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临床试验/NCT00066001
NCT00066001已完成2 期

The Effect of Systemically Administered Metronidazole Alone and in Combination With Professional Supragingival Plaque Removal on Plaque Composition

The Forsyth Institute1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2002年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
154
试验地点
1
主要终点
Change in mean attachment level

研究概览

简要总结

The purpose of this study is to determine the clinical and microbiological effects of systemically administered metronidazole alone or in combination with professional plaque removal on periodontally diseased patients.

详细描述

Major goals of periodontal research are to differentiate pathogenic from host compatible plaque microbiotas and to optimize treatments to convert the former to the latter. To this end, in the previous award period the composition of supra and subgingival plaques, the associations among species both within and between supra and subgingival plaques, and differences between plaques from healthy and diseased individuals were determined. One major finding was the frequent detection of anaerobic periodontal pathogens at low numbers in supragingival plaque of periodontally diseased and to a lesser extent healthy subjects. Weekly professional supragingival plaque removal for 3 months in 18 periodontitis subjects demonstrated astonishing reductions in the subgingival microbiota which were maintained for 9 months after cessation of the professional program. The composition of the microbiota at 12 months in these subjects was similar to that found in periodontal health. In another of our studies, systemically administered metronidazole produced similar effects. Thus, in SA1 a 2 year randomized clinical trial will be performed comparing the effects of 1) SRP alone or in combination with 2) weekly professional supragingival plaque removal, 3) systemically administered metronidazole or 4) a combination of the 2 on clinical parameters and supra and subgingival plaque composition. 200 periodontitis patients will receive SRP under local anaesthesia and will be randomly assigned to the 4 treatment groups. All subjects will be evaluated clinically and for supra and subgingival plaque composition at 2 weeks, 3, 6, 12, 18 and 24 months. Supra and subgingival plaque samples will be taken separately from the mesial aspect of each tooth and evaluated individually for their content of 40 bacterial species using checkerboard DNA-DNA hybridization providing over 3.6 million bacterial counts. The results will determine if the beneficial effect of the individual therapies persist beyond one year and whether combined treatment produces even greater benefit to the patient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

1, 2, 3, 4

Placebo Comparator

The 4 arms of the study are based on the treatment groups: 1. scaling and root planing alone (SRP); 2. SRP plus repeated professional supragingival plaque removal; 3. SRP + systemically administered metronidazole; 4. SRP + repeated professional supragingival plaque removal + systemically administered metronidazole.

干预措施: metronidazole (Drug)

结局指标

主要结局

Change in mean attachment level

时间窗: Baseline, 3, 6 12 18 and 24 months

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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