Evaluation of Computer-Guided Secondary Alveolar Cleft Bone Grafting With and Without Platelet-Rich Fibrin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Closure of oronasal fistula
研究概览
简要总结
This study aims at investigating the role of platelet-rich fibrin in alveolar cleft secondary grafting. This grafting is done from the patient's chin using a computer-guided stent that is customized for each patient, and the cleft volume is analysed at first to estimate the needed amount of bone to be harvested.
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
- None
入排标准
- 年龄范围
- 9 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients who are classified according to the American Society of Anesthesiologists (ASA) physical status classification as class I.
- •Patients seeking treatment and accepting to be enrolled in the study, so as their guardians.
- •Patients who will age 9-14 years old by the surgery day.
- •Patients with adequate chin bone volume that could be harvested without marked donor site morbidity, as pre-determined by cone beam computed tomography.
排除标准
- •Patients with systemic illness, i.e. ASA(22) classes II, III, IV, and V.
- •Patients with previously operated alveolar clefts and seeking revision for the same cleft.
- •Patients that wouldn't be able to attend the recalls.
- •Patients with other craniofacial anomalies and associated syndrome conditions.
- •Edentulous maxilla, atypical or non-described cleft diagnosis.
- •Patients with history of chemotherapy or radiotherapy.
结局指标
主要结局
Closure of oronasal fistula
时间窗: Six months postoperatively
* By questioning the patient if there's a nasal regurgitation or not. * Qualitative outcome (positive or negative).
Volume of newly formed bone
时间窗: Six months postoperatively
* By computerized measurement on the Cone-Beam Computed Tomography software. (Volume tool in Invesalius ® software (Invesalius, CTI, Brazil)). * Quantitative outcome (in cubic millimetres (mm3)).
Average density of newly formed bone
时间窗: Six months postoperatively
* By computerized measurement on the Cone-Beam Computed Tomography software. (Average density tool in Invesalius ® software (Invesalius, CTI, Brazil)). * Quantitative outcome (in Hounsfield Units (HU)).
次要结局
未报告次要终点