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临床试验/NCT01310283
NCT01310283已完成不适用

Caries Management by Risk Assessment in Children

University of California, San Francisco4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
4
主要终点
new decayed surfaces

研究概览

简要总结

The goal of this study is to address the effectiveness of a modified cavity prevention protocol for 5-9 year-old children which emphasizes better diet modification, more frequent professional fluoride applications, and xylitol product usage based on individual risk status in a 1-year randomized controlled clinical trial in the University of California, San Francisco (UCSF) Tenderloin Community Pediatric Dental Clinic. The investigators hypothesize that the regimen will help to reduce new cavities in children who are at risk for dental cavities.

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients of record at the UCSF Pediatric Dental Clinic, or the UCSF Tenderloin Community Pediatric Dental Clinic, and must be:
  • Patients of record at the Tenderloin community and UCSF pediatric dental clinics
  • 5-9 years old
  • Be able to give informed assent, consent and answer questionnaires in English, Spanish or Chinese by parents or guardian
  • Be unlikely to move from the area during the study period
  • Be willing to participate regardless of group assignment and comply with all study procedures

排除标准

  • Persons with:
  • Prolonged antibiotic use in the past three months.
  • Dental needs outside of the community pediatric clinics, such as care provided in specialty clinics

结局指标

主要结局

new decayed surfaces

时间窗: 1 year

次要结局

  • cariogenic bacteria levels(6 month and 1 year)

研究者

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

Ling Zhan

Asisstant professor in residence

University of California, San Francisco

研究点 (4)

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