Mouthpiece manufacturing method

Abstract

This invention provides a mouthpiece used to be fitted into the dental arch in the oral cavity while filled with medication, and a mouthpiece that facilitates the retention of medication between the mouthpiece and the teeth, as well as a method for manufacturing the same. [Solution] A mouthpiece is fitted to the teeth of the wearer, the mouthpiece is made of a resin sheet, and has a roughened portion on the inner surface of the mouthpiece that contacts the surface of the teeth in the oral cavity, the surface roughness (Ra) of the roughened portion measured in accordance with JIS B 0601 (2013) is 5 to 25 μm, and the inner surface of the mouthpiece is filled with a drug.

Description

Technical Field

[0001] The present invention relates to a mouthpiece and a method for manufacturing a mouthpiece, and particularly to a mouthpiece that makes it easy to leave a drug on the teeth of the wearer of the mouthpiece through the mouthpiece, and a method for manufacturing the same.

Background Art

[0002] A mouthpiece worn on the dental arch of the oral cavity is manufactured by previously making a model (dental model) that mimics the shape of the dental arch of the wearer, and then manufacturing a mouthpiece having a shape that matches this dental model. Conventionally, dental models have been made of plaster. The simplification of the production of dental models has progressed from the production of dental models using plaster to the use of a laminated manufacturing apparatus (3D printer) (see Patent Document 1).

[0003] Since the mouthpiece is individually created according to the shape of the wearer's dental arch, the degree of shape matching is high. Therefore, it is often used for treatment purposes such as teeth and gums, and further for procedures such as whitening to decolorize tooth discoloration and make the teeth white (see Patent Document 2). The inner surface side of the mouthpiece is filled with the necessary drug, and it is worn on the dental arch while holding the drug.

[0004] However, it has been regarded as a problem that the drug in the mouthpiece leaks out after the mouthpiece is worn. The more the drug remains between the mouthpiece and the teeth, the more the effect of the drug lasts. This is particularly prominent in whitening and the like. Even if the viscosity of the drug to be used is increased, there is a limit with the current structure of the mouthpiece.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0006] The inventors diligently studied the problem of drug residue after wearing the mouthpiece. They then found an effective solution to increase the amount of drug residue remaining in the oral cavity by improving the structure of the mouthpiece.

[0007] The present invention has been made in view of the above points, and provides a mouthpiece for use in the dental arch of the oral cavity with a drug filling inside, a mouthpiece that facilitates the retention of the drug between the mouthpiece and the teeth, and a method for manufacturing the mouthpiece. [Means for solving the problem]

[0008] In other words, the embodiment is a mouthpiece that is fitted to the dental arch of the wearer's mouth, wherein the mouthpiece has a roughened portion on the inner surface of the mouthpiece that contacts the surface of the dental arch in the oral cavity, and the surface roughness (Ra) of the roughened portion, measured in accordance with JIS B 0601 (2013), is 5 to 25 μm.

[0009] Furthermore, the mouthpiece may be formed from a resin sheet.

[0010] Furthermore, in the case of a mouthpiece, when the mouthpiece is placed in the wearer's oral cavity, the drug may be filled into the inner surface of the mouthpiece, and the drug may remain in the roughened area.

[0011] Furthermore, in the case of a mouthpiece, the medication may be a whitening agent or a tooth sensitivity treatment agent.

[0012] The method for manufacturing a mouthpiece according to the embodiment comprises: a tooth row data generation step of imaging the dental arch of the wearer's mouth and generating three-dimensional dental row data of the dental arch in the mouth; a model manufacturing step of creating a dental model of the wearer based on the three-dimensional dental row data; and a mouthpiece manufacturing step of attaching a resin sheet to the dental model and transferring the surface shape of the dental model to the resin sheet to manufacture a mouthpiece to be worn in the wearer's mouth, wherein in the mouthpiece manufacturing step, a roughened portion is formed on the inner surface of the mouthpiece when transferring the surface shape of the dental model to the resin sheet.

[0013] Furthermore, in the manufacturing method of the mouthpiece, the surface roughness (Ra) of the roughened portion, measured in accordance with JIS B 0601 (2013), may be set to 5 to 25 μm.

[0014] Furthermore, in the manufacturing method of the mouthpiece, the dental model may be manufactured using a 3D printer during the model making process.

[0015] Furthermore, in the manufacturing method of the mouthpiece, when the mouthpiece is placed in the wearer's oral cavity, the drug is filled into the inner surface of the mouthpiece, and the drug remains in the roughened area. It would be acceptable to do so.

[0016] Furthermore, in the method for manufacturing the mouthpiece, the drug may be a whitening agent or a tooth sensitivity treatment agent. [Effects of the Invention]

[0017] The mouthpiece of the present invention is a mouthpiece that is fitted to the teeth of the wearer's mouth, and the mouthpiece has a roughened portion on the inner surface of the mouthpiece that contacts the surface of the teeth in the mouth, and the surface roughness (Ra) of the roughened portion measured in accordance with JIS B 0601 (2013) is 5 to 25 μm, so when used to be fitted to the teeth in the mouth with medication filled in, the medication can be easily retained between the mouthpiece and the teeth.

[0018] The method for manufacturing a mouthpiece of the present invention includes a dental data generation step of imaging the dentition of the wearer's oral cavity and generating three-dimensional dental data of the dentition in the oral cavity, a mold manufacturing step of manufacturing a dental mold of the wearer based on the three-dimensional dental data, and a mouthpiece manufacturing step of attaching a resin sheet to the dental mold and transferring the surface shape of the dental mold to the resin sheet to manufacture a mouthpiece to be worn in the wearer's oral cavity. In the mouthpiece manufacturing step, when transferring the surface shape of the dental mold to the resin sheet, a roughened portion is formed on the inner surface portion of the mouthpiece, so that appropriate irregularities can be formed on the inner surface of the mouthpiece for wearing in the oral cavity filled with a drug, and the mouthpiece can be optimally manufactured.

Brief Description of the Drawings

[0019] [Figure 1] (A) is an overall perspective view of the mouthpiece of the embodiment, and (B) is a partially enlarged perspective view thereof. [Figure 2] It is a schematic longitudinal sectional view when the mouthpiece is worn. [Figure 3] It is a partially enlarged schematic longitudinal sectional view of FIG. 2. [Figure 4] It is a schematic view when imaging the dentition of the wearer's oral cavity. [Figure 5] It is a schematic view of three-dimensional dental data. [Figure 6] It is an overall perspective view of the dental mold. [Figure 7] (A) is a first schematic view of mouthpiece manufacturing, (B) is a second schematic view thereof, and (C) is a third schematic view thereof. [Figure 8] Regarding the sag test, (A) is a photograph before the test, and (B) is a photograph after the test.

Embodiments for Carrying Out the Invention

[0020] The mouthpiece of this embodiment is a device used to allow the medication held within the mouthpiece to penetrate the teeth. It is fitted onto the upper and lower teeth of the wearer, with a predetermined medication filled into the inner surface (concave side) of the mouthpiece. The medication filled into the mouthpiece of this embodiment is either a whitening agent or a tooth desensitizing agent. The whitening agent contains hydrogen peroxide, etc., and decolorizes yellowed and stained teeth. The tooth desensitizing agent penetrates from the surface of the tooth and alleviates symptoms by acting on the nerves inside the tooth or sealing the dentinal tubules.

[0021] The structure of the mouthpiece 1 of the embodiment will be described using Figures 1 to 3. Figure 1(A) is an overall perspective view of the mouthpiece 1 of the embodiment, and the mouthpiece 1 is composed of a main body 10 formed from a thermoplastic resin sheet. The resin sheet is a sheet material such as PET (polyethylene terephthalate), PE (polyethylene), PP (polypropylene), EVA (ethylene vinyl acetate), hydrogenated styrene-isoprene block copolymer, nylon (polyamide) resin, or polyvinyl chloride resin, and has a thickness of 0.5 to 2 mm. The mouthpiece 1 (main body 10) is divided into an inner surface part 11 and an outer surface part 12 (see Figures 2 and 3 below), and the inner surface part 11 is in contact with the wearer's teeth.

[0022] Figure 1(B) is a partially enlarged perspective view of mouthpiece 1, which corresponds precisely to the upper front teeth. Thus, the mouthpiece 1 of this embodiment is formed to precisely correspond to the upper and lower dentition of the wearer. The mouthpiece 1 of this embodiment has a U-shape that is worn over the entire upper or lower dentition. However, the mouthpiece 1 may also be designed to be worn only on the upper or lower front teeth (central incisors, which are visible when the mouth is open) or other necessary areas.

[0023] Figure 2 is a schematic cross-sectional view of the mouthpiece 1 of the embodiment in a fitted state, and Figure 3 is a partially enlarged cross-sectional view thereof. The illustration shows a cross-section near the lower anterior teeth. As described in the manufacturing method below, the inner surface portion 11 of the mouthpiece 1 is shaped to match the shape of the surface of the tooth 20 (anterior tooth: central incisor in the illustration). The tooth 20 is formed from the outermost enamel 21, with dentin 23 inside, and the pulp 22 (so-called nerve) at the deepest part. The tooth 20 is held in place by the lower jawbone 24, and the area around the tooth 20 is protected by the gums 25.

[0024] When the mouthpiece 1 is fitted onto the tooth 20, the surface of the tooth 20 is almost entirely covered by the inner surface 11 of the mouthpiece 1. As shown in Figure 3, the drug D is then filled into the inner surface 11. The drug D is sandwiched between the tooth 20 (enamel 21) and the inner surface 11 of the mouthpiece 1, remaining in the gap between the tooth 20 and the mouthpiece 1. There, the components of the drug D act on the enamel 21 and dentin 23 of the tooth 20, causing decolorization (whitening). Alternatively, the drug D can be used to treat hypersensitivity by penetrating in the order of enamel 21, dentin 23, and pulp 22, sealing the tubules of the pulp 22 or dentin 23. In addition, the drug D used with the mouthpiece 1 may also be used for the prevention and treatment of periodontal disease, and for bad breath care.

[0025] When the mouthpiece 1 is fitted onto the teeth 20, the peeling and leakage of the drug D from the surface of the teeth 20 in the oral cavity is suppressed, and the whitening effect due to the penetration of the drug is sustained. However, since the main body 10 of the mouthpiece 1 is a resin sheet, both sides of the resin sheet are smooth. In the case of conventional mouthpieces using resin sheets, the drug tends to leak out from the gap between the teeth and the mouthpiece due to the smoothness of the surface of the mouthpiece itself.

[0026] In view of this, in the mouthpiece 1 of the embodiment, a roughened portion 13 is formed on the inner surface portion 11 (see Figure 3). The roughened portion 13 has fine irregularities. Because the inner surface portion 11 of the mouthpiece 1 has a roughened portion 13, the drug D remains in the depressions of the irregularities of the roughened portion 13. In addition, the drug D is more likely to remain in the irregularities of the roughened portion 13 due to its surface tension. In other words, when the mouthpiece is placed in the mouth of the wearer, the drug D is filled into the inner surface portion 11 of the mouthpiece 1 and remains in the roughened portion 13. As a result, the amount of drug D remaining increases when the inner surface portion 11 is formed with a roughened portion 13 compared to when the inner surface portion 11 is smooth.

[0027] The degree of unevenness of the roughened portion 13 can be defined as surface roughness. Therefore, the surface roughness (Ra: arithmetic mean roughness) measured in accordance with JIS B 0601 (2013) is in the range of 5 to 25 μm, more preferably 10 to 20 μm. If the surface roughness (Ra) of the roughened portion 13 is less than 5 μm, the degree of unevenness on the surface is too small, and no contribution to drug retention is observed. If the surface roughness (Ra) of the roughened portion 13 is greater than 25 μm, the unevenness is too large, and the surface tension of the drug does not act effectively. Therefore, the appropriate range for surface roughness (Ra: arithmetic mean roughness) is 5 to 25 μm, more preferably 10 to 20 μm. In the measurement of the embodiment, the arithmetic mean roughness (Ra) and the ten-point mean roughness (Rz) tend to approximate each other. Therefore, the ten-point mean roughness (Rz) can be substituted by the arithmetic mean roughness (Ra). When measuring surface roughness, other relevant standards such as ISO 25178-6:2010 can also be used.

[0028] Next, the method for manufacturing the mouthpiece 1 of the embodiment will be explained using Figures 4 to 7.

[0029] Figure 4 shows a schematic diagram of the imaging of the dentition in the wearer's mouth. For example, the wearer U is a person who is about to receive treatment or procedures at a dental clinic. The three-dimensional shape of the dentition MT in the wearer U's mouth M is imaged and measured by a known non-contact type three-dimensional scanner 30. Laser light or the like is irradiated from the three-dimensional scanner 30 onto the dentition MT, and the laser light or the like reflected from the dentition MT is received by the three-dimensional scanner 30. Information such as the irradiation angle and the received angle after reflection is aggregated to form a point cloud with three-dimensional positional information. Of course, irradiation and reception are not limited to laser light, and appropriate optical methods can be used. The positional relationship of the surface shape of the dentition MT is converted into data from the point cloud. Of course, the gingival area may also be included in the dentition MT.

[0030] From this point cloud, three-dimensional dental arch data 31 (see Figure 5) is generated showing the dental arch MT within the oral cavity M of the wearer U ("dental arch data generation process"). As can be understood from the schematic diagram in Figure 5, the three-dimensional dental arch data 31 is digitized data, and via a personal computer 35 in a dental clinic or the like, the dentist and the wearer U can confirm the shape of the dental arch MT generated after imaging from the three-dimensional dental arch data 31.

[0031] Figure 6 is an overall perspective view of the dental model 40. Based on the three-dimensional dental arch data 31, a dental model 40 that mimics the dental arch MT of the wearer U is manufactured ("model manufacturing process"). In this embodiment, the dental model 40 is manufactured using a known 3D printer (not shown). The three-dimensional dental arch data 31, which is a collection of point clouds, is transferred to the 3D printer, and the 3D printer operates to manufacture the dental model 40 based on the three-dimensional dental arch data 31. The dental model 40 consists of a tooth model 41 and a base 42.

[0032] While the method of 3D printing for three-dimensional modeling may vary, in light of the purpose of creating the mouthpiece 1 of the embodiment, namely forming a roughened surface 13 on the inner surface 11, the tooth model 40 is manufactured by melting and agglomerating resin powder using a 3D printer. Thermoplastic resins are exclusively used as the resin powder, and powders and beads of resins such as PET (polyethylene terephthalate), PE (polyethylene), PP (polypropylene), EVA (ethylene vinyl acetate), hydrogenated styrene-isoprene block copolymer, nylon (polyamide) resin, and vinyl chloride resin are used. In the embodiment described later, nylon 12 (polyamide) resin powder is used. The average particle size of the resin powder is preferably in the range of 30 to 70 μm.

[0033] If the average particle size of the resin powder is too fine, the surface of the resulting dental model 40 will be smooth, and the roughened surface 13 will not be formed on the inner surface 11 of the mouthpiece 1. Conversely, if the average particle size of the resin powder is too large, the surface of the dental model 40 will become extremely rough, and the adhesion between the inner surface 11 of the mouthpiece 1 and the teeth 40 will decrease.

[0034] Based on the three-dimensional dental arch data 31, a 3D printer melts and aggregates resin powder, resulting in the creation of the dental model 40 shown in Figure 6. Figure 7 shows the process of creating a mouthpiece using the completed dental model 40 ("Mouthpiece Fabrication Process").

[0035] In the schematic cross-sectional view of Figure 7(A), a dental model 40, which has been fabricated through the model fabrication process, is prepared. The resin sheet 2, being made of thermoplastic resin, is preheated to be plastically deformable in order to form the main body 10 of the mouthpiece 1, and is placed in a predetermined position directly above the dental model 40.

[0036] In the schematic cross-sectional view of Figure 7(B), the resin sheet 2 is attached to the tooth model 40. At this time, the air in the gap between the tooth model 40 and the resin sheet 2 is removed by vacuum forming, and the adhesion between the tooth model 40 and the resin sheet 2 is improved. In other words, not only the shape of the tooth model 40 but also the irregularities of the surface shape of the tooth model 40 are precisely transferred to the resin sheet 2.

[0037] The resin sheet 2 is attached to the dental model 40 and adheres to it through vacuum forming. After the resin sheet 2 cools, the surface shape of the dental model 40 is transferred to it. Then, in the schematic cross-sectional view of Figure 7(C), the resin sheet 2 is released from the dental model 40. In this way, the main body 10 is completed. After release, excess parts are cut off from the main body 10, and the edges are chamfered, filed, etc., to finish it into a mouthpiece 1.

[0038] As can be understood from the series of manufacturing steps for the mouthpiece 1 in the embodiment, the dental model 40 is formed from resin powder. Therefore, when the dental model 40 is completed, fine irregularities remain on the surface of the dental model 40 due to the particle shape of the resin powder, resulting in a roughened surface. Conventional methods of manufacturing dental models using plaster cannot obtain a roughened surface with fine irregularities like that of the dental model 40. Then, when the surface shape of the dental model 40 with fine irregularities is transferred to the resin sheet 2, a roughened portion 13 is formed on the inner surface portion 11 of the mouthpiece 1.

[0039] In other words, in the mouthpiece 1 of this embodiment and its manufacturing method, by intentionally leaving fine irregularities on the surface of the dental model 40 and transferring the roughened surface shape of the dental model 40, a roughened portion 13 can be formed on the inner surface portion 11 of the mouthpiece 1. Since it is not easy to roughen the inner surface portion 11 of the mouthpiece 1 after the mouthpiece 1 is completed, roughening it during the manufacturing stage of the mouthpiece 1 simplifies the manufacturing of the mouthpiece 1.

[0040] In addition, in this manufacturing method, the dental model 40 is produced by melting and agglomerating resin powder using a 3D printer, thus automating the production process. In particular, since the dental model 40 is produced directly from the three-dimensional dental arch data 31 using a 3D printer, it is possible to eliminate the previous steps of taking an impression of the wearer's oral cavity and producing a plaster model based on that impression. [Examples]

[0041] [Preparation of test samples] Five glass slides (approximately 26 x 76 x 5 mm) were stacked and fixed to a sheet of paraffin wax to create a prototype of the dentition. This prototype was imaged using a 3D scanner, and a model derived from the prototype (equivalent to a so-called dental impression) was fabricated using a 3D printer (HP Jet Fusion 5210) and nylon 12 (PA12; manufactured by Hewlett-Packard, average particle size approximately 60 μm) as resin powder. On the resin powder-derived model, a tray (equivalent to a so-called mouthpiece in the embodiment) was fabricated using a tray sheet (manufactured by White Essence Co., Ltd., Whitening Home 10% (ethylene vinyl acetate resin sheet)) (experimental group).

[0042] An impression was taken using silicone impression material on the aforementioned prototype, and an anhydrite was injected to create a model. A tray (corresponding to a conventional mouthpiece) was then fabricated on this plaster model using the aforementioned tray sheet (control group).

[0043] [Drip Test] Approximately 10 x 35 mm test pieces were cut from the flat surface of each tray in the experimental and control groups. The samples from both groups were attached to a glass slide with the inner surface of the tray facing outwards using double-sided tape to create the test surface. A suitable amount (approximately 10 mg) of a viscosity standard solution (21000 cp) (Brookfield) with black food coloring (Kyoritsu Foods Co., Ltd.) added was dropped onto the edge of the test surface, ensuring that the same amount was used for both test pieces. Immediately after dropping, the samples were left to stand vertically. The dripping of the dropped liquid was recorded on video, and the distance the liquid had dripped 10 minutes after being left to stand vertically was measured based on the video footage. Three samples were used for both the experimental and control groups (n=3). All procedures were performed at room temperature.

[0044] [Results and discussion of the dripping test] Figure 8 shows photographs of the drip test, with Figure 8(A) showing the condition before the test and Figure 8(B) showing the condition after the test. In each photograph, "3" represents a tray of models made from resin powder (experimental group), and "Stone" represents a tray of models made from plaster (control group). From the comparison of the photographs, it was found that the amount (length) of dripping was less in the tray of models made from resin powder. The average of the three cases in the experimental group was 8.8 mm, and the average of the three cases in the control group was 14.9 mm.

[0045] Based on the dripping test, when a model made from resin powder is prepared, the rough surface structure of the model, which is due to the material, is transferred to the tray, forming a roughened area on the tray side. It can be said that surface tension acts on the fine irregularities of the roughened area, making it easier for the liquid to remain.

[0046] [Surface roughness measurement] Based on the aforementioned "Preparation of Test Samples" and "Results and Discussion of the Dripping Test," the effectiveness of the tray (corresponding to the mouthpiece in the embodiment) made from a resin powder-derived model was clarified. Therefore, its performance was evaluated through measurement of surface roughness.

[0047] For surface roughness measurement, a non-contact surface texture measuring instrument (Opt-scope R200, manufactured by Tokyo Seimitsu Co., Ltd.) was used, and measurements were taken under conditions of a temperature of 20.2 to 20.5°C and a humidity of 50 to 60%. The measurements were conducted in accordance with JIS B 0601 (2013).

[0048] [Results / Discussion] The following materials were used for measurement, and the arithmetic mean roughness (Ra) and ten-point mean roughness (Rz) were measured. Tray sheet Ra: 0.0269μm (average), 0.0063μm (standard deviation) Rz: 0.1889μm (average), 0.0562μm (standard deviation)

[0049] Plaster cast model Ra: 1.8557μm (average), 0.1819μm (standard deviation) Rz: 9.9387μm (average), 0.2826μm (standard deviation)

[0050] Models made from resin powder (using a 3D printer) Ra: 15.6325μm (average), 2.2247μm (standard deviation) Rz:76.0542μm (average), 9.1204μm (standard deviation)

[0051] Mouthpiece made from a plaster cast model (conventional manufacturing method) Ra: 3.0726μm (average), 0.0834μm (standard deviation) Rz: 16.7166μm (average), 0.4377μm (standard deviation)

[0052] Mouthpiece made from a model derived from resin powder (3D printing method) Ra: 14.2645μm (average), 1.4150μm (standard deviation) Rz: 78.0576μm (average), 7.5345μm (standard deviation)

[0053] The surface roughness measurements revealed a significant difference in surface roughness between the plaster-based model and the resin powder-based model. Furthermore, the rough surface shape of the resin powder-based model was transferred to the tray sheet, and the roughening effect was also reproduced in the mouthpiece made from the resin powder-based model. Thus, the effectiveness of the manufacturing method of the embodiment was verified, and together with the results of the aforementioned drip test, it was found that the formation of a roughened area in the mouthpiece is effective in the retention and retention of the drug.

[0054] For example, during home whitening treatment, it is unavoidable that a small amount of whitening agent may leak from the edges of a custom-made tray tailored to the wearer's teeth. As long as the amount of leakage is small, it is not considered a problem. However, it is desirable to minimize the amount of leakage as much as possible. Furthermore, if the amount of whitening agent leaking is large, it may affect the whitening effect. While fabricating a custom tray with a good edge fit is effective in suppressing this, using a tray with low liquid fluidity, such as a tray made from resin powder, is also effective. Therefore, by fabricating a custom tray using the techniques and materials used for resin powder models, effective home whitening becomes possible. Of course, the same applies to the treatment of tooth sensitivity. [Explanation of Symbols]

[0055] 1. Mouthpiece 2. Resin sheet 10 Main body 11 Inner surface part 12 Outer surface 13 Roughened area 20 teeth 30 3D scanners 31. Three-dimensional dental arch data 40 Dental Models 41 Tooth model 42 Base U Person wearing the garment M oral cavity MT dentition

Claims

1. A mouthpiece that is fitted to the teeth of the wearer's mouth, The mouthpiece has a roughened portion on the inner surface of the mouthpiece that contacts the surface of the teeth in the oral cavity. A mouthpiece characterized in that the surface roughness (Ra) of the roughened portion, measured in accordance with JIS B 0601 (2013), is 5 to 25 μm.

2. The mouthpiece according to claim 1, wherein the mouthpiece is formed from a resin sheet.

3. The mouthpiece according to claim 1, wherein when the mouthpiece is placed in the mouth of the wearer, a drug is filled into the inner surface of the mouthpiece, and the drug remains in the roughened portion.

4. The mouthpiece according to claim 3, wherein the aforementioned agent is a whitening agent or a tooth sensitivity treatment agent.

5. A tooth row data generation step involves imaging the tooth row of the wearer's mouth and generating three-dimensional tooth row data of the tooth row in the mouth, A model manufacturing process is performed to create a dental model of the wearer based on the aforementioned three-dimensional dental arch data. The process includes a step of manufacturing a mouthpiece, which involves attaching a resin sheet to the dental model and transferring the surface shape of the dental model to the resin sheet to create a mouthpiece to be worn in the mouth of the wearer. In the mouthpiece manufacturing process, when transferring the surface shape of the dental model to the resin sheet, a roughened area is formed on the inner surface of the mouthpiece. A method for manufacturing a mouthpiece characterized by the following:

6. The method for manufacturing a mouthpiece according to claim 5, wherein the surface roughness (Ra) of the roughened portion, measured in accordance with JIS B 0601 (2013), is 5 to 25 μm.

7. The method for manufacturing a mouthpiece according to claim 5, wherein in the model manufacturing step, the dental model is manufactured by a 3D printer.

8. The method for manufacturing a mouthpiece according to claim 5, wherein the dental model is manufactured by melting and agglomerating resin powder using the 3D printer.

9. The method for manufacturing a mouthpiece according to claim 5, wherein when the mouthpiece is placed in the mouth of the wearer, a drug is filled into the inner surface of the mouthpiece, and the drug remains in the roughened portion.

10. The method for manufacturing a mouthpiece according to claim 9, wherein the aforementioned agent is a whitening agent or a tooth sensitivity treatment agent.

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