Shell-shaped dental instrument with anti-caries function and manufacturing method thereof

Abstract

One aspect of the present application provides a shell-shaped dental instrument, comprising: a body in an integral shell shape and forming a cavity for accommodating teeth; and the anti-caries film has a certain thickness, is formed on at least partial region of the inner surface of the body, and can react with saliva to release fluorine ions.

Description

[0001] This application is a divisional of a Chinese invention patent application filed on May 8, 2020, with application number 202010381338.1 and titled “Shell-shaped dental device with anti-caries function and its manufacturing method”. Technical Field

[0002] The present application generally relates to a shell-shaped dental appliance with caries prevention function and a method for making the same. Background Art

[0003] Tooth decay is one of the most common oral diseases. Therefore, preventing tooth decay is of vital importance.

[0004] It is generally believed that the main causes of dental caries are two types of bacteria. One is the acid-producing bacteria (for example, Streptococcus mutans, Actinomyces and Lactobacillus), which can decompose food residues (for example, carbohydrates) to produce acid, thereby causing demineralization of tooth inorganic matter; the other type of bacteria (for example, Gram-positive cocci) can destroy organic matter and form cavities after long-term action.

[0005] Tooth decay can be prevented and controlled. Currently, fluoride is internationally recognized as an effective substance for preventing tooth decay. Fluoride can inhibit the growth of cariogenic bacteria in the mouth and inhibit bacterial acid production. It can also reduce the solubility of tooth enamel on the surface and promote the remineralization of demineralized tooth enamel. Intake of an appropriate amount of fluoride during tooth development can make tooth cusps rounded and grooves shallower. This change in tooth morphology makes teeth easier to clean themselves and enhances resistance to the formation of tooth decay.

[0006] At present, there are three main types of fluoride anti-caries technology:

[0007] Fluoride toothpaste is the most widely used anti-caries technology. Sodium fluoride and other inorganic fluorides are added to toothpaste, which allows people to obtain certain anti-caries effects while cleaning their teeth, which is convenient and quick. However, the toothpaste stays in the mouth and acts for a short time.

[0008] Fluoridation foam is an internationally recognized fast and effective anti-caries technology. High-concentration fluoridation foam acts on teeth for three minutes to prevent caries. Currently, fluoridation foam is basically only used to prevent caries in young children.

[0009] Fluoride varnish is a technology that applies a substance containing high concentrations of fluoride ions to the surface of teeth to prevent caries. Typical examples include Colgate's Durofluor and 3M's White Varnish. Fluoride varnish requires the operation of a professional dentist. Currently, this technology is only used in clinical practice and consumers cannot use it in their daily lives.

[0010] The inventors of the present application believe that, in view of the importance of caries prevention, it is necessary to provide different caries prevention means. Summary of the invention

[0011] One aspect of the present application provides a shell-shaped dental device, comprising: a body, which is an integral shell and forms a cavity for accommodating teeth; and an anti-caries film, which has a certain thickness and is formed on at least a portion of the inner surface of the body and can react with saliva to release fluoride ions.

[0012] In some embodiments, the anti-caries film may have a thickness of less than 25 μm.

[0013] In some embodiments, the body is made of polymer material.

[0014] In some embodiments, the anti-caries film comprises a film-forming agent and a fluoride-containing substance.

[0015] In some embodiments, the fluorine-containing substance may be a fluorine-containing organic substance that can hydrolyze to release fluoride ions.

[0016] In some embodiments, the fluorine-containing organic compound may be a fluorine-containing silane.

[0017] In some embodiments, the weight content of fluorine in the anti-caries film may be 600 to 11200 ppm.

[0018] In some embodiments, the film former is a polymer capable of forming a continuous film.

[0019] In some embodiments, the film former may be one of the following: aromatic isocyanate, acrylate, and mixtures thereof.

[0020] In some embodiments, the anti-caries film further comprises a fragrance.

[0021] In some embodiments, the geometry of at least a portion of the cavity matches a corresponding portion of the patient's dentition.

[0022] Another aspect of the present application provides a method for manufacturing a shell-shaped dental device, comprising: obtaining a shell-shaped dental device body, wherein the body is an integral shell and forms a cavity for accommodating teeth; and forming an anti-caries film on at least a portion of the inner surface of the body, which can react with saliva to release fluoride ions.

[0023] In some embodiments, the geometry of at least a portion of the cavity matches a corresponding portion of the patient's dentition.

[0024] In some embodiments, the body is made of polymer material.

[0025] In some embodiments, the method for manufacturing a shell-shaped dental appliance may further include: applying an anti-caries solution on at least a portion of the inner surface of the body; and curing the anti-caries solution applied on the inner surface of the body to form the anti-caries film.

[0026] In some embodiments, the coating amount of the anticaries solution is controlled so that the thickness of the anticaries film is less than 25 μm.

[0027] In some embodiments, the anti-caries solution comprises ingredients including an organic solvent, a film-forming agent, and a fluorine-containing substance.

[0028] In some embodiments, the organic solvent in the anticaries solution coated on the inner surface of the body gradually evaporates, so that the anticaries film hardly contains the organic solvent.

[0029] In some embodiments, the film former is a polymer capable of forming a continuous film.

[0030] In some embodiments, the film former is one of the following: aromatic isocyanate, acrylate, and mixtures thereof.

[0031] In some embodiments, the fluorine-containing substance may be a fluorine-containing organic substance that can hydrolyze to release fluoride ions.

[0032] In some embodiments, the fluorine-containing organic compound may be a fluorine-containing silane.

[0033] In some embodiments, the content of the fluorine-containing substance in the anti-caries solution is such that the weight content of fluorine in the anti-caries film is 600 to 11200 ppm. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] The above and other features of the present application will be further described below in conjunction with the accompanying drawings and detailed descriptions thereof. It should be understood that these drawings only illustrate several exemplary embodiments according to the present application and should not be considered as limiting the scope of protection of the present application. Unless otherwise specified, the drawings are not necessarily to scale and similar reference numerals represent similar components.

[0035] Figure 1 This is a schematic flow chart of a method for manufacturing a shell-shaped dental appliance in one embodiment of the present application;

[0036] Figure 2 Schematically illustrates a shell-shaped dental appliance in one embodiment of the present application; and

[0037] Figure 3 for Figure 2 The shell-shaped dental appliance is shown in cross-section at AA. DETAILED DESCRIPTION

[0038] The following detailed description refers to the drawings that form part of this specification. The illustrative embodiments mentioned in the specification and drawings are for illustrative purposes only and are not intended to limit the scope of protection of the present application. Under the guidance of the present application, those skilled in the art will understand that many other embodiments can be adopted and various changes can be made to the described embodiments without departing from the subject matter and scope of protection of the present application. It should be understood that the various aspects of the present application described and illustrated herein can be arranged, replaced, combined, separated and designed according to many different configurations, and these different configurations are within the scope of protection of the present application.

[0039] Shell-shaped dental devices based on polymer materials (such as shell-shaped orthodontic appliances, retainers and snoring suppressants) are becoming increasingly popular due to their aesthetics, convenience and ease of cleaning.

[0040] Generally, shell-shaped dental appliances are worn for a long time. For shell-shaped appliances, patients are required to wear them all day, except for eating and brushing their teeth, generally for no less than 22 hours a day, and the orthodontic treatment cycle may be as long as 1 to 3 years. For shell-shaped retainers and anti-snoring devices, patients need to wear them during sleep and may need to use them for life.

[0041] Shell-shaped dental instruments isolate teeth from the oral environment for a long time, placing the teeth in a relatively closed oxygen-deficient environment and hindering the normal contact of saliva with the teeth (saliva is essential for oral hygiene, as it can flush bacteria in the mouth and maintain the balance of the flora, and the enzymes in the saliva can decompose food residues). Therefore, wearing shell-shaped dental instruments may accelerate the growth and reproduction of anaerobic bacteria on the surface of teeth, produce dental plaque, and subsequently cause many problems such as caries, yellow teeth, periodontal disease and bad breath.

[0042] The inventors of the present application are aware of the necessity of providing different anti-caries means, and are aware of the above-mentioned problems existing in shell-shaped dental instruments. Driven by this, they have developed a shell-shaped dental instrument with anti-caries function and a method for manufacturing the same.

[0043] Please refer to Figure 1 , which is a schematic flow chart of a method 100 for manufacturing a shell-shaped dental instrument in one embodiment of the present application.

[0044] In 101 , a shell-shaped dental appliance body is obtained.

[0045] The shell-shaped dental instrument body is made of polymer material, is in an integrated shell shape, and forms a cavity for accommodating teeth, wherein the shape of at least a part of the cavity substantially matches the corresponding part of a tooth layout of the patient.

[0046] At present, the most common method for making a shell-shaped dental instrument body is a hot pressing film forming process. The basic manufacturing process is to press a heated polymer film material on a dental mold, and then cut and polish it after cooling to obtain a shell-shaped dental instrument body.

[0047] In one embodiment, the shell-shaped dental appliance body can be made of a single layer of material. In another embodiment, the shell-shaped dental appliance body can also be made of two or more layers of material.

[0048] In one embodiment, the cavity of the shell-shaped dental appliance body can accommodate the entire dentition. In another embodiment, the cavity of the shell-shaped dental appliance body only accommodates a partial dentition (multiple teeth).

[0049] In one embodiment, the shell-shaped dental appliance can be a shell-shaped orthodontic appliance, which is used to reposition the patient's teeth from a current first layout to a second layout. In this example, the dental mold used to make the shell-shaped dental appliance body can be substantially consistent with the second layout of the patient's teeth, or deviate slightly in the correction direction, so that the shell-shaped dental appliance can reposition the patient's teeth to the second layout.

[0050] In another embodiment, the shell-shaped dental instrument body can also be made by 3D printing technology. In another embodiment, the body of the shell-shaped dental instrument can also be made by cutting blanks using a numerical control machine tool.

[0051] In 103 , an anti-caries film is formed on at least a portion of the inner surface of the shell-shaped dental appliance body.

[0052] The anti-caries film is attached to the inner surface of the shell-shaped dental appliance body and has a certain thickness.

[0053] In one embodiment, the anti-caries film can be formed only on selected areas of the inner surface of the shell-shaped dental appliance body, and the area requiring the anti-caries film can be selected according to specific conditions and needs. In another embodiment, the anti-caries film can be formed on the entire inner surface of the shell-shaped dental appliance body.

[0054] In one embodiment, the anti-caries solution may be applied to the inner surface of the shell-shaped dental appliance body, and the anti-caries film may be formed after the solution is cured.

[0055] In one embodiment, the anti-caries solution may include an organic solvent, a film former, and a fluoride-containing substance.

[0056] The organic solvent is used to dissolve the film-forming agent and the fluorine-containing substance and mix them uniformly, and its examples include but are not limited to: ethyl acetate, butyl acetate, isoamyl acetate, isoamyl propionate, isoamyl butyrate, etc. and mixtures thereof. In the process of forming the anticaries film, the organic solvent in the anticaries solution gradually evaporates, and the final anticaries film contains almost no organic solvent. Therefore, when wearing the shell-shaped dental appliance of the present application, the patient will not feel uncomfortable due to the organic solvent.

[0057] The film former is a polymer capable of forming a continuous film, and examples thereof include, but are not limited to, aromatic isocyanates, acrylates, and mixtures thereof. It is understood that aromatic isocyanates and acrylates each refer to a class of substances, which may include different specific substances. Therefore, the film former may be a mixture of two or more aromatic isocyanates, a mixture of two or more acrylates, and a mixture of one or more aromatic isocyanates and one or more acrylates.

[0058] On the one hand, aromatic isocyanate and acrylate film-forming agents are colorless and transparent, and can form colorless and transparent films, which can keep the appearance of the shell-shaped dental appliance unchanged to the greatest extent. In the case where the color of the shell-shaped dental appliance needs to be changed, a coloring agent can be added to the anti-caries solution to make the part of the shell-shaped dental appliance covered with the anti-caries film present the required color. On the other hand, aromatic isocyanate and acrylate film-forming agents have the characteristics of low viscosity, so that the anti-caries solution has a better leveling effect, is evenly coated, and has good coating operability.

[0059] In light of the present application, it can be understood that the physical properties of the anti-caries film (eg, hardness and adhesion properties) are mainly determined by the film-forming agent, and the film-forming agent can be selected according to specific circumstances and requirements.

[0060] The fluorine-containing substance can react with saliva to produce fluorine ions to prevent dental caries. In one embodiment, it can be a fluorine-containing organic substance that can hydrolyze to release fluorine ions. In one embodiment, it can be a fluorine-containing organic silane with a structural formula of R-[SiFm(OH)3-m]n, wherein m is in the range of 1 to 3 and n is in the range of 1 to 4.

[0061] In one embodiment, in order to improve the wearing experience, the anti-caries solution may further include a fragrance, examples of which include but are not limited to: menthol, cooling agent, edible fruit flavor, etc.

[0062] In one embodiment, the weight content of the fluorine-containing substance is 0.5% to 10%, the weight content of the film-forming agent is 5% to 25%, the weight content of the organic solvent is 75% to 90%, and the weight content of the aromatic agent is 0.05% to 0.1%.

[0063] In one embodiment, the weight content of fluorine in the anti-caries film is greater than or equal to 600 ppm. In another embodiment, the weight content of fluorine in the anti-caries film may be 600-11200 ppm.

[0064] The anti-caries solution can be applied by spraying, dipping or hand coating.

[0065] Please refer to Figure 2 and Figure 3 ,in, Figure 2 The shell-shaped dental appliance 200 in one embodiment of the present application is schematically shown. Figure 3 yes Figure 2 The shell-shaped dental appliance 200 is shown in cross-section at AA.

[0066] The shell-shaped dental appliance 200 comprises a body 201 which is in an integral shell shape and forms a cavity 203 for accommodating teeth. A layer of anticaries film 205 is formed on the inner surface of the body 201 (ie, the surface of the cavity 203).

[0067] In one embodiment, the thickness of the anti-caries film 205 can be determined according to specific needs and circumstances. For example, for a shell-shaped appliance made based on a hot pressing film molding process, if its tolerance to dental model errors is ±100 μm, then the thickness of the anti-caries film 205 can be controlled to be below 50 μm (micrometers), or even below 25 μm, so that the anti-caries film 205 basically does not affect the correction performance of the shell-shaped appliance.

[0068] The formation of the anti-caries film is described below using two specific examples.

[0069] Example 1

[0070] The ingredients of the anti-caries solution are as follows:

[0071] Fluorinated organic matter (using fluorinated organic matter that is more soluble in organic solvents): 1% fluorinated organic silane (fluorine content of about 0.1%)

[0072] Film former: Aromatic isocyanate film former 11%

[0073] Organic solvent: ethyl acetate 62.9% and isoamyl propionate 25%

[0074] Aromatherapy: Cooling agent 0.1%

[0075] Apply the anti-caries solution evenly to the inner surface of the shell-shaped appliance with a brush and solidify it at room temperature.

[0076] Among them, the structural formula of fluorinated organic silane is as follows:

[0077]

[0078] In this example, toluene diisocyanate-trimethylolpropane-diglycol adduct is used as the film-forming agent, and the film-forming agent is cured by reacting with water vapor in the air.

[0079] In this example, the anticaries film adheres well to the shell appliance and in the cross-cut test, its adhesion received the highest grade: ISO 2409:2013-2a-0.

[0080] The pencil hardness of the anti-caries film reaches H grade.

[0081] The fluoride release rate of the anti-caries film is greater than 500mg / kg, and it has good anti-caries effect.

[0082] Example 2

[0083] The ingredients of the anti-caries solution are as follows:

[0084] Fluorinated organic matter: 1% fluorinated organic silane (fluorine content about 0.1%)

[0085] Film former: aromatic isocyanate 11%

[0086] Organic solvent: Butyl acetate 87.9%

[0087] Aromatherapy: Lemon essence 0.1%

[0088] Apply the anti-caries solution evenly to the inner surface of the shell-shaped appliance with a brush and solidify it at room temperature.

[0089] Among them, the structural formula of fluorinated organic silane is as follows:

[0090]

[0091] In this example, toluene diisocyanate-trimethylolpropane prepolymer is used as the film-forming agent, and the film-forming agent is cured by reacting with water vapor in the air.

[0092] In this example, the anticaries film adheres well to the shell appliance and in the cross-cut test, its adhesion received the highest grade: ISO 2409:2013-2a-0.

[0093] The pencil hardness of the anti-caries film reaches H grade.

[0094] The fluoride release rate of the anti-caries film is greater than 500mg / kg, and it has good anti-caries effect.

[0095] It can be understood that as long as a sufficient amount of fluoride ions are released, sufficient caries-preventing effect can be achieved. The caries-preventing films of the above two examples can ensure the caries-preventing effect for 3 to 6 months.

[0096] It can be understood that the shell-shaped dental instrument of the present application not only solves the antibacterial problems existing in traditional shell-shaped dental instruments to a certain extent, but also provides a new caries prevention method, and the caries prevention method does not require additional operations by doctors and patients, which is very convenient.

[0097] Although various aspects and embodiments of the present application are disclosed herein, other aspects and embodiments of the present application will be apparent to those skilled in the art in light of the present application. The various aspects and embodiments disclosed herein are for illustrative purposes only and not for limiting purposes. The scope and subject matter of the present application are determined solely by the appended claims.

[0098] Likewise, various diagrams may illustrate exemplary architectures or other configurations of the disclosed methods and systems that aid in understanding the features and functions that may be included in the disclosed methods and systems. The claimed content is not limited to the exemplary architectures or configurations shown, and the desired features may be implemented with various alternative architectures and configurations. In addition, for flow charts, functional descriptions, and method claims, the order of blocks presented herein should not be limited to various embodiments that are implemented in the same order to perform the described functions, unless otherwise clearly indicated in the context.

[0099] Unless otherwise expressly noted, the terms and phrases used herein and their variations should be interpreted as open ended, not restrictive. In some instances, the appearance of broad words and phrases such as "one or more", "at least", "but not limited to", or other similar terms should not be understood as an intent or need to indicate a narrowing of the example where such broad terms may not be present.

Claims

1. A shell-shaped dental appliance, comprising: A body, which is in the shape of an integrated shell and forms a cavity for accommodating the teeth, and is made of a polymer material; and an anti-caries film, having a certain thickness, formed on at least a portion of the inner surface of the body, capable of reacting with saliva to release fluoride ions, wherein the anti-caries film comprises a film-forming agent and a fluoride-containing substance; The fluorine-containing substance is a fluorine-containing organic substance, and the film-forming agent is one of the following: aromatic isocyanate, acrylate and a mixture thereof.

2. The shell-shaped dental device according to claim 1, characterized in that: The anti-caries film has a thickness of less than 25 μm.

3. The shell-shaped dental device according to claim 1, characterized in that: The anti-caries film is formed after the organic solvent in the anti-caries solution coated on the inner surface of the body volatilizes, and the components of the anti-caries solution include the film-forming agent, fluorine-containing organic matter and organic solvent.

4. The shell-shaped dental device according to claim 1, characterized in that: The fluorine-containing organic compound is fluorine-containing silane.

5. The shell-shaped dental device according to claim 1, characterized in that: The fluorine-containing organic compound can be hydrolyzed to release fluoride ions.

6. The shell-shaped dental device according to claim 1, characterized in that: The weight content of fluorine in the anti-caries film is 600 to 11200 ppm.

7. The shell-shaped dental device according to claim 1, characterized in that: The anti-caries film also contains fragrance.

8. The shell-shaped dental device according to claim 1, characterized in that: The geometry of at least a portion of the cavity matches a corresponding portion of the patient's dentition.

9. The shell-shaped dental device according to claim 1, characterized in that: The film-forming agent is a film-forming agent that can increase the hardness of the anticaries film.

10. A method for manufacturing a shell-shaped dental instrument, comprising: Obtain a shell-shaped dental instrument body, wherein the body is in an integrated shell shape and forms a cavity for accommodating teeth, and the body is made of a polymer material; applying an anti-caries solution on at least a portion of the inner surface of the body; and The anti-caries solution coated on the inner surface of the body is solidified to form an anti-caries film, which can react with saliva to release fluoride ions. The components of the anti-caries solution include an organic solvent, a film-forming agent and a fluorine-containing substance, and the organic solvent in the anti-caries solution coated on the inner surface of the body gradually evaporates during the curing process, so that the anti-caries film almost does not contain the organic solvent; The fluorine-containing substance is a fluorine-containing organic substance, and the film-forming agent is one of the following: aromatic isocyanate, acrylate and a mixture thereof.

11. The method for manufacturing a shell-shaped dental appliance according to claim 10, wherein: The geometry of at least a portion of the cavity matches a corresponding portion of the patient's dentition.

12. The method for manufacturing a shell-shaped dental appliance according to claim 10, wherein: The coating amount of the anticaries solution is controlled so that the thickness of the anticaries film is less than 25 μm.

13. The method for manufacturing a shell-shaped dental appliance according to claim 10, wherein: The fluorine-containing organic compound can be hydrolyzed to release fluoride ions.

14. The method for manufacturing a shell-shaped dental appliance according to claim 10, wherein: The fluorine-containing organic compound is fluorine-containing silane.

15. The method for manufacturing a shell-shaped dental appliance according to claim 10, wherein: The content of the fluorine-containing substance in the anti-caries solution is such that the weight content of fluorine in the anti-caries film is 600 to 11200 ppm.

16. The method for manufacturing a shell-shaped dental appliance according to claim 10, wherein: The film-forming agent is a film-forming agent that can increase the hardness of the anticaries film.

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