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临床试验/NCT04096209
NCT04096209Unknown不适用

The Effect on Dental Implant Stability With and Without Using 1:1 Mixture of Autogenous Bone and Anorganic Bovine Bone Minerals Particulates in Immediate Implant Placement in the Dental Esthetic Zone (A Randomized Clinical Trial)

Cairo University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
26
试验地点
1
主要终点
Implant stability

研究概览

简要总结

Xenografts are graft materials derived from the inorganic portion of animal bones; the most common source is bovine the removal of the organic component are processed to remove their antigenicity, while the remaining inorganic components provide a natural matrix as well as an excellent source of calcium. The disadvantage of xenografts is that they are only osteoconductive and the resorption rate of bovine cortical bone is slow.

However leaving the jumping gap empty has been the gold standard for immediate implantation as the formed blood clot will allow bone fill in that area.

详细描述

Not using a grafting material in the jumping gap was chosen as a comparator as it's the standard procedure usually applied and showed high success rates. This should allow us to assess whether the chosen grafting material would have a positive influence on the study outcomes as compared to it.

Intraoral and extraoral autologous bone grafts could be considered as the "Gold standard" pre-prosthetic dentoalveolar reconstruction of atrophic jaws with cortico-cancellous bone grafts from intraoral and/or extraoral donor sites as a predictable technique for the facilitation of dental rehabilitation of atrophic ridges, associated with high bone survival rate and long term implant success. Autogenous bone corresponds to bone graft obtained from the same individual. It is considered the gold standard for filling of bone defects since it allows (I) osseointegration: direct contact with bone tissue without fibrous tissue ; (II) osteoconduction: support to bone growth (III) osteoinduction: differentiation of mesenchymal cells of surrounding tissue (receptor site) into osteoblastic cells ; and (IV) osteogenesis: bone neoformation by osteoblastic cells present in the graft material. Although few mature osteoblasts survive to grafting, precursor cells are responsible for the osteogenic potential

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Age from 20-60 years
  • Both sexes
  • non-restorable maxillary incisors, canine and premolars
  • Good oral hygiene
  • Adequate bone height apical to the alveolus of the failing tooth

排除标准

  • Systematic disease which affect osseointegration (uncontrolled diabetes, cancer, etc...)
  • Bad oral hygiene
  • Bruxism, clenching, deep bite, edge to edge and abnormal habits
  • Non-treated periodontal diseases
  • Pregnancy and smokers
  • Severe infection
  • Absence of labial plate of bone (Fenestration, dehiscence).

研究组 & 干预措施

Graft-less and grafting using xenograft and autograft

Experimental

Extraction of badly decayed teeth with immediate implant placement using graft-less and grafting using autogenous bone and xenograft between the implant and labial socket bone

干预措施: autograft mixed with xenograft bone (Device)

结局指标

主要结局

Implant stability

时间窗: 4-6 months

implant stability will be measured using osstell

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

Sherine Osama El ebiary

principal investigator

Cairo University

研究点 (1)

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