Effect of Buccal Fat Pad Derived Stem Cells in Maxillary Sinus Augmentation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Buccal Fat Pad Derived Mesenchymal Stem Cells Loaded on Allograft and Platelet-rich Plasma in Maxillary Sinus Augmentation

Conditions
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Alveolar Bone Loss

Intervention / Treatment
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* Procedure: BFPSCs+ DFDBA+ PRF
* Procedure: DFDBA + PRF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with posterior maxillary edentulism pneumatized sinus less than 5mm bone height between the alveolar crest and sinus membrane Exclusion Criteria: smoking history of malignancy radiation chemotherapy pregnancy systemic diseases contradicting dental and surgical treatments conditions or drugs affecting bone remodeling or bone metabolism and connective tissue allergy to collagen

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BFPSC+<br>The group receives a combination (DFDBA)+buccal fat pad derived stem cells BFPSC and PRF for sinus augmentation | Procedure: BFPSCs+ DFDBA+ PRF<br> <br> |
| Active Comparator: BFPSC-<br>The group receives a combination of demineralized freeze-dried bone allografts DFDBA (lacking any cells) and PRF for sinus augmentation | Procedure: DFDBA + PRF<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of regenerated bone | the amount of regenerated bone will be assessed by Image Pro software in CBCT images | 6 months | 
| amount of regenerated bone | the percent of regenerated bone will be assessed on bone biopsies obtained during implant insertion by H&E staining by microscope | 6 months |