Efficacy of a New-generation Platelet-Rich Fibrin in the Treatment of Periodontal Intrabony Defects : a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Periodontal clinical parameters
研究概览
简要总结
The aim of this randomized clinical trial was to clinically evaluate and compare the healing of intrabony defects after treatment with advanced platelet-rich fibrin (A-PRF+) toped flap debridement (OFD) in periodontitis patients.
详细描述
Thirty (30) intrabony defects are randomly divided in two treatment groups: test (n = 15) and control (n = 15). The intrabony defects are filled with A-PRF+ (n=15) in the test group, respectively treated with open flap debridement in the control group, and fixed with sutures to ensure wound closure and stability.
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •no systemic diseases
- •a good level of oral hygiene
- •presence of a 2-, 3-, or combined 2-3-wall intrabony defect with a defect angle of 20-40 (+/- 5) degrees
- •with a minimum PPD of 6 mm and intrabony component of a minimum 4 mm as detected on radiographs
- •no smoking
排除标准
- •systemic diseases that could influence the outcome of the therapy
- •poor oral hygiene
- •horizontal bone loss
结局指标
主要结局
Periodontal clinical parameters
时间窗: Change from baseline after 6 month and after 12 month
to determine the clinical attachment level (CAL) With a calibrated periodontal probe we are examining the changes of periodontal probing depth (PPD) and gingival recession (GR) after surgical procedure in mm, the two parameters are used to determine the clinical attachment level (CAL).
次要结局
未报告次要终点