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临床试验/NCT00497029
NCT00497029已完成不适用

Early Childhood Caries Prevention at a Pediatric Clinic

University of Maryland, Baltimore2 个研究点 分布在 1 个国家目标入组 219 人开始时间: 2004年6月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
219
试验地点
2
主要终点
dmfs scores

研究概览

简要总结

This purpose of this study was to evaluate effectiveness of a risk-based dental caries prevention program conducted by dental personnel at an urban pediatric primary care clinic serving largely low-income residents of Baltimore, Maryland, and to appraise this program as a model for similar urban pediatric settings.

详细描述

A demonstration caries prevention trial lasting 26 months was conducted with a total of 219 children aged 6 to 27 months of age. The "prevention" group consisting of children 6-15 months of age at their initial visit were compared at the end of the trial with a "comparison" group at their initial visit. The comparison group was 12 months older than the enrollment age of the prevention group (18-27 months) and had not received previous routine professional dental care. Interventions were dental examination and periodic recalls, caries-risk assessments, monitoring of oral mutans streptococci (MS) levels, application of 5.0% sodium fluoride varnish to teeth, dental health counseling to care-givers, referral for dental treatment if indicated and periodic recalls.

Outcome measures were: 1) number of decayed, missing, filled primary tooth surfaces, 2) number of pre-carious lesions, 3) counts of oral MS and 3) care-giver responses to a questionnaire about the child's diet and home care.

Prevention group children at the last recall experienced fewer mean carious dental surfaces (0.1 vs. 1.29, p<0.014) and over 8-fold less MS (p<0.013) than comparison group subjects at the initial visit. The number of precarious lesions, however, were not significantly different. In the absence of carious or precarious lesions, oral levels of MS was a reliable indicator of caries risk status, particularly for low risk subjects (sensitivity, 0.64; specificity, 0.98). Caregiver reports of dietary practices and presence or absence of visible dental plaque also served as caries-risk determinants.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
6 Months 至 27 Months(Child)
性别
All
接受健康志愿者

入选标准

  • children in good health who were dentate and 6-27 months
  • a signed informed consent

排除标准

  • antibiotic usage within the previous 14 days
  • oral topical fluoride administration within the previous 7 days
  • previous routine professional dental care

结局指标

主要结局

dmfs scores

时间窗: 12 months

次要结局

  • caries-preventive behaviors by care-givers(12 months)

研究者

申办方类型
Other

研究点 (2)

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