Comparative Study Between Porcine and Autologous Cortical Plates
2019年12月17日 更新者：Jesús Torres García Denche、Universidad Complutense de Madrid
Split Bone Block Technique: Clinical and Radiographic Study Between Autologous and Porcine Xenogeneic Cortical Plates. Randomized Clinical Trial
The aim of this study is to evaluate the outcome of three-dimensional bone regeneration procedures using thin cortical porcine xenograft plates in combination with autogenous bone chips compared with thin autogenous cortical plates and autogenous bone chips.
研究概览
详细说明
Materials and methods: 16 patients referred for implant placement and with insufficient bucco-lingual (BL) alveolar bone width (<4 mm) were included in the study.
Patients received autogenous cortical plates (ACP) of either porcine xenogeneic (XCP).
The aforementioned groups were compared in regards to bone augmentation using General Estimating Equations (GEE) and logistic regression.
Demographic data, trabecular bone density, graft site, postoperative pain, and time consuming were also analyzed
研究类型
介入性
注册 (实际的)
16
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 68年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients were enrolled in the study on the basis of having insufficient bone height (<6mm), width (<3mm) or both, in either maxilla or mandible
Exclusion Criteria:
Patients with severe systemic disease (American Society of Anesthesiology III or IV) were excluded from the study.
In addition, patients who were pregnant, or patients with diseases affecting bone, such as:Paget's disease, osteomalacia, diabetes, vitamin D deficiency, alcoholism, hyperthyroidism cancer or osteoporosis as well as those on medications that might affect bone metabolism, such as bisphosphonates, corticosteroids or antiepileptic medicaments were also excluded from the study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Autologous cortical plate
Thin autologous cortical plates that allow to made a rigid and resistant framework that will be filled with autogenous bone chips bone
|
A graft surgery using autogenous bone chips surrounded by a rigid framework made over the atrophic sites of the mandible and maxilla to obtain bone augmentation to support dental implants
|
|
实验性的：Porcine cortical plate
Thin porcine cortical platesthat allow to made a rigid and resistant framework that will be filled with autogenous bone chips bone
|
A graft surgery using autogenous bone chips surrounded by a rigid framework made over the atrophic sites of the mandible and maxilla to obtain bone augmentation to support dental implants
|
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 |
|---|---|---|
|
Volume of bone augmentation
大体时间：4 months
|
Volume of bone augmentation of the surgical sites was measured in the postoperative parasagittal CT scans using a region of interest (ROI) containing the entire bone box regenerated area using the closed polygon tool of the OsiriX software.
This measurements have been done in mm3
|
4 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative pain
大体时间：4 months
|
The amount of pain was classified into three categories: heavy pain, with the patient taking more than eight painkillers (ibuprofen 400); moderate pain, when the patient took four to eight painkillers; or little pain, when the patient needed fewer than four painkillers.
|
4 months
|
|
Bone box time consuming
大体时间：Minutes
|
In the control group this was measured from the moment the osteotomy incision began with the MicroSaw until the bone block was completely removed, splitting cortical plates and fixation to the buccal and lingual/palatal side of the bone defect using osteosynthesis screws after it is filled with the bone chips harvested previously.
In experimental group the time was measured from the open of porcine cortical plate envelope until the bone box was completely filled and sealed.
|
Minutes
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jesús Torres, Associate、Universidad Complutense de Madrid
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年5月10日
初级完成 (实际的)
2017年9月8日
研究完成 (实际的)
2019年9月13日
研究注册日期
首次提交
2019年12月15日
首先提交符合 QC 标准的
2019年12月17日
首次发布 (实际的)
2019年12月19日
研究记录更新
最后更新发布 (实际的)
2019年12月19日
上次提交的符合 QC 标准的更新
2019年12月17日
最后验证
2019年12月1日
更多信息
与本研究相关的术语
其他研究编号
- P-15/567
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.