JP2010131181A - Method of manufacturing mouth guard - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a mouth guard capable of being comfortably worn with the optimal occlusion provided by a simple method without requiring an exclusive device according to a method of manufacturing the mouth guard to be used for preventing burdens on the jaw tissue or preventing external injury to the jaws at the time of sports. <P>SOLUTION: The mouth guard is manufactured by waxing the shape of the mouth guard in a dentition model 1; making a mold 4 of a material for the mold, such as autopolymerizing resin; boring two holes, an injection hole 6 and a discharge hole 7, in the mold; covering the dentition model 1 with the mold; and injecting an elastic material such as room-temperature addition-polymerization silicone into the dentition model 1. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to a method for manufacturing a mouth guard used for preventing a burden on a jaw tissue and trauma during sports.

Conventionally, mouth guards (mouthpieces or mouth protectors) used in contact sports such as boxing as a sport protection device or oral protection device for preventing jaw tissue trauma during sports and protecting teeth and jaw bones Also known as).
In general, the purpose of wearing a mouth guard for sports is to protect the teeth and periodontal tissues (especially the maxillary anterior teeth) from the external force directly applied to the face from the front and side, and by the teeth on the lips, tongue and cheeks by external force Prevents damage, protects teeth, periodontal tissue, prosthesis, etc. from impact due to contact with the upper jaw when external force is applied to the lower jaw, protects the temporomandibular joint (joint cavity, joint disc, etc.) from external force It is intended to protect or prevent damage to the brain such as concussion due to impact on the brain through the temporomandibular joint and dentition.

By using an elastic material having excellent flexibility as a material, the mouth guard can exhibit effects such as prevention of trauma in the jaw and oral cavity and absorption / relaxation of shock to the brain as described above. That is, by mounting the mouth guard, the external force is diffused throughout the mouth guard, and the concentration of impact can be suppressed.
With regard to the mouth guard, for example, in Patent Document 1, a frame having a size suitable for the size of the user's dentition is selected from ready-made silicone frames having a plurality of sizes, and a gap is provided on the inner surface thereof. A mouth guard manufactured by filling a paste-like silicone rubber as a layer, inserting it into the mouth dentition of the mouth guard user, and curing it is disclosed.
In Patent Document 2, an ethylene-vinyl acetate copolymer (hereinafter referred to as EVA), which is a thermoplastic elastic material previously formed into a sheet shape, is heated and softened using a heat-pressure welding suction device dedicated to manufacturing a mouth guard. There is disclosed a mouth guard that is manufactured by being brought into close contact with a dental model by being pressed and sucked.
Also, in Patent Document 3, mouth guard-shaped wax-up is performed on a model, buried with gypsum, cast wax, filled with an elastic material such as polyvinyl alcohol (hereinafter referred to as PVA) gel, cooled, etc. A mouth guard manufactured by a method similar to a method for manufacturing a denture more hardened is disclosed.
Japanese Patent No. 1563289 Japanese Patent No. 2594830 JP 2003-102478 A

The mouth guard disclosed in the above-mentioned Patent Document 1 does not require a technical operation and cures the silicone of the gap layer in the oral cavity of the user. There is an advantage that it can be easily manufactured, but there are the following problems.
(1) Since ready-made frames prepared in several sizes in advance are used, it is difficult to give an optimal occlusion according to each user (hereinafter referred to as the first problem).
(2) It is difficult to control the thickness of the entire mouth guard and the wearing feeling is not good (hereinafter, the second problem)
(3) Since the interface between the frame and the gap layer is held only by mechanical fitting force, the durability is not sufficient (hereinafter, referred to as a third problem).
(4) There is a problem that dirt is likely to adhere to the interface between the frame and the gap layer and is not hygienic (hereinafter referred to as a fourth problem).
The mouth guard disclosed in Patent Document 2 is a simple technical operation because the mouth guard is molded by softening, pressing and sucking a sheet-like thermoplastic elastic material on a dental model using a dedicated device. Has the advantage of producing a well-matched mouth guard, but has the following problems.
(5) Since a dedicated device is required, there is a problem that initial investment is required to introduce the device (hereinafter, the fifth problem).
The mouth guard disclosed in Patent Document 3 has a merit that a mouth guard having a good fit and proper occlusion can be manufactured using a general technical tool. However, the following problems are encountered. is there.
(6) In order to manufacture a mouth guard in the same manner as in the manufacture of dentures, the dental model must be buried with gypsum, and the operation is complicated, and the gypsum takes time to harden, making it time consuming and laborious. There was a problem that it took too much (hereinafter referred to as the sixth problem).
Accordingly, an object of the present invention is to provide a method for manufacturing a mouth guard that solves the first to sixth problems.

As a result of intensive studies to solve the above-mentioned problems, the present inventors performed mouthguard-shaped wax-up on the dentition model, and produced a mouthguard mold using a polymerizable resin as a mold material. The mold is provided with two holes, an injection hole and a discharge hole. The hole is covered with a dental model, and an uncured silicone liquid material is injected and cured as a curable elastic material. By manufacturing, the manufacturing method of the mouth guard which eliminates the said 1st-6th problem was discovered, and it came to complete this invention.
That is, the present invention
Polymerization resin as a material for dentition model, wax, formwork, silicone as an elastic material to form mouth guard,
Forming a mouth guard shape by overlaying wax on the dentition model;
A step of mold-curing a mouth guard-shaped wax with a polymerizable resin which is a material for a mold, and
Removing the wax from the molded formwork;
Before and after the wax removal step, cutting the injection hole and the discharge hole in the mold,
A process of demolding the cured product after injecting and curing an uncured liquid silicone material, which is an elastic material, with the formwork attached to the dentition model;
A mouth guard manufacturing method comprising:
In the mouth guard manufacturing method, room temperature addition polymerization type silicone is preferably used for silicone which is an elastic material.
The mouth guard manufacturing method performs a process of cutting the injection hole and the discharge hole in the mold before the wax removing process, and in the wax removing process, the mold is heated while attached to the dental model, It is preferable to discharge the melted wax from at least one of the injection hole and the discharge hole.
In the above mouth guard manufacturing method, it is preferable to use a room temperature addition polymerization type silicone having a tear strength of 10 or more to silicone which is an elastic material.
In the mouth guard manufacturing method, it is preferable to use a room temperature addition polymerization type silicone having a Shore A hardness of 40 to 90 for silicone which is an elastic material.

In the mouth guard manufacturing method of the present invention, since the thickness of the mouth guard can be controlled by waxing up the mouth guard shape on the dentition model, an optimal occlusion can be given and a mouth guard with a good wearing feeling can be manufactured. The first and second problems do not occur.
Since the manufactured mouth guard is composed of a single material, it is possible to manufacture a sanitary mouth guard that is durable and does not accumulate dirt, so that it does not peel off. Problem 4 does not occur.
In addition, since a dedicated device is not required for manufacturing the mouth guard, no initial investment is required for the introduction of the device, so the fifth problem does not occur.
Furthermore, the sixth problem can be solved because a mouth guard-shaped mold is formed by waxing up with a polymerizable resin without using a method similar to that for manufacturing a denture, for example, an embedding operation with gypsum.
In addition, by using room temperature addition polymerization type silicone as the elastic material silicone, it can be polymerized at room temperature, there is no surface unpolymerization due to oxygen inhibition, so no polishing operation is required, coloration is low, and machinability A good mouth guard can be manufactured.

Hereinafter, a method for manufacturing a mouth guard according to an embodiment of the present invention will be described with reference to the drawings.
In the mouth guard manufacturing method of the present invention, a step of waxing up a mouth guard shape on a dental model using a dental resin, wax, a polymerizable resin as a material for a mold, and silicone as an elastic material, and a mouse that has been waxed up The process of casting the guard shape with a polymerizable resin, which is a material for molds, the process of removing wax from the molds that have been cast, and the mold removal before and after the wax removal process are injected into the molds It consists of a step of cutting the hole and the discharge hole, and a step of returning the mold to the model and injecting silicone as an elastic material. Hereinafter, each process will be described sequentially.

FIG. 1 is a perspective view of the dentition model 1.
First, before proceeding to the wax-up process, a mouth guard dental model 1 to be formed is prepared. The dentition model 1 is formed by covering a tooth with a viscous mold picking agent to form a tooth mold, and filling the model material into the tooth-shaped space to form the dentition model 1.
The dentition model 1 used in the wax-up process is not particularly limited as long as it is manufactured using a known model material. The model material of the dentition model 1 includes a gypsum model material such as ordinary plaster, hard gypsum, and super hard gypsum, a resin model material such as an epoxy resin model material, and a fireproof material such as a phosphate fire model material. Examples include model materials and metal model materials such as amalgam. These model materials can be used without limitation, but gypsum-based model materials are preferable from the viewpoints of ease of handling, material cost, and speed of curing. Furthermore, cemented gypsum is preferable from the viewpoint of the dimensional reproducibility in the oral cavity due to the small hardening expansion and the wear resistance that cannot be scraped off by a technical operation.

[Wax-up process]
In the manufacturing method according to the present embodiment, examples of the wax-up method in the wax-up process include the following (A) to (C).
(A) Method of waxing up by immersing the model in a wax bath in which wax is dissolved, taking out the model from the wax bath and curing it (dipping method)
(B) Waxing up by melting and taking wax with a warmed instrument and placing and curing the wax taken and melted at the target site (raising method)
(C) A method of pressing and pasting a ready-made wax pattern or sheet-like wax on a model (pressure welding method)
and so on.
These wax-up methods can be used without limitation, but from the viewpoint of giving a uniform thickness quickly and waxing up the mouth guard shape, and removing the wax after mold making can be done easily without using a flowing wax operation. The pressure welding method (C) using a sheet-like wax having a constant thickness is preferable.

  A known wax can be used as the kind of wax for waxing up the mouth guard shape to the dentition model 1. Examples of such a wax include mineral waxes such as paraffin, microcrystalline wax and ceresin, insect waxes such as beeswax, and plant waxes such as carnauba and dammar. These waxes can be used as they are, or a mixture mixed at an arbitrary mixing ratio can be used without limitation, but from the viewpoint of removal of flowing wax and wax with hot water, the melting temperature is as low as about 40 to 60, and paraffin with little tackiness. Is preferred. In addition, paraffin wax in which beeswax or ceresin is added to paraffin is preferable in order to improve moldability by cutting or melt build-up. Furthermore, it is preferable to use a sheet-like paraffin wax molded to a constant thickness so that a uniform thickness can be easily given during wax-up and the thickness can be controlled.

As shown in FIG. 1, the sheet-like wax 2 is formed in a rectangular plate shape having a constant thickness and extending in one direction. The sheet-like wax 2 is deformed into a U shape so as to match the tooth row 3, and press-contacted so as to cover the sheet-like wax 2 around the tooth row 3 as shown in FIGS.
In order to make the sheet-shaped wax 2 easy to press, it is preferable to perform the pressure-welding after the sheet-shaped wax 2 is softened by a heat source such as a torch at the time of pressing. In this way, the wax can be spread to every corner of the dentition. At the time of wax removal, a wax separating material may be applied to the dentition model 1 before waxing up in order to facilitate removal of the wax from the dentition model.
Mouth guard that eliminates the first and second problems by performing wax-up of sheet-like wax (hereinafter, a deformed sheet-like wax is simply referred to as molding wax) 2 by such a method. Can be produced.

[Molding process]
After the wax-up process, a mold making process is performed. In the mold making process, the mouthguard-shaped molding wax 2 is cast with a material for a mold, and a mold 4 is formed as shown in FIGS. 3A and 3B.
In the manufacturing method according to the present embodiment, it is desirable that the mold taking step preferably covers the entire mouthguard-shaped molding wax 2 with a mold material. It is desirable not to entrap air bubbles at the interface between the wax 2 and the mold frame 4 during the molding so that reliable molding can be performed.
In addition, in order to improve the sealing property that the elastic material does not leak from the edge of the mold 4 in the injection process described later, the mold material exceeds the edge of the mouth guard shape by wax, It is desirable to be in contact or close. Preferably, a known separating agent can be used so that the formwork material does not adhere to the dentition model 1.

As the material of the mold 4, a polymerizable resin is used because it is easy to handle. The polymerizable resin may be either a chemical polymerization type or a photopolymerization type. Generally, a room temperature polymerizable chemical polymerization type resin, which is generally called an immediate polymerization resin, is used. These resins are non-silicone resins, and preferably have no adhesiveness to the material for the mold when the elastic material made of silicone as the mouth guard is cured. Usually, those composed of a polymerizable composition containing a polymerizable monomer such as a (meth) acrylic polymerizable monomer, a polymerization initiator, a filler and the like as main components are used.
In addition, when injecting an uncured silicone liquid material that is an elastic material, the mold material is not deformed by external force when it is cured in order to prevent the mold from deforming and adversely affecting the shape of the mouth guard. What is hard to occur is desirable.
By producing the mold by such a method, an embedding operation with gypsum is not required, and thus a mouth guard that solves the sixth problem can be manufactured.

[Wax removal process]
When the material for the mold is sufficiently cured, the mold 4 is removed from the model and the molding wax 2 is removed. A suitable removal of the molding wax 2 is desirable because a method of peeling off the molding wax 2 inscribed in the mold 4 with Evans or the like can be performed quickly and in a short time. Moreover, you may perform a flowing wax operation.
In addition, although this wax removal process may be performed after the hole cutting process demonstrated below, this is demonstrated by a hole cutting process.

[Hole cutting process]
FIG. 4 is a perspective view of the mold 4 removed from the dentition model 1. With reference to FIG. 4, in the hole cutting process, the injection hole 6 and the discharge hole 7 are cut in the mold 4 that has been molded, and a hole is formed in the side surface of the mold 4.
In the hole cutting process according to the present embodiment, there are two holes to be cut, one being used as the injection hole 6 and the other being used as the discharge hole 7. The place where the holes 6 and 7 are cut can be arbitrarily determined. Preferably, when the elastic material overflows from the discharge hole 7 in the elastic material injection process described later, the mold 4 and the dentition model 1 are used. The two holes are located at the farthest part of the mouth guard, on the buccal side of the molar, so that it can be confirmed that the mouth guard-shaped gap formed between It is desirable to cut the holes one by one. However, the number of holes may be three or more.
A known cutting tool can be adopted as the tool for cutting the hole. Preferably, it is desirable to use a high torque electric drill such as a technical micromotor from the viewpoint of reliable cutting and shortening of working time. Moreover, a hole can be easily cut if a round bar is used for a cutting jig. The size of the round bar is desirably selected in accordance with the diameter of the syringe or syringe tip for injecting the elastic material.
As described above, when the hole cutting step is performed before the wax removing step described above, the molding wax 2 is left as it is, the injection hole 6 and the discharge hole 7 are formed first, and the mold is used as the dentition model. It heats with mounting | wearing, melt | dissolves the wax in a frame, and the wax melt | dissolved from the injection hole 6 and / or the discharge hole 7 is discharged | emitted. When the molten wax is substantially discharged by the above operation, it is preferable to inject hot water having a temperature equal to or higher than the melting temperature of the wax into the mold from the injection hole 6, discharge from the discharge hole 7, and wash away the remaining wax. In this method, the wax removal operation can be easily performed, and it is not necessary to align the dentition model 1 and the mold 4, and positioning can be performed without forming a positioning portion on the dentition model 1 and the mold 4. It is possible to manufacture a mouth guard with an accurate shape. An efficient method for removing the wax by using the injection hole 6 and / or the discharge hole 7 while melting the internal wax while the mold is mounted on the dentition model, as an effective wax removal process. As will be described later, in the present invention, a polymerizable resin is used as a material for a mold, and silicone is used as an elastic material for forming a mouth guard.

[Elastic material injection process]
FIG. 5A is a perspective view of a state in which the mold 4 is again put on the dentition model 1 after completing the hole cutting step, and FIG. 5B is a cross-sectional view thereof.
As shown in the figure, by attaching the mold 4 to the dentition model 1, a mouth guard-shaped gap 8 is formed between them, and the mold 4 is returned to the dentition model 1 in the elastic material injection step. Then, an uncured silicone liquid material (including paste) is injected between the dental model 1 and the mold 4 as an elastic material.
Before returning the mold 4 to the dentition model 1, it is preferable to apply a separating agent to the dentition model 1 so that silicone and the dentition model 1 do not stick together. In the operation of returning the mold to the model, it is preferable to return the mold to an appropriate position where the mold has been taken, and to seal the gap between the edge of the mold and the dentition model with wax or an instantaneous adhesive. In this case, known waxes and instant adhesives used for sealing can be used.

  As a tool for injecting an uncured liquid material of silicone, a publicly known tool can be used, but it does not include a member containing a paste or a liquid curing catalyst (backer) and a curing catalyst. It is preferable to use an extruder equipped with a chip that is filled with two members (second materials) separately and is paste-kneaded by extrusion at the tip. This eliminates the need to knead the paste with a spatula in the form of kneaded paper, reduces the possibility of entrapment of bubbles in the paste, has no air bubbles, is durable, and has little dirt. A guard can be made.

  In the injection method, one hole is used as an injection hole 6, silicone uncured liquid material is injected from the injection hole 6, another hole is used as a discharge hole 7, and the uncured liquid material overflows from the discharge hole 7. It is preferable to inject until it comes. Furthermore, in order to spread silicone to every corner without introducing bubbles into the mouth guard-shaped gap 8 made by the mold 4 and the dentition model 1, as shown in FIG. It is preferable to inject with the discharge hole 7 facing up. By using this method, the uncured liquid material of heavy silicone is gradually filled from the bottom of the mouth guard-shaped gap 8 formed by the mold 4 and the dentition model 1, and the weight in the gap is filled. Since the light air is discharged from the discharge hole, the silicone can be distributed without entraining air bubbles to every corner.

FIG. 6 is a perspective view of the state in which the mold 4 is removed after injecting an uncured silicone liquid material into the gap 8 between the dental model 1 and the mold 4.
As shown in the figure, when the silicone is cured by filling the gap 8 with an uncured liquid material of silicone, carefully remove the mold 4 from the dentition model 1, and further remove the hardened mouth guard 10 from the dentition model 1. The silicone sprues 11 and 11 formed in the injection hole 6 and the discharge hole 7 are cut. If necessary, the mouth guard 10 is completed by cutting burrs formed on the edge of the mouth guard.
For the occlusal adjustment of the mouth guard, known methods such as occlusal adjustment using the upper and lower jaw models and occlusal adjustment performed by attaching to the user's dentition can be adopted without limitation.

Here, the elastic material used as the material of the mouth guard 10 is demonstrated.
The elastic material used in the elastic material injecting step is deformed when a force is applied, but it needs to have a property of returning to its original dimensions when unloaded, and silicone is used in the present invention.
Silicone has excellent characteristics as a dental material that is excellent in flexibility, water repellency, non-adhesiveness, relatively stable and physiologically non-toxic. Moreover, since it has a low affinity with the polymerizable resin, which is a material for the mold, it is preferable because it does not integrate even if cured in the mold and can be easily removed. In the present invention, as an elastic material for forming the mouth guard as described above, a polymerizable resin which is a material for a mold and silicone having low adhesiveness are used. Due to this, in the present invention, as described above, in the wax removal step, the wax inside is melted and the injection hole 6 and / or the discharge hole 7 are formed while the mold is mounted on the dentition model. It becomes possible to adopt a method of discharging by using. That is, when the wax is removed by this method, it is usually unavoidable that a small amount of wax is adsorbed and remains on the inner surface of the mold or dentition model, but the elastic material to be cured between these is silicone. Since the silicone has a polyorganosiloxane as a main component, the curing heat generation is smaller than that of a resin or the like at the time of curing. Therefore, the wax remaining on the inner surface of the mold or the dental model is melted and mixed into the silicone at the time of curing. There is almost nothing. When many other elastic materials such as an acrylic resin are used, the heat generated by the curing is large. When the wax is removed by the above method, it is inevitable that the wax is mixed into the surface at the time of curing. Pieces are affected by polymerization inhibition and surface properties deteriorate, or purity decreases and surface roughness occurs. However, in the present invention using silicone as an elastic material, such a problem does not occur and efficient (type It is possible to operate the wax removing process without having to seal the gap between the frame edge and the dentition model. Further, since the remaining wax serves as a separating material for gypsum and silicone, a secondary effect is obtained in which the silicone can be removed from the model without applying the separating material.
Silicone includes heat-polymerized silicone and room-temperature-polymerized silicone. In the wax removing step, the wax inside is melted while the mold is attached to the dentition model to melt the injection hole 6 and / or. When the method of discharging using the discharge holes 7 is adopted, it is possible to cure without requiring a heating operation for the reason of preventing the mixture of the wax remaining on the inner surface of the mold and the dentition model as much as possible. Polymerized silicone is preferred. In this case, if a heat polymerization type silicone is used, it is preferable to use one having a heating temperature equal to or lower than the melting temperature of the wax.
In general, as a method for preparing room temperature polymerization type silicone, a base material and a curing material are stored separately, and both are kneaded immediately before use. Therefore, in the production method of the present invention, the above room temperature polymerization type silicone is suitable for producing a mouth guard by a simple operation of injecting a paste and waiting for curing.

Furthermore, a room temperature addition polymerization type silicone is most preferable from the viewpoint of a feeling of wearing due to a difference in dimensional stability accompanying polymerization shrinkage. The room temperature addition polymerization type silicone is excellent in dimensional stability because there is no by-product accompanying polymerization and the polymerization shrinkage is small. Therefore, the mouth guard made of room temperature addition polymerization type silicone has a good fit with the model, the feeling of wearing during use is not tight, and a good fit can be obtained.
In addition, it is preferable to use polyorganosilsesquioxane fine particles as a filler for room temperature addition polymerization type silicone from the viewpoints of machinability and color resistance. A room temperature addition polymerization type silicone having good machinability and good coloration resistance is disclosed in JP-A-7-41411. That is, polyorganosilsesquioxane fine particles are used as a filler for room temperature addition polymerization type silicone, and the filler has higher hydrophobicity than silica-based powder and has Si—O bond, Si—CH ₃ bond, and the like. For this reason, it is well-familiar with silicone as a matrix, and further has a reinforcing effect on silicone rubber, so that the cured elastic body has a certain level of mechanical strength and a small amount of coloring. Furthermore, by selecting a material having an appropriate particle size, it is possible to fill with a high filling rate and to give sufficient rigidity to the cured elastic body. Therefore, cutting properties can be imparted to the cured elastic body. Therefore, the cutting property for performing occlusal adjustment and form correction can be provided, and coloring during the production and use of the mouth guard can be suppressed.

The room temperature addition polymerization type silicone does not undergo polymerization inhibition by oxygen during curing, so that almost no unpolymerized components remain on the surface, and a smooth surface can be obtained without performing a polishing operation. Therefore, it is possible to manufacture a sanitary mouth guard 10 that omits the polishing operation and hardly adheres to dirt. Further, the room temperature addition polymerization type silicone has an advantage that no by-product is generated.
By manufacturing a lump-molded mouth guard from such room temperature addition polymerization type silicone, a mouth guard 10 that eliminates the third and fourth problems can be manufactured.
Durable mouse having a tear strength (value obtained by preparing a test piece according to JIS K 6250 and obtaining a test according to JIS K 6252) in the room temperature addition polymerization type silicone used for the elastic material is 10 or more. This is preferable from the viewpoint of manufacturing a guard.
In addition, in the room temperature addition polymerization type silicone used for the elastic material, a Shore A hardness of 40 to 90 is preferable from the viewpoint of exerting effects such as prevention of trauma of jaw tissue and absorption / relaxation of shock to the brain. .
Since the mouth guard is manufactured by the above manufacturing method, a dedicated device is not required, and thus the mouth guard 10 can be manufactured by a method for solving the fifth problem.

In order to describe the present invention more specifically, examples and comparative examples are shown below, but the present invention is not limited to these examples.
With respect to the production of the mouth guard, the working time, wearing feeling, presence / absence of a dedicated device, tensile test, impact absorption test, and surface condition of the mouth guard were evaluated under the conditions as in the following examples and comparative examples.

[Example 1]
An upper and lower jaw dentition model of a mouth guard user was prepared. Next, a mouth guard-shaped wax-up was performed on the maxillary dentition model. Wax-up used 1.5mm sheet-like paraffin wax, softened with a tabletop torch, and pasted on the model to form a mouth guard shape that covered the entire upper dentition. . The occlusal relationship was confirmed and adjusted by engaging with the lower dentition model (wax-up process working time 10 minutes).
Next, using an instant polymerization resin “Ostron” (manufactured by GC), 100 parts by weight of the powder and 33 parts by weight of the liquid are mixed, kneaded until a uniform bowl shape, and a 2 mm thick sheet using a glass plate It was pressed into a shape and pressed from above the wax-up model, and a mouthguard-shaped mold was taken (molding process working time 10 minutes). When the immediate polymerization resin hardened, a hole capable of injecting resin was cut on one side of each side of the mold in a state where the mold was still attached to the dentition model. A round bar was used to give the hole to the hole by a technical micromotor (hole cutting process 1 minute). Next, the dental model with the mold attached is immersed in hot water (80-90 ° C) to dissolve the wax sufficiently, then taken out of the hot water, and hot water is poured from one of the holes (injection holes) opened in the mold. Poured and discharged from another hole (discharge hole) to wash away the wax (wax removal process working time 10 minutes).
Next, an uncured liquid material obtained by mixing an equal amount of a base material of a room temperature addition polymerization type silicone “Sofuri Liner Tough” (manufactured by Tokuyama Dental Co., Ltd., Shore A hardness 43, tear strength 18.5) and a curing material. Was injected from one of the holes (injection hole) opened in the mold, and injection was performed with a syringe until the silicone was discharged from the other hole (discharge hole). When injecting, the injection was carried out with the injection hole facing down and the discharge hole facing up so that air bubbles would not enter the mouth guard. When the silicone was discharged from the discharge hole, the injection was stopped and the silicone was cured. When the injected room-temperature addition-polymerized silicone cures, remove the mold from the dentition model, remove the molded mouth guard, and sprue formed in the shape of the injection hole and discharge hole on the buccal side of both sides of the mouth guard. And the mouth guard was completed (injection process work time 15 minutes).

[Example 2]
The mold making process was performed in the same manner as in Example 1, the mold was removed from the maxillary dentition model, and the paraffin wax attached to the maxillary dentition model and the mold was removed using Evans. An injection hole and a discharge hole similar to those in Example 1 were cut and imparted to the removed formwork. Vaseline was applied to the maxillary dentition model as a silicone separation material, the mold was returned to the maxillary dentition model, and the gap between the mold frame and the maxillary dentition model was sealed with an instantaneous adhesive (wax removal) Process and drilling process working time 20 minutes). Thereafter, in the same manner as in Example 1, injection, curing, removal, and sprue cutting of an uncured liquid material of room temperature addition polymerization type silicone were carried out to complete a mouth guard.

[Example 3]
In the same manner as in Example 1, the process up to the elastic material injection step was performed. Next, in the elastic material injection step, the heat addition polymerization type silicone “TSE3453” (manufactured by Momentive Co., Ltd.) is used instead of the room temperature addition polymerization type silicone “Sofri Liner Tough” used in Example 1 as the elastic material to be used. Then, 100 parts by weight of the base material and 10 parts by weight of the curing material are mixed to obtain an uncured liquid material, which is injected into the mold with a syringe, and the dental model with the mold attached is heated at 100 ° C. Then, it was carried out in a mode of curing (injection process working time 20 minutes). Thereafter, it was removed in the same manner as in Example 2, and the sprue was cut off to complete the mouth guard.

[Example 4]
In the elastic material injecting step of Example 1, instead of room temperature addition polymerization type silicone “Sofuri Liner Tough”, room temperature addition polymerization type silicone “Sofuri Liner SS” (manufactured by Tokuyama Dental Co., Ltd., Shore A hardness 23, tear strength 3 0.1) was used and the mouth guard was completed in the same manner as in Example 1 except that the base material and the curing material were mixed in equal amounts.

[Example 5]
In the elastic material injecting step of Example 1, instead of the room temperature addition polymerization type silicone “Sofuri Liner Tough”, the room temperature addition polymerization type silicone “Sofuri Liner Tough” and the room temperature addition polymerization type silicone “Sofly Liner SS” A mouth guard was completed in the same manner as in Example 1 except that an equal amount of the cured material was used (the cured product had a Shore A hardness of 33 and a tear strength of 11).

[Example 6]
In the elastic material injecting step of Example 1, instead of room temperature addition polymerization type silicone “Sofuri Liner Tough”, room temperature condensation type liquid silicone “TES350 (base material), CE601 (curing material)” (manufactured by Momentive), A mouth guard was completed in the same manner as in Example 1 except that 100 parts by weight of the base material and 1 part by weight of the curing material were mixed.

[Comparative Example 1]
Using a heated pressure welding suction device, a 3.0 mm thick EVA sheet was softened (10 minutes), and a mouth guard user's upper jaw dentition model was softened into a heated pressure welding suction device dedicated to mouthguard manufacturing. The EVA sheet was brought into close contact with the maxillary dentition model (working time 10 minutes). The mouth guard outline was written on the closely attached EVA sheet, and the EVA guard sheet was cut off along the outline to correct the edge shape of the mouth guard, thereby completing the mouth guard (working time 15 minutes). Since this manufacturing method requires a dedicated device, an initial investment for introducing the device is required.

[Comparative Example 2]
A pre-made horseshoe-shaped mouth guard frame prepared in advance with silicone rubber was filled with paste-like silicone rubber as a gap layer, and inserted into the maxillary dentition in the mouth of the mouth guard user (working time 10 minutes). After curing, the mouth guard was removed from the oral cavity, and the protruding silicone rubber was cut off to complete the mouth guard (working time 10 minutes). In this method, since the ready-made frame body becomes the occlusal surface, it was difficult to give an optimal occlusion, and the engagement felt poor. In addition, since the thickness on the cheek tongue side was not uniform, the mouth guard felt an irregular hit on the cheek tongue side, and there was a sense of incongruity.

[Comparative Example 3]
A mouth guard user's upper and lower jaw dentition model was prepared, and the mouth guard was waxed up (wax up process working time 10 minutes). A gypsum separating material was applied to the wax-up dentition model and buried in the flask with ordinary plaster. For burial, bury the lower part of the dentition model in the lower flask (bubbling up to the edge of the mouth guard, primary burial) (working time 20 minutes). The wax flask was buried (secondary embedding) (working time 20 minutes). When the secondary buried gypsum hardened, the whole flask was immersed in hot water, the wax was softened, the primary and secondary buried were divided by removing the flask at the top and bottom, and the mold was cast into a concave mold with gypsum The mouth guard-shaped part was washed away with hot water and the wax was removed (working time 15 minutes). The mouth guard concave shape made of gypsum is filled with polyvinyl alcohol (PVA) dry gel heated and dissolved together with a predetermined amount of water, the upper and lower flasks are matched, the whole flask is immersed in room temperature water, the dissolved PVA is cooled and re-cooled. Gelled (60 minutes). Thereafter, a mouth guard was dug from the plaster in the flask to complete the mouth guard (20 minutes). Since this method is manufactured in the same manner as in the manufacture of dentures, it takes a lot of time for the burying operation, and it takes time to manufacture the mouth guard.

[Comparative Example 4]
In the same manner as in Example 1, the process up to the elastic material injection step was performed. Next, the elastic material injection process is changed to room temperature addition polymerization type silicone “Sofuri Liner Tough”, and an immediate polymerization resin “Provenise” (manufactured by Matsukaze Co., Ltd.) is used to make the powder and liquid into a loose paste. The mixture was injected into the mold with a syringe and cured. However, in this method, it was not possible to remove the mouth guard-shaped resin cured body from the dentition model. Therefore, the cured resin was cut with a diamond disk mounted on a technical micromotor, removed from the dentition model, and the condition of the inner surface (contact surface with the dentition model) was confirmed. The surface of the resin cured body was not sufficiently cured because of the inhibition of curing by the wax dissolved from the surface of the row model.

[Comparative Example 5]
In the same manner as in Example 1, the process up to the elastic material injection step was performed. Next, the elastic material injection step is changed to room temperature addition polymerization type silicone “Sofuri Liner Tough”, and PVA dry gel is heated and dissolved together with a predetermined amount of water and injected into the mold with a syringe. The whole was immersed in water at room temperature, and the dissolved PVA was cooled and regelled. (Injection process working time 65 minutes) However, in this method, it took time to re-gelate by dissolution and cooling of PVA, and it took time to manufacture mouth guard. Moreover, by pouring PVA which became high temperature by heating and melting, the wax remaining on the surface of the dentition model and the formwork surface was melted and mixed with PVA, so that the mouth guard surface property was roughened.

  The test results are shown in Table 1.

The evaluation of the above Examples and Comparative Examples is as follows.
(1) Working time In the above-mentioned examples and comparative examples, the evaluation of the mouth guard manufacturing method relating to the working time was performed by measuring the actual working time until the mouth guard was completed in minutes. Those with less than 60 minutes were marked with ○, and those with more than 60 minutes were marked with ×.
Regarding the working time, in particular, 60 minutes were spent for cooling and regelling the PVA in which Comparative Example 3 and Comparative Example 5 were dissolved, and the evaluation was x. The working time spent in each example and comparative example is listed in Table 1.

(2) A feeling of wearing Evaluation of the feeling of wearing of the completed mouth guard was evaluated according to the following judgment criteria: ○, Δ, ×.
A: The thickness is uniform, there is no unnatural feeling on the cheeks and tongue, and the wearing feeling is very good.
○: Wearing feeling is good, but there is a feeling of strangeness.
X: Uneven thickness, unnatural feel on cheeks and tongue, and poor fit.
Regarding the feeling of wearing, Comparative Example 1 had a feeling of strangeness, and Comparative Example 2 had a bad feeling of wearing and feeling of strangeness.

(3) Presence / absence of dedicated device When manufacturing the mouse guard, the manufacturing method using the dedicated device was “necessary”, and the manufacturing method not requiring the dedicated device was “none”. “None” was marked with ○, and “Necessary” was marked with ×.
Since only the comparative example 1 uses the heating pressure welding suction device, the evaluation is x.

(4) Tensile test The completed mouth guard was allowed to stand in air at 37 ° C for 24 hours, and then the middle part of the mouth guard was stretched with both hands, and the strength against tension was evaluated in the state of the mouth guard when released. Evaluation was made according to the following judgment criteria: ◎, ○, Δ, ×.
◎: Same as the original state ○: Slightly stretched △: There is a cut ×: When it is stretched, it is separated into two parts In the tensile test, the mouth guard of Comparative Example 2 is made of a frame and a gap Peeling occurred at the interface, and in Comparative Example 3 and Comparative Example 5, cutting occurred.

(5) Impact absorption test The elastic material used for manufacturing the mouse guard was produced using a mold in a sheet shape having a thickness of 1.5 mm, a length of 10 cm, and a width of 10 cm. A white paper was placed on a wooden table, a carbon sheet was overlaid thereon, and a sheet of elastic material prepared thereon was placed thereon. An iron ball having a height of 50 cm to a weight of 100 g was dropped on the sheet. The impact absorbability of the elastic material was evaluated depending on how the white paper was printed at this time. Evaluation was made according to the following judgment criteria: ◎, ○, Δ, ×.
◎: Not printed at all ○: Lightly black △: Clearly printed with dots ×: Clearly printed with large circles In the shock absorption test, black was printed slightly in Examples 4 and 5 It became evaluation.

(6) Evaluation of the surface condition of the mouth guard The surface condition of the mouth guard was evaluated by visual and hand touch. The case where the surface was sufficiently cured was evaluated as ◎, the case where there was an uncured portion on the surface, but the region which could be used as a mouth guard was evaluated as ○, and the case where it was not cured as a mouth guard was evaluated as ×.
In the evaluation of the surface condition of the mouth guard, inadequate curing was observed in Example 3 and Comparative Examples 4 and 5, but the use was possible and the evaluation was good.

  The present invention has been described in detail based on the embodiments with reference to the accompanying drawings. However, the present invention is not limited to the above-described embodiments, and other modifications can be made without departing from the scope of the present invention. Or it can be changed.

It is a perspective view of the dentition model used with the manufacturing method of the mouth guard by the embodiment of the present invention. 1A is a perspective view of a state in which wax is waxed up on the dentition model of FIG. 1, and B is a sectional view. A is a perspective view of a state in which a formwork material is superimposed on the wax-up dental model shown in FIG. 2, and B is a cross-sectional view. FIG. 4 is a perspective view of a state in which a mold formed of the mold mold material of FIG. 3 is separated from a dentition model and an injection hole and an extraction hole are formed. 3A is a perspective view of a state in which the wax is removed from the dentition model of FIG. 3 and the formwork of FIG. 4 is again superimposed on the dentition model, and a gap serving as a mouth guard is formed between them, and B is a cross-sectional view. . FIG. 6 is a perspective view of a mouth guard covering a dental model in a state where a formwork is removed from A of FIG. 5.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Dental row model 2 Sheet-like wax 3 Teeth row 4 Formwork 6 Injection hole 7 Ejection hole 8 Space | gap 10 Mouth guard 11 Sprue

Claims (6)

Polymerization resin as a material for dentition model, wax, formwork, silicone as an elastic material to form mouth guard,
Forming a mouth guard shape by overlaying wax on the dentition model;
A step of mold-curing a mouth guard-shaped wax with a polymerizable resin which is a material for a mold, and
Removing the wax from the molded formwork;
Before and after the wax removal step, cutting the injection hole and the discharge hole in the mold,
A process of demolding the cured product after injecting and curing an uncured liquid silicone material, which is an elastic material, with the formwork attached to the dentition model;
A mouth guard manufacturing method comprising:   2. The mouth guard manufacturing method according to claim 1, wherein a room temperature polymerization type silicone is used as the elastic material silicone.   The mouthguard manufacturing method according to claim 2, wherein the room temperature polymerization type silicone is a room temperature addition polymerization type silicone.   Before the wax removal step, a step of cutting the injection hole and the discharge hole in the mold is performed. In the wax removal step, the mold is heated while attached to the dental model, and the melted wax is injected into the injection hole and The mouth guard manufacturing method according to any one of claims 1 to 3, wherein the mouth guard is discharged from at least one of the discharge holes.   The method for producing a mouth guard according to any one of claims 1 to 4, wherein room temperature addition polymerization type silicone having a tear strength of 10 or more is used for silicone which is an elastic material.   6. The mouth guard manufacturing method according to claim 1, wherein a normal temperature addition polymerization type silicone having a Shore A hardness of 40 to 90 is used as the elastic material silicone.

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