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临床试验/NCT00529555
NCT00529555已完成3 期

A 9 Month,3-arm Multicenter Clinical Trial of Treatment With Periocline Gel (2.1% Minocycline HCl) for Adjunctive Use to Scaling and Root Planing (SRP) in Adults With Periodontal Disease.

Sunstar Americas10 个研究点 分布在 1 个国家目标入组 602 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
602
试验地点
10
主要终点
Change in Pocket Depth.

研究概览

简要总结

Periodontal disease (commonly called gum disease) is generally treated by deep cleaning of the root surfaces of the teeth. This is also called scaling and root planing. Placing a topical antibiotic into the periodontal pocket at the time of scaling and root planing may help reduce pocket depth and thus help the periodontal disease. Periocline (minocycline HCl) 2.1% gel is a topical antibiotic approved in a number of countries for this use, and is now being tested in the US.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • moderate to severe periodontitis

排除标准

  • recent periodontal therapy
  • certain medical or dental conditions
  • pregnancy
  • allergy to active drug or related drugs

研究组 & 干预措施

Scaling and root planing + SHAM TX

Sham Comparator

sham treatment

干预措施: Scaling and root planing (Procedure)

Scaling and root planing + Vehicle

Placebo Comparator

Placebo

干预措施: Scaling and root planing (Procedure)

Scaling & root planing + Periocline Gel

Active Comparator

Minocycline HCL 2.1%

干预措施: minocycline HCl 2.1% (Drug)

结局指标

主要结局

Change in Pocket Depth.

时间窗: baseline & 9 months

Average change of Pocket Depth at 9 months from baseline

次要结局

未报告次要终点

研究者

发起方
Sunstar Americas
申办方类型
Industry
责任方
Sponsor

研究点 (10)

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