TY - JOUR
T1 - Collagen Membrane for Guided Bone Regeneration in Dental and Orthopedic Applications
AU - Allan, Brent
AU - Ruan, Rui
AU - Landao-Bassonga, Euphemie
AU - Gillman, Nicholas
AU - Wang, Tao
AU - Gao, Junjie
AU - Ruan, Yonghua
AU - Xu, Yuan
AU - Lee, Clair
AU - Goonewardene, Mithran
AU - Zheng, Ming-Hao
PY - 2021/3
Y1 - 2021/3
N2 - Treatment of cortical bone defects is a clinical challenge. Guided bone regeneration (GBR), commonly used in oral in maxillofacial dental surgery, may show promise for orthopedic application in repair of cortical defects. However, a limitation in the use of GBR for cortical bone defects is the lack of an ideal scaffold that provides sufficient mechanical support to bridge the cortical bone with minimal interference in the repair process. We have developed a new collagen membrane, CelGro™, for use in GBR. We report the material characterisation of CelGro™, and evaluate the performance of CelGro™ in translational preclinical and clinical studies. The results show CelGro™ has a bilayer structure of different fibre alignment and is composed almost exclusively of type I collagen. CelGro™ was found to be completely acellular and free from xenoantigen, α-gal. In the preclinical study of a rabbit cortical bone defect model, CelGro™ demonstrated enhanced bone-modelling activity and cortical bone healing. Micro-CT evaluation showed early bony bridging over the defect area 30 days post-operatively, and nearly complete restoration of mature cortical bone at the bone defect site 60 days post-operatively. Histological analysis at day 60 after surgery further confirmed that CelGro™ enables bridging of the cortical bone defect by induction of newly-formed cortical bone. Compared to a commercially available collagen membrane, Bio-Gide®, CelGro™ showed much better cortical alignment and reduced porosity at the defect interface. Owning the fact that selection of orthopedic patients with cortical bone defects is complex, we conducted a clinical study in a total of 16 dental implants which were placed in 10 participants receiving GBR. The results showed that Celgro™ restore bone defect with no complications or adverse events. Cone-beam computed tomography (CBCT) images show significantly increased bone formation in both horizontally and vertically, which provids sufficient support to the implants within 4 months. Together, the the findings of our study demonstrate that CelGro™ is an ideal membrane for GBR not only in oral maxillofacial reconstructive surgery but also in orthopedic applications.
AB - Treatment of cortical bone defects is a clinical challenge. Guided bone regeneration (GBR), commonly used in oral in maxillofacial dental surgery, may show promise for orthopedic application in repair of cortical defects. However, a limitation in the use of GBR for cortical bone defects is the lack of an ideal scaffold that provides sufficient mechanical support to bridge the cortical bone with minimal interference in the repair process. We have developed a new collagen membrane, CelGro™, for use in GBR. We report the material characterisation of CelGro™, and evaluate the performance of CelGro™ in translational preclinical and clinical studies. The results show CelGro™ has a bilayer structure of different fibre alignment and is composed almost exclusively of type I collagen. CelGro™ was found to be completely acellular and free from xenoantigen, α-gal. In the preclinical study of a rabbit cortical bone defect model, CelGro™ demonstrated enhanced bone-modelling activity and cortical bone healing. Micro-CT evaluation showed early bony bridging over the defect area 30 days post-operatively, and nearly complete restoration of mature cortical bone at the bone defect site 60 days post-operatively. Histological analysis at day 60 after surgery further confirmed that CelGro™ enables bridging of the cortical bone defect by induction of newly-formed cortical bone. Compared to a commercially available collagen membrane, Bio-Gide®, CelGro™ showed much better cortical alignment and reduced porosity at the defect interface. Owning the fact that selection of orthopedic patients with cortical bone defects is complex, we conducted a clinical study in a total of 16 dental implants which were placed in 10 participants receiving GBR. The results showed that Celgro™ restore bone defect with no complications or adverse events. Cone-beam computed tomography (CBCT) images show significantly increased bone formation in both horizontally and vertically, which provids sufficient support to the implants within 4 months. Together, the the findings of our study demonstrate that CelGro™ is an ideal membrane for GBR not only in oral maxillofacial reconstructive surgery but also in orthopedic applications.
U2 - 10.1089/ten.tea.2020.0140
DO - 10.1089/ten.tea.2020.0140
M3 - Article
C2 - 32741266
SN - 1937-3341
VL - 27
SP - 372
EP - 381
JO - Tissue Engineering Part A
JF - Tissue Engineering Part A
IS - 5-6
ER -