Efficacy of Sinus Floor Augmentation Using Large or Small Bovine Bone Mineral.
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
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Jerusalem,、以色列
- Hadassah Medical Organization
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：1
small particles
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bovine bone mineral particles used for sinus augmentation prior to dental implant placement
其他名称：
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有源比较器：2
large particles
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bovine bone mineral particles used for sinus augmentation prior to dental implant placement
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
the relative amount of mineralised tissue (=newly formed bone plus BO)
大体时间：20 monthes
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20 monthes
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Relative amount of newly formed bone, graft residues, bone marrow, residual bone and connective tissue.
大体时间：20 monthes
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20 monthes
|
|
Clinical parameters:
大体时间：32 monthes
|
32 monthes
|
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complications during surgery related to the material.
大体时间：20 monthes
|
20 monthes
|
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post-operative complications.
大体时间：20 monthes
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20 monthes
|
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Max torque for implant insertion.
大体时间：20 monthes
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20 monthes
|
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short-term implant survival (up to one year post loading)
大体时间：32 monthes
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32 monthes
|
合作者和调查者
调查人员
- 首席研究员：Lior Shapira, PhD, DMD、department of periodontology, Hadassah Medical Organization
- 研究主任：Tali Chackartchi, DMD、department of periodontology,Hadassah Medical Organization
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- shapiral-HMO-CTIL
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