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

Shahid Beheshti University of Medical Sciences

Status and phase: Completed; Phase 1

Conditions: Cleft of Alveolar Ridge

Treatments: Biological: lateral ramus cortical bone+BFPSC+NBBM; Biological: anterior iliac crest graft+BFPSC+NBBM; Biological: anterior iliac crest graft

Study type: Interventional

Funder types: Other

Identifiers

NCT02859025

sbmu9221

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

A:Iiac

Active Comparator group

Description:

Treated with anterior iliac crest spongy bone to fill defects, followed by coverage with collagen membrane.

Treatment:

Biological: anterior iliac crest graft

B:MSCs+LRCP

Experimental group

Description:

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

Treatment:

Biological: lateral ramus cortical bone+BFPSC+NBBM

C:MSCs+liac

Experimental group

Description:

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.

Treatment:

Biological: anterior iliac crest graft+BFPSC+NBBM