and 5 other(s)
〇Background It is well known that gold standard for bone reconstruction is autograft. However, it has serious limitations including the invasive surgery to healthy site and insufficient availability. Allograft and Xenograft also have limitations including potential infection risks. 〇Aim/Hypothesis To solve these problems, we focused on synthetic carbonated apatite granules (CO3Ap), which is similar to inorganic component of human bone. In this study, we aimed to evaluate the efficacy and biocompatibility of CO3Ap by two in vivo studies and biological evaluation based on ISO. 〇Material and Methods CO3Ap granules was fabricated by compositional transformation based on dissolution precipitation reaction. The animal experiments were performed at Hamri Co., Ltd(approved by the AAALAC International). [Study A] Bone defects (D3.6×8 mm) in dog mandible were created 2 months after extraction. 3 materials were randomly applied: CO3Ap, HAp, b-TCP. After healing period of 4 and 12 weeks, histological evaluation was performed. [Study B]D3.8 mm dental implants were placed in center of the distal and mesial sockets of dog lower premolaras. The extraction sockets were randomly divided into CO3Ap, HAp, b-TCP and negative control. After healing period of 12 weeks, histological evaluation were performed. [Study C] Histopathological evaluations in bone defect was performed using rabbits according to ISO 10993-6. CO3Ap was implanted to bone defect (D5 mm×8 mm) created in femoral shaft of rabbit. After healing period of 4, 8 and 12 weeks, histological evaluation of the implanted site were performed. 〇Results [Study A] Bone formation was observed from the area adjacent to the bone wall in all tested materials at 4 weeks. CO3Ap group showed higher new bone area compared to HAp group and b-TCP group. [Study B] The result of histomorphomettric assessments was 80.6% in CO3Ap group, 82.8% in b-TCP group, 41.9% in HAp group and 64.1% in control group. New bone area was higher in CO3Ap group (90.0%), b-TCP group (91.6%) and control group (90.2%) comapared to HAp group (23.0%). Epithelial downgrowth area was less in the CO3Ap group (0/4 site, 0 mm2) than b-TCP group (3/4 site, 0.18 mm2), HAp group (4/4 site, 0.28 mm2) and control group (3/4 site, 0.51 mm2). These results suggest that CO3Ap promote connective tissue ingrowth and thus minimize epithelial downgrowth. [Study C] The results showed no evidence of inflammatory cell migration, no epidermal necrosis, no vacuolar degeneration of basal cell, no adnexal atrophy and vesicle formation of any samples. 〇Conclusion and Clinical implications CO3Ap showed the potential of being an effective and biocompatible bone graft substitute, which shows the potential of using this material to generate bone and repair the peri-implant bone defect clinically.
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