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Bone Quality and Quantity Following Guided Bone Regeneration

2017年11月29日 更新者:Hadassah Medical Organization

Examining Bone Quantity and Quality Following Standard Guided Bone Regeneration Procedures

Edentulism refers to a state of full or partial lack of teeth. This situation may interfere with essential functions such as mastication, speech and even appearance.

Dental implants inserted to the mandible or maxilla is a common treatment modality aiming to restore edentulus alveolar ridges by providing support and anchorage for removable or fixed dental prosthesis.There are cases which in addition to a lack of teeth suffer from lack of sufficient bone tissue volume to support the dental implant.A situation like this may originate from a variety of reasons such as residual bone atrophy, prior alveolar bone destruction due to periodontal disease and even a traumatic tooth extraction. In such cases, a routine alveolar bone augmentation is done to enable a dental implant installation at this site.Guided bone regeneration (GBR) is a widely used technique used to augment edentulus bone ridges. It relies on an inert membrane covering a bone substitute placed over the bony site requiring augmentation. The bone substitute provides a scaffold to alveolar regeneration by the host's osteoblasts while the membrane prevents unwanted epithelial cells to migrate to the bony defect area.

The investigators research is a aimed to preform a follow up after patients who already went through a GBR procedure and before inserting a dental implant. Patients answering the inclusion but not the exclusion criteria will go through an alveolar computerized tomography (C.T) done routinely before inserting dental implants.At the day of Dental implantation - residual bone left from the site of implantation (after preparing the site with a trephine bur) will be taken to a histological analysis. The results from the C.T and the histological examination will be analyzed for bone quantity (volume) and quality and will allow a comparison of bone characteristics obtained by using different routinely used bone substitutes.

研究概览

地位

完全的

研究类型

观察性的

注册 (实际的)

13

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。

学习地点

      • Jerusalem,、以色列
        • Hadassah Medical Organization

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

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Healty over 18 years of age Patients who went through a GBR procedure previous to an insertion of a dental implant which hasn't been insertd yet

描述

Inclusion Criteria:

  1. Healthy men and women over 18 years of age, eligible for signing
  2. Patients who went through a GBR procedure previous to an insertion of a dental implant which hasn't been inserted yet
  3. Patients who understand the meaning of the treatment (routine dental implant insertion) and the follow up study, and approves participation in booth of them

Exclusion Criteria:

  1. Pregnant or nursing women. children or non judgemental patients
  2. Patients with uncontrolled diabetas mellitus, rheumatoid arthritis or osteoporosis.
  3. Patients with a pathology present near the site of dental implantation

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

队列和干预

团体/队列
patients after GBR procedure
The study will comprise of patients who already underwent a routine Guided Bone Regeneration (GBR) procedure in order to augment a bony ridge before dental implant insertion. The patients will be followed up in order to determine bone quality and quantity formed after the usage of routinely used bone substitutes during GBR procedure.

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
Volume of the new bone formed after a GBR procedure
大体时间:Volume of the new bone formed after the GBR procedure will be determined 6-7 months after the GBR procedure and before the insertion of dental implants.
Bone volume obtained following a GBR procedure will be detemined through a comparison of a 3 dimensional analysis of computed tomography images done before and after the GBR procedure.
Volume of the new bone formed after the GBR procedure will be determined 6-7 months after the GBR procedure and before the insertion of dental implants.

次要结果测量

结果测量
措施说明
大体时间
Bone quality
大体时间:Bone quality will be assesed through histological analysis that will be carried out at the time of implants insertion 7-8 months after the GBR procedure.
The collected bone sample will be subjected to histo-morphometric analysis in order to determine the size, shape and orientation of the bony trabeculae,the size and porosity of the bony cortex in addition to the new bone/ bone substitute ratio.
Bone quality will be assesed through histological analysis that will be carried out at the time of implants insertion 7-8 months after the GBR procedure.

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。

调查人员

  • 首席研究员:Lior Shapira, Professor、Department of Periodontology

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

2012年2月1日

初级完成 (实际的)

2013年2月21日

研究完成 (实际的)

2013年2月21日

研究注册日期

首次提交

2011年5月18日

首先提交符合 QC 标准的

2011年5月25日

首次发布 (估计)

2011年5月26日

研究记录更新

最后更新发布 (实际的)

2017年11月30日

上次提交的符合 QC 标准的更新

2017年11月29日

最后验证

2013年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • bondbone-HMO-CTIL

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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