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临床试验/NCT02406924
NCT02406924Unknown不适用

Maxillary Horizontal and Vertical Bone Augmentation Using Particulated Biomaterial Associated With Autogenous Bone, Covered and Stabilized by a Collagen Membrane and Pins

Pedro Tortamano0 个研究点目标入组 24 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
24
主要终点
vertical gain

研究概览

简要总结

Twenty four patients with bone resorption on the anterior maxilla will be divided into two groups with different kinds of grafting: bone block associated with particulated biomaterial and particulated mixture of autogenous bone and biomaterial stabilized by collagen membrane and pins. The techniques will be compared according to volume gain, quality of graft osseointegration, implant survival and maintenance of the level of soft tissues.

详细描述

Twenty four patients will be selected analysing the resorption on the front maxilla and will be divided into two groups. Experimental group will receive a particulated mixture of autogenous and lyophilized bovine bone, stabilized with a collagen membrane and pins over the vertical and/or horizontal defect, while Control group will receive a bone block graft, stabilized with fixation screws , covered with lyophilized bone and a collagen membrane. After a period of nine months, the volume increase will be measured trough the difference found between the initial computerized tomography and the final computerized tomography.

Dental implants will be placed according to the prosthetic need and bone cylinders will be removed from the respective location. The cylinders will be histologically analysed in order to verify the quality of the graft osteointegration. After the prosthesis installation, the implant survival and the soft and hard tissues will be followed up for a minimum period of 24 months.

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 (Outcomes Assessor)

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

  • absence of teeth at anterior maxilla
  • need of vertical or horizontal bone reconstruction at anterior maxilla

排除标准

  • smoking habits
  • systemic diseases which interfere with osseous metabolism
  • active periodontal disease

结局指标

主要结局

vertical gain

时间窗: 9 months

Measures will be taken from computerized tomography in axial sections

implants survival

时间窗: 24 months

Clinical examination and standardized radiographs will be taken periodically

soft tissue volume

时间窗: 24 months

Measures will be taken from images generated by intraoral scanning in an occlusal view

horizontal gain

时间窗: 9 months

Measures will be taken from computerized tomography in transverse sections

次要结局

未报告次要终点

研究者

发起方
Pedro Tortamano
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pedro Tortamano

PHD

University of Sao Paulo

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