MOTOR-Maternal Oral Therapy to Reduce Obstetric Risk

描述(由申请人提供)：最近的研究证实，孕妇牙周疾病和导致早产的妊娠并发症之间存在关联[例如，胎龄(GA)和37周：调整后的优势比2.1(CI95%：1.12，4.09)，GA和LT的OR=4.2；28周(CI95%：1.42，12.6)]和胎儿体重下降[例如，在35-37周出生的GA的母亲中，患有牙周病的母亲(4+个部位，5+mm PD和2+mm AL)的新生儿小13.8%(p=0.004)。母亲牙周感染对怀孕的有害影响在非裔美国人中尤其明显，这可能在一定程度上解释了这些不幸并发症发病率差异的部分原因。不仅在怀孕早期存在牙周病会增加风险，而且在怀孕期间牙周病的恶化-一种相对频繁的事件(814次分娩中有35.5%)似乎独立地增加了胎儿接触牙周病原体(如胎儿脐带血抗孕妇口腔病原体IgM抗体)和早产(OR=5.0，CI95%：2.22，11.3)的风险。这些数据表明，牙周病及其进展可能是一种感染性和炎症性暴露，可能在怀孕期间产生严重的有害影响。为了科学地确定牙周病是否与早产有因果关系并具有任何可改变的风险，关键是要证明治疗孕妇的牙周病可以减少早产和生长受限的发生率。我们的中心假设是，患有牙周炎的母亲在怀孕中期接受牙周治疗将经历较低的早产率和较高的早产儿平均出生体重。我们建议进行一项为期5年的随机、双臂临床试验，在3个医疗/牙科中心(北卡罗来纳大学/杜克大学、UAB和UTHSCSA)完成1800名母亲，这些中心结合了牙周和妇产科临床试验的专业知识。我们建议将1800名患有牙周病的孕妇随机分配到两个治疗组之一：1)妊娠中期的刮治和根面平整；2)产后的刮治和根面平整。在进行研究期间，将收集生物样本并将其存档，以便今后进行调查，进一步阐明产妇口腔和阴道感染对怀孕的作用。我们假设，孕期牙周治疗将显著降低妊娠35周的早产发生率，并增加妊娠37周的平均体重。这项研究的动力进一步得到了UAB进行的一项先导研究的结果的支持，该研究表明，刮除和根部规划将GA&lt；35周的发生率从未治疗组的6.4%降低到0.81%。这个名为MOTER(降低产科风险的母体口腔治疗)的应用程序包括5个独立的组成部分：一个行政监督项目(北卡罗来纳大学牙科学校)、3个临床试验绩效站点(北卡罗来纳大学牙科/杜克医学院、UAB牙科和医疗以及UTHSCSA牙科和医学)和一个临床试验数据和统计协调中心(北卡罗来纳大学公共卫生学院协作研究协调中心)。

DESCRIPTION (provided by applicant): Recent studies have confirmed that there is an association between maternal periodontal disease and pregnancy complications that result in premature delivery [e.g. gestational age (GA)<37 weeks: adjusted odds ratio 2.1(CI95%:1.12, 4.09)and OR=4.2 for GA<28 weeks (CI95%: 1.42,12.6)] and decreased fetal weight [e.g. among mothers with births of GA between 35-37 weeks, those with periodontal disease (4+ sites with 5+mm PD and 2+mm AL) have neonates that are 13.8% smaller (p=0.004). The deleterious effect of maternal periodontal infection on pregnancy is particularly pronounced among African Americans and may, in part, account for some of the disparities in the prevalence of these unfortunate complications. Not only does the presence of periodontal disease early in pregnancy confer risk, but the worsening of periodontal disease during pregnancy - a relatively frequent event (35.5% of 814 deliveries) appears to independently enhance the risk of fetal exposure to periodontal pathogens (as evidenced by fetal cord blood IgM antibody to maternal oral pathogens) and preterm birth (OR=5.0, CI95%:2.22,11.3). These data suggest that periodontal disease and its progression may represent an infectious and inflammatory exposure that could have serious deleterious effects during pregnancy. Scientifically, to determine whether periodontal disease is causally related to preterm delivery and confers any modifiable risk, it will be critical to demonstrate that treating periodontal disease in pregnant mothers results in a decreased incidence of preterm birth and growth restriction. It is our central hypothesis that mothers with periodontitis that receive periodontal treatment during the second trimester of pregnancy will experience a lower rate of preterm delivery and a higher mean birth weight of the premature infants. We propose to conduct a 5-year randomized, 2-armed, clinical trial completing 1800 mothers at 3 medical/dental centers (UNC/Duke, UAB & UTHSCSA) that combine both periodontal and Obstetrics/Gynecology clinical trial expertise. We propose to randomly assign 1800 pregnant mothers with periodontal disease to one of two treatment arms 1) scaling and root planning during the second trimester or 2) scaling and root planning post-partum. Biological samples will be collected and archived during the conduct of the study to enable future investigations that will seek to further elucidate the role of maternal oral and vaginal infections on pregnancy. We hypothesize that periodontal treatment during pregnancy will significantly reduce the incidence of preterm deliveries of GA<35 weeks and also enhance the mean weight of those of GA<37 weeks. The impetus for this study is further supported by results from a pilot study conducted at UAB that demonstrated that scaling and root planning reduced the rate of GA<35 weeks from 6.4% in the untreated group to 0.81%. This application entitled MOTOR (Maternal Oral Therapy to Reduce Obstetric Risk) includes 5 separate components: an administrative oversight project (UNC Dental School), 3 clinical trial performance sites (UNC Dental/Duke Medical, UAB Dental & Medical and UTHSCSA Dental & Medical) and a clinical trials data and statistical coordinating center (UNC Collaborative Studies Coordinating Center, School of Public Health).