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临床试验/NCT01361321
NCT01361321已完成不适用

Examining Bone Quantity and Quality Following Standard Guided Bone Regeneration Procedures

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
1
主要终点
Volume of the new bone formed after a GBR procedure

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Volume of the new bone formed after a GBR procedure

时间窗: 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.

次要结局

  • Bone quality(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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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