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临床试验/NCT04376320
NCT04376320已完成不适用

Comparison of Two Pre-prosthetic Surgical Techniques for Augmentation of Mandibular Vertical Ridge Defects

Lydia Nabil2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14
试验地点
2
主要终点
mean percentage of change of alveolar bone height

研究概览

简要总结

The aim of this study is to compare two pre-prosthetic surgical techniques for augmentation of vertical mandibular ridge defects in preparation for implant placement, the first using customized ceramic membranes and the second using tenting titanium screws in conjunction with particulate bone graft and collagen membrane (modified sausage technique).

详细描述

Background: Expansion of the periosteum and soft tissue matrix by tenting has been described as a method of Guided Bone Regeneration (GBR) for reconstruction of atrophic alveolar ridges.

Materials and Methods

The current study is a prospective controlled clinical trial, conducted on 14 patients, having about 7 mm of vertical bone height in the posterior mandible above the inferior alveolar canal. They are divided into 2 equal groups, each consisting of 7 patients. The first group receives customized ceramic membranes with a vertical height 5 mm above the crest of the ridge to tent out the soft tissue matrix, while in the second group, tenting of the soft tissue is done by fixation of two tenting screws, particulate bone graft is packed then covered by collagen membrane that is fixed by bone tacks (modified sausage technique).

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients of both genders
  • with age range from 40 to 60 years,
  • having about 7 mm of vertical bone height in the posterior mandible above the inferior alveolar canal and
  • requiring prosthetic rehabilitation with dental implants.

排除标准

  • heavy smokers,
  • patients undergoing radiotherapy or chemotherapy,
  • those having infection or local lesions in the area of surgery, and
  • patients with bone diseases which may compromise the results

结局指标

主要结局

mean percentage of change of alveolar bone height

时间窗: 6 months

change of alveolar bone height after surgery

次要结局

未报告次要终点

研究者

发起方
Lydia Nabil
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lydia Nabil

Assistant Professor of Oral and Maxillofacial Surgery

University of Alexandria

研究点 (2)

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