Treatment of Residual Pockets in Periodontal Patients Using an Oscillating Chitosan Device - A Randomized Parallel Arm Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Probing Pocket Depth
研究概览
简要总结
The aim of the current study was to investigate the effect of a chitosan brush on the treatment of residual pockets in patients already treated for periodontal disease. Thirty-six patients with chronic periodontitis (Stage ΙΙΙ, ΙV) that had already completed causative therapy and exhibited at least two residual periodontal pockets ≥ 5mm that bled on probing, were randomly assigned to two groups. In the test group debridement of residual pockets was performed with ultrasonic scaler and the chitosan brush, whereas in the control group only ultrasonic scalers were used.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18 or over
- •Subjects diagnosed with chronic periodontitis, Stage III or IV, and had received full mouth scaling and root planning at least three months prior to baseline examination
- •Subjects with at least two residual periodontal pockets of at least 5mm depth that bled on probing
- •Full mouth plaques scores ≤20%
排除标准
- •Subjects that had received antibiotic therapy 6 months prior to initial examination
- •Subjects with compromised systemic conditions
- •Patients undergoing chemotherapy or radiotherapy
- •Pregnant or lactating women
结局指标
主要结局
Probing Pocket Depth
时间窗: baseline, 6 weeks, 3 months, 6 months
the distance from the mucosa margin to the bottom of the periodontal pocket
MMP-8
时间窗: baseline, 6 weeks, 3 months, 6 months
levels of matrix metalloproteinase -8 in gingival crevicular fluid
次要结局
- Gingival Recession(baseline, 6 weeks, 3 months, 6 months)
- Bleeding on Probing(baseline, 6 weeks, 3 months, 6 months)
- Clinical Attachment Level(baseline, 6 weeks, 3 months, 6 months)
研究者
Georgia Tseleki
Postgraduate Student, principal investigator
Aristotle University Of Thessaloniki