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临床试验/NCT04101617
NCT04101617已完成不适用

Cooperation Between Dentists and Pediatricians to Improve Dental Health Among Toddlers in the Dominican Republic

Universidad Iberoamericana1 个研究点 分布在 1 个国家目标入组 306 人开始时间: 2019年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
306
试验地点
1
主要终点
Dental caries status

研究概览

简要总结

Caries prevalence in the Dominican Republic (DR) seems high, although recent information is lacking. In DR there is a growth and development program for all children from the age of 0 to 5.Even though there is a mandatory educational health program for children and parents in this program, where periodically pediatricians examine them, this program does not include oral health education/prevention. Thus, it is proposed A) to devise materials to be used by pediatricians to share relevant information about caries control to parents of toddlers, and B) to evaluate the impact of such material on caries prevention for groups of toddlers over a 1.5-year period. Educational material will be developed for parents, and the pediatricians will deliver this material to 10-months-old children randomly selected at Plaza de la Salud Hospital. The PI will train the pediatricians in caries prevention and how to deliver the information to the parents in a clear manner. A total of 306 will be allocated into two groups. The experimental group (128 children) will receive the devised educational materials at 10 months, follow-up information will be provided at growth and development visits when the child is 18-, and 24 months old. The second group will be considered as the control group and will not receive any educational materials (178 children). All the enrolled children will receive fluoride containing toothpaste and tooth brushes. After 18 months when the children will be about 3 years old they will be examined to assess dental caries status. A sample mortality rate of 40% is expected during the two-year follow-up. Differences in caries status between the two groups will be examined using Welch's independent t-tests for unequal variances.

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, Outcomes Assessor)

入排标准

年龄范围
10 Months 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy children
  • Parents agreed to participate in the program

排除标准

  • 未提供

结局指标

主要结局

Dental caries status

时间窗: Up to ten months

Detection of dental caries lesions using the International Caries Detection and Assessment System (ICDAS) criteria.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ninoska Abreu Placeres

Researcher

Universidad Iberoamericana

研究点 (1)

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