Regeneration Bone Grafting & Soft Tissue Management

Regeneration Bone Grafting & Soft Tissue Management

OSTEON TM II

Table of Contents Bone Graft Material OSTEON TM II Collagen 04 OSTEON TM Collagen 06 OSTEON TM II 08 OSTEON TM 12 ORTHOPEDIC OSTEON TM 14 Membrane OSTEOGuide TM 15 Collagen Membrane 16 HA Collagen Membrane 18

04 Regeneration Bone Grafting & Soft Tissue Management OSTEON TM Il Collagen Application of OSTEON TM II Collagen Simple grafting (volume up) Ridge augmentation Extraction site & osteotomy Cystic cavities Periodontal defect Characteristics of OSTEON TM II Collagen Bone void filler composed of synthetic bonegraft(osteon TM II) and natural type I collagen Moldable to various defect shape after being wet Easy handling, thus shortened operation time OSTEON TM II is highly resorbable due to higher β-tcp content (HA:β-TCP=30:70) Collagen is absorbed over several weeks after helping the initial shaping Microstructure In Vitro Dissolution Test of OSTEON TM II Animal Test Animals : New Zealand white rabbit Implantation Area : Femur Period : 6 weeks CT image

Regeneration Bone Grafting & Soft Tissue Management 05 Products Type REF Size (mm) Particle Size (mm) OTCC0605M Ø6.0 x 5.0 Cylinder 0.2~1.0 OTCC0610M Ø6.0 x 10.0 Clinical Case Case I_Bone grafting Bone defect OSTEON II Collagen Suture After 4 months - Final prosthesis Follow up - 5 months Case II _ Socket preservation Pre-op Bone defect OSTEON II Collagen After 3 months - New bone formation After 6 months

06 Regeneration Bone Grafting & Soft Tissue Management OSTEON TM Collagen Application of OSTEON TM Collagen Ridge augmentation Extraction site & osteotomy Cystic cavities Sinus lift Periodontal defect Description OSTEON TM Collagen is a bone void filler composed of synthetic bone(osteon TM ), and natural type I collagen. Characteristics of OSTEON TM Collagen Collagen coating enables easy handling, and thus shortened operation time Moldable to various defect shape after being wet Collagen dissolves after helping the initial handling Excellent new bone formation and space maintenance Hemostatic function Highly pure type I collagen derived from bovine tendon Cell Adhesion Test X 1000 X 5000 Osteoblasts spread well on the OSTEON TM Collagen

Regeneration Bone Grafting & Soft Tissue Management 07 Animal Test Animals: new zealand white rabbit Implantation area: calvaria Period: 8 weeks Staining method: goldner trichrome 8 weeks Products Type REF Size (mm) Particle Size (mm) Cylinder GOCC0605 Ø6.0 x 5.0 GOCC0610 Ø6.0 x 10.0 0.5 ~ 1.0 Clinical Case Case I_Bone grafting Ye Dental Clinic / Dr. Jong-Chan Park Bone defect OSTEON Collagen After 1 month - Final prosthesis Case II _ GBR Follow up - 1 month Follow up - 1 month Pre-op Bone defect OSTEON Collagen + Collagen Membrane After 3 months - Final prosthesis Follow up - 5 months

08 Regeneration Bone Grafting & Soft Tissue Management OSTEON TM II Application of OSTEON TM II Ridge augmentation Extraction site & osteotomy Cystic cavities Sinus lift Periodontal defect Composition of OSTEON TM II Osteoconductive biphasic calcium phosphate with higher β-tcp OSTEON TM II = HA 30% + β-tcp 70% Characteristics of OSTEON TM II Highly resorbable due to higher β-tcp content Easy manipulation Excellent wettability Osteoconductive synthetic bonegraft Pore size : 250μm Porosity : 70% Cell Adhesion Test Osteoblasts attached & spreaded well In Vitro Dissolution Test

Regeneration Bone Grafting & Soft Tissue Management 09 Animal Test 12-weeks follow up in rabbit calvaria model OSTEON TM OSTEON TM II Products Type REF Volume (cc) Particle Size (mm) DT7G0205025 0.25 DT7G0205050 0.5 0.2~0.5 OSTEON II (Vial type) OSTEON II Sinus (Syringe type) OSTEON II Lifting (Syringe type) DT7G0205100 1.0 DT7G0510025 0.25 DT7G0510050 0.5 DT7G0510100 1.0 DT7G1020025 0.25 DT7G1020050 0.5 DT7G1020100 1.0 DT7G0510050SS 0.5 DT7G1020050SS 0.5 DT7G0205025LS 0.25 DT7G0510025LS 0.25 0.5~1.0 1.0~2.0 0.5~1.0 1.0~2.0 0.2~0.5 0.5~1.0 Clinical Case GBR Pre-op Bone defect OSTEON II Collagen Membrane Follow up - 7 months

10 Regeneration Bone Grafting & Soft Tissue Management OSTEON TM Application of OSTEON TM Ridge augmentation Extraction site Cystic cavities Sinus lift Periodontal defect Composition of OSTEON TM 100% Synthetic bone graft : HA scaffold coated with β-tcp OSTEON TM = HA 70% + β-tcp 30% Specification of OSTEON TM 100% synthetic bone graft Interconnected porous structure similar to that of human cancellous bone Osteoconductive material as a bone growth scaffold OSTEON TM Human bone Cell Adhesion Test Human osteoblast cell OSTEON TM Osteoblast cell was well attached and spreaded on OSTEON TM surface. X 1000 X 1000 X 5000

Regeneration Bone Grafting & Soft Tissue Management 11 Human Histology 6.5 months after sinus graft surgery New bone OSTEON TM 0.5mm 0.25mm OSTEON TM area = 1.24mm 2 (17.1%) New bone area = 1.63mm 2 (22.7%) 10 months after sinus graft surgery OSTEON TM New bone 1.0mm 1.5mm OSTEON TM area = 3.04mm 2 (35.5%) New bone area = 2.38mm 2 (27.7%) 21 months after sinus graft surgery OSTEON TM New bone 0.5mm 0.25mm OSTEON TM area = 6.30mm 2 (40.4%) New bone area = 5.12mm 2 (33.0%)

12 Regeneration Bone Grafting & Soft Tissue Management Products Product REF Particle Size (mm) Volume (cc) GBG0305 0.3~0.5 OSTEON (Vial type) GBG0510 0.5~1.0 0.25 / 0.5 / 1.0 GBG1020 1.0~2.0 OSTEON Sinus (Syringe type) GBG0510SS 0.5~1.0 GBG1020SS 1.0~2.0 0.5 OSTEON Lifting (Syringe type) GBG0305LS 0.3~0.5 GBG0510LS 0.5~1.0 0.25 Syringe Size Product Syringe outer diameter Syringe inner diameter OSTEON Sinus OSTEON II Sinus OSTEON Lifting OSTEON II Lifting Ø7.0mm Ø5.0mm Ø5.0mm Ø3.4mm

Regeneration Bone Grafting & Soft Tissue Management 13 Instruction 1 Slightly retract the plunger and gently tap to loosen particles. Gently push plunger back into place. 2 Place syringe into a sterile dappen dish and retract plunger to draw liquid into the syringe. 3 To optimize delivery, OSTEON TM should be wetted and loosened sufficiently. 4 Expel excess liquid by applying very gentle pressure on the plunger. 5 When sufficiently hydrated, OSTEON TM will expel with ease from the syringe. Before injecting OSTEON TM, remove the cap from the syringe. 6 Deliver OSTEON TM directly into the surgical site with the syringe. Clinical Case OSTEON TM Sinus case (Sinus grafting - lateral approach) After 9 months OSTEON TM Lifting case (Sinus grafting - crestal approach)

14 Regeneration Bone Grafting & Soft Tissue Management ORTHOPEDIC OSTEON TM Application of ORTHOPEDIC OSTEON TM Bone filling Fractures with bone defects Pseudoarthrosis with or without bone defects Tibial osteotomy In certain cases of arthroplasty revision Products Product REF Particle Size (mm) Volume (cc) ORTHOPEDIC OSTEON GOBG2040 2.0~4.0 GOBG4070 4.0~7.0 3.0 / 4.0 / 5.0 / 10.0 / 15.0 / 20.0 GOBG0510, GOBG1020, GOBG2030, GOBG3040, GOBG4050 are available. Animal Test - Rabbit Femur Model X 12.5 X 100 12 weeks after bone grafting in rabbit femur. After bone grafting in rabbit femur for 12 weeks, new bone was well formed in the pores and around ORTHOPEDIC OSTEON TM. Clinical Case Bone void filler

Regeneration Bone Grafting & Soft Tissue Management 15 OSTEOGuide TM Description Non-resorbable GBR membrane Biocompatible polymer PCL Thin for easy manipulation Porous membrane Products Product REF Size (mm) Thickness (mm) GPM1020 10 X 20 OSTEOGuide TM GPM2030 20 X 30 0.12 GPM3040 30 X 40 Composition of OSTEOGuide TM Bio-compatible polymer = 100% PCL (Polycaprolactone) The porous outer surface of the OSTEOGuide TM allows easy entry of the adjacent cells assuring rapid and good tissue attachment. Good nutrient flow and blood vessel formation supported by the porous structure. Animal test rabbit calvaria model New bone was well formed on the bottom of the OSTEOGuide TM and cells did not penetrate into the defect. Soft tissue OSTEOGuide TM

16 Regeneration Bone Grafting & Soft Tissue Management Collagen Membrane Application of Collagen Membrane Biodegradable barrier membrane for guided bone / tissue regeneration Periodontal / infrabony defects Ridge augmentation Extraction sites (implant preparation / placement) Sinus lift Characteristics of Collagen Membrane Easy manipulation Dual-sided usage Barrier function lasting for 6 months Highly pure type I collagen derived from bovine tendon Thinner membrane(300μm ) with multiple layers for easy manipulation and sufficient mechanical strength in surgery. Resorption period of 6 months to provide enough time for stabilizing graft materials and supporting bone growth. Multiple-layered structure enables more effective bone regeneration by sparing enough space for hard tissue formation and facilitates proliferation of osteoblast. Microstructure X 1000 X 5000

Regeneration Bone Grafting & Soft Tissue Management 17 Animal Test Rabbit calvaria model, 6-12 weeks In vitro Degradation Test 6 weeks 12 weeks Products Product REF Size (mm) Thickness (mm) GCM1020 10 X 20 Collagen Membrane GCM1520 15 X 20 0.3 GCM2030 20 X 30 Clinical Case Case I_GBR Win Dental Clinic / Dr. Dong-Wook Chang Pre-op Bone defect Collagen Membrane After 3 months After 10 months - Final prosthesis Case II _ GBR Dr. Seung-Min Han Pre-op Bone defect Collagen Membrane After 5 months After 6 months - Final prosthesis

18 Regeneration Bone Grafting & Soft Tissue Management HA Collagen Membrane Application of HA Collagen Membrane Resorbable collagen membrane containing hydroxyapatite (HA) particles Periodontal / Infrabony defects Ridge augmentation Extraction sites Guided Bone Regeneration(GBR) procedure Sinus lift Characteristics of HA Collagen Membrane Resorbable barrier membrane Osteoconductive due to HA particles New bone formation through the membrane Highly pure type I collagen derived from bovine tendon Cell Adhesion Test MC3T3 / E1 (Osteoblast cell) X 500 Microstructure X 1000 X 70000

Regeneration Bone Grafting & Soft Tissue Management 19 Animal Test Rabbit calvaria model, 12 weeks Products Product REF Size (mm) Thickness (mm) GCHM 1020 10 X 20 HA Collagen Membrane GCHM 1520 15 X 20 GCHM 2030 20 X 30 0.3 Clinical Case Case I_GBR Pre-op OSTEON II Collagen + HA Collagen Membrane After 5 months - New bone formation After 7 months - Final prosthesis Follow up - 2 months Case II _ Socket preservation Fixture installation OSTEON II HA Collagen Membrane After 1 month - Final prosthesis Follow up - 5 months

26 Regeneration Bone Grafting & Soft Tissue Management OSTEON TM II

Regeneration Bone Grafting & Soft Tissue Management OSTEON TM II Collagen / OSTEON TM Collagen / OSTEON TM II / OSTEON TM ORTHOPEDIC OSTEON TM / OSTEOGuide TM / Collagen Membrane / HA Collagen Membrane Copyright January, 2013 DENTIUM

Regeneration Bone Grafting & Soft Tissue Management Specifications are subject to change without prior notice. Some products to be launched in the market after necessary approvals are also listed in this catalog. CAT-B0401(REV.19,1301) HEAD OFFICE 3105 Trade Tower, 513 Yeongdong-daero, Gangnam-gu, Seoul, Korea 135-731 T +82-2-501-8560 F +82-2-567-9578 MANUFACTURER 1F, Gyeonggi R&DB Center / 226, 2F, GSBC, 105 Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea 1F, 31, Deogyeong-daero 1499beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea T +82-31-888-5100 F +82-31-888-5105 HOMEPAGE www.dentium.com / www.genoss.com