Alveolar Bone Loss Clinical Trial
Official title:
The Effect of Buccal Fat Pad Derived Mesenchymal Stem Cells Loaded on Allograft and Platelet-rich Plasma in Posterior Mandible Augmentation
In this study the buccal fat pad derived stem cells (BFPSCs) is harvested from buccal fat pad tissue of the patients receiving posterior mandible 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 control group receivesFDBA (without any cells)+PRF. In all the groups the combination are placed between the recipient site and the block graft obtained from lateral ramus. The results will be evaluated by cone beam computed tomography (CBCT)and hematoxylin and eosin staining in 6 months.
Autogenous bone blocks are harvested from lateral ramus.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 FDBA with PRF for posterior
mandible augmentation and the control group receives combination of PRF and FDBA (lacking
any cells). The BFPSCs+FDBA+PRF in the test group and FDBA+PRF in the control group are
placed in the gap between the block graft and recipient site. 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 during implant placement.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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