NCT01781221Unknown不适用
Sinus Floor Elevation Using Separately Two Different Xenografts - A Prospective Randomized Clinical Trial
University Hospital of Cologne0 个研究点目标入组 44 人开始时间: 2013年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 44
- 主要终点
- Uneventful healing and histological bone formation
研究概览
简要总结
The purpose of this study is to compare the regenerative results of using separately two different xenografts after two-step sinus floor elevation.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who will present with a moderately or severely atrophic posterior maxilla with 1-6 mm residual alveolar bone .
- •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.
结局指标
主要结局
Uneventful healing and histological bone formation
时间窗: 6 months following sinus floor augmentation
次要结局
- X-ray demonstration of volume - stable results(6 months following augmentation procedures.)
- Equally high implant survival rates and crestal bone loss(After 1,2 years)
研究者
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