Paquette D W, Fiorellini J P
Department of Periodontology, Harvard School of Dental Medicine, Boston, MA 02115.
Curr Opin Periodontol. 1994:87-98.
A number of new periodontitis therapies have recently emerged for either inhibiting disease progression or regenerating lost tissues. As basic research continues to define specific bacteria and host response mechanisms involved in periodontitis, the development of new treatment strategies will continue to expand. This surge in biotechnology along with a tightening of federal regulations has prompted intense interest in clinical trials for testing new periodontitis therapies. A clinical trial is a scientific experiment involving human subjects in which treatment is initiated specifically for evaluation. The overall goal of any clinical trial is to minimize bias and variability. Studying periodontitis in clinical trials presents three problems related to this goal. Periodontitis is a heterogeneous disease grouping, the course of disease is often irregular, and conventional assessment instruments are associated with high error thresholds. Several methods can be used to minimize bias and variability when planning periodontitis trials. These include experimental design selection; inclusion and exclusion criteria; randomization of treatment and blinding; and standardization of treatment, follow-up, and assessment procedures. In addition, recently developed automated periodontal probes and computer-assisted radiography show promise in accurately detecting subtle changes in periodontal support. With improved planning, conduct, and reporting of periodontal clinical trials, investigators can facilitate the transfer of information to clinicians, who can decide on the utility of these new therapies for their periodontitis patients.
最近出现了一些用于抑制疾病进展或再生缺失组织的新型牙周炎治疗方法。随着基础研究不断明确牙周炎中涉及的特定细菌和宿主反应机制，新治疗策略的开发将持续扩展。生物技术的蓬勃发展以及联邦法规的收紧，引发了人们对测试新型牙周炎治疗方法的临床试验的浓厚兴趣。临床试验是一项涉及人类受试者的科学实验，其中专门启动治疗以进行评估。任何临床试验的总体目标都是尽量减少偏差和变异性。在临床试验中研究牙周炎存在与该目标相关的三个问题。牙周炎是一种异质性疾病分类，疾病进程通常不规则，并且传统评估工具存在较高的误差阈值。在规划牙周炎试验时，可以使用几种方法来尽量减少偏差和变异性。这些方法包括实验设计选择；纳入和排除标准；治疗随机化和盲法；以及治疗、随访和评估程序的标准化。此外，最近开发的自动牙周探针和计算机辅助放射成像在准确检测牙周支持组织的细微变化方面显示出前景。通过改进牙周临床试验的规划、实施和报告，研究人员可以促进信息向临床医生的传递，临床医生可以据此决定这些新疗法对其牙周炎患者的效用。
