Clinical and Radiographic Evaluation of Injectable PRF With Demineralized Freeze-Dried Bone Allograft (DFDBA) Compared to (DFDBA) in Treatment of Intraosseous Defects in Patients With Stage III Periodontitis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Clinical attachment level gain (CAL)
研究概览
简要总结
Clinical and radiographic evaluation of injectable platelet rich fibrin (i-PRF) and demineralized freeze-dried bone allograft (DFDBA) compared to demineralized freeze-dried bone allograft (DFDBA) alone in management of intraosseous defects in stage III periodontitis patients.
详细描述
Intraosseous defects are defined by the apical location of the periodontal pocket to the alveolar crest. In a recent radiographic study employing cone-beam computed tomography, a high prevalence of intraosseous defects 83% has been reported. Treatment of intraosseous defects is clinically challenging, as they often require complex regenerative periodontal therapy. Current regenerative techniques often employed in treatment of intraosseous defects demonstrate variation in improvement of clinical outcomes and degree of periodontal regeneration achieved.
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
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 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 ≥ 5 mm and pocket depth ≥ 6 mm.
- •Defect not extending to a root furcation area
- •Vital teeth
- •Non-smokers.
- •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.
- •Able to sign an informed consent form.
- •Patients age between 25 and 50 years old.
- •Patients who are cooperative, motivated, and hygiene conscious.
- •Systemically free according to Cornell Medical Index
排除标准
- •Pregnancy or breast feeding
- •The presence of an orthodontic appliance
- •Teeth mobility greater than grade I
研究组 & 干预措施
Injectable Platelet Rich Fibrin (i-PRF) with DFDBA
In i-PRF assigned group, 10 cc of blood per intraosseous defect will be collected right after administering the anaesthesia and will be processed according to the technique proposed by Choukroun et al., 2017 (centrifuged at 700 rpm, for 2-3 minutes). The yellow part will be collected using a syringe and added to a cup that contains the bone grafting material.
The i-PRF consolidated bone graft will placed into the intraosseous defect.
干预措施: Injectable platelet rich fibrin combined with DFDBA (Procedure)
Demineralized Freeze-Dried Bone Allograft (DFDBA) alone
After debridement and intraoperative recordings, in the control group, the bone graft material will be placed in the intraosseous defect without overfilling.
干预措施: Demineralized Freeze Dried Bone Allograft (Procedure)
结局指标
主要结局
Clinical attachment level gain (CAL)
时间窗: CAL will be measured at base line, 3, 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)(PD will be measured at base line, 3, 6, and 9 months postoperative)
- Gingival Recession Depth (RD)(RD will be measured at base line, 3, 6, and 9 months postoperative)
- Radiographic defect fill (IBD)(Radiographic defect fill will be measured at base line, 6, and 9 months postoperative)
- Post-surgical patient satisfaction(After 9 months postoperative)
研究者
Mashaal Mohammed Abdullah Mohammed
Principal Investigator
Cairo University