Effect of Buccal Fat Pad Derived Stem Cells in Maxillary Sinus Augmentation
Primary Purpose
Alveolar Bone Loss
Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
BFPSCs+ DFDBA+ PRF
DFDBA + PRF
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss
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:
- 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
Sites / Locations
- School of Dentristry at Shahid Beheshti University of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BFPSC+
BFPSC-
Arm Description
The group receives a combination (DFDBA)+buccal fat pad derived stem cells BFPSC and PRF for sinus augmentation
The group receives a combination of demineralized freeze-dried bone allografts DFDBA (lacking any cells) and PRF for sinus augmentation
Outcomes
Primary Outcome Measures
amount of regenerated bone
the amount of regenerated bone will be assessed by Image Pro software in CBCT images
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02745379
First Posted
April 18, 2016
Last Updated
October 13, 2016
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02745379
Brief Title
Effect of Buccal Fat Pad Derived Stem Cells in Maxillary Sinus Augmentation
Official Title
Effect of Buccal Fat Pad Derived Mesenchymal Stem Cells Loaded on Allograft and Platelet-rich Plasma in Maxillary Sinus Augmentation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BFPSC+
Arm Type
Experimental
Arm Description
The group receives a combination (DFDBA)+buccal fat pad derived stem cells BFPSC and PRF for sinus augmentation
Arm Title
BFPSC-
Arm Type
Active Comparator
Arm Description
The group receives a combination of demineralized freeze-dried bone allografts DFDBA (lacking any cells) and PRF for sinus augmentation
Intervention Type
Procedure
Intervention Name(s)
BFPSCs+ DFDBA+ PRF
Intervention Type
Procedure
Intervention Name(s)
DFDBA + PRF
Primary Outcome Measure Information:
Title
amount of regenerated bone
Description
the amount of regenerated bone will be assessed by Image Pro software in CBCT images
Time Frame
6 months
Title
amount of regenerated bone
Description
the percent of regenerated bone will be assessed on bone biopsies obtained during implant insertion by H&E staining by microscope
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arash Khojasteh, DMD, OMFS
Phone
00989121060032
Email
arashkhojasteh@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arash Khojasteh, DMD, OMFS
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dentristry at Shahid Beheshti University of Medical Sciences
City
Tehran
ZIP/Postal Code
19839
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arash Khojasteh, DDS, OMFS
Phone
00989121060032
Email
arashkhojasteh@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Buccal Fat Pad Derived Stem Cells in Maxillary Sinus Augmentation
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