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Khoury's Bone Shell Technique Versus Titanium-Reinforced Polytetrafluoroethylene for Augmentation of Horizontal Deficiency in Posterior Mandible (Histomorphometry Analysis)

2026年7月15日 更新者:Abdelaziz、British University In Egypt

Khoury's Bone Shell Technique Versus Titanium-Reinforced Polytetrafluoroethylene for Augmentation of Horizontal Deficiency in Posterior Mandible (Histomorphometry Analysis): A Randomized Clinical Trial

The purpose of the study is the comparison of bone gained histologically from the Bone Shell Khoury's Technique in comparison with the usage of non-resorbable membrane polytetrafluoroethylene and discussing its eligibility for implant placement in restoring the atrophic posterior mandible.

研究概览

详细说明

The aim of this study is to assess the bone gained histologically when comparing the following different techniques:

One of the techniques that is used for bone augmentation is the Khoury technique which entails that a split cortical bone shell obtained from the ramus area through piezoelectric surgery. The thin laminae of bone obtained is stabilized in the defect area labially through micro screws and the generated gap is filled through a mixture of autogenous that could be obtained from the retromolar area through special burs as the auto chip maker (ACM) or via bone scrapper. The obtained is mixed with an equal ratio with xenograft or bone obtained from animal source to fill the created gap.

Another technique involves the usage of a non-resorbable membrane known as reinforced titanium PTFE that is stabilized from both the lingual and labial aspects via micro screws .It's then filled with a mixture of both autogenous and xenograft for maximizing the bone formation capability. In some cases, the reinforced titanium PTFE is covered with collagen membrane to avoid one of the common drawbacks of this technique which is wound dehiscence.

This study aims to evaluate the bone quality gained from both techniques.

研究类型

介入性

注册 (估计的)

16

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Cairo、埃及
        • 招聘中
        • The British university in Egypt
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  1. Have two or more missing teeth in the posterior mandibular segment.
  2. The patients age of 18 and above.
  3. The alveolar ridge in the edentulous site of the selected patients will have a buccolingual width of less than 4mm.
  4. Sufficient vertical bone height.
  5. Free of any local or systemic condition that may contraindicate ridge expansion procedure.

Exclusion Criteria:

  1. Patients taking any medication that may interfere with bone healing or bone biology.
  2. Patients with any systemic disease that may affect bone healing.
  3. Any patients with any previous bone grafting procedure at the site of interest.
  4. Smokers.
  5. Patient's that have been diagnosed with periodontal disease, as sufficient ridge height would be improbable.
  6. Patients with significant vitamin D deficiency.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:GBR using Ti based PTFE
This group will receive a non resorbable membrane using titanium reinforced polytetrafluorethylene membrane.
Patients will receive a non resorbable membrane using titanium reinforced polytetrafluorethylene membrane with full releasing flap buccal and lingual with the lingual dissection for the releasing of the mylohyoid attachment and nerve dissection of the mental nerve buccally. The membrane needs to be fixed lingually with microscrews or titanium screws then the gap will be filled through Auto Chip Maker ACM or bone scraper from the external oblique ridge. Then the harvested bone shall be mixed xenograft with ratio 70 to 30 then the membrane fixed buccally as well as covered by collagen membrane to avoid one of the main obstacles of the procedure which is wound dehiscence.
有源比较器:Bone Shell Khoury's Technique
This group will receive a block graft using Khoury Technique.
A block graft using Khoury Technique: Prior to harvesting the needed bone, measurement of the defect size as well as measurement of the donor site bone block will be harvested from the mandibular retromolar area. The bone shall be acquired through piezoelectric device that perform the osteotomy then separated through the usage of thin chisel. The acquired bone needs to be smoothened to avoid any sharp edge that may cause wound dehiscence or infection. The harvested bone will be divided into two thinner bone shells through using titanium disk with copious irrigation with saline. The bone shell shall be fixated in the defect site buccally through two microscrews at least then the created space shall be filled with a combination of autogenous bones harvested through Auto Chip Maker (ACM) or bone scraper from the external oblique ridge. The harvested bone will be combined with xenograft with ratio 70 to 30 then the defect shall be covered with collagen membrane.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Histomorphometric analysis of gained bone
大体时间:6 Months
Primary evaluation is achieved through re opening of the flap after 6 months for removing the microscrews used in Khoury group and the nonresorbable membrane as well as the screws will be removed from the nonresorbable membrane group. Then the usage of 2 millimeters bur for core biopsy at the site of the implant that will be placed.
6 Months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年6月20日

初级完成 (估计的)

2026年10月1日

研究完成 (估计的)

2027年3月1日

研究注册日期

首次提交

2026年6月21日

首先提交符合 QC 标准的

2026年6月21日

首次发布 (实际的)

2026年6月25日

研究记录更新

最后更新发布 (实际的)

2026年7月16日

上次提交的符合 QC 标准的更新

2026年7月15日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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