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

Phase 1

Completed

• Conditions: Cleft of Alveolar Ridge
• Interventions: Biological: anterior iliac crest graft; Biological: anterior iliac crest graft+BFPSC+NBBM; Biological: lateral ramus cortical bone+BFPSC+NBBM

• Registration Number: NCT02859025
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

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.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2016-01
• Study Completion: 2016-02
• Study First Submitted: 2016-07-30
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-03
• Last Update Submitted: 2016-08-03
• Study First Posted: 2016-08-08
• Last Update Posted: 2016-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A:Iiac	anterior iliac crest graft	Treated with anterior iliac crest spongy bone to fill defects, followed by coverage with collagen membrane.
C:MSCs+liac	anterior iliac crest graft+BFPSC+NBBM	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.
B:MSCs+LRCP	lateral ramus cortical bone+BFPSC+NBBM	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

Primary Outcome Measures

Name	Time	Method
change in bone volume	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.

Trial Locations

Locations (1)

School of Dentristry at Shahid Beheshti University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of