Effects of Periodontal Therapy on Preterm Birth

牙周治疗对早产的影响

• 批准号: 7166065
• 负责人: BRYAN S MICHALOWICZ
• 金额: $ 113.75万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7166065
• 关键词: Affect; Animals; Birth; Clinical; Clinical Trials; Control Groups; Cost Savings; Data; Data Analyses; Dental Care; Dental caries; Enrollment; Fetal Growth Retardation; Gestational Age; Goals; Healthcare; Human; Immune response; Incidence; Inflammation; Informed Consent; Kentucky; Link; Low Birth Weight Infant; Measures; Mechanics; Minnesota; Minority; Mississippi; Monitor; Morbidity - disease rate; Neonatal Mortality; New York City; Numbers; Operative Surgical Procedures; Oral health; Outcome; Patient currently pregnant; Periodontal Diseases; Periodontal Infection; Periodontitis; Population; Pregnant Women; Premature Birth; Public Health; Randomized; Randomized Clinical Trials; Rate; Recruitment Activity; Reporting; Risk Factors; Surgeon; Testing; Week; Woman; cost; dental abscess; mortality; neonatal morbidity; prenatal; prevent; volunteer

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.

描述（由申请人提供）：本多中心随机临床试验的目的是确定对患有牙周炎的孕妇进行非手术治疗是否能降低早产的发生率。正如2000年外科医生关于口腔健康的报告所指出的那样，早产和低出生体重是美国主要的产前问题，据估计，每年与早产相关的费用总计为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和死亡的一个主要原因。此外，早产更有可能影响在保健方面存在差距的少数民族妇女。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起来，并且有初步数据表明牙周病治疗可以减少早产的发生率。在获得知情同意后，该临床试验将招募怀孕13至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）四个少数民族人口多、早产率高的地区招募。他们将被随机分配到试验组[n=408]或对照组[n=408]。试验组接受非手术牙周机械治疗。对照组患者将牙周治疗推迟到分娩后。如果有进展性牙周炎的迹象，所有受试者都将接受监测和尽快治疗，所有受试者都将接受必要的牙科护理，以恢复龋齿和治疗脓肿的牙齿。早产和/或宫内生长受限的产妇危险因素将被用作数据分析中的协变量。两组随访至分娩，主要分娩结局变量为出生时胎龄。我们还将记录牙周治疗对免疫反应、全身炎症标志物、牙周感染和临床牙周测量的影响。如果这项研究证明牙周治疗在减少早产方面有积极作用，它将在新生儿死亡率、发病率和成本节约方面产生巨大的公共卫生影响。