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Clinical Trials/NCT02859025
NCT02859025
Completed
Phase 1

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

Shahid Beheshti University of Medical Sciences1 site in 1 country10 target enrollmentJanuary 2015

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Cleft of Alveolar Ridge
Sponsor
Shahid Beheshti University of Medical Sciences
Enrollment
10
Locations
1
Primary Endpoint
change in bone volume
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
February 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Arash Khojasteh

Associate professor

Shahid Beheshti University of Medical Sciences

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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