Designed by nature, developed for clinicians. creos xenogain and creos xenoprotect

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1 Designed by nature, developed for clinicians xenogain and

2 A comprehensive range of regenerative solutions A reliable foundation of sufficient bone is key to improving patients quality of life with dental implant treatment. With, we offer an outstanding regenerative solutions portfolio. The xenogenic assortment features an extensive range of options for a wide variety of clinical indications and preferences. For your peace of mind, our xenogenic products are manufactured according to Medical Device Quality System Standards 1, resulting in quality products that enable effective and reliable GBR and GTR procedures. 2 xenogain Deproteinized bovine bone mineral matrix with a low crystalline structure and a large specific surface area. 3,4,5 xenogain collagen A composite of xenogain and 1 % porcine collagen type 1 for easy graft application, in extraction sockets, for example. xenogain bowl A new form of application that eliminates the need for an additional sterile dappen dish. Two granule sizes: small and large. Three different forms of application: bowl, vial or syringe. Up to four volume options:.25 g,.5 g, 1 g, 2 g. Two different forms of application: block or syringe. Up to three volume options: 1 mg, 25 mg, 5 mg. 2

3 Natural, resorbable and non-chemically cross-linked membrane. It s composed of a network of interwoven, highly purified porcine collagen and elastin fibers. Three sizes 15 x 2 mm 25 x 3 mm 3 x 4 mm Whether for larger bone augmentations or smaller periodontal defects, the optimal fit can be found without extensive trimming, limiting waste and minimizing costs for you and your patients. 3

4 xenogain the natural framework for bone formation The xenogain portfolio comprises an extensive range of bovine bone substitutes for guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures. xenogain bone substitute 1 Easy handling 2 Treat your patients with confidence Available in a vial, a syringe or a bowl for fast and easy application. Two granule sizes and a variety of volumes. Biocompatible. 6 9 Unique processing methods remove bovine proteins and lipids. 3,1 Ca/P ratio similar to human bone. 3,5,11 3 The scaffold for successful regeneration 4 A solid foundation for implant treatment Non-sintered, characterized by microand macrostructures. 3,1 Interconnected macropores. 3,6,7 Hydrophilic graft. Slowly resorbing scaffold. 7 Maintains space for bone regeneration. 7 Integrates with the newly formed bone, building a basis for successful implant placement. 4

5 What impressed me about this product was the variety of sizes and dosage forms, each offering very good handling properties week after implant placement 4 weeks 9 weeks p=.2 2 weeks Dr. Bastian Wessing, Aachen (Germany) Biocompatible The xenogain bone substitute is biocompatible 6 9 and unique processing methods remove the bovine proteins and lipids. 3,1 With a calcium phosphate ratio that reflects the composition in human bone and a low crystalline structure, xenogain is accepted by the body as a suitable framework for bone formation. 3,5,11 Human osteoblast attachment 12 Ca/P ratio similar to human bone Ca/P ratio.5. xenogain 3,5 Human bone 11 xenogain is proven to have a similar calcium-phosphorus ratio (Mol/Mol) to human bone. SEM image of human osteoblasts seeded on xenogain spreading and attaching to the material surface in the characteristic filopodia formation. Magnification 35 x. References 1 ISO 13485:23, ISO 13485: Kim Y-T, et.al. Periodontal Repair on Intrabony Defects treated with Anorganic Bovine-derived Xenograft. J Korean Acad Periodontol. 27;37(3): Data on file Nobel Biocare Material properties of xenogain / biomaterials. 4 Data on file NIBEC Porosity Analysis (BET measurement). 5 Data on file NIBEC Atomic emission spectrometry analysis. 6 Park H-N et.al. A study on the safety and efficacy of bovine bone-derived bone graft material(ocs-b). J Korean Acad Periodontol. 25 Jun;35(2): Park J-B, et al. Maxillary sinus floor augmentation using deproteinized bovine bone-derived bone graft material(ocs-b). Clinical and histologic findings in human. The Journal of the Korean Dental Association. 27;45(8):

6 2 p=.2 2 weeks (n=6) 2% area [%] (n=6) 9.2% area [%] p<.5 Chemically cross-linked collagen membranes (n=6) Suitable framework for new bone formation 9.2% (n=6) xenogain is a non-sintered xenogenic bone substitute, characterized by micro- and interconnected macropore structures and a large specific surface area. 2% 3,4,1 area [%] area [%] A scaffold for successful regeneration Promotes rapid hydration p<.5 xenogain offers a suitable environment for new bone xenogain absorbs 1.75 x its weight formation. 3,6,7 of water mass % xenogain (1 g) ALP activity (nm/ml/min) and calcium content (mg/ml) Time (days) 2 ALP activity Calcium content Pro-collagen content ALP = Alkaline phosphatase Analysis 18of biochemical markers shows that xenogain supports the new bone formation process in-vitro Pro-collagen content (ng/ml) Absorbed water mass (g) Time(s) Capillary kinetics measured by the Washburn method, displaying the wettability potential of xenogain References 6 8 Shin 4 S-Y, et al. Long-term results of new deproteinized bovine bone material in a maxillary sinus graft procedure. J Periodontal Implant Sci. 214;44: Data 2on file NIBEC Biocompatibility tests: OCS-B and OCS-B Collagen. 1 Data on file NIBEC. 11 Kyriazis.1V, Tzaphlidou.1 M. Skeletal.1 Calcium/Phosphorus 1 1 Ratio Measuring 1 1 Techniques and Results. I. Microscopy and Microtomography. The Scientific World Journal. 24;4: Data on file NIBEC Cell Morphology on the bone graft observed by SEM. 13 Data on file NIBEC ALP activity & pro-collagen expression of bone graft, matrix mineralization detected by calcium contents. 6

7 After using the non-sintered xenogain bone substitute, I appreciated its handling properties and I see its high hydrophilicity as a biological advantage in peri-implant defect regeneration and sinus grafting. Univ.-Prof. DDr. Werner Zechner, Vienna (Austria) Preserved macro- and micropore structures 3 Micropores support liquid uptake due to capillary forces. Mesenchymal stem cells, osteoblasts and capillaries are able to enter macropores of a bone substitute particle. Fluids 2 18 Micropores Incremental pore volume (% of total) Macropores Pore diameter (µm) Mesenchymal stem cell Capillary blood vessel Osteoblasts mean 3μm 5 1μm 2 3μm Unique processing methods remove bovine protein and lipids and preserve the natural bone matrix. 3,1 SEM image of a xenogain granule. Magnification 3 x. SEM image of xenogain nanostructured surface. Magnification 5, x. 7

8 A solid foundation for implant treatment xenogain acts as a slowly resorbing scaffold and maintains space for bone regeneration. 7 The graft integrates with the newly formed bone, building a basis for successful implant placement. New bone formation visible nine months after grafting procedure in the sinus 7 G: graft NB: new bone CT: connective tissue OT: osteoid Magnification 4 x. CT OT OT G NB G NB CT G G NB G CT Human histology based on undecalcified sample taken with a trephine bur in the posterior maxilla prior to implant insertion. Embedded in formalin solution, multiple staining, photographed with optical microscope. 8

9 GBR procedure with xenogain collagen Clinical case Right upper first premolar of a 6-year-old male patient is extracted due to chronic periodontitis. One month after extraction, GBR surgery with a xenogain collagen block and a resorbable collagen membrane is performed to support the regeneration of the bony defect and re-establish necessary bone volume for implant placement. After nine months of uneventful healing, a dental implant is placed in an optimized position in the regenerated bone. Radiographic view before surgery. Extraction socket when raising the flap. Note the buccal defect. Grafting using xenogain collagen and collagen membrane application. Re-entry nine months after grafting with xenogain collagen. Implant placement. Radiographic view after implant placement. Case courtesy of Prof. Seung Yun Shin, Seoul (South Korea) 9

10 the natural barrier is a resorbable non-cross-linked collagen membrane for guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures. collagen membrane 1 Outstanding handling 2 High mechanical stability Easy to reposition and unfold. Rehydrates in seconds and adheres well to the defect shape. Minimal increase in size when hydrated. 14 Outstanding mechanical strength properties. 15 Resistant to stress Extended barrier function 4 Excellent tissue integration Highly resistant to degradation for prolonged protection of the graft site. 15 Excellent vascularization behavior and tissue compatibility. 15 1

11 I really like the handling of this material. The fact that it does not lose all of its shape when you place it in conjunction with the tissue is a great benefit. It gives you the possibility to remove the membrane for trimming. After a minute or so, when it is soaked, it attaches very nicely to the bone. Prof. Christer Dahlin, Gothenburg (Sweden) Lateral view showing a dense meshwork, primarily composed of highly interwoven collagen fibers. Magnification 482 x. (SEM image Schupbach Ltd, Switzerland) Outstanding handling properties Once moistened, does not stick to the graft site or instruments, meaning repositioning or unfolding is easy. The change in size after hydration is minimal, enabling a good fit to the defect when the membrane is trimmed in a dry state. 14 It can be stretched over the bone augmentation site and fixated with pins to stabilize the bone graft material in major horizontal augmentations. 18 Overhead view showing a dense meshwork, primarily composed of highly interwoven collagen fibers. The enlarged circular detail reveals collagen fibrils in their typical cross- striated appearance. Magnification 1, x. (SEM image Schupbach Ltd, Switzerland) References 14 Arrighi I, et al. Resorbable Collagen Membranes Expansion In Vitro. J. Dent. Res 93 (Spec Iss B):#631, Bozkurt A, et al. Differences in degradation behavior of two non-cross-linked collagen barrier membranes: an in vitro and in vivo study. Clin Oral Implants Res. 214 Dec;25(12): Gasser A, et al. Mechanical stability of collagen membranes: an in vitro study. J Dent Res 95 (Spec Iss A): Abstract 1683, 216 ( 17 Bunyaratavej P, Wang HL. Collagen membranes: a review. J Periodontol. 21;72: Wessing B, et al. Horizontal ridge augmentation with a novel resorbable collagen membrane A retrospective analysis of 36 consecutive patients. Int J Periodontics Restorative Dent 216;36: Friedmann A, et al. Randomized controlled trial on lateral augmentation using two collagen membranes: morphometric results on mineralized tissue compound. J Clin. Periodontol. 211;38:

12 Slower degradation for longer site protection The unique manufacturing process for 1 week preserves 7 the after natural implant collagen 4 weeksfiber network and respective natural links, placement resulting in high mechanical p=.2 strength and 6 resistance to degradation. 15,16 5 Superior to 9 weeks 2 weeks 4 degrades significantly more slowly than. 15 Slower degradation is proven to protect the grafted site longer. (n=6) Resistance (n=6) to denaturation similar to chemically cross-linked membranes In-vitro tests have shown that 9.2% denaturates at temperatures similar to chemically cross-linked membranes and at higher 2% temperatures than most non-cross-linked membranes including area. [%] 22 area [%] p<.5 2 Slower degradation for longer site protection Greater bone formation Membrane thickness (μm) 1 week 7 after implant Non-chemically 4 weeks placementcross-linked collagen 6 membranes 12% 5 9 weeks % p=.2 Chemically cross-linked collagen membranes 2 weeks 39 64% (n=6) 9.2% area [%] p<.5 (n=6) 2% area [%] Time after implantation (weeks) Significantly slower membrane degradation with in vivo for longer 2. protection of the grafted site References 2 Zubery 1. Y, et al. Ossification of a novel cross-linked porcine collagen barrier in guided bone regeneration in dogs. J Periodontol. 27 Jan;78(1): Zubery Y, et al. Ossification of a collagen membrane cross-linked by sugar: a human.5 case series. J Periodontol. 28 Jun;79(6): Data on file Matricel...2 Significantly greater bone formation in the center portion of the defect at day 21 with in vivo Dahlin C, et al. Tissue dynamics of a native collagen membrane for Guided Bone Regeneration. J Dent Res 95 (Spec Iss A): Abstract 1141, 216 (

13 I was pleasantly surprised to still find remnants of the membrane after six months. This long degradation time provides a greater chance of success. Dr. Hadi Antoun, Paris (France) Excellent tissue integration Superior tissue integration of natural membranes compared 1 week with chemically 7 after implant cross-linked 4 weeksmembranes Studies show placement that purified natural membranes p=.2 allow for better 6 tissue integration than chemically cross-linked membranes, 17 resulting in: 5 Fast vascularization. Excellent tissue compatibility with no foreign 3 body reactions. 24 Lower risk of dehiscence / membrane exposure. 2 9 weeks 2 weeks Excellent revascularization behavior Lower dehiscence risk with natural membranes Chemically cross-linked collagen membranes 12% Non-chemically cross-linked collagen membranes 22 32% 39 64% Lower dehiscence rate with compared with chemically cross-linked as well as other non-chemically cross-linked membranes in vivo. 18 Histological section (Toluidine blue stain) after 2 weeks healing time in rats (subcutaneous implantation). Numerous blood vessels penetrate the membrane (circles). Enlarged detail reveals a blood vessel with entrapped erythrocytes. (Light microscopic picture Schupbach Ltd, Switzerland) 24 Rothamel D, et al. Biodegradation of differently cross-linked collagen membranes: an experimental study in the rat. Clin. Oral Impl. Res. 25;16: Schwarz F, et al. Angiogenesis pattern of native and cross linked collagen membranes: an immune histochemical study in the rat. Clin. Oral Impl. Res. 26;17: Becker J, et al. Use of a new cross-linked collagen membrane for the treatment of dehiscence-type defects at titanium implants: a prospective, randomized controlled double blinded clinical multicenter study. Clin. Oral Impl. Res. 29;2: Tal H, et al. Long-term bio-degrada tion of cross-linked and non-cross-linked collagen barriers in human guided bone regeneration. Clin. Oral Impl. Res. 28;19:

14 High mechanical stability is the strongest membrane after hydration compared with other noncross-linked and chemically cross-linked membranes in vitro. 16 Highest mechanical strength. Highest resistance to stress. Best suture retention thanks to highest pull-out force. 1 (N) CX CO JS OF BG BE ML OP BM CY Non-cross-linked collagen membranes CX: [Nobel Biocare] CO: CopiOs [Zimmer Biomet] JS: Jason [botiss] OF: Osseoguard Flex [Zimmer Biomet] BG: [Geistlich] Cross-linked collagen membranes 1 Highest force at break 16 2 (N/mm²) CX CO JS OF BG BE ML OP BM CY BE: BioMend Extend [Zimmer Biomet] ML: Mem-Lok [BioHorizons] OP: Ossix Plus [Datum Dental] BM: BioMend [Zimmer Biomet] CY: Cytoplast RTM [Osteogenics] 2 Highest stress at break 16 3 (N) Highest suture retention CX CO JS OF BG BE ML OP BM CY Statistically significant difference compared with. 14

15 Extraction socket preservation with Clinical case A 54-year-old male patient presents at the clinic with a periapical infection and an open fistulous track toward the root of tooth #21. A perio-endo lesion is identified and tooth extraction is indi cated. During careful extraction, loss of the buccal bone plate is evident and a lateral bone augmentation procedure is needed. As a scaffold, deproteinized bovine bone matrix (DBBM) is used, and the collagen membrane is placed as a protective barrier. After six months of uneventful healing, a dental implant is placed in the optimal position in the regenerated bone. At the initial visit, the patient presents with a periapical infection. The tooth is carefully extracted. The bone defect is revealed after extraction. The entire buccal bone plate has been lost. The bone defect is filled with deproteinized bovine bone matrix and covered with a collagen membrane ( ). Six months later, an implant is placed in its optimized position. Final restoration four months after implant placement. Case courtesy of Dr Mariano Sanz, Madrid (Spain) 15

16 Order today collagen membrane Membrane 15 x 2 mm 25 x 3 mm 3 x 4 mm N152 N253 N34 xenogain bone substitute Granule size.25 g.5 g 1. g 2. g Vial Small (.2 1. mm) N111 N112 N113 N114 Large (1. 2. mm) N1111 N1121 N1131 N1141 Conversion table g / cc.25 g.5 g 1. g 2. g Small.55 cc 1. cc 1.9 cc 3.8 cc Large.7 cc 1.3 cc 2.7 cc 5.5 cc Bowl Small (.2 1. mm) N111-B N112-B N113-B N114-B Large (1. 2. mm) N1111-B N1121-B N1131-B N1141-B Syringe Small (.2 1. mm) N121 N Large (1. 2. mm) N1211 N xenogain bone substitute with 1 % collagen 1 mg 25 mg 5 mg Block N132 N133 N134 Syringe - N141 N142 Order online Order from our complete range of implants, regenerative solutions and prefabricated prosthetics 24 hours a day through the Nobel Biocare online store. nobelbiocare.com/store Order by phone For more information, and to place an order, contact your Nobel Biocare representative or customer support. nobelbiocare.com/contact For more information visit nobelbiocare.com/ 8716 GB 169 Printed in the EU Nobel Biocare Services AG, 216. All rights reserved. Distributed by Nobel Biocare. Nobel Biocare, the Nobel Biocare logotype and all other trademarks are, if nothing else is stated or is evident from the context in a certain case, trademarks of Nobel Biocare. Please refer to nobelbiocare.com/trademarks for more information. Product images are not necessarily to scale. Disclaimer: Some products may not be regulatory cleared/released for sale in all markets. Please contact the local Nobel Biocare sales office for current product assortment and availability. For prescription use only. Caution: Federal (United States) law restricts this device to sale by or on the order of a licensed dentist. See Instructions for Use for full prescribing information, including indications, contraindications, warnings and precautions.