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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
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02859025
Enrollment
10
Registered
2016-08-08
Start date
2015-01-31
Completion date
2016-02-29
Last updated
2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft of Alveolar Ridge

Keywords

Alveolar cleft, Osteoplasty, Tissue engineering, Stem cells, Regenerative medicine, Bone, Lateral ramus

Brief 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.

Interventions

BIOLOGICALanterior iliac crest graft

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

BIOLOGICALlateral ramus cortical bone+BFPSC+NBBM

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

BIOLOGICALanterior iliac crest graft+BFPSC+NBBM

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

Sponsors

Shahid Beheshti University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in bone volumebefore the surgery and 6 months after the surgery1-mm coronal sections of the treated region were taken before and after surgery, and new bone formation was assessed by CBCT.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026