Effect of Buccal Fat Pad Derived Mesenchymal Stem Cells Loaded on Allograft and Platelet-rich Plasma in Maxillary Sinus Augmentation
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- amount of regenerated bone
研究概览
简要总结
In this study the buccal fat pad derived stem cells (BFPSCs) will be harvested from buccal fat pad tissue of patients receiving maxillary sinus augmentation. In the test group the patients receive a combination of platelet rich fibrin (PRF) and freeze dried bone allograft (FDBA) (SureOss, Hansbiomed, Korea) loaded with BFPSCs. The results will be evaluated by cone beam computed tomography (CBCT)and hematoxylin and eosin staining in 6 months.
详细描述
The buccal fat pad derived stem cells (BFPSCs) is harvested from buccal fat pad tissues. The BFPSCs will be loaded on freeze dried bone allograft (FDBA) (SureOss, Hansbiomed, Korea). Furthermore, twenty milliliters of the venous blood is obtained, placed and collected in a sterile tube, and centrifuged (GAC medical) for 14 minutes at 2800 rpm (approximately 400 g). Following centrifugation, three layers are separated in the tube: cellular plasma at the top, platelet rich fibrin (PRF) clot in the middle and red blood cells at the bottom of the tube. The PRF clot is separated by a sterile pincette.
The patients in the test group receives BFPSCs loaded on DFDBA with PRF for sinus augmentation and the control group receives combination of PRF and DFDBA (lacking any cells).The results will be evaluated by cone beam computed tomography (CBCT) in 6 months and microscopic evaluation of the biopsies by hematoxylin and eosine staining.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with posterior maxillary edentulism
- •pneumatized sinus
- •less than 5mm bone height between the alveolar crest and sinus membrane
排除标准
- •history of malignancy
- •chemotherapy
- •systemic diseases contradicting dental and surgical treatments
- •conditions or drugs affecting bone remodeling or bone metabolism and connective tissue
- •allergy to collagen
研究组 & 干预措施
BFPSC+
The group receives a combination (DFDBA)+buccal fat pad derived stem cells BFPSC and PRF for sinus augmentation
干预措施: BFPSCs+ DFDBA+ PRF (Procedure)
BFPSC-
The group receives a combination of demineralized freeze-dried bone allografts DFDBA (lacking any cells) and PRF for sinus augmentation
干预措施: DFDBA + PRF (Procedure)
结局指标
主要结局
amount of regenerated bone
时间窗: 6 months
the amount of regenerated bone will be assessed by Image Pro software in CBCT images
次要结局
未报告次要终点
研究者
Arash Khojasteh
Associate professor
Shahid Beheshti University of Medical Sciences