NZ733547B2 - Biocompatible molded part - Google Patents
Biocompatible molded part Download PDFInfo
- Publication number
- NZ733547B2 NZ733547B2 NZ733547A NZ73354716A NZ733547B2 NZ 733547 B2 NZ733547 B2 NZ 733547B2 NZ 733547 A NZ733547 A NZ 733547A NZ 73354716 A NZ73354716 A NZ 73354716A NZ 733547 B2 NZ733547 B2 NZ 733547B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- molded part
- bone
- granulate
- composition
- biocompatible
- Prior art date
Links
- 210000000988 Bone and Bones Anatomy 0.000 claims abstract description 137
- 239000000463 material Substances 0.000 claims abstract description 133
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- 238000004519 manufacturing process Methods 0.000 claims abstract description 26
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- 239000008187 granular material Substances 0.000 claims description 81
- MAKUBRYLFHZREJ-JWBQXVCJSA-M sodium;(2S,3S,4R,5R,6R)-3-[(2S,3R,5S,6R)-3-acetamido-5-hydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-4,5,6-trihydroxyoxane-2-carboxylate Chemical compound [Na+].CC(=O)N[C@@H]1C[C@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](C([O-])=O)O[C@@H](O)[C@H](O)[C@H]1O MAKUBRYLFHZREJ-JWBQXVCJSA-M 0.000 claims description 41
- 229920002674 hyaluronan Polymers 0.000 claims description 33
- 229960003160 hyaluronic acid Drugs 0.000 claims description 33
- 239000000126 substance Substances 0.000 claims description 28
- QORWJWZARLRLPR-UHFFFAOYSA-H Tricalcium phosphate Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims description 26
- 239000011505 plaster Substances 0.000 claims description 25
- 102000008186 Collagen Human genes 0.000 claims description 18
- 108010035532 Collagen Proteins 0.000 claims description 18
- VTYYLEPIZMXCLO-UHFFFAOYSA-L calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims description 18
- 229960005188 collagen Drugs 0.000 claims description 18
- 229920001436 collagen Polymers 0.000 claims description 18
- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Inorganic materials [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 claims description 17
- ZOMBKNNSYQHRCA-UHFFFAOYSA-J calcium sulfate hemihydrate Chemical compound O.[Ca+2].[Ca+2].[O-]S([O-])(=O)=O.[O-]S([O-])(=O)=O ZOMBKNNSYQHRCA-UHFFFAOYSA-J 0.000 claims description 17
- 239000011507 gypsum plaster Substances 0.000 claims description 17
- 241000195493 Cryptophyta Species 0.000 claims description 16
- 239000002245 particle Substances 0.000 claims description 12
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 12
- 238000001035 drying Methods 0.000 claims description 11
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- 229940083879 Antibiotics FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE Drugs 0.000 claims description 8
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- 229940042786 Antitubercular Antibiotics Drugs 0.000 claims description 8
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- 229940024982 Topical Antifungal Antibiotics Drugs 0.000 claims description 8
- 229940029983 VITAMINS Drugs 0.000 claims description 8
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- 239000003242 anti bacterial agent Substances 0.000 claims description 8
- 230000003115 biocidal Effects 0.000 claims description 8
- 239000005312 bioglass Substances 0.000 claims description 8
- 239000001506 calcium phosphate Substances 0.000 claims description 8
- 235000011010 calcium phosphates Nutrition 0.000 claims description 8
- 239000000919 ceramic Substances 0.000 claims description 8
- 239000000284 extract Substances 0.000 claims description 8
- 239000002471 hydroxymethylglutaryl coenzyme A reductase inhibitor Substances 0.000 claims description 8
- 229940079866 intestinal antibiotics Drugs 0.000 claims description 8
- 229940005935 ophthalmologic Antibiotics Drugs 0.000 claims description 8
- 239000011573 trace mineral Substances 0.000 claims description 8
- 235000013619 trace mineral Nutrition 0.000 claims description 8
- 239000011782 vitamin Substances 0.000 claims description 8
- 235000013343 vitamin Nutrition 0.000 claims description 8
- 229930003231 vitamins Natural products 0.000 claims description 8
- 150000007942 carboxylates Chemical class 0.000 claims description 7
- 239000004568 cement Substances 0.000 claims description 7
- 239000000316 bone substitute Substances 0.000 claims description 6
- 229910000389 calcium phosphate Inorganic materials 0.000 claims description 6
- 239000004068 calcium phosphate ceramic Substances 0.000 claims description 6
- 239000003178 glass ionomer cement Substances 0.000 claims description 6
- 229910052588 hydroxylapatite Inorganic materials 0.000 claims description 6
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 claims description 6
- 239000003566 sealing material Substances 0.000 claims description 6
- FDFYYWMHPJTGEO-UHFFFAOYSA-K tetracalcium;phosphate Chemical compound [Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O FDFYYWMHPJTGEO-UHFFFAOYSA-K 0.000 claims description 6
- 239000012153 distilled water Substances 0.000 claims description 5
- 230000001954 sterilising Effects 0.000 claims description 5
- 238000002156 mixing Methods 0.000 claims description 3
- 230000012010 growth Effects 0.000 abstract description 22
- 210000000963 osteoblast Anatomy 0.000 abstract description 19
- 230000000790 osteoblast Effects 0.000 abstract description 19
- 230000003416 augmentation Effects 0.000 abstract description 9
- 230000003902 lesions Effects 0.000 abstract description 4
- 210000004204 Blood Vessels Anatomy 0.000 description 15
- 206010061218 Inflammation Diseases 0.000 description 9
- 210000004027 cells Anatomy 0.000 description 9
- 239000003814 drug Substances 0.000 description 9
- 230000015572 biosynthetic process Effects 0.000 description 8
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- 238000011069 regeneration method Methods 0.000 description 8
- 230000015556 catabolic process Effects 0.000 description 6
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- 235000015097 nutrients Nutrition 0.000 description 5
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- 210000004195 Gingiva Anatomy 0.000 description 4
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- 230000000694 effects Effects 0.000 description 4
- 235000020638 mussel Nutrition 0.000 description 4
- 229920001296 polysiloxane Polymers 0.000 description 4
- 238000002360 preparation method Methods 0.000 description 4
- 102000004169 proteins and genes Human genes 0.000 description 4
- 108090000623 proteins and genes Proteins 0.000 description 4
- 230000029663 wound healing Effects 0.000 description 4
- 210000003460 Periosteum Anatomy 0.000 description 3
- 230000001580 bacterial Effects 0.000 description 3
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- OYPRJOBELJOOCE-UHFFFAOYSA-N calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 2
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- TUJKJAMUKRIRHC-UHFFFAOYSA-N hydroxyl radical Chemical class [OH] TUJKJAMUKRIRHC-UHFFFAOYSA-N 0.000 description 2
- 230000002519 immonomodulatory Effects 0.000 description 2
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- 231100000915 pathological change Toxicity 0.000 description 2
- 230000036285 pathological change Effects 0.000 description 2
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2/2803—Bones for mandibular reconstruction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30988—Other joints not covered by any of the groups A61F2/32 - A61F2/4425
- A61F2/3099—Other joints not covered by any of the groups A61F2/32 - A61F2/4425 for temporo-mandibular [TM, TMJ] joints
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
- A61F2240/002—Designing or making customized prostheses
- A61F2240/004—Using a positive or negative model, e.g. moulds
-
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
- A61L2/0029—Radiation
- A61L2/0035—Gamma radiation
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/21—Pharmaceuticals, e.g. medicaments, artificial body parts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/12—Materials or treatment for tissue regeneration for dental implants or prostheses
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/025—Other specific inorganic materials not covered by A61L27/04 - A61L27/12
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/38—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells
- A61L27/3839—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells characterised by the site of application in the body
- A61L27/3843—Connective tissue
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L27/42—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L27/42—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix
- A61L27/425—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix of phosphorus containing material, e.g. apatite
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L27/42—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix
- A61L27/427—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix of other specific inorganic materials not covered by A61L27/422 or A61L27/425
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/58—Materials at least partially resorbable by the body
Abstract
For the targeted growth of osteoblasts on the human or animal jaw bone, it is known to form cavities in a molded part. Osteoblasts can grow in these cavities and thereby fill bone defects or augment the height and/or width of the jaw. However, in the event of relatively large lesions, some of these materials do not offer sufficient stability for satisfactory osteogenesis or ossification and moreover are absorbed too quickly and unevenly. As a result, the objective of filing or augmentation is often not met. The invention provides a biocompatible molded part for supporting new bone formation, in particular the reformation of a jaw bone or a jaw bone portion in a mammal, preferably a human, wherein the molded part is suitable to be placed on the jaw bone and is designed as a solid body. The invention also provides a composition for producing a biocompatible molded part, a method for producing a biocompatible molded part, a use of a biocompatible molded part and a kit comprising a plurality of molded parts. e materials do not offer sufficient stability for satisfactory osteogenesis or ossification and moreover are absorbed too quickly and unevenly. As a result, the objective of filing or augmentation is often not met. The invention provides a biocompatible molded part for supporting new bone formation, in particular the reformation of a jaw bone or a jaw bone portion in a mammal, preferably a human, wherein the molded part is suitable to be placed on the jaw bone and is designed as a solid body. The invention also provides a composition for producing a biocompatible molded part, a method for producing a biocompatible molded part, a use of a biocompatible molded part and a kit comprising a plurality of molded parts.
Description
Biocompatible molded part
The invention relates to a biocompatible molded part for supporting new bone formation.
In medicine, there are numerous applications in which it is desirable for bone material to be
newly formed by the human or animal patient itself. This applies in particular in dental
medicine, if the jaw bone is attacked and partially destroyed, for example, by periodontitis.
For the targeted growth of osteoblasts on the human or animal jaw bone it is known to form
cavities in a molded part. Osteoblasts can grow in these cavities and thereby fill bone defects
or augment the height and/or width of the jaw. It has proved disadvantageous that, in particular
in the event of relatively large lesions, some of these materials do not offer sufficient stability
for satisfactory osteogenesis or ossification and moreover are reabsorbed too quickly and
unevenly. As a result, the objective of filling or augmentation is often not met.
Although other materials are reabsorbed very slowly, they do not allow any more osteoblast
growth in the upper layers, since because of the long residence time of the barrier there is no
longer any nutrient medium available for the osteoblast growth.
Therefore, the object of the present invention is to overcome the disadvantages of the prior
art and to provide a molded part which encourages osteoblast growth.
This object is achieved by a biocompatible molded part according to claim 1. Preferred
embodiments of the invention are the subject of the dependent claims.
According to the invention a biocompatible molded body is provided, which serves to support
the new bone formation, in particular the reformation of a jaw bone or of a jaw bone portion in
a mammal, preferably in a human. In this case the molded part is suitable to be placed on a
bone base, in particular the jaw bone. The biocompatible molded part according to the
invention is formed as a solid body into which blood vessels and osteoblasts grow in the
course of the treatment. Bone formation then takes place during the progressive reabsorption
of the molded part. On the one hand, this solid body gives sufficient stability for the reformation
of the jaw bone during the osteoblast growth, and on the other hand the solid body is designed
in such a way that blood vessels and newly forming bone material can grow through it
completely. Because of the biocompatibility, the osteogenesis is promoted by the solid body
or the material forming it, and at the same time a stabilization of the jaw bone is achieved until
the bone augmentation is concluded.
During use, i.e. in the course of the bone formation, the molded part or the solid body is
reabsorbed little by little. This reabsorption is accompanied by a corresponding filling of the
lesion with newly formed bone material or filling with osteoblasts which initiate or perform the
osteogenesis.
Surprisingly it has been shown that the chosen block form advantageously supports the
ossification or osteogenesis, since it is possible for osteoblasts to migrate in from at least two
sides and thus a more complete and more uniform growth can take place. A more uniform
bony prominence forms, which proves overall to be conducive for the stability of the newly
formed bone. This results in advantages during the insertion of implants into newly formed
bone.
Thus, the invention provides a molded part which initially forms a space for blood vessels to
grow into and for the subsequent ossification. The molded part serves for temporary filling or
bridging of bone defects and lesions which cannot be remedied solely by the regenerative
capacity of the body. At the same time the molded part can also serve as a filling element for
reconstructive surgery, bone tumors or for augmentations, for example before insertion of
dental implants.
By the conclusion of the treatment the molded part is completely replaced by newly formed
bone substance. The components of the molded part are successively reabsorbed and thus
create space in which new bone can form. Until this space is filled with bone material, the
slowly degrading molded part stabilizes the newly formed bone structure.
It is regarded as advantageous if the molded part is formed from a composition which
comprises at least one structuring material and consists of or comprises a granulate. The
composition is not restricted to these two components but can additionally comprise further
components. For production of the molded part, water, preferably distilled water, is additionally
added to the composition in order to ensure the moldability. This water is either bound by the
composition or evaporates in the course of drying of the finished molded part.
The structuring material is preferably selected from the group consisting of impression plaster,
plaster of Paris, hard plaster, super-hard plaster, glass ionomer cement, carboxylate cement
or mixtures thereof. All the aforementioned materials can be completely reabsorbed and are
known from their use in the field of jaw surgery and implant medicine and are suitable for use.
Plaster of Paris is preferably used, which in addition to a corresponding reabsorbability
ensures a sufficient stability of the molded part or solid body during the bone growth. At the
same time this material favors the growth of blood vessels. The term "plaster of Paris" is well
known from dentistry. With regard to its hardness, plaster of Paris is between the impression
plaster which is likewise used in the dental field and a hard plaster. After production of the
molded part with simple dental tools, this plaster can be further processed and thus allows an
adaptation of the solid body to the conditions in the jaw.
The molded part is also capable of absorbing and stabilizing blood clots which form. This
increases the chances that blood vessels can grow simultaneously in the entire molded part.
These blood vessels serve for the supply of nutrients to the osteoblasts, so that an ossification
or osteogenesis can occur, during which new bone material forms and thus, for example, a
jaw bone previously damaged due to periodontitis can be reconstructed.
In this case the molded part which can be completely reabsorbed by the body is permanently
inherently stable and dimensioned so that the reabsorption process is concluded only after
sufficient ossification or osteogenesis, i.e. when a supporting structure is no longer required.
The molded part according to the invention can preferably be mass-produced in different sizes.
In this case the molded part is formed in such a way that it can be used directly at or on the
bone without changes, apart from minor corrections. For this purpose, the molded part is made
available in different sizes and adapted to different positions for use. It is regarded as
advantageous if the molded part is completely reabsorbable by the human or animal body.
Hyaluronic acid (or hyaluronic acid derivatives), which can likewise be used in the context of
the present invention, has an advantageous effect on the treatment of pathological changes
of the periodontium and shows positive effects on fibroblasts, bone regeneration and wound
healing. In the context of the present invention hyaluronic acid (or derivatives thereof) added
directly to or admixed with the composition according to the invention. Alternatively, after
preparation of the molded part and during the insertion or the placing on a bone base a
hyaluronic acid preparation can be added to or poured onto the operating location. In this
case, hyaluronic acid has different functions.
The basic operating principle of hyaluronic acid in the context of the present invention provides
that in an aqueous environment a three-dimensional mesh network is produced following a
spontaneous aggregation of the hyaluronic acid chains. Cellular and fibrous components can
be embedded in this network. This favors and promotes the formation of a bone structure. At
the same time, hyaluronic acid has a regulating function in the organization of the extracellular
matrix and its components. In this case the hyaluronic acid network which is formed is a
prerequisite for the exchange of substances and serves simultaneously as a barrier against
the penetration of extraneous substances. Due to the formation of the networks and the
condensation thereof cells can be protected against degradation processes and hydroxyl
radicals. The hyaluronic acid sheaths thus provided serve different cell types as protection
against external, for example viral or bacterial, influences and thus also favors the probability
of survival of the osteoblasts.
Moreover, negatively charged hyaluronic acid has the ability to bind enormous quantities of
water and different plasma proteins by means of hydrogen bonds and the polar ends and thus
functions as a type of "osmotic buffer" of the extracellular matrix. Hyaluronic acid also proves
advantageous in controlling centers of chronic inflammation and has an anti-inflammatory
potential. Hyaluronic acid also influences cellular growth factors and thus has a positive
influence on cellular growth processes and thus supports the tissue regeneration. These
numerous advantages are used in connection with the present invention or the composition.
Surprisingly it has been shown that the regeneration of the bone or bone material can be
significantly improved.
Surprisingly it has been shown that the molded part according to the present invention enables
a clearly superior form of ossification or osteogenesis by comparison with the prior art.
It is regarded as advantageous if the granulate provided in the molded part or the composition
is selected from a basic material selected from the group consisting of aragonite, seashell,
allogenic bone material, autogenic bone material, xenogenic bone material, FDBA (freeze-
dried bone allografts), DFBDA (decalcified freeze-dried bone allografts), algae or algae
extract, ceramic, calcium phosphate, in particular tri- or tetracalcium phosphate, α- or ß-
tricalcium phosphate, hydroxylapatite, calcium phosphate ceramic, bioglass, bone
replacement material based on aragonite (z.B. BioCoral ®) or mixtures thereof.
In particular, it is conceivable to produce the granulate from donor bone. Granulate which is
produced from bone from bone banks is also covered by the invention.
The invention also regards the use of FDBA (freeze dried bone allografts) or DFDBA
(decalcified freeze dried bone allografts) as advantageous. The bone growth can proceed
optimally due to the formation of the granulate from a material taken from a genetically different
individual of the same species. The probability of inflammatory reactions is advantageously
reduced. The use of xenogenic materials for production of the granulate also proves
advantageous.
For the production of granules which are suitable for humans, bones of cattle, pigs and horses
are particularly suitable. It is also possible and is covered by the invention that the granulate
is formed from algae, in particular algae extracts, corals or mussels. The shells of mussels
prove particularly suitable for the production of the granules, since they consist of a
calcium/protein mixture, more precisely aragonite, and therefore can be reabsorbed
particularly well by the body.
In addition, it is also possible to produce the granulate from autogenic material, i.e. material
provided by the patient itself. For this purpose, first of all bone material is taken from the
patient, is processed to form a granulate and is prepared for use in the molded part according
to the invention, which is inserted or implanted into the patient in the context of further
treatment. In this case the probability of the occurrence of inflammatory reactions in the
patient's body is minimal.
Furthermore, it is possible to use alloplastic materials such as calcium phosphates, ceramics
or bioglasses for the production of the granulate.
The basic material of the granulate preferably consists of: aragonite in combination with
between 0 and 50%, in particular between 15 and 35%, preferably 25% bone material, in
particular allogenic or autogenic bone material. The use of xenogenic bone material or one or
more of the other above-mentioned materials is likewise possible and covered by the
invention. Combinations or mixtures of different materials and use thereof in combination with
aragonite are also covered.
It is advantageous if the basic material of the granulate is only formed of bone material, in
particular allogenic, autogenic and/or xenogenic bone material.
The granulate preferably has a particle size of between 1 and 3 mm, in particular between 1.1
and 2 mm, preferably 1.5 mm. These particle size or particle size ranges prove optimal from
the point of view of reabsorption. By a choice of the grain size adapted to the particular patient
or intended use the duration and speed of reabsorption can be defined and thus the success
of the treatment can be further improved. In addition to the particle size the porosity of the
granulate material is also a criterion to which attention should be paid. A large number of pores
or porous bodies in the granulate or on the granulate surface can substantially enlarge the
surface available for the growth of blood vessels or osteoblasts and the osteoblast growth can
be improved as a result. The porosity of the granulate material results on the one hand from
the material itself or on the other hand can be set in a defined range by suitable pre-treatment
of the granulate or granulate starting material, or by an acid treatment or similar.
It proves advantageous if a sealing material is provided between the molded part and the bone
base in order to prevent the growth of blood vessels or the penetration into the molded part of
substances or microorganisms which damage the bone growth. In this case the sealing
material is formed in particular from collagen, preferably collagen type 1 or type 3 or a mixture
of collagen type 1 and collagen type 3 and/or hyaluronic acid or hyaluronic acid derivative.
In a further embodiment of the invention which is regarded as advantageous it is provided that
the composition forming the molded part contains at least one further substance. This is
preferably selected from the group consisting of statins, vitamins, trace elements, antibiotics
or mixtures thereof. Whilst vitamins and trace elements serve to supply the newly formed cells,
statins or statin preparations facilitate the immunomodulation and thus reduce the tendency
to inflammation. Antibiotics serve to control or prevent bacterial infections on or in the bone
base. The invention is not limited to the aforementioned substances, but includes all
substances and mixtures of substances which are familiar to the person skilled in the art and
can be used in the context of the present invention.
In this connection, it has proved advantageous if the at least one further substance constitutes
between 0.1 and 3%, in particular between 0.2 and 1.5%, preferably 0.25% of the composition.
According to the invention the molded part in the basic configuration is formed from the
structuring material as defined above and the granulate which is likewise pre-defined. In this
connection, it is regarded as advantageous if a ratio of structuring material to granulate of
between 1:1 and 1:4 is provided in the molded part. A molded part which is formed from 1 part
of the structuring material and 2 parts of granulate is regarded as particularly advantageous.
Depending upon the intended use and the conditions at the site at which new bone is to be
formed, the aforementioned ratios can of course also be set differently. The water required for
the production of the moldable compound from the composition, preferably distilled and
sterilized water, remains unconsidered.
Surprisingly it has been shown that a ratio of structuring material to granulate of 1:2 has proved
the most successful, if it was a question of allowing a sufficiently stable bone material to grow.
In addition to the structure provided by the molded part configured in this way for the bone
growth or the ossification, a corresponding ratio of structuring material and granulate also
ensures a temporally defined reabsorption.
The biocompatible molded part is preferably block-shaped or cuboid. In this case,
understandably, there is also the possibility of forming the molded part so that it is adapted in
shape to a recess in the bone, in particular the jaw bone or jaw bone portion. If a standardized
molded part is made available, before it is placed on the bone this part can be adapted in its
shape, that is to say in particular in its height, width and length. Thus, it is ensured that a
molded part is provided which is adapted to the conditions in the patient. A further advantage
is that production of a molded part having a uniform shape can be standardized and therefore
cost-effective.
It is regarded as advantageous if the molded part which is block-shaped or cuboid or is
adapted in its shape to a recess in the bone, in particular a jaw bone or jaw bone portion, has
edges with an edge length of between 1 and 5 cm in each case. It is regarded as advantageous
if the edge length is between 1.5 and 3 cm. Such a standardized molded part 1 preferably has
a maximum width of 1.5 cm, a maximum height of 3 cm and a maximum height likewise of 1.5
cm. The corresponding edge lengths and the resulting size and the volume of the molded part
ensure that a complete blood vessels can flow completely through it and a sufficiently stable
osteogenesis can take place. Simultaneously a complete reabsorption of the molded part in
the course of the healing process is achieved.
In a further embodiment of the biocompatible molded part according to the invention it is
regarded as advantageous if this molded part has at least one bore. This bore serves for the
passage of a fastening means, in particular a screw, which is used for fastening of the molded
part on the bone. In this case the bore or the bores are already introduced into the molded
part during production, i.e. modelling, of the molded part. Alternatively, there is obviously also
the possibility that these bores are introduced retrospectively into the molded part using
suitable tools. A previously defined or individually adapted arrangement, which is adapted to
the later arrangement points of the molded part on the bone, can also be provided in the
molded part.
A composition for production of the biocompatible molded part is of equal inventive
significance. This comprises or consists of a structuring material and a granulate. Structuring
material and granulate are mixed in defined ratios in order, after addition of water, to form a
molded part from this, in particular according to the present invention.
The structuring material is preferably selected from the group consisting of impression plaster,
plaster of Paris, hard plaster, super-hard plaster, glass ionomer cement, carboxylate cement
or mixtures thereof. All the aforementioned materials can be completely reabsorbed and are
known from their use in the field of orthopedic jaw surgery and implant medicine known and
are suitable for use. Plaster of Paris is preferably used which, in addition to a corresponding
reabsorbability, ensures a sufficient stability of the molded part or solid body. The term "plaster
of Paris" is well known from dentistry. With regard to its hardness, plaster of Paris is between
the impression plaster which is likewise used in the dental field and a hard plaster. After
production of the molded part, this plaster can be further processed and thus allows an
adaptation of the solid body to the conditions in the jaw with simple tools.
It is regarded as advantageous if the granulate is selected from a basic material selected from
the group consisting of aragonite, seashell, allogenic bone material, autogenic bone material,
xenogenic bone material, FDBA (freeze-dried bone allografts), DFBDA (decalcified freeze-
dried bone allografts), algae or algae extract, ceramic, calcium phosphate, in particular tri- or
tetracalcium phosphate, α- or ß-tricalcium phosphate, hydroxylapatite, calcium phosphate
ceramic, bioglass, bone replacement material based on aragonite (z.B. BioCoral ®) or
mixtures thereof.
In particular, it is conceivable to produce the granulate from donor bone. Granulate which is
produced from bone from bone banks is likewise covered by the invention.
The invention also regards the use of FDBA (freeze dried bone allografts) or DFDBA
(decalcified freeze dried bone allografts) as advantageous. The bone growth can proceed
optimally due to the formation of the granulate from a material taken from a genetically different
individual of the same species. The probability of inflammatory reactions is advantageously
reduced. The use of xenogenic materials for production of the granulate also proves
advantageous.
For the production of granules which are suitable for humans, bones of cattle, pigs and horses
are particularly suitable. It is also possible and is covered by the invention that the granulate
is produced from algae, in particular algae extracts, corals or mussels. The shells of mussels
prove particularly suitable for the production of the granules, since they consist of a
calcium/protein mixture, more precisely aragonite, and therefore can be reabsorbed
particularly well by the body.
In addition, it is also possible to produce the granulate from autogenic material, i.e. material
provided by the patient itself. For this purpose, first of all bone material is taken from the
patient, is processed to form a granulate and is prepared for use in the molded part according
to the invention, which is inserted or implanted into the patient in the context of further
treatment. In this case the probability of the occurrence of inflammatory reactions in the
patient's body is minimal.
Furthermore, it is possible to use alloplastic materials such as calcium phosphates, ceramics
or bioglasses for the production of the granulate.
The granulate preferably has a particle size of between 1 and 3 mm, in particular between 1.1
and 2 mm, preferably 1.5 mm. These particle size or particle size ranges prove optimal from
the point of view of reabsorption. By a choice of the grain size adapted to the particular patient
or intended use the duration and speed of reabsorption can be defined and thus the success
of the treatment can be further improved. In addition to the particle size the porosity of the
granulate material is also a criterion to which attention should be paid. A large number of pores
or porous bodies in the granulate or on the granulate surface can substantially enlarge the
surface available for the growth of blood vessels or osteoblasts and the growth thereof can be
improved as a result. The porosity of the granulate material results on the one hand from the
material itself or on the other hand can be set in a defined range by suitable pre-treatment of
the granulate or granulate starting material, or by an acid treatment or similar.
In a further embodiment of the invention which is regarded as advantageous it is provided that
the composition contains at least one further substance. This is preferably selected from the
group consisting of statins, vitamins, trace elements, antibiotics or mixtures thereof. Whilst
vitamins and trace elements serve to supply the newly formed cells, statins or statin
preparations facilitate the immunomodulation and reduce the tendency to inflammation.
Antibiotics serve to control or prevent bacterial infections on or in the bone base. The invention
is not limited to the aforementioned substances, but includes all substances and mixtures of
substances which are familiar to the person skilled in the art and can be used in the context
of the present invention.
In this connection, it has proved advantageous if the at least one further substance constitutes
between 0.1 and 3%, in particular between 0.2 and 1.5%, preferably 0.25% of the composition.
The granulate or the basic material preferably has a sheathing layer made of at least one
collagen, hyaluronic acid and/or hyaluronic acid derivative or mixtures thereof.
Further advantages are provided by the coating of the granulate or basic material. Thus, blood
is absorbed from the patient, so that body cells are available at every site within and on the
molded part. The growth of the blood vessels growing into the molded part is likewise
promoted, since these blood vessels are crucial for the permanent supply of nutrients to the
osteoblasts. New bone material can only form if there is a sufficient supply of nutrients.
Hyaluronic acid (or hyaluronic acid derivatives), which can likewise be used in the context of
the present invention, has an advantageous effect on the treatment of pathological changes
of the periodontium and shows positive effects on fibroblasts, bone regeneration and wound
healing. In the context of the present invention hyaluronic acid (or derivatives thereof) is
applied directly to the granulate. In this case the hyaluronic acid has different functions. The
basic operating principle of the hyaluronic acid in the context of the present invention provides
that in an aqueous environment a three-dimensional mesh network is produced following a
spontaneous aggregation of the hyaluronic acid chains. Cellular and fibrous components can
be embedded in this network. This favors and promotes the formation of a bone structure. At
the same time, hyaluronic acid has a regulating function in the organization of the extracellular
matrix and its components. In this case the hyaluronic acid network which is formed is a
prerequisite for the exchange of substances and serves simultaneously as a barrier against
the penetration of extraneous substances. Due to the formation of the networks and the
condensation thereof cells can be protected against degradation processes and hydroxyl
radicals. The hyaluronic acid sheaths thus provided serve different cell types as protection
against external, for example viral or bacterial, influences and thus also favors the probability
of survival of the osteoblasts.
Moreover, negatively charged hyaluronic acid has the ability to bind enormous quantities of
water and different plasma proteins by means of hydrogen bonds and the polar ends and thus
functions as a type of "osmotic buffer" of the extracellular matrix. Hyaluronic acid also proves
advantageous in controlling centers of chronic inflammation and has an anti-inflammatory
potential. Hyaluronic acid also influences cellular growth factors and thus has a positive
influence on cellular growth processes and thus supports the tissue regeneration. These
numerous advantages are used in connection with the present invention. Surprisingly, it has
been shown that the regeneration of the bone or bone material can be significantly improved.
Thus, a form of ossification or osteogenesis which is clearly superior by comparison with the
prior art is effected, which is produced inter alia from the composition according to the
invention and the hyaluronic acid contained or released in combination with the other
components.
According to the invention the composition is formed from the structuring material as defined
above and the granulate which is likewise pre-defined. In this connection, it is regarded as
advantageous if a ratio of structuring material to granulate of between 1:1 and 1:4 is provided
in the composition. A composition is regarded as particularly advantageous which is formed
from one part of structuring material and two parts of granulate. Depending upon the intended
use the aforementioned ratios can of course also be reversed or modified are available.
Surprisingly, however, it has been shown that a ratio of structuring material to granulate in the
composition of 1:2 has proved the most successful. The reabsorption of the material can be
controlled by means of the defined ratio of structuring material to granulate.
Overall, however, all the components of the composition are reabsorbable by the human or
animal body.
The basic material of the granulate which can be used in the composition consists of aragonite
in combination with between 0 and 50%, in particular between 15 and 35%, preferably 25%
bone material, in particular allogenic or autogenic bone material. The use of xenogenic bone
material or one or more of the other above-mentioned materials is likewise possible and
covered by the invention. Combinations of different materials and use thereof in combination
with aragonite are also covered.
The invention also comprises a method for producing a biocompatible molded part. In this
case the method comprises the following steps:
(i) producing a moldable modeling material by mixing the composition as previously
defined. For this purpose, water, preferably distilled and sterile water, is used.
(ii) modeling the molded part as a block-shaped or cuboid molded part and
(iii) drying the molded part.
In this case the molded part is preferably produced as a standardized part and thus is
particularly suitable for mass production. The molded part produced in the method can be
adapted in use to the respective conditions in the patient's jaw bone.
The drying takes place at room temperature or in a special drying oven at an elevated
temperature. In one embodiment of the invention burning of the molded part is provided.
The shrinking of the molded part in the course of drying is taken into account as an oversize
allowance during the production/modeling.
Optionally or alternatively the method can also comprise the following steps:
(ia) determining a form of a bone structure, in particular the shape of the jaw bone or
jaw bone portion in or on which the molded part is to be introduced, and
(iia) modelling the molded part with reference to the determined form. In this case the
shape of the jaw bone or jaw bone portion in or on which the molded part is to be
introduced is deduced, for example, from an X-ray image.
Before insertion, the molded part is already adapted to the respective defective sites or
produced in coordination therewith. Thus, subsequent processing of the finished molded part
is circumvented and a precisely fitting molded part is provided.
In order to further improve the adaptation of the molded part, the optional creation of a negative
model of the bone structure can be carried out beforehand.
In order to prevent the growth of germs and thus avoid inflammation, or in order to prevent the
bacterial count, it is regarded as advantageous if the method further comprises the step (iv)
of sterilizing the molded part, in particular by irradiation with gamma radiation. Naturally, heat
sterilization is also possible.
The production of the molded part is substantially simplified by the use of a mold, preferably
a silicone mold, for the modeling. This mold can be produced and made available in different
sizes. During the production, the mold is filled with the modeling material produced from the
composition according to the invention using water. After removal of the mold the molded parts
are dried, optionally processed (smoothing, drilling, milling, chamfering, etc.), subsequently
sterilized and then packaged.
In order to enable fastening of the molded part on the jaw or jaw bone, it is regarded as
advantageous to introduce at least one through bore into the molded part before or after the
drying. This/these bore(s) then serve(s) for the passage of screws by means of which the
molded part is connected to the jaw. After the formation of the bone and the reabsorption of
the molded part these screws can then be removed from the newly formed bone.
The invention also provides for use of a molded part as defined above. The molded part is
particularly suitable for use in plastic medicine or dental medicine. The use preferably takes
place according to the invention for supporting new bone formation, in particular in the jaw
bone, wherein the molded part bone stabilizes the newly forming bone and subsequently or
during the new bone formation is completely reabsorbed and replaced by newly formed bone.
In this connection, the use of the molded part for bone augmentation of an existing bone
structure is regarded as advantageous. In this case, in particular a bone augmentation of up
to approximately 1.5 cm is possible.
When the molded part is used, it is regarded as advantageous if adaptation of the length, width
and/or height of the molded part is carried out before use.
The invention also comprises a kit which comprises a plurality of molded parts as described
above. In this case the molded parts preferably have the same or different sizes and/or
shapes. Thus, in use the most suitable molded part can be selected from the kit and can be
used for the augmentation of the jaw bone. In this case the molded part which is most suitable
from the point of view of size and shape can be selected and then an adaptation of the length,
width and/or height of the molded part can be carried out before the part is used. The reworking
of the prefabricated molded part then takes place using conventional tools. The size can be
adapted by simple abrasion of excess material. The kit according to the invention enables the
user to select the most suitable molded part, so that the need for adaptation is only very low.
Example:
The advantageous ossification or osteogenesis induced by the molded part according to the
invention could be demonstrated in the animal experiment. In the animal experiment block-
shaped molded parts, designated hereafter as molded part 1 or molded part 2 were implanted
on the calvaria of three pigs.
In this case the molded parts had the following features:
molded part A:
weight: approximately 15g
composition:
2/3 plaster as structuring material
1/3 granulate according to the invention
dimensions of the molded part:
length: 2 cm
width: 1 cm
height: 1.5 cm
molded part B:
weight: approximately 15g
composition:
2/3 carboxylate cement as structuring material
1/3 granulate according to the invention
dimensions of the molded part:
length: 2 cm
width: 1 cm
height: 1.5 cm
The above-mentioned molded parts were implanted on the calvaria of three pigs. Molded
part A on the left-hand side, molded part B on the right-hand side of the respective animal.
For fastening the molded parts to the calvaria, bores were introduced into the calvaria.
These bores served for the passage of screws by means of which the molded parts were
screwed to the calvaria.
After 8 weeks, the animals were sacrificed and the implanted sites were examined
histologically.
Result:
At the sites where the molded part A was implanted the degradation of the material and the
reabsorption thereof had started. Simultaneously there was detectable bone regeneration or
new bone formation. Good healing and a vertical increase in height could be seen. In the bone
which has formed, the screws 6 are surrounded by bone material.
During the time of the experiment, at the sites where the molded part B was implanted there
was a reduction or even an absence of degradation of the material. Also, no bone regeneration
or new bone formation could be detected there. Some disorders of wound healing occurred.
Further advantages and expedient embodiments can be seen from following description of the
figures and from the drawings. In the drawings:
Figure 1 shows a schematic representation of a preferred embodiment of a molded part, and
Figure 2 shows the evaluation by computer tomography of the illustrative experiment
described above.
The molded part 1 is shown in perspective in Figure 1. At the top the molded part 1 has a
rounding 2 which is adapted to the shape of the jaw bone. The further end surfaces 3 of the
molded part 1 are at right angles with respect to one another. This results in a block-shaped
or cuboid molded part 1. This molded part 1 illustrated here as a standard element can be
adapted before use to the particular conditions in the patient's jaw. As a result, the end
surfaces 3 are correspondingly trimmed or abraded. In this case the size of the molded part 1
can also be adapted. In the embodiment illustrated in Figure 1 the molded part 1 has a length
of 3 cm, a height of 1.5 cm and a width of likewise 1.5 cm. The molded part 1 is formed from
a composition which is produced from plaster of Paris and a granulate formed from a bone
material. The composition was mixed with distilled water until a compound with a moldable
consistency was produced. Next a silicone mold was filled with the modeling material. This
silicone mold has the shape of the finished molded part 1. After removal from the mold the
molded part 1 was dried. The shrinkage of the material during drying was taken into account
in the dimensioning of the silicone mold. After sterilization and packaging the molded part 1
was available for use. Final processing of the molded part 1 takes place before it is inserted
or placed on the jaw bone. In addition, two bores 4 are provided in the molded part. Through
these bores 4 the molded part 1 can be fastened by means of bone screws to the jaw bone
(not shown). After reabsorption of the molded part 1 and conclusion of the new bone formation
the screws can be removed again from the jaw. The remaining apertures are, for example,
filled with a material which also promotes osteogenesis and subsequently ossified.
In order to prevent cells of the periosteum or cells of the gingiva from penetrating adversely
into the molded part 1, the molded part 1 can be sealed with respect to the surrounding teeth
with the aid of collagen.
In order to attach the molded part 1 to the jaw bone, first of all the upper flap of gingiva is
folded back. The surface of the jaw bone is optionally roughened in order to promote the
growth of the bone. Then the molded part 1 is applied to the corresponding location and is
fixed to the jaw bone by pins or screws. Then the flap of gingiva is folded over the molded part
1 and fixed to the outer face of the molded part 1. The periosteum then grows along the outer
face of the molded part 1, so that after some time the original jaw situation with complete jaw
bone, periosteum and gingiva is restored. A second operation for removal of the molded part
1 after new bone formation has taken place is not necessary, since the molded part 1 is
completely degraded by the body.
Blood vessels and bone cells grow into the molded part 1 and little by little they pass through
it completely. As this happens the jaw bone is successively remodeled. Overall the inserted
molded part 1 provides a structure which serves as a base or framework for the formation of
new blood vessels. Ultimately this base leads to a new bone formation if osteoblasts have a
sufficient supply of nutrients in order to form new bone material. The molded part 1 is
completely reabsorbed by the body. The entire insertion site of the molded part 1 can be
washed with a hyaluronic acid solution which favors the blood vessel growth in the first growth
phase.
Figure 2 shows the evaluation by computer tomography of the illustrative experiment
described above.
The implantation site of the molded part A 1 on the calvaria 5 of a pig can be seen and
identified on the left in Figure 2. The molded part B 1 is shown on the right in Figure 2. For
fastening the molded parts 1 to the calvaria 5, bores 4 have been introduced into the calvaria.
These bores 4 serve for the passage of screws 6 which can still be seen in the CT image and
by means of which the molded parts 1 are screwed to the calvaria 5.
Figure 2 shows the result after the experiment has been running for 8 weeks. At the site where
the molded part A 1 was implanted the degradation of the material of the molded part 1 and
the reabsorption thereof has started. Simultaneously there has been detectable bone
regeneration or new bone formation. Good healing and a vertical increase in height can be
seen. In the bone 7 which has formed the screws 6 are surrounded by bone material.
During the time of the experiment, at the sites where the molded part B 1 was implanted there
was a reduction or even an absence of degradation of the material. Also, no bone regeneration
or new bone formation could be detected there. Some disorders of wound healing occurred.
The invention comprises:
A biocompatible molded part for supporting new bone formation, in particular the reformation
of a jaw bone or a jaw bone portion in a mammal, preferably a human, wherein the molded
part is suitable to be placed on the jaw bone and is designed as a solid body.
A biocompatible molded part configured as above, wherein the molded part is formed from a
composition comprising or consisting of at least one structuring material and a granulate.
A biocompatible molded part configured as above, wherein the structuring material is selected
from the group consisting of impression plaster, plaster of Paris, hard plaster, super-hard
plaster, glass ionomer cement, carboxylate cement or mixtures thereof, preferably plaster of
Paris.
A biocompatible molded part configured as above, wherein the granulate is formed from a
basic material selected from the group consisting of: aragonite, seashell, allogenic bone
material, autogenic bone material, xenogenic bone material, FDBA (freeze-dried bone
allografts), DFBA (decalcified freeze-dried bone allografts), algae or algae extract, ceramic,
calcium phosphate, in particular tri- or tetracalcium phosphate, α- or ß-tricalcium phosphate,
hydroxylapatite, calcium phosphate ceramic, bioglass, bone replacement materials based on
aragonite (e.g. BioCoral ®) or mixtures thereof.
A biocompatible molded part configured as above, wherein the granulate has a particle size
of between 1 and 3 mm, in particular between 1.1 and 2 mm, preferably 1.5 mm.
A biocompatible molded part configured as above, wherein in the composition the structuring
material and the granulate are provided in a ratio of between 1:1 and 1:4, preferably 1:2.
A biocompatible molded part configured as above, wherein the composition contains at least
one further substance, in particular wherein the at least one further substance is selected from
the group consisting of statins, vitamins, trace elements, antibiotics hyaluronic acid, hyaluronic
acid derivatives, collagen and/or mixtures thereof, in particular wherein the at least one further
substance constitutes between 0.1 and 3%, in particular between 0.2 and 1.5%, preferably
0.25% of the composition.
A biocompatible molded part configured as above, wherein the solid body is completely
reabsorbable by the human or animal body.
A biocompatible molded part configured as above, wherein the basic material of the granulate
consists of:
- aragonite and
- 0-50%, in particular between 15 and 35%, preferably 25% bone material, in particular
allogenic or autogenic bone material.
A biocompatible molded part configured as above, wherein a sealing material is provided
between the molded part and the jaw bone or the bone base, in particular wherein the sealing
material is formed from a collagen, in particular collagen type 1 or a mixture of collagen type
1 and collagen type 3 and hyaluronic acid or hyaluronic acid-derivative.
A biocompatible molded part configured as above, wherein the molded part is substantially
block-shaped or cuboid or is adapted in shape to a recess in the bone, in particular the jaw
bone or jaw bone portion.
A biocompatible molded part configured as above, wherein the molded part is substantially
block-shaped or cuboid and is adapted in shape to a recess in the bone, in particular the jaw
bone or jaw bone portion.
A biocompatible molded part configured as before, wherein the molded part which is
substantially block-shaped or cuboid or is adapted in shape to a recess in the bone, in
particular a jaw bone or jaw bone portion, has edges with an edge length in each case of
between 1 and 5 cm, preferably between 1.5 and 3 cm.
A biocompatible molded part configured as above, wherein the molded part which is
substantially block-shaped or cuboid or is adapted in shape to a recess in the bone, in
particular the jaw bone or jaw bone portion, is provided with at least one bore for the passage
of fastening means, in particular screws.
Furthermore, the invention comprises a composition for production of a biocompatible molded
part as defined above, comprising or consisting of a structuring material and a granulate.
A composition configured as above, wherein the structuring material is selected from the group
consisting of impression plaster, plaster of Paris, hard plaster, super-hard plaster, glass
ionomer cement, carboxylate cement or mixtures thereof, preferably plaster of Paris.
A composition configured as above, wherein the granulate is formed from a basic material
selected from the group consisting of: Aragonite, seashell, allogenic bone material, autogenic
bone material, xenogenic bone material, FDBA (freeze-dried bone allografts), DFBA
(decalcified freeze-dried bone allografts), algae or algae extract, ceramic, calcium phosphate,
in particular tri- or tetracalcium phosphate, α- or ß-tricalcium phosphate, hydroxylapatite,
calcium phosphate ceramic, bioglass, bone replacement material based on aragonite (e.g.
BioCoral ®) or mixtures thereof.
A composition configured as above, wherein the granulate or the basic material preferably has
a sheathing layer made of at least one collagen, hyaluronic acid and/or hyaluronic acid
derivative or mixtures thereof.
A composition configured as above, wherein the granulate has a particle size of between 1
and 3 mm, in particular between 1.1 and 2 mm, preferably 1.5 mm.
A composition configured as above, wherein in the composition the structuring material and
the granulate are provided in a ratio of between 1:1 and 1:4, preferably 1:2.
A composition configured as above, wherein the composition contains at least one further
substance, in particular wherein the at least one further substance is selected from the group
consisting of statins, vitamins, trace elements, antibiotics or mixtures thereof, in particular
wherein the at least one further substance constitutes between 0.1 and 3%, in particular
between 0.2 and 1.5%, preferably 0.25% of the composition.
A composition configured as above, wherein a complete reabsorbability of the components by
the human or animal body is provided.
A composition configured as above, wherein the basic material of the granulate consists of:
- aragonite and
- 0-50%, in particular between 15 and 35%, preferably 25% bone material, in particular
allogenic or autogenic bone material.
The invention also comprises a method for producing a biocompatible molded part, in
particular a molded part defined as above, comprising the steps:
(iv) producing a moldable modeling material by mixing the composition as defined in claims
12 to 20 with water, preferably distilled water,
(ii) modeling the molded part as a block-shaped or cuboid molded part and
(iii) drying the molded part.
The method referred to above, alternatively comprising the steps:
(ia) determining a form of a bone structure, in particular the shape of the jaw bone or
jaw bone portion in or on which the molded part is to be introduced, and (iia) modeling
the molded part with reference to the determined form.
The method referred to above, optionally comprising the step:
(ib) creation of a negative model of the bone structure.
The method referred to above, further comprising (iv) sterilizing the molded part, in particular
by irradiation with gamma radiation.
The method referred to above, wherein the modeling of the molded part takes place using a
mold.
The method referred to above, wherein at least one through bore is introduced into the molded
part before or after the drying.
The invention also comprises a use of a biocompatible molded part as defined above, formed
from the composition referred to above and produced according to the aforementioned
method, in medicine, in particular in plastic medicine or dental medicine, preferably for
supporting a new bone formation, in particular in the jaw bone, wherein the biocompatible
molded part provides a basic structure for the new bone formation and is completely
reabsorbed in the course of new bone formation.
The aforementioned use, for bone augmentation of an existing bone structure.
The aforementioned use, wherein an adaptation of the length, width and/or height of the
molded part is provided before use.
The invention also comprises a kit comprising a plurality of molded parts as defined above.
The aforementioned kit, wherein the molded parts have the same or different sizes and/or
shapes.
The aforementioned kit, wherein an adaptation of the length, width and/or height of the molded
part is provided before use.
The claims filed now with the application and later are attempts at formulation without prejudice
for the achievement of more far-reaching protection.
If closer examination, in particular also of the relevant prior art, reveals that one or the other
feature is favorable for the object of the invention, but is not crucially important, then of course
a formulation will be sought which no longer includes such a feature, in particular in the main
claim.
It should also be noted that the configurations and variants of the invention described in the
various embodiments and illustrated in the drawings can be combined with one another in any
way. In this case individual features or a plurality of features are interchangeable with one
another in any way. These combinations of features are also disclosed.
The dependencies set out in the dependent claims refer to the further embodiment of the
subject matter of the main claim by the features of the respective subordinate claim. However,
these are not to be understood as a renunciation of the achievement of independent objective
protection for the features of the dependent subordinate claims.
In the course of the proceedings features which hitherto have only been disclosed in the
description may be claimed as of essential significance to the invention, for example for
differentiation from the prior art, claimed are being.
Features which have only been disclosed in the description or also individual features from
claims which include a plurality of features can be incorporated into claim 1 in order to
distinguish them over the prior art at any time, even when such features have been mentioned
in connection with other features or also achieve particularly favorable results in connection
with other features.
Claims (19)
1. A biocompatible molded part for supporting new bone formation, in particular the reformation of a jaw bone or a jaw bone portion in a mammal, preferably a human, wherein the molded part is suitable to be placed on the jaw bone and is designed as a solid body completely reabsorbable by the human or animal body, wherein the molded part is substantially block-shaped or cuboid or adapted in shape to a recess in the jaw bone or jaw bone portion and wherein the molded part is formed from a composition comprising or consisting of at least one structuring material and a granulate with the structuring material and the granulate provided in a ratio of between 1:1 and 1:4, preferably 1:2 and with the granulate having a particle size of between 1 and 3 mm, in particular between 1.1 and 2 mm, preferably 1.5 mm.
2. The biocompatible molded part according to claim 1, wherein the molded part is formed from a composition comprising or consisting of at least one structuring material and a granulate, wherein the structuring material is selected from the group consisting of impression plaster, plaster of Paris, hard plaster, super-hard plaster, glass ionomer cement, carboxylate cement or mixtures thereof, preferably plaster of Paris, and/or the granulate is formed from a basic material selected from the group consisting of aragonite, seashell, allogenic bone material, autogenic bone material, xenogenic bone material, FDBA (freeze-dried bone allografts), DFBA (decalcified freeze-dried bone allografts), algae or algae extract, ceramic, calcium phosphate, in particular tri- or tetracalcium phosphate, α- or ß-tricalcium phosphate, hydroxylapatite, calcium phosphate ceramic, bioglass, bone replacement material based on aragonite or mixtures thereof, in particular wherein the granulate has a particle size of between 1 and 3 mm, in particular between 1.1 and 2 mm, preferably 1.5 mm.
3. The biocompatible molded part according to one of the preceding claims, wherein the composition contains at least one further substance, in particular wherein the at least one further substance is selected from the group consisting of statins, vitamins, trace elements, antibiotics, hyaluronic acid, hyaluronic acid derivatives, collagen and/or mixtures thereof.
4. The biocompatible molded body according to claim 3, wherein the at least one further substance constitutes between 0.1 and 3%, in particular between 0.2 and 1.5%, preferably 0.25% of the composition.
5. The biocompatible molded part according to one of the preceding claims, wherein the basic material of the granulate consists of: − aragonite and − 50%, in particular between 15 and 35%, preferably 25% bone material, in particular allogenic or autogenic bone material.
6. The biocompatible molded part according to one of the preceding claims, wherein a sealing material is provided between the molded part and the jaw bone or the bone base, in particular wherein the sealing material is formed from a collagen, in particular collagen type 1 or a mixture of collagen type 1 and collagen type 3 and hyaluronic acid or hyaluronic acid-derivative.
7. The biocompatible molded part according to one of the preceding claims, wherein the molded part which is substantially block-shaped or cuboid or is adapted in shape to a recess in the bone, in particular a jaw bone or jaw bone portion, has edges with an edge length in each case of between 1 and 5 cm, preferably between 1.5 and 3 cm.
8. The biocompatible molded part according to one of the preceding claims, wherein the molded part has at least one bore for the passage of fastening means, in particular screws.
9. A composition for production of a biocompatible molded part according to one of claims 1 to 8, comprising or consisting of a structuring material and a granulate, wherein the structuring material is in particular selected from the group consisting of impression plaster, plaster of Paris, hard plaster, super-hard plaster, glass ionomer cement, carboxylate cement or mixtures thereof, preferably plaster of Paris, and/or the granulate is formed from a basic material selected from the group consisting of aragonite, seashell, allogenic bone material, autogenic bone material, xenogenic bone material, FDBA (freeze-dried bone allografts), DFBA (decalcified freeze-dried bone allografts), algae or algae extract, ceramic, calcium phosphate, in particular tri- or tetracalcium phosphate, α- or ß- tricalcium phosphate, hydroxylapatite, calcium phosphate ceramic, bioglass, bone replacement material based on aragonite or mixtures thereof, wherein the granulate or the basic material preferably has a sheathing layer made of at least one collagen, hyaluronic acid and/or hyaluronic acid derivative or mixtures thereof.
10. The composition according to claim 9, wherein in the composition the structuring material and the granulate are provided in a ratio of between 1:1 and 1:4, preferably 1:2.
11. The composition according to one of claims 9 to 10, wherein the composition contains at least one further substance, in particular wherein the at least one further substance is selected from the group consisting of statins, vitamins, trace elements, antibiotics, or mixtures thereof.
12. The composition according to claim 11, wherein the at least one further substance constitutes between 0.1 and 3%, in particular between 0.2 and 1.5%, preferably 0.25% of the composition, wherein the composition is characterized in particular by a complete reabsorbability of the components by the human or animal body.
13. The composition according to one of claims 9 to 12, wherein the basic material of the granulate consists of: - aragonite and - 0-50%, in particular between 15 and 35%, preferably 25% bone material, in particular allogenic or autogenic bone material.
14. A method for production of a biocompatible molded part, in particular a molded part according to one of claims 1 to 8, comprising the steps: (i) producing a moldable modeling material by mixing the composition as defined in claim 13 with water, preferably distilled water, (ii) modeling the molded part as a block-shaped or cuboid molded part and (iii) drying the molded part.
15. The method according to claim 14, alternatively comprising the steps: (ia) determining a form of a bone structure, in particular the shape of the jaw bone or jaw bone portion in or on which the molded part is to be introduced, and (iia) modeling the molded part with reference to the determined form, in particular optionally comprising the step: (ib) creating a negative model of the bone structure.
16. The method according to claim 14 or 15, further comprising (iv) sterilizing the molded part, in particular by irradiation with gamma radiation and/or wherein the modeling of the molded part takes place using a mold.
17. The method according to one of claims to 16, characterized in that at least one through bore is introduced into the molded part before or after the drying.
18. A kit comprising a plurality of molded parts according to one of claims 1 to 8, in particular wherein the molded parts have the same or different sizes and/or shapes.
19. The kit according to claim 18, wherein an adaptation of the length, width and/or height of the molded parts is provided before use.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102015100806.8 | 2015-01-20 | ||
| DE102015100806.8A DE102015100806A1 (en) | 2015-01-20 | 2015-01-20 | Biocompatible molding |
| PCT/EP2016/051042 WO2016116465A1 (en) | 2015-01-20 | 2016-01-19 | Biocompatible molded part |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| NZ733547A NZ733547A (en) | 2020-09-25 |
| NZ733547B2 true NZ733547B2 (en) | 2021-01-06 |
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