Split Bone Block Technique: Clinical and Radiographic Study Between Autologous and Porcine Xenogeneic Cortical Plates. Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Volume of bone augmentation
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Bone augmentation procedures using autogenous cortical plates or xenograft cortical plates were carried on, both using autogenous bone chips to fill the resulting gap. Patients included in this clinical trial were randomly allocated by a blinded assistant in two groups: Autogenous Cortical Plates (ACP) and Xenograft Cortical Plates (XCP). Random allocation of participants to intervention groups was performed using a computerized random number generated by the GraphPad- QuickCalc software (GraphPad Soft- ware Inc., La Jolla, CA) As a result, 9 patients were randomly assigned to de ACP group and 9 to the XCP group. All surgeries were performed by the same oral surgeon (JT).
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients were enrolled in the study on the basis of having insufficient bone height (<6mm), width (<3mm) or both, in either maxilla or mandible
排除标准
- •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.
结局指标
主要结局
Volume of bone augmentation
时间窗: 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
次要结局
- Bone box time consuming(Minutes)
- Postoperative pain(4 months)
研究者
Jesús Torres García Denche
Associate Professor
Universidad Complutense de Madrid