellín, there are not data of dental caries prevalence in children under 5 years old.
The fact that the official studies do not recognize this world tendency and are limited to age groups over 5 years old, underestimate the disease as an early appearing process in life, specially in underprivileged groups. When dental caries is not properly treated, it becomes a risk factor for other systemic and infectious diseases. Early infant dental caries has been strongly related with malnutrition in children under 6 years old; is has been proved that once their dental problem is treated, weight and size are recovered.
Design and implementation of prevention programs for preschool children must be a priority.This study pretends evaluate some combined preventive measures of easy application in children under 6 as education, brush teeth, fluoride free and fluoridated tooth paste, professional cleaning and fluoride varnish application considering this an easy application measure for this group of age, which eventually it could be more cost-effective than the sealant.
The importance of doing new clinical studies to evaluate the efficacy of fluoride varnishes combined with other preventive measures, is supported in most of other studies have used a non treated group or placebo as a control group.12 The evaluation of the non fluoride toothpaste will give us an exact idea of the contribution of each of the preventive measures in dental caries reduction.
In Colombia, there is not doubt that past preventive programs had a positive effect in dental health of school children. However, preschool children have been out of these programs.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 29 Months 至 41 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children since 2.5 and 3.5 years old
- •Deciduous teeth complete formula
- •They are part of Su Salud health Service Company
- •Healthy chlildrens
排除标准
- •children with any mental or fhisical incapacity
结局指标
主要结局
Dental Caries reduction as if the patient has or not new dental caries.
时间窗: Three years with clinical examination every one year.
次要结局
未报告次要终点
研究者
Alexandra Saldarriaga Cadavid Ms
Principal investigator
CES University