Sinus Floor Elevation Using Alpha-Bio's GRAFT Natural Bovine Bone Versus Commercially Available Bone Graft. A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 44
- 主要终点
- Histological bone formation following sinus floor augmentation [ evaluated by biopsies harvested from the implant sites]
研究概览
简要总结
This clinical study is designed to compare the regenerative outcome of using separately two different Xenografts during sinus floor augmentation.
Aim of this prospective randomized-controlled clinical trial is to compare the regenerative results of Alpha-Bio's GRAFT Natural Bovine Bone versus commercially available bone graft after two-step sinus floor elevations by clinical and histological analysis.
Clinical Parameters are wound healing parameters, radiological volume stability and implant survival rates. Histological parameters are based on a histomorphometrical analysis of trephine cores harvested in progress of implant bed preparation.
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
- Single (Participant)
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
- •Patients who will present with a moderately or severely atrophic posterior maxilla with 1-6 mm residual alveolar bone will be selected for the study.
- •Men and women over the age of 18 years.
- •Patient has signed the Informed Consent.
排除标准
- •Chronic steroid therapy,
- •Uncontrolled diabetes,
- •Cardiovascular disease,
- •Past irradiation of head and neck
- •Maxillary sinus cysts,
- •Active chronic sinusitis,
- •Smoking more than ten cigarettes per day during the 3 months preceding this study .
- •Malignant disease in the 5 years preceding this study
- •Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia
- •Disease that compromise the immune system
- •Psychiatric disorder
- •Hypersensitivity to titanium, collagen or bovine bone.
- •Women who are pregnant or nursing.
- •Patients with non-treated periodontal disease.
- •Medical and/or general contraindications for intraoral surgical procedures
研究组 & 干预措施
Alpha-Bios GRAFT Natural Bovine Bone treatment
Pure Hydroxyapatite ceramic mineral with high similarity to the human bone
干预措施: Alpha-Bio GRAFT Natural Bovine Bone (Device)
natural bone substitute
natural bone substitute material derived from the mineral portion of bovine bone
干预措施: natural bone substitute (Device)
结局指标
主要结局
Histological bone formation following sinus floor augmentation [ evaluated by biopsies harvested from the implant sites]
时间窗: 6 months
次要结局
- Bone volume-stable results six months following augmentation procedures [ demonstrated by X-ray evaluation].(6 months)