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（infectious endocarditis，IE）的发病率和死亡率较高。超过30%的IE病例是 由口腔细菌进入血液并寄生在心脏瓣膜引起。频繁 来自牙生物膜（菌斑）的菌血症发作可能是 IE的发展。我们之前的工作表明：1）只有非正式的指导方针 预防90%的IE风险人群; 2）刷牙导致高发病率， 导致IE的菌血症; 3）这种菌血症的风险随着牙科水平的增加而增加 存在牙菌斑和牙结石;以及4）IE患者具有更高的牙菌斑负担， 比匹配的非IE控制。尽管美国有数百万人面临IE的风险， 由于预先存在的心脏疾病，没有前瞻性研究或可靠的证据表明 表明改善口腔卫生减少了日常活动引起的菌血症（例如， 刷牙）。然而，有证据表明，菌血症是一个强有力的替代标记， 的风险。缺乏支持数据意味着长期以来关于 口腔卫生和牙龈炎症作为IE的危险因素对IE的影响太小。 关于预防、临床实践或预防保健资金的实践指南。下一步 是为了确定专业的规模和口腔卫生指导是否显着减少 刷牙导致IE菌血症的发生率和持续时间。我们计划招收320人 进入临床试验入选者将被随机分配到专业规模和口腔 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IE致病菌引起的菌血症的途径：1） 确定专业洁治和口腔卫生指导对发病率的影响， 在刷牙期间和刷牙之后，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指标 这些措施的改善是否与减少的发病率和持续时间有关， 刷牙引起的菌血症;以及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， 在干预后保持。这项研究将提供新的，重要的数据， 卫生保健界、指导委员会和卫生资助机构， 改善口腔卫生和减少牙龈炎症是所有人的主要预防措施 有IE风险的人