Clinical and Radiographic Evaluation of Using Iliac Crest Graft With and Without Platelet-Rich Fibrin (PRF) in Repair of Congenital Alveolar Cleft
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Changes in bucco-lingual thickness of the bone at the recipient site
研究概览
简要总结
A randomized clinical trial aims to evaluate the clinical and radiographic outcomes of the repair of congenital alveolar clefts using Iliac crest graft with and without mixing with platelet-rich fibrin
详细描述
Alveolar clefts occur in response to deviations from normal development in the growth, exposure, and fusion of the frontal eminence. The most common alveolar portion of the cleft is located between the central incisors and canines. The treatment of alveolar clefts is multidisciplinary and aimed at restoring normal ridge contour and functionality. Surgical wound closure is insufficient to repair bony defects, Additional materials are needed for these types of defects, such as bone grafts. Aim: The aim of this study is to evaluate the efficiency of using iliac crest bone graft with and without platelet-rich fibrin in repair of alveolar clefts. Methodology: This study will be conducted on 16 patients with alveolar clefts. The patients will be divided equally and randomly into 2 groups: Group 1 : 8 patients will be treated with iliac crest bone graft only (control group).Group 2: 8 patients will be treated with iliac crest bone graft with platelet-rich fibrin (study group).
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with congenital alveolar cleft who need secondary alveolar cleft repair.
- •Patients who are medically fit for surgery under general anaesthesia
排除标准
- •ASA 4 OR ASA 5 patients
- •Uncooperative patients
研究组 & 干预措施
with platelet-rich fibrin
study group: the patients will be treated with iliac crest bone graft with platelet-rich fibrin
干预措施: alveolar bone grafting Plus Platelet rich fibrin (Procedure)
without Platelet-rich fibrin
control group : the patients will be treated with iliac crest bone graft only
干预措施: alveolar bone grafting (Procedure)
结局指标
主要结局
Changes in bucco-lingual thickness of the bone at the recipient site
时间窗: 3 months and 6 months postoperatively
Post-operative cone beam computed tomographic radiographs will be done using the Scanora 3DX imaging system using a CMOS flat panel detector with isotropic voxel size 133 µm. The x-ray tube that is used to scan the patients possesses a current intensity of 10 mA, 90 KVp, and a focal spot size of 0.5 mm. The scanning time is 14 seconds of pulsed exposure, resulting in an effective exposure time of 3.2 seconds to scan FOV (field of view) of 14 cm height × 16.5 cm width. The raw DICOM data set images will be imported to the On-Demand software (Cybermed, Seoul, Korea) for secondary reconstruction and image analysis. CBCT will be performed, and linear measurements will be obtained in axial, sagittal, and coronal cuts to assess the changes in buccolingual thickness of the bone at the recipient site 3 months and 6 months post-operatively.
次要结局
- Calculation of the volume of bone fill in the recipient site(6 months postoperative)
- wound dehiscence(immediate, 7 days and 14 days postoperative)