This study aims to assess the effectiveness of mesenchymal stem cells with allografts and platelet rich fibrin (PRF) in maxillary sinus bone augmentation.This study includes 20 patients with less than 5 mm bone height between alveolar crest and sinus membrane. The samples are randomly allocated (with use of blocks) to two groups of test and control with 10 patients and will receive the surgery at Department of Oral and Maxillofacial Surgery at Shahid Beheshti University of Medical Sciences. In the test group, 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 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 is placed over the maxillary sinus membrane. The results 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:IRCT2016040427184N2
Registration date:2016-07-13, 1395/04/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-13, 1395/04/23
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
Effect of Buccal Fat Pad Derived Mesenchymal Stem Cells Loaded on Allograft with Platelet-rich Plasma in Maxillary Sinus Augmentation
Public title
Effect of Buccal Fat Pad Derived Stem Cells in Maxillary Sinus Augmentation
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 18 years old to 139 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 was performed by randomization blocks
Secondary Ids
1
Registry name
clinicaltrials.gov
Secondary trial Id
NCT02745379
Registration date
2016-04-18, 1395/01/30
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe at Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Daneshju blvd, Velenjak
City
Tehran
Postal code
-
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
Ir.sbmu.rids.rec.1392.9212
Health conditions studied
1
Description of health condition studied
Maxillary bone deficiency
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 (microscopic evaluation)
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group:
The group receives a combination of FDBA+ BFPSC and PRF for sinus augmentation
Category
Treatment - Surgery
2
Description
Control group: The group receives a combination of FDBA (lacking any cells) and PRF for sinus augmentation
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
Department of Oral and Maxillofacial Surgery, School of Dentistry,Shahid Beheshti University of Medical Sciences, Daneshju blvd,Velenjak
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Institute of Dental Sciences
Full name of responsible person
Dr. Mohammad Reza Safavi
Street address
5th flour, School of Dentistry,Shahid Beheshti University of Medical Sciences, Daneshju blvd, Velenjak
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
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
School of Advanced Technologies in Medicine, Taleghani Hospital, Arabi st, Daneshju blvd
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 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
School of Advanced 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 Beheshti 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 Beheshti 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
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)