Oral composition material and method for detecting biological adaptability thereof

Abstract

According to the oral composition material and the biological adaptability detection method thereof provided by the invention, the fluorine-containing glass compound and the polymerized alkylenic acid compound are reacted to generate the oral composition material, and the oral composition material is mixed into the caries damaged tooth filling material to enhance the caries resistance of the residual tooth part of a patient; the preparation method comprises the following steps: carrying out an acid-base reaction on a fluorine-containing glass compound and a polymerized alkylenic acid compound in a molar ratio of 1: (1-5) in a water environment to generate a hydrogel-like substance, curing the hydrogel-like substance, and grinding to obtain powdery granular silanide with different particle size grades; according to a specific tooth filling shape, needing to be repaired, of a caries patient, the powdery granular silanide with a corresponding particle size grade is selected, and a cysteine methacrylate material and a glass ion adhesive material are used for bonding on the surface of a cavity repairing filling solid, so that the cavity repairing filling solid is formed. The further lesion development of the repaired caries patient can be correspondingly improved and prevented according to the caries lesion condition, and sufficient biological adaptability is achieved.

Description

Technical Field

[0001] The present invention relates to the field of biomedical materials, and in particular to an oral composition material and a biocompatibility detection method thereof. Background Art

[0002] The research and development of oral composite materials is an eternal topic in the field of dental medicine and has a wide range of applications. With the improvement and enhancement of people's living standards, the demand for the functionality and protection of oral composite materials as tooth filling materials is becoming increasingly higher, and the improvement of their bioadaptability has also become a further demand.

[0003] In the real use environment, that is, the human oral environment under different dietary hygiene and living habits, the presence of various microorganisms will also cause damage to tooth filling materials and tooth residues. Once the use environment is conducive to the growth and reproduction of microbial flora, the corrosion caused by the microbial flora will significantly shorten the service life of tooth filling materials. The environmental adaptability test of general tooth filling materials only considers the effects of temperature and humidity, ignoring the effects of microbial species in the real use environment. The conclusions drawn about environmental adaptability are not accurate, and it is impossible to accurately draw the correct conclusions about the environmental adaptability of oral composition materials.

[0004] Therefore, it is very necessary to study the microbial adaptability of oral composition materials for the improvement of materials. Summary of the invention

[0005] In view of the above-mentioned issues, in order to solve the technical problems in the above-mentioned prior art, the present invention provides an oral composition material, and studies a method for detecting the microbial resistance adaptability of the oral composition material, selects corresponding microorganisms for mold tests according to the oral environment of a specific user population, and carefully studies whether the mold resistance of the oral composition material meets the use requirements, supplements the vacancy in the study of microbial adaptability in the environmental adaptability of the oral composition material, and more comprehensively and fully assesses the adaptability of the oral composition material in the oral environment of a specific user population and the factors affecting its service life.

[0006] Preferably, the present invention provides an oral composition material, which is generated by the reaction of a fluorine-containing glass compound and a polymeric alkene acid compound, and is mixed into a dental filling material for caries-damaged teeth to enhance the caries resistance of the remaining teeth of the patient. The fluorine-containing glass compound and the polymeric alkene acid compound undergo an acid-base reaction in a water environment at a molar ratio of 1:1 to 5 to generate a hydrogel-like substance, and the hydrogel-like substance is solidified and ground to obtain powdery granular silanes of different particle size grades. The powdery granular silanes of corresponding particle size grades are selected according to the specific tooth filling shape that needs to be repaired by the dental patient, and are bonded to the surface of the cavity repair filling solid using a cysteine ​​methacrylate material and a glass ion cement material.

[0007] In addition, preferably, in the oral composition material of the present invention, the particle size grades of the powdery particulate silane include at least 3 grades, and the difference between each grade is 2 to 10 times.

[0008] Furthermore, preferably, in the oral composition material of the present invention, the difference between the lowest grade and the highest grade among the at least three grades is no more than 20 times.

[0009] In addition, preferably, in the oral composition material of the present invention, the weight ratio of the cysteine ​​methacrylate material to the glass ionomer cement material is 3-5:100.

[0010] In addition, preferably, in the oral composition material of the present invention, the glass ionomer cement material comprises one or more of aluminum oxide, zirconium oxide, titanium dioxide and bioactive glass material.

[0011] In addition, preferably, in the oral composition material described in the present invention, the glass ionomer cement material contains one or more of methacryloyloxyethyl phosphorylcholine, methacrylic acid sulfobetaine, phosphatidylcholine, dimethylpropionic acid thiophene, fenugreek, tetrahydropyrimidine, betaine, N-dimethylaminopropane sulfonate, N-(3-methacrylimide)propyl-N, and 3-(2′-vinylpyridine)propane sulfonate.

[0012] In addition, preferably, in the oral composition material described in the present invention, the powder granular silane of the corresponding particle size grade is selected according to the following conditions: when the specific tooth filling shape that the caries patient needs to repair does not have a side opening, the powder granular silane of the minimum particle size grade is selected; when the specific tooth filling shape that the caries patient needs to repair has a side opening width greater than 1 mm, the powder granular silane of the maximum particle size grade is selected; when the specific tooth filling shape that the caries patient needs to repair has a side opening width less than or equal to 1 mm, the powder granular silane of the intermediate particle size grade other than the maximum particle size grade and the minimum particle size grade is selected.

[0013] Furthermore, preferably, in the oral composition material described in the present invention, in addition to the specific tooth filling shape that needs to be repaired by the caries patient, the powdered granular silane of the corresponding particle size grade is further selected according to the thinnest wall thickness corresponding to the specific tooth cavity that needs to be repaired.

[0014] In addition, preferably, the present invention also provides a method for detecting the biocompatibility of an oral composition material, comprising the following steps: sampling the oral composition material of the present invention, preparing an inorganic salt solution, an immersion solution and sterile water to prepare a test sample, and preparing a control sample of the oral composition material of the present invention; on a bracket located at the center of the test box, according to the required technical state, hanging the test sample and the control sample close to each other vertically to ensure that they are subjected to the same test environment, and pre-treating the test sample and the control sample for 4 hours under the test conditions of a temperature of 30°C and a relative humidity of 95%RH; The test and control samples were inoculated at the same time and under the same conditions. The mixed spore suspension was sprayed in the form of mist on the exposed inner and outer surfaces of the test samples and the control samples with a sprayer. The door of the chamber should be closed immediately after the inoculation, and the mold test was carried out for 28 days at 30°C and 95% RH. After 7 days, the mold growth of the test samples and the control samples was checked to confirm that the environment in the test chamber was suitable for mold growth. When it was confirmed that at least 90% of the surface of each control sample at the same level as the test sample was covered with mold, the test sample was confirmed and sterilized. The biological adaptability of the test sample was evaluated with reference to the biological growth index of the oral environment.

[0015] The present invention can provide an oral composition material that can predict the lesion development trend corresponding to the lesion status of caries and prevent the accelerated deterioration of caries lesions after restoration, and the oral composition material has sufficient biocompatibility. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required for use in the description of the embodiments are briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work, among which: Figure 1 A flow chart showing steps for preparing an oral composition material according to one embodiment of the present invention. DETAILED DESCRIPTION

[0017] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Other embodiments or variations obtained based on the embodiments in the present application by ordinary technicians in this field without creative work are all within the scope of protection of this application.

[0018] Figure 1 A flow chart showing steps for preparing an oral composition material according to one embodiment of the present invention.

[0019] The preparation method of the oral composition material according to one embodiment of the present invention is as follows Figure 1 As shown, the method comprises the following steps: using fluorine-containing glass compounds and polymeric alkene acid compounds to react and mix them into caries-damaged tooth filling materials to enhance the caries resistance of the remaining tooth parts of the patient; using fluorine-containing glass compounds and polymeric alkene acid compounds to react with an acid-base reaction in a water environment at a molar ratio of 1:1-5 to generate a hydrogel-like substance; solidifying the hydrogel-like substance and obtaining powdery granular silanes of different particle size grades through grinding; selecting the powdery granular silanes of corresponding particle size grades according to the specific tooth filling shape to be repaired by the caries patient; and bonding the surface of the cavity repair filling solid with cysteine ​​methacrylate material and glass ion cement material.

[0020] Corresponding to the above-mentioned embodiments, a plurality of comparative examples outside the end point values ​​of the molar ratio range are provided. Among them, the molar ratio of the fluorine-containing glass compound and the polymerized alkene acid compound in comparative example 1 is 1:0.1; the molar ratio of the fluorine-containing glass compound and the polymerized alkene acid compound in comparative example 2 is 1:0.5; the molar ratio of the fluorine-containing glass compound and the polymerized alkene acid compound in comparative example 3 is 1:0.95; the molar ratio of the fluorine-containing glass compound and the polymerized alkene acid compound in comparative example 4 is 1:5.05; the molar ratio of the fluorine-containing glass compound and the polymerized alkene acid compound in comparative example 5 is 1:5.50; the molar ratio of the fluorine-containing glass compound and the polymerized alkene acid compound in comparative example 6 is 1:6.

[0021] In addition, preferably, in the oral composition material described in an embodiment of the present invention, the particle size grades of the powdery particulate silane include at least 3 grades, and the difference between each grade is 2 to 10 times.

[0022] Corresponding to the above preferred embodiment, a plurality of comparative examples outside the end point values ​​of the grade difference range are provided. Among them, the three grades of comparative example 7 differ by 1 times; the three grades of comparative example 8 differ by 1.9 times; the three grades of comparative example 9 differ by 10.1 times; the three grades of comparative example 10 differ by 11 times.

[0023] Furthermore, preferably, in the oral composition material according to an embodiment of the present invention, the difference between the lowest grade and the highest grade among the at least three grades is no more than 20 times.

[0024] Corresponding to the above preferred embodiment, a plurality of comparative examples outside the end value of the grade difference range are provided. Among them, the difference between the lowest grade and the highest grade among the three grades of comparative example 11 is 21 times; the difference between the lowest grade and the highest grade among the three grades of comparative example 12 is 30 times.

[0025] In addition, preferably, in the oral composition material described in one embodiment of the present invention, the weight ratio of the cysteine ​​methacrylate material to the glass ionomer cement material is 3-5:100.

[0026] Furthermore, preferably, in the oral composition material described in one embodiment of the present invention, the glass ionomer cement material comprises one or more of aluminum oxide, zirconium oxide, titanium dioxide and bioactive glass material.

[0027] In addition, preferably, in the oral composition material described in one embodiment of the present invention, the glass ionomer cement material contains one or more of methacryloyloxyethyl phosphorylcholine, methacrylic acid sulfobetaine, phosphatidylcholine, dimethylpropionic acid thiophene, fenugreek, tetrahydropyrimidine, betaine, N-dimethylaminopropane sulfonate, N-(3-methacrylimide)propyl-N, and 3-(2′-vinylpyridine)propane sulfonate.

[0028] In addition, preferably, in the oral composition material described in one embodiment of the present invention, the powder granular silane of the corresponding particle size grade is selected according to the following conditions: when the specific tooth filling shape that the caries patient needs to repair does not have a side opening, the powder granular silane of the minimum particle size grade is selected; when the specific tooth filling shape that the caries patient needs to repair has a side opening width greater than 1 mm, the powder granular silane of the maximum particle size grade is selected; when the specific tooth filling shape that the caries patient needs to repair has a side opening width less than or equal to 1 mm, the powder granular silane of the intermediate particle size grade other than the maximum particle size grade and the minimum particle size grade is selected.

[0029] Furthermore, preferably, in the oral composition material described in one embodiment of the present invention, in addition to the specific tooth filling shape that needs to be repaired by the caries patient, the powdered granular silane of the corresponding particle size grade is further selected according to the thinnest wall thickness corresponding to the specific tooth cavity that needs to be repaired.

[0030] In addition, preferably, a method for detecting the biocompatibility of an oral composition material according to an embodiment of the present invention comprises the following steps: sampling the oral composition material of the present invention, preparing an inorganic salt solution, an immersion solution and sterile water to prepare a test sample, and preparing a control sample of the oral composition material of the present invention; on a bracket located at the center of the test box, according to the required technical state, hanging the test sample and the control sample close to each other vertically to ensure that they are subjected to the same test environment, and pre-treating the test sample and the control sample for 4 hours under the test conditions of a temperature of 30°C and a relative humidity of 95%RH; The samples and control samples are inoculated at the same time and under the same conditions. The mixed spore suspension is sprayed in the form of mist on the exposed inner and outer surfaces of the test samples and the control samples with a sprayer. The door of the chamber should be closed immediately after the inoculation is completed, and the mold test is carried out for 28 days at 30°C and 95% RH. After 7 days, the mold growth of the test samples and the control samples is checked to confirm that the environment in the test chamber is suitable for mold growth. When it is confirmed that at least 90% of the surface of each control sample at the same level as the test sample is covered with mold, the test sample is confirmed and sterilized. The biological adaptability of the test sample is evaluated with reference to the biological growth indicators of the oral environment.

[0031] The present invention can provide an oral composition material that can predict the lesion development trend corresponding to the lesion status of caries and prevent the accelerated deterioration of caries lesions after restoration, and the oral composition material has sufficient biocompatibility.

[0032] In the embodiment of the present invention, the microorganisms are divided into five levels according to their growth degree. L1 is basically no mold growth; L2 is scattered, rare or very limited mold growth; L3 is intermittent spread of mold on the surface of the material or loose distribution of colonies, or continuous extension of hyphae on the entire surface, and the surface of the material under the single mold is still clearly visible; L4 is a large number of molds are found to grow, and the material begins to show corrosion and permeability changes not only on the surface but also in the structure; L5 is serious and dense mold growth.

[0033] After the mold test, sample inspection and sterilization experiments are completed, refer to the above classification standards, analyze the mold growth conditions and provide more accurate reference indicators for the oral environment of specific groups of people, further evaluate the test results, assess the growth status of mold on the sample surface, and determine the mold resistance level according to the above standards.

[0034] In addition, the fungal species group 1 includes: Aspergillus niger AS3.3928, the test material is vinyl resin; Aspergillus terreus AS3.3935, the test material is cloth-based material; Aspergillus variotii AS3.3928, the test material is vinyl resin; Aspergillus niger AS3.3928, the test material is vinyl resin; Aspergillus niger AS3.4253, the test material is cortex; Penicillium funiculum AS3.4302, the test material is plastic material; Penicillium viride AS3.4302, the test material is plastic material; and Penicillium brachypodioides AS3.3985, the test material is rubber-based material.

[0035] Fungal species group 2 includes: Aspergillus flavus AS3.3950, the test material is cortical material; Aspergillus versicolor AS3.3885, the test material is cortical material; Penicillium funiculosum AS3.3875, the test material is vinyl resin; Chaetomium globosum AS3.4254, the test material is cellulose; Aspergillus niger AS3.3928, the test material is vinyl resin.

[0036] The samples obtained in all embodiments of the present invention passed the above test and obtained the microbial flora growth level L1, that is, basically no mold growth was found, while Comparative Examples 1 to 12 outside the scope of the present invention all showed varying degrees of mold growth, that is, they did not reach the L1 level, but were between L2 and L5.

[0037] Compared with the prior art, the present invention has the following beneficial effects: 1) Corresponding microorganisms are selected for testing in a specific use environment. A single strain or a group of strains can be selected. The strain combinations are diverse, and the mold resistance of oral composition materials can be more comprehensively assessed; 2) The gap in the study of microbial adaptability in the environmental adaptability of oral composition materials is supplemented, and the adaptability of textile coating oral composition materials in the oral environment of a specific population and the factors affecting their service life are more comprehensively and fully assessed; 3) The anti-fouling effect of the oral composition materials on harmful substances to teeth, such as the biofilm that can be blocked, is improved.

[0038] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

[0039] Each embodiment in this specification is described in a related manner, and the same or similar parts between the embodiments can be referenced to each other, and each embodiment focuses on the differences from other embodiments.

[0040] The above is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed by the present invention should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

[0041] The above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the embodiments here. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. An oral composition material, produced by reacting a fluorine-containing glass compound with a polymeric alkene acid compound, and mixed into a filling material for a tooth damaged by caries to enhance the caries resistance of the remaining teeth of the patient, characterized in that: Fluorine-containing glass compounds and polymerized alkene acid compounds are used in a 1:1-5 molar ratio to produce an acid-base reaction in a water environment to form a hydrogel-like substance. The hydrogel-like substance is solidified and ground to obtain powdery silanized particles of different particle size grades. According to the specific tooth filling shape that needs to be repaired by the caries patient, the powder granular silanized material with the corresponding particle size grade is selected, and the surface of the cavity repair filling solid is bonded with cysteine ​​methacrylate material and glass ion cement material.

2. The oral composition material according to claim 1, characterized in that: The particle size grades of the powdery granular silanide include at least 3 grades, and the difference between each grade is 2 to 10 times.

3. The oral composition material according to claim 2, characterized in that: The difference between the lowest level and the highest level among the at least 3 levels does not exceed 20 times.

4. The oral composition material according to claim 1, characterized in that: The weight ratio of the cysteine ​​methacrylate material to the glass ionomer cement material is 3-5:

100.

5. The oral composition material according to claim 1, characterized in that: The glass ionomer cement material comprises one or more of alumina, zirconia, titanium dioxide and bioactive glass material.

6. The oral composition material according to claim 1, characterized in that: The glass ionomer cement material comprises one or more of methacryloyloxyethyl phosphorylcholine, methacrylic acid sulfobetaine, phosphatidylcholine, dimethylpropionate, trigonelline, ectoine, betaine, N-dimethylaminopropane sulfonate, N-(3-methacrylimide)propyl-N, and 3-(2′-vinylpyridine)propane sulfonate.

7. The oral composition material according to claim 2, characterized in that: The powdery particulate silane compound of the corresponding particle size grade is selected according to the following conditions: When the specific tooth filling shape that needs to be restored by the caries patient does not have a side opening, selecting the powder particulate silanized material of the smallest particle size grade; When the specific tooth filling shape to be repaired by the caries patient has a side opening width greater than 1 mm, the powder granular silanized material of the largest particle size grade is selected; When the specific tooth filling shape to be repaired by the caries patient has a side opening width of less than or equal to 1 mm, the powdery particulate silanide of the intermediate particle size class except the maximum particle size class and the minimum particle size class is selected.

8. The oral composition material according to claim 7, characterized in that: In addition to the specific tooth filling shape that needs to be repaired by the caries patient, the powder granular silanized material of the corresponding particle size grade is further selected according to the thinnest wall thickness corresponding to the specific tooth cavity that needs to be repaired.

9. A method for detecting the biocompatibility of an oral composition material, characterized in that: The following steps are involved: Sampling the oral composition material according to any one of claims 1 to 8, preparing an inorganic salt solution, an immersion solution and sterile water to prepare a test sample, and preparing a control sample without the oral composition material according to any one of claims 1 to 8; On the bracket located in the center of the test chamber, hang the test sample and the control sample vertically close to each other according to the required technical status to ensure that they are subjected to the same test environment. Pre-treat the test sample and the control sample for 4 hours under the test conditions of temperature of 30°C and relative humidity of 95%RH; Inoculate the test sample and the control sample at the same time and under the same conditions, and spray the mixed spore suspension in the form of mist on the exposed inner and outer surfaces of the test sample and the control sample with a sprayer. After the inoculation is completed, the door of the chamber should be closed immediately, and the mold test should be carried out for 28 days at 30℃ and 95% RH; After 7 days, check the mold growth of the test samples and control samples to confirm that the environment in the test chamber is suitable for mold growth. When it is confirmed that at least 90% of the surface of each control sample at the same level as the test sample is covered with mold, confirm the test sample and sterilize it; The biological adaptability of the test samples was evaluated by referring to the biological growth indicators of the oral environment.

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