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临床试验/NCT03716323
NCT03716323Unknown不适用

Evaluation of Marginal Bone Loss After Immediate Implant Placement in Maxillary Premolar Zone With Allograft Versus Xenograft

Cairo University0 个研究点目标入组 42 人开始时间: 2018年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
42
主要终点
Marginal Bone Loss

研究概览

简要总结

Immediate implant placement has the disadvantage of difficulty in obtaining primary stability, lack of adequate soft tissue coverage and also the control of the implant position is difficult in addition to the cost of the graft. Autogenous bone graft is considered to be the golden standard for grafting as it has osteoconductive , osteoinductive and osteogenic functions , however it has the problems of donor site morbidity , the need for two surgeries as well as post operative swelling and discomfort of the patient , so alternative bone grafts as allografts and xenografts, has been introduced.

详细描述

Allograft bone is obtained from individuals of the same species, derived from human-cadaver bone that has been selected and tested to be free of HIV and transmitted diseases. The most common allograft used is dematerialized freeze-dried bone allograft (DFDBA), provide type I collagen, which comprises most of the organic component of bone. In addition, allograft contains BMPs, which stimulate osteoinduction. There are thirteen proteins have been identified (BMP1-BMP13) which are osteoinductive compounds and stimulate new bone formation. A previous study demonstrated that, a combination of osseous coagulum collected during preparation and freeze-dried bone allograft placed at immediate implant insertion and loading. Xenografts are one of the most successful and widely used grafting materials nowadays as a replacement for autogenous bone grafts. Studies showed that xenografts are very successful because of their osteoconductive properties, their denisty which provides stabilization to the graft and implant and they supply the necessary minerals for bone formation as xenograft don't resorb completely.

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
25 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients with badly broken teeth in upper premolar zone indicated for extraction, presence of at least 3 mm of bone beyond the root apex to guarantee implant primary stability, implant placement within the alveoli confines.
  • Both sexes.
  • No intraoral soft and hard tissue pathology.
  • No systemic condition that contraindicate implant placement.

排除标准

  • Presence of fenestrations or dehiscence of the residual bony walls after extraction.
  • Heavy smokers more than 20 cigarettes per day.
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.

研究组 & 干预措施

immediate premolar implant with xenograft and allograft

Experimental

Immediate Implant Placement in Maxillary Premolar zone with grafting the jumping gap using xenograft and allograft

干预措施: immediate premolar implant with xenograft and allograft (Device)

结局指标

主要结局

Marginal Bone Loss

时间窗: 6 months

The amount of marginal bone loss will be measured using cone beam computed tomography

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

Ahmed Mohammed Abdallah AbdelFattah

principal investigator

Cairo University

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