Use of Autologous Platelet Concentrate in Pre-Implantation Reconstruction of Maxilla.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Radiological outcome measure : the bone height under the sinus on the two sides.
研究概览
简要总结
This is a randomized open label trial that evaluates the efficacy of an autologous platelet concentrate (APC) in pre-implantation reconstruction of maxilla.
The sinus occlusion will be performed under general anaesthetic. On one side by the usual technique with hipbone transplant, the other side will be restored with APC mixed with autologous bone tissue removed from the surgery site.
The side selection will be determined by the randomization.
详细描述
Rational
Maxillary Edentulous is one of the more frequent handicaps that cause many problems for dental prosthesis. Dental implants are currently the most convenient solution but require sufficient bone sinus height.
The filling of the sinus can be made by two ways :
- Either with autologous bone removed from hipbone or cranial bone. This method has several drawbacks such as the multiplicity of the surgery sites.
- Or with alloplasty materials that are subject to uncertain osseointegration and that are very expensive.
The aim of this study is to show the interest of an autologous platelet concentrate (APC) in this surgery. We will use the osteogenic property of platelets associated with a small quantity of spongy bone removed from the surgery site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
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
- •Age above 18 years
- •ASA1 class of anesthetic risk
- •SA3 or SA4 of the Misch classification
排除标准
- •Progressive sinusal lesion or previous history of maxillary sinusitis
- •Previous history of maxillary surgery
- •Hemopathy
- •Contraindication to cytapheresis
- •Progressive cardiopathy
- •Severe cerebellar arteriopathy
- •Infectious state
- •Thrombopenia < 150 g/l controlled by citrate
- •Serology : antibody anti-HVC, anti-HIV 1 & 2, anti HTLV 1 & 2 positive
结局指标
主要结局
Radiological outcome measure : the bone height under the sinus on the two sides.
次要结局
- Radiological outcome measure : the bone density
- Clinical outcome measure : assessment of the alveolar crest quality, possible orals complications, and complications at the removal site.
- Histological outcome measures : with bone core boring at the implant site.
- All these measurements will be matched for each patient on both sides.