Histological Assessment of Deproteinized Bovine Bone Loaded by Bone Marrow Aspirate Versus Deproteinized Bovine Bone Alone for Guided Sinus Floor Elevation. (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Histological assessment
研究概览
简要总结
Aim : The aim of present study was to evaluate BMAC/bovine graft utilization in Sinus membrane augmentation on bone quality and quantity. Methodology: sixteen patients suffering from atrophic posterior maxilla with sinus pneumatization were randomly divided into two equal groups: study group: the sinus membrane was elevated with BMAC/bovine graft whereas the control group recieved bovine graft only for sinus floor augmentation.
All patients will be evaluated at 1 week, 4 months to measure bone height and bone core biopsy for histological assessment at 4 months during implant placement.
详细描述
Aim : The aim of present study was to evaluate BMAC/bovine graft utilization in Sinus membrane augmentation on bone height gain and quality of bone on histological assessment.
Methodology: sixteen patients suffering from atrophic posterior maxilla with sinus pneumatization were randomly divided into two equal groups: study group: the sinus membrane was elevated with bone marrow aspirate concentrate loaded on bovine graft whereas the control group recieved bovine graft only for sinus floor augmentation.
All patients will be evaluated at 1 week, 4 months by CBCT to measure bone height and bone core biopsy for histological assessment at 4 months during 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with missing upper posterior teeth and atrophic posterior maxilla with a residual bone height ranging from 4 to 6 mm
- •Patients who has as deficient as 4 mm vertical bone height in posterior maxilla that need bone augmentation before delayed implant placement.
- •Highly motivated patients
排除标准
- •Patients suffering from any systemic disease or those under any medication that may interfere with normal bone healing.
- •Patients suffering from any sinus pathosis.
- •Patients with conditions that could potentially compromise BM quality, previous BMA, or acute illness.
- •Heavy smoker (> 20 cigarettes daily)
研究组 & 干预措施
BMAC/bovine graft
Bone marrow aspirate concentrate loaded on bovine graft (Tutogen Medical GmbH, Neunkirchen am Brand, Germany, 1- 2mm particle size) utilization for sinus floor augmentation with residual alveolar bone height less than 5 mm, 1st arm
干预措施: BMAC loaded on bovine graft (Drug)
Bovine graft group
bovine graft utilization for sinus floor augmentation with residual alveolar bone height less than 5 mm, 2nd arm
干预措施: Bovine graft only (Drug)
结局指标
主要结局
Histological assessment
时间窗: After 4 months of surgery
Histological assessment of core biopsy obtained at time of implant placement for percentage of new bone formation and residual graft
次要结局
- Implant stability(After 4 months of surgery)
- Bone gain(Preoperative, immediate and 4 months Postoperative)
研究者
Walaa Kadry
Lecturer of oral and Maxillofacial Surgery
Cairo University