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.
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
- 否
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 treatment
干预措施: Scaling and root planing (Procedure)
Scaling and root planing + Vehicle
Placebo
干预措施: Scaling and root planing (Procedure)
Scaling & root planing + Periocline Gel
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
