"Periodontal Disease as a Possible Risk Factor for Complications During Pregnancy and Childbirth
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- CAOD
研究概览
简要总结
Pregnancy is a physiological state that is part of the reproductive life of women, establishing their fertile age between 15 and 45 years mainly. This stage will not only mark the birth of the baby but also cause various changes both immunological and physiological, to accommodate the growing fetus.
Maternal periodontitis has direct and indirect potential to influence the health of the fetus-maternal unit. According to the literature reviewed, the first evidence that oral bacteria influenced pregnancy outcomes was reported by Collins et al. The injection of P. gingivalis into pregnant hamsters caused intrauterine growth retardation and smaller fetuses, together with an increase in the levels of proinflammatory mediators (IL-1b and PGE2) in the amniotic fluid.
Two hypotheses have been pointed out regarding the link between oral health and the adverse outcome of pregnancy. The first states that periodontal disease causes abnormal systemic immune changes, leading to complications in pregnancy. While the second hypothesis suggests that oral bacteria directly colonize the placenta, causing localized inflammatory responses, resulting in prematurity and other adverse outcomes.
详细描述
Pregnancy is a physiological state that is part of the reproductive life of women, establishing their fertile age between 15 and 45 years mainly. This stage will not only mark the birth of the baby but also cause various changes both immunological and physiological, to accommodate the growing fetus. In Spain, according to the Spanish National Institute of Statistics (INE), a total of 195,555 births were registered in 2017.
However the arrival of the birth sometimes has adverse results for the mother and baby, such as low birth weight (<2500 g), premature birth (<37 weeks), growth restriction (weight for gestational age), preeclampsia, spontaneous abortion and / or inanimate birth. Some of these results occur together, and it is not clear if they share common mechanisms.
According to the WHO, every year around 15 million babies are born in the world before they reach term, that is, more than 1 in 10 births. Of them approximately, one million premature children die every year due to complications in childbirth. As well as every day about 830 women die from complications related to pregnancy or childbirth. While 75% of maternal deaths are due, among other causes, to gestational hypertension (preeclampsia and eclampsia).
The most common risk factor associated with premature birth is the previous history of premature birth. Other less prevalent factors are the short interval between pregnancies, assisted reproduction procedures, multiple gestation and infectious diseases such as periodontitis.
Maternal periodontitis has direct and indirect potential to influence the health of the fetus-maternal unit. According to the literature reviewed, the first evidence that oral bacteria influenced pregnancy outcomes was reported by Collins et al. The injection of P. gingivalis into pregnant hamsters caused intrauterine growth retardation and smaller fetuses, together with an increase in the levels of proinflammatory mediators (IL-1b and PGE2) in the amniotic fluid.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women over 12 weeks.
- •Pregnant women who consent to participate in the study by signing informed consent.
排除标准
- •Pregnant with less than 6 teeth.
- •Pregnant women who have been treated for Periodontal Disease in the last 6 months. -E Multiple branches.
结局指标
主要结局
CAOD
时间窗: 9 months
CAOD Index: 0: Absent or Great Destruction 1: Caries 2: Closed. It will be calculated: C + A + O.
Bleeding on probing
时间窗: 9 months
Ainamo and Bay index modified for bleeding on probing: when inserting the probe into the groove if: 0- does not bleed; 1-bleed It will be computed according to the following formula: number of bleeding points between the number of points examined per 100.
Presence of plate
时间窗: 9 months
Index of Silness and Löe: If when passing the probe: 0, there is no plate; 1, plate when passing the probe; 2, plate with the naked eye; 3, abundant plaque around the tooth even with tartar. It will be calculated by adding the values obtained for each tooth, among the number of teeth present.
Periodontal insertion level
时间窗: 9 months
Distance of the cementoenamel line to the bottom of the periodontal pocket (probing depth + recession, or probing depth - hyperplasia). It will be measured in 6 sites per tooth (mesial-vestibular, vestibular, disto-vestibular and palatal / lingual-distal, palatal / lingual, palatal / lingual-mesial).
Depth of stock
时间窗: 9 months
Distance from the gingival margin to the bottom of the periodontal pocket (junctional epithelium). It will be measured with a millimetric probe. It will be measured in 6 sites per tooth (mesial-vestibular, vestibular, disto-vestibular and palatal / lingual-distal, palatal / lingual, palatal / lingual-mesial).
Periodontal disease
时间窗: 9 months
Periodontitis was diagnosed when the loss of buccal epithelial attachment (vestibular-palatal) was greater than 3 mm and depth of the pouch greater than or equal to 3 mm in 2 teeth or more.
次要结局
未报告次要终点
研究者
María José Aguilar Cordero
Doctor of science in Nursing
Universidad de Granada