Concomitant Use of Buccal Fat Pad Derived Cells and Autogenous Bone in Alveolar Cleft Osteoplasty

August 3, 2016 updated by: Arash Khojasteh, Shahid Beheshti University of Medical Sciences

Lateral Ramus Cortical Bone Plate in Alveolar Cleft Osteoplasty: Concomitant Use of Buccal Fat Pad Derived Cells and Autogenous Bone in a Preliminary Study

Our aim was to combine regenerative techniques with bone grafting in human models to increase predictability and survival of reconstructed tissue. The MSCs in this study were derived from an intra oral fat source (BFP) and were cultured over natural bovine bone mineral granules and delivered within the lateral ramus cortical bone plate (LRCP)to treat human alveolar cleft defects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients enrolled in the present study were suffering from alveolar cleft and had previously received orthodontic treatment and only required secondary alveolar grafting. The buccal fat pad derived stem cells (BFPSCs) were harvested from buccal fat pad tissues of the patients. Patients were divided into 3 groups. Group A , the control group, was treated with anterior iliac crest (AIC) spongy bone to fill defects, followed by coverage with collagen membrane. Group B was treated with lateral ramus cortical bone cage (LRCP), used to create a protected healing space by fixing it to adjacent walls of the cleft defect. Group C was treated with (AIC) as in Group 1, but BFP-derived MSCs cultured over NBBM were put over the spongy bone and covered with a collagen membrane.Passage 3 BFPSCs were loaded on the implants ( Cerabone (Botiss, Berlin, Germany) a natural bovine bone mineral (NBBM); a granular biomaterial with a 200- to 850-µm particle size) 3 days prior to transplantation.Cone beam computed tomography (CBCT) was obtained after 6 months.

Study Type

Interventional

Enrollment (Actual)

10

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 Locations

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unilateral congenital cleft lip and palate
  • Previous presurgical orthodontic treatment

Exclusion Criteria:

  • History of malignancy
  • History of radiation
  • History of chemotherapy
  • Pregnancy
  • Systemic diseases contradicting dental and surgical treatments
  • Conditions or drugs affecting bone remodeling or bone metabolism and connective tissue
  • 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
Active Comparator: A:Iiac
Treated with anterior iliac crest spongy bone to fill defects, followed by coverage with collagen membrane.
Biological: anterior iliac crest graft
Anterior iliac crest spongy bone filled the defects followed by coverage with collagen membrane.
Experimental: B:MSCs+LRCP
Treated with lateral ramus cortical bone plate (LRCP) to create a protected healing space by fixing it to adjacent walls of the cleft defect. BFPScs were loaded on NBBM and delivered to the defect
Biological: lateral ramus cortical bone+BFPSC+NBBM
ramus cortical bone cage created a protected healing space and BFPSCs cultured over NBBM were put over the graft.
Experimental: C:MSCs+liac
Treated with anterior iliac crest spongy bone as in Group 1, but BFP-derived mesenchymal stem cells (MSCs ) cultured over NBBM were put over the spongy bone and covered with a collagen membrane.
Biological: anterior iliac crest graft+BFPSC+NBBM
Anterior iliac crest spongy bone filled the defects and BFPSCs cultured over NBBM were put over the spongy bone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in bone volume
Time Frame: before the surgery and 6 months after the surgery
1-mm coronal sections of the treated region were taken before and after surgery, and new bone formation was assessed by CBCT.
before the surgery and 6 months after the surgery

Collaborators and Investigators

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

Sponsor

Shahid Beheshti University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

July 30, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 8, 2016

Study Record Updates

Last Update Posted (Estimate)

August 8, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • sbmu9221

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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