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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cleft of Alveolar Ridge

Intervention / Treatment
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* Biological: anterior iliac crest graft
* Biological: lateral ramus cortical bone+BFPSC+NBBM
* Biological: anterior iliac crest graft+BFPSC+NBBM


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A:Iiac<br>Treated with anterior iliac crest spongy bone to fill defects, followed by coverage with collagen membrane. | Biological: anterior iliac crest graft<br>* Anterior iliac crest spongy bone filled the defects followed by coverage with collagen membrane.<br>|
| Experimental: B:MSCs+LRCP<br>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<br>* ramus cortical bone cage created a protected healing space and BFPSCs cultured over NBBM were put over the graft.<br>|
| Experimental: C:MSCs+liac<br>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<br>* Anterior iliac crest spongy bone filled the defects and BFPSCs cultured over NBBM were put over the spongy bone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | before the surgery and 6 months after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone, Alveolar cleft, Osteoplasty, Tissue engineering, Stem cells, Regenerative medicine, Lateral ramus