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Clinical Trials/NCT02745379
NCT02745379
Unknown
Phase 1

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

Shahid Beheshti University of Medical Sciences1 site in 1 country20 target enrollmentJanuary 2016

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Alveolar Bone Loss
Sponsor
Shahid Beheshti University of Medical Sciences
Enrollment
20
Locations
1
Primary Endpoint
amount of regenerated bone
Last Updated
9 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
December 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Arash Khojasteh

Associate professor

Shahid Beheshti University of Medical Sciences

Eligibility Criteria

Inclusion Criteria

  • patients with posterior maxillary edentulism
  • pneumatized sinus
  • less than 5mm bone height between the alveolar crest and sinus membrane

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

amount of regenerated bone

Time Frame: 6 months

the percent of regenerated bone will be assessed on bone biopsies obtained during implant insertion by H\&E staining by microscope

Study Sites (1)

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