Design issues specific to studies of periodontitis.
Design issues specific to studies of periodontitis.
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针对牙周炎研究的设计问题。
DOI：
10.1111/j.1600-0765.1992.tb01704.x
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发表时间：
1992
影响因子：
3.5
通讯作者：
DeRouen,TA
中科院分区：
文献类型：
--
作者：
Page,RC;DeRouen,TA
由于目前正在开发的药物、药剂和设备种类繁多，因此迫切需要证明牙周炎治疗的等效性或优越性的临床试验指南。本文重点讨论三个设计问题。这些是主要结果变量及其测量、疾病活跃与疾病非活跃部位和患者以及研究持续时间。选择结果变量的决定因素包括要观察的生物学事件、牙周炎特有的变化以及检测这些变化所选择的方法。牙周炎特异且适合在临床试验中使用的主要结果变量是牙周附着水平和牙槽骨状态。现在可以使用改进的测量方法，具有出色的准确性和可重复性。过去十年对未经治疗的患者进行的研究清楚地表明，存在疾病活跃和疾病非活跃的口袋，在任何给定的时间点，大多数都是不活跃的，疾病进展是偶发性的，并且在大多数患者中很少发生，并且一小部分人群（可能约为 5％）异常容易受到疾病快速进展的影响。在将受试者纳入牙周炎临床试验时需要考虑这些观察结果。建议进行预研究以确定活跃的患病部位和易感受试者，或进行筛查以丰富活跃部位的比例。学习期限的确定是一个非常复杂的问题。它与要观察的生物事件发生最大变化和稳定所需的时间长度、用于检测变化的结果变量以及要研究的治疗干预的性质有关。没有单一的持续时间适用于所有牙周炎临床试验。我们对牙周炎试验设计的了解仍然存在很大差距，需要进行更多研究。
Guidelines for clinical trials demonstrating equivalence or superiority for treatments for periodontitis are badly needed because of the great variety of drugs, agents, and devices now being developed. This paper focuses on three design issues. These are primary outcome variables and their measurement, disease‐active vs disease‐inactive sites and patients, and study duration. Determinants for selection of outcome variables include the biologic events to be observed, changes that are specific for periodontitis, and methods chosen to detect those changes. The primary outcome variables specific for periodontitis and appropriate for use in clinical trials are periodontal attachment level and alveolar bone status. Improved methods for measurement of both with excellent accuracy and reproducibility are now becoming available. Studies performed on untreated patients over the past decade demonstrate clearly that disease‐active and disease‐inactive pockets exist, at any given point in time most are inactive, disease progression is episodic and in most patients infrequent, and a rather small portion of the population—possibly around 5%—are unusually susceptible to rapid disease progression. These observations need to be taken into account in enrolling subjects into periodontitis clinical trials. Conducting a prestudy to identify actively diseased sites and susceptible subjects, or screening to enrich the proportion of active sites, is recommended. Determination of study duration is a very complex issue. It is related to the length of time required for maximal change and stabilization to occur in the biological events to be observed, the outcome variable(s) used to detect change, and the nature of the therapeutic interventions to be studied. No single duration is applicable to all periodontitis clinical trials. Large gaps in our knowledge about the design of periodontitis trials still exist, and additional research is needed.
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使用非甾体类抗炎药氟比洛芬改变人类牙槽骨流失的进程。
DOI：
--
发表时间：
1989
期刊：
The Journal of Periodontology
影响因子：
--
作者：
Ray C. Williams;Marjorie K. Jeffcoat;T. Howell;Arturo R. Rolla;Derek F Stubbs;Kok W. Teoh;Michael S. Reddy;Paul Goldhaber
通讯作者：
Paul Goldhaber
四环素纤维疗法的多中心评价：一、实验设计、方法和基线数据。
影响因子：
3.5
作者：
J. M. Goodson;M. Cugini;Ralph Kent;Gary C. Armitage;Charles M. Cobb;Daniel H. Fine;M. Fritz;Edward Green;M. Imoberdorf;W. Killoy;C. Mendieta;Richard Niederman;Steven Offenbacher;E. J. Taggart;Maurizio S. Tonetti
通讯作者：
Maurizio S. Tonetti
影响因子：
3.5
作者：
PERSSON, GR;DEROUEN, TA;PAGE, RC
通讯作者：
PAGE, RC
基于裂隙液的诊断测试。
DOI：
--
发表时间：
1991
期刊：
影响因子：
--
作者：
J. Nw
通讯作者：
J. Nw
DOI：
--
发表时间：
1981
期刊：
The Journal of Periodontology
影响因子：
--
作者：
E. B. Hancock
通讯作者：
E. B. Hancock