'A Comparison of Platelet Rich Fibrin & Mineralised Freezed Dried Bone Allograft to Radiographically Evaluate Healing Post Endodontic Surgery'- an In-vivo Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in radiographic healing of periapical tissue after Apicoectomy
研究概览
简要总结
AIM: The aim of this study was to compare and evaluate the radiographic healing in patients undergoing apical surgery, using Freeze dried mineralized bone allograft and Platelet-rich Fibrin. OBJECTIVES: To evaluate radiographic healing after periapical surgery using Freeze dried mineralized bone allograft. To evaluate radiographic healing after periapical surgery using Platelet rich Fibrin. To compare the radiographic healing after periapical surgery using Freeze dried mineralized bone allograft and Platelet rich Fibrin. Method: Patients were selected(according to the inclusion criteria) and randomly allocated to PRF and Bone Graft groups.Following apicoectomy PRF gel and FDBA graft were prepared and placed in the osseous defect followed by placement of PRF membrane for graft stabilization and flap closure. Radiographic follow up was done at 1st, 3rd, 6th and 12th months for evaluation of healing using Molven Criteria.
详细描述
The present study will be carried out to compare the post surgical healing of Platelet Rich Fibrin (PRF) & Mineralised freeze-dried bone allograft (FDBA) in the Department of Conservative Dentistry & Endodontics at Saraswati Dental College, Lucknow. The study will be commenced only after due permission and clearance from the Institutional Review Board and Ethical Committee.
Cases will be selected according to the inclusion criteria after obtaining informed consent from the parents. Patients will be diagnosed based on clinical signs & symptoms, intraoral & radiographic findings. A routine medical history followed by blood investigations will be part of the surgical protocol.
After meeting the above criteria the patients will be randomly assigned to either PRF group (Group-A) or Mineralised FDBA group (Group-B) After successful administration of Local Anaesthesia the surgical procedure will be carried out that will include reflection of a full thickness mucoperiosteal flap by sulcular incision and two relieving vertical incisions. Debridement of tissues at the defect site will be done followed by irrigation with sterile saline solution.
In Group-A patients :- 10ml of venous blood will be drawn from the patients by using a 18 gauge needle after selecting a suitable site for venipuncture. Blood will be collected in tubes without anticoagulant and immediately centrifuged at 3,000 rpm for 10min which will result in a fibrin clot containing the platelets located in the middle of the tube, between a layer of red blood cells at the bottom and acellular plasma at the top. This clot will be removed from the tube and the attached red blood cells will be scraped off and discarded.
PRF will be placed into the defect site and wound closure will be performed using appropriate sutures.
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)
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult teeth with failed conventional endodontic therapy and a need for periapical root end surgery.
- •Teeth with bony defect confined to periapical area.
- •Adult individuals presenting a tooth with persisting periapical radiolucency.
- •Adult individuals presenting a tooth with persistent fistula.
- •Adult individuals presenting a tooth with persisting symptoms after orthograde re-treatment.
排除标准
- •Patients with severe systemic disorder (i.e. uncontrolled diabetes, immunologic diseases, malignancy), thrombocytopenia or insufficient compliance.
结局指标
主要结局
Change in radiographic healing of periapical tissue after Apicoectomy
时间窗: Change from Baseline radiographic score at 12 months
Two endodontists extraneous to the present study evaluated the radiographs post intervention and scored the healing according to Molven's scoring criteria for radiographic healing where 0 is representative of unsatisfactory healing and 3- complete healing
次要结局
未报告次要终点
研究者
Madhur Garg
Principal Investigator
Saraswati Dental College