CLINICAL TRIAL: SYSTEMIC METRONIDAZOLE ON PLAQUE

临床试验：斑块上全身使用甲硝唑

• 批准号: 7718981
• 负责人: ANNE DENISE HAFFAJEE
• 金额: $ 3.15万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718981
• 关键词: Adult; Affect; Anaerobic Bacteria; Antibiotics; Clinical; Clinical Trials; Complex; Computer Retrieval of Information on Scientific Projects Database; Data; Dental caries; Ecosystem; Enrollment; Excision; Funding; Gingiva; Grant; Habitats; Infection; Institution; Literature; Lung; Metronidazole; Microbial Biofilms; Monitor; Patients; Periodontal Diseases; Periodontitis; Placebos; Research; Research Personnel; Resources; Sampling; Source; Thinking; Time; United States National Institutes of Health; Work; cardiovascular disorder risk; microbial; scaling and root planing; tooth surface

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. We hypothesize first that the clinical and microbiological benefits resulting from scaling and root planing (SRP) will be enhanced by either systemically administered metronidazole, repeated professional plaque removal, or both, and second that the combination of the adjunctive therapies will have greater clinical and microbiological benefit than either adjunct alone, and that these changes will be sustained for a longer period of time. Complex microbial ecosystems exist on tooth surfaces both above and below the gingival margin. These biofilms (plaques) can adversely affect their habitat both locally in terms of dental caries and periodontal disease and perhaps systemically in terms of increased risk of cardiovascular disease and lung infection Metronidazole is attractive for the treatment of adult periodontitis patients in part because of the narrow spectrum within which this agent is thought to work -- specifically on the anaerobes associated with periodontal diseases. Our data and the literature suggest that metronidazole may be the antibiotic of choice to be used in conjunction with other treatments to control specific pathogenic segments of the subgingival microbiota. Four groups of forty-four subjects (N=176) with adult periodontitis will be enrolled. The study will evaluate the effects of four periodontal treatments: 1.) Scaling and root planing (SRP) plus placebo; 2.) SRP plus metronidazole; 3.) SRP plus cleaning; 4.) SRP plus metronidazole plus cleaning. Subjects will be clinically monitored and plaque samples taken at baseline, 3, 6, 12, 18, and 24 months.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 我们首先假设，通过系统给予的甲硝唑，反复的甲硝唑，重复的专业斑块去除或两者，辅助疗法的组合将增加临床和微生物学益处的组合将比单独使用更大的变化，从而可以持续更长的时间。 复杂的微生物生态系统都存在于牙齿表面上方和下方的牙齿表面上。 这些生物膜（斑块）在龋齿和牙周疾病方面都会在本地影响其栖息地，也许就心血管疾病和肺部感染的风险增加而言可能会对他们的栖息地产生不利影响。 甲硝唑对治疗成年牙周炎患者的治疗有吸引力，部分原因是该药物被认为可以起作用 - 特别是在与牙周疾病相关的厌氧菌中。 我们的数据和文献表明，甲硝唑可能是选择与其他治疗方法一起使用的抗生素，以控制尺寸微生物群的特定致病片段。 四组患有成人牙周炎的四十四组受试者（n = 176）将被招募。 该研究将评估四种牙周治疗的影响：1。）缩放和根策划（SRP）加安慰剂； 2.）SRP加甲硝唑； 3.）SRP加清洁； 4.）SRP加甲硝唑和清洁。 受试者将在基线3、6、12、18和24个月时进行临床监测，并采集斑块样品。