A Phase 1 interventional study of anterior iliac crest graft and lateral ramus cortical bone+BFPSC+NBBM in Cleft of Alveolar Ridge, sponsored by Shahid Beheshti University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Per ClinicalTrials.gov, last updated 2016-08-08.
Sponsored by Shahid Beheshti University of Medical Sciences · Phase 1, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
Treated with anterior iliac crest spongy bone to fill defects, followed by coverage with collagen membrane.
Biological: anterior iliac crest graft
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
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 followed by coverage with collagen membrane.
ramus cortical bone cage created a protected healing space and BFPSCs cultured over NBBM were put over the graft.
Anterior iliac crest spongy bone filled the defects and BFPSCs cultured over NBBM were put over the spongy bone.
change in bone volume
1-mm coronal sections of the treated region were taken before and after surgery, and new bone formation was assessed by CBCT.
Time frame: before the surgery and 6 months after the surgery
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Shahid Beheshti University of Medical Sciences