Ceros TCP Granules Synthetic -TCP bone substitute material

Transcription

1 Ceros TCP Granules Synthetic -TCP bone substitute material SWISS PRECISION AND INNOVATION.

2 Ceros TCP Granules Over 25 years of clinical experience Bone substitute materials play an important role in oral surgery and implantology in order to assure the best possible patient care. Treatment with autologous bone is the so-called gold standard because of its osteoconductive, osteoinductive and osteogenic properties. Despite these advantages, the clinical use of autologous bone is limited due to the need for a second application, possible complications, as well as its limited availability. Therefore, bone graft substitutes serve a very important function. They can be used to fill defects and/or extend the volume of autologous bone and serve as a scaffold for guided bone regeneration. Bone substitute materials consisting of beta-tricalcium phosphate ( -TCP) have a longstanding clinically proven history. These synthetic bone replacement materials are characterized by their high biocompatibility. 1, 2, 3, 5, 7, 10, 12, They are resorbed and completely transformed into vital bone. 14, 15, 17, 18, 19, 21 Advantages at a glance 100 % synthetic Provides high biocompatibility, preventing any risk of pathogen transmission. Unlike autologous bone and xenografts, there are no limitations with regard to quantity and/or quality. Osteoconductive Their porous structure makes Ceros TCP Granules an optimal matrix for the infiltration of bone cells and blood vessels, thus ideal for the remodeling into vital bone. Complete remodelling into vital bone Ceros TCP Granules are remodeled into new vital bone within 6 18 months. 2 Thommen Medical

3 Ceros TCP Granules are a fully synthetic and resorbable bone graft substitute made of pure beta-tricalcium phosphate ( -TCP) with an overall porosity of 60 %. Scanning Electron Microscope (SEM) picture of Ceros TCP Granules (magnification 50). Ceros TCP Granules consist of macropores distributed mainly within a range of μm and micropores smaller than 10 μm. 6, Distribution < >500 Pore size (μm) The size and distribution of the macropores (A) has been proven to promote the new formation of blood vessels and vital bone. 20 The porous structure (B) facilitates the transport of blood, blood components and bone marrow into the core of the bone substitute to ensure 22, 25 cell nutrition during resorption and bone formation. Micropores smaller than 10 μm (C) increase the surface area of the bone 7, 22 substitute and thus are promoting the resorption by osteoclast activity. A 500 μm B B 30 μm C C 20 μm Thommen Medical 3

4 Ceros TCP is completely remodeled into vital bone A substance can be resorbed if the Ca:P ratio is < 1.6. If this ratio is > 1.6, as in hydroxyapatite, the bone substitute is not resorbed. 13 Ceros TCP Granules are resorbable since the Ca:P ratio is 1.5. Osteoclastic resorption of Ceros TCP Granules therefore ensures extensive resorption and remodeling into vital bone. The progression of the remodeling process over time depends on different factors (vitality of the bone bed, localization, etc.). It lasts approximately 6 to 18 months. Percent by volume In a study investigating jaw defects in minipigs, Buser et al. showed that Ceros TCP Granules were almost completely remodeled into a bone matrix within 24 weeks. The percentage of Ceros TCP Granules was reduced over the investigation period of 4 to 24 weeks from 19 % to 6 %, while the bone matrix increased from 23 % to 68 % weeks 12 weeks 24 weeks Bone matrix Marrow space Ceros TCP Time Result of the histomorphometric analysis from the study of Buser et al. 18 Clinical Experience Since 1982, Ceros TCP Granules have proved their worth in traumatologic, spinal and orthopaedic surgery and in dental surgery for filling endosseous defects and augmenting volume in cases with an insufficient quantity of 2, 3, 5, 10, 11, 15 17, 19, 23, 26 autologous cancellous bone. Ceros TCP Granules long-term clinical results and studies show good clinical results, excellent biologic compatibility as well as a complete bony 2, 3,4,7 10, 14 19, 21, 23, 24, 25, 26, 27 integration and substitution with natural bone. 4 Thommen Medical

5 Fields of application/indications Ceros TCP Granules are indicated for use as a bone void filler in non-loadbearing regions requiring cancellous rather than cortical bone material. For example, Ceros TCP Granules may be used to: supplement autologous cancellous bone act as a support and stabiliser for guided bone regeneration, GBR fill bone defects after hemisection of teeth, bone removal, osteotomy, tumour resection, root apex resection, tooth extraction or cystectomy fill bone defects resulting from traumatic or pathological origin augment an atrophied mandibular ridge (only in conjunction with the GBR membrane technique) prepare the implant bed (e.g. sinus lift) fill bone defects around dental implant after immediate placement into extraction sockets minor bone deficits such as fenestration defects on implants and periodontal defects can be made to heal well with Ceros TCP Granules, possibly in combination with a membrane as part of Guided Bone Regeneration (GBR). In general, the larger the number of bone walls at bone defects and the more favourable the morphology of the defect-covering soft tissue, the more predictable is the success of the intervention. Examples of dental defects Root apex resection ( about 1.0 g) Sinus lift (about g) Periodontal defect (about g) Alveolar defect (about g) Thommen Medical 5

6 Important considerations for application Mixture of the Ceros TCP Granules with the patients own blood, including cancellous bone or bone marrow if available, makes insertion into the defect easier, since the granules become incorporated into the coagulate. For good bony integration of Ceros TCP Granules, a mechanically stable situation as well as an appropriate defect configuration are most important. Ceros TCP Granules must always be applied by endosseous or subperiosteal implantation, i.e. in direct contact with the vital bone. For preparation of the implant bed, inflamed and necrotic tissue must be removed and the bone freshly exposed. The quantity of bone graft substitute to be used depends on the size of the bone defect and the prospectively desired jaw contour. The appropriate granule size is determined by the size of the bone defect, the extent of the bleeding, the size of the spongiosa chips if used, etc. Care should be taken to ensure an adequate packing density. The bone defect must be filled completely with granules. However, to ensure tension-free wound closure, it is essential to avoid overfilling. The regions of the endosseous vessel and nerve cords should be kept clear to avoid pressure sores. Dislodged granules must be removed from the soft tissue. It is important to ensure that the wound is closed free of tension and made saliva-tight. Coverage of granule-filled defects with a membrane is recommended, especially in augmented regions that are exposed to mastication forces or facial muscle movements. Under certain circumstances it may be advisable to place a layer of autologous spongy bone on labial and buccal applications of Ceros TCP Granules and cover it with the periosteum or a membrane. As a general recommendation when placing implants using a staged approach, it is suggested to wait 4 6 months between bone augmentation and implant placement for defect-filling cases, and 6 12 months for sinus lift cases. Due to their composition, Ceros TCP Granules are radiopaque. Therefore, it is possible to monitor the resorption and remodelling of the bone around the implant or implant site. Mixture Ceros TCP Granules can be mixed with sterile physiologic solution, patient blood, bone (cancellous bone) or bone marrow. Note In large defects and labial/buccal augmentations, the use of a mixture with autologous cancellous bone is recommended. 6 Thommen Medical

7 Product overview/literature Ceros TCP Granules, Porosity 60%, sterile Package unit Volume Grain size g 0.7 cc mm g 1.3 cc mm g 0.7 cc (0.5 g) mm g 1.6 cc mm g 3.9 cc mm g 0.8 cc (0.5 g) mm References 1 Rueger JM, Siebert HR, Wagner K, Pannike A. Synthetische und biologische Knochenersatzmittel. Tierexperimentelle Untersuchungen der osteoinduktiven Eigenschaft. Chir. Forum für experimentelle und klinische Forschung. Springer Verlag, Berlin. 1984; Pochon JP, Schwöbel M, Illi O, Weihe WH. Knochenersatzplastiken mit Beta- Tricalciumphosphat Resultate experimenteller Studien und klinische Fallbeispiele. Z Kinderchirurgie 1986; 41: Pochon JP, Illi O. Die operative Versorgung juveniler Knochenzysten mit Beta- Tricalciumphosphatkeramik. Therapeutische Umschau 1986; 43: Rueger JM, Siebert HR, Wagner K, Pannike A. Biologische Aktivität von Knochenersatzmitteln (Knochenmatrixextrakte, Calciumphosphate und deren Kombinationen) im Tierexperiment. Dt. Verband Materialprüfung. Eigenverlag Berlin. 1986; Waisbrod H, Gerbershagen HU. A pilot study of the value of ceramics for bone replacement. Arch. Orthop. Trauma Surgeon 1986; 105: Div. Autoren. Synthes Bulletins 1987; 52a: Eggli PS, Mueller W, Schenk RK. The role of pore size on bone ingrowth and implant substitution in Hydroxylapatit and Tricalcium phosphat ceramics. A histologic and morphometric study in rabbits. In: Pizzoferrato A, Marchetti PG, Ravaglioli A, Lee AJC (Hrsg): Biomaterials and Clinical Applications. Elsevier. Amsterdam 1987: Geret V, Müller W, Tepic M, Rahn BA, Perren SM. Comparison of calciumhydroxyapatite and beta-tricalciumphosphate in vivo with stable soft tissue interface. In: Pizzoferrato A, Marchetti PG, Ravaglioli A, Lee AJC (Hrsg): Biomaterials and Clinical Applications. Elsevier. Amsterdam 1987: Rueger JM, Wagner K, Inglis R, Siebert HR, Pannike A. Performance of organic and inorganic bone replacement materials and their combinations in repair of bony defects in the rat. In: Pizzoferrato A, Marchetti PG, Ravaglioli A, Lee AJC (Eds): Biomaterials and Clinical Applications. Elsevier. Amsterdam Waisbrod H, Schlaadt M, Krainick JU. Klinische Erfahrungen mit Keramik als Knochenersatz. Hefte zur Unfallheilkunde Springer Verlag Berlin/Heidelberg; 1987: 1051 ff. 11 Markwalder T. Füllung von Alveolen nach Zahnextraktion mit Ceros TCP-Granulat. Case Report Eggli PS, Müller W, Schenk RK. Porous hydroxyapatite and tricalciumphosphate cylinders with two different pore size ranges implanted in the cancellous bone of rabbits: a comparative histomorphometric and histologic study of bony ingrowth and implant substitution. Clinical Orthopaedics and Related Research : Mathys R sen., Mathys R jun., Müller W, Weigum H. Hydroxylapatit und Tri- Calciumphosphatwerkstoffe. Hefte zur Unfallheilkunde : Gatti A M, Zaffe D, Poli G P. Behaviour of tricalcium phosphate and hydroxyapatite granules in sheep bone defects. Biomaterials 1990; 11 (7): Pochon J.P., Knochenersatzplastiken mit Tricalciumphosphatkeramik im Kindesalter. Aktuelle Probleme in Chirurgie und Orthopädie 1990 (36). Huber Verlag Bern/Stuttgart/Toronto. 16 Roesgen M. Knöcherne Regeneration und Calciumphosphatkeramiken. Traumatologie 1991 (4). Georg Thieme Verlag Stuttgart/New York. 17 Ghazal G, Prein J, Müller W. Knochendefektfüllungen in den Kieferknochen mit Tricalciumphosphat. Swiss Dent 1992; 13 (1): Buser D, Hoffmann B, Bernard JP, Lussi A, Mettler D, Schenk R K. Evaluation of filling materials in membrane-protected bone defects. Clin Oral Impl. Res 1998; 9: Lambrecht J T, Schiel H J. Die Kieferhöhlenbodenosteoplastik (Sinus graft). Acta Dent Helv 1999; 4 (3): Lu JX, Flautre B, Anselme K, Hardouin P, Gallur A, Descamps M, Thierry B. Role of interconnections in porous bioceramics on bone recolonization in vitro and in vivo. Journal of Materials Science: Materials in Medicine 1999; 10: Stoll T, Maissen O, Meury T, Becker S. New Aspects in Osteoinduction Neue Aspekte in der Osteoinduktion. Mat.-wiss. u. Werkstofftech. 2004; 35 (4): Bohner M, Baumgart F. Theoretical model to determine the effects of geometrical factors on the resorption of calcium phosphate bone substitutes. Bio materials 2004; 25: Halbhübner, S. Augmentation dorsaler Spondylodesen bei der operativen Behandlung der idiopathischen Adoleszentenskoliose: autologer Knochen versus -Tricalciumphosphat. Dissertation, vorgelegt der Medizinischen Fakultät Charité der Humboldt-Universität zu Berlin, Jensen SS, Broggini N, Hjorting-Hansen E, Schenk R, Buser D. Bone healing and graft resorption of autograft, anorganic bovine bone and -tricalcium phosphate. A histologic and histomorphometric study in the mandibles of minipigs. Clin. Oral Impl. Res. 2006; 17: von Doernberg MC, von Rechenberg B, Bohner M, Grünenfelder S, von Lenthe GH, Müller R, Gasser B, Mathys R, Baroud G, Auer J. In vivo behavior of calcium phosphate scaffolds with four different pore sizes. Biomaterials 2006; 27: Lindenmüller IH, Lambrecht JH. Sinusbodenelevation und Implantation eine retrospektive Untersuchung. Schweiz Monatsschr Zahnmed 2006; 2: Becker S, Maissen O, Ponomarev I, Stoll T, Rahn B, Wilke I. Osteopromotion by a -Tricalcium Phosphate/Bone Marrow Hybrid Implant for Use in Spine Surgery. Spine 2006; 31(1): Nakajima Y, Fiorellini JP, Kim DM, Weber HP. Régénération de défauts osseux mandibulaires avec une membrane en polytétrafluoroéthylène expansé et différents matériaux osseux de comblement. Parodontie Dentisterie Restauratrice 2007; 27(2): Thommen Medical 7

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