THREE PERIODONTAL THERAPIES (THE SMOKING STUDY)

三种牙周治疗（吸烟研究）

• 批准号: 7607013
• 负责人: ANNE DENISE HAFFAJEE
• 金额: $ 21.73万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7607013
• 关键词: Adult; Amoxicillin; Anti-Bacterial Agents; Antibodies; Blood; Cigarette Smoker; Clinical; Complex; Computer Retrieval of Information on Scientific Projects Database; Dental; Depth; Double-Blind Method; Doxycycline; Funding; Gingival Crevicular Fluid; Grant; Institution; Maintenance; Measures; Metronidazole; Monitor; Outcome; Patients; Periodontal Infection; Periodontitis; Porphyromonas gingivalis; Prevalence; Research; Research Personnel; Resources; Saliva; Sampling; Series; Serum; Site; Smoker; Smoking; Source; Time; Treponema denticola; United States National Institutes of Health; cytokine; day; non-smoker; randomized placebo controlled trial; scaling and root planing

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. This double blind, placebo controlled, randomized study will compare three treatment strategies for periodontal infections in smokers and non-smokers. A conventional periodontal therapy, scaling and root planing (SRP), will be compared with two more aggressive antibacterial therapies: 1. SRP plus systemically administered metronidazole, and 2. SRP plus systemically administered metronidazole, amoxicillin, and locally administered doxycycline. Changes in clinical and microbiological parameters will be evaluated, together with serum antibody levels to specific subgingival species, and levels of cytokines in gingival crevicular fluid (GCF). Three groups of adult periodontitis subjects, divided equally into smokers and non-smokers, will be evaluated. All patients will have a detailed clinical dental examination and a series of subgingival plaque samples taken. Subjects will provide samples of GCF, blood, and saliva at baseline, and a separate saliva sample at 14 days. All subjects will receive SRP and will be assigned to one of the three treatment groups described above. Subjects will be clinically and microbiologically monitored periodically for 2 years after initial SRP. Maintenance SRP will be given every 3 months. The primary outcome variables are changes in pocket depth and attachment level for each subject and prevalence of the "red complex" species (T. forsythensis, P. gingivalis, T. denticola) as measured by the percent of sites colonized by these species in each subject before and at different time points post-therapy. The primary outcomes will be long and short term treatment results for current cigarette smokers.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这项双盲、安慰剂对照、随机研究将比较吸烟者和非吸烟者牙周感染的三种治疗策略。 传统的牙周治疗、刮牙和根面平整术 (SRP) 将与两种更积极的抗菌疗法进行比较：1. SRP 加全身给予甲硝唑，2. SRP 加全身给予甲硝唑、阿莫西林和局部给予多西环素。 将评估临床和微生物参数的变化，以及针对特定龈下物种的血清抗体水平以及龈沟液（GCF）中的细胞因子水平。 将评估三组成人牙周炎受试者，平均分为吸烟者和非吸烟者。 所有患者都将接受详细的临床牙科检查并采集一系列龈下菌斑样本。 受试者将提供基线时的 GCF、血液和唾液样本，并在 14 天时提供单独的唾液样本。 所有受试者都将接受 SRP 并被分配到上述三个治疗组之一。 在初始 SRP 后的 2 年内，将定期对受试者进行临床和微生物学监测。 维护 SRP 将每 3 个月给出一次。 主要结果变量是每个受试者的口袋深度和附着水平的变化，以及“红色复合体”物种（T. forsythensis、P. gingivalis、T. denticola）的流行率（通过这些物种在每个受试者中定殖的位点百分比来衡量）。受试者在治疗前和治疗后的不同时间点。 主要结果将是当前吸烟者的长期和短期治疗结果。