Assessment of the Quality and Quantity of Bone Regeneration
Assessment of the Quality and Quantity of Bone Regeneration in the Maxillary Sinus Using Osteocel With Scaffold or Allograft Materials: A Radiographic and Histomorphometric Randomized Controlled Clinical Study.
The purpose of this study is to histologically and radiographically evaluate the maxillary sinus bone volume and density, with reference to percentage of vital bone present, after four months of grafting with either Osteocel or a cortical-cancellous allograft.
- To assess the quality and quantity of the maxillary sinus bone prior to the placement of dental implants and subsequent restorations, approximately 20 patients will be randomly assigned to receive an augmentation of the maxillary sinus region using either Osteocel or a cortical-cancellous allograft.
- With the use of pre-operative and four months post-operative CBCT radiography, the maxillary sinus bone density will be assessed and compared between the individuals receiving Osteocel and the individuals receiving conventional cortical-cancellous allograft material.
- Histomorphometric analysis will be used to assess, compare and contrast the quality and the quantity of the new vital bone cells generated when using these different graft materials
研究概览
详细说明
Eligible patients will be randomly assigned into one of two treatment groups using a randomization table generated by a computer. The test group (10 sinuses) will receive Osteocel Plus and control group (10 sinuses) will receive conventional cortical-cancellous particulate allograft material. The objective of this research is to serve as a pilot study, gathering information that will guide the design of a larger subsequent study. Little is known about the distribution of bone quality changes in patients who receive Osteocel Plus graft to augment the maxillary sinus. Ten subjects per group is reasonable for a pilot study, providing an 89% probability of estimating the true mean for bone quality and implant stability to within half a standard deviation in each group. These means, along with the observed standard deviations and within-subject correlations that the investigators obtain will prove essential for designing the larger, confirmatory study that constitute the next phase of this research.
A clinical radiographic/surgical guide will be fabricated for each patient to be used for CBCT scan prior to sinus augmentation procedure. The same clinical radiographic/surgical guide will be used for CBCT scan prior to the implant placement to measure the amount of bone regeneration following four months of healing at the exact sites. One line will measure the horizontal width and the other line will measure the vertical height. The horizontal width will be measured at a vertical height of 10 mm from the sinus floor in the sinus cavity based on the conventional average length of dental implant used in implant dentistry. The difference in the measurements for all surgical sites after the grafting procedure and before the implant placement will provide a clinical assessment of the amount of bone regeneration.
Forty trephined core samples will be retrieved surgically from two areas of the grafted lateral window at the time of implant placement. One core sample will be retrieved from the anterior area, approximately 4 mm distal to the anterior tack which was used to fix the resorbable membrane, and the other one will be retrieved from the posterior area, approximately 4 mm mesial of the posterior tack which was used to fix the resorbable membrane. Histomorphometric analysis will be performed on three fields for each section using specialized software. Volume of vital bone, graft remnants, and connective tissue will be measured based on the averages of the percentages at a magnification of 63X. Data will be statistically analyzed using Statistical Package for the Social Sciences (SPSS 13.0 for Windows software) program to compare between test and control groups.
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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Kentucky
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Lexington、Kentucky、美国、40536
- University of Kentucky College of Dentistry
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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:
Must be 22 years old or older. Must have at least one edentulous posterior site requiring grafting. Must have an implant restoration to replace at least one tooth in the edentulous site.
Must be available for the follow-up examinations.
Exclusion Criteria:
Current smokers Dental infections of bone Untreated periodontal disease Pregnant patients or those who are nursing Uncontrolled diabetes (via patient reported A1C) Chemotherapy/Radiation patients Autoimmune diseases Kidney disease Liver disease
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:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Osteocel Plus
Experimental product will be placed in one sinus while the control product will be placed in the contralateral sinus.
(Randomized)
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Lateral window sinus augmentation with core samples harvested from the window following 4 months of healing.
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有源比较器:alloOss
The control product will be placed in one sinus while the control product will be placed in the contralateral sinus.
(Randomized)
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Lateral window sinus augmentation with core samples harvested from the window following 4 months of healing.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Quality of Bone Regeneration (Number of Osteoblasts per histologic section)
大体时间:4 months post-operative of sinus augmentation.
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Core samples of bone will be evaluated histomorphometrically for number of osteoblasts present.
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4 months post-operative of sinus augmentation.
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Quantity of Bone Regeneration (Linear measurements)
大体时间:3.5 months post-operative of sinus augmentation.
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Linear measurement of HEIGHT of bone gain
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3.5 months post-operative of sinus augmentation.
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Quantity of Bone Regeneration (Linear measurements)
大体时间:3.5 months post-operative of sinus augmentation.
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Linear measurement of WIDTH of bone gain
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3.5 months post-operative of sinus augmentation.
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Quantity of Bone Regeneration (Linear measurements)
大体时间:3.5 months post-operative of sinus augmentation.
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Linear measurement of DEPTH of bone gain
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3.5 months post-operative of sinus augmentation.
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
研究记录更新
最后更新发布 (实际的)
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
- 17-0102-F2L
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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Bilateral Sinus Augmentation的临床试验
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Medical University of South CarolinaNeilMed Pharmaceuticals完全的