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临床试验/NCT07839507
NCT07839507已完成不适用

Evaluation of Alveolar Cleft Grafting Using Khoury Shell Technique

Ministry of Health, Kuwait1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年1月3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
30
试验地点
1
主要终点
CBCT

研究概览

简要总结

Iliac cancellous bone is considered the gold standard graft material for secondary ABG, which was applied as a block or granules, and difficult to be stabilized in the recipient site causing dislodgment of the graft which in turn leads to resorption and/or continuity between nasal and oral cavities. On the other hand, the cortico-cancellous block graft produces more mechanical strength and stability, but the cortical part is less vascular, and so establishment of nutritional supply to cortical cells is a slow process. Therefore, this graft generally resorbs and is replaced by invasion of bone cells originating from the recipient site. Khoury F. and Khoury CH. made a variation by splitting the solid cortical bone into two thinner shells, so more vascular chips can be packed and take the advantage of more and early revascularization of cancellous bone plus the advantage of cortical bone in terms of mechanical stability and restoring the labial plate. In this study, we evaluate the regenerated bone following alveolar cleft grafting using Khoury shell technique.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 14 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •were patients within the age range of 7-14 years and with a unilateral or bilateral alveolar cleft in anterior maxilla.

排除标准

  • •were history of intravenous and/or oral bisphosphonate use, irradiation of the head and neck region, infection, immunocompromised and medically compromised (such as Diabetics) patients.

研究组 & 干预措施

inclusive arm

Active Comparator

This a single arm evaluative study in which an alveolar cleft grafting was done using Khoury shell technique from anterior iliac crest

干预措施: Alveolar Ridge Reconstruction (Procedure)

结局指标

主要结局

CBCT

时间窗: 6 months

Continuity of labial plate and maxillary arch

时间窗: 6 months

次要结局

未报告次要终点

研究者

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

Khalid Karkar

Oral & Maxillofacial Specialist

Ministry of Health, Kuwait

研究点 (1)

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