Bacteremia from Dental Extraction vs. Oral Hygiene

描述：(申请人提供)：使用抗生素预防 预防口腔病原体的远程感染(DSI)仍然是一项 临床实践中有争议的问题。人们对这一事件知之甚少， 自然发生的菌血症的性质、程度和持续时间(INMD) 或侵入性牙科手术，或预防性抗生素对 INMD。这项前瞻性、随机、临床研究的主要目的是 受试者要：1)确定和比较菌血症的真实INMD 从高度侵入性的牙科办公室程序(单颗牙齿拔除)和 微创和自然发生的菌血症来源(牙齿 刷牙)，从10种特定的口腔病原体(S.mitis、S.sanguis.唇形藻S.oralis.S. 中间链球菌、变形链球菌、唾液链霉菌。、伴生放线菌、核杆菌、伴生放线菌 E.腐蚀性和牙龈假单胞菌)，已被报告导致DSI；以及2) 衡量美国心脏协会指南对 阿莫西林预防单牙菌血症的临床研究 拔牙。受试者将随机分为三等分成三等分 组：用阿莫西林拔牙，用安慰剂拔牙，和牙齿 刷牙。血液进行需氧和厌氧细菌培养和聚合酶链式反应 在这些口述程序之前、期间和之后的六个时间点进行抽签。 INMD将确定如下：1)每次抽血的发病率数字 将采用高度敏感的肉汤血液培养系统(BACTEC)；2) 自然界将通过确定病原体种类的传统方法来确定 由BACTEC培养，提高口腔病原菌的特异性 来自BACTEC的基因序列分析；3)菌血症程度 将通过聚合酶链式反应对每个血样进行检测；以及4)菌血症持续时间 将与顺序抽血中口腔病原体的存在相对应 在刷牙和拔牙之后。这项研究将提供更多的 全面了解入侵的影响(即刷牙与 拔牙)和口腔疾病的程度。此外，我们还将 拥有独特和关键的数据，用于未来研究和开发 关于个人抗生素预防的循证指南 目前认为有发生DSI的风险。

DESCRIPTION: (provided by applicant): The use of antibiotic prophylaxis to prevent distant site infections (DSI) from oral pathogens remains a controversial issue in clinical practice. Little is known about the incidence, nature, magnitude, and duration (INMD) of bacteremia from naturally occurring or invasive dental procedures, or the impact of prophylactic antibiotics on the INMD. The major purposes of this prospective, randomized, clinical study of 300 subjects is to: 1) determine and compare the true INMD of bacteremia resulting from a highly invasive dental office procedure (single tooth extraction) and a minimally invasive and naturally occurring source of bacteremia (tooth brushing), from 10 specific oral pathogens (S. mitis, S. sanguis. S. Oralis. S. intermedius, S. mutans, S. Salivarius. F. nucleatum, A. Actinomycetemcomitans, E. corrodens and P. gingivalis) that have been reported to cause DSI; and 2) measure the effect of the American Heart Association's guidelines for amoxicillin prophylaxis on the INMD of bacteremia resulting from a single tooth extraction. Subjects will be randomized into three equal into three equal groups: extraction with amoxicillin, extraction with placebo, and tooth brushing. Blood for aerobic and anaerobic bacterial cultures and PCR will be drawn at six time points before, during, and following these oral procedures. INMD will be determined as follows: 1) incidence figures for each blood draw will employ a highly sensitive, broth-based blood culturing system (BACTEC); 2) nature will be determined by conventional methods of speciating pathogens cultivated by BACTEC, and we will improve the specificity of the oral pathogens from BACTEC with the use of gene sequence analysis; 3) magnitude of bacteremia will be determined by PCR for each blood sample; and 4) bacteremia duration will correspond to the presence of oral pathogens in sequential blood draws following tooth brushing and extractions. This study will provide a more complete understanding of the impact of invasiveness (i.e., brushing vs. extraction) and the degree of oral disease on the INMD. Additionally, we will have unique and critical data for the development of both future research and evidence-based guidelines concerning antibiotic prophylaxis for individuals currently felt to be at risk for DSI.