Buccal Fat Pad Derived Stem Cells With Cortical Tenting in Posterior Mandible Reconstruction
Primary Purpose
Alveolar Bone Loss, Atrophy
Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
BFPSC+FDBA+PRF
FDBA+PRF
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss
Eligibility Criteria
Inclusion Criteria:
- patients with posterior mandible edentulism and atrophic bone with less than 4mm bone width at bone crest or less than 8 mm bone height (considering 2-3 mm distance to anatomic structures)
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
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 combination of BFPSC+FDBA+PRF is utilized in cortical tenting technique with block graft obtained from lateral ramus for posterior mandible augmentation procedure.
The combination of FDBA+PRF is utilized in cortical tenting technique with block graft obtained from lateral ramus for posterior mandible augmentation procedure
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
NCT02745366
First Posted
April 18, 2016
Last Updated
October 13, 2016
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02745366
Brief Title
Buccal Fat Pad Derived Stem Cells With Cortical Tenting in Posterior Mandible Reconstruction
Official Title
The Effect of Buccal Fat Pad Derived Mesenchymal Stem Cells Loaded on Allograft and Platelet-rich Plasma in Posterior Mandible 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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss, Atrophy
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 combination of BFPSC+FDBA+PRF is utilized in cortical tenting technique with block graft obtained from lateral ramus for posterior mandible augmentation procedure.
Arm Title
BFPSC-
Arm Type
Active Comparator
Arm Description
The combination of FDBA+PRF is utilized in cortical tenting technique with block graft obtained from lateral ramus for posterior mandible augmentation procedure
Intervention Type
Procedure
Intervention Name(s)
BFPSC+FDBA+PRF
Intervention Type
Procedure
Intervention Name(s)
FDBA+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 mandible edentulism and atrophic bone with less than 4mm bone width at bone crest or less than 8 mm bone height (considering 2-3 mm distance to anatomic structures)
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
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
Plan to Share IPD
Undecided
Learn more about this trial
Buccal Fat Pad Derived Stem Cells With Cortical Tenting in Posterior Mandible Reconstruction
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