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临床试验/NCT03544580
NCT03544580已完成不适用

Soft Tissue Esthetic With Autogenous Dentin Chips and Immediate Implantation Versus Conventional Immediate Implantation With Xenograft in Thin Buccal Bone: (Randomized Controlled Clinical Trial )

Cairo University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Soft tissue esthetics

研究概览

简要总结

After tooth extraction, host bone resorption and atrophy of alveolar ridge may be observed. Bone resorption occurs specially in incisors and premolar area of jaw in region of thin buccal bone that may lead to change in contour. Total clinical bone loss height approximately 2-5 mm at first 6 months may be observed in vertical dimension , after 12 months alveolar ridge may lose up to 50 % of its width.

详细描述

Recently augmentation with bone grafting became one of the most common techniques surgically ; progressive bone resorption may be prevented by using augmentation procedures with use of graft materials. The gold standard in regenerative procedures is autogenous bone graft because of osteoinduction , osteoconduction and osteointergration properties required in regeneration. In autogenous bone graft there is need for a second surgical site , donor site morbidity and limited availability will lead to challenge for alternative bio-materials.

Extracted healthy non functional teeth from human are considered to be a dental waste all over the world. High proportion of extracted sockets are left untreated for physiological healing. Inadequate or failure of bone healing in sockets has been seen due to absence of bone graft material. Stem cells, matrix , trace metal ions and growth factors are rich in human tooth. Bone and dentin tissue structure are different but ratio of components is similar (mineral 70% , collagen 20% and body fluid 10% by weight). Dentin after demineralization is mainly composed of type 1 collagen 95% and non collagenous proteins as growth factors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient related :
  • Patient who only need to restore this single tooth.
  • Good oral hygiene
  • Systemically healthy (free from any systemic diseases)
  • Site related :
  • Hopeless tooth (nonrestorable, badly broken, endodontically treated) indicated for extraction and immediate implant placement
  • Esthetic area with thin buccal bone
  • Having periapical bone more than 3mm for primary stability

排除标准

  • Patient related :
  • Pregnant woman
  • Site related
  • Teeth that have to be extracted due to advanced periodontal bone loss
  • Trauma in aesthetic area
  • Periapical infection.

结局指标

主要结局

Soft tissue esthetics

时间窗: 12 months

pink esthetic score will be taken by photos from the day of surgery till 12 months postoperatively. The PES will evaluate the mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, and root convexity/ soft tissue color and texture at the facial aspect of the implant site as five variables. A score of 2, 1, or 0 is assigned to each of five PES parameters. Thus, in case of an implant restoration, a maximum total PES of 10 is possible

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

Cherine Emad Mahmoud Mohamed Hamada

principal investigator

Cairo University

研究点 (2)

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