Factors Influencing Bone Block Allograft Resorption. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Percentage of Bone Augmentation
研究概览
简要总结
A main drawback of bone block graft surgery is the resorption occurring in early stages of healing. The aim of this work was investigate different factors associated with graft resorption in allogeneic bone block graft surgery.
详细描述
Introduction
A main drawback of bone block graft surgery is the resorption occurring in early stages of healing. The aim of this work was investigate different factors associated with graft resorption in allogeneic bone block graft surgery.
Materials and methods
Twenty-eight patients referred for implant placement and with insufficient bucco-lingual (BL) alveolar bone width (<4 mm) were included in the study. Patients received freeze dried bone allograft (FDBA) blocks of either allogeneic cancellous or cortico-cancellous bone obtained from the iliac crest. The aforementioned groups were compared in regards to bone resorption using General Estimating Equations (GEE) and logistic regression. Demographic data, trabecular bone density, graft site 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
Patients included in the clinical trial were randomly allocated by a blinded assistant in two groups: in the cortico-cancellous group (CC), and cancellous group (C). Allocation of participants to intervention groups in a truly unpredictable, randomized sequence was performed using a computerized random number generated by the GraphPadQuickCalc software (GraphPad Software Inc., La Jolla, CA). Blocked randomization was performed to maintain equal group size. As a result 14 patients were randomly assigned to de CC group and other 14 to the C group. All bone augmentation surgeries were performed by the same oral surgeon, with expertise on block surgeries (JT).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Twenty eight totally and partially edentulous patients referred for dental implant therapy from January 2011 to September 2015 were enrolled in the study. All patients had insufficient bucco-lingual (BL) alveolar bone width (<4 mm) that prevented placement of regular size implants
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.
研究组 & 干预措施
Cortico-Cancellous
Graft surgery with cortico-cancellous block, freeze dried bone allograft (FDBA) for treatment the atrophic maxilla prior implant placement
干预措施: graft surgery (Procedure)
Cancellous
Graft surgery with cancellous block, freeze dried bone allograft (FDBA) for treatment the atrophic maxilla prior implant placement
干预措施: graft surgery (Procedure)
结局指标
主要结局
Percentage of Bone Augmentation
时间窗: 0 months
A region of interest (ROI) containing the entire trabecular bone area of the alveolar ridge was created using the closed polygon tool of the OsiriX software.
次要结局
- Percentage of bone resorption(4 months)
研究者
Jesús Torres García Denche
Associate Profesor
Universidad Complutense de Madrid