Alpha-Bio Tec, a world leader in advanced implantology solutions, is proud to present its growing biomaterials product line: Alpha-Bio's GRAFT, which has taken a leading position in the global dental biomaterials market over the past few years. Today, Alpha-Bio Tec offers a complete portfolio of Xenograft, Allograft and Synthetic bone substitutes and resorbable membranes. The company's development strategy and vast market experience in implant dentistry combine to create a comprehensive product line that suits the requirements of implantologists. Alpha-Bio's GRAFT offers the best combination of quality & value with efficient, easy-to-use products that meet a wide variety of dental procedures from the simplest to the most demanding ones. The combination of these benefits allows dentists to focus on the surgical procedure and ensure patients have a natural healing process, long-lasting clinical effectiveness and excellent aesthetic results. A Growing Success 3
Xenograft Alpha-Bio's GRAFT Natural Bovine Bone Synthetic Alpha-Bio's GRAFT Synthetic, Resorbable Bone Alpha-Bio's GRAFT removes all organic components, resulting in a protein free Hydroxyapatite ceramic mineral similar to the human bone and allowing for excellent integration and bone formation. The unique proprietary processing of this product assures excellent long term volume preservation as well as exceptional patient blood resorption ability, resulting in superior handling qualities. Similar to human bone Hydrophilic surface with large internal surface area Interconnective high porosity with optimal pore size distribution & quantity supports top line vascularisation High level of osteoconductivity Convenient usage with superb liquid uptake High quality & volume of new formed bone Excellent porosity and surface structure* s Additional Product of choice for long term volume preservation. Supports immediate loading when applicable Xenograft Bovine Biologic Hydroxyapatite Resistible to resorption Osteoconduction, referred as non resorbable Radiopacity allows easy x-ray identification & diagnosis Alpha-Bio's GRAFT Synthetic, Resorbable Bone is an innovative, fully synthetic biphasic bone substitute with exceptional controlled resorption properties and outstanding handling characteristics. The homogenous composition of 60% hydroxyapatite (HA) and 40% Beta-Tri Calcium Phosphate (β-tcp) results in two mineral phases of activity: supporting the formation of new vital bone, while maintaining volume and mechanical stability. Alpha-Bio's GRAFT Synthetic, Resorbable Bone features high osteoconductivity and high macroporosity, supporting osteogenic cell growth and regeneration of vital bone. Homogeneous phase distribution Available bioactive phosphate and calcium ions Controlled resorption suits a wide diversity of procedures Supports new bone mineralization process Rough hidrophilic extensive surface area* Additional Product of choice for those seeking best results with a fully synthetic product Synthetic (Alloplastic) Fully synthetic (biphasic) Biphasic 60% hydroxyapatite and 40% β-tricalcium Phosphate Dual phase resorption process Osteoconduction, partially resorbable Radiopacity allows easy x-ray identification & diagnosis Bone SUBStitUteS ~2mm ~1mm ~500µm ~100µm ~1mm ~100µm ~20µm ~10µm SEM X 30 Numerous inter connected pores with rounded surface area to minimize risk of fenestration SEM X 50 Prominent similarity to human bone SEM X 85 Extensive cancellous surface SEM X 500 Intact surface area both inside and outside the macropores SEM X 50 High porosity granules SEM X 500 Rough surface area SEM X 2000 Large surface area SEM X 5000 Hydrophilic surface area Granules Size Small (0.5-1mm) Large (1-2mm) Granules Size Small (0.5-1mm) Large (0.8mm-1.5mm) Volume 0.5cc 1cc 2cc 5cc 2cc 5cc Volume 0.5cc 1cc 0.5cc 2cc Ref. No. 3225 3236 3207 3206 3232 3237 Ref. No. 3201 3202 3203 3204 * Provided by Tel Aviv University - Wolfson Applied Materials Research Center. Images are decreased by 40%. * Provided by Tel Aviv University - Wolfson Applied Materials Research Center. Images are decreased by 40%. 4 5
Allografts CorticocAncellous Granules * (FDBA Freeze Dried Bone AllogrAFT) Demineralized Cortical Granules * (DFDBA Demineralized Freeze Dried Bone AllogrAFT) Alpha-Bio's GRAFT Corticocancellous Granules combines freeze dried cortical and cancellous bone. The combination of cortical and cancellous bone provides the variety of characteristics required to enable high quality new vital bone formation. In addition to excellent integration, this product offers ideal regeneration as it allows unification of the resorption and regeneration curves. Further, it has high osteoconductive abilities and provides a scaffold for new bone growth, allowing for a first-rate fitting for the widest possible range of procedures among all allograft products currently available on the market. The product is provided in a vial or an included syringe, which enables prompt rehydration with saline or the patient's blood. Natural human bone reach in collagen Cortical parts provide structural support and space-maintaining capability Cancellous component offers a porous architecture for new blood vessle formation (angiogenesis) Syringe Natural integration with newly forming bone allows good drilling sense while placing implants Excellent bone remodeling due to adequate combination of cortical and cancellous bone supporting osteoconduction and revascularization Natural human bone structure** s Product of choice in diversity of procedure fit & regeneration efficiency Allows dentist & patients quick re-entry time for implant placement Allograft Human donation Corticocancellous, cortical & cancellous bland Resorbable Osteoconduction Alpha-Bio's GRAFT Demineralized Cortical Granules Syringe is comprised of freeze dried cortical bone, which has undergone a demineralization process. This process exposes the growth factors that are naturally available within the bone, supporting both osteoconduction and osteoinduction mechanisms. The osteoinductive ability was proven to accelerate the formation of natural bone. The included syringe enables prompt rehydration with saline or the patient's blood. Natural human bone rich in collagen and essential biological components for new bone formation Both osteoconductive & osteoinductive Natural prompt integration with newly forming bone Facilitates attachment of osteogenic precursor cells Intact Collagen structures, natural surface area and well distributed pores s Product of choice for minor defects not requiring Guided Bone Regeneration, Allows minimal re-entry time (when applicable) Allograft Human donation Cortical bone Resorbable Osteoconduction & osteoinduction Bone SUBStitUteS ~1mm ~100µm ~20µm ~20µm SEM X 50 Natural human bone structure SEM X 500 Intact osteoconductive surface area SEM X 2000 Rough surface area with macro, micro and nano porosity ~500µm SEM X 100** General granule ~400µm ESEM X 300*** Multi porosity surface area SEM X 1,500** Natural collagen structure ~10µm ESEM X 10,000*** Micro & nano porosity Granules Size Small (0.2-0.85mm) Large (0.5-1mm) Granules Size Small (0.2-0.85mm) Volume 0.5cc 1cc 2cc 5cc Volume 0.5cc Units 1 syringe 2 syringe 1 vial 1 vial Units 1 syringe Ref. No. 3249 3250 3254 3258 Ref. No. 3272 * Available in selected countries. ** Provided by Tel Aviv University - Wolfson Applied Materials Research Center. Images are decreased by 40%. 6 * Available in selected countries. ** Provided by Tel Aviv University - Wolfson Applied Materials Research Center. Images are decreased by 40%. *** Provided by Tel Aviv University - Center for Nanoscience and Nanotechnology - Wolfson Applied Materials Research Center. Images are decreased by 40%. 7
Allografts cancellous Block 10x10x10 * Allografts Corticocancellous Block 6x12x20 * Alpha-Bio's GRAFT Cancellous Block is composed of pure cancellous bone. The formation of the block supports cell expansion within the block matrix, while enabling ideal blood vessel formation. This process results in the creation of new cell aggregation that supports the creation of new bone formation. Product of choice for horizontal augmentation when usage of particulate form alone is not applicable Alpha-Bio's GRAFT Corticocancellous Block is a double layered, one piece block consisting of cortical and cancellous natural layers. The dual layer block enables the ideal use of bone qualities for both fixation and healing processes. Product of choice for horizontal augmentation when usage of particulate form alone is not applicable Natural high osteoconductive framework & ability of the cancellous structure offers top line architecture for new blood vessel formation (angiogenesis) Full vascularization support allows fast remodeling of high quality patient bone Minimize morbidity and provide an alternative for secondary surgery using autogenous bone Ideal blood vessels matrix with intact collagen structures Allograft Human donation Cancellous bone Resorbable Osteoconduction One piece of original corticocalncellous bone Natural high osteoconductive framework & ability of the cancellous structure offers adequate architecture for vasqularization Cortical layer allows friendly fixation Full vascularization support allows fast remodeling of patient bone Natural surface area with maximal porosity** Allograft Human donation Corticocancellous human bone Resorbable Osteoconduction Bone SUBStitUteS ~2mm SEM X 20** Edge shows high porosity & original cancallous macro & micro structure ~200µm SEM X 200** Natural collagen structure ~2mm SEM X 20** General cancellous area view ~200µm SEM X 200** Pores split area shows intact bone & collagen structure Size 10x10x10mm Size 6x12x20mm Ref. No. 3261 Ref. No. 3260 * Available in selected countries. ** Provided by Tel Aviv University - Wolfson Applied Materials Research Center. Images are decreased by 40%. 8 * Available in selected countries. ** Provided by Tel Aviv University - Wolfson Applied Materials Research Center. Images are decreased by 40%. 9
Alpha-Bio's GRAFT CollAGen Membrane Alpha-Bio's GRAFT CollAGen Fleece Alpha-Bio's GRAFT Collagen Membrane provides an effective barrier function for epitel cells as well as an excellent matrix for new blood vessel growth. Due to its unique production process, the superior properties of the native pericardium are preserved, maintaining the characteristics of this natural tissue. The membrane provides rapid rehydration and easy manipulation during use in both wet and dry conditions and is naturally resorbed. Efficient barrier function with Epithelium cells occlusivity Fully resorbed supporting structure for vascularization Easy to shape, tear proof, non-chemical crossed linked collagen Finest support for both Guided Bone Regeneration (GBR) & Guided Tissue Regeneration (GTR) Eliminates the need for a second procedure and supports new high quality bone and tissue formation due to excellent vascularization abilities Exceptional adaptability to surface contours. Returns to flat position when re-dried to allow re-fit to surgical site Smooth epitel barrier layer with multilayer collagen matrix for new blood vesicles growth* ~100µm SEM X 500 Edge showing dense epitel barrier layer and inner structure ~50µm SEM X 1000 Internal structure showing adequate blood vessel supporting matrix Pericardium membrane provides leading barrier function capabilities Resorbable organic membrane Native collagen (pericarduim) Fully resorbed Barrier function Alpha-Bio's GRAFT Collagen Fleece is a ph-neutral, wet-stable, haemostatic native collagen sponge. The potent haemostatic effect of the collagen is induced by the adhesion of platelets to the collagen fibrils. As a result, platelets aggregate and release coagulation factors. This initiates the coagulation cascade resulting in hemostasis. The neutral PH level which is unique for this product prevents soft tissue irritation. The product's flexible compressible structure allows a convenient manipulation by the dentist and adequate fit for wide range of procedures. Potent haemostatic effect, facilitates adhesion of platelets to the collagen fibrils Fully resorbed supporting non dense structure Excellent ability to stabilize fitting surgical sites by fast haemostasis Easily manipulated to fit all indicated spaces Supports prompt natural healing Easily manipulated structure with phenomenal blood uptake and wound healing support ~1mm ESEM X 100** General view of 3D structure ~100µm SEM X 500* Collagen fleece fibers Prompt resorption time & neutral PH level supports natural healing Biological collagen Porcine Fully resorbed Enables soft tissue healing Resorbable MeMBranes Size 15x20mm 20X30mm 30X40mm Size Content 20x20mm 12 separately packed units Ref. No. 3246 3242 3212 Ref. No. 3205 * Provided by Tel Aviv University - Wolfson Applied Materials Research Center. Images are decreased by 40%. 10 * Provided by Tel Aviv University - Wolfson Applied Materials Research Center. Images are decreased by 40%. ** Provided by Tel Aviv University - Center for Nanoscience and Nanotechnology - Wolfson Applied Materials Research Center. Images are decreased by 40%. 11
Alpha-Bio's GRAFT Biocryl Membrane * Alpha-Bio's GRAFT Sample DATA & Procedures TABle 1 Alpha-Bio's GRAFT Biocryl Membrane is made from a synthetic absorbable copolymer of glycolide and lactide, a closely woven material which consists of non-dyed suturing fibers. Alpha-Bio's GRAFT Biocryl Membrane is primarily a separating structure for therapeutic oral surgery. Strong fully and promptly resorbed matrix structure providing physical support for complex grafting sites Product Bone Substitutes Resorbable Membranes Xenograft Synthetic Allograft Biological Collagen Synthetic Fully resorbed closely woven matrix fiber structure Minimizes inflammation and tissue irritation Excellent ability to physically stabilize surgical sites and act as a short term partial barrier Supports quick healing Synthetic Synthetic copolymer Copolymer of glycolide and lactide Fully resorbed Product Image Product Name Sinus Floor Elevation Socket / Ridge Preservation Horizontal Augmentation Vertical Augmentation Natural Bovine Bone Synthetic, Resorbable Bone Corticocancellous Granules Demineralized Granules Cancellous Block Corticocancellous Block Collagen Membrane Collagen Fleece Biocryl Membrane CUT & SAVE Periodontal Defects ~1mm SEM X 50** Biocryl membrane matrix view Size 10x10mm 10X20mm 20X30mm Ref. No. 3151 3152 3153 * Available in selected countries. ** Provided by Tel Aviv University - Wolfson Applied Materials Research Center. Images are decreased by 40%. 12 ~200µm SEM X 200** Biocryl closely woven fibers Covering Palatinal Gingival Donor Sites Estimated Re-entry time 8-9 6-8 6-8 6-8 8 8 (by months) 1 Estimated Main Integration <9 <4 <6 2-3 6-8 6-8 3 1 2 (by months) 1 Wide match Optional match 1 Data in this document is provided as general example only. It is based on a combination of manufacturers IFU's, professional literature and manufacturer//supplier written materials. Appropriate product selection and usage quantity must be determined based on dentist's clinical judgment considering patient systemic conditions, bone type, defect severity, and additional parameters when required. Reported values can vary depending on patient and defect clinical condition. 13
Product codes and ref. No. CASE 1 natural Bovine Bone Bone Substitutes Dr. Alessandro Bermond Des Ambrois - M.D. Italy Xenograft Synthetic Allograft Product Name Size Natural Bovine Bone Synthetic, Resorbable Bone Corticocancellous Granules Small (0.5-1mm) Large (1-2mm) Small (0.5-1mm) Large (0.8-1.5mm) Small (0.2-0.85mm) Large (0.5-1mm) Demineralized Granules Small (0.2-0.85mm) Cancellous Block 10X10X10mm Corticocancellous Block Volume 0.5cc 1cc 2cc 5cc 2cc 5cc 0.5cc 1cc 0.5cc 2cc 0.5cc 1cc 2cc 5cc 0.5cc 1 1 Units 1 1 1 1 1 1 1 1 1 1 1 syringe 2 syringe 1 vial 1 vial 1 syringe 6X12X20mm 1 1 Ref. no. 3225 3236 3207 3206 3232 3237 3201 3202 3203 3204 3249 3250 3254 3258 3272 3261 3260 Resorbable Membranes Biological Collagen Synthetic Product Name Collagen Membrane Collagen Fleece Biocryl Membrane Size 15X20mm 20X30mm 30X40mm 20X20mm 10X10mm 10X20mm 20X30mm A clinical case of a very extended post-extraction bone defect with a chronic infection. In this case, a GBR intervention was planned, using biomaterial of bovine origin (Alpha-Bio's GRAFT, Israel) together with a CGF technique (Concentrated Growth Factors), which is obtained by a specific blood separator (Medifuge, Silfradent, Italy). It should be noted that the bone defect is comprised of a complete loss of the buccal cortical plate and wide palatal fenestration. After 6 months it became possible to insert an implant into the regenerated site with a small peri-implant regeneration. 1 2 3 4 5 Pre-operative x-ray Follow up x-ray after 2 months, following extraction Healing of soft tissues after 8 weeks Bone defect present with palatal fenestration 6 7 8 9 10 Suture obtaining primary closure of the wound Bone healing. Follow up x-ray after 4 months Healing of soft tissues after 6 months Healing after 6 months Biomaterial in situ with CGF blend Preparation of the implant site in regenerated bone Clinical Case Reports Units 1 1 1 12 1 1 1 11 12 13 14 Ref. no. 3246 3242 3212 3205 3151 3152 3153 Implant in situ Peri-implant regeneration Healing of the soft tissues 1 month after surgery Follow up x-ray 14 15
CASE 2 Synthetic, ResorBABle Bone CASE 3 Alpha Bio's GRAFT CollAGen Fleece Dr. Luca Savio - B.D.S Italy A case of immediate post-extraction regeneration with covering of the biomaterial (beta tricalcium phosphate 40% and hydroxyapatite 60%), is described by means of a collagen membrane (Alpha-Bio's GRAFT, Israel) left exposed in the oral environment in accordance with the socket preservation technique described by several authors. This enabled the preservation of bone volume as well as the extraction, with healing of the soft tissues as secondary intention. The histology obtained after 5 months shows an initial bone healing with the presence of lamellar bone at depth and woven bone more superficially. The bone quality found allowed insertion of the fixture, however, having practiced open alveolar regeneration, a further peri-implant reconstruction at a coronal level was necessary, as is often the case when applying this method. These issues were all described by Dutch authors in their systematic review of the literature, which concluded that the best technique is still to wait for the soft tissues to heal, making closed regeneration possible, more protected and consequently more predictable (Ten Heggler, 2011). 1 2 3 4 5 Palatal probing at a root fracture Pre-operative x-ray Immediate post extractive regeneration Collagen membrane exposed with healing by secondary closure 6 7 8 9 10 Follow up x-ray of post-extractive regeneration DR. Yaniv Mayer D.M.D, Periodontist. Israel Sinus floor elevation while handling a tear in the Schneiderian membrane. A 55 years old male patient, normally healthy, required a sinus floor elevation in order to place implants. 1 2 3 4 5 The prepared window required for sinus floor elevation, exposing a tear in the Schneiderian membrane CASE 4 Collagen Fleece was placed under the Schneiderian membrane in order to support tear closure and separate prepared grafting material disperse within the sinus Dr. Leif Rotenberg - D.D.S, Specializes in Oral & Maxillofacial Surgery. Israel Placement of a natural bovine bone to gain volume in the sinus Covering grafted area with Alpha-Bio's GRAFT Collagen Membrane Corticocancellous Block On lay GrAFTing 9 month following grafting procedure, implants were located on right upper quadrant. An adequate bone formation around the implants following the procedure is shown A 57 years old woman, experiencing 22-24 edentulous combined with significant bone lack in both vertical and horizontal dimensions - an applicant for implant based restoration. With the aim of repairing the osseous contour, a block onlay grafting was performed using an allograft corticocancellous block combined with Alpha Bio's GRAFT Natural Bovine Bone. Grafted site was covered by Alpha Bio's GRAFT Collagen Membrane. 1 2 3 Clinical Case Reports Surgery re-entry after 5 months following socket preservation Coring of the regeneration obtained Histology of the postextractive regeneration obtained Implant inserted and additional peri-implant regenerative 1 year post surgery x-ray follow up (fully restored) CT view pre operative procedure (1-3) 4 5 6 16 CT view post operative procedure (4.5 months post operation) shows adequate healing and sufficient bone volume supporting implants (4-6) 17
CASE 5 Alpha Bio's GRAFT CollAGene Membrane Dr. Dr. Daniel Rothamel M.D, D.M.D, Ph.D, Specializes in Oral and Maxillofacial Surgery. Germany 1 2 3 4 5 CASE 6 Corticocancellous Granules (FDBA) DR. Yaniv Mayer D.M.D, Periodontist. Israel A 47 years old woman, usually healthy, shows a broken tooth (No.11) in gingival height with secondary caries and failed root treatment. Instable bridge situation with abscess formation at tooth 15 after apicectomia OPG 6 months after tooth extraction shows vertical deficiency at 15 Clinical situation with scar formation at former abscess incision site Mucoperiosteal flap elevation reveals a bone-containing defect at 15 and a non-containing lateral bone defect at 14 12 6 7 8 9 10 Light bone spreading at 12 for lateral widening of the crest Internal sinus grafting to compensate the vertical deficiency at 15 After implant installation, lateral bone defects need further augmentation Mixture of small granules of Natural Bovine Bone with the harvested autogenous bone chips 11 12 13 14 15 Application of a long-lasting pericardium membrane (Collagen Membrane) to separate the graft from the soft tissue Tense-free soft tissue closure is mandatory for undisturbed soft tissue healing Postoperative X-ray showing the position of implants and internal sinus grafting Stable conditions after 6 month healing period In progress of implant bed preparation at 12, 14 and 15, bone chips are collected Application of the graft material on the lateral aspect Perfect integration of the bovine bone in newly formed bone matrix 1 2 3 4 5 Front tooth root (No. 11) remaining with no rehabilitation option Surgical site post operation view (following 4 month of healing) shows good volume preservation of the ridge Atraumatic extraction with preservation of the buccal plate and with no severance of the periost Surgical site post operation view (following 4 month of healing) shows good esthetic result Socket volume preservation using abundant filling of the socket with Alpha-Bio's Graft Corticocancellous Granules Three dimensional CT simulation shows complete volume preservation and fine bone recovery Socket opening cover with Alpha-Bio's GRAFT Collagen Membrane 6 7 8 9 10 Insertion of Alpha-Bio Tec SPI implant in the exposed osseous ridge following 4 month of healing. Ridge bone looks vital with no bone substitute residues Surgical site closure using live connective tissue taken from the palate. Suturing using 5/0 Nylon sutures Suturing of the surgical site post implant insertion Clinical Case Reports 16 17 18 18 Implant uncovering and installation of gingival healing abutments Prosthetic situation after one year and professional oral hygiene Radiological situation after one year 19
1 3 6 995-0199 R5/08.13 2 4 5 exactdesign.co.il 7 8 1 Alpha-Bio's GRAFT Collagen Membrane integration 4 weeks following procedure 2 Corticocancellous Block 6x12x20 3 Cancellous Block 10x10x10 4 Alpha-Bio's GRAFT Synthetic, Resorbable Bone 6 Months Following Sinus Lift 5 Alpha-Bio's GRAFT Natural Bovine Bone Integration 6 Months Following Sinus Lift 6 Alpha-Bio's GRAFT Synthetic, Resorbable Bone 7 Alpha-Bio's GRAFT Natural Bovine Bone 8 Alpha-Bio's GRAFT Natural Bovine Bone We are proud to invite new and existing customers to experience this innovative, high-value, easy-to-use product line. To download additional information, please scan the code: Alpha-Bio's GRAFT products are CE-marked in accordance with the Council Directive 93/42/EEC and Amendment 2007/47/EC or complies with FDA requirements. Products are available in selected countries.