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

NCT02745366 | Unknown Phase 1

• 1 other identifier: sbmu9217
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Bone Loss; Atrophy

Outcome Measures

Primary Outcomes (2)

• amount of regenerated bone

  the amount of regenerated bone will be assessed by Image Pro software in CBCT images

  6 months

• 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

Study Arms (2)

BFPSC+

EXPERIMENTAL

The combination of BFPSC+FDBA+PRF is utilized in cortical tenting technique with block graft obtained from lateral ramus for posterior mandible augmentation procedure.

Procedure: BFPSC+FDBA+PRF

BFPSC-

ACTIVE COMPARATOR

The combination of FDBA+PRF is utilized in cortical tenting technique with block graft obtained from lateral ramus for posterior mandible augmentation procedure

Procedure: FDBA+PRF

Interventions

BFPSC+FDBA+PRF PROCEDURE

BFPSC+

FDBA+PRF PROCEDURE

BFPSC-

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

School of Dentristry at Shahid Beheshti University of Medical Sciences

Tehran, Tehran Province, 19839, Iran

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss; Atrophy

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Arash Khojasteh, DMD, OMFS

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arash Khojasteh, DMD, OMFS

CONTACT

00989121060032; arashkhojasteh@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 20, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

IR (1)