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临床试验/NCT03302429
NCT03302429已完成不适用

Evaluation of Platelet-rich Fibrin / Biphasic Calcium Phosphate Effect Versus Autogenous Bone Graft on Reconstruction of Alveolar Cleft Defect in the Maxillary Arch: Randomized Controlled Clinical Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2017年11月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
bone height

研究概览

简要总结

P- Maxillary alveolar cleft defects I- Platelet-rich fibrin (PRF) combined with biphasic calcium phosphate (BCP) C- Autogenous bone graft O- Outcome measure : bone height, bone volume, hospital stay, operation duration T- 6 months S- Randomized controlled clinical trial this study aimed to answer a clinical question whether the use of Platelet-rich Fibrin (PRF) combined with Biphasic Calcium Phosphate (BCP), can be an alternative to autogenous bone graft in reconstruction of alveolar cleft defect in maxillary arch.

详细描述

this study aimed to answer a clinical question whether the use of Platelet-rich Fibrin (PRF) combined with Biphasic Calcium Phosphate (BCP), can be an alternative to autogenous bone graft in reconstruction of alveolar cleft defect in maxillary arch

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
8 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients suffering from maxillary alveolar cleft
  • Patients' age 8 years and older

排除标准

  • Syndromic cases will be excluded
  • Patients suffering from platelets disorders.

研究组 & 干预措施

PRF/ BCP

Experimental

Biphasic calcium phosphate (BCP)"bioceramic bone substitute combined with platelet rich fibrin PRF

干预措施: PRF/ BCP (Other)

autogenous bone graft

Active Comparator

Autogenous bone graft involving utilizing bone obtained from the same individual receiving the graft

干预措施: Autogenous bone graft (Other)

结局指标

主要结局

bone height

时间窗: six months postoperative.

the vertical bone height measured from the most coronal level of the pyriform aperture to the most apical level of the bony bridge.

次要结局

  • bone volume(six months postoperative.)
  • operation duration(within 4 hours ( the actual number of hours will be determined intra-operative ))
  • hospital stay(within 7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hebatallah G Samra El-Shamy

resarcher

Cairo University

研究点 (2)

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