WO2015016421A1

WO2015016421A1 - Shielding membrane for tooth implant and method of manufacturing same

Info

Publication number: WO2015016421A1
Application number: PCT/KR2013/009104
Authority: WO
Inventors: 배태성; 이민호; 박형호; 박일송; 이유리
Original assignee: 전북대학교산학협력단
Priority date: 2013-07-31
Filing date: 2013-10-11
Publication date: 2015-02-05
Also published as: KR20150015073A; KR101509322B1

Abstract

The present invention relates to a shielding membrane for a tooth implant and a method of manufacturing the same and, more particularly, to a shielding membrane that can easily be bent without having a separate cut line so as to have good flexibility that allows a treated area to be easily shielded. Therefore, the procedure is simplified, and the blocking of cells is provided to minimize infiltration into a defective bone region of soft tissue below the shielding membrane. Also, by providing an osteogenesis accelerating function to the surface of the shielding membrane, bone is easily formed, and the specific surface area of the shielding membrane is increased so as to maximize the osteogenesis accelerating function. The ostegenesis accelerating function of the shielding membrane can continue until bone growth in the alveolar region is complete. Furthermore, the shielding membrane for a tooth implant can reduce post-procedure recovery time and increase the success rates of procedures.

Description

【Specification】

[Name of invention]

Shielding film for dental implants and manufacturing method thereof

Technical Field

The present invention relates to a shield for a dental implant and a method of manufacturing the same, more specifically, having a superior flexibility and ease of treatment, having a barrier that can greatly prevent the penetration of soft tissue into bone defects, and the manufacture of a shield for the dental implant It's about how

Background Art

Dental implants are the placement of artificial teeth in the alveolar bone at the site of a missing or extracted tooth. Recently, as implants are widely used in patients with periodontal disease, fixed prostheses are increasing in edentulous patients. However, due to various anatomical limitations when implanting implants, sufficient upper and lower mandibular width and length may not be secured or severe alveolar bone defects may be difficult to perform. In order to obtain aesthetics along with the functionality of these patients, quantitative and qualitative increase of bone is required.In this case, bone regeneration using granular bone graft material is performed as one of the ways to increase the height and width of bone. have. The membrane is used in the application of such bone induction regeneration procedure, the membrane is used for the purpose of selectively re-proliferating cells in the application of bone induction regeneration. That is, it prevents other tissue cells from penetrating between the artificial bone and the alveolar bone to prevent the formation of bone tissue, thereby inducing stable bone tissue formation.

Early studies of dental implant shields ("shields") have attracted major interest in the use of them in the treatment of alveolar bone defects, but currently promote the enhancement of alveolar defects and improve the healing of peri-implant bones. In addition to inducing complete bone regeneration, it is also used to improve bone graft outcomes and to treat failed implants.

The use of shielding membranes prevents unwanted tissues, especially connective tissues, from invading where bone regeneration is intended, thereby preventing bone formation and disrupting blood clots along the interface between the healing tissue and the root surface. Prevent it. In addition, the shielding membrane allows the blood clot to be maintained below by forming a space, and the blood clot acts as a scaffold for internal growth of cells and blood vessels derived from the bottom of the defect. Thus, the shield can maximize the natural and biological capacity for functional regeneration. It is used to create a viable environment, to form and maintain a blood-filled space, to prevent bacterial infection, and to separate the regeneration space from unwanted tissue.

<5>

Meanwhile, the barrier membrane may be classified into a non-resorbable barrier membrane and a resorbable barrier membrane according to biodegradability.

First, as the non-absorbing shielding film, an expanded-polytetraf luorethylene (ePTFE) shielding film has been widely used because of its excellent osteoinductive ability. However, it was often observed that the ePTFE barrier had a function of securing and maintaining the regeneration space of the bone defect area, and the barrier was recessed during the healing period, and once exposed in the oral cavity, plaque was easily deposited due to the rough surface of the barrier, causing infection.

Next, the absorbent shield was developed to compensate for the non-absorbent shield as the secondary surgery is required. The absorbent shield is mainly made of collagen or polylactide / polyglycerol copolymer, and most of the absorbent shield is formed of bone. Not only does it tend to be decomposed before it is completely made, but it is not robust, and thus there is a problem in that it does not fully exhibit the function of securing and maintaining a playing space.

<9>

As described above, there is a problem in the case of the non-absorbent shielding membrane ePTFE and the absorbent shielding membrane. In order to overcome this problem, a metal shielding membrane, particularly a titanium shielding membrane, has been highlighted. Despite the burden of performing secondary surgery, the remarkable ability to secure and maintain regeneration space, physical and chemical stability due to the nature of the material, and excellent biocompatibility have attracted attention due to the low inflammatory response upon exposure.

<π> However, despite the above advantages, due to the high rigidity of titanium (r igidi ty), there was a problem of being inclined and bent when bent in conformity with the shape of the curved bone defect, and thus not easily bent in conformity with the shape of the treatment part.

<12> Titanium mesh currently on the market forms perforated holes in various sizes, ranging from 0.4 to 2 mm in size, and because the soft tissue grows about 6 times faster than the bone, the mesh There was a problem that the bone is not formed completely because the tissue grows downward.

<13> Korean Utility Model Registration No. 2004-57226 discloses a dental shielding membrane, and a plurality of shielding membrane bodies are formed at regular intervals so that the shielding membrane body can be manufactured in a tunnel shape. The incision was included so that it bends well into the tunnel shape. However, the shielding film requires a separate process of making an incision, which leads to complexity of the manufacturing process and an increase in manufacturing cost.It is difficult to perform a precise procedure due to deformation of the incision portion during or after the procedure, or a precise procedure after the procedure. There is a problem that can be difficult to maintain the shape.

In addition, since the shielding film uses a conventional titanium shielding film, the diameter of the perforation is large, and thus there is a problem in that penetration of the soft tissue into the lower part of the shielding film cannot be prevented.

[Detailed Description of the Invention]

[Technical problem]

The present invention has been made to solve the above problems, the first problem to be solved of the present invention has excellent flexibility and ease of treatment by bending well without bending, etc. according to the shape of the treatment part To provide a shielding membrane to minimize penetration by blocking the penetration of the shielding membrane of the soft tissue.

The second problem to be solved of the present invention is to significantly increase the specific surface area of the shielding membrane to maximize the bone formation promoting function, which is the third problem to be solved below, and to promote bone formation until the bone formation of the alveolar bone is completed. It is to continue.

<1 7> The third problem to be solved of the present invention is to provide a tissue regeneration ability to the bone defects of the alveolar bone to shorten the recovery period after implantation and to impart a function of promoting bone formation to increase the success rate of the procedure It is to provide a shielding film.

Technical Solution

In order to solve the first problem described above,

In the shielding membrane for dental implants comprising a plurality of perforations, the average diameter of the perforations is 0.2 mm or less, and a perforation membrane having a diameter of 0.2 mm or less of the total perforations is provided in the dental implant shielding membrane.

According to a preferred embodiment of the present invention, the shielding film includes a perforation corresponding to 5 to 20% of the area of the car shielding film, and is made of any one material of titanium and titanium alloy. It may be a shield for a dental implant.

<21>

In order to solve the second problem described above,

According to another preferred embodiment of the present invention, the shielding film may include a plurality of protruding nanotubes having at least one surface of an average length of 500 nm to 2000 nm and an outer diameter of 50 nm to 150 nm. Can be. 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 promoter including phosphate to promote bone formation inside and outside the nanotubes. In addition, the present invention to solve the above problems,

(1) provides a method for producing a dental implant shielding membrane comprising the step of forming a plurality of perforations having an average diameter of 0.2 mm or less in the shielding membrane and a perforation having a diameter of 0.2 mm or less of the total perforations of 95% or more; .

According to a preferred embodiment of the present invention, the step (1) may form a perforation by any one or more of laser beam processing, chemical etching processing, electric discharge processing and press working.

According to another preferred embodiment of the present invention, the step (2) after the step (2) may include the step of oxidizing the shielding film to form a nanotube protruding on the surface of the shielding film.

According to another preferred embodiment of the present invention may include the step of layering the bone formation accelerator on the shielding film formed with the nanotube in the step (3) after the step (2).

According to another preferred embodiment of the present invention, the bone formation promoter in step (3) may be filled with the bone formation promoter of 0.01 M to 0.1 M over 11 to 100 times in a period of 2 to 600 seconds. In addition, the present invention provides a shielding membrane for a dental implant prepared by the above-described method to solve the above problems.

Advantageous Effects

First, the shielding membrane for dental implants of the present invention has excellent flexibility by allowing it to bend well without overcoming the existing shielding for dental implants. In addition, this can easily shield the site without distortion to the curved bone defects, there is ease of the procedure. Furthermore, the penetration of the soft tissue into the lower portion of the shielding membrane can be minimized by having a diameter smaller than the aperture diameter of the conventional shielding membrane. Secondly, by increasing the specific surface area of the shielding membrane, the function of promoting bone formation may be maximized, and the function of promoting bone formation may continue until bone formation is completed in the alveolar bone.

Third, it is possible to effectively form bones for bone defects by forming a material containing bone components in the shielding membrane to add bioactivity to minimize the difficulty of bone regeneration and prolongation of bone regeneration time. .

[Brief Description of Drawings]

1 is a plan view of a schematic diagram of a shielding film according to an exemplary embodiment of the present invention.

2 is a photograph bent according to the mandible shape the shielding film according to a preferred embodiment of the present invention.

3 is a photograph bent according to the shape of the mandible the shielding film that is not perforated.

4 is a photograph of a perforated shielding membrane applied to the maxilla.

FIG. 5 is a SEM photograph of the shielding film according to the preferred embodiment of the present invention. FIG.

6 is a SEM photograph of the shielding film according to the preferred embodiment of the present invention.

7 is a perspective view schematically illustrating a shielding film according to an exemplary embodiment of the present invention.

8 is an SEM photograph of a shielding film according to an exemplary embodiment of the present invention.

9 is a SEM photograph of a cross section of a shielding film according to an exemplary embodiment of the present invention.

10 is a SEM photograph of a cross section of a nanotube included in a shielding film according to an exemplary embodiment of the present invention.

FIG. 11 is a cross-sectional view schematically illustrating a shielding film filled with a bone formation layer. FIG.

12 is a SEM photograph of the shielding film according to the preferred and comparative examples of the present invention.

FIG. 13 is a SEM photograph of a cross-sectional view of a shielding film according to an exemplary embodiment and a comparative example of the present invention.

14 is a SEM photograph of the surface of the shielding film in which the shielding film according to the preferred and comparative examples of the present invention is immersed in the analogous fluid for 1 day.

<53>

[Form for implementation of invention]

Hereinafter, the present invention will be described in more detail with reference to the accompanying drawings.

<55> As described above, in the case of a conventional dental implant shield using a metal material such as titanium, the surface may be bent, warped, and bent in a desired shape due to rigidity (r igidi ty). There was a problem that could not be done. In addition, since soft tissue grows about 6 times faster than bone tissue, there is a problem in that tissue is grown under the shield and bone is not completely formed.

<57>

In the present invention, in the dental implant shielding membrane comprising a plurality of perforations, the average diameter of the perforations is 0.2 mm or less, the perforation having a diameter of 0.2 mm or less of the total perforation is 95% or more shielding membrane for the dental implant The solution to the above problem was sought by providing. Through this, the site can be easily shielded according to the shape of the treatment part flexibly without unintentional change of shape during the procedure. In addition, by minimizing the growth of soft tissues under the shield and creating a space for bone regeneration, bone can be smoothly regenerated in the missing alveolar bone.

<59>

Specifically, FIG. 1 is a plan view of a schematic diagram of a shielding film according to an exemplary embodiment of the present invention. The shielding membrane 100 has a plurality of perforations in order to induce bone formation in the alveolar bone defect by smoothly supplying extracellular fluid such as blood to the lower shielding membrane.

(101, 102, 103, 104) are formed.

The perforation formed in the conventional shielding membrane was manufactured to have a large diameter of 0.4 to 2 mm in order to supply blood, lymph fluid, and the like, and to attach tissues. The soft tissue cells penetrate into the bone graft site, the soft tissue is formed in the bone to be formed, there was a fatal problem that the implant procedure can fail.

<62>

Thus, in one embodiment of the present invention, the average diameter of the perforations in consideration of the size of the cells constituting the soft tissue to 0.2 隱 or less, but the diameter of 0.2 瞧 or less perforation of the conventional perforation to 95% or more of the total perforation Like the shielding membrane, the above-mentioned problem was solved by greatly minimizing the penetration of the soft tissue into the lower portion of the shielding membrane while maintaining the ease of bending and other procedures.

If the average diameter of the perforation exceeds 0.2 mm, there may be ease of bending, but soft tissues may excessively penetrate into the lower part of the shielding membrane and inhibit bone formation. If given, bone formation with reduced surface area The problem that the promoting effect is lowered may occur.

<65>

In addition, in the shielding film, perforations satisfying the diameter of 0.2 mm or less are included in the perforation of 95% or more, preferably 98% or more, and more preferably 100% or more. As a result, the penetration of the soft tissue into the lower portion of the shielding membrane can be minimized, and the bending of the shielding membrane can be facilitated, and the distortion can be minimized. If less than 95% of the perforations satisfying the diameter of 0.2 mm or less are included in the perforation exceeding 0.2 mm, the soft tissue may excessively penetrate into the lower part of the shielding membrane and inhibit bone formation. When giving bone formation promoting function may cause a problem that the bone formation promoting effect is lowered due to the reduction of the surface area. However, if the size of the perforation is too small to attach epithelial cells, the upper valve may become thin or the occlusion may be exposed into the oral cavity, so the average diameter of the perforation may be 0.01 mm or more.

<67>

If a shielding film without a perforation is used, it may prevent penetration into the lower portion of the soft tissue shielding film, but there is a problem that bending is not easy and bending occurs.

Specifically, FIG. 2 is a photograph bent according to the mandible shape of the shielding film according to a preferred date of the present invention, FIG. 3 is a picture bent according to the shape of the mandible, and FIG. 4 is a non-perforated shielding film. As a photograph performed on the maxilla, the distortion did not appear when bent in FIG. 2, but in FIG. 3, it was confirmed that the distortion was not severely generated. Figures 2 and 3 are bent on the side of the mandible or the actual implants during the procedure, the distortion due to the bend may be more severe and the actual implant procedure picture 4 to see that the distortion of the membrane is very severe Can be.

<70>

The size of the shielding film 100 may be a conventional shielding film size, and preferably, the width (a of FIG. 1) may be 25 to 40 mm 3, and the length (b of FIG. 1) may be 35 to 60 mm. However, it is not limited to the above description and may vary depending on the size of the site to be treated.

<72>

The shielding film 100 may include perforations in which the total area of the perforations corresponds to 5 to 20% of the shielding film area. In this case, the average number of perforations per unit area (lcirf) can be between four and eight. If the total area of perforation is less than 5% If not only the movement of blood or body fluids can not be made smoothly, but also the adhesion of tissues is lowered and the deformation may occur during bending. On the contrary, if it exceeds 20%, the specific surface area decreases. The problem of lowering bioactivity may occur. The shielding film thickness may be the thickness of a conventional shielding film, preferably, the thickness may be 50 to 200 ym, but is not limited to the above description.

<74>

The distance of the cloth space of the shielding film may be preferably 200 to 600 μιη.

Specifically, FIGS. 5 and 6 are SEM photographs of the shielding film according to the preferred embodiment of the present invention, and the distance of the cloth space of the shielding film, which is the SEM photograph object of FIG. 5, is 532 to 548 μηι, and the diameter of the aperture is FIG. 6. It can be confirmed that 172 μ ιτι.

<76>

In addition, in the case of the shielding film material of the present invention, titanium, titanium alloy, stainless steel, cobalt-cr (Co-Cr) alloy (molybdenum as a casting alloy, molybdenum as a forging alloy) Alloys further containing Mo) and nickel (Ni)), niobium, tantalum, zirconium, and platinum (Pt). Preferably, it may be titanium or a titanium alloy, and the titanium alloy may include at least one of niobium and tantalum. The metals are excellent in corrosion resistance as those which do not cause side effects by reacting with biological tissues in the human body. Titanium or titanium alloys are light, malleable, and have good specific strength. However, the shielding film material is not limited to the metals described above as long as there is no side effect in the human body and the space securing and maintaining ability is excellent.

<78>

According to another preferred embodiment of the present invention, the shielding membrane is formed at least in order to increase the specific surface area of the shielding membrane and to maintain the bone formation promoting function described below until the bone formation of the alveolar portion is completed. It may include a plurality of protruding nanotubes on one surface.

This allows more bone formation promoters, which will be described below, to be more layered than when coated on untreated shielding membranes, and bone formation on untreated shielding membranes as the bone formation promoters are layered in the nanotubes. When the promoter is coated, the bone formation promoter may be eluted in the body fluid for a long time. The nano-lube may be preferably formed through oxidation treatment, but is not limited thereto. <81>

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

Preferably, the average length (g) of the nanotubes may be 500 to 2000 nm. If the length of the nanotube exceeds 2000 nm, the nanotube may be damaged during the procedure. If the length of the nanotube is less than 500 nm, the amount of the bone formation promoter that is layered in the nanotube is small, and thus, the effect of promoting bone formation is reduced in the area where the alveolar portion is missing. There is a problem that can be.

Further, preferably, the average diameter (h) of the outer diameter of the nanotube may be 50 to 150 nm. If the average diameter (h, i) of the outer and inner diameters of the nanotubes is increased, 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. If the average diameter (h) of the outer diameter of the nanotube is less than 50 nm, there is a problem that it may be difficult to induce the penetration and bonding of the substance promoting bone formation.

<85>

Specifically, FIG. 8 is an SEM photograph of the shielding film according to the preferred embodiment of the present invention. The shielding film used as the SEM image was a voltage of 20 V and a current density of 20 mA using a titanium shielding film as an anode, a platinum plate as a cathode, and a solution containing 20 wt% water and 1% NH 4 F as a electrolyte solution as an electrolyte solution. Power was applied to / cirf for anodization for 60 minutes. As can be seen in Figure 8, the resulting nanotubes had an outer diameter of 74.3 to 156.4 nm.

In addition, FIGS. 9 and 10 used a shielding film which is the object of the SEM photograph as an SEM photograph of the cross section of the shielding film according to the preferred embodiment of the present invention. As can be seen in FIG. 9, the average length of the formed nanotubes was 763.3 nm, and as shown in FIG. 10, the bone formation promoting layer, which will be described below, may penetrate into the nanotubes as shown in FIG. 10. have.

<88>

According to a preferred embodiment of the present invention, in order to promote bone formation in the bone defected alveolar bone formation promoter may be layered on the inside and outside of the nanotubes, thereby improving the recovery period after implantation. It has the effect of shortening and increasing the success of the procedure.

In the case of conventional titanium shielding membranes, bioactivity is not imparted. There was a problem that often takes a long time and failing to obtain a decent bone mass.

In order to solve the above problems, the inventors of the present invention have filled a bone formation accelerator into the shielding film, and as described above, a non-surface area that can form a nanotube layer on the surface of the shielding film so that the bone formation promoter may be layered. By broadening, the effect of promoting bone formation was further enhanced.

11 is a cross-sectional view schematically illustrating a shielding film layered with a bone formation layer.

Nanotubes 320 are formed on at least one surface of the 300 and the bone formation promoting layer 310 may be filled in the inner (j) and the outer (k) of the nanotubes.

The inside (j) of the nanotubes formed on the surface of the shielding film refers to the hollow of the nanotubes, and the outer zero refers to the space between the nanotubes in which the shielding film is etched to form the nano-lube and the top of the protruding nanotubes. do. Since the bone formation promoter 310 is laminated inside the nanotubes 320, the etched portion between the nanotubes, and the nanotubes, a greater amount of the bone formation promoter layer may be filled than the shielding film without any treatment. Minimization of the promotion layer after the implant procedure can be minimized. In addition, by striking the bone formation layer, the deactivation of nutrient supply due to the decrease of blood supply to the upper and lower portions of the shielding membrane, which may occur in case of injuries, and the difficulty of bone regeneration or prolonged regeneration time You can eliminate the problem.

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

<95>

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

First, in the step (1), the shielding film has an average diameter of 0.2 mm or less, and a step of forming a plurality of perforations having 95% or more of perforations having a diameter of 0.2 mm or less out of all perforations.

In the step (1), the material of the shielding film, the average diameter of the perforation, etc. are as described above, and the perforation may be any one or more of laser beam processing, chemical etching processing, electric discharge processing and spring processing. It can be formed through the method. Preferably laser ablation is excellent in that it is applicable to a variety of biocompatible metals or alloys thereof and can be drilled quickly and accurately to the desired diameter.

<99> <ioo> As a next (2) step, at least one surface of the shielding film that has passed the step (1) may be oxidized to form a nanotube protruding on the surface of the shielding film. Preferably the oxidation may be anodization. The anodization is advantageous in that nanotube formation is simpler than other methods and the manufacturing time is shortened.

<101>

Hereinafter, the anodization will be described in detail.

First, the electrolyte solution used for the anodization is glycerol, ammonium fluoride.

(NH ₄ F) Acidic ammonium fluoride (NH ₄ HF ₂ ), sodium fluoride (NaF) and water (¾) may include at least one. Preferably glycerol, ammonium fluoride (NH ₄ F), water

(¾0), and more preferably, 0.3 to 2 parts by weight of ammonium fluoride (NH ₄ F) and 5 to 30 parts by weight of water (¾0) may be mixed with 100 parts by weight of glycerol. If the mixed amount of ammonium fluoride (NH ₄ F) is less than 0.3 parts by weight or more than 2 parts by weight, there is a problem that the nanotube structure formed may be incomplete. In addition, when the amount of water (¾0) is less than 5 parts by weight, the diameter of the nanotube may be excessively reduced. When the amount of water (¾0) is exceeded, the length of the nanotube may be excessively longer than the diameter of the nanotube, resulting in damage to the nanotubes during implantation. There is a problem that can occur.

<104>

Next, the electrode may be a cathode electrode as the cathode electrode, and the cathode electrode may be any one of platinum, tungsten, and silver. The cathode electrode is not limited to the above description, and there is no limitation on the use of the cathode electrode as long as it is a cathode electrode used for ordinary anodization. The electrode spacing may be 10 to 50 kV, preferably 20 to 30 kV, and the voltage may be 10 to 50 V. The reaction time may be 10 to 180 minutes, and preferably, electrochemical reaction may be performed for 30 to 60 minutes to form a nanotube protruding on the shielding film of the anode.

In addition, the shielding film may be rotated or moved left and right during the oxidation treatment for smooth formation and structural improvement of the nanotubes.

<107>

As a next step (3), it is possible to layer the bone formation promoter on the shielding film on which the nano-lube is formed. There is no restriction on the filling method of the bone formation promoter, and preferably may be dip coat (ing).

<10> Specifically, the immersion coating will be described below. <i io> First, the immersion liquid may be a solution containing phosphate ions (phosphate ion) as a bone formation promoter and a solution capable of depositing the phosphate ion. The solution containing the phosphate ion is preferably sodium hydrogen phosphate (Na¾PO ₄ ) ᅳ sodium phosphate

(Na ₂ HP0 ₄ ), ammonium dihydrogenphosphate (NH ₄ H ₂ P0 ₄ ), diammonium phosphate

(H ₄ ) ₂ HP0 ₄ ) may be a solution containing at least one. In this case, the solvent may be water. However, it is not limited to the said description. .

<ι ι ι> The solution capable of precipitating the phosphate ion may form a salt with the phosphate ion, and if the salt formed is harmless to the human body, there is no limitation and may be a solution containing a divalent cation and more preferably. Preferably it may be an aqueous solution of calcium hydroxide (Ca (0H) ₂ ,) or magnesium hydroxide (Mg (0H) ₂ ). However, it is not limited to the said description.

<1 12> ^■

The concentration of the bone formation promoter may be preferably 0.01 M to 0.1 M, and even more preferably the concentration of the bone formation promoter may be 0.01 to 0.05 M. If the concentration is less than 0.01 M, the time required for the bone formation accelerator to be laminated inside and outside the nanotube may be long and the amount of filling may be small. There may be a problem that it is difficult to penetrate into the tube.

<1 14>

The method of the immersion coating is not limited, but may be preferably alternately immersed in the shielding film in each of the solution containing the bone formation promoter and the solution capable of depositing phosphate ions. In this case, the time for which the shielding film is immersed in each solution may be preferably 1 to 300 seconds. If the shielding film is less than 1 second, acid-base reaction with the surface of the shielding film may not occur effectively, and thus, the bone formation promoter may not be precipitated. If it exceeds a second, the problem may occur that the bone formation promoter blocks the inlet of the nanotube so that no penetration into the interior occurs.

<1 16>

<1 1 7> In addition, when one cycle of immersing the shielding membrane alternately in each of the solution containing the bone formation accelerator and the solution capable of depositing phosphate ions,

11 to 100 treatments may be performed every 2 to 600 seconds. If the treatment time is less than 11 times, the amount of bone formation promoters formed inside and outside of the nanotube layer on the surface of the shielding film is small, thus reducing the release rate and release amount of the bone formation promoters that are released after the procedure. It is difficult to expect sexual function, and the time required for bone formation may be prolonged. In addition, if more than 100 times the treatment is excessively formed bone formation promoter has a problem that can be eliminated during the bending operation of the shielding membrane formation agent.

<1 18>

<U 9> Specifically, FIG. 12 is an SEM image of a shielding film according to an exemplary embodiment and a comparative example of the present invention. It can be seen that many bone formation promoting layers are formed.

In addition, FIG. 13 is a SEM image of a cross-sectional view of the shielding film according to the preferred and comparative examples of the present invention. It can be seen that more bone formation promoting layers are formed inside and outside the formed nanotube layer.

<i 2i> Furthermore, FIG. 14 is an SEM image of the surface of the shielding film in which the shielding film according to one embodiment and the comparative example of the present invention is immersed in the analog liquid for one day. In FIG. 14A, which is filled with the bone formation promoter 10 times, when the bone formation promoter is deposited in the analogous fluid, there is almost no projection showing in the early stage of the release of the bone formation promoter. As can be seen, when the point A of FIG. 14A is enlarged, FIG. 14B shows that the nano-leave formed in the upper part of the shielding film is almost exposed, and the bone formation accelerator is not formed as a whole but in some places.

< ^| On the contrary, in the case of FIG. 14E which is filled with the bone formation accelerator 30 times, when the bone formation accelerator is deposited in the analogous fluid, the protrusions appearing at the beginning of the release of the bone formation accelerator are very dense and the release of the bone formation promoter is smoothly performed. It can be seen that there is. In addition, in FIG. 14F in which the point C of FIG. Me is enlarged, it can be seen that the nano-levers formed on the shielding film are barely exposed and the bone formation promoter is formed as a whole.

<123>

On the other hand, the present invention includes a shielding membrane for a dental implant prepared by the above manufacturing method.

<125>

The shielding film of the present invention prepared as described above can be easily bent to flexibly shield the site in conformity with the shape of the treatment portion. In addition, when the shielding film is bent to maintain a certain mechanical strength can maintain the shape during the procedure even after the procedure. In addition, it is possible to avoid the problem that the bone-forming material formed on the surface peels off when the shielding film is bent, and further, extracellular fluid such as blood flows smoothly over and under the shielding film. At the same time, it can minimize the penetration of soft tissue under the shield.

Furthermore, the material of the shielding membrane does not cause side effects by reacting with biological tissues in the human body.

On the other hand, by forming a nanotube on the surface of the shielding film to increase the specific surface area of the shielding film, the bone formation promoting function can be continued until the bone formation of the alveolar portion is completed. The increased specific surface area of the membrane allows more bone formation promoters to be layered and the bone formation promoters can be eluted in body fluids for a long time as the bone formation promoters are deposited in the nanotubes. In addition, the bone formation promoter is laminated on the nanotubes in order to promote bone formation in the bone defects of the bone defects can shorten the recovery period after implantation and contribute to the improvement of the success of the procedure.

<12>

Hereinafter, the present invention will be described in more detail with reference to Examples, but the following Examples are not intended to limit the scope of the present invention, which will be construed as to help the understanding of the present invention.

<13 1>

<133> Titanium shielding film 35 mm wide, 50 mm long and 100 μηι thick with a laser processing machine using a laser processing machine with an average diameter of 0.1 mm and a diameter of 0.2 mm or less out of the total 100% The total perforation area of the shielding film surface area was 4.97%.

<134>

The shielding film of Example 1 was formed to form a titanium dioxide nanotube layer on the surface of the shielding film.

The positive electrode of the DC electrostatic source device was connected, and a platinum (Pt) plate was connected to the negative electrode. The two electrodes were placed in an electrolyte solution (79 wt% glyceride, 1 wt% ammonium fluoride, 20 \% water) at a distance of 20 mm, and a voltage was applied at 20 V for 60 minutes. ₂ ) The nano-levers were formed. The nanotube-coated shielding film was deposited in 80 ^° C NaH ₂ P0 ₄ 0.02M solution and 100 ^° C Ca (0H) ₂ saturated aqueous solution, respectively, for 1 minute immersion time and 30 immersion times, to obtain titanium dioxide (Ti0 _2). Induced penetration of hydroxyapatite (HAp) into nanoleuve to prepare a titanium shielding layer in which hydroxyapatite was layered inside and outside of titanium dioxide nanotubes. <Example 3>

Titanium was carried out in the same manner as in Example 2 except that the number of immersion was 20 instead of 30.

A shielding film was prepared.

Titanium was carried out in the same manner as in Example 2 except that the number of immersions was 40 instead of 30.

A shielding film was prepared.

Titanium shielding film was prepared in the same manner as in Example 2 except that the number of immersion times was 10 times instead of 30 times.

Experimental Example 1

For the shielding film prepared in Example 1 and an unperforated shielding film of the same material, size, and thickness as those of the shielding film, each shielding film was bent in the shape of the mandibular side surface to visually observe the distortion of the bent surface. 3 and Table 1 are shown. Specifically, as a result of visual observation, in Example 1, there was no distortion of the curved surface, but in the case of the unperforated shielding membrane, severe distortion was observed.

Experimental Example 2

The concentrations of phosphoric acid (P) and calcium (Ca) on the surface of the shielding membrane were analyzed by FE-SEM EDS analysis on the titanium shielding membranes prepared in Examples 2 to 4 and Comparative Example 1, and the results are shown in Table 2. . Specifically, it was confirmed that the concentration of phosphoric acid and scab on the surface of the occlusion membrane increased as the number of times increased compared to Comparative Example 1 having 10 dipping cycles. <159><Experimental Example 3>

<i60> Analogous solution of the titanium shielding membranes prepared in Examples 2, 3 and Comparative Example 1 for 1 day

After immersion in (simulated body fluid: SBF), SEM pictures were taken of the respective shielding films, and the results are shown in FIG. 14.

<161>

Specifically, in the group immersed 10 times (FIG. 14 a, b), the analog fluid for 1 day

(SBF) showed no significant change after deposition. On the contrary, in the 20 (C, d) and 30 (FIG. 14 e, f) immersion groups, as the number of immersion treatments increased, protrusions appearing at the initial stage of precipitation of hydroxyapatite (HAp) were more dense. It showed a declining aspect.

<163>

<164> [Table 1]

<165> [Table 2]

<166>

<167>

Industrial Applicability

The present invention is applicable to the production and processing industry of shielding membranes required for implants.

<169>

<170>

Claims

[Range of request]

[Claim 1]

In the shielding membrane for dental implants comprising a plurality of perforations,

The average diameter of the perforation is 0.2 mm or less, the perforation having a diameter of 0.2 mm or less of the total perforation is 95% or more shielding membrane for a dental implant.

[Claim 2]

The method of claim 1,

The shielding membrane includes a perforation in which the total area of the perforation corresponds to 5 to 20% of the shielding membrane area, and the shielding membrane for the dental implant, characterized in that the material of any one of titanium and titanium alloy.

[Claim 3]

In U,

The shielding membrane is a shield for a dental implant, characterized in that it comprises at least one surface of a plurality of protruding nanotubes having an average length of 500 to 2000 nm, the outer diameter of 50 to 150 nm of a single natotube.

[Claim 4]

According to claim 3,

The shielding membrane is a dental implant shielding membrane, characterized in that the bone formation promoting material, including phosphate to promote bone formation is filled inside and outside the nanotubes.

[Claim 5]

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

[Claim 6]

The method of claim 5,

Step (1) is a method of manufacturing a dental implant shielding film, characterized in that the perforation is formed by at least one method of laser beam processing, chemical etching processing, electrical discharge processing and pressing processing.

[Claim 7]

The method of claim 5, wherein after step (1) above,

(2) oxidizing the shielding film to form nanotubes protruding on the surface of the shielding film.

[Claim 8]

According to claim 7, After the step (2),

(3) laminating a bone formation promoter on the shielding film on which the nano-lube is formed.

[Claim 9]

According to claim 8,

Step (3) in the step bone formation promoter is a method for producing a dental implant shield membrane, characterized in that the filling of 0.01 M to 0.1 M bone formation promoter over 11 to 100 times every 2 to 600 seconds cycle.

[Claim 10]

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