NCT02859025

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cleft of Alveolar Ridge

Interventions

Type	Name	Description
BIOLOGICAL	anterior iliac crest graft	Anterior iliac crest spongy bone filled the defects followed by coverage with collagen membrane.
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.
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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-01-01
• Completion: 2016-02-01
• First posted: 2016-08-08
• Last updated: 2016-08-08

Locations

1 site across 1 country: Iran