Effects of Periodontal Therapy on Preterm Birth

牙周治疗对早产的影响

• 批准号: 6656931
• 负责人: BRYAN S MICHALOWICZ
• 金额: $ 561.28万
• 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 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6656931
• 关键词: clinical research; clinical trials; dentistry; disease /disorder prevention /control; disease /disorder proneness /risk; female; human pregnant subject; human therapy evaluation; oral health; patient oriented research; periodontium disorder; premature infant human; preventive dentistry

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）：这项拟议的多中心随机临床试验的目的是确定[牙周炎]孕妇的非手术治疗是否降低早产的发生率。正如2000年外科医生关于口腔健康的报告所指出的，早产和低出生体重是美国主要的产前问题，据估计，与早产相关的年度费用总计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，早产更有可能影响到在保健方面存在差距的少数群体妇女。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治疗可以降低早产的发生率。在获得知情同意后，本临床试验将入组[816名妊娠13 - 16周的女性]。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）]的四个人群中招募，这些人群中少数民族人数较多，早产率较高。他们将被随机分配到试验组[n=408]或对照组[n=408]。试验组受试者将接受非手术机械牙周治疗。对照组受试者的牙周治疗将延迟至分娩后。如果有进行性牙周炎的证据，将对所有受试者进行监测和尽快治疗，所有受试者都将接受基本的牙科护理，以修复龋齿和治疗龋齿。早产和/或宫内生长受限的母体风险因素将用作数据分析中的协变量。两组均将随访至分娩，主要出生结局变量为出生时胎龄。[We还将记录牙周治疗对免疫反应、炎症的全身标志物、牙周感染和临床牙周测量的影响。如果这项研究表明牙周治疗在减少早产方面具有积极作用，那么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。