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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-02-29

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.

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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.

Conditions

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Cleft of Alveolar Ridge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A:Iiac

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

Group Type ACTIVE_COMPARATOR

anterior iliac crest graft

Intervention Type BIOLOGICAL

Anterior iliac crest spongy bone filled the defects followed by coverage with collagen membrane.

B:MSCs+LRCP

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

Group Type EXPERIMENTAL

lateral ramus cortical bone+BFPSC+NBBM

Intervention Type BIOLOGICAL

ramus cortical bone cage created a protected healing space and BFPSCs cultured over NBBM were put over the graft.

C:MSCs+liac

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.

Group Type EXPERIMENTAL

anterior iliac crest graft+BFPSC+NBBM

Intervention Type BIOLOGICAL

Anterior iliac crest spongy bone filled the defects and BFPSCs cultured over NBBM were put over the spongy bone.

Interventions

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anterior iliac crest graft

Anterior iliac crest spongy bone filled the defects followed by coverage with collagen membrane.

Intervention Type 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.

Intervention Type 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.

Intervention Type BIOLOGICAL

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No