Synthetic and bioactive
bone graft substitute

GlassBONE™ is indicated in regenerative medicine like a synthetic, bioactive bone substitute which comes in the form of granules. GlassBONE™ combines natural biological action and optimum safety for reliable and reproducible results.

Based on innovative technology, GlassBONE™ is a bioactive glass 45S5 ceramic composed of silicium, sodium, phosphorus and calcium oxide. All of these elements are naturally present in the human body and are crucial agents in the osteogenesis process. This bioactivity, marks a new stage in bone regeneration products.

The mineral ion formula of GlassBONE™ increases its biocompatibility and removes the risk of transmitting pathogens. The bone regeneration product GlassBONE™ comes from a technology developed in France with local partners to ensure highest quality.

GlassBONE™ offers surgeons and patients optimum safety during implantation for natural, effective bone restoration for all indication encountered in daily their practice.


boite GlassBone


GlassBONE™, a bone substitute biomaterial, is a class III medical device, manufactured by NORAKER SAS, the compliance of which has been assessed by GMED (0459). GlassBONE™ is intended for the filling of bone defects. GlassBONE™ is supported by the French health insurance organizations in certain situations, more information on the ameli. fr website. In the context of a dental indication, GlassBONE™ is not subject to reimbursement by the French health insurance institutions. GlassBONE™ can be supported in certain situations depending on regulations of the country, see the health codes of the country for more information. Read carefully the user leaflet provided with the product, for complete information regarding the indications, contraindications, warnings, precautions for use and adverse effects.

Features and Benefits



Bioactive

Osteostimulative

Hydrophilic

Synthetic

Antibacterial

Volume preservation

Bioactive
Stimules osteogenesis


GlassBONE™ has a higher degree of bioactivity.


Natural bone remodelling of the patient is the major factor for implant osteointegration. Bioactivity of GlassBONE™ ensures natural bone remodelling in two crucial stages: first, formation of a mineral layer of calcium phosphate and second, stimulation of osteogenesis. (1)

diagramme de Biotactivité

GlassBONE™ dissolution brings about ionic exchanges with biological fluids able to form a mineral layer of calcium phosphate, which allows binding between the biomaterial granules and the bone. This binding will prevent any micro-movement of the granules, which would prevent osteointegration. (1)(2)



The release of an optimum level of silicium will genetically stimulate the recruitment and proliferation of the stem cells and the differentiation and proliferation of the osteoblasts: these are the main agents of osteogenesis. This is osteostimulation.

The intrinsic properties of GlassBONE™ help to promote the natural process of bone regeneration, thanks to the release of mineral ions. This innovative technology offers the safest and most effective solution for dental surgeons and for their patients.



microscope granules GlassBONE

Characterization of the mineral
layer formed on GlassBONE™
granules after 45 days,
Scanning Electron Microscope



(1) Hench, L.L. The story of Bioglass. J Matter Sci: Matter Med. Springer Science, 2006, Vol. 17, p. 967-978.
(2) Jones, J.R. Review of bioactive glass: from Hench to hybrids. Acta Biomaterialia. Elsevier, 2013, Vol. 9, pp.4457-4486.

Osteostimulative
Accelerates full natural bone remodelling


GlassBONE™ accelerates natural bone regeneration 2 time.


The high level of silicium in the composition of GlassBONE™ bone graft substitute and its dissolution brings about the bioactivity process. GlassBONE™ genetically stimulates the recruitment, differentiation and proliferation of the stem cells in osteoblasts for complete and natural bone remodelling. (Mechanism of action). (3)(4)(5)(6)


The new bone and capillaries form rapidly between the granules, restoring the natural biological and mechanical properties of the bone. Bone growth is approximately twice as fast as the bone growth observed with the use of others synthetic bone substitutes.(7) The natural bone remodelling guarantees successful clinical results.



croissance osseuse


Studies showed the percentage of bone formation. The bioactive glass 45S5 allows bone restoration in two weeks instead of the six weeks required by other inert ceramics to achieve the same result.


Coupe histologique à 26 semaines d’un comblement de plancher sinusien chez l’humain

Histological section at 26 weeks of the filling of a sinus floor in a human. The edges of the osteoid are extensive and thick in the newly formed tissue, and there are large numbers of resorption cavities. This means that the remodelling is intense with extensive formation and resorption.



(3) Jell, G. and al. Gene activation by bioactive glasses. J Mater Sci: Mater Med. Springer Science, 2006, Vol. 17, pp.997-1002.
(4) Xynos, I.D. and al. Ionic products of bioactive glass dissolution increase proliferation of human osteoblasts and induce insulin-like growth factor II mRNA expression and protein synthesis. Biochemical and Biophysical Research Communications. 2000, Vol. 276, 2, pp. 461-5.
(5) Hench, L.L. Genetic design of biactive glass. Journal of the European Ceramic Society. Elsevier, 2009, Vol. 29, pp. 1257-1265.
(6)Tsigkou, O. and al. Differentiation of fetal osteoblasts and formation of mineralized bone nodules by 45S5 Bioglass conditioned medium in the absence of osteogenic supplements. Biomaterials. Elsevier, 2009, Vol. 30, pp.3542-50.
(7) Oonishi, H. and al. Quantitative comparison of bone growth behavior in granules of Bioglass, A-W glass ceramic and hydroxyapatite. J Biomed Mater Res. John Wiley & Sons, Inc., 2000, Vol. 51.

Hydrophilic
Optimal handling & easy to use


GlassBONE™ has a good degree of hydrophilic property.


GlassBONE™ has a high affinity for biologic fluids which improves its handling. When it is mixed with patients’ blood or with normal saline solution, it forms a cohesive mass, making it easy to handle and implant in the mouth of the patient.

Action granulaire glassbone

From the first instants after humidification, the blood enters the granular clusters. GlassBONE™ can be mixed with a low volume of blood. This strong hydrophilic property is characterized by hydrogen bonds between the blood and the bone graft substitute.



Volume preservation
Aesthetic guaranteed


Optimal bioabsorption for a complete bone remodelling.


The aesthetic requirements of your patients can be met with the restoration and preservation of bone volume. Bone volume preservation is the result of bone graft substitute bioabsorption and bone remodelling that takes place. GlassBONE™ degradation is ensured because it dissolves after implantation which will initiate bone remodelling.(2)


maintien du volume osseux glassbone

Restoration and preservation of bone volume are guaranteed by bone regeneration with natural biological and mechanical properties, meaning success for your clinical cases.



croissance osseuse


The dissolution of Activioss™ stimulates the natural process of bone regeneration. It has been demonstrated on the one hand that the use of Bioactive Glass 45S5 is at least as effective as autologous bone, and on the other hand that the use of Bioactive Glass 45S5 in combination with autologous bone leads to bone growth that is twice as fast as with autologous bone alone.



(2) Jones, J.R. Review of bioactive glass: from Hench to hybrids. Acta Biomaterialia. Elsevier, 2013, Vol. 9, pp.4457-4486.

Synthetic
Reliable, predictable and reproducible results


100% synthetic, 100% sure, 45% bioactive elements.


GlassBONE™ belongs to the family of bioactive glasses, a synthetic and bioactive bone substitute. It is composed of mineral elements such as silicon, calcium, sodium and phosphorus. All of the mineral ions that make up GlassBONE™ are naturally present in the human body and are known to play physiologically crucial roles in the process of bone formation and mineralisation.(8) This composition overcomes the risk of transmission of pathogens and provides optimum safety for patients and surgeons.

45% silicium oxide,
24.5% calcium oxide,
24.5% sodium oxide,
6% phosphorus oxide.

glassbone


The 45% of silicon in the compound of GlassBONE™ ensures bioactivity in the process of natural bone regeneration.





(8) Hoppe, A., Nusret, S.G. and Boccaccini, A.R. A review of the biological response to ionic dissolution products from bioactive glasses and glass-ceramics

Antibacterial effect
Optimal safety


GlassBONE™ has the ability to inhibit bacterial proliferation.


The ions released after implantation of GlassBONE™ contribute to the increase in pH of the medium and the increase in osmotic pressure. These two effects are responsible for localised antibacterial activity.(9)(10) This local antibacterial effect is both bacteriostatic and bactericidal.



antibacterien glassbone

Coupe histologique à 26 semaines d’un comblement de plancher sinusien chez l’humain



The GlassBONE™ effect on 29 pathogens.
3 - Good growth,
2 - Moderate growth,
1 - Poor growth,
0 - No growth



GlassBONE™ with ion release plays a part in the physiological processes which lead to successful surgery.



(9) Allan, I., Newman, H. and Wilson, M. Antibacterial activity of particulate Bioglass against supra- and subgingival bacteria. Biomaterials. Elsevier, 2001, Vol.22, pp. 1683-1687.
(10) Manukka, A. and al. Bactericidal effects of bioactive glasses on clinically important aerobic bacteria. J Mater Sci: Mater Med. Springer Science, 2008, Vol. 19

DOCUMENTATION
DISPONIBLE

Indications and recommendations



The GlassBONE™ synthetic and bioactive bone substitute is indicated in the temporary filling of a defect caused by trauma, disease or surgery, with a view to bone regeneration:



Filling bone defects in orthopedic surgery:
o Filling bone defects after tumor resection,
o Vertebral Arthrodesis
o Prosthesis revision
o Traumatology
o Tibia Osteotomy

Filling bone defects in oral and cranio maxillofacial surgery:
o Periodontal / infrabony defects
o Ridge augmentation
o Filling tooth sockets for ridge maintenance following extraction
o Filling bone defects such as cyst or dental granuloma
o Sinus floor augmentation



Bioactive Bone substitute


GlassBONE™ has to be mixed normal saline solution, autologous bone, patient blood or PRF (Platelet-Rich Fibrin). In order to enhance the host site vascularization, heighten the host cortical bone walls. When placing the graft material, pack it with a compress moistened by normal saline solution. Excess filling is recommended.



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