Dental separator membrane and method for manufacturing same

Abstract

The invention discloses a dental isolating membrane and a manufacturing method thereof. The dental isolating membrane comprises a porous layer and a hydrophilic layer. The porous layer comprises a porous structure and a bone regeneration material attached to the porous structure, and the porous structure is formed by biodegradable macromolecules. The total weight of the porous layer is 100 weight percent, the content of the porous structure is 22 to 50 weight percent, and the content of the bone regeneration material is 50 to 78 weight percent.

Description

Technical Field

[0001] This application relates to a dental isolation film and a manufacturing method thereof, in particular to a dental isolation film for alveolar bone and a manufacturing method thereof. Background Art

[0002] Before a dental implant operation, generally guided bone regeneration (GBR), commonly known as bone grafting surgery, is first performed to solve the problem of alveolar bone atrophy caused by long-term tooth loss in the dental implant area.

[0003] Please refer to Figure 4 As shown, during the guided bone regeneration process, the gum G is first lifted, and bone powder B is placed at the bone defect to promote bone growth in the tooth ridge R. To prevent soft tissues such as the gum G and oral mucosa from occupying the bone growth space during cell proliferation, an isolation film F needs to be covered on the bone powder B to protect and stabilize the bone powder B, isolate the alveolar bone from the soft tissues, and finally suture the gum G. In this way, bone cell growth can be controlled within a specific space to achieve the purpose of reconstructing the tooth ridge R.

[0004] Currently, the commonly used isolation film in the industry is made of collagen (hereinafter simply referred to as the collagen film). The physical properties of collagen are weak, and it is easy to rupture after dental implantation, resulting in the problem of artificial bone falling off. Moreover, the collagen film does not have the function of shaping. To completely cover the wound, doctors need to use stitches or other auxiliary methods to fix the shape of the collagen film. Therefore, the collagen film has the problems of weak physical properties and inconvenient use.

[0005] Therefore, how to improve the existing isolation film to enhance its physical properties and increase its usability to overcome the above defects has become one of the important issues to be solved in this field. Summary of the Invention

[0006] The technical problem to be solved by this application is to provide a dental isolation film and a manufacturing method thereof in view of the deficiencies of the prior art.

[0007] To solve the above technical problems, one of the technical solutions adopted by the present invention is to provide a dental isolation film. The dental isolation film includes a porous layer and a hydrophilic layer. The porous layer includes a porous structure and a bone regeneration material attached to the porous structure. The porous structure is formed of a biodegradable polymer. Based on the total weight of the porous layer being 100 weight percentages, the content of the porous structure is 22 weight percentages to 50 weight percentages, and the content of the bone regeneration material is 50 weight percentages to 78 weight percentages.

[0008] Furthermore, the thickness of the dental isolation film is 100 micrometers to 300 micrometers.

[0009] Furthermore, the porosity of the porous layer is 10% to 30%.

[0010] Furthermore, the bone regeneration material includes calcium phosphate.

[0011] Furthermore, the size of the bone regeneration material is 10 micrometers to 30 micrometers.

[0012] Furthermore, the biodegradable polymer includes polylactic acid, and the weight of polylactic acid in the biodegradable polymer is greater than or equal to 50 weight percentages.

[0013] Furthermore, the weight average molecular weight of the biodegradable polymer is 100,000 grams / mole to 600,000 grams / mole.

[0014] Furthermore, the hydrophilic substance includes hyaluronic acid.

[0015] To solve the above technical problems, another technical solution adopted by the present invention is to provide a method for manufacturing a dental isolation film. The method for manufacturing a dental isolation film includes: preparing a polymer solution; performing an electrospinning process to obtain a porous layer using the polymer solution; and immersing the porous layer in a treatment solution to form a hydrophilic layer covering the porous layer. The polymer solution contains a solvent, a biodegradable polymer, and a bone regeneration material. Based on the solid content in the polymer solution being 100 weight percentages, the content of the biodegradable polymer is 22 weight percentages to 50 weight percentages, and the content of the bone regeneration material is 50 weight percentages to 78 weight percentages.

[0016] Furthermore, in the step of preparing the polymer solution, the solvent is selected from the group consisting of acetone, methyl ethyl ketone, ethylene glycol, isopropyl alcohol, chitosan, N,N-dimethylformamide, dimethylacetamide, dimethyl sulfoxide, and ether.

[0017] Furthermore, in the electrospinning process, the ejection speed of the polymer solution is 5 milliliters per hour to 10 milliliters per hour.

[0018] Furthermore, in the step of infiltrating the porous layer, the treatment solution contains 10 wt% to 30 wt% of hyaluronic acid.

[0019] One of the beneficial effects of the present invention is that the dental isolation film and its manufacturing method provided by the present invention can improve the physical properties of the dental isolation film and enable the dental isolation film to have the effect of helping osteocyte growth through the technical solution of "taking the total weight of the porous layer 10 as 100 wt%, the weight of the porous structure as 22 wt% to 50 wt%, and the weight of the bone regeneration material 12 as 50 wt% to 78 wt%".

[0020] In order to further understand the features and technical content of the present application, please refer to the following detailed description and drawings of the present application. However, the provided drawings are only for reference and illustration and are not used to limit the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a schematic side cross-sectional view of the dental isolation film of the present invention.

[0022] Figure 2 It is a scanning electron microscope image of the dental isolation film of the present invention.

[0023] Figure 3 It is a flowchart of the steps of the manufacturing method of the dental isolation film of the present invention.

[0024] Figure 4 It is an explanatory schematic diagram of guided bone regeneration surgery. DETAILED DESCRIPTION OF THE INVENTION

[0025] The following are specific examples to illustrate the embodiments of the "dental isolation film and its manufacturing method" disclosed by the present invention. Those skilled in the art can understand the advantages and effects of the present invention from the content disclosed in this specification. The present invention can be implemented or applied through other different specific embodiments, and various details in this specification can also be modified and changed based on different viewpoints and applications without departing from the concept of the present invention. Additionally, the drawings of the present invention are only simple schematic illustrations and are not drawn according to actual dimensions, and this is stated in advance. The following embodiments will further detail the relevant technical content of the present invention, but the disclosed content is not used to limit the protection scope of the present invention. In addition, the term "or" used herein should, depending on the actual situation, possibly include any one or a combination of more of the associated listed items.

[0026] The dental isolation membrane of the present invention can be applied in guided bone regeneration and serves as an isolation membrane for separating bone powder and soft tissue. The dental isolation membrane has good physical properties and flexibility, which can improve the problem that the isolation membrane is prone to rupture during previous dental implant procedures. It can also be bent according to the shape of the alveolar bone and bone powder. Moreover, the dental isolation membrane of the present invention contains components that can promote the regeneration of alveolar bone cells. In addition to its function as an isolation membrane, it can also replace a part of the bone powder.

[0027] [First Embodiment]

[0028] Please refer to Figure 1 As shown, the dental isolation membrane of the present invention includes a porous layer 10 and a hydrophilic layer 20, and the hydrophilic layer 20 covers the porous layer 10.

[0029] The porous layer 10 is the main structure of the dental isolation membrane, which can effectively isolate epithelial cells and bone cells to prevent epithelial cells from proliferating and occupying the growth space of bone cells. The porous layer 10 has good physical strength and flexibility, which can improve the overall physical properties of the dental isolation membrane.

[0030] Considering the convenience of use and the mechanical strength of the dental isolation membrane, the thickness of the porous layer 10 can be 100 microns to 300 microns, for example: 125 microns, 150 microns, 175 microns, 200 microns, 225 microns, 250 microns or 275 microns.

[0031] The porous layer 10 includes a porous structure 11 and a bone regeneration material 12, and the bone regeneration material 12 is attached to the porous structure 11.

[0032] The porous structure 11 is formed by winding and stacking multiple polymer fibers. During the winding and stacking process, the polymer fibers cannot completely overlap, and pores will inevitably form between the multiple polymer fibers. Accordingly, the porous structure 11 with pores is formed.

[0033] The pores of the porous structure 11 allow blood or nutrients to pass through, but the pores of the porous structure 11 should not be too many or too few. Too many pores will affect the structural strength of the dental isolation membrane and is not conducive to the doctor's use during the operation. Moreover, soft tissues such as gums and oral mucosa may pass through the dental isolation membrane and occupy the growth space of bone cells. Too few pores are not conducive to the passage of blood or nutrients.

[0034] Specifically, the porosity of the porous layer 10 is 10% to 30%, preferably 15% to 25%. For example, the porosity of the porous layer 10 can be 12.5%, 15%, 17.5%, 20%, 22.5%, 25% or 27.5%.

[0035] The porous structure 11 is formed of a biodegradable polymer. For example, the biodegradable polymer is selected from the group consisting of: polylactic acid (PLA), polycaprolactone (PCL), polyhydroxyalkanoate (PHA), and polyglycolic acid (PGA). From the perspective of biocompatibility, the biodegradable polymer is preferably polylactic acid. In some embodiments, the biodegradable polymer may also be a mixture of polylactic acid and other biodegradable polymers.

[0036] The porous structure 11 needs to support the overall dental isolation membrane, so the biodegradable polymer needs to have a certain degree of mechanical strength. In some embodiments, the molecular weight of the biodegradable polymer can be from 100,000 g / mol to 600,000 g / mol, and is preferably from 150,000 g / mol to 350,000 g / mol, for example: 200,000 g / mol, 250,000 g / mol, or 300,000 g / mol.

[0037] The bone regeneration material 12 can help the growth of bone cells and can also be used to replace a part of bone powder. Therefore, the dental isolation membrane of the present invention has the effects of both an isolation membrane and bone powder. Specifically, in addition to adhering to the porous structure 11, the bone regeneration material 12 can also be stuck in the pores of the porous structure 11. For the scanning electron microscope image of the dental isolation membrane, please refer to Figure 2 as shown.

[0038] During use, the bone regeneration material 12 will gradually be released from the dental isolation membrane to achieve the effect of promoting the growth of bone cells. Therefore, the relative relationship between the porosity of the porous structure 11 and the size of the bone regeneration material 12 is more important. The porosity of the porous structure 11 and the size of the bone regeneration material 12 will affect the loading capacity of the bone regeneration material 12 in the dental isolation membrane and will also affect the release rate of the bone regeneration material 12.

[0039] In the exemplary embodiment, the bone regeneration material 12 includes calcium phosphate (Ca3(PO4)2). Specifically, the bone regeneration material 12 is bone-conductive calcium phosphate (β-tricalcium phosphate, β-TCP), which can accelerate the growth of bone cells.

[0040] The bone regeneration material 12 can exist in the form of particles, and the size of the bone regeneration material 12 is from 10 microns to 30 microns. Within this particle size range, the bone regeneration material 12 can just be stuck on the porous structure 11 and helps the growth of bone cells. If the particle size is too large, it is not conducive to cell use. If the particle size is too small, it is not conducive to being carried on the porous structure 11. Therefore, the particle size of the bone regeneration material 12 can be 12 microns, 14 microns, 16 microns, 18 microns, 20 microns, 22 microns, 24 microns, 26 microns, or 28 microns.

[0041] In the present invention, the weight ratio of the bone regeneration material 12 in the porous layer 10 is higher than 50 weight percent. The high proportion of the bone regeneration material 12 can achieve the effect of replacing a part of the bone powder. Moreover, the bone regeneration material 12 can also achieve the effect of enhancing the mechanical strength of the dental isolation membrane.

[0042] Specifically, based on the total weight of the porous layer 10 being 100 weight percent, the content of the porous structure 11 is 22 weight percent to 50 weight percent, and the content of the bone regeneration material 12 is 50 weight percent to 78 weight percent.

[0043] It should be noted that the content of the bone regeneration material 12 is not the higher the better. When the content of the bone regeneration material 12 is too high, the growth condition of osteocytes is not as good as expected. Experiments on the growth condition of osteocytes with different contents of the bone regeneration material 12 will be described later.

[0044] In other embodiments, the content of the porous structure 11 can be 25 weight percent, 30 weight percent, 35 weight percent, 40 weight percent, or 45 weight percent. The content of the bone regeneration material 12 can be 55 weight percent, 60 weight percent, 65 weight percent, 70 weight percent, or 75 weight percent.

[0045] The hydrophilic layer 20 coats the porous layer 10. Further, the hydrophilic layer 20 adheres to the surfaces of the porous structure 11 and the bone regeneration material 12 to enhance the hydrophilicity of the dental isolation membrane. The setting of the hydrophilic layer 20 can improve the usability of the dental isolation membrane. The dental isolation membrane can have better conformability to adhere to the alveolar bone or bone powder, and is conducive to the passage of blood or nutrients.

[0046] In addition to completely coating the porous layer 10, a part of the hydrophilic layer 20 is also provided inside the porous layer 10 and fills a part of the pores in the porous structure 11 to facilitate the passage of hydrophilic substances or nutrients.

[0047] The hydrophilic layer 20 is formed by hydrophilic substances, preferably substances not rejected by the human body. The hydrophilic substances are selected from the group consisting of hyaluronic acid and its derivatives and water-soluble vitamins (such as vitamin C and vitamin B group), preferably hyaluronic acid. Through the setting of the hydrophilic layer 20, the dental isolation membrane of the present invention can absorb water to reach a plasticized soft state in a shorter time.

[0048] In this way, the outer surface of the dental isolation film has a water contact angle of less than 80°, so as to greatly shorten the soaking and wetting time before use, and the dental isolation film has better plasticity and coating conformability after being fully wetted. In the present invention, the contact angle between the outer surface of the dental isolation film and water is preferably less than 60°, more preferably less than 30°, and most preferably less than 10°.

[0049] However, without seriously damaging the effect of the invention, in some embodiments, other substances containing hydrophilic groups can also be used to perform the hydrophilization treatment, such as substances containing hydroxyl groups, substances containing carboxylic acid groups, substances containing sulfonic acid groups, substances containing ether groups, substances containing epoxy groups, substances containing amine groups, etc.

[0050] It should be added that when the hydrophilic substance is hyaluronic acid, the molecular weight of hyaluronic acid is not particularly limited, preferably between 10,000 and 1,000,000, and more preferably between 10,000 and 700,000. If the molecular weight of hyaluronic acid is less than 10,000, it is not conducive to the binding of hyaluronic acid to the porous layer 10; if the molecular weight of hyaluronic acid is greater than 1,000,000, it is not conducive to the penetration of hyaluronic acid into the porous layer 10.

[0051] Since the hydrophilic layer 20 covers the porous layer 10 and the thickness of the hydrophilic layer 20 itself is extremely thin. Therefore, the thickness of the dental isolation film is 100 to 300 microns, which is almost the same as the thickness of the porous layer 10. For example, the thickness of the dental isolation film can be 125 microns, 150 microns, 175 microns, 200 microns, 225 microns, 250 microns or 275 microns.

[0052] The tensile strength of the dental isolation film of the present invention under the conditions of 25°C and an absolute humidity of 50% is 0.3 MPa to 5 MPa. And, the adhesion strength of the dental isolation film of the present invention measured according to the ASTM D3121-2006 method is 0.3 N to 0.7 N.

[0053] It should be noted that although the characteristics of the dental isolation film of the present invention are described by taking the bone grafting surgery as an example in this article, the dental isolation film of the present invention can be used in other human surgical operations.

[0054] [Second Embodiment]

[0055] Please refer to Figure 3 As shown, the second embodiment of the present invention provides a method for manufacturing a dental isolation film, which can be used to manufacture the dental isolation film described in the first embodiment. The method for manufacturing the dental isolation film of the present invention at least includes the following steps: Step S100, preparing a polymer solution; Step S102, using the polymer solution to manufacture a porous layer; and Step S104, forming a hydrophilic layer on the surface of the porous layer. The following will be combined with Figure 1Describe the specific implementation details of each step separately.

[0056] In step S100, the polymer solution includes a bone regeneration material, a biodegradable polymer, and a solvent.

[0057] The content of the solid components in the polymer solution can be adjusted according to the manufacturing method in step S102. For example, the porous layer can be made by non-woven spinning technology, freeze-drying technology, or electrospinning technology. In the second embodiment, electrospinning technology is taken as an example for illustration. To adapt to the operation mode of electrospinning technology, based on the total weight of the polymer solution being 100 weight percentages, the content of the solid components in the polymer solution is 1 weight percentage to 50 weight percentages, and the solvent content is 50 weight percentages to 99 weight percentages.

[0058] The solid components in the polymer solution include a biodegradable polymer and a bone regeneration material. In the present invention, based on the solid content of the polymer solution being 100 weight percentages, the content of the biodegradable polymer is 22 weight percentages to 50 weight percentages, and the content of the bone regeneration material is 50 weight percentages to 78 weight percentages.

[0059] In practical applications, the solvent can be selected from the group consisting of acetone, butanone, ethylene glycol, isopropanol, deacetylated chitin (DAC), N,N-dimethylformamide (DMF), dimethylacetamide (DMAC), dimethyl sulfoxide (DMSO), and ether, preferably acetone or a mixture of acetone and dimethylacetamide.

[0060] Calcium phosphate composite particles and polylactic acid particles are used as raw materials for the biodegradable polymer and the bone regeneration material. Specifically, the calcium phosphate composite particles contain calcium phosphate and polylactic acid, and the polylactic acid particles contain 100 weight percentages of polylactic acid. Therefore, the solid components in the polymer solution include calcium phosphate and polylactic acid.

[0061] Specifically, based on the total weight of the calcium phosphate composite particles being 100 weight percentages, the content of calcium phosphate is 10 weight percentages to 90 weight percentages, but the present invention is not limited thereto. To control the content ratio of the bone regeneration material and the biodegradable polymer, the added weight ratio of the polylactic acid particles and the calcium phosphate composite particles is 1:0.9 to 1:5.

[0062] In step S102, the porous layer is manufactured by electrospinning technology using the polymer solution. After electrospinning and drying, the solid components in the polymer solution form the porous layer 10. Among them, polylactic acid forms the porous structure 11, and calcium phosphate forms the bone regeneration material 12 attached to or filling the pores in the porous structure 11.

[0063] In the electrospinning process, the prepared polymer solution is added to the liquid storage tank, and the positive and negative electrodes of a high-voltage power supply are electrically connected to the nozzle and the collection plate respectively. After applying the high-voltage power supply, the polymer solution is ejected from the nozzle. Under the action of the electric field, the polymer solution solidifies to form polymer fibers, which are deposited on the collection plate. By controlling the movement of the nozzle, the polymer fibers can be closely stacked, wound or interwoven in a specific direction, thereby forming a porous layer 10 with a uniform thickness.

[0064] Next, a drying process is carried out to volatilize the solvent in the polymer solution, leaving only the porous structure 11 and the bone regeneration material 12 to form the porous layer 10 of the present invention.

[0065] The parameters used in the electrospinning process include: the electrospinning temperature can be 5°C to 95°C, and preferably 10°C to 90°C; the voltage intensity of the high-voltage power supply is 10 kilovolts (kV) to 36 kV. The ejection speed of the electrospinning solution is 5 cc / hr to 10 cc / hr; the collection distance between the nozzle and the collection plate is 15 cm to 90 cm.

[0066] In step S104, the porous layer 10 is immersed in a treatment solution at room temperature, and the treatment solution contains hydrophilic substances. After immersion, the hydrophilic substances will adhere to the surface of the porous layer 10 and also penetrate into the porous layer 10. Therefore, a hydrophilic layer 20 covering the surface of the porous layer 10 is formed.

[0067] Next, a drying process is carried out to volatilize the solvent in the treatment solution, leaving only the hydrophilic substances attached to the surfaces of the porous structure 11 and the bone regeneration material 12 to form the hydrophilic layer 10 of the present invention.

[0068] Based on the total weight of the treatment solution (100 wt%), the content of the hydrophilic substance can be 10 wt% to 30 wt%. Preferably, the content of the hydrophilic substance can be 15 wt%, 20 wt%, 25 wt% or 30 wt%. In the exemplary embodiment, the hydrophilic substance is hyaluronic acid, and the treatment solution contains 95% ethanol, water and hyaluronic acid, wherein the weight ratio of 95% ethanol to water is 1:1 to 3:2.

[0069] [Experimental data]

[0070] In order to confirm that the dental separator of the present invention has the effect of promoting the growth of bone cells, the dental separators with different contents of bone regeneration material (calcium phosphate) are prepared in the present invention, and the osteocyte differentiation test is carried out on the dental separators. The test results are listed in Tables 1 and 2. In addition, the mechanical strength test is carried out on the dental separators, and the test results are listed in Table 3.

[0071] In Table 1, Table 2, and Table 3, the difference between the examples and the comparative examples lies in the different contents of the bone regeneration material in the porous layer.

[0072] In Table 1 and Table 2, in the osteocyte differentiation test, a dental isolation membrane was cut into square membrane pieces with a side length of 1 cm and placed in a 24-well plate. 60 microliters (λ) of rat bone marrow mesenchymal stem cells (BMSC) containing 3×10 4 cells were seeded on the membrane pieces and placed in a cell culture incubator at 37°C and a carbon dioxide concentration of 5% for one hour to allow the cells to adhere to the membrane pieces.

[0073] After confirming that the cells had completely adhered, the culture medium was added to the 24-well plate to 500 microliters and placed in the cell culture incubator at 37°C and a carbon dioxide concentration of 5% overnight. Then, the culture medium in the 24-well plate was removed, osteogenic induction culture medium was added, and it was placed in the cell culture incubator at 37°C and a carbon dioxide concentration of 5% and changed every 2 to 3 days for a total of 14 or 12 days of culture.

[0074] After 14 or 12 days of culture, the culture medium in the 24-well plate was removed, the cells were washed with phosphate buffer solution (PBS), fixed with formalin, and then washed with phosphate buffer solution (PBS) again. Finally, 500 microliters of para-Nitrophenylphosphate (p-NPP) with a concentration of 5 mg / ml was added to the 24-well plate. After standing at room temperature in the dark for 45 minutes, 100 microliters of the sample was taken and the absorbance was measured at a wavelength of 405 nm.

[0075] In Table 3, the tensile stress (dry) refers to the tensile stress of the dental isolation membrane tested at a temperature of 25°C and an absolute humidity of 50%. The tensile stress (wet) refers to the tensile stress of the dental isolation membrane after being immersed in physiological saline at 37°C for 30 minutes.

[0076] Table 1

[0077] Comparative Example 1 Example 1 Example 2 Content of bone regeneration material in the porous layer 0 wt% 48 wt% 75 wt% Absorbance value after 14 days of culture (-) 1.0 1.5 1.75

[0078] Table 2

[0079]

[0080]

[0081] Table 3

[0082] Example 5 Example 6 Example 7 Comparative Example 3 Content of bone regeneration material in the porous layer 50 wt% 66.6 wt% 75 wt% 0 wt% Thickness of dental separator film (μm) 150 150 100 350 <![CDATA[Tensile stress (dry) (Kgf / cm 2 )]]> 7.9 7.8 8.6 5.3 <![CDATA[Tensile stress (wet) (Kgf / cm 2 )]]> 4 3.5 4.2 7.4

[0083] As can be seen from the results in Table 1, when a bone regeneration material is added to the dental isolation film, it can help the growth of bone cells. Moreover, the higher the concentration of the bone regeneration material, the better the effect of helping the growth of bone cells.

[0084] As can be seen from the results in Table 2, when the concentration of the bone regeneration material is too high, it will instead inhibit the growth of bone cells. Therefore, in the porous layer, the content of the bone regeneration material is preferably 50 weight percent to 78 weight percent.

[0085] As can be seen from the results in Table 3, adding a bone regeneration material to the dental isolation film can not only help the growth of bone cells, but also improve the mechanical strength of the dental isolation film. Even in the case of a relatively thin thickness, the dental isolation film in the dry state can still have good tensile stress.

[0086] [Advantages of the Embodiment]

[0087] One of the beneficial effects of the present invention is that the dental isolation film provided by the present invention can improve the physical properties of the dental isolation film and enable the dental isolation film to achieve the effect of helping the growth of bone cells through the technical solution of "taking the total weight of the porous layer 10 as 100 weight percent, the weight of the porous structure 11 is 22 weight percent to 50 weight percent, and the weight of the bone regeneration material 12 is 50 weight percent to 78 weight percent".

[0088] Furthermore, the dental isolation film of the present invention contains a high content of bone regeneration material. In addition to helping the growth of bone cells, it can also improve the mechanical strength of the dental isolation film and replace a part of the bone powder. Therefore, during use, the dental isolation film can be directly contacted with the bone defect or bone powder of the alveolar bone.

[0089] Furthermore, due to the setting of the hydrophilic layer, the dental isolation film of the present invention can absorb water to reach a plastic softened state within a short time (5 minutes) to adapt to different three-dimensional shapes. In addition, the dental isolation film of the present invention can firmly adhere to the affected area (such as the bone defect area), and can provide sufficient growth space for the affected area to help the repair, regeneration and integration of the affected area.

[0090] The content disclosed above is only the preferred feasible embodiment of the present application, and does not limit the protection scope of the claims of the present application. Therefore, all equivalent technical changes made by using the content of the specification and drawings of the present application are included in the protection scope of the claims of the present application.

Claims

1. A dental isolation membrane, characterized in that: The dental isolation film comprises: A porous layer, the porous layer comprising a porous structure and a bone regeneration material attached to the porous structure, the porous structure being formed of a biodegradable polymer; wherein, based on the total weight of the porous layer being 100 weight percent, the weight of the porous structure is 22 weight percent to 50 weight percent, and the weight of the bone regeneration material is 50 weight percent to 78 weight percent; and A hydrophilic layer, which is coated on the porous layer, and the hydrophilic layer is formed of a hydrophilic substance; Wherein, the dental isolation membrane contacts the alveolar bone or bone powder.

2. The dental isolation film according to claim 1, characterized in that: The thickness of the dental isolation film is 100 micrometers to 300 micrometers.

3. The dental isolation membrane according to claim 1, characterized in that: The porosity of the porous layer is 10% to 30%.

4. The dental isolation film according to claim 1, characterized in that: The bone regeneration material includes calcium phosphate.

5. The dental isolation film according to claim 1, characterized in that: The size of the bone regeneration material is 10 microns to 30 microns.

6. The dental isolation film according to claim 1, characterized in that: The biodegradable polymer includes polylactic acid, and the content of the polylactic acid in the biodegradable polymer is greater than or equal to 50 weight percent.

7. The dental isolation film according to claim 1, characterized in that: The weight average molecular weight of the biodegradable polymer is 100,000 g / mol to 600,000 g / mol.

8. The dental isolation film according to claim 1, characterized in that: The hydrophilic substance includes hyaluronic acid.

9. A method for producing a dental isolation membrane, characterized in that: The manufacturing method comprises: Prepare a polymer solution, wherein the polymer solution comprises a solvent, a biodegradable polymer and a bone regeneration material; when the solid content in the polymer solution is 100 weight percent, the content of the biodegradable polymer is 22 weight percent to 50 weight percent, and the content of the bone regeneration material is 50 weight percent to 78 weight percent; Performing an electrospinning process to prepare a porous layer using the polymer solution; and The porous layer is immersed in a treatment solution to form a hydrophilic layer covering the porous layer.

10. The manufacturing method according to claim 9, characterized in that: In the step of preparing the polymer solution, the solvent is selected from the group consisting of acetone, butanone, ethylene glycol, isopropanol, chitosan, N,N-dimethylformamide, dimethylacetamide, dimethyl sulfoxide and diethyl ether.

11. The manufacturing method according to claim 9, characterized in that: In the electrospinning process, the ejection speed of the polymer solution is 5 ml / hour to 10 ml / hour.

12. The manufacturing method according to claim 9, characterized in that: In the step of infiltrating the porous layer, the treatment solution contains 10 weight percent to 30 weight percent of hyaluronic acid.

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