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临床试验/NCT03175458
NCT03175458Unknown不适用

Schnederian Membrane Elevation and Augmentation With Deproteinized Bovine Bone [Tutu-gen Bone] Versus Graft Less Tenting Technique With Simultaneous Implant Placement: Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
patient satisfaction

研究概览

简要总结

30 recruited patients indicated for sinus membrane elevation with simultaneous implant placement. patients are divided into 2 groups each group contain 15 patients, one group assigned for placement of bovine bone graft after membrane elevation and insertion of the implants while the other group assigned for graft-less tenting technique after membrane elevation and insertion of the implant.

详细描述

On the 2 groups a mucoperiosteal flap is elvated then a lateral wondow is created then sinus membrane is elevated then the implants are placed, in the control group deproteinized bovine bone graft substitute is placed in the sinus for augmentation while in the study group no bone graft is added inside the sinus( graftless tenting technique)

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with atrophic maxilla and pneumatization of the maxillary sinus with residual bone height at least 5mm as per MISCH criteria.
  • both sexes.

排除标准

  • sinus pathology
  • heavy smokers(more than 20 cigarettes per day.
  • patients with systemic disease that may affect normal healing.

结局指标

主要结局

patient satisfaction

时间窗: 7 days post operative

evaluation of post operative complications in terms of pain and edema using patient pain chart

次要结局

  • implant stability(will be measured intraoperatively immediately after insertion of the implants and will be measure one more time 6 months after the 1st operation at the time of exposure of the implants)
  • height of bone gained or lost around the implants(6 months postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Waleed Fouad Mahmoud

doctor

Cairo University

研究点 (1)

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