NCT04331314已完成不适用
Sinus Augmentation Using Symbios Versus Algipore as Bone Graft Material - A Randomized Controlled Clinical Pilot Study
Medical University of Graz0 个研究点目标入组 20 人开始时间: 2015年2月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Implant stability
研究概览
简要总结
Twenty patients scheduled for lateral-window sinus floor Elevation (SFE) are randomized into two groups: use of SYMBIOS® Biphasic Bone Graft Material (Group 1) or of Algipore® Bone Substitution Material (Group 2).
Biopsies are taken 3 months after SFE and during implant surgery after 6 months. One ground section per biopsy (n=40) is stained, scanned, and histomorphometrically analyzed for new bone, old bone, soft tissue, graft, bone infiltration of graft, bone-to-graft contact, and penetration depth.
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)
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
- 否
入选标准
- •Capability of giving an informed consent
- •Good health as defined by the subject's medical history
- •Patients age 20-75 years
- •Fully edentulous or partially edentulous patients with unilateral or bilateral missing teeth in the maxillary premolar or molar areas with severe alveolar atrophy and a residual alveolar ridge height of maximal 5 mm requiring a two-staged sinus floor elevation and implant placement.
排除标准
- •Patients without detailed baseline medical data
- •Patients with medical history of local inflammations in the posterior maxilla
- •Skeletal immaturity
- •Patients with osteoporosis in their medical history
- •Patients with severe illnesses, malignant diseases, radiotherapy or chemotherapy in their medical history
- •Patients with pathological fractures
- •Patients treated with bisphosphonates
- •Uncontrolled diabetes mellitus
- •Uncontrolled periodontal diseases
结局指标
主要结局
Implant stability
时间窗: 12 months after sinus augmentation
measured with Periotest®
次要结局
- Crestal bone level after implant(12 months after implant placement)
- Probing on depth(24 months after sinus augmentation)
- Newly formed bone area in mm²(6 months after sinus augmentation)
- New bone infiltration area in bone substitute in mm²(6 months after sinus augmentation)
- Bleeding on probing(24 months)
- Survival rate of the implants(24 months after sinus augmentation)
- Complications(6 months after sinus augmentation)
- Tissue area in mm²(6 months after sinus augmentation)
- Old bone area in mm²(6 months after sinus augmentation)
- Bone substitute area in mm²(6 months after sinus augmentation)
- new bone to bone substitute contact in mm(6 months after sinus augmentation)
- Penetration depth in mm(6 months after sinus augmentation)
研究者
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