Multicenter evaluation of tetracycline fiber therapy: I. Experimental design, methods, and baseline data.
Multicenter evaluation of tetracycline fiber therapy: I. Experimental design, methods, and baseline data.
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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。
DOI：
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发表时间：
1991
影响因子：
3.5
通讯作者：
Maurizio S. Tonetti
中科院分区：
文献类型：
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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
描述了一项多中心试验的研究设计和基线特征，以测试局部给药的四环素治疗成人牙周炎的有效性和安全性。局部给药由直径0.5 mm的乙烯-乙酸乙烯酯共聚物纤维负载25%的盐酸四环素，放入牙周袋中，用粘合剂保持10(+/-2)天。共有113名受试者(56名男性和57名女性；平均年龄49.3岁)参与了这项研究。受试者有4颗不相邻的牙齿，有6-10 mm的凹槽，在探诊时出血。每个受试者中选择的部位被随机分配到4个试验组：四环素纤维组、对照纤维组、根面平整组和未处理组。因此，建立了一个平衡的实验设计，其中每个受试者通过提供4个临床可比较的地点进行评估而做出同样的贡献。为了给牙周炎治疗试验提供一个更特异的模型，在研究开始之前，通过牙周上结石清除和家庭护理指导来预防牙周炎。分别在基线、30d和60d测量牙周袋深度减少、附着水平增加和控制力探诊时的出血。通过菌斑样本的DNA探针分析检测6种可能的牙周病原体。这项研究的设计提供了几个独特的分析机会。对照包括与常规治疗的比较，车辆影响的分析，以及未治疗部位的影响。试验组与对照的比较允许评估可能影响结果解释的主要变量。(摘要截断250字)
The study design and baseline characteristics of a multicenter trial to test the effectiveness and safety of locally delivered tetracycline for treatment of adult periodontitis are described. Local delivery was provided by 0.5 mm diameter ethylene vinyl acetate copolymer fibers loaded 25% with tetracycline hydrochloride which were placed into periodontal pockets and maintained by an adhesive for 10 (+/- 2) days. A total of 113 subjects (56 male and 57 female; mean age 49.3 yr) at five centers participated in the study. Subjects were selected who had 4 nonadjacent teeth with 6-10 mm pockets that bled on probing. The selected sites in each subject were randomly assigned to 4 test groups: tetracycline fiber, control fiber, scaling with root planing, or untreated. A balanced experimental design was thereby established in which each subject contributed equally by providing 4 clinically comparable sites for evaluation. To provide a more specific model for testing periodontitis therapy, gingivitis was treated prior to the initiation of the study by prophylaxis with supragingival calculus removal and home care instruction. Clinical response variables measured were pocket depth reduction, attachment level gain and bleeding on controlled-force probing measured at baseline, 30 d, and 60 d. Levels of 6 bacterial species selected as probable periodontal pathogens were measured by DNA probe analysis of plaque samples. The design of this study provided several unique analytical opportunities. Controls included a comparison with conventional treatment, analysis of vehicle effects, and effects at untreated sites. Comparison of the test group with controls permitted evaluation of the principal variables that could effect interpretation of results.(ABSTRACT TRUNCATED AT 250 WORDS)
牙周炎的临床测量。
影响因子：
6.7
作者：
Goodson,JM
通讯作者：
Goodson,JM
影响因子：
6.7
作者：
Haffajee,AD;Socransky,SS;Goodson,JM;Lindhe,J
通讯作者：
Lindhe,J
重新检查依恋水平和依恋水平变化的口内相关性。
影响因子：
6.7
作者：
Fleiss,JL;Wallenstein,S;Chilton,NW;Goodson,JM
通讯作者：
Goodson,JM