Efficacy of Sinus Floor Augmentation Using Large (1-2mm) or Small (0.25-1mm) Bovine Bone Mineral Particles (Bio-Oss®): A Comparative Histomorphometric Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- the relative amount of mineralised tissue (=newly formed bone plus BO)
研究概览
简要总结
The aim of this clinical study is to compare the amount of newly formed bone after bone augmentation with Bio-Oss® (BO) 0.25-1 mm vs. Bio-Oss® (BO) 1-2 mm in the sinus floor augmentation procedure bilaterally in 8 patients.
Hypothesis:
There is no difference in the relative amount of newly formed bone plus BO between the large (1-2 mm) and small (0.25 - 1 mm) granules.
详细描述
the use of bovine bone mineral particles (Bio-Oss®)in sinus floor augmentation is well established. bovine bone mineral is an oseoconductive material which serves as a space maintainer and a scaffold for bone augmentation. the commercial product is manufactured in two different particles sizes, "large"1-2 mm, and "small"0.25-1 mm.
Comparison: the histologic characteristics of augmented bone after the use of Bio-Oss® (BO) with particle size of 0.25-1 mm vs. Bio-Oss® (BO)with particle size of 1-2 mm.
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
- 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
- 是
入选标准
- •The patients included in this study are over 18 year old men and women.
- •The patient must be a candidate for sinus floor augmentation.
- •The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures.
- •The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent.
排除标准
- •Pregnant women.
- •People who smoke more than 10 cigarettes a day.
- •Alcohol and drug abusers.
- •People suffering from uncontrolled diabetes, severe osteoporosis, rheumatic arthritis, precancer or neoplastic lesions of oral cavity.
- •The patient is nursing.
研究组 & 干预措施
1
small particles
干预措施: bovine bone mineral particles (Bio-Oss®) (Device)
2
large particles
干预措施: bovine bone mineral particles (Bio-Oss®) (Device)
结局指标
主要结局
the relative amount of mineralised tissue (=newly formed bone plus BO)
时间窗: 20 monthes
次要结局
- Relative amount of newly formed bone, graft residues, bone marrow, residual bone and connective tissue.(20 monthes)
- Clinical parameters:(32 monthes)
- complications during surgery related to the material.(20 monthes)
- post-operative complications.(20 monthes)
- Max torque for implant insertion.(20 monthes)
- short-term implant survival (up to one year post loading)(32 monthes)
研究者
Lior Shapira
Head of periodontal department
Hadassah Medical Organization