Lindhe J, Socransky S, Wennström J
J Clin Periodontol. 1986 May;13(5):488-99. doi: 10.1111/j.1600-051x.1986.tb01495.x.
The present paper on the design of clinical trials of periodontal therapy first addresses the issue of the etiology of periodontal disease. It is suggested that most if not all forms of destructive periodontal disease are caused by microorganisms and that there are different forms of disease with different microbial etiologies. The progressive nature of destructive periodontal disease is subsequently discussed and it is emphasized that, in a given patient, periodontal sites which show signs of inflammation and attachment loss may not over a period of several months and years show further sign of attachment loss. The present methods of assessing periodontal disease do not allow us to discriminate between potentially active and inactive sites in untreated patients. The significance and variability of indicators of periodontal disease such as bleeding on probing, probing pocket depth and probing attachment level measurements are discussed. The errors inherent in the various measurements are analyzed and suggestions are presented describing how alterations in any of the above parameters could be identified and presented in a clinical trial. Of concern for the statistical analysis of clinical data of periodontal disease is the definition of the "experimental unit". For a number of years, the "experimental unit" in periodontal trials was the patient. It is clear, however, that different sites within the same individual show different patterns of disease progression and lesion morphology and often respond differently to periodontal therapy. Statistical analyses must consequently be designed which recognize differences in site-to-site infection and lesion morphology within a common host. Until such analyses are available, the investigator should be wary of pooling data within the same individual, since such pooling may obscure meaningful alternatives which may take place in individual periodontal sites. Some goals of periodontal therapy are subsequently identified. 4 goals are discussed more in detail, namely: to establish conditions which will allow the patient to maintain a dentition without further breakdown of the periodontium; to reduce pocket depth to establish an anatomy in the dentogingival region which with proper maintainance care will prevent the re-establishment of the subgingival infection; to gain attachment as a result of treatment; to assess the effect of a certain chemotherapeutic agent on periodontal disease.
本文关于牙周治疗临床试验的设计首先探讨了牙周病的病因问题。研究表明，大多数（即便不是所有）破坏性牙周病的形式都是由微生物引起的，而且存在不同形式的疾病，其微生物病因也各不相同。随后讨论了破坏性牙周病的进展性质，并强调在特定患者中，显示出炎症和附着丧失迹象的牙周部位在数月乃至数年的时间里可能不会出现进一步的附着丧失迹象。目前评估牙周病的方法无法让我们区分未经治疗患者中潜在活跃和不活跃的部位。文中讨论了牙周病指标（如探诊出血、探诊袋深度和探诊附着水平测量）的意义和变异性。分析了各种测量中固有的误差，并提出了一些建议，描述如何在临床试验中识别和呈现上述任何参数的变化。牙周病临床数据统计分析所关注的是“实验单位”的定义。多年来，牙周试验中的“实验单位”是患者。然而，很明显，同一个体内的不同部位显示出不同的疾病进展模式和病变形态，并且对牙周治疗的反应往往也不同。因此，必须设计出能够认识到同一宿主内不同部位感染和病变形态差异的统计分析方法。在有此类分析方法之前，研究者应谨慎对待汇总同一个体内的数据，因为这样的汇总可能会掩盖各个牙周部位可能出现的有意义的差异情况。随后确定了牙周治疗的一些目标。详细讨论了4个目标，即：创造条件使患者能够维持牙列，而牙周组织不再进一步破坏；减小袋深度，在牙齦区域建立一种解剖结构，通过适当的维护护理可防止龈下感染再次形成；通过治疗获得附着；评估某种化疗药物对牙周病的影响。
