Disinfectant and / or antibacterial article and method for producing same

By immersing elastic polymer materials in weakly acidic hypochlorous acid to store and release molecular hypochlorous acid, the method addresses bacterial contamination in soft lining materials for dentures, ensuring antibacterial and sterilizing effects while preserving material properties.

JP7620320B2Active Publication Date: 2025-01-23TOKUYAMA DENTAL CORP
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Patent Information

Application Number
JP2021507316
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2019-03-15
Filing Date
2020-03-13
Publication Date
2025-01-23
Estimated Expiration
2040-03-13

AI Technical Summary

Technical Problem

Existing soft lining materials for dentures, which are used to cushion the impact of occlusal forces, are prone to bacterial contamination due to their rough molecular structure, leading to mucous membrane diseases and bad odors, and incorporating antibacterial inorganic powders affects viscoelasticity and transparency.

Method used

A method involving immersing an elastic polymer material in a weakly acidic hypochlorous acid solution to store molecular hypochlorous acid, which is then slowly released, providing antibacterial and sterilizing properties without using inorganic powders, maintaining the material's physical properties.

Benefits of technology

The method allows for sustained antibacterial and sterilizing effects without impairing the material's viscoelasticity, effectively preventing bacterial growth and maintaining transparency.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention provides a disinfectant and / or antibacterial article characterized in that at least some of the surface of the article is constituted of a flexible member formed from a polymeric elastic material having a solubility parameter (SP value) of 10 (MPa1 / 2) or greater but not greater than 25 (MPa1 / 2), that the polymeric elastic material, which constitutes the flexible member, holds molecular hypochlorous acid therein by sorption, and that the article gradually releases the molecular hypochlorous acid through the surface of the flexible member into the ambient atmosphere to thereby exhibit disinfectant and / or antibacterial properties.
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Description

[Technical field]

[0001] The present invention relates to an article having a flexible member made of a polymer elastomer, such as a denture lined with a soft lining material, the lining portion of which has been given disinfectant and / or antibacterial properties, and a method for producing the same. [Background technology]

[0002] With the advent of an aging society, the number of patients who require dentures is on the rise. Among such denture patients, elderly patients in particular generally suffer from significant bone resorption in the alveolar ridge, which tends to increase the occlusal force per unit area. In addition, the alveolar ridge mucosa also becomes thin due to senile atrophy, so the impact of occlusion and chewing pressure is not absorbed but is transmitted directly to the alveolar bone. For these reasons, the number of patients who suffer from pain due to the thin mucosa sandwiched between the hard resin denture base and the hard alveolar bone being squeezed and damaged every time they bite is rapidly increasing.

[0003] In such difficult cases, making a denture base only from the commonly used methyl methacrylate resin does not provide good results in terms of denture maintenance, stability, and support. Therefore, it is necessary to line the mucosal surface of the resin denture base with a soft material to compensate for the lost viscoelasticity of the alveolar ridge mucosa and provide cushioning to absorb the impact during occlusion. Soft lining materials (also called soft reline materials) and mucosa conditioners (also called tissue conditioners) are typical soft materials for denture base lining used for such purposes, that is, to overcome various obstacles caused by the hard material of the denture base pressing against the mucosa underneath the base (hereinafter, these soft materials for lining the mucosal surface of the denture base are collectively referred to as "soft lining materials").

[0004] Although soft lining materials have such excellent effects, in order to have the necessary flexibility, their molecular structure must be coarse compared to hard materials such as methyl methacrylate resin, etc. This makes them susceptible to physical and chemical contamination, and for example, various bacteria that adhere to the denture during use can grow, causing problems such as mucosal diseases and bad odors.

[0005] To solve such problems, it has been proposed to incorporate an antibacterial material into the soft lining material. For example, Patent Document 1 describes an antibacterial soft lining material that contains a specific phosphate-based silver compound as an antibacterial component. In addition, Patent Document 2 describes an antibacterial dental silicone resin composition that contains inorganic particles that are surface-treated with an antibacterial organosilane compound having a specific quaternary ammonium group as a composition for a silicone resin material for soft lining that can prevent the proliferation of bacteria that come into direct contact with the material for a long period of time. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] Japanese Patent Application Publication No. 8-252270 [Patent Document 2] JP 2004-352617 A Summary of the Invention [Problem to be solved by the invention]

[0007] The techniques described in Patent Documents 1 and 2 are both for uniformly dispersing antibacterial components, which are inorganic powders, in a soft lining material, and not only do they require advanced kneading using a kneader or the like, but also require careful component adjustments in order to obtain a soft lining material with the desired viscoelasticity, since the viscoelasticity, which is the most important physical property of the soft lining material, is affected by the shape, surface properties, particle size, amount of the antibacterial component particles to be blended, etc. Furthermore, since silver compounds are themselves colored, their addition inevitably leads to a decrease in transparency (although to different degrees, in principle).

[0008] Therefore, an object of the present invention is to provide a technique capable of imparting antibacterial properties to a soft lining material without using an antibacterial component which is an inorganic powder. [Means for solving the problem]

[0009] The present inventors have conducted extensive research to solve the above problems. As a result, they have confirmed the phenomenon that when a soft lining material is immersed in and left in a weakly acidic hypochlorous acid aqueous solution and then removed, molecular hypochlorous acid is gradually released from the soft lining material, and the antibacterial and / or disinfecting effect is sustained for a certain period of time not only in the soft lining material but also in the surrounding atmosphere. As a result of further detailed research into this phenomenon, they have found that this phenomenon is not limited to soft lining materials, but is also observed in other polymeric elastic materials whose solubility parameters (SP values) are significantly lower than that of water, and have completed the present invention.

[0010] That is, in the first embodiment of the present invention, the solubility parameter (SP value) is 10 (MPa 1 / 2 ) or more, 25 (MPa 1 / 2 ) or less, at least a portion of the surface of the flexible member is formed from a polymeric elastic material that forms the flexible member, molecular hypochlorous acid is sorbed and held inside the polymeric elastic material that forms the flexible member, and the molecular hypochlorous acid is gradually released from the surface of the flexible member into the surrounding atmosphere, thereby exhibiting disinfecting and / or antibacterial properties.

[0011] In the above disinfecting and / or antibacterial article, the polymeric elastic material preferably has a hardness of 20 or more and 80 or less in Shore A hardness, or 5 or more and 50 or less in Shore E hardness.

[0012] A second aspect of the present invention is a method for producing the disinfecting and / or antibacterial article, comprising the steps of: 1 / 2 ) or more, 25 (MPa 1 / 2) or less, and contacting the flexible member of the article to be treated with a weakly acidic aqueous hypochlorous acid solution having an effective chlorine concentration of 10 ppm or more and 1000 ppm or less to sorb molecular hypochlorous acid in the weakly acidic aqueous hypochlorous acid solution into the polymeric elastic material forming the flexible member.

[0013] The third aspect of the present invention is a solubility parameter (SP value) of 10 (MPa 1 / 2 ) or more, 25 (MPa 1 / 2 The disinfectant and / or antibacterial agent is for imparting disinfecting and / or antibacterial properties to a flexible member of a treated article, the flexible member being at least a part of the surface of which is formed from a polymeric elastic material having an effective chlorine concentration of 10 ppm or more and 1000 ppm or less, the disinfectant and / or antibacterial properties being characterized in that the disinfectant and / or antibacterial properties are primarily comprised of a weakly acidic aqueous hypochlorous acid solution having an effective chlorine concentration of 10 ppm or more and 1000 ppm or less.

[0014] The disinfecting and / or antibacterial agent has at least a part having a solubility parameter (SP value) of 10 (MPa 1 / 2 ) or more, 25 (MPa 1 / 2 ) or less of a soft lining material made of a polymeric elastic material or a tissue conditioner, and this includes a denture base or a denture having a restored part lined with said tissue conditioner, for imparting disinfecting and / or antibacterial properties to said restored part.

[0015] A third aspect of the present invention is a disinfecting and / or antibacterial article according to the first aspect of the present invention; or a flexible member for the article; and a disinfecting and / or antibacterial agent according to the second aspect of the present invention; A container for storing these; The packaging body has the above-mentioned structure, characterized in that the flexible member of the disinfecting and / or antibacterial article is contained in the container in an airtight and liquid-tight manner as is, or the flexible member for the article and the disinfecting and / or antibacterial agent are arranged so as to be in contact with each other. Effect of the Invention

[0016] According to the method of the present invention, for example, "at least a part of the solubility parameter (SP value) is 10 (MPa 1 / 2 ) or more, 25 (MPa 1 / 2 "A denture base or denture having a restoration lined with a soft lining material made of a polymer elastic material having a solubility parameter (SP value) of 10 (MPa 1 / 2 ) or more, 25 (MPa 1 / 2 For a "treated article" consisting of an article having at least a portion of its surface constituted by a flexible member formed of a polymeric elastic material having a molecular weight of 100 or less, the flexible member (corresponding to the denture base or the restored part of the denture) can be imparted with the sustained release of molecular hypochlorous acid by the simple procedure of contacting the flexible member with weakly acidic hypochlorous acid water. The disinfecting and / or antibacterial article of the present invention obtained in this manner is capable of disinfecting not only the surface of the flexible member but also the surrounding atmosphere for a certain period of time and inhibiting the growth of bacteria due to its sustained release of molecular hypochlorous acid.

[0017] Moreover, since there is no need to blend an antibacterial component made of inorganic powder when imparting disinfecting and / or antibacterial properties, the inherent physical properties of the flexible member are not impaired. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] As mentioned above, the present invention is based on the discovery of the phenomenon that when a polymeric elastic material, such as a soft material for lining, whose solubility parameter (SP value) is significantly lower than that of water is immersed in a weakly acidic hypochlorous acid aqueous solution and then taken out, molecular hypochlorous acid is gradually released from the polymeric elastic material. The mechanism by which such a phenomenon occurs is not necessarily clear, but since water does not penetrate into the polymeric elastic material after the immersion, it is presumed that the following mechanism is involved. That is, hypochlorous acid exists as an electrically neutral molecule in a weakly acidic hypochlorous acid aqueous solution. Therefore, when a non-polar substance such as a polymeric elastic material, whose SP value is significantly lower than that of water, is immersed in a weakly acidic hypochlorous acid aqueous solution, it is presumed that the solute molecular hypochlorous acid selectively migrates into the polymeric elastic material, since it can exist more stably in the polymeric elastic material than in water in a polar environment. In addition, it is estimated that the molecular hypochlorous acid that migrates into the polymer elastic material is absorbed or adsorbed (sorbed) between the molecules that make up the polymer elastic material with a certain affinity, and therefore, even if it is removed from the aqueous solution, it is not released into the atmosphere all at once, but is released slowly (gradually) over time.

[0019] The form of hypochlorous acid in an aqueous solution changes depending on the pH. Specifically, in the weak acidic region of pH 3 to 6 (hereinafter, A to B may be simply written as "A to B"), most of the hypochlorous acid exists as molecular hypochlorous acid (HClO), and in the basic region of pH 9 or higher, it exists as dissociated hypochlorous acid ions (OCl - In the strongly acidic range (for example, below pH 3), the generation of chlorine molecules (Cl2) becomes predominant as the pH decreases. Among these forms, molecular hypochlorous acid (HClO) has an extremely high bactericidal effect, and its bactericidal effect is enhanced by ionic hypochlorous acid (OCl). - ) is said to be about 80 times stronger than that of the weakly acidic aqueous solution of hypochlorous acid with a pH of 3 to 6, which contains a large amount of molecular hypochlorous acid with such a high bactericidal effect, and is relatively safe for the human body, so it is used as a disinfectant or bactericide in various fields such as medicine, dentistry, agriculture, and food processing.

[0020] The disinfecting and / or antibacterial article according to the first embodiment of the present invention has a solubility parameter (SP value) of 10 (MPa 1 / 2 ) or more, 25 (MPa 1 / 2 ) or less, molecular hypochlorous acid is sorbed and held inside the polymeric elastic material that forms the flexible member, and the molecular hypochlorous acid is gradually released from the surface of the flexible member into the surrounding atmosphere, thereby exhibiting disinfecting and / or antibacterial properties.

[0021] Here, the sorption of molecular hypochlorous acid into the inside of the polymeric elastic material forming the flexible member is performed by contacting the flexible member with a weakly acidic aqueous solution of hypochlorous acid. Therefore, except for the fact that molecular hypochlorous acid is sorbed into the inside of the polymeric elastic material, the disinfecting and / or antibacterial article of the present invention has a "solubility parameter (SP value) of 10 (MPa 1 / 2 )~25(MPa 1 / 2 There is no particular difference between this and a "treated article" consisting of an article at least a part of whose surface is constituted by a flexible member formed of a polymeric elastic material. Therefore, first, the treated article will be described.

[0022] At least a part of the surface of the article to be treated has a solubility parameter (SP value) of 10 (MPa 1 / 2 )~25(MPa 1 / 2 At least a part of the surface is made of a flexible member formed of a polymer elastic material. Here, the solubility parameter (SP value) is the square root of the cohesive energy density (MPa) (MPa 1 / 2 ), and is known as a parameter that can be used as an indicator when evaluating the solubility of materials in solvents, the solvent resistance of polymeric materials, and the aggregation and decomposition properties of fine particles in solvents. The SP value of water, which is highly polar and has hydrogen bonds, is 47.9 (MPa 1 / 2 The polymer elastic material used as the material for the flexible member in the present invention has a high SP value of 10 (MPa 1 / 2 )~25(MPa 1 / 2), preferably 10 (MPa 1 / 2 )~22(MPa 1 / 2 ), more preferably 10 (MPa 1 / 2 )~20(MPa 1 / 2 ) The SP value is 25 (MPa 1 / 2 If the SP value exceeds 10 (MPa), not only will it be difficult to adsorb molecular hypochlorous acid, but water may also penetrate inside. 1 / 2 ) is difficult to obtain. Examples of polymeric elastic materials that can be suitably used in the present invention include silicone rubber (SP value: about 15), natural rubber (NR) (SP value: about 16 to 18), isoprene rubber (IR) (SP value: about 17), styrene butadiene rubber (SBR) (SP value: about 17), ethylene propylene rubber (EPM, EPDM) (SP value: about 17), acrylic rubber (SP value: about 18 to 19), and urethane rubber (SP value: about 21). From the viewpoint of the amount of sorption of molecular hypochlorous acid, silicone rubber is preferred. From the viewpoint of the sorption speed, the Shore A hardness is preferably 20 to 80, or the Shore E hardness is preferably 5 to 50.

[0023] The flexible member may be entirely made of the polymeric elastic material, or may have all or only a part of its surface region made of the polymeric elastic material. The flexible member is arranged (with the part made of the polymeric elastic material exposed on the surface) so as to constitute at least a part of the surface of the article to be treated for the purpose of contact with the human body, anti-slip properties, cushioning properties, etc.

[0024] The main body of the article to be treated is not particularly limited, and a suitable one is used depending on the purpose and function of the article to be treated. In addition, when the main body of the article to be treated is not to be contacted with the weakly acidic hypochlorous acid water, it is preferable that the flexible member is detachable.

[0025] Examples of suitable treated articles include denture bases or dentures whose mucosal surface is lined with a silicone-based soft lining agent; denture bases or dentures whose mucosal surface has been adjusted with a silicone-based tissue conditioner; toilet seats, headrest covers (for office chairs or vehicle seats), shoe insoles, or slipper insoles whose back surface or the entire article is made of silicone resin; (electric) toothbrushes, writing utensils, and other everyday items whose grip portions are made of silicone resin in whole or in part; and the like.

[0026] In the disinfecting and / or antibacterial article of the present invention, the amount of molecular hypochlorous acid sorbed and retained inside the polymeric elastic material forming the flexible member can be set arbitrarily as long as it is equal to or less than the maximum sorption amount calculated from the product of the saturation sorption amount of the polymeric elastic material used {the amount of adsorption (mg) per 1 (g) of the polymeric elastic material at ambient temperature} and the amount used (g). The saturation sorption amount of the polymeric elastic material differs depending on the type of the polymeric elastic material and cannot be generally stated, but for example, the saturation sorption amount of dimethyl silicone rubber having a Shore A hardness of 35 to 45 at 25°C is about 35 (mg / g). Then, a sheet (surface area of ​​6 cm2) made of the dimethyl silicone rubber having the saturation sorption amount of molecular hypochlorous acid sorbed therein is prepared. 2 When a sample of about 1000g of water (approximately 100g / cm2 and a thickness of about 2mm) is left in the air at 25°C, the 2 It can release molecular hypochlorous acid at a rate of about 1000 mg / kg / hour. In the disinfecting and / or antibacterial article of the present invention, the amount of molecular hypochlorous acid sorbed and retained inside the polymeric elastic material forming the flexible member is preferably 1 to 40 (mg / g), and more preferably 3 to 30 (mg / g).

[0027] The disinfecting and / or antibacterial article of the present invention can be suitably produced by the following method using the article to be treated, which includes the steps of: preparing an article to be treated; and contacting the flexible member of the article to be treated with a weakly acidic aqueous hypochlorous acid solution having an effective chlorine concentration of 10 ppm to 1000 ppm to cause the molecular hypochlorous acid in the disinfecting and / or antibacterial agent to be sorbed into the polymeric elastic material forming the flexible member.

[0028] The weakly acidic hypochlorous acid aqueous solution has an effective chlorine concentration of 10 ppm to 1000 ppm from the viewpoint of efficiently sorbing an effective amount of molecular hypochlorous acid into the polymeric elastic material. Here, the effective chlorine concentration is a concentration measured by absorptiometry using an iodine reagent, and can be measured using an effective chlorine concentration measuring kit AQ-202 type (Shibata Scientific Co., Ltd.). In a weakly acidic hypochlorous acid metal salt aqueous solution having a pH of 3.0 to 5.5, hypochlorous acid is almost entirely present in molecular form, so the effective chlorine concentration essentially means the effective chlorine concentration derived from molecular hypochlorous acid. From the viewpoint of sorption efficiency and availability, the effective chlorine concentration is preferably 30 ppm to 900 ppm, particularly 50 ppm to 850 ppm.

[0029] The pH of the weakly acidic hypochlorous acid aqueous solution is usually about 3 to 6, and molecular hypochlorous acid can be stably dissolved within this pH range. The weakly acidic hypochlorous acid aqueous solution may contain additives such as fragrances and colorants within a range that does not adversely affect the stability of molecular hypochlorous acid.

[0030] The amount of the weakly acidic hypochlorous acid aqueous solution when contacting the flexible member with the weakly acidic hypochlorous acid aqueous solution is preferably set so that the total amount (mol) of molecular hypochlorous acid (or amount equivalent to available chlorine) contained in the aqueous solution used is 1.5 to 20 times, preferably 2 to 10 times, the amount (mol) of molecular hypochlorous acid (or amount equivalent to available chlorine) to be sorbed.

[0031] Although a saturation state is reached by a long contact time, for example, 7 hours or more, it is also possible to sorb a predetermined amount of molecular hypochlorous acid in a short time by adjusting the temperature and the available chlorine concentration of the weakly acidic hypochlorous acid aqueous solution.

[0032] The contact method is not particularly limited as long as it is a method that allows the flexible member of the article to be treated to come into contact with the weakly acidic hypochlorous acid aqueous solution, and for example, a method of immersing the article to be treated in the weakly acidic hypochlorous acid aqueous solution, a method of immersing the detached flexible member in the weakly acidic hypochlorous acid aqueous solution if the flexible member can be removed from the article to be treated, a method of attaching a woven fabric, nonwoven fabric, sponge, etc. that has been soaked in the weakly acidic hypochlorous acid aqueous solution to the surface of the flexible member, etc. can be used.

[0033] In addition, when the article to be treated is "a denture base or denture having a restoration lined at least in part with a soft relining material made of the polymeric elastic material" (hereinafter also referred to as "relining denture"), since the relining denture is used by patients on a daily basis, the surface of the soft relining material (flexible member) is often soiled by the adhesion of organic matter immediately after removal from the oral cavity. Since the presence of such dirt reduces the sorption efficiency of molecular hypochlorous acid, it is preferable to clean the surface of the relining material (flexible member) before the contact. In addition, when the soft relining material that has been given disinfecting and / or antibacterial properties is worn in the oral cavity, the sorbed molecular hypochlorous acid gradually decreases due to gradual release and decomposition, and the antibacterial effect decreases. Therefore, it is preferable to immerse the soft relining material again in a weakly acidic hypochlorous acid aqueous solution after wearing it in the oral cavity for a certain period of time, so that the molecular hypochlorous acid is sorbed into the soft relining material. An example of practical use is to clean the dentures with a brush before going to bed, and then immerse them in a weakly acidic aqueous solution of hypochlorous acid while sleeping.

[0034] Regarding the weakly acidic aqueous hypochlorous acid solution used for such a purpose, one that has the above-mentioned suitable effective chlorine concentration may be used as the disinfecting and / or antibacterial agent as it is, but in consideration of user convenience in terms of storage space, purchase frequency, and the like, it is preferable to use a high-concentration solution that has the above-mentioned suitable effective chlorine concentration when diluted at a specified dilution ratio as the disinfecting and / or antibacterial agent.

[0035] Such a weakly acidic aqueous hypochlorous acid solution that can be used as an agent for imparting disinfecting and / or antibacterial properties can be produced, for example, by an electrolysis method in which an aqueous sodium chloride solution is electrolyzed, a hydrochloric acid method in which hydrochloric acid is added to a basic aqueous hypochlorite solution, or an ion exchange method in which a raw aqueous solution of a hypochlorite solution is treated with an ion exchange resin.

[0036] In addition, the disinfecting and / or antibacterial article of the present invention and the flexible member for the article (the flexible member to which molecular hypochlorous acid has been previously sorbed) can be provided to consumers in a packaged product form. A disinfecting and / or antibacterial article of the present invention; or a flexible member for the article and the disinfecting and / or antibacterial agent; A container for storing these; The flexible member of the disinfecting and / or antibacterial article (the flexible member having molecular hypochlorous acid previously sorbed thereon) is either directly contained in the container or is disposed so that the flexible member for the article and the disinfecting and / or antibacterial agent are in contact with each other, and the flexible member is airtightly and liquidtightly contained in the container.

[0037] The packaged article may be a disinfectant and / or antibacterial article or a flexible member for the article (flexible member with molecular hypochlorous acid previously sorbed thereon) as long as molecular hypochlorous acid is sorbed on the flexible member in the package, and may be stored in the form of an "article to be treated" or a "flexible member with no molecular hypochlorous acid sorbed thereon" when stored in a container. If the flexible member and the weakly acidic hypochlorous acid aqueous solution come into contact with each other in the container and are stored without being opened for a certain period of time or more, the molecular hypochlorous acid in the weakly acidic hypochlorous acid aqueous solution will migrate into the flexible member and naturally become the "disinfectant and / or antibacterial article of the present invention" or the "flexible member for the article (flexible member with molecular hypochlorous acid sorbed therein)".

[0038] The container used in the above-mentioned package is not particularly limited as long as it can accommodate the contents in a liquid-tight and airtight manner, and for example, a bottle, a packaging bag, etc. can be used. The material of the container is not particularly limited, but from the viewpoint of usability and airtightness, it is preferable that it is a synthetic resin such as polyethylene, polypropylene, polyvinyl alcohol, or an ethylene-vinyl alcohol copolymer. In addition, from the viewpoint of the stability of the molecular hypochlorous acid present inside, these synthetic resin containers have a multi-layer structure, and the inner surface layer that comes into contact with the weakly acidic hypochlorous acid aqueous solution is preferably composed of a material such as glass, silica coating, or titania coating. In addition, in order to avoid decomposition by ultraviolet light, it is preferable that the container has light-shielding properties. EXAMPLES

[0039] In order to specifically explain the present invention, examples and comparative examples will be given below, but the present invention is not limited to these in any way.

[0040] First, the soft lining material, tissue conditioner, elastic body, resin, aqueous hypochlorous acid solution, and indicator used in the examples and comparative examples will be described. [Soft lining material] Silicone-based (cured product becomes silicone rubber. SP value: 15MPa 1 / 2 ) Softliner Tough Medium (Tokuyama Dental) Softliner Medium Soft (Tokuyama Dental) Acrylic type (cured product becomes acrylic rubber. SP value: 18-19MPa 1 / 2 ) Bioliner (manufactured by Nissin) [Mucosa conditioning material] Acrylic type (cured product becomes acrylic rubber. SP value: 18-19MPa 1 / 2 ) Tissue Care (Tokuyama Dental) Fictioner (manufactured by Nissin) [Elastic body] - Urethane rubber (SP value: 21MPa 1 / 2 ) [resin] 66 nylon (SP value: 27.8MPa 1 / 2 ) Polyethylene (SP value: 16-17MPa 1 / 2 ) [Hypochlorous acid solution] Dentzia (Tokuyama Dental): Available chlorine concentration 370 ppm, pH 4.0 [Indicator] Powdered reagent for high residual chlorine concentration (Shibata)

[0041] (1) Evaluation method (1-1) Evaluation of hypochlorous acid release from soft lining materials, tissue conditioners, elastomers, and resins 1 For each material, a test plate measuring 25 mm long x 25 mm wide x 2 mm thick was prepared and immersed in 50 ml of various immersion solutions. After 12 hours, the test plate was removed, the solution adhering to the surface was wiped off, and the test plate was placed in an empty 50 ml glass bottle, and 0.08 g of indicator (powder) was placed on the surface of the test plate and 0.08 g on the bottom edge of the glass bottle. After storing in an incubator at 37°C for 12 hours, the presence or absence of coloring of the indicator was confirmed. The indicator is mainly composed of potassium iodide, and is colored yellow to brown by reaction with an oxidizing substance (hypochlorous acid). The degree of this coloring was visually evaluated according to the following criteria. ◎: The indicator turned deep yellow to brown. ○: The indicator turned yellow. △: The indicator turned slightly yellow. ×: There was no change in the color of the indicator.

[0042] (1-2) Shore A hardness measurement The Shore A hardness, which is an index of the flexibility of soft lining materials, was measured based on JIS-T6520 (Durometer Type A). Measurements were taken after mixing and leaving the material to stand overnight at 37°C, after absorbing hypochlorous acid water, and after sustained release.

[0043] (1-3) Shore E hardness measurement The Shore E hardness, which is an index of the flexibility of the tissue conditioner, was measured based on JIS-T6520 (Durometer Type E). Measurements were taken at the time when the material was left to stand overnight at 37°C after kneading, after adsorption of hypochlorous acid water, and after sustained release.

[0044] (1-4) Evaluation of hypochlorous acid adsorption by soft lining materials, elastomers, and resins For each material, two test plates measuring 70 mm long x 30 mm wide x 2 mm thick were prepared, one of which was immersed in 200 ml of hypochlorous acid aqueous solution (Dentzia: effective chlorine concentration 568 ppm pH 4.2). The other was immersed in distilled water, and the test plate was taken out at predetermined intervals, the moisture on the surface was wiped off with a Kimwipe, and the mass was measured. The mass of the test piece immersed in distilled water was calculated by subtracting the mass of the test piece immersed in hypochlorous acid aqueous solution for the same immersion time from the mass of the test piece immersed in distilled water, and the mass of hypochlorous acid adsorbed on the test piece was calculated by subtracting the mass of the test piece immersed in hypochlorous acid aqueous solution for the same immersion time from the mass of the test piece immersed in distilled water.

[0045] (1-5) Evaluation of sustained release of hypochlorous acid from soft lining materials and elastic bodies 2 For each material, a test plate (Sofriliner Tough Medium: 5.0 g, Tissue Care: 4.8 g, Polyethylene: 2.1 g) measuring 70 mm in length, 30 mm in width, and 2 mm in thickness was prepared and immersed in 200 ml of hypochlorous acid solution (Dentzia: effective chlorine concentration 568 ppm, pH 4.2). After immersion for 60 hours or more, the test plate was removed, the moisture adhering to it was wiped off with a Kimwipe, and it was left in the air at 27°C, and the mass was measured at specified intervals.

[0046] (Examples 1 to 6, Comparative Examples 1 to 7) Test panels were prepared using the materials and immersion solutions shown in Table 1. These test panels were used to perform hypochlorous acid sustained release evaluation 1. The results are shown in Table 1.

[0047] [Table 1]

[0048] In Examples 1 to 6, the indicator attached to the surface of the soft lining material, the mucous membrane conditioner, and the elastic test plate and the indicator placed at the bottom of the glass bottle were both colored, suggesting that hypochlorous acid was adsorbed to the hardened body and released gradually. However, in Example 6, the indicator was lighter in color after 12 hours than in Examples 1 to 5, suggesting that the amount of release was small. On the other hand, in the test plate immersed in distilled water in Comparative Examples 1 to 5, no change in the color of the indicator was observed. In addition, in the case of 66 nylon immersed in hypochlorous acid water in Comparative Example 6, the indicator attached to the surface of the test plate was light yellow, but no change in the color of the indicator placed at the bottom of the glass bottle was observed. Furthermore, in the case of polyethylene in Comparative Example 7, no change in the indicator was observed either on the surface of the hardened body or in the glass bottle.

[0049] The Shore A hardness was measured for Examples 1 to 3 and Comparative Examples 1 to 3. The results are shown in Table 2.

[0050] [Table 2]

[0051] The Shore E hardness was measured for Examples 4 to 5 and Comparative Examples 4 to 5. The results are shown in Table 3.

[0052] [Table 3]

[0053] The Shore A and Shore E hardness of the soft lining material and tissue conditioner did not change from the initial value both when hypochlorous acid was adsorbed and after sustained release.

[0054] Hypochlorous acid adsorption evaluation was performed for Examples 1 and 4 and Comparative Examples 1 and 7. The results are shown in Tables 4 to 6. Table 4 shows the hypochlorous acid adsorption evaluation results for Example 1 and Comparative Example 1. Table 5 shows the hypochlorous acid adsorption evaluation results for Example 4, and Table 6 shows the hypochlorous acid adsorption evaluation results for Comparative Example 7.

[0055] [Table 4]

[0056] [Table 5]

[0057] [Table 6]

[0058] The mass of the test piece immersed in distilled water in Comparative Example 1 hardly changed, while the mass of the test piece immersed in hypochlorous acid water in Example 1 increased, suggesting that hypochlorous acid was adsorbed to silicone. When tissue care (acrylic) and polyethylene resin were similarly evaluated, hypochlorous acid was adsorbed in tissue care (acrylic) in Example 4 (Table 5), but hypochlorous acid was not adsorbed in polyethylene resin in Comparative Example 7 (Table 6).

[0059] For Examples 1 and 4, sustained release evaluation 2 of hypochlorous acid was performed. The results of Example 1 are shown in Table 7, and the results of Example 4 are shown in Table 8.

[0060] [Table 7]

[0061] [Table 8]

[0062] The mass of the test specimen gradually decreased over time, suggesting the sustained release of hypochlorous acid.

Claims

1. A denture base or denture having a restoration lined with a soft lining material on at least a portion of the mucosal surface of the denture base, The soft lining material constituting the repair portion has a solubility parameter (SP value) of 10 (MPa 1/2 ) or more, 25 (MPa 1/2 ) or less of a polymeric elastic material, A denture base or denture characterized in that 1 to 40 (mg) of molecular hypochlorous acid per 1 (g) of polymeric elastic material is sorbed and retained inside the polymeric elastic material, and the molecular hypochlorous acid is gradually released from the surface of the restoration part into the surrounding atmosphere, thereby exhibiting disinfecting and / or antibacterial properties on the surface of the restoration part and its surrounding atmosphere during the period during which the slow release continues.

2. A method for producing a denture base or a denture according to claim 1, comprising the steps of: A process for preparing a treated article comprising a denture base or a denture having a restorative portion lined with a soft relining material made of the polymeric elastic material on at least a portion of the mucosal surface of the denture base, (1) a denture base or a denture in which molecular hypochlorous acid is not sorbed and held in the restorative portion, or (2) a denture base or a denture in which the amount of molecular hypochlorous acid sorbed and held in the restorative portion is less than a desired amount; and a step of contacting the repaired portion of the article to be treated with a disinfecting and / or antibacterial agent comprising a weakly acidic aqueous hypochlorous acid solution having an effective chlorine concentration of 10 ppm or more and 1000 ppm or less, and sorbing molecular hypochlorous acid in the disinfecting and / or antibacterial agent in an amount of 1 to 40 (mg / g-polymeric elastic material) into the polymeric elastic material forming the repaired portion; The method comprising:

3. The method according to claim 2, wherein the denture base or denture described in claim 1 is used as the treated article for a certain period of time, and the amount of molecular hypochlorous acid sorbed and retained in the polymeric elastic material by sustained release is reduced.

Citation Information

Patent Citations

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