Bacteremia from Dental Extraction vs. Oral Hygiene

描述：（由申请方提供）：使用抗生素预防， 预防口腔病原体引起的远端部位感染（DSI）仍然是一个 临床实践中存在争议。对发病率知之甚少， 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， 受试者将：1）确定并比较菌血症的真实INMD， 从一个高度侵入性的牙科办公室程序（单牙拔除）和一个 最小侵入性和自然发生的菌血症源（牙齿 刷牙），从10个特定的口腔病原体（S. mitis、细叶山蚂蝗S. sanguis。S.口腔S. intermedius，S. mutans、S.唾液流F. nucleatum、具核A.伴放线菌， E.腐蚀性牙菌和牙龈卟啉单胞菌）引起DSI;以及2） 衡量美国心脏协会指南的效果， 阿莫西林预防单颗牙引起的菌血症的INMD 萃取受试者将被随机分为三组， 组：阿莫西林拔牙、安慰剂拔牙和牙齿 刷牙需氧和厌氧细菌培养和PCR的血液将 在这些口头程序之前，期间和之后的六个时间点抽取。 INMD的确定如下：1）每次抽血的发生率数字 将采用高灵敏度的肉汤血液培养系统（BACTEC）; 2） 将通过常规的病原体物种鉴定方法来确定其性质 培养的BACTEC，我们将提高口腔病原体的特异性 从BACTEC与使用基因序列分析; 3）菌血症的幅度 将通过PCR测定每个血液样本的菌血症持续时间;以及 将对应于连续抽血中口腔病原体的存在 在刷牙和拔牙之后。这项研究将提供更多 完全理解侵入性的影响（即，刷牙与 提取）和口腔疾病的程度上的INMD。此外，我们将 为未来研究的发展提供独特和关键的数据， 关于个体抗生素预防的循证指南 目前认为有DSI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.