Assessment of the Effect of Sinus Floor Perforation During Sinus Floor Elevation on Bone Formation Within the Augmentation Material
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- New bone formation
研究概览
简要总结
The aim of the present study is to compare the rate of new bone formation after sinus floor elevation with or without perforation of the cortical sinus floor prior to insertion of augmentation material. Twelve patients requiring bilateral sinus floor elevation will be recruited for a pilot study in split-mouth design. On both sides a lateral window will be prepared and the sinus mucosa will be elevated. After this step, the sides are assigned as test or control side. While the control side is just filled with augmentation material, an additional step is performed for the test side, i.e., prior to inserting the augmentation material, the cortical bone layer of the sinus floor is perforated several times into the trabecular bone layer to improve the blood supply to the grafting material. Thereafter, both sides are left to healing for 4-6 months until implant installation. At timepoint of implant installation, a bone biopsy will be collected to allow histological assessment of the grafted area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 120 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •in need of bilateral sinus floor elevation
- •residual alveolar ridge height 2-6mm
- •residual alveolar ridge width > 4mm
排除标准
- •uncontrolled periodontal disease
- •acute or chronic sinusitis
研究组 & 干预措施
Control
standard sinus floor elevation
干预措施: no perforation of the sinus floor (Procedure)
Test
standard sinus floor elevation with additional perforation of the sinus floor
干预措施: perforation of the sinus floor (Procedure)
结局指标
主要结局
New bone formation
时间窗: 4-6 months after sinus floor elevation
histological assessment of new bone formation after sinus floor elevation (%)
次要结局
未报告次要终点
研究者
Kristina Bertl
Principal Investigator
Medical University of Vienna
