KR20150015073A

KR20150015073A - Membrane for dental implants and method for manufacturing thereof

Info

Publication number: KR20150015073A
Application number: KR1020130090566A
Authority: KR
Inventors: 배태성; 이민호; 박형호; 박일송; 이유리
Original assignee: 전북대학교산학협력단
Priority date: 2013-07-31
Filing date: 2013-07-31
Publication date: 2015-02-10
Also published as: WO2015016421A1; KR101509322B1

Abstract

The present invention relates to a shielding film for dental implants and a method of manufacturing the same, and more particularly, to a shielding film for dental implants and a method of manufacturing the same, And has a cell barrier property that minimizes penetration of soft tissue defect into the lower part of the shielding membrane. In addition, by giving the function of promoting bone formation to the surface of the shielding film, the bone formation is smooth and the specific surface area of the shielding film is increased, so that the function of promoting bone formation can be maximized. The present invention relates to a tea membrane for dental implants which can be continued until the bone formation is completed in the dentition, and further can shorten the recovery period after the operation and increase the success rate of the procedure.

Description

TECHNICAL FIELD [0001] The present invention relates to a shielding film for dental implants,

The present invention relates to a shielding film for dental implants and a method of manufacturing the same, and more particularly, to a shielding film for dental implants having excellent flexibility and easiness of operation, .

A tooth implant refers to placing an artificial tooth in a portion of a tooth defect or an alveolar bone of an extracted portion. Recently, as the implant is widely used in patients with periodontal disease, fixed prosthesis is increasingly used in edentulous patients. However, due to various anatomical limitations in implant placement, there are cases in which the width and length of the mandible are insufficient, or the alveolar bone is severely damaged. In order to obtain the aesthetics with the functionalities of these patients, quantitative and qualitative increase of the bone is required. In this case, as one of the methods of increasing the height and width of the bone, the bone inductive regeneration using the granular bone graft is performed have. In the application of the bone induction regeneration, a shielding membrane is used. In the application of the bone induction regeneration treatment, the shielding membrane is selectively used for regrowing cells. That is, it plays a role to induce stable bone formation by preventing other tissue cells from penetrating between the artificial bone and the alveolar bone to prevent the formation of the bone tissue.

Early research on shielding membranes for dental implants (hereinafter referred to as "shielding membranes") focused on the use of these in the treatment of alveolar bone defects, but now it has been shown that it promotes enhancement of ridge defects, improves bone healing around the implants, It is used not only to induce bone regeneration, but also to improve the results of bone grafting and to treat failed implants.

The use of shielding membranes prevents intrusion of undesirable tissue, particularly connective tissue, into areas intended for bone regeneration, thereby preventing bone formation, and the destruction of blood clots along the interface between the healing tissue and the root surface It prevents you. In addition, the shielding film allows a blood clot to be maintained downward by forming a certain space, allowing the blood clot to function as a scaffold for intracellular growth of cells and blood vessels derived from the defect base. Shielding membranes are therefore used to create an environment that maximizes natural and biological capacity for functional regeneration, to form and maintain a space filled with blood clots to prevent bacterial infections and to separate regeneration spaces from undesired tissue .

On the other hand, shielding membranes can be classified into non-resorbable barrier membranes and resorbable barrier membranes depending on biodegradability.

First, an expanded-polytetrafluorethylene (ePTFE) shielding film has been widely used as the non-absorptive shielding film since it has excellent bone inducing ability. However, the ePTFE shielding membrane often fails to secure and regenerate the regenerative space of the osseointegrated defect. Therefore, occlusion of the shielding membrane during healing is often observed, and once exposed to the oral cavity, the surgeon easily deposits plaque due to the rough surface.

Next, the absorbent shielding film is developed to complement the non-absorbable shielding membrane due to the demand for secondary surgery, and it is mainly made of collagen or polylactide / polyglycerol copolymer. Most of the absorbent shielding membrane is formed before the bone formation is completed There is a tendency that they are disintegrated, they are not robust, and thus, the function of securing and maintaining the regeneration space can not be sufficiently exhibited.

As described above, there is a problem in the case of the non-absorptive shielding film ePTFE and the absorbing shielding film. To overcome this problem, a metal shielding film, especially a titanium shielding membrane, is highlighted. The titanium shielding film is used for a secondary operation Despite the burden of having to play, it has attracted attention because it has excellent ability to secure and maintain regeneration space, physical and chemical stability due to the characteristics of the material, and excellent biocompatibility.

However, despite the above advantages, there is a problem that the titanium is not bent properly according to the shape of the treatment part due to the high rigidity of the titanium, which is twisted and wrinkled when bent according to the shape of the curved bone defect.

Currently commercially available titanium mesh has holes of varying sizes ranging from 0.4 to 2 mm in perforated pore sizes. The soft tissue grows about 6 times faster than the bone, There is a problem in that the valleys are not formed completely.

The Korean Utility Model Patent Application No. 2004-57226 discloses a dental shielding membrane. The shielding membrane body includes a plurality of incisions at regular intervals in the shielding membrane body so that the shielding membrane body can be manufactured in a tunnel shape, Respectively. However, there is a problem in that the shielding film requires a separate process of incisional cutting, which complicates the manufacturing process and raises the manufacturing cost. In addition, it is difficult to perform the precise operation due to the modification of the incisional portion during or after the procedure, There is a problem that it is difficult to maintain the shape.

Further, since the shielding film uses a conventional titanium shielding film, there is a problem that penetration into the lower portion of the shielding film of the soft tissue can not be prevented because the diameter of the penetration is large.

SUMMARY OF THE INVENTION The present invention has been conceived to solve the problems as described above, and it is an object of the present invention to provide a medical treatment device which has excellent flexibility and easiness of operation without bending and twisting at the time of bending according to the shape of a treatment part, Thereby minimizing the penetration of the shielding film.

A second problem to be solved by the present invention is to significantly increase the specific surface area of the shielding membrane and to continue the function of promoting osteogenesis until the bone formation of the alveolar bone is completed in order to maximize the bone formation promoting function, .

A third problem to be solved by the present invention is to provide a shielding film which is provided with a function of promoting bone formation in order to shorten the recovery period after implantation and increase the success rate of the procedure by providing tissue regenerating ability to bone defect portions of alveolar bone .

In order to solve the above-described first problem,

A shield for a dental implant comprising a plurality of perforations, wherein an average diameter of the perforations is 0.2 mm or less, and a perforation having a diameter of 0.2 mm or less in total perforations is 95% or more.

According to a preferred embodiment of the present invention, the shielding film is made of any one of titanium and titanium alloys, the total area of the perforations including perforations corresponding to 5 to 20% Shielding film.

In order to solve the above-mentioned second problem,

According to another preferred embodiment of the present invention, the shielding film may include a plurality of protruding nanotubes having an average length of 500 to 2000 nm and an average diameter of 50 to 150 nm in a single natto tube on at least one side .

In order to solve the third problem described above,

According to another preferred embodiment of the present invention, the shielding film may be filled with the bone formation promoting material including phosphate to promote bone formation, both inside and outside the nanotube.

Further, in order to solve the above-mentioned problems,

(1) forming a plurality of perforations having an average diameter of not more than 0.2 mm in the shielding film and not less than 95% of the perforations having a diameter of not more than 0.2 mm in the entire perforations, .

According to a preferred embodiment of the present invention, the step (1) may be performed by any one of laser beam processing, chemical etching processing, discharge processing, and press processing.

According to another preferred embodiment of the present invention, the step (1) may include the step of forming the protruded nanotubes on the surface of the shielding film by oxidizing the shielding film in the step (2).

According to another preferred embodiment of the present invention, the step (3) may include filling the shielding film having the nanotubes formed therein with an osteogenesis promoter.

According to another preferred embodiment of the present invention, in the step (3), the bone formation promoting agent may be filled with the bone formation promoter of 0.01 M to 0.1 M over a period of 2 to 600 seconds over 11 to 100 times.

The present invention also provides a shielding film for a tooth implant manufactured by the above method in order to solve the above-mentioned problems.

The shielding film for a dental implant according to the present invention has excellent flexibility by allowing the shielding film to bend well without being distorted as compared with a shielding film for a conventional dental implant. In this way, the site can be easily shielded without being wrinkled with respect to the curved bone defect, thus facilitating the operation. Furthermore, by having a diameter smaller than the diameter of the perforation of the conventional implant shielding film, infiltration of the soft tissue into the lower portion of the shielding film can be minimized.

Secondly, the specific surface area of the shielding film is increased to enhance the added bone formation promoting function and the osteogenesis promoting function can be continued until the bone formation is completed in the alveolar bone.

Third, by forming a material containing bone components in the shielding film so as to minimize the problem of bone regeneration and prolonging the bone regeneration time, bioactivity can be added to effectively form bone to the bone defect.

1 is a schematic plan view of a shielding film according to a preferred embodiment of the present invention.
2 is a photograph showing a shielding film according to a preferred embodiment of the present invention bent according to the shape of the mandible.
3 is a photograph showing a shielding film which is not perforated bent according to the shape of the mandible.
Fig. 4 is a photograph showing a shielding film which is not punctured in the maxillary bone.
5 is a SEM photograph of a carbon film according to a preferred embodiment of the present invention.
And 6 are SEM photographs of the carbapenes according to a preferred embodiment of the present invention.
7 is a perspective view illustrating a shielding film according to a preferred embodiment of the present invention.
8 is a SEM photograph of a shielding film according to a preferred embodiment of the present invention.
9 is a SEM photograph of a cross section of a shielding film according to a preferred embodiment of the present invention.
10 is a SEM photograph of a cross section of a nanotube included in a shielding film according to a preferred embodiment of the present invention.
11 is a cross-sectional view schematically showing a shielding film filled with a bone forming layer.
12 is a SEM photograph of a shielding film according to a preferred embodiment and a comparative example of the present invention.
13 is a SEM photograph of a cross section of a shielding film according to a preferred embodiment and a comparative example of the present invention.
FIG. 14 is a SEM photograph of a shielding film surface obtained by immersing a shielding film according to one preferred embodiment of the present invention and a comparative example for 1 day in a simulated body fluid.

BRIEF DESCRIPTION OF THE DRAWINGS The invention will be described in more detail with reference to the accompanying drawings.

As described above, in the case of a shielding film for a tooth whitening plate using a metal material such as titanium, if it is bent in accordance with the shape of a curved bone defect due to its rigidity, it is twisted and wrinkled, . In addition, since the soft tissue grows about 6 times faster than the bone tissue, the tissue grows below the shielding membrane and the bone can not be completely formed.

Accordingly, the present invention provides a shield for a dental implant comprising a plurality of perforations, wherein an average diameter of the perforations is 0.2 mm or less, and a perforation having a diameter of 0.2 mm or less in total perforations is 95% or more And solved the above-mentioned problem. Thus, it is possible to easily block the portion according to the shape of the treatment portion without changing the shape unintentionally during the operation. In addition, it is possible to minimize the inflow of soft tissue to the lower part of the shielding membrane and to make space for regenerating the bone, thereby allowing the bone to be smoothly regenerated to the alveolar bone defect.

1 is a plan view of a shielding film according to a preferred embodiment of the present invention. A plurality of perforations 101, 102, 103, and 104 are formed in the shielding film 100 to induce osteogenesis in the alveolar bone deficient area by facilitating the supply of extracellular fluid such as blood to the lower portion of the shielding membrane.

The perforations formed in the conventional shielding film have been manufactured such that the diameter of the perforations is made as large as 0.4 to 2 mm in order to supply the blood, lymphatic fluid, etc. and to adhere the tissues. In this case, bending or the like may be easy, There was a fatal problem that the cells could penetrate into the bone graft site and the soft tissue was formed at the site where the bone was to be formed and the implant procedure could fail.

In one embodiment of the present invention, the average diameter of the perforations is set to 0.2 mm or less in consideration of the size of the cells constituting the soft tissue, and the perforation having a diameter of 0.2 mm or less is made to be 95% The penetration into the lower portion of the shielding membrane is minimized while solving the above-mentioned problems.

If the average diameter of the perforations exceeds 0.2 mm, it may be easy to bend, but the soft tissue may excessively penetrate into the lower part of the shield to inhibit bone formation. When the function of promoting osteogenesis is provided on the surface of the shield, There is a problem that the effect of promoting bone formation is lowered.

In the shielding film, perforations satisfying a diameter of 0.2 mm or less may be included in the total perforations of 95% or more, preferably 98% or more, and more preferably 100% or more. As a result, penetration of the soft tissue into the lower portion of the shielding film can be minimized, and bending of the shielding film can be facilitated and wrinkling can be minimized. If the pore size of less than 0.2 mm is less than 95% of the total perforations, the soft tissue may penetrate the lower portion of the shield membrane excessively, When the osteogenesis promoting function is given, the effect of promoting osteogenesis may be deteriorated due to the reduction of the surface area. However, if the size of the perforation is too small to attach the epithelial cells, the upper valve may be thinned or the shield may be exposed to the oral cavity, so that the average diameter of the perforations may be 0.01 mm or more.

If a non-porous film is used, it is possible to prevent penetration into the lower portion of the shielding film of the soft tissue, but it is not easy to bend, and it is wrinkled when bent.

More specifically, FIG. 2 is a photograph in which the shielding membrane according to a preferred embodiment of the present invention is bent according to the shape of the mandible, FIG. 3 is a photograph of the shielding film that is not perforated bent according to the shape of the mandible, FIG. In FIG. 2, no wrinkles were observed at the time of bending in FIG. 2, but in FIG. 3, it can be seen that the wrinkles were severely caused by not being perforated. FIGS. 2 and 3 show that the wrinkles due to the bending may become worse depending on the position of the bending of the mandible or the position of the implant during the actual implant procedure. As shown in FIG. 4 of the actual implant operation photograph, .

The size of the shielding film 100 may be a conventional shielding film size, and may preferably be 25 to 40 mm in width (a in Fig. 1) and 35 to 60 mm in length (b in Fig. 1). However, the present invention is not limited to the above description and may vary depending on the size of a site to be treated.

The shielding film 100 may include perforations having a total area of 5 to 20% of the area of the shielding film. In this case, the average number of perforations per unit area (1 cm 2) may be 4 to 8. If the total area of the perforation is less than 5% of the surface area of the shielding membrane, the blood or body fluids can not be smoothly moved, and the tissue adherence is deteriorated, and deformation such as wrinkling may occur during the bending process. On the other hand, %, The specific surface area may be decreased and the bioactivity may be lowered during the surface treatment. The thickness of the shielding film may be a thickness of a conventional shielding film, and preferably, the thickness may be 50 to 200 占 퐉, but the present invention is not limited thereto.

The distance between the perforations of the shielding film may preferably be 200 to 600 mu m. 5 and 6 are SEM photographs of a carbon film according to a preferred embodiment of the present invention, wherein the distance between the perforations of the shielding film subjected to the SEM photograph of FIG. 5 is 532 to 548 μm and the diameter of the perforation is as shown in FIG. 6 172 μm.

In addition, in the case of the shielding film material of the present invention, molybdenum (Mo) is used as an alloy for casting, molybdenum (Mo) and nickel (molybdenum) are used for a forging alloy, and titanium, titanium alloy, stainless steel, cobalt- (Which may further include an alloy of Ni and Ni), niobium, tantal, zirconium, and platinum (Pt). Preferably, the titanium alloy may be titanium or a titanium alloy, and the titanium alloy may include at least one of niobium and tantalum. The above metals are excellent in corrosion resistance because they do not cause side effects by reacting with living tissues in the human body. Titanium or titanium alloys are lightweight, ductile and have excellent strength. However, the material of the shielding film is not limited to the above-mentioned metal insofar as it has no adverse effects in the human body and is excellent in securing and maintaining the space.

According to another preferred embodiment of the present invention, in order to increase the specific surface area of the shielding film and to allow the bone formation promoting function, which will be described below, to continue until the bone formation of the alveolar bone is completed, the shielding film has a plurality of projections Gt; nanotubes < / RTI >

As a result, the osteogenesis promoter described below can be filled more than when the shielding film is coated on the shielding film, and the osteogenesis promoter is coated on the shielding film that has not been treated since the osteogenesis promoter is filled in the nanotube The osteogenesis promoter can be eluted for a long time in body fluids. The nanotubes may be formed through an oxidation treatment, but the present invention is not limited thereto.

FIG. 7 is a perspective view illustrating a shielding film according to another embodiment of the present invention. The shielding film 200 may include a plurality of nanotubes 201 and 202 on at least one surface thereof.

Preferably, the average length (g) of the nanotubes may be 500 to 2000 nm. If the length of the nanotubes exceeds 2000 nm, the nanotubes may be damaged during the procedure. If the length is less than 500 nm, the amount of the bone formation promoter filled in the nanotubes is small, There is a problem that can become.

In addition, preferably, the average diameter h of the outer diameter of the nanotubes may be 50 to 150 nm. If the average diameter (h, i) of the outer diameter and the inner diameter of the nanotube is large, it may be advantageous to fill the bone formation promoting layer, but it may be difficult to produce nanotubes having an average diameter h of the outer diameter exceeding 150 nm, When the average diameter (h) of the outer diameter of the nanotube is 50 nm, it is difficult to induce penetration and binding of a substance promoting bone formation.

8 is a SEM photograph of a shielding film according to a preferred embodiment of the present invention. The shielding film to be subjected to the SEM photograph was prepared by using a glycerol solution containing 20 wt% of water and 1 wt% of NH4F as an electrolyte solution, using a titanium shielding film as a cathode and a platinum plate as a cathode, applying a voltage of 20 V, a current density of 20 mA / Cm < 2 > for 60 minutes. As can be seen from Fig. 8, the diameter of the produced nanotubes was 74.3 to 156.4 nm.

9 and 10 are SEM photographs of cross-sections of a shielding film according to a preferred embodiment of the present invention. As shown in FIG. 9, the average length of the formed nanotubes was 763.3 nm. As shown in FIG. 10, the inside of the nanotube is empty, and the bone formation promoting layer described below can penetrate into the inside of the nanotube.

According to a preferred embodiment of the present invention, an osteogenesis promoter can be filled inside and outside of the nanotube to promote bone formation in the bone defect-reduced dentition, thereby shortening the recovery period after implantation, .

In the case of the conventional titanium shielding film, bioactivity is not imparted, so that a long period of time is required for bone formation and a case where a sufficient amount of bone is not obtained often occurs.

In order to solve the above problems, the inventor of the present invention has filled a shielding film with a bone formation promoter. By forming a nanotube layer on the surface of the shielding film as described above, the specific surface area capable of filling the bone formation promoter can be widened, Thereby further enhancing the effect of promotion.

Specifically, Fig. 11 is a cross-sectional view schematically illustrating a shielding film filled with a bone forming layer, in which nanotubes 320 are formed on at least one surface of a shielding film 300, Facilitating layer 310 may be filled.

The inside (j) of the nanotube formed on the surface of the shielding film means the hollow of the nanotube, and the outside (k) means the space between the nanotubes on which the shielding film is etched to form the nanotube and the protruded nanotube upper part . Since the inside of the nanotube 320, the etched portion between the nanotubes, and the top of the nanotube are filled with the bone formation promoter 310, a larger amount of the bone formation facilitating layer can be filled than a shielding film that has not undergone any treatment The dislocation of the facilitated layer can be minimized after the implant procedure. In addition, by filling the bone formation promoting layer, it is possible to eliminate problems such as difficulty in nutrition supply due to reduction of blood supply to the upper and lower portions of the shielding membrane, and difficulty in bone regeneration or prolonged regeneration time, can do.

The bone formation promoter may include phosphates and calcium ions as main components of the bone, and the thickness of the bone formation promoter 310 to be filled may be 10 to 1500 nm, but the present invention is not limited thereto.

The shielding film of the present invention can be manufactured through the following process.

In step (1), a step of forming a plurality of perforations having an average diameter of the perforations of 0.2 mm or less in the shielding film and a perforation having a diameter of 0.2 mm or less in total perforations of 95% or more.

The material of the shielding film in the step (1), the average diameter of the perforations and the like are as described above, and the perforation is formed through any one of laser beam processing, chemical etching processing, . Preferably, laser beam machining is also applicable to a variety of biocompatible metals or alloys thereof, and is excellent in that it can be drilled quickly and accurately to a desired diameter.

In the next step (2), at least one surface of the shielding film having been subjected to the step (1) may be oxidized to form a protruded nanotube on the surface of the carbon film. Preferably, the oxidation may be anodic oxidation. The anodization is advantageous in that nanotube formation is simpler than other methods and the manufacturing time is shortened.

Hereinafter, the anodic oxidation will be described in detail.

First, the electrolyte solution used for the anodic oxidation is one or more of glycerol, ammonium fluoride (NH ₄ F) acid ammonium fluoride (NH ₄ HF ₂ ), sodium fluoride (NaF) and water (H ₂ O) . Preferably glycerol (glycerol), ammonium fluoride (NH ₄ F), water (H ₂ O) the may include, more preferably, ammonium fluoride, based on 100 parts by weight of glycerol than (NH ₄ F) of 0.3 to 2 (H ₂ O) may be mixed in an amount of 5 to 30 parts by weight. If the mixing amount of ammonium fluoride (NH ₄ F) is less than 0.3 parts by weight or more than 2 parts by weight, the formed nanotube structure may become incomplete. If the amount of water (H ₂ O) is less than 5 parts by weight, the diameter of the nanotubes may be excessively reduced. If the amount of water is more than 30 parts by weight, the length of the nanotubes may be too long, There is a problem that can happen.

Next, the electrode may be a shielding film according to the present invention as an anode electrode, and one of platinum, tungsten and silver as a cathode electrode may be a cathode electrode. In the case of the cathode electrode, the present invention is not limited to the above description, and the cathode electrode is not limited in its use as long as it is a cathode electrode used for ordinary anodization. The electrode spacing can be between 10 and 50 mm, preferably between 20 and 30 mm, and the voltage can be between 10 and 50 volts. The reaction time may be 10 to 180 minutes, preferably 30 to 60 minutes, to form protruded nanotubes on the anode shielding film.

Further, in order to smoothly form and improve the structure of the nanotubes, the shielding film can be rotated or moved left or right during the oxidation process.

In step (3), the shielding film having the nanotubes formed therein may be filled with an osteogenesis promoter. There is no limitation on the filling method of the bone formation promoter, and it may be dip coating.

Specifically, the immersion coating will be described below.

First, the immersion liquid may be a solution containing phosphate ions as a bone formation promoter and a solution capable of precipitating the phosphate ions. The solution containing the phosphate ions is preferably sodium hydrogen phosphate (NaH ₂ PO ₄ ), sodium phosphate (Na ₂ HPO ₄ ), ammonium dihydrogen phosphate (NH ₄ H ₂ PO ₄ ), diammonium Phosphate ((NH ₄ ) ₂ HPO ₄ ). The solvent may be water. However, the present invention is not limited to the above description.

The solution capable of precipitating the phosphate ion may form a salt with the phosphate ion, and the salt is not limited as long as it is harmless to the human body. The salt may be a solution containing a divalent cation, more preferably a calcium hydroxide Ca (OH) _2, or an aqueous solution of magnesium hydroxide (Mg (OH) ₂ ). However, the present invention is not limited to the above description.

The concentration of the bone formation promoting agent may be preferably 0.01 M to 0.1 M, and more preferably, the concentration of the bone formation promoting agent may be 0.01 to 0.05 M. If the concentration is less than 0.01 M, the time required for the bone formation promoter to fill the inside and outside of the nanotube may be long and the amount to be filled may be small. If the concentration exceeds 0.1 M, the inside of the protruded nanotube There is a problem that penetration becomes difficult.

The method of immersion coating is not limited, but preferably the solution containing the bone formation promoter and the solution capable of precipitating phosphate ions can be dipped alternately with the shielding film. In this case, the time for immersing the shielding film in each solution may be preferably from 1 to 300 seconds, and if less than 1 second, the acid-base reaction with the shielding film surface does not take place effectively, Sec, the osteogenesis promoter may block the entrance of the nanotubes so that the penetration into the inside may not occur.

When the solution containing the bone formation promoting agent and the solution capable of precipitating the phosphate ions are immersed alternately in each of the shielding membranes, the bone formation promoter may be treated 11 to 100 times at a period of 2 to 600 seconds have. If the treatment time is less than 11 times, the amount of the bone formation promoter formed inside and outside the nanotube layer on the shielding film surface is small, so that the release rate and release amount of the bone formation promoting agent released after the procedure is lowered, And the time required for bone formation may be prolonged. In addition, if the treatment exceeds 100 times, there is a problem that the osteogenesis promoter is excessively formed and the osteogenesis promoter may be detached in the process of bending the shielding membrane.

12 is a SEM photograph of a shielding film according to a preferred embodiment and a comparative example of the present invention. In FIG. 12D, which is filled 40 times as compared with FIG. 12A in which an osteogenesis promoter is filled 10 times, Layer is formed.

13 is a SEM photograph of a shielding membrane section according to one preferred embodiment of the present invention and a comparative example. In FIG. 13D, which is filled 40 times compared to FIG. 13A in which an osteogenesis promoter is filled 10 times, It can be confirmed that more bone formation promoting layer is formed inside and outside the layer.

14 is a SEM photograph of a shielding film surface of a shielding film according to a preferred embodiment and a comparative example of the present invention immersed in a simulated body fluid for 1 day. In Fig. 14A, in which the osteogenic promoter was filled 10 times, it was found that there was almost no protrusion phase visible at the early stage of the release of the osteogenic promoter when the osteogenic promoter was immersed in the simulated body fluid, In FIG. 14B where the point A in FIG. 14A is enlarged, it can be seen that the nanotubes formed on the shielding film are almost exposed, and the bone formation promoter is formed instead of the whole.

On the other hand, in the case of FIG. 14E in which the bone formation promoter is filled 30 times, it is known that the protrusion phase seen at the early stage of the release of the bone formation promoter becomes very dense when the bone formation promoter is immersed in the similar body fluid, have. Also, in FIG. 14F where the point C in FIG. 14E is enlarged, it can be seen that the nanotube formed on the shielding film is hardly exposed and the bone formation promoter is formed as a whole.

Meanwhile, the present invention includes a shielding film for dental implants manufactured by the above-described manufacturing method.

The shielding film of the present invention manufactured as described above can easily bend and flexibly conform to the shape of the treatment part to easily cover the part. In addition, when the shielding film is bent, it has a constant mechanical strength, so that the shape during the operation can be maintained even after the operation. In addition, it is possible to avoid the problem that the osteogenic material produced on the surface is peeled off when the shielding film is bent, and further, the extracellular fluid such as blood can smoothly pass through the shielding film and the lower part, Can be minimized.

Further, the material of the shielding film does not cause side effects by reacting with the biotissue in the human body.

On the other hand, the nanotubes are formed on the surface of the shielding film to increase the specific surface area of the shielding film and the function of promoting bone formation can be continued until the bone formation of the dental portion is completed. The increased specific surface area of the shielding film allows the bone formation promoter to be filled more and the osteogenesis promoter is filled in the nanotube, so that the bone formation promoter can be eluted for a long time in the body fluid. In addition, the osteogenesis promoter is filled in the nanotubes to promote bone formation in the bone defect-damaged dentition, thereby shortening the recovery period after the implant treatment and contributing to improvement in the procedure success rate.

Hereinafter, the present invention will be described in more detail with reference to the following examples. However, the following examples should not be construed as limiting the scope of the present invention, and should be construed to facilitate understanding of the present invention.

< Example 1>

The average diameter of the perforation was 0.18 mm and the perforation with a diameter of 0.2 mm or less in the whole perforation was 98% by using a laser processing machine with a width of 35 mm, a length of 50 mm and a thickness of 100 μm. Was 4.97%.

< Example 2>

To form the titanium dioxide nanotube layer on the surface of the shielding film, the shielding film of Example 1 was connected to the anode of the DC electrostatic power source device, and a platinum (Pt) plate was connected to the cathode. Two electrodes were placed in an electrolyte solution (glycerol 79 wt%, ammonium fluoride 1 wt%, water 20 wt%) with an electrode interval of 20 mm and a voltage of 20 V for 60 minutes to form a titanium dioxide (TiO ₂ ) The tubes were allowed to form. NaH ₂ PO ₄ 0.02M aqueous ℃ 80 and 100 ℃ Ca (OH) ₂ was immersed for one minute in each of a saturated aqueous solution, immersing the titanium dioxide recovered through the fill process conditions to 30 times the shielding film is formed nanotubes (TiO ₂₎ nanotube To induce penetration bonding of hydroxyapatite (HAp) to produce a titanium shielding film in which hydroxyapatite is packed inside and outside the titanium dioxide nanotube

< Example 3>

The procedure of Example 2 was repeated except that the number of times of immersion was 20 times instead of 30 times,

A shielding film was produced.

< Example 4>

The procedure of Example 2 was repeated except that the number of times of immersion was changed to 40 instead of 30 times to prepare titanium

A shielding film was produced.

< Comparative Example 1>

A titanium shielding film was produced in the same manner as in Example 2, except that the number of immersions was 10 instead of 30 times.

< Experimental Example 1>

The shielding film produced according to Example 1 and the shielding film of the same material, size and thickness as those of the shielding film were bent in the shape of the lateral surface of the mandible to visually observe the wrinkling of the bent surface. 3 and Table 1, respectively.

Specifically, in the case of Example 1, there was no wrinkling of the curved surface, but severe wrinkling was observed in the case of the shielding film not perforated.

< Experimental Example 2>

The concentration of phosphoric acid (P) and calcium (Ca) on the shielding film surface was analyzed by FE-SEM EDS analysis on the titanium shielding membranes prepared in Examples 2 to 4 and Comparative Example 1. The results are shown in Table 2.

Specifically, it was confirmed that the concentration of phosphoric acid and calcium on the surface of the shielding film increases as the number of times of immersion is increased compared to Comparative Example 1 in which the immersion frequency is 10 times.

< Experimental Example 3>

The titanium shielding membranes prepared in Examples 2 and 3 and Comparative Example 1 were immersed in a simulated body fluid (SBF) for 1 day, and then SEM pictures were taken for each of the shielding membranes. The results are shown in FIG. 14 .

Specifically, in the group subjected to the immersion treatment 10 times (FIG. 14A and FIG. 14B), no significant change was observed after immersing in a simulated body fluid (SBF) for 1 day. On the other hand, in the groups subjected to the immersion treatment 20 times (FIG. 14D and FIG. 14E), the number of immersion treatments increases, Respectively.

Example 1
Unperforated shield Visual observation
result
Worse none Worse 2 3

100: Shield film
101 ~ 104: Perforation

Claims

1. A shielding film for a dental implant comprising a plurality of perforations,
Wherein the average diameter of the perforations is 0.2 mm or less, and the perforations having a diameter of 0.2 mm or less in the entire perforations are 95% or more.

The method according to claim 1,
Wherein the shielding film is made of any one of titanium and titanium alloys, wherein the total area of the perforations includes perforations corresponding to 5 to 20% of the area of the secondary membrane.

The method according to claim 1,
Wherein the shielding film comprises a plurality of protruding nanotubes having an average length of a single natto tube of 500 to 2000 nm and an average diameter of an outer diameter of 50 to 150 nm on at least one surface thereof.

The method of claim 3,
Wherein the shielding film is filled inside and outside the nanotube with an osteogenesis promoting material including phosphate to promote bone formation.

(1) forming a plurality of perforations having an average diameter of the perforations of 0.2 mm or less in the shielding film and a perforation having a diameter of 0.2 mm or less in total perforations of 95% or more.

6. The method of claim 5,
Wherein the step (1) is performed by any one of laser beam machining, chemical etching, electrical discharge machining, and press machining to form the perforations.

6. The method of claim 5, wherein after the step (1)
(2) forming the protruding nanotubes on the surface of the shielding film by oxidizing the shielding film.

8. The method of claim 7, wherein after step (2)
(3) filling the shielding film on which the nanotubes are formed with an osteogenesis promoting agent.

9. The method of claim 8,
Wherein the step osteogenesis promoter is filled with an osteogenesis promoter of 0.01 M to 0.1 M over a period of 2 to 600 seconds over a period of 11 to 100 times in the step (3).

A shield for a dental implant produced by a method according to any one of claims 5 to 9.