Effects of Periodontal Therapy on Preterm Birth

描述(申请人提供)：这项拟议的多中心随机临床试验的目标是确定患有牙周炎的孕妇的非手术治疗是否能降低早产的发生率。正如2000年卫生局局长关于口腔健康的报告中指出的那样，早产和低出生体重是美国主要的产前问题，据估计，每年与早产有关的成本总计54亿美元。尽管为预防早产作出了重大努力，但早产仍然是新生儿发病率和死亡率的主要原因。此外，早产更有可能影响在医疗保健方面存在差距的少数族裔妇女。人类、动物和细菌学研究已经将牙周病与早产和低出生体重联系在一起，初步数据表明，牙周治疗可能会降低早产的发生率。在获得知情同意后，这项临床试验将招募怀孕13到16周的[816名妇女]。志愿者将从明尼苏达州、密西西比州、[肯塔基州]和纽约市(哈莱姆区)的四个少数民族人口和早产率较高的人口中招募。他们将被随机分配到试验组[n=408]或控制组[n=408]。试验组受试者将接受非手术机械牙周治疗。对照组受试者将牙周治疗推迟至产后。如果有证据表明牙周炎的进展，所有受试者都将被尽快监测和治疗，所有受试者都将接受基本的牙齿护理，以修复龋齿和治疗脓肿的牙齿。在数据分析中，母亲早产和/或宫内发育受限的危险因素将被用作协变量。这两组人都将接受跟踪，直到分娩，主要的出生结局变量将是出生时的胎龄。[我们还将记录牙周治疗对免疫反应、炎症系统标志物、牙周感染和临床牙周措施的影响。]如果这项研究证明牙周疗法在减少早产方面有积极的效果，它将在新生儿死亡率、发病率和节省成本方面对公共卫生产生巨大的影响。

DESCRIPTION (provided by applicant): The goal of this proposed multi-center randomized clinical trial is to determine if non-surgical therapy for pregnant women with [periodontitis] reduces the incidence of preterm birth. As noted in the year 2000 Surgeon General's Report on Oral Health, preterm birth and low birth weight are the leading prenatal problems in the U.S. and it has been estimated that the annual costs associated with preterm birth total $5.4 billion. Despite significant efforts to prevent preterm birth, it remains a major cause of neonatal morbidity and mortality. Moreover, preterm birth is more likely to affect minority women who have disparities in health care. Human, animal, and bacteriologic studies have linked periodontal disease with preterm delivery and low birth weight and there are preliminary data indicating that periodontal therapy may reduce the incidence of preterm birth. After obtaining informed consent, this clinical trial will enroll [816 women] who are 13 to 16 weeks pregnant. Volunteers will be recruited from four populations in Minnesota, Mississippi, [Kentucky, and New York City (Harlem)] with high numbers of minorities and high rates of preterm birth. They will be randomly assigned to either a Test [n=408] or a Control [n=408] Group. Test Group subjects will receive non-surgical mechanical periodontal therapy. Control Group subjects will have periodontal therapy delayed until after delivery. All subjects will be monitored and treated as soon as possible if there is evidence of progressive periodontitis and all will receive essential dental care to restore caries and treat abscessed teeth. Maternal risk factors for preterm birth and/or intrauterine growth restriction will be used as covariates in the data analysis. Both Groups will be followed until delivery and the primary birth outcome variable will be gestational age at birth. [We will also document the effect of periodontal therapy on immune response, systemic markers of inflammation, periodontal infection and clinical periodontal measures.] If this study demonstrates that periodontal therapy has a positive effect in reducing preterm birth, it will have enormous public health implications in terms of neonatal mortality, morbidity and cost savings.