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.
研究组 & 干预措施
Albumin Platelet Rich Fibrin (Alb-PRF)
For the production of Alb-PRF membrane, two 10 ml vacuum plastic tubes will be centrifuged at 700 g for 8 minutes. After centrifugation, the upper layer (yellow layer) shows the liquid plasma layer. The most upper layer of platelet-poor plasma (PPP) will be collected in a syringe and then will be heated in a heat block device at 75°C for 10 minutes to create denatured albumin (albumin gel). After heating, the albumin gel will be cooled to room temperature for approximately 10 minutes. An injectable albumin gel was then prepared. The liquid platelet-rich layer (liquid-PRF), including the buffy coat layer with accumulated platelets, leukocytes and growth factors, will be collected in a separate syringe and will be reserved at room temperature (20°C). The albumin gel and liquid PRF will be then thoroughly mixed by utilizing a female-female luer lock connector
干预措施: Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST) (Procedure)
Minimally Invasive Surgical Technique (MIST)
Surgical approach will be the Minimally Invasive Surgical Technique (MIST) approach according to; simplified or modified papilla-preservation flap design upon the papilla width.
Defects will be thoroughly debrided using Gracey curettes and ultrasonic scalers.
Then, a single internal mattress suture using 5-0 polypropylene sutures will be placed at the defect-associated inter-dental area.
干预措施: Minimally invasive surgical technique (MIST) (Procedure)
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