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临床试验/NCT07066293
NCT07066293已完成不适用

Evaluation of Using Sticky Bone Grafting Combined With Concentrated Growth Factor Membrane for Repair of Unilateral Alveolar Cleft

Tanta University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年11月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
inflammation

研究概览

简要总结

The aim of this study is to evaluate using Sticky Bone grafting combined with concentrated growth factor membrane for repair of unilateral alveolar cleft.

详细描述

This study will be carried out on ten patients with unilateral alveolar clefts, The patients will be recieved, clinically& radiographically examined and managed at Oral & Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University.

Preoperative evaluation:

Clinical evaluation will include presence of oronasal fistulas, nasal regurgitation and Presence of erupting teeth in cleft. .Preoperative cone beam computed tomography (CBCT) scans will be analyzed to measure alveolar cleft dimensions and the total cleft defect volume will be calculated.

Surgical technique:

Under general anesthesia, mucoperiosteal flaps will be raised along the cleft margins, exposing the defect. The nasal lining will be sutured with 4/0 Vicryl, followed by the application of a concentrated growth factor (CGF) membrane to cover the nasal mucosa. The sticky bone graft will be packed tightly into the cleft, ensuring complete defect filling. A CGF membrane will be then placed over the graft to enhance stability and healing. The flaps will be sutured using tension-free interrupted 3/0 Vicryl sutures to ensure full coverage of the graft.

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
13 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with unilateral alveolar clefts requiring repair.
  • patients free from any systemic disease that may affect normal healing of bone.
  • patients at an age older than 12 years

排除标准

  • Bilateral alveolar clefts.
  • Immunocompromised patients.
  • Syndromic patients.

研究组 & 干预措施

Sticky Bone grafting with concentrated growth factor membrane for unilateral alveolar cleft

Experimental

This will include 10 patients in whom unilateral alveolar cleft will be repaired using sticky bone grafting combined with concentrated growth factor membrane

干预措施: Unilateral alveolar cleft repair (Procedure)

结局指标

主要结局

inflammation

时间窗: 1 month

mild, moderate, severe

nasal regurgitation

时间窗: 1 month

Yes or No

fistula recurrence

时间窗: 1 month

positive or negative

bone mineral density

时间窗: 1 month

soft ware

bone graft volume

时间窗: 1 month

soft ware

次要结局

  • bone graft volume(9 months)
  • bone mineral density(9 months)

研究者

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

Maram Nashaat Breshah

Lecturer of Oral & Maxillofacial Surgery

Tanta University

研究点 (2)

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