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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02745366

Enrollment

Registered

2016-04-20

Start date

2016-01-31

Completion date

2016-12-31

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Loss, Atrophy

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.

Interventions

PROCEDUREBFPSC+FDBA+PRF

PROCEDUREFDBA+PRF

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Iran

Contacts

Primary ContactArash Khojasteh, DMD, OMFS

arashkhojasteh@yahoo.com00989121060032

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026