School of Dentristry at Shahid Beheshti University of Medical Sciences
Tehran, Tehran Province, 19839, Iran
Completed
NCT Number: NCT02859025
Concomitant Use of Buccal Fat Pad Derived Cells and Autogenous Bone in Alveolar Cleft Osteoplasty
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.
Completed
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Conditions
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
anterior iliac crest graft
BiologicalAnterior iliac crest spongy bone filled the defects followed by coverage with collagen membrane.
lateral ramus cortical bone+BFPSC+NBBM
Biologicalramus cortical bone cage created a protected healing space and BFPSCs cultured over NBBM were put over the graft.
anterior iliac crest graft+BFPSC+NBBM
BiologicalAnterior iliac crest spongy bone filled the defects and BFPSCs cultured over NBBM were put over the spongy bone.
Primary outcomes
-
change in bone volume
Time frame: before the surgery and 6 months after the surgery
1-mm coronal sections of the treated region were taken before and after surgery, and new bone formation was assessed by CBCT.
Sponsors and collaborators
Lead sponsor
Shahid Beheshti University of Medical Sciences
Other
Registry information
Official study title
Lateral Ramus Cortical Bone Plate in Alveolar Cleft Osteoplasty: Concomitant Use of Buccal Fat Pad Derived Cells and Autogenous Bone in a Preliminary Study
Important dates
- Study start
- 2015
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Aug 8, 2016
- Registry last updated
- Aug 8, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.