Lateral Ridge Augmentation Using Autogenous-xenogeneic or Allogeneic-xenogeneic Graft Mix With a Cross-linked Collagen Membrane: a Randomized Pilot Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Linear bone width changes
研究概览
简要总结
To treat resorbed alveolar ridges, many surgical procedures are available in the literature such as ridge splitting, distraction osteogenesis, block grafting techniques and guided bone regeneration, which is the most documented technique. Various grafting materials are available but there is a lack of evidence on the superiority of a material or a combination of materials.
详细描述
Bone width at the implant site is an important prerequisite for a predictable and long-term prognosis in implant dentistry. Different types of membranes and bone grafts are used in the GBR procedure. However, there is a lack of studies in the literature about the combination allograft/xenograft. The aim of the present trial is to compare two different bone graft combinations (autogenous-xenogeneic and allogeneic-xenogeneic) covered with a cross-linked collagen membrane in a horizontal alveolar ridge augmentation (without simultaneous implant placement).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients, non-smokers or smokers <10 cigarettes/day.
- •Age between 20 and
- •Full mouth bleeding score (FmBS) <20 %.
- •Full mouth plaque score (FmPS) <15%.
- •Residual bone width < 5 mm and adequate bone height in the maxilla and the mandible.
- •Tooth extraction performed at least 6 weeks before surgery.
- •Presence of enough teeth to support an occlusal stent/radiographic guide.
排除标准
- •Systemic diseases.
- •Heavy smokers (> 10 cigarettes/day).
- •History of radiotherapy in the head and neck region in the last 5 years.
- •Active periodontitis on the remaining teeth.
- •Pregnancy.
- •Intake of medications that may have an effect on bone turnover and mucosal healing (i.e., tetracycline within the last month, steroids within the last 6 months, bisphosphonates or fluorides at bone therapeutic levels, vitamin D and metabolites at therapeutic levels within the last 6 months).
结局指标
主要结局
Linear bone width changes
时间窗: 6 months
Linear bone width changes assessed clinically and radiographically in mm
Volumetric bone changes
时间窗: 6 months
Volumetric bone changes assessed radiographically in cubic mm
次要结局
- Clinical Ridge Height gain(6 months)
- Probe penetration(6 months)
研究者
Celine Rassi
Periodontology resident
Saint-Joseph University