MOTOR-Maternal Oral Therapy to Reduce Obstetric Risk

最近的研究证实，孕妇牙周病和妊娠并发症之间存在联系， 导致早产[例如，胎龄（GA）<37周：校正比值比2.1（CI 95%：1.12，4.09），OR=4.2， GA<28周（CI 95%：1.42，12.6）]和胎儿体重下降[例如，在35-37周之间分娩GA的母亲中， 牙周病患者（4+个部位，PD 5+mm，AL 2+mm）的新生儿小13.8%（p=0.004）。的 母体牙周感染对妊娠的有害影响在非裔美国人中特别明显， 这在一定程度上解释了这些不幸的并发症发病率的差异。不仅是因为 牙周病在怀孕早期会带来风险，但在怀孕期间牙周病的恶化-一个相对 频繁事件（814例分娩中的35.5%）似乎独立地增加了胎儿暴露于牙周病原体的风险（如 （2）新生儿脐带血IgM抗体阳性（OR=5.0，CI 95%：2.22，11.3）。这些数据 表明牙周病及其进展可能代表感染和炎症暴露， 怀孕期间的严重不良影响。科学地确定牙周病是否与早产有因果关系 分娩和赋予任何可改变的风险，这将是至关重要的，以证明治疗牙周病在孕妇 导致早产和生长受限的发生率降低。我们的中心假设是， 在妊娠中期接受牙周治疗的孕妇早产率较低， 早产儿的平均出生体重较高。我们计划进行一项为期5年的随机、双组临床试验 完成了3个医疗/牙科中心（ESTA/杜克，UAB和UTHSCSA）的1800名母亲，结合联合收割机牙周和 产科/妇科临床试验专业知识。我们建议随机分配1800名患有牙周病的孕妇， 两个治疗组之一：1）妊娠中期刮治和牙根平整，或2）产后刮治和牙根平整。 将在研究进行期间采集生物样本并存档，以便将来进行研究， 进一步阐明母体口腔和阴道感染对妊娠的作用。我们假设牙周治疗期间， 妊娠将显著降低GA<35周早产的发生率， GA<37周。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， 结果表明，刮治和根面平整将GA<35周的比率从未治疗组的6.4%降低到0.81%。这 名为MOTOR（降低产科风险的产妇口服治疗）的应用程序包括5个单独的组成部分： 行政监督项目（牙科学校），3项临床试验

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%:l.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 an 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