Osteoplastic Materials from the BIO3 Implants Company

Unfortunately, spare parts are not given out at birth. Regeneration of soft fabrics proceeds quickly enough but what to do, when it is necessary to restore the damaged sites of a bone? Various plastic materials of a biological and inorganic origin are used for the reconstruction of their anatomic integrity. However, in spite of the fact that institutes and universities conduct multiplane researches, results of these researches are not popularized, therefore the range of domestic materials in the Ukrainian market leaves much to be desired.

The priority direction of the Bio 3 Implants company is the creation of scientific ally-justifiedmethods and technologies of receiving import-substituting biomaterials. Improvement of knowledge about fabrics regeneration, understanding the mechanism of transplants degradation, generalisation of results of foreign researches promoted a formation of the new, innovative direction of the Bio 3 Implants company — releasing the biocompatible Bio 3 Bone and Bio 3 Bone Beta osteoplastic materials intended for surgical stomatology, maxillofacial surgeries, traumatology and orthopedics.

Mass-production of Bio 3 Bone and Bio 3 Bone Beta materials open not only a new page in the development of company’s capacity, but also confirms a real possibility of domestic producers to substitute import in various scopes of high technologies.

Let-out production corresponds to the requirements of internal Russian and international standards, quality management systems of ISO 13485-2003 and GOST ISO 9001-2008.

BIOMATERIALS FOR FIRM FABRICS REGENERATION

Considerable share of osteoplastic materials of the Bio 3 Implants company consists of highly sterile calcium phosphates (ß-tricalcium phosphate and/or hydroxyapatite) as their chemical composition is similar to bone fabric. The synthetic Bio 3 Bone Beta material represents the granules made using the technologies of receiving spherical granules: micro (to 10 microns) and macroporosity (150 — 200 microns). Porosity of granules promotes penetration of osteogene cells, vascularization and diffusion of biological liquids between material particles. Existence of mutually communicating pores provides high bioactivity. The choice of the size of granules depends on the size and location of defect: 100 — 500 microns — minor periodontal bone defects; 500 — 1000 microns — average and minor cystal and alveolar defects; 1000 — 2000 microns — serious cystaldefects and a sinus lift. Depending on the size of granules and genetic potential of the organism the Bio 3 Bone Beta material resorbs completely within 9 — 15 months. The resorption proceeds parallel to regeneration process.

The Bio 3 Bone Beta materials are applied in various clinical cases. In periodontics: filling of two - or multiwalled bone pockets, and also bi-and trifurcation of teeth, augmentation of an atrophied maxillary bosom. In implantology: a sinus lift or a raising of the sinus basis (subantral augmentation), filling of alveolar defects for maxillary bosom support after a tooth extraction, filling of extraction defects for the basis creation for an implant. To fill the cystal defects after bone cyst extirpation, a resection of a top of a root and surgical removal of impacted teeth, as well as other multigrid bone defects of alveolar shoots and facial bones of a skull.

The Bio 3 Bone Beta material is issued in types of:

• granules on the pure phase of ß-tricalcium phosphate basis
• granules on the ß-tricalcium phosphate(60 %)/hydroxyapatite (40 %) basis
• ß-tricalcium phosphate granules in a hyaluronic matrix
• ß-tricalcium phosphate granules in a collagenic matrix
• a mineral - polymeric granules (ß-tricalcium phosphate/PLGL)
• a mineral - polymeric granules (ß-tricalcium phosphate/PLGL)
• a mineral - polymeric granules (ß-tricalcium phosphate/PLGL)
• bone root transplants (cone, block).

Granules on the pure phase of ß-tricalcium phosphate basis Bio 3 Bone Beta, as well as on the basis of ß-tricalcium phosphate (60 %) and a hydroxyapatite (40 %) obtained in the course of agglomeration of synthetic raw materials, do not contain substances of an animal origin, are biologically compatible to organism fabrics, possess high micro, macro - and intergranular porosity that creates ideal conditions for restoration of the bone defect. The special additive makes a material radio-opaque.

Osteoinductive Bio 3 Bone Beta granules, containing hyaluronate, sodium and collagen in its structure, have stimulating effect on cell growth and promotes activation of reparative osteogenesisin the trauma area, accelerate differentiation of a neogenic bone fabric that is expressed first of all in rapid increase of specific weight of regenerate’s bone components, and also in more intensive maturation of bone substance.

The osteoinductive Bio 3 Bone Beta material represents a mineral - the polymeric granules consisting of the pure phase ß-tricalcium phosphatet and a polylactide-glycolide coating (5 microns). The technology of receiving granules of the set porosity and the architectonics closest to biological bone matrix, promotes integration acceleration of an implant with a bone fabric.

The Bio 3 Bone Beta cosolvent material consists of ß-tricalcium phosphate granules covered with a thin biodegrading polylactide-glycolide copolymer coating (10 microns), and a cosolvent. After mixing the granules with a cosolvent the granules stick together among themselves, forming a plastic material with high micro and intergranular porosity which can be entered into bone defect directly from a syringe. At contact with blood or oral liquid the material gets a form of bone defect that provides its stability in defect and facilitates procedure of a wound suturing.

In order to create an exact copy of a root of remote tooth for the purpose of an atrophy prevention of an alveolar shoot and a bone fabric restoration the Bio 3 Bone Beta membrane biomaterial consisting of a synthetic membrane, representing a polylactide-glycolide ccopolymer, and granules on the pure phase ß-tricalcium phosphate basis, bagged in a polymeric cover (10 microns). Under the influence of the temperature the granules stick together among themselves, forming a mechanically strong copy of tooth root which is entered into a hole of just removed tooth, keeping its anatomic form and size, stops the bleeding and interferes with its infectioning. The exact copy of a tooth root is made within 5 minutes after its removal. A transplant is completely resorbed within 6 — 8 months, being replaced with a recreated bone tissue and providing optimal conditions for the subsequent dental implantation or orthopedic rehabilitation by way of fixed dental bridge structures.

During the restoration of periodontal defects (filling of two – or multiwalled bone pockets, bi-and trifurcation of teeth, augmentation of an atrophied maxillary bosom) it is recommended to use the osteoplastic Bio 3 Bone Beta material optimising regeneration of soft and bone tissues.

The material represents a resorbed calcium –phosphate multilayered granules with the prolonged liberation of active ingredients. The basis of a granule consists of a radio-opaque ß-tricalcium phosphate (20 %) and hydroxyapatite (80 %) in a polylactide-glycolide matrix. The inner layer of a coating contains sodium hyaluronate which has stimulating effect on cell growth and promotes a reparative osteogenesis activation in rauma area, accelerating process of differentiation of a neogenic bone tissue that is expressed first of all in rapid increase of specific weight bone components of a regenerate, and also in more intensive maturing of a bone substance. The external coat layer includes a hydrocortisone, chlorhexidine and lidocaine which possess antibacterial action in relation to anaerobic protozoa and bacterias, inhibit the synthesis of proteins in microorganisms, having bacteriostatic and bactericidal effect, are active concerning a wide range of vegetative forms of gramme-negative and gramme-A positive micro £ organisms, yeast and lipophilic viruses.

The structure of the Bio 3 Bone Beta biomaterial includes ß-tricalcium phosphatet, monohydrate and monocalcium phosphate, sodium hyaluronite, regulators of plasticity and structure integrity of a material. The hardening of a materialoccurs as a result of the acid-lead interaction with the formation as the main product of a dihydrate dicalcium phosphate dehydrate crystal hydrates, having a structure:

Са (N, Ð 04) 2 • Н20 + ß-Ca3 (P04) 3 + 7Н, 0-> "4СаНР04" 2Н20, possessing a bigger speed of a resorption (3 — 4 months), than cements on the hydroxyapatite basis (8-12 months).

Sodium hyaluronate, which is a part of a material, considerably improves its osteoinductive properties. Dense contact between a bone and a surface of a dental implant promotes formation of a new autogenic bone fabric and interferes with the growth of soft fabrics, being effective replacement of a traditional granulated material — membrane combination. The indicator of durability of the hardened material is equivalent to durability of a trabecular bone.

AUTOBONE ALTERNATIVE - BIO3 BONE

Despite the considerable successes reached in biomaterials science, synthetically received hydroxyapatite differs from natural on physical and chemical properties that not always provides a stable regeneration. In the majority of clinical cases the preference is given to the natural biomaterials received from a bone fabric. Biomaterials of a natural origin remain the only functionally reliable substance possessing high biocompatibility, adjustable and controllable process of a desctruction in a live organism.

The Vladmiva company produces a highly sterile osteoplastic Bio 3 Bone material with preservation of a hydroxyapatite of a biological origin and dimensional architectonics that promotes fixing of biologically active substances on biomaterial structures without decrease in their biological activity.

The technology of obtaining the Bio 3 Bone material is based on a step-by-step multiphasic cleaning of a trabecular (cortical) bone fabric of KRS by a method of the chemically fermented processing, or a deproteinization. The material is deprived of cell elements and albuminous fractions. It is an ideal skeleton of germination of blood vessels and cell growth from a bone bed as possesses porous structure of a trabecular and dyaphyseal part of tubular bones (a micropore, a macrotime, haversian channels).

The hydroxyapatite of a biological origin promotes angiogenesis, to migration and an attachment to a surface of granules of stromal stem cells of a marrow, their differentiation into osteoblasts and reparative osteogenesis.

The Bio 3 Bone biomaterial contains highly sterile sulfated glycosaminoglycans, possesses osteogene (an osteoconductive and osteoinductive) properties, the high biological compatibility promoting absence of immune reactions of an organism of the recipient, is combined with all types of transplants, implants, fixators. The biomaterial is rather strong, resorbing in time matrix (6 — 8 months) with speed of the bioresorption synchronised with process of formation of a new fabric. The physiological resorption proceeds with formation of nontoxical products of disintegration.

The scope of the Bio 3 Bone material covers practically all clinical cases at restoration of structural integrity of bone defects in surgical stomatology and maxillofacial surgery:

• filling of defects after cystectomy, root resections;
• filling of holes of remote teeth for prevention of an atrophy of a contour of an alveolar crest;
• filling of cavities during sinus lifting;

Reconstruction of an alveolar shoot;

• closing of a perforation of a maxillary shoot and mandibular channel;
• filling of periodontal defects. Besides, this biomaterial is recommended to to use in traumatology, orthopedics, ophthalmosurgery and other areas of medicine.

The osteoplastic Bio 3 Bone material (the crumb, chips), received by a method of chemically fermented processing, contains in its structure a hydroxyapatite of an animal origin and the highly sterile native collagen, and also sulfated glycosaminoglycans within biological norm (no less than 800 mkg/cm3).Demineralized Bio 3 Bone blocks are ideally suited for filling of defects of a difficult anatomic form.

The crumb, impregnated with lincomycin or chlorhexidine and metronidazole, is most effective for application in a surgical periodontology. Lincomycin inhibits the synthesis of proteins in microorganisms, having a bacteriostatic and bactericidal effect concerning gramme-positive bacteria and mycoplasmas. Metronidazole possesses an antiprotozal and antibacterial action in relation to anaerobic protozoa and bacteria. The mechanism of its action is in biochemical restoration of nitrogroups of metronidazole and their further interaction with DNA of a cell of microorganisms that inhibits synthesis of nucleinic acids and leads to the death of bacteria. Chlorhexidine is active concerning a wide range of vegetative forms of gramme-negative and gramme-positive microorganisms, yeast and lipophilic viruses. The bactericidal effect is caused by linkage of the cations which are forming in a result of a chlorhexidine dissociation in the physiological environment with negatively charged phosphatic groups of bacterial cellular membranes and extramicrobial complexes.

The osteoplastic Bio 3 Bone material (the crumb, blocks), received by a deproteinization of xenomaterials by means of complete removal of organic components, keeps strong three-dimensional structure and mineral structure of a bone fabric. The material is a rather strong, gradually resorbing matrix (6 — 8 months) on the surface of which in the conditions of bone defects the neogenic bone is formed. As a result of a deproteinization the material is deprived of cellular elements and albuminous fractions.

BIOMATERIALS FOR REGENERATION OF SOFT FABRICS

Resorbing, collagenic membranes are intended for the creation of the mechanical barrier preventing migration of soft fabrics in bone defect at surgical intervention:

• implantation at defects of a bone fabric;
• restoration of the congenital and acquired defects of bone and soft fabrics;
• sinus lifting;
• Cystectomy;
• parodontytes (low-invasive methods of treatment and reconstructive operations);
• resection of a top of a root;
• filling of defects after removal of cysts;
• closing of perforation of a maxillary bosom and perforations of the mandibular channel;
• tooth removal (complicated / not complicated);
• as the clot stabilizer.

The two-layer Bio3Bone membrane represents I-type collagem (derma), does not contain additional chemical additives. Has morphology of the dense focused fibres for achievement of mechanical durability, of immunogen, it is inert, which results in an absence of inflammatory reaction or the expressed reaction to a foreign matter. A membrane is not antigenic, it is highly biocompatible, the epithelium prevents a proliferation and migration, creating optimum conditions for the directed regeneration of a bone fabric. The structure of the collagen allows to close bone defect reliably. A material is completely resorbed without fibrous regeneration.

Bio 3 Bone VD the membrane represents the type -II collagen whose interfiber structure is restored due to the cross-section sewing of polypeptide chains. The membrane biocompatible, promotes linkage of factors of growth, trombocyte aggregation, osteoblasts and osteoclasts, causes a bone fabric remodelling and stimulates a reparation of bone defect. Bio 3 Bone VD membrane keeps barrier function in the course of fabric regeneration without fiber formation, does not contain antigenic factors, is capable of integration with surrounding fabrics, without causing reciprocal immune reaction. It is easily modelled, possesses optimum rigidity and plasticity.

For reliable protection and the accelerated healing of wounds

Bio 3 Bone Beta gel fixes an augmental material, carrying out function of a biological membrane. Sodium hyaluronate, which is a part of the gel, represents biopolymer of high extent of sterility, on structure equivalent to the natural human. This, as well as the lack of proteins of an animal origin reduces the risk of allergic reactions. Thanks to its high viscosity, the gel slows down the process of penetration of bacteria and viruses in a fabric that positively influences on the healing process.

The hyaluronic acid mixed with materials for bone regeneration considerably improves clinical results, increasing osteoinductance and fixing of these materials in application places, preventing shift of an augmentation material and providing volume stability.

Gel, when carrying out a function of a biological membrane, effectively fixes auto-or hallo - gene augmentation materials. Protective action and slow absorption of hyaluronic acid provides reliable and predictable regeneration of an augmentate, especially at sinus lifting surgeries. Hyaluronic acid positively influences formation of a new bone material and strongly connects particles of granulate that allows to carry out augmentation of defects even in hard-to-reach spots. Bio3 Bone Beta gel effectively removes hypostasis and an inflammation of a mucous oral cavity before surgical manipulations. Part of the gel, chondroitin sulphate, promotes healing of inflamed periodont due to the decrease in activity of proteolytic enzymes and bacterial flora hyaluronidase. The Gel normalises a metabolism in epythelium cells and fibroplasts and microblood circulation that leads to fast reduction of puffiness and bleeding of gums, promotes inflammation localisation. Besides, chondroitin sulphate considerably improves a condition of a dentine and an exchange in odontoblasts. Chlorhexidin provides the prolonged bactericidal effect on microorganisms of a plaque, promotes the prevention and treatment of gingivitis, reduces an inflammation of gums.

At long application gel does not cause allergic reactions. It is applied until the reduction of hypostasis and an inflammation of fabrics of a mucous mouth at surgeries concerning traumas, changes, a splintage of jaws; closings of perforations of a maxillary bosom and perforations of the mandibular channel; at tooth removal (complicated / not complicated). Indications are also: prevention and treatment of periodontitis, gingivitis and stomatitis. Gel can be used as the clot stabilizer.