Allogenic Bone Blocks and Particulate Graft for Horizontal Bone Augmentation in the Posterior Mandible: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Histological composition
研究概览
简要总结
This study aimed to compare two different methods used to augment bone in the posterior lower jaw prior to implant placement in patients with insufficient bone width. Eligible patients were included in the study and received a horizontal bone augmentation with one of two methods, which differed in the materials used for the bone augmentation. The group allocation was randomised. After 6 months of healing following parameters were assessed: histological evaluation, survival of the bone graft, the need for further bone augmentation at the time of implant placement, changes in soft tissue characteristics, radiologically and clinically assessed changes in bone width.
详细描述
Objective
The objective of this study is to compare the histological, clinical, and radiographic outcomes of particulate bone substitutes versus allogenic bone block grafts for primary bone augmentation in the posterior mandible.
Materials and Methods
This randomised controlled clinical trial included adult patients in need for a staged bone augmentation prior to implant placement in the posterior mandible. Patients were randomly assigned to one of two treatments groups. Patients allocated in the BBL group received allogenic bone blocks, whereas patients in the GBR group received allogenic bone granules for the primary bone augmentation. In both groups grafting materials were covered with a resorbable collagen membrane, which was fixated with non-resorbable fixation pins. The primary outcome of this study was defined as the composition of the histological samples at least 6 months after the primary bone augmentation. Secondary outcomes included graft survival rates, the need for further augementation procedures at time of implant placement, soft tissue measurements and radiographically and clinically analyzed changes in bone width and radiographically analyzed changes in bone volume. These outcomes were measured at baseline (prior to bone augmentation surgery) and at the follow-up (at least 6 months after bone augmentation).
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
- None
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
- •Aged ≥18 years
- •Insufficient bone width in posterior mandible requiring staged bone augmentation prior to implant placement
- •Minimum of 1 mm bone width available
- •Willing to provide signed informed consent
排除标准
- •Pregnant or lactating
- •Known or suspected incompliance
- •Patients smoking more than 10 cigarettes per day
- •Systemic diseases or medications affecting bone metabolism (such as osteoporosis, intake of bisphosphonates)
- •Active periodontal disease
结局指标
主要结局
Histological composition
时间窗: 6 months
Histological samples were obtained at the time of reentry for implant placement at least 6 months after the primary bone augmentation procedure. Sample analysis included the measurement of the total sample area, the area of identified bone, biomaterial and soft tissue per sample. Furthermore, the percentage of bone, biomaterial and soft tissue per sample was calculated.
次要结局
- Need for further augmentation procedures at the time of implant placement(6 months)
- Keratinized tissue height(Baseline and 6 months)
- Vertical soft tissue thickness(Baseline and 6 months)
- Clinically measured bone width(Baseline and 6 months)
- Radiologically measured bone width(Baseline and 6 months)
- Changes in bone volume(Baseline and 6 months)
研究者
Algirdas Puisys, DDS, PhD
DDS, PhD
Vilniaus Implantologijos Centro (VIC) Klinika