Effect of Buccal Fat Pad Derived Stem Cells in Maxillary Sinus Augmentation

October 13, 2016 updated by: Arash Khojasteh, Shahid Beheshti University of Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 19839
        • Recruiting
        • School of Dentristry at Shahid Beheshti University of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. patients with posterior maxillary edentulism
  2. pneumatized sinus
  3. less than 5mm bone height between the alveolar crest and sinus membrane

Exclusion Criteria:

  1. smoking
  2. history of malignancy
  3. radiation
  4. chemotherapy
  5. pregnancy
  6. systemic diseases contradicting dental and surgical treatments
  7. conditions or drugs affecting bone remodeling or bone metabolism and connective tissue
  8. allergy to collagen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BFPSC+
The group receives a combination (DFDBA)+buccal fat pad derived stem cells BFPSC and PRF for sinus augmentation
Procedure: BFPSCs+ DFDBA+ PRF
Active Comparator: BFPSC-
The group receives a combination of demineralized freeze-dried bone allografts DFDBA (lacking any cells) and PRF for sinus augmentation
Procedure: DFDBA + PRF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount of regenerated bone
Time Frame: 6 months
the amount of regenerated bone will be assessed by Image Pro software in CBCT images
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Investigators

  • Principal Investigator: Arash Khojasteh, DMD, OMFS, Shahid Beheshti University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

April 18, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Estimate)

October 17, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sbmu9212

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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