cerabone®

the natural bovine bone graft

 

ccerabone® is a natural bovine bone grafting material that is the material of choice for a high number of dentists. By today, more than 800.000 patients have been successfully treated with cerabone® in more than 90 countries. It is a highly reliable, long-term stable and particularly safe bone substitute. Due to the strong hydrophilicity of the surface, a mix of cerabone® with blood or physiological saline solution provides a suitable stickiness for optimal moldability and contouring.

 

CERABONE® IS A RELIABLE, LONG-TERM STABLE AND PARTICULARLY SAFE BONE SUBSTITUTE

 

cerabone® is derived from the mineral phase of bovine bone, which shows a high resemblance to human bone regarding surface porosity and chemical composition [1]. It is a mineral scaffold possessing a 3-dimensional pore network that allows fast penetration and adsorption of blood and serum proteins. The unique manufacturing process based on high temperature heating at > 1200 °C reliably removes all organic components [2,3,4,5] and even inactivates prions [6], therefore minimizing the risk of immunological reactions or disease transmission. Both product and production process are fulfilling the German and EU-regulatory and security requirements for bovine bone grafts including DIN EN ISO 22422-1, DIN EN ISO 22442-2 and DIN EN ISO 22442-3.

CLINICAL APPLICATION

Periodontal intrabony defect
Dr. Raluca Cosgarea, Prof. Dr. Dr. Anton Sculean, Marburg, Germany
and Bern, Switzerland
cerabone® for coverage of implant dehiscence and ridge augmentation

Dr. Marius Steigmann,
Neckargemünd, Germany

Two-stage sinus lift with cerabone® and Jason® membrane

Prof. Dr. Dr. Daniel Rothamel,
University Dusseldorf, Germany

PROPERTIES

  • Proven natural bovine bone substitute with high long-term volume stability
  • 100% pure biologic bone apatite
  • Highest possible safety due to high temperature treatment
  • Highly interconnected osteoconductive scaffold
  • Rough surface favouring optimal cell adhesion and blood absorption
  • Easy handling

INDICATIONS

Generally, the high stability of cerabone® makes it the ideal choice in cases where long-term stability is important.

 

Implantology, Periodontology and Oral and CMF Surgery

  • Sinus lift
  • Horizontal and vertical augmentation
  • Ridge preservation
  • Peri-implant defects
  • Socket preservation
  • Bone defect augmentation
  • Periodontal intrabony defects
  • Furcation defects (class I-II)

Further handling tips, clinical cases and videos on cerabone® can be found in the

INDICATION MATRIX.

DETAILS

specific facts

Maximum safety

Safety due to patented manufacturing process including high temperature treatment (> 1200 °C)

For the production of cerabone® a unique manufacturing process was developed including high temperature treatment at > 1200 °C. This treatment reliably removes all organic components including potential bacteria, viruses and prions [2, 3, 4, 6] and ensures maximum possible safety.

The purity of cerabone®, consisting solely of the mineral bone phase, was tested by different analytical methods [5] . In 2011 the high purity of cerabone® was confirmed by a leading biochemical laboratory [7]. Final sterility of cerabone® is ensured by gamma irradiation.

 

Safety due to the source of the raw material

The sourcing of raw materials also contributes to the high safety of the final product. cerabone® is produced from bovine cancellous bone originating from registered abattoirs in New Zealand. According to the world organization for animal health New Zealand is a country with negligible risk for BSE [8].
A quality agreement with the abattoir allows the back tracing of individual animals. Additionally, a health certificate for every animal is issued by a veterinarian.

 

cerabone® is in compliance with the European guidelines

Both, the product cerabone® and its production process fulfill the German and EU-regulatory and security requirements for bovine bone grafts including DIN EN ISO 22442-1, DIN EN ISO 22 442-2 and DIN EN ISO 22442-3.

High purity

For the production of cerabone® a special production process was developed based on the stepwise heating f the raw materials up to 1200°C.  Several studies demonstrated that heating to temperatures above 1000 °C reliably removes all organic components [2, 3, 4] and creates a crystalline biologic bone apatite of high purity [5]. Due to a special production procedure, the natural porosity and surface structure of the bone mineral are not affected [1].

Porosity and hydrophilicity

Interconnected pores and rough surface morphology are fundamental to good hydrophilicity. cerabone® is a highly porous bone graft with a porosity of ~65-80 % and a mean pore size of ~600-900 μm [1]. Macro-pores allow fast ingrowth of blood vessels and bone-forming cells, while micro-pores promote quick blood uptake by the capillary effect. Due to their excellent hydrophilicity, the cerabone® particles quickly absorb liquids and adhere to each other after mixing, thereby facilitating handling.  Adhesion of proteins and signaling molecules from the blood further improves the biological properties of cerabone.

Osteoconductive scaffold with rough surface

High porosity and rough surface morphology lay the basis for the good osteoconductivity of cerabone®. The cerabone® granules provide an excellent structure for adhesion and invasion of bone forming cells. The natural bone structure with interconnected pores allows complete integration of the implant due to the ingrowth of cells and blood vessels.

Osseous integration and permanent structural stability

The sintering process makes cerabone® a highly crystalline material [5, 9] that degrades very slowly under physiological conditions. cerabone®  therefore presents remarkable volume stability [10].

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Product Specifications

cerabone® granules
Art.-No.Particle Size
Content
15100.5 – 1.0 mm1 × 0.5 ml
15110.5 – 1.0 mm1 × 1.0 ml
15120.5 – 1.0 mm1 × 2.0 ml
15150.5 – 1.0 mm1 × 5.0 ml
15201.0 – 2.0 mm1 × 0.5 ml
15211.0 – 2.0 mm1 × 1.0 ml
15221.0 – 2.0 mm1 × 2.0 ml
15251.0 – 2.0 mm1 × 5.0 ml
cerabone® block
Art.-No.Dimension Content
172020 x 20 x 10 mm1 × block
LITERATURE

[1] Seidel, P. and Dingeldein, E. (2004), “Cerabone®– eine Spongiosa-Keramik bovinen Ursprungs”, Materialwissenschaft und Werkstofftechnik, Vol. 35 No. 4, pp. 208–212.
[2] Becker, Organikum, Ambrosius Verlag, Leipzig 1993
[3] Morrison, Boyd, VCH 1986
[4] Murugan R, Panduranga Rao K, Sampath Kumar T S. Heat-deproteinated xenogeneic bone from slaughterhouse waste: Physico-chemical properties. Bulletin of Materials Science 2003;26(5):523-528
[5] Tadic, D. and Epple, M. (2004), “A thorough physicochemical characterisation of 14 calcium phosphate-based bone substitution materials in comparison to natural bone”, Biomaterials, Vol. 25 No. 6, pp. 987–994.

[6] Brown, P., Rau, E.H., Johnson, B.K., Bacote, A.E., Gibbs, C.J. and Gajdusek, D.C. (2000), “New studies on the heat resistance of hamster-adapted scrapie agent: threshold survival after ashing at 600 degrees C suggests an inorganic template of replication”, Proceedings of the National Academy of Sciences of the United States of America, Vol. 97 No. 7, pp. 3418–3421.
[7] Prof. C. Vogt, University Hanover, 2011, data available on request
[8] LINK
[9] Fathi et al. 2008
[10] Riachi, F., Naaman, N., Tabarani, C., Aboelsaad, N., Aboushelib, M.N., Berberi, A. and Salameh, Z. (2012), “Influence of material properties on rate of resorption of two bone graft materials after sinus lift using radiographic assessment”, International journal of dentistry, Vol. 2012, p. 737262.