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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要感染性心内膜炎（IE）具有很高的发病率和死亡率。超过 30% 的 IE 病例是由进入血液并定植于心脏瓣膜的口腔细菌引起。经常牙齿生物膜（菌斑）引起的菌血症可能是严重的危险因素 IE的开发。我们之前的工作表明：1）只有非正式的指导方针 90% 的 IE 风险人群得到预防； 2）刷牙导致牙病发生率高引起 IE 的菌血症； 3）此类菌血症的风险随着牙科水平的提高而增加存在牙菌斑和牙石； 4) IE 患者的牙菌斑负担较高，微积分比匹配的非 IE 控件要好。尽管美国有数百万人面临 IE 的风险由于已有心脏病史，没有前瞻性研究或确凿证据表明研究表明，改善口腔卫生可减少日常活动（例如，刷牙）。然而，有证据表明，菌血症是一个强有力的替代标志物 IE 的风险。缺乏支持数据意味着长期以来对其重要性的猜测口腔卫生和牙龈炎症作为 IE 的危险因素，对 IE 的影响太小有关预防、临床实践或预防性护理资金的实践指南。下一步是为了确定专业洗牙和口腔卫生指导是否能显着减少刷牙引起 IE 菌血症的发生率和持续时间。计划招生320人有 IE 风险进入临床试验。参与者将被随机分配到专业尺度和口语卫生指导与常规口腔护理。我们将测试假设因果关系中的步骤从改善口腔卫生到减少引起 IE 的菌血症的途径：1) 确定专业洗牙和口腔卫生指导对发病率和口腔卫生指导的影响刷牙期间和刷牙后引起 IE 的菌血症的持续时间； 2）比较随机治疗组和测试之间的口腔卫生和牙龈健康措施这些措施的改进是否与减少发病率和持续时间有关刷牙引起的菌血症； 3) 确定菌血症减少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干预后维持。这项研究将提供新颖、重要的数据来告知医疗界、指导委员会和卫生资助机构的重要性改善口腔卫生和减少牙龈炎症作为所有人的主要预防措施有 IE 风险的人。