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临床试验/NCT00066131
NCT00066131已完成3 期

Effects of Periodontal Therapy on Preterm Birth

University of Minnesota2 个研究点 分布在 1 个国家目标入组 823 人开始时间: 2003年3月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
823
试验地点
2
主要终点
Gestational age at birth

研究概览

简要总结

The purpose of this study is to determine if non-surgical periodontal (gum) treatment can reduce the incidence of preterm birth and low birth weight babies in mothers with periodontitis (gum disease).

详细描述

Eight hundred sixteen women who are between 13 and 16 weeks pregnant will be enrolled in this trial. Volunteers will be recruited from Hennepin County Medical Center (MN), the Jackson Medical Mall (MS), the University of Kentucky, and Harlem (NY) Hospital. The incidence of preterm birth is higher at these sites than the national average. Subjects will be randomly assigned to receive non-surgical mechanical periodontal therapy (scaling and root planing) either prior to 20 weeks of their pregnancy or soon after delivery. All subjects will be monitored for progressive periodontitis and will be treated immediately regardless of their group assignment. All women will also receive essential dental care to restore caries and treat abscessed teeth. The primary birth outcome is gestational age at birth and the secondary outcome is birthweight. Maternal risk factors for preterm birth and/or intrauterine growth restriction will be used as covariates in the data analysis. The study will also document the effect of periodontal therapy on immune response, systemic markers of inflammation, periodontal infection and clinical periodontal measure.

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
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Gestational age at birth

时间窗: At delivery

次要结局

  • Infant birth weight(At delivery)
  • Clinical attachment loss(29-32 weeks of gestation)
  • Bleeding following periodontal probing(29-32 weeks)
  • Periodontal probing depth(29-32 weeks of gestation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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