Randomized Trial of non-Surgical Therapy and Oral Hygiene Instruction to Reduce Risk of Infective Endocarditis

非手术治疗和口腔卫生指导降低感染性心内膜炎风险的随机试验

• 批准号: 10348489
• 负责人: PETER B LOCKHART
• 金额: $ 66.08万
• 依托单位: CAROLINAS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-01 至 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10348489
• 关键词: Address; Antibiotic Prophylaxis; Bacteremia; Blood; Blood Circulation; Calculi; Cardiac; Clinical Trials; Data; Dental Calculus; Dental Hygiene; Dental Offices; Dental Plaque; Development; Disease; Educational Intervention; Enrollment; Frequencies; Funding; Funding Agency; Gingiva; Goals; Guidelines; Health; Heart Valves; Incidence; Infective endocarditis; Inflammation; Instruction; Intervention; Life; Measures; Morbidity - disease rate; Mouth Diseases; National Institute of Dental and Craniofacial Research; Oral; Oral cavity; Participant; Pathway interactions; Patients; Persons; Practice Guidelines; Prevention; Prevention Guidelines; Prevention Protocols; Preventive care; Preventive measure; Procedures; Prospective Studies; Randomized; Reporting; Risk; Risk Factors; Risk Marker; Solid; Step Tests; Surrogate Markers; Testing; Time; Toothbrushing; Work; clinical practice; dental biofilm; group intervention; healthcare community; improved; mortality; novel; oral care; randomized trial; treatment group; universal prevention

Project Summary Infective endocarditis (IE) has high morbidity and mortality. Upwards of 30% of cases of IE are caused by oral bacterial species that enter the bloodstream and colonize heart valves. Frequent episodes of bacteremia from dental biofilm (plaque) are likely to be significant risk factors for development of IE. Our prior work demonstrates that: 1) there are only informal guidelines for prevention in 90% of people at risk for IE; 2) tooth brushing results in a high incidence of bacteremia of IE-causing species; 3) the risk of such bacteremia increases with the level of dental plaque and calculus present; and 4) patients with IE have a higher burden of dental plaque and calculus than matched non-IE controls. Although millions of people in the U.S. are at risk for IE because of pre-existing cardiac conditions, there are no prospective studies or solid evidence to show that improving oral hygiene reduces bacteremia from routine daily activities (e.g., toothbrushing). Evidence does show, however, that bacteremia is a strong surrogate marker for risk of IE. The lack of supporting data means that longstanding speculation about the importance of oral hygiene and gingival inflammation as risk factors for IE have had too little impact on practice guidelines on prevention, clinical practice, or funding for preventive care. The next step is to determine if professional scaling and oral hygiene instruction significantly reduce the incidence and duration of IE-causing bacteremia from toothbrushing. We plan to enroll 320 people at risk for IE into a clinical trial. Enrollees will be randomized to professional scaling and oral hygiene instruction versus routine oral care. We will test the steps in the hypothesized causal pathway from improved oral hygiene to decreased bacteremia from IE-causing species by: 1) determining the impact of professional scaling and oral hygiene instruction on the incidence and duration of bacteremia with IE-causing species during and following toothbrushing; 2) comparing oral hygiene and gingival health measures between randomized treatment groups and testing whether improvement in these measures is associated with reduced incidence and duration of bacteremia from toothbrushing; and 3) determining the degree to which reduction in bacteremia incidence and duration, and improvement in oral hygiene and gingival inflammation scores, are maintained following the intervention. This study will provide novel, important data to inform the healthcare community, guideline committees, and health funding agencies of the importance of improving oral hygiene and reducing gingival inflammation as primary preventive measures for all people at risk of IE.

项目摘要 感染性心内膜炎（IE）具有高发病率和死亡率。超过30％的IE病例是 由口腔细菌引起的，进入血液并定居心脏瓣膜。频繁 牙齿生物膜（斑块）的菌血症发作可能是重要的危险因素 IE的发展。我们先前的工作表明：1）只有非正式准则 90％有IE风险的人预防； 2）刷牙导致高发病率 引起IE的菌血症； 3）这种菌血症的风险随牙科水平而增加 存在斑块和微积分； 4）IE患者的牙菌斑负担更高 微积分比匹配的非IE对照。尽管美国有数百万的人有IE的风险 由于心脏疾病先前存在，没有前瞻性研究或可靠的证据 表明改善口腔卫生可以减少日常活动的菌血症（例如， 牙刷）。但是，有证据表明，菌血症是强烈的替代标记 IE的风险。缺乏支持数据意味着长期以来对重要性的猜测 口腔卫生和牙龈发炎作为IE的危险因素的影响很小 预防，临床实践或预防保健资金的实践指南。下一步 是确定专业缩放和口腔卫生指导是否显着降低 牙刷引起IE引起IE的菌血症的发病率和持续时间。我们计划注册320人 有IE进入临床试验的风险。入学者将被随机分为专业缩放和口头 卫生教学与常规口腔护理。我们将测试假设因果关系中的步骤 从改善口腔卫生到降低引起IE的菌血症的途径：1） 确定专业缩放和口腔卫生教学对发病率的影响 在牙刷中和之后，菌血症与引起IE引起的物种的持续时间； 2）比较 随机治疗组与测试之间的口腔卫生和牙龈健康测量 这些措施的改进是否与发病率和持续时间降低有关 牙刷的细菌血症； 3）确定菌血症降低的程度 发病率和持续时间以及口腔卫生和牙龈炎症评分的改善是 干预后保持。这项研究将提供新颖的重要数据，以告知 医疗保健社区，指南委员会和健康资助机构的重要性 改善口腔卫生并减少牙龈炎症，作为所有人的主要预防措施 有IE风险的人。