Maxillary Horizontal and Vertical Bone Augmentation Using Particulated Biomaterial Associated With Autogenous Bone, Covered and Stabilized by a Collagen Membrane and Pins
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
- 否
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
Pedro Tortamano
PHD
University of Sao Paulo
