This study aims to assess the effectiveness of mesenchymal stem cells with allografts and PRF in reconstruction of mandible atrophy.This study includes 20 patients with less than 8 mm bone height in posterior mandible. The samples are randomly (by blocks) allocated to two groups of test and control with 10 patients and receive the surgery at Department of Oral and Maxillofacial Surgery at Shahid Beheshti University of Medical Sciences. In the test groups, buccal fat pad derived stem cells (BFPSCs) is harvested from buccal fat pad tissue of the patients. 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 receives FDBA (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 amount of the regenerated bone will be evaluated by cone beam computed tomography (CBCT) and hematoxylin and eosin staining in 6 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040227184N1
Registration date:2016-06-13, 1395/03/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-13, 1395/03/24
Registrant information
Name
Pantea Nazeman
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2241 3897
Email address
pnazeman@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Institute of Dental Sciences at Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-01-01, 1394/10/11
Expected recruitment end date
2016-08-01, 1395/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Buccal Fat Pad Derived Mesenchymal Stem Cells Loaded on Allograft and Platelet-rich Plasma in Posterior Mandible Augmentation
Public title
Buccal Fat Pad Derived Stem Cells With Cortical Tenting in Posterior Mandible Reconstruction
Purpose
Treatment
Inclusion/Exclusion 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 like CEJ and adjacent tooth)
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
Age
From 18 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization is performed by using blocks
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe at Shahid Beheshti University of Medical Sciences
Street address
Daneshju blvd, Velenjak
City
Tehran
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
Ir.sbmu.rids.rec.1392.9217
Health conditions studied
1
Description of health condition studied
bone atrophy in posterior mandible
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Amount of regenerated bone
Timepoint
before the surgery and 6 months after the surgery
Method of measurement
cone beam computed tomography and histology
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The combination of BFPSC+FDBA+PRF is utilized in cortical tenting technique with block graft obtained from lateral ramus for posterior mandible augmentation procedure.
Category
Treatment - Surgery
2
Description
Control group: The combination of FDBA+PRF is utilized in cortical tenting technique with block graft obtained from lateral ramus for posterior mandible augmentation procedure
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Oral and Maxillofacial Surgery at Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Arash Khojasteh
Street address
City
tehrna
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Institute of Dental Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Safavi
Street address
5th floor, School of Dentistry,Shahid Beheshti University of Medical Sciences, Velenjak, Daneshju blvd
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute of Dental Sciences, Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Advanced Technologies in Medicine
Full name of responsible person
Dr. Arash Khojasteh
Position
Dean/ Associate professor of Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Daneshju blvd, Velenjak, Arabi st, Taleghani Hospital, School of Advanced Technologies in Medicine
City
Tehran
Postal code
Phone
+98 21 2243 9847
Fax
Email
arashkhojasteh@yahoo.com
Web page address
www.omfsresearch.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Advance Technologies in Medicine, Shahid Beheshti University of MEdical Sciences
Full name of responsible person
Dr. Arash Khojasteh
Position
Dean of School of Advance Technologies in Medicine/ Associate professor of Oral and Maxillofacial Su
Other areas of specialty/work
Street address
School of Advance Technologies in Medicine, Taleghani Hospital, Arabi st,Daneshju blvd, Velenjak
City
Tehran
Postal code
Phone
+98 21 2243 9847
Fax
Email
arashkhojasteh@yahoo.com
Web page address
www.omfsresearch.com
Person responsible for updating data
Contact
Name of organization / entity
Dental Research Center, Research Institute of Dental Sciences, Shahid Behshti University of Medical
Full name of responsible person
Pantea Nazeman
Position
DDS, Research fellow
Other areas of specialty/work
Street address
Dental Research Center, Research Institute of Dental Sciences, School of Dentistry,Shahid Behshti University of Medical Sciences, Daneshju blvd, Velenjak
City
Tehran
Postal code
Phone
+98 21 2241 3897
Fax
+98 21 2241 3897
Email
pnazeman@yahoo.com
pnazeman@sbmu.ac.ir
Web page address
http://drc.sbmu.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)