Buccal Fat Pad Derived Stem Cells With Cortical Tenting in Posterior Mandible Reconstruction

Alveolar Bone Loss Clinical Trial

Official title:

The Effect of Buccal Fat Pad Derived Mesenchymal Stem Cells Loaded on Allograft and Platelet-rich Plasma in Posterior Mandible Augmentation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02745366
• Other study ID #: sbmu9217
• Status: Recruiting
• Phase: Phase 1
• First received: April 18, 2016
• Last updated: October 13, 2016
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: October 2016
• Source: Shahid Beheshti University of Medical Sciences
• Contact: Arash Khojasteh, DMD, OMFS
• Phone: 00989121060032
• Email: arashkhojasteh[@]yahoo.com
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Atrophy

Intervention

Procedure:
• BFPSC+FDBA+PRF

• FDBA+PRF

Locations

Country	Name	City	State
Iran, Islamic Republic of	School of Dentristry at Shahid Beheshti University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of regenerated bone	the amount of regenerated bone will be assessed by Image Pro software in CBCT images	6 months	No
Primary	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	6 months	No