Periodontal Disease, Inflammatory Markers, and Preterm Birth
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To determine the relationship between periodontal disease and upper genital tract inflammation as measured by cytokine levels IL-6, IL-1, and TNF-α and MMP levels from the posterior fornix of the vagina.
研究概览
简要总结
To determine the relationship between periodontal disease and upper genital tract inflammation in pregnancy. To determine whether certain fluid levels in the oral cavity and the vagina are associated with preterm birth or low-birth weight.
详细描述
Patients will be enrolled in the study at their first prenatal visit after the details of the study have been discussed. Potential subjects will be presented with a questionnaire to determine eligibility for the study. The patient will be scheduled for an exam between 18-24 weeks at which time they will undergo a periodontal assessment, to determine the presence or absence of periodontal disease, a sampling of gingival crevicular fluid (GCF) and a vaginal swab collection. Periodontal disease will be determined by measuring the depth of gingival sulci, amount of periodontal attachment loss, and prevalence of gingival bleeding at six sites for each tooth present.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 15-35
- •Singleton gestation
排除标准
- •Diabetes prior to pregnancy
- •Require antibiotic prophylaxis prior to dental treatment
- •Require steroids during pregnancy
结局指标
主要结局
To determine the relationship between periodontal disease and upper genital tract inflammation as measured by cytokine levels IL-6, IL-1, and TNF-α and MMP levels from the posterior fornix of the vagina.
时间窗: 4 years
次要结局
- To determine whether IL-1β levels in the oral cavity and the vagina are associated with preterm birth or low-birth weight.(4 years)