Effect of Adjunctive Treatment With Arestin on the Subgingival Microflora in Patients With Moderate to Advanced Periodontitis

OraPharma5 个研究点分布在 1 个国家目标入组 128 人开始时间: 2004年1月1日最近更新: 2006年9月25日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: OraPharma
入组人数: 128
试验地点: 5
主要终点: The change in the mean sum of primary pathogens (P. gingivalis, To forsythensis, and T. denticola) from baseline to 30 days.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to measure the antimicrobial effects of Arestin in subjects with moderate to advanced periodontal disease

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Single

入排标准

年龄范围: 30 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Generalized moderate to advanced chronic periodontitis, five sites with probing depths of >5 mm in 5 non-adjacent interproximal spaces, excluding the distal of terminal teeth, at least 16 teeth excluding 3rd molars and implants

排除标准

•Allergy to tetracycline
•Subjects with aggressive periodontitis
•Acute necrotizing ulcerative gingivitis, or gross decay
•Systemic conditions which could influence the course of periodontal disease (i.e, diabetes, autoimmune disease, etc)
•Individuals requiring prophylactic antibiotics
•Any periodontal therapy within the previous 3 months (excluding maintenance therapy)
•Systemic or local antibiotic therapy within three months

结局指标

主要结局

The change in the mean sum of primary pathogens (P. gingivalis, To forsythensis, and T. denticola) from baseline to 30 days.

次要结局

Changes in the numbers of each of the primary pathogens, changes in pocket depth, attachment level, and proportion of sites bleeding on probing

研究者

发起方

OraPharma

申办方类型

Industry

研究点 (5)

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