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: 10746079
• 负责人: PETER B LOCKHART
• 金额: $ 117.97万
• 依托单位: CAROLINAS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-14 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10746079
• 关键词: Randomized; Trial; non; Surgical; Therapy

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)具有较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。频密 牙科生物膜(菌斑)菌血症的发作可能是 工业工程的发展。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高危人群；2)刷牙导致高发病率 引起IE菌血症的菌血症；3)这种菌血症的风险随着牙科水平的增加而增加 有牙菌斑和结石存在；4)IE患者有更高的牙菌斑负担和 微积分高于匹配的非IE对照组。尽管美国有数百万人面临IE的风险 由于先前存在的心脏疾病，没有前瞻性的研究或确凿的证据表明 表明改善口腔卫生可以减少日常活动中的菌血症(例如， 刷牙)。然而，有证据表明，菌血症是一种强有力的替代标记物。 IE的风险。缺乏支持性数据意味着长期以来对这一重要性的猜测 口腔卫生和牙周炎作为IE的危险因素对 关于预防、临床实践或预防保健资金的实践指南。下一步 是为了确定专业的鳞片和口腔卫生指导是否显著降低了 刷牙引起IE菌血症的发生率和持续时间。我们计划招收320人 面临IE进入临床试验的风险。参赛者将被随机分配到专业评估和口试 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引起的菌血症的途径如下：1) 确定专业评分和口腔卫生指导对患病率和患病率的影响 刷牙过程中和刷牙后引起IE的菌血症持续时间；2)比较 随机治疗组和试验组之间的口腔卫生和牙龈健康措施 这些措施的改善是否与减少发病率和持续时间有关 刷牙引起的菌血症；以及3)确定菌血症的减少程度 发病率和持续时间，以及口腔卫生和牙周炎评分的改善，是 在干预之后保持不变。这项研究将提供新的、重要的数据来告知 医疗保健社区、指南委员会和卫生筹资机构对 改善口腔卫生和减少牙周炎是ALL的主要预防措施 有IE风险的人。