Treatment of Advanced Periodontitis Using an Oscillating Chitosan Device With or Without a Chitosan Gel - a Randomized Parallel Arm Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Bleeding on Probing change
研究概览
简要总结
In the here suggested study, the aim is to test non-surgical treatment of advanced periodontal disease with a chitosan brush with or without chitosan gel in patients with advanced periodontal disease having responded poorly to a more conventional treatment strategy, with the aim to hinder the progression of bone loss around the teeth.
详细描述
Labrida GeliX Chitosan gel 4% (LABRIDA AS, Oslo, Norway) is a chitosan gel. Labrida GeliX Chitosan gel 4% consists of water, chitosan (4%) and lactic acid (2%) and with pH 3.86. In this study GeliX Chitosan gel 4% shall be tested as an adjunct to mechanical debridement of infected tooth surfaces affected by periodontal disease and which have responded poorly to conventional treatment.
Hypotheses and study objectives
Null hypothesis and alternate hypothesis
H0:
There will be no significant difference in reduction in parameters of periodontal inflammation between the test and control groups after 6 and 12 months.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Bleeding on Probing change
时间窗: 12 months
Change in periodontal inflammation measured with the inflammation surrogate marker Bleeding on Probing using a categorial scale (modified Bleeding on Probing index (mBoP: 0, 1, 2, 3)) and
Pocket Probing depths change
时间窗: 12 months
Difference between test and control sites in Probing Pocket Depth (PPD)4 weeks , 3 months, 6, 9 and 12 months after baseline.
次要结局
未报告次要终点
研究者
Caspar Wohlfahrt
Head of Research and Development
Labrida AS