MOTOR-Maternal Oral Therapy to Reduce Obstetric Risk

描述（由申请人提供）：最近的研究证实，孕妇牙周病与导致早产的妊娠并发症之间存在关联[例如，胎龄(GA)<37周：校正优势比2.1(CI95%:1.12, 4.09)， GA<28周（CI95%:1.12, 4.09） OR=4.2]。1.42,12.6)]和胎儿体重下降[例如，在35-37周之间出生GA的母亲中，患有牙周病（4个以上部位有5+mm PD和2+mm AL）的新生儿体重要小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为明显，这可能部分解释了这些不幸并发症患病率的一些差异。妊娠早期牙周病的存在不仅会带来风险，而且牙周病在妊娠期间的恶化——这是一个相对频繁的事件（814次分娩中的35.5%）似乎单独增加了胎儿暴露于牙周病原体的风险（胎儿脐带血对母体口腔病原体的IgM抗体证明了这一点）和早产（OR=5.0, CI95%:2.22,11.3）。这些数据表明，牙周病及其进展可能是一种感染和炎症暴露，在怀孕期间可能产生严重的有害影响。科学地说，要确定牙周病是否与早产有因果关系，并赋予任何可改变的风险，证明孕妇治疗牙周病可降低早产和生长受限的发生率至关重要。我们的中心假设是，患有牙周炎的母亲在妊娠中期接受牙周治疗，早产率较低，早产儿的平均出生体重较高。我们建议在3个医学/牙科中心（UNC/Duke， UAB和UTHSCSA）对1800名母亲进行为期5年的随机、两组临床试验，结合牙周和妇产科临床试验专业知识。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中：1)妊娠中期刮治和牙根规划；2)产后刮治和牙根规划。在进行研究期间，将收集生物样本并将其存档，以便将来进行调查，进一步阐明产妇口腔和阴道感染对妊娠的作用。我们假设妊娠期牙周治疗可显著降低GA<35周的早产发生率，并可提高GA<37周的平均体重。UAB进行的一项试点研究的结果进一步支持了这项研究的动力，该研究表明，除垢和根规划将GA<35周的比率从未治疗组的6.4%降低到0.81%。这个名为MOTOR（产妇口腔治疗降低产科风险）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院），3个临床试验执行地点（北卡罗来纳大学牙科/杜克医学，UAB牙科和医疗以及UTHSCSA牙科和医疗）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合作研究协调中心）。

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).