Evaluation of CAL Gain Following Treatment of Intraosseous Defects With A-PRF+ Compared to Open Flap Debridement in Patients With Stage III Periodontitis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Clinical Attachment Level (CAL) gain
研究概览
简要总结
To assess the effectiveness of advanced PRF+ as compared to open flap debridement in treatment of periodontal intraosseous defects in stage III periodontitis patients.
详细描述
The application of platelet concentrates characterized by high concentrations of platelets and growth factors have been applied and investigated as possible periodontal regenerative therapy. The application of platelet rich fibrin in management of intraosseous and furcation defects produce more favorable outcome compared to open flap debridement.
A-PRF+ represents the latest generation of platelet concentrates that could provide sustained and increased release of growth factors and could serve as an autologous cost-effective membrane in periodontal tissue regeneration procedures
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 (Outcomes Assessor)
盲法说明
Due to the type of intervention only the outcome assessor and the statistician will be blinded.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stage III periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intraosseous defect ≥ 3 mm in depth (assessed by bone sounding, radiographic examination) with clinical attachment level (CAL) ≥ 5mm and pocket depth (PD) ≥ 6 mm.
- •Defect not extending to a root furcation area
- •Non-smokers.
- •No history of intake of medications affecting the periodontium in the previous 6 months.
- •Able to sign an informed consent form.
- •Patients age between 18 and 60 years old.
- •Patients who are cooperative, motivated, and hygiene conscious.
- •Systemically free according to Cornell Medical Index (Broadbent, 1951).
排除标准
- •Pregnancy or breast feeding
- •The presence of an orthodontic appliance
- •Teeth mobility greater than grade I
结局指标
主要结局
Clinical Attachment Level (CAL) gain
时间窗: Change from Baseline Clinical Attachment Level (CAL) at 9 months
Clinical Attachment Level (CAL) will be measured from the cemento enamel junction (CEJ) to the bottom of the gingival sulcus/periodontal pocket using University of North Carolina (UNC) periodontal probe at six sites per tooth
次要结局
- Probing Depth (PD)(Probing Depth will be measured at base line,3,6, and 9 months postoperative)
- Radiographic defect fill(Radiographic defect fill will be measured at 6,9,months)
- Gingival Recession Depth (RD)(Gingival Recession Depth will be measured at base line,3,6, and 9 months postoperative)
研究者
Yasser Ali Abdu
Principal Investigator
Cairo University