Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin (Alb-PRF) Versus Minimally Invasive Surgical Technique (MIST) in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Clinical attachment level (CAL)
研究概览
简要总结
Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients.
The goal of this clinical trial is to compare Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. The main question aims to answer are:
will Albumin Platelet Rich Fibrin (Alb-PRF) as adjunct to minimally invasive surgical technique (MIST) be superior in terms of improvement in clinical parameters compared to the use of PRF with MIST.
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 intrabony defect ≥3 mm in depth (assessed by bone sounding, radiographic examination) with clinical attachment level (CAL) ≥5mm and probing pocket depth (PPD) ≥6 mm with no defect extending to a root furcation area.
- •Vital teeth.
- •No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
- •No periodontal therapy carried out in the past 6 months.
- •Ability to sign an informed consent form.
- •Patients age ≥18 years old.
- •Patients who are cooperative, motivated, and hygiene conscious.
- •Systemically free according to Cornell Medical Index.
排除标准
- •Patient undergoing orthodontic treatment.
- •Pregnant females or breast feeding.
- •Teeth mobility greater than grade I.
结局指标
主要结局
Clinical attachment level (CAL)
时间窗: CAL will be measured at base line, 6, and 9 months postoperative
CAL will be measured from the cemento-enamel junction to the bottom of the gingival sulcus/periodontal pocket using the University of North Carolina periodontal probe at six sites per tooth.
次要结局
- Probing Depth (PD)(CAL will be measured at base line, 6, and 9 months postoperative)
- Radiographic Linear Defect Depth (RLDD)(Radiographic defect fill will be measured at base line, 6, and 9 months postoperative)
- Recession Depth (RD)(RD will be measured at base line, 6, and 9 months postoperative)
- Post-operative Pain(During first week postoperative)
- Radiographic defect fill (RDF)(Radiographic defect fill will be measured at base line, 6, and 9 months postoperative)
研究者
Mashaal Mohammed Abdullah Mohammed
Principal Investigator
Cairo University