DESIGN AND ANALYSIS OF PERIODONTAL CLINICAL TRIALS

研究培训计划的目的是：1)提供完善的 牙周设计与分析的理论基础 临床试验和2)开展人群病例对照研究 早发性疾病的遗传流行病学调查研究 牙周炎。这一目标将通过有组织的5-t=年来实现 旨在提供接触流行病学和 获得流行病学博士学位的生物统计学方法论。 第一阶段的培训将包括5个部分：(1)课程工作 流行病学、统计学和生物统计学；(2)独立研究 相关数据分析领域；(3)相关数据分析的方法学研究 将现有的统计和流行病学方法扩展到问题 牙周病临床研究的设计与分析； 已发表的牙周治疗疗效研究的Meta分析 疾病；和(5)参与讲授入门 牙科研究生生物统计学课程。 进入第二阶段项目的标准是：(A) 令人满意地完成第(1)和(2)部分概述的课程 第一阶段；(B)完成提交的文章或专著 解决临床研究中的方法学问题的出版物 牙周病；。(C)完成须呈交的文章。 关于第一阶段第四部分中进行的荟萃分析的出版物； (D)通过博士普通考试。 第二阶段的培训将包括执行人口- 以病因学为基础的病例对照研究 早发性牙周炎。本研究的具体研究假设 研究包括： H01：人类白细胞抗原组织类型与早发无关 牙周炎。 H02：人类白细胞抗原单倍型与早发性牙周炎基因分离 独立的。 拒绝这些假设将导致显著改善 我们对早发性牙周炎遗传成分的认识 并导致了几个潜在的临床应用：(1)诊断，(2) 识别高危人群；(3)预防性治疗 程序；(4)牙周病的分类。 总而言之，拟议的培训计划将为Hujoel博士提供 在临床设计、分析和实施方面进行良好的培训 审判。这将为他提供发展成为一名 独立研究调查员，获得研究经验 流行病学和生物统计系的监督，以及 启动一项研究计划，以获得博士论文。

The purpose of the research training plan is 1) to provide a sound theoretical foundation in the design and analysis of periodontal clinical trials and 2) to carry out a population bases case-control study investigating the genetic epidemiology of early onset periodontitis. This goal will be achieved by a structured 5-t=year program intended to provide exposure to epidemiological and biostatistical methodology leading to a PhD degree in Epidemiology. The training in Phase-I will consist of 5 components: (1) Course work in epidemiology, statistics, and biostatistics; (2) Independent study in the area of correlated data analysis; (3) Methodological research on extending existing statistical and epidemiological methods to problems of design and analysis of clinical studies of periodontal disease; (4) Meta-analysis of published studies on treatment efficacy for periodontal diseases; and (5) Participation in teaching an introductory biostatistics course in dental graduate students. The criteria for proceeding to Phase II of he programs are: (a) Satisfactory completion of courses outlined in Parts (1) and (2) of Phase I; (b) completion of an article or monograph to be submitted for publication addressing the methodologic issues in clinical studies of periodontal diseases; (c) completion of an article to be submitted for publication addressing the meta-analysis conducted in Part 4 of Phase I; and (d) Passing of Ph.D. general examinations. The training in Phase II will consist of the execution of a population- based etiologic case control study investigating the genetic component of early onset periodontitis. The specific research hypothesis of the studies are: H01: There is no association between HLA tissue types and early-onset periodontitis. H02: HLA haplotypes and the "early-onset periodontitis" gene segregate independently. Rejection of these hypotheses would lead to a significant improvement of our understanding of the genetic component of early onset periodontitis and lead to several potential clinical applications: (1) diagnosis, (2) identification of high risk individuals, (3) preventive treatment programs, and (4) classification of periodontal diseases. In summary, the proposed training program will provide Dr. Hujoel with a sound training in the design, analyses, and execution of clinical trials. It will provide him with the opportunity to develop into an independent research investigator, to obtain research experience under the supervision of the Department of Epidemiology and Biostatistics, and to initiate a research program leading to a Ph.D. Dissertation.