跳至主要内容
临床试验/NCT00066963
NCT00066963已完成3 期

Comprehensive Oral Health Center for Discovery: New Strategies for Enhancing Tissue Integrity and Repair Early Childhood Caries: Prevention and Treatment Outcomes

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 376 人开始时间: 2002年10月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
376
试验地点
1
主要终点
Number of Caries Incident Cases

研究概览

简要总结

The purpose of this study is to compare the efficacy of fluoride varnish (FV) applied once or twice a year with counseling to counseling alone in preventing early childhood caries (ECC) (tooth decay in children under the age of five).

详细描述

This project was a prospective, randomized clinical trial (RCT) among initially caries-free children from about six months old (when primary teeth erupt) up to age three at two public health facilities in San Francisco, one serving a primarily Latino and one a primarily Asian population. The RCT 1) Compared the efficacy of once or twice/year fluoride varnish (FV) application and counseling to counseling alone in preventing early childhood caries (ECC); 2) Assessed pre-intervention salivary markers (biologic and chemical), behavioral and demographic factors as predictors of ECC; 3) Compared the efficacy of these interventions between sites serving different ethnic populations with a high prevalence of ECC; and 4) Determined the salivary fluoride release profile following exposure to fluoride varnish.

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
6 Months 至 36 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children < 44 months old
  • •Caries-free
  • •4 erupted maxillary incisors
  • •Residing in fluoridated community (San Francisco)
  • •Cleft Palate
  • •Developmental or learning disabilities
  • •Children with transient residence (homeless, migrant, foster home)
  • •Children with an another household member participating in the study

排除标准

  • 未提供

研究组 & 干预措施

Counseling Only

No Intervention

Counseling Only

FV every 12mo for 24mo + Counsel

Experimental

Preventive fluoride varnish every 12mo for 24mo plus Counseling

干预措施: Fluoride Varnish (Device)

FV every 6mo for 24mo + Counseling

Experimental

Preventive fluoride varnish every 6mo for 24mo plus Counseling

干预措施: Fluoride Varnish (Device)

结局指标

主要结局

Number of Caries Incident Cases

时间窗: two years

A trained, calibrated dentist blinded to treatment arm performed visual-tactile dental exams at 1 and 2 years post-baseline. Group-specific number of incident cases were reported as the number of individual participants with caries at a follow-up visit.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验