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临床试验/NCT06095843
NCT06095843已完成不适用

"Bony Changes Around Dental Implant Placed in Free Vascularized Fibular Graft Versus Non-Vascularized Iliac Crest Graft in Mandibular Reconstruction"

Ain Shams University2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
stability of dental implants

研究概览

简要总结

The goal of this clinical trial is to evaluate the bony changes around dental implants in non-vascularized iliac crest grafts and free vascularized fibular flap in mandibular reconstruction.

The main question it aims to answer are:

• evaluate the bony changes around dental implants and it's survival rate in both groups

详细描述

The current prospective study was conducted on 10 patients that were selected and admitted for early or delayed mandibular reconstructive surgery from the outpatient who were referred to the department of Oral and Maxillofacial Surgery Faculty of Dentisry, Ain Shams University in the period from January 2018 till June 2022.

The patients in this study were divided into two groups. First group endured non-vascularized iliac crest grafting with delayed implant insertion while the second group endured vascularized fibular flap with delayed implant insertion. Implant placement was done six months after performing reconstructive surgery.At the second stage surgery, all succeeded implants were loaded with fixed implant supported prothesis. Follow- up was done 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks postoperatively.

Crestal bone stability was analyzed using CBCT radiographs along with the percentages of of the survived implants and ISQ values were measured using an ostell device.

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

入选标准

  • patients following traumatic injuries
  • gunshot injuries
  • tumor ablative surgeries
  • osteomylitis and osteonecrosis affecting the mandible

排除标准

  • cardiovascular or pulmonary disease
  • vascular or bone disorder
  • previous fractures or surgeries related to the donor site

结局指标

主要结局

stability of dental implants

时间窗: 1 year

measuring primary and secondary stability (ISK)

bony changes around dental implants

时间窗: 1 year

measuring crestal bone loss (mm)

survival rate of dental implants

时间窗: 1 year

measuring survival rate of dental implants (%)

次要结局

未报告次要终点

研究者

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

Maged Mohamed Mostafa

Assistant lecturer of oral and maxillofacial surgery

Ain Shams University

研究点 (2)

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