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临床试验/NCT02521688
NCT02521688已完成不适用

Inflammatory Cytokines in Gingival Crevicular Fluid and Placental Tissues in Chronic Periodontitis Patients With Preterm Delivery

Ain Shams University0 个研究点目标入组 40 人开始时间: 2013年8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
40
主要终点
Proinflammatory cytokine level

研究概览

简要总结

Investigators have shown the presence of elevated proinflammatory cytokines in amniotic fluid in patients in preterm labor.However, there is limited and mostly negative evidence that the elevation of these mediators in gingival crevicular fluid (GCF), and amniotic fluid are associated with pregnancy complications in periodontitis patients. Thus this case control study will be conducted to

  1. To determine the level of proinflammatory cytokines in gingival crevicular fluid in women with spontaneous preterm delivery with chronic periodontitis.
  2. To investigate the expression of macrophage inflammatory protein-1α in placental tissues.
  3. To assess the possible correlation between chronic periodontitis and preterm delivery.

详细描述

Periodontal disease is a commonGram-negative chronic anaerobic infection of the periodontium, with an estimatedworld prevalence of 10% to 15% (Genco RJ, et al. 1992, Petersen PE & Ogawa H. 2005). It Involves both direct tissue damage resulting from plaque bacterial products, and indirect damage via host inflammatory and immune responsesmediated by interactions between numerous cell populations and inflammatory mediators (Yucel-Lindberg T&Båge T.2013).

Periodontal infections have been associated with different systemic diseases; cardiovascular disease, cerebrovascular disease, diabetes mellitus, respiratory infections and others including osteoporosis, cancer, rheumatoid arthritis, erectile dysfunction, Alzheimer's disease, gastrointestinal disease, prostatitis and renal diseases(Gulati M, et al. 2013). Moreover, many investigators have reported an association between periodontal disease and adverse pregnancy outcomes, including preterm birth, low birth weight, foetal growth restriction, preeclampsia and perinatal mortality (Ide M&Papapanou PN.2013).

Preterm birth, defined as a live birth before 37 weeks of gestation, is the leading cause of infant mortality in both developed and developing countries (Saigal S & Doyle LW. 2008), whether following spontaneous preterm labour, premature rupture of membranes, or caesarean section due to foetal distress or maternal medical conditions (Goldenberg RL, et al. 2008).The World Health Organization has recently estimated that annually 12.9 million or 9.6% of all children are born preterm worldwide, despite extensive research and public health efforts(Beck S, et al. 2010).

Major causes for preterm birth are intra-amniotic infections which subsequently cause inflammation, as well as sterile inflammation (Madan I, et al 2010). Moreover, smoking, alcohol consumption, black race, low socio-economic status, low or high maternal body mass index, stress, previous preterm birth, advanced maternal age and short cervix are other associated risk factors (DjelantikA, et al. 2012).

Offenbacher et al in 1996 first hypothesized that gram-negative anaerobic pathogens from periodontium and associated endotoxins and maternal inflammatory mediators could have a possible adverse effect on the developing fetus (Offenbacher S, et al. 1996), whether through translocation of periodontal pathogens to the feto-placental unit or the action of the periodontal reservoir of inflammatory mediators, which elaborated at the remote site of infection and trigger prostaglandins synthesis, resulting in cervical dilation, entry of more microbes into the uterus, and continuation of the "viscous cycle" resulting in premature birth (Gibbas RS, 2001).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Undergoing spontaneous term delivery (TD) at ≥37 weeks of gestation without any obstetrical or medical complications or spontaneous preterm delivery (PTD)at< 37 weeks of gestation after uterine contraction or rupture of membranes(Keelan JA, et al. 1999).
  • With a body mass index (BMI) ranged from 19-
  • Having no systemic disease as evidenced by Burkett's oral medicine health history questionnaire (Glick et al, 2008).

排除标准

  • Mothers receiving antibiotics or corticosteroids during last three months of pregnancy or at delivery.
  • Current Smokers and drug abusers or stopped from period shorter than 6 months.
  • Mothers with urinary tract infection, vulvovaginal infection, previous preterm birth, or any othermedical disorder associated with pregnancy as obtained from patient's record.

结局指标

主要结局

Proinflammatory cytokine level

时间窗: 1 year

MIP, TNF, Pentrixin 3 measured in placental tissue homogenate and in GCF

次要结局

未报告次要终点

研究者

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

Ola Mohamed Ezzatt

lecturer of oral medicine and periodontology

Ain Shams University

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