• Journal of Periodontal and Implant Science
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• v.39 no.3
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• pp.349-358
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• 2009

Purpose: This study was aimed to evaluate the effect of the Freeze Dried Bone Allograft and Demineralized Bone Matrix on osseous regeneration in the rat calvarial defects. Methods: Eight mm critical-sized calvarial defects were created in the 80 male Sprague-Dawley rats. The animals were divided into 4 groups of 20 animals each. The defects were treated with Freeze Dried Bone Allograft($SureOss^{TM}$), Demineralized Bone Matrix($ExFuse^{TM}$ Gel, $ExFuse^{TM}$ Putty), or were left untreated for sham-surgery control and were evaluated by histologic and histomorphometric parameters following a 2 and 8 week healing intervals. Statistical analysis was done between each groups and time intervals with ANOVA and paired t-test. Results: Defect closure, New bone area, Augmented area in the $SureOss^{TM}$, $ExFuse^{TM}$ Gel, $ExFuse^{TM}$ Putty groups were significantly greater than in the sham-surgery control group at each healing interval(P < 0.05). In the New bone area and Defect closure, there were no significant difference between experimental groups. Augmented area in the $ExFuse^{TM}$ Gel, $ExFuse^{TM}$ Putty groups were significantly greater than $SureOss^{TM}$ group at 2weeks(P < 0.05), however there was no significant difference at 8 weeks. Conclusions: All of $SureOss^{TM}$, $ExFuse^{TM}$ Gel, $ExFuse^{TM}$ Putty groups showed significant new bone formation and augmentation in the calvarial defect model.

• Journal of Korean Neurosurgical Society
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• v.67 no.3
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• pp.354-363
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• 2024

Objective : This study aims to determine the optimal dose of recombinant-human bone morphogenic protein-2 (rhBMP-2) for successful bone fusion in minimally invasive lateral lumbar interbody fusion (MIS LLIF). Previous studies show that rhBMP is an effective alternative to autologous iliac crest bone graft, but the optimal dose remains uncertain. The study analyzes the fusion rates associated with different rhBMP doses to provide a recommendation for the optimal dose in MIS LLIF. Methods : Ninety-three patients underwent MIS LLIF using demineralized bone matrix (DBM) or a mixture of rhBMP-2 and DBM as fusion material. The group was divided into the following three groups according to the rhBMP-2 usage : group A, only DBM was used (n=27); group B, 1 mg of rhBMP-2 per 5 mL of DBM paste (n=41); and group C, 2 mg of rhBMP-2 per 5 mL of DBM paste (n=25). Demographic data, clinical outcomes, postoperative complication and fusion were assessed. Results : At 12 months post-surgery, the overall fusion rate was 92.3% according to Bridwell fusion grading system. Groups B and C, who received rhBMP-2, had significantly higher fusion rates than group A, who received only DBM. However, there was no significant increase in fusion rate when the rhBMP-2 dosage was increased from group B to group C. The groups B and C showed significant improvement in back pain and Oswestry disability index compared to the group A. The incidence of screw loosening was decreased in groups B and C, but there was no significant difference in the occurrence of other complications. Conclusion : Usage of rhBMP-2 in LLIF surgery leads to early and increased final fusion rates, which can result in faster pain relief and return to daily activities for patients. The benefits of using rhBMP-2 were not significantly different between the groups that received 1 mg/5 mL and 2 mg/5 mL of rhBMP-2. Therefore, it is recommended to use 1 mg of rhBMP-2 with 5 mL of DBM, taking both economic and clinical aspects into consideration.

• Journal of Periodontal and Implant Science
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• v.41 no.5
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• pp.227-233
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• 2011

Purpose: The aim of this study was to compare osteoblast behavior on zirconia and titanium under conditions cultured with bone morphogenetic protein-2. Methods: MC3T3-E1 cells were cultured on sandblasted zirconia and sandblasted/etched titanium discs. At 24 hours after seeding MC3T3-E1, the demineralized bone matrix (DBM) gel alone and the DBM gel with bone morphogenetic protein-2 (BMP-2) were added to the culture medium. The surface topography was examined by confocal laser scanning microscopy. Cellular proliferation was measured at 1, 4, and 7 days after gel loading. Alkaline phosphatase activity was measured at 7 days after gel loading. The mRNA expression of ALPase, bone sialoprotein, type I collagen, runt-related transcription factor 2 (Runx-2), osteocalcin, and osterix were evaluated by real-time polymerase chain reaction at 4 days and 7 days. Results: At 1, 4, and 7 days after loading the DBM gel alone and the DBM gel with BMP-2, cellular proliferation on the zirconia and titanium discs was similar and that of the groups cultured with the DBM gel alone and the DBM gel with BMP-2 was not significantly different, except for titanium with BMP-2 gel. ALPase activity was higher in the cells cultured with BMP-2 than in the other groups, but there was no difference between the zirconia and titanium. In ALPase, bone sialoprotein, osteocalcin, Runx-2 and osterix gene expression, that of cells on zirconia or titanium with BMP-2 gel was much more highly increased than titanium without gel at day 7. The gene expression level of cells cultured on zirconia with BMP-2 was higher than that on titanium with BMP-2 at day 7. Conclusions: The data in this study demonstrate that the osteoblastic cell attachment and proliferation of zirconia were comparable to those of titanium. With the stimulation of BMP-2, zirconia has a more pronounced effect on the proliferation and differentiation of the osteoblastic cells compared with titanium.

• Clinics in Shoulder and Elbow
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• v.19 no.1
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• pp.2-7
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• 2016

Background: The purpose of this study is to compare the radiological and clinical outcomes after open reduction and plate fixation of midshaft clavicle fractures between patients who achieved successful anatomical reduction and those who had a remaining fracture gap even after open reduction and plate fixation, and were thus treated with additional demineralized bone matrix (DBM). Methods: This retrospective analysis was conducted on 56 consecutive patients who underwent open reduction and internal fixation using a locking compression plate for acute displaced midshaft clavicle fractures, and who underwent radiographic and clinical outcome evaluations at least 6 months postoperatively. The outcomes between those who achieved perfect anatomical reduction without remnant gap (n=32) and those who had a remaining fracture gap even after open reduction and plate fixation treated with additional DBM (n=24) were evaluated. Results: There were no differences in the use of lag screws or wiring and operation time (all p>0.05) between those with and without remnant gap. No difference in the average radiological union time and clinical outcomes (satisfaction and Constant score) was observed between the two groups (all p>0.05). However, significantly faster union time was observed for AO type A fracture compared with other types (p=0.012), and traffic accident showed association with worse clinical outcomes compared with other causes of injury. Conclusions: Surgical outcome of midshaft clavicle fracture was more affected by initial fracture type and event, and re-reduction and re-fixation of the fracture to obtain a perfect anatomical reduction spending time appears to be unnecessary if rigid fixation is achieved.

• Journal of Korean Neurosurgical Society
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• v.64 no.4
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• pp.562-574
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• 2021

Objective : This study is to evaluate the efficacy and safety of demineralized bone matrix (DBM) gel versus DBM gel with recombinant human bone morphogenetic protein-2 (rhBMP-2) used in transforaminal lumbar interbody fusion (TLIF). Methods : This study was designed as a prospective, multi-center, double-blind method, randomized study. All randomized subjects underwent TLIF with DBM gel with rhBMP-2 group (40 patients) as an experimental group or DBM gel group (36 patients) as a control group. Post-operative observations were performed at 12, 24, and 48 weeks. The spinal fusion rate on computed tomography scans and X-rays films, Visual analog scale pain scores, Oswestry disability index and SF-36 quality of life (QOL) scores were used for the efficacy evaluation. The incidence rate of adverse device effects (ADEs) and serious adverse device effects (SADEs) were used for safety evaluation. Results : The spinal fusion rate at 12 weeks for the DBM gel with rhBMP-2 group was higher with 73.68% compared to 58.82% for the DBM gel group. The 24 and 48 weeks were 72.22% and 82.86% for the DBM gel with rhBMP-2 group and 78.79% and 78.13%, respectively, for the DBM gel group. However, there were no significant differences between two groups in the spinal fusion rate at 12, 24, and 48 weeks post-treatment (p=0.1817, p=0.5272, p=0.6247). There was no significant difference between the two groups in the incidence rate of ADEs (p=0.3836). For ADEs in the experimental group, 'Pyrexia' (5.00%) was the most common ADE, followed by 'Hypesthesia', 'Paresthesia', 'Transient peripheral paralysis', 'Spondylitis' and 'Insomnia' (2.50%, respectively). ADEs reported in control group included 'Pyrexia', 'Chest discomfort', 'Pain', 'Osteoarthritis', 'Nephropathy toxic', 'Neurogenic bladder', 'Liver function analyses' and 'Urticaria' (2.86%, respectively). There was no significant difference between the two groups in the incidence rate of SADEs (p=0.6594). For SADE in the experimental group, ''Pyrexia' and 'Spondylitis' were 2.50%. SADE reported in the control group included 'Chest discomfort', 'Osteoarthritis' and 'Neurogenic bladder'. All SADEs described above were resolved after medical treatment. Conclusion : This study demonstrated that the spinal fusion rates of DBM gel group and DBM gel with rhBMP-2 group were not significantly different. But, this study provides knowledge regarding the earlier postoperative effect of rhBMP-2 containing DBM gel and also supports the idea that the longer term follow-up results are essential to confirm the safety and effectiveness.

• Maxillofacial Plastic and Reconstructive Surgery
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• v.35 no.6
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• pp.353-359
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• 2013

Purpose: Extensive research is actively ongoing for development of an ideal bone substitute that meets the gold standard. Tooth was selected as a donor site for evaluation of potentials in bone substitutes based on its similar chemical compositions to alveolar bone. Previous studies have evaluated inorganic components of autogenous tooth bone graft material (AutoBT) and osteoconductivity. In continuation from the previous studies, the current study was conducted for analysis of organic components and evaluation of osteoinductivity of AutoBT. Methods: Forty-six extracted teeth were collected from actual patients (Korea Tooth Bank, R&D Institute). Extracted teeth were processed into AutoBT and implanted in dorsal subcutaneous muscular tissues of 15 athymic mice. Biopsy samples were harvested at two, five, and eight weeks. The Bradford assay, sodium dodecyl sulphate polyacrylamide gradient gel, and western blotting were performed for investigation of organic contents of AutoBT. Results: Histology analyses showed signs of new bone formation as early as two weeks. Results of the Bradford assay indicated the existence of noncollagenous proteins (NCP). 0.29% (2.89 mg/g) of proteins were extracted by weight in the root portion of AutoBT; 0.02% (0.029 mg/g) and 1.79% (17.93 mg/g) of proteins were measured by weight in crown and block-form of AutoBT, respectively. However, recombinant human bone morphogenetic protein-2 was not observed in AutoBT. Conclusion: Within the limitation of the current study, AutoBT induced new bone formation by NCP embedded in dentin.