阅读说明：本技术 具有不同的性质的牙科器具 (Dental appliances with different properties ) 是由 雷·F·斯图尔特 于 2018-03-01 设计创作，主要内容包括：描述的是改进的牙科材料和由其制成的器具,其具有一定范围的柔韧性和强度并且在正畸和其它治疗中显示改善的舒适性和有效性。(Described are improved dental materials and appliances made therefrom that have a range of flexibility and strength and exhibit improved comfort and effectiveness in orthodontics and other treatments.)

1. A dental appliance, comprising:

(i) conforming to a model corresponding to one or more teeth (A1), the model having a gum line and a gum region (A2), the one or more teeth extending above the gum line and the gum region being below the gum line, and

(ii) at least a first polymeric material and a second polymeric material that is the same as or different from the first polymeric material, the first polymeric material conforming to at least a portion of one or more teeth above the gum line and the second polymeric material conforming to at least a portion of the gum region, wherein at least one of the first component and the second component has a functional effect when the dental appliance housing is applied to a person's teeth.

2. A dental appliance comprising two or more different materials adapted to conform to at least a portion of a tooth (a1) and a corresponding gingival region (a2), wherein at least a portion of the material (MA2) that conforms to the gingival region has different material properties than the material (MA1) that conforms to at least a portion of the tooth.

3. The dental appliance of claim 2, wherein at least a portion of the material conformable to the gingival region is trimmed to the gum line.

4. The dental appliance of claim 2, wherein at least a portion of the material conformable to the gingival region is trimmed to about 0.5mm, 1mm, 2mm, 3mm, 4mm, and 5mm, 0.5 to 1.5mm, 1 to 2.5mm, 2 to 3mm, or 3 to 4mm past (over) the gum line.

5. The dental appliance of claim 2, wherein the material property is one or more of a mechanical property, an optical property, an electrical property, a physical property, a chemical property, and a biochemical property.

6. The dental appliance of claim 5, wherein the material properties include modulus as a mechanical property and the modulus of M1A is greater than or equal to the modulus of MA 2.

7. The dental appliance of claim 6, wherein the modulus of M1A is greater than the modulus of MA2 by a factor selected from the group consisting of: 1.5 times, 2 times, 5 times, 10 times, 1 to 2 times, 2 to 3 times, 3 to 5 times, and 5 to 10 times.

8. The dental appliance of claim 5, wherein the material properties include one or more of optical properties of visible light transmission, reflection, anti-glare, gloss control, haze, and color.

9. The dental appliance of claim 8, wherein the light transmission of MA1 is less than the light transmission of MA 2.

10. The dental appliance of claim 5, wherein the material property is one or more of: (a) oxygen permeability as a physical property, wherein the oxygen permeability of MA2 is greater than the oxygen permeability of MA1, (b) fluid permeability as a physical property, wherein the fluid permeability of MA1 is greater than the fluid permeability of MA2, (c) antibacterial activity as a biochemical property, wherein the antibacterial activity of MA1 is greater than the antibacterial activity of MA2, and (d) calcium binding, wherein the calcium binding activity of MA1 is greater than the calcium binding capacity of MA 2.

11. The dental appliance of claim 2, including at least a first or innermost component and a second or outermost component.

12. The dental appliance of claim 11, wherein the innermost component and the outermost component comprise similar or identical materials.

13. The dental appliance of claim 11, wherein the innermost component and the outermost component comprise different materials.

14. The dental appliance of claim 11, wherein the innermost component is thermoformed to fit over the tooth and trimmed to the gum line so that the gums are barely covered.

15. The dental appliance of claim 11, wherein the thickness of the innermost component is selected from the group consisting of: 0.0125 to 0.75mm, 0.0125 to 0.5mm, 0.0125 to 0.25mm, 0.0125 to 0.05mm, 0.025 to 0.75mm, 0.025 to 0.5mm, 0.025 to 0.25mm, 0.025 to 0.125mm, 0.025 to 0.05mm, 0.125 to 0.5mm, and 0.125 to 0.25 mm.

16. The dental appliance of claim 11, wherein the thickness of the outermost component is selected from the group consisting of: 0.125 to 1mm, 0.25 to 1mm, 0.375 to 1mm, 0.5 to 1mm, 0.75 to 1mm, 0.125 to 0.75mm, 0.25 to 0.75mm, 0.375 to 0.75mm, 0.5 to 0.75mm, 0.125 to 0.5mm, 0.25 to 0.5mm, and 0.375 to 0.5 mm.

17. The dental appliance of claim 11, wherein the innermost component and the outermost component of the dental appliance are attached or laminated to one another.

18. The dental appliance of claim 4, further having catalytic activity for decomposing a peroxide compound, wherein the catalytic activity of MA1 is greater than the catalytic activity of MA 2.

19. The dental appliance of claim 18, further having a property selected from the group consisting of: (a) a catalytic activity for decomposing a peroxy compound, the catalytic activity derived from the chemical nature of (i) one or more of an iron compound, a nickel compound, or a manganese compound, (ii) a heterogeneous catalyst, (iii) Zeolite Socony Mobil-5 (ZSM-5), or (iv) a magnetically separable iron mixed oxide, and (b) a photocatalytic activity, wherein the photocatalytic activity of MA1 is greater than that of MA 2.

20. A dental appliance comprising a unitary polymeric shell adapted to fit over a tooth, wherein the dental appliance has a property selected from the group consisting of: (a) a catalytic activity for decomposing a peroxy compound, the catalytic activity derived from the chemical nature of (i) one or more of an iron compound, a nickel compound, or a manganese compound, (ii) a heterogeneous catalyst, (iii) Zeolite Socony Mobil-5 (ZSM-5), or (iv) a magnetically separable iron mixed oxide, and (b) a photocatalytic activity, wherein the photocatalytic activity of MA1 is greater than that of MA 2.

Technical Field

The present disclosure relates to improved dental materials and dental appliances (dental applications) made therefrom.

Background

Much effort and expense is expended to alter the appearance or function of a person's teeth. Some dental appliances are purely cosmetic, others are designed to cause movement of the teeth. Some dental appliances are housings comprising a clear plastic comprising polycarbonate, polyurethane, polyester, or other rigid plastic. Orthodontic retainers (orthodontics retainers) are commonly used to hold teeth in a particular arrangement (alignment) after an orthodontic procedure, and utilize a combination of plastic and metal components (Hawley Retainer).

Many useful dental appliances, such as orthodontic tooth positioners (positioners) or aligners (aligners), are produced by forming shells adapted to fit over one or more teeth, as described below: chisti et al, U.S. Pat. No.5,975,893, Phan et al, U.S. Pat. No.6,524,101, Tricca et al, U.S. Pat. No.7,255,561; a holder as described below: anderson, WO 2006009745, Stewart, WO 2013130552; protective denture (mouthguard), as described below: mack, U.S. patent publication No.20110179851, Ambis, 20110088703; bleached tray (bleaching tray), as described below: schwartz, U.S. patent No.6,089,869, Jensen, U.S. patent No.6,354,837; and dental splints or night guards (light guard) as described below: schwartz, U.S. patent publication No. 20090298006. U.S. patent No.6,454,565 discloses a method and configuration for producing devices having different mechanical properties in different areas. Us patent No.9,138,298 discloses an appliance that incorporates a reinforcing fabric in selected areas to alter the forces acting on the teeth to promote movement. U.S. patent No.8,986,003 discloses an orthotic made of polyurethane resin in which at least the facial surface is pearlescent white. The entire disclosure of each of these patents and publications is incorporated herein by reference for all purposes.

Such devices may be conveniently manufactured by one of several methods including thermoforming, subtractive machining (3D) printing, additive (3D) printing, or by other well-known methods or combinations of methods.

Some dental appliances function to impart a considerable force to the teeth and may prevent the teeth from moving or mitigate mechanical impact on the teeth. The rigidity of such polymeric devices is a result of the modulus of the thermoformable polymeric material from which the polymeric device is made. The higher the modulus of the material, the harder the appliance. However, the stiffer the appliance, the more difficult it is to fit it over the teeth and the more uncomfortable it is for the wearer. In addition, polymeric shells can degrade due to the environment in the oral cavity and lose their effectiveness over time in terms of mechanical properties or aesthetics.

Dental appliances are described that include a layered shell composed of at least two layers, wherein at least a portion of an innermost layer is configured to engage an individual tooth and the outermost layer has a lower modulus of elasticity than the inner layer. Such appliances impart different forces to the immediately underlying teeth, e.g., the portion of the appliance that covers the molars imparts a different force than the portion of the appliance that covers the remainder of the teeth.

Dental appliances are also described that include a layered shell having an inner layer and an outer layer, wherein the inner layer includes at least two segments (segments) that conform to individual teeth or groups of teeth, and the outer layer is joined with the segments of the inner layer, wherein the outer layer has a lower modulus of elasticity than the inner layer.

Dental appliances are described that use elastomeric polymeric shells to deliver substances to the teeth or gums (gum) while realigning the teeth. The substance is disposed in active form in or on a carrier or binder, encapsulated in a device, or microencapsulated in a polymeric material used to make the housing. Exemplary agents include antibiotics, bleaching materials such as carbamide peroxide, fluorides, and breath fresheners (breath fresheners), among others. The options currently available for improving the appearance of teeth have considerable disadvantages. Many cosmetic procedures utilize bleaching agents that are applied directly to the teeth. Such bleaching agents may damage the natural tooth structure itself and/or may produce inconsistent cosmetic effects or stains on the natural tooth structure and/or fillings or crowns. Other proposed cosmetic procedures utilize a process that forms a coating on the teeth. Such treatments are difficult to apply uniformly and accurately, often degrade relatively quickly, and are difficult to remove. Cosmetic options for improving the appearance of teeth are described, for example, in U.S. patent nos. 4,032,627; 6,343,933; 6,368,576, respectively; 6,503,485 and 6,986,883, and U.S. patent publication nos. 20050175552 and 20070086960, the entire disclosure of each of which is incorporated herein by reference for all purposes.

While there are many dental appliances on the market and various features are available, there is still a need for dental appliances that have a range of flexibility, maintain strength in orthodontic treatment, and exhibit improved effectiveness. In addition, it is of interest to provide dental appliances that have a more natural appearance, are more comfortable for the individual wearing the dental appliance, and/or are useful for administering forms of therapeutic or cosmetic treatments.

Disclosure of Invention

In a first aspect, an improved dental appliance is provided which includes a first or innermost component and a second or outermost component, which components may be made of the same material, similar materials, or different materials. The innermost and outermost components of the dental appliance may be attached or laminated to each other.

In one embodiment, at least a portion of the material conformable to a gingival region (gingival area) (a2) may be trimmed (trimmed) to the gum line, or trimmed to about 0.5mm, 1mm, 2mm, 3mm, 4mm, and 5mm, 0.5 to 1.5mm, 1 to 2.5mm, 2 to 3mm, or 3 to 4mm past (beyond) the gum line.

In other embodiments, at least a portion of the dental appliance material (MA2) that conforms to the gingival region has one or more different material properties than at least a portion of the material that conforms to at least a portion of the tooth (MA 1). The material property may be one or more of a mechanical property, an optical property, an electrical property, a physical property, a chemical property, and a biochemical property.

In some embodiments, the material property may be one or more of: (1) mechanical properties: a modulus, wherein the modulus of M1A is greater than or equal to the modulus of MA 2; (2) optical properties: light transmission (light transmission), reflection, anti-glare, gloss control, haze or color; (3) physical properties: oxygen permeability, wherein the oxygen permeability of MA2 is greater than the oxygen permeability of MA 1; (4) physical properties: fluid permeability, wherein the fluid permeability of MA1 is greater than the fluid permeability of MA 2; (5) biochemical properties: antibacterial activity, and the antibacterial activity of MA1 is greater than that of MA 2; (6) biochemical properties: calcium binding, wherein the calcium binding activity of MA1 is greater than the calcium binding capacity of MA 2; (7) the chemical properties are as follows: catalytic activity for decomposing a peroxide compound (peroxide compound); and (8) chemical properties: photocatalytic activity.

In other aspects, a dental appliance is provided that includes a polymeric shell adapted to fit over a tooth, wherein the dental appliance has a catalytically active chemistry. The catalytic activity may be decomposition of the peroxy compound or photocatalytic activity.

Drawings

FIG. 1 is a schematic view of a cast model of an individual tooth.

Fig. 2A is a schematic representation of a first or innermost polymeric material thermoformed over a cast model of a tooth.

Fig. 2B is a schematic diagram showing a side view of a single tooth of the first or innermost polymeric material thermoformed onto the tooth.

Fig. 3A is a schematic illustration of a first or innermost polymeric material thermoformed over a cast model of a tooth, wherein the polymeric material is carefully trimmed to very close to the gum line and closely follow the shape of the tooth.

Fig. 3B is a schematic diagram showing a side view of a single tooth of the first or innermost polymer material thermoformed over the tooth, with the polymer material carefully trimmed very close to the gum line and closely following the shape of the tooth.

Fig. 4A is a schematic representation of a first or innermost polymeric material thermoformed over a cast model of a tooth, carefully trimmed very close to the gum line and placed back on the model to create a dental appliance in which the polymeric material portion does not extend beyond the tooth area. The second or outermost polymeric material is thermoformed over the appliance, creating a laminate structure in which the outermost material extends beyond the gum line.

Fig. 4B is a schematic side view of a single tooth showing a first or innermost polymeric material thermoformed over the tooth, carefully trimmed very close to the gum line, with a second or outermost polymeric material thermoformed over the first or innermost polymeric material, creating a laminate structure with the outermost material extending beyond the gum line.

Fig. 5A is a schematic representation of a first or innermost polymeric material thermoformed over a cast model of a tooth, carefully trimmed very close to the gum line and placed back on the model to create a dental appliance in which the polymeric material portion does not extend beyond the tooth area. The second or outermost polymeric material is thermoformed over the appliance, creating a laminate structure, and trimmed about 2mm beyond the gum line, typically conforming to the edge of the tooth.

Fig. 5B is a schematic representation of a first or innermost polymeric material thermoformed over a cast model of a tooth, carefully trimmed very close to the gum line and placed back on the model to create a dental appliance in which the polymeric material portion does not extend beyond the tooth area. The second or outermost polymeric material is thermoformed over the appliance, creating a laminate structure, and trimmed about 2mm beyond the gum line, with substantially straight edges that do not directly conform to the contours of the teeth.

Fig. 5C is a schematic side view of a single tooth showing a first or innermost polymeric material thermoformed over the tooth, carefully trimmed very close to the gum line, and a second or outermost polymeric material thermoformed over the first or innermost polymeric material, creating a laminate structure in which the second material is trimmed about 2mm beyond the gum line.

Detailed Description

All patents, publications, and patent applications cited in this specification are herein incorporated by reference as if each individual patent, publication, or patent application were specifically and individually indicated to be incorporated by reference in its entirety for all purposes.

Definition of

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the subject matter belongs. Although other methods and materials similar or equivalent to those described herein can be used in the practice of the present subject matter, the preferred materials and methods are described herein.

In describing and claiming the present subject matter, the following terminology will be used in accordance with the definitions set out below.

As used in this specification and the appended claims, the singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise.

The term "a 1" is used herein to refer to a portion of a tooth, e.g., two or more teeth for each of the upper and lower jaws, e.g., 2, 3,4, 5, 6, 7, 8,9, 10, 11, 12, 13, 14, or 15 teeth.

The term "a 2" is used herein to refer to the gingival region (gingival region) corresponding to (or adjacent to) the portion of the tooth identified by "a 1".

Unless otherwise indicated, the term "color measurement" is used herein to refer to measurements made using the LAB CIE color scale (color scale), where L refers to total reflected light, a refers to the red (+) -green (-) color axis measured using a D65 light source (sunlight), and B refers to the yellow (+) -blue (-) color axis. However, the CYMK standard using digital images can also be used to measure color. Other color measurement systems are known, and any suitable method may be used to evaluate the products described herein.

The term "dental appliance" is used herein to refer to any device that is placed in or on a subject's teeth. Dental appliances include, but are not limited to, orthodontic devices, prosthetic (prosthetic) devices, retention devices, snoring/airway (snoring/airway) devices, cosmetic devices, therapeutic devices, and habit-altering devices.

The term "dye" is used herein to refer to a colorant that is soluble or molecularly dispersed in a polymer.

The term "elastic modulus" is used herein to refer to the rigidity of a material and/or the resistance of a material to elastic deformation. The higher the elastic modulus of the material, the harder the material.

The term "fluorescent agent" is used herein to refer to a material that absorbs light in one region of the spectrum and emits light in the same or a different region of the spectrum. The transmission may be almost instantaneous or may be delayed. The fluorescers are selected from the group consisting of triazine stilbenes (triazinethilidenes), coumarins, imidazolines, diazoles, triazoles, benzyl oxazolines and biphenyl stilbenes or other fluorescers.

The term "gum line" refers herein to a line that separates the gums (gum) (or gingiva) from the exposed portions of the teeth.

The term "incident light" is used herein to refer to light that impinges on an object and may be reflected, scattered, or at least partially absorbed by the object.

The term "light scattering particles" is used herein to mean particles that are about 0.2 μ to about 20 μ in size and are transparent or substantially white. By white is meant that the particles do not absorb significant amounts of light in the range of about 400nm to about 700 nm.

The term "light transmittance" is used herein to refer to the amount of light that passes through a sample. Unless otherwise indicated, transmission refers to visible light measured by methods similar to the ASTM D1003-11 standard test methods for haze and light Transmittance (Luminous Transmittance) of transparent plastics. The light transmission can also be measured using a colorimeter and a white reference sample, in which case the measurement involves two light channels through the sample. Other measurements may be used and the specific method reported based on the equipment and sample characteristics used.

The term "MA 1" is used herein to refer to a material that conforms to at least a portion of a tooth.

The term "MA 2" is used herein to refer to a material that conforms to at least a portion of the gingival region. MA2 has at least one material property different from MA 2.

The term "material property" is used herein to refer to a property selected from the group consisting of a mechanical property, an optical property, a chemical property, a physical property, an electrical property, and a biochemical property.

The term "optical additive" is used herein to mean an additive that substantially changes the color or light transmittance properties of a polymeric material. The optical additive comprises one or more of a pigment, a dye, a light scattering or absorbing particle, and a fluorescent material having optical properties.

The term "pigment" is used herein to denote a solid particulate colorant that may be mixed with one polymer or a mixture of more than one polymer. The polymer may be selected from the group consisting of: elastomers, polyesters, polyurethanes, polyolefins, acrylics, methacrylic resins, polyamides, polycarbonates, polyethers, ionomer resins, cellulose esters, cellulose ethers, and fluoropolymers, examples of which are listed in table 5.

The term "reflected light" is used herein to refer to incident light that is reflected from the surface of an object after impact on the object.

The term "diffuse light" is used herein to mean light that deviates from a straight path after it impinges on an object.

The term "shell" is used herein to refer to a polymeric shell that fits over and is removably placed over a tooth.

The term "stain resistant" is used herein to refer to materials that are designed to resist staining.

The term "thermoplastic polymer" is used herein to denote the following polymers: the polymer is relatively hard at lower temperatures, becomes relatively soft when heated and pressurized, and becomes relatively hard again when cooled, provided that the heat and pressure do not chemically decompose the polymer.

The term "thermosetting polymer" is used herein to denote a polymeric material as follows: the polymeric material is a solid or viscous material at relatively low temperatures and irreversibly changes to an infusible polymer network when it is heated and/or subjected to suitable radiation, and/or when the material undergoes one or more chemical reactions. The term thermally cured polymer is used to denote a cured thermoset polymer.

The terms "tooth" and "tooth" include: natural teeth, including natural teeth modified by fillings or by crowns; an implanted tooth; an artificial tooth as part of a bridge or other fitting (fitting) secured to one or more natural or implanted teeth; and artificial teeth as part of the removable fitting.

The term "trimmed to the gum line" is used herein to mean forming, trimming (or cutting) at least a portion of a dental appliance or housing to track (track) the line where the gum meets the tooth (i.e., the gum line or gingival margin).

The term "functional effect" is used to mean that the dental appliance does not have a purely cosmetic function. However, it should be understood that the shell may also improve the appearance of the teeth.

Dental appliance

Currently available appliance systems from a variety of suppliers include a series of clear or transparent polymeric appliances that are removably positioned over the teeth. The patient wears the first appliance for a number of days or more, then removes the first appliance and replaces it with the second appliance. Each appliance is responsible for moving the teeth to their final intended or aesthetically correct position. Patients undergoing this treatment often experience significant discomfort and the appliances often fail to move one or more of the patient's teeth to a prescribed position. This can require adjustments to the treatment process, resulting in delays, additional visits to the orthodontist's office and extended treatment times, as well as increased costs and patient discomfort. There is a need for a more effective polymeric dental appliance that provides strength and flexibility and that fits tightly but comfortably over the teeth. There is a further need for a dental appliance that: the dental appliance provides a good appearance consistent with a patient's normal teeth and may provide therapeutic or cosmetic treatment to the teeth over an extended period of time.

It is sometimes desirable for an appliance to have different material properties in different areas of the dental appliance. In one aspect, the appliance is prepared by thermoforming one or more thermoplastic components over a model of a patient's teeth.

When constructing the appliance by thermoforming a thin sheet of material (typically about 0.25 to about 4mm in thickness), the thermoformed device is removed from the mold and excess material trimmed. The trimming may be done at the gum line that closely follows the shape of the tooth (fig. 1), or slightly below (beyond) the gum line so that the device covers a portion of the gum (fig. 2). Studies disclosed herein show that appliances trimmed below (beyond) the gum line by about 1-2mm are more effective in maintaining strength and moving teeth than comparable appliances trimmed at or very near the gum line. Furthermore, the inventors have found that appliances trimmed at the gum line are more prone to breakage and are more irritating to the patient than devices that extend below (beyond) the gum line.

Therefore, it seems prudent to always trim beyond the gum line. The inventors have found that additional problems can arise by trimming the device beyond the gum line. The material used to construct the orthotic (typically polyester or polyurethane) is rigid and inflexible, making removal difficult. In addition, such orthotics have low oxygen permeability.

The bleaching tray is used to maintain a tooth whitening agent (typically hydrogen peroxide or carbamide peroxide) near the surface of the teeth. However, since these trays are trimmed below (beyond) the gum line, the gum area is subjected to irritating bleaching agents, which can cause irritation or damage to the gum tissue.

Therefore, it is difficult to balance the properties of a dental appliance so that it functions adequately for both the tooth structure and the gum region of a patient.

Through extensive experimentation and evaluation, the present inventors have discovered a new, useful and cost-effective device configuration that optimizes dental appliance properties for both the tooth and gum regions, thereby allowing for easy optimization of overall device performance.

In some embodiments, a dental appliance comprises two or more materials adapted to conform to at least a portion of a tooth (a1) and at least a portion of a corresponding gingival region (a2), wherein at least a portion of the material (MA1) that conforms to a portion of a tooth and the material (MA2) that conforms to at least a portion of a gingival region differ in at least one material property selected from a mechanical property, an optical property, an electrical property, a physical property, a chemical property, or a biochemical property.

In some embodiments, the dental appliance includes at least inner and outer components. The inner and outer components may comprise distinct or different materials, and there may or may not be a distinct line of demarcation between them. The components may or may not be multiple layers. When the assembly is multi-layered, each layer may comprise a different material.

The components of the dental appliance may differ in mechanical properties, such as modulus of elasticity, and/or other mechanical properties. The modulus of elasticity is a measure of the degree to which a material resists deformation. If the sample has a high modulus, it resists deformation. If the sample has a low modulus, it is easily deformed.

In some embodiments, by including additives such as CaCO₃Talc, TiO₂Glass, diamond or polymer powder, or by increasing or otherwise changing the elastic modulus of the material by methods such as layering (layering), coating, treating the material or appliance with a chemical agent, or changing the temperature.

Typically, the dental appliance will have an elastic modulus of 0.5 to 5 gigapascals (GPa), e.g., 0.5GPa, 0.6GPa, 0.7GPa, 0.8GPa, 0.9GPa, 1.0GPa, 1.1GPa, 1.2GPa, 1.3GPa, 1.4GPa, 1.5GPa, 1.6GPa, 1.7GPa, 1.8GPa, 1.9GPa, 2.0GPa, 2.1GPa, 2.2GPa, 2.3GPa, 2.4GPa, 2.5GPa, 2.6GPa, 2.7GPa, 2.8GPa, 2.9GPa, 3.0GPa, 3.1GPa, 3.2GPa, 3.3GPa, 3.4GPa, 3.5GPa, 3.6GPa, 3.7GPa, 3.8GPa, 3.9GPa, 4.0, 4.1GPa, 4.2, 4.3, 4.4, 4.5GPa, 3.6GPa, 3.7GPa, 3.8GPa, 3.9GPa, 4.0, 4, 4.1GPa, 4, 4.2GPa, 4, 4.5GPa, 0, 4.5GPa, 0, 0.5GPa, 0, 0.6GPa, 0, 0.7GPa, 0, 0.7GPa, 0, 0.8GPa, 0.

In some embodiments, the modulus of the material covering the teeth (MA1) is 1.5 times, 2 times, 3 times, 4 times, 5 times, 6 times, 7 times, 8 times, 9 times, 10 times, 1 to 2 times, 2 to 3 times, 3 to 4 times, 4 to 5 times, 5 to 6 times, 6 to 7 times, 7 to 8 times, 8 to 9 times, or 9 to 10 times the modulus of the material covering the gum region (MA 2).

In some embodiments, the modulus of the material covering the teeth (MA1) is the same as the modulus of the material covering the gingival region (MA 2).

In some embodiments, the modulus of the material covering the gingival region (MA2) is 1.5 times, 2 times, 3 times, 4 times, 5 times, 6 times, 7 times, 8 times, 9 times, 10 times, 1 to 2 times, 2 to 3 times, 3 to 4 times, 4 to 5 times, 5 to 6 times, 6 to 7 times, 7 to 8 times, 8 to 9 times, or 9 to 10 times greater than the modulus of the material covering the teeth (MA 1).

Optical properties include, but are not limited to, visible light transmission, reflectance, antiglare, gloss control, haze, and color. See, for example, U.S. patent publication No.20150374464, which is expressly incorporated herein by reference.

The polymer composition may comprise a single optical additive or a mixture of two or more optical additives. The polymeric material may contain other additives than optical additives. The optical additive may be one or more optical additives selected from the group consisting of pigments, dyes, light scattering particles, and fluorescent materials.

In some embodiments, the light transmittance of MA1 is less than MA 2. In some embodiments, MA1 has a light transmission of less than 80%, less than 70%, less than 60%, less than 50%, from 70% to 80%, from 60% to 70%, from 50% to 60%, from 40% to 50%, from 30% to 40%, or from 20% to 30%, and MA2 has a light transmission of greater than 70%, greater than 80%, greater than 85%, greater than 90%, from 70% to 80%, from 80% to 90%, from 90% to 95%, or from 95% to 100%.

In some embodiments, MA1 has a haze value greater than MA 2. In some embodiments, the haze value of MA1 is less than 10 and the haze value of MA2 is greater than 10.

In some embodiments, the material comprising the optical additive may optionally have one or both of the following properties: (1) absorbing light in a range of about 550nm to about 700 nm; or (2) an a value of about-2 to +2 and a B value of about +2 to-10 when measured on a reference white plate using CIELAB scale values for a combination of a white plate (tile) and a material having an L value between about 80 and 95. See, for example, U.S. patent publication No.20150374464, which is expressly incorporated herein by reference in its entirety.

In some embodiments, the material comprising the optical additive can change the perceived color of the black panel when measured on a reference black panel using a Byk Gardner colorimeter as follows. Color measurements were made directly on the black panel and CIELAB color scale values were recorded. Next, a thin film of water was applied to the colored plate, and the test film was placed on the plate and gently smoothed to remove excess water, thereby providing good optical coupling between the film and the colored plate. The color measurements were then repeated, and LAB color values were measured and recorded on the combined structure as shown in tables 1 and 2.

TABLE 1 film composition, Structure and color values measured on Black plates

TABLE 2 film composition, Structure and color values measured on yellow plates

In some embodiments, the material increases "brightness", as indicated by the L value, and decreases the yellowness of the panel, as indicated by the B value.

In some embodiments, the visible light transmittance of the material is greater than 50%, 60%, 70%, or 75%.

In some embodiments, the incident light reflectance of the material is greater than 20%, 25%, 35%, 45%, 55%, 60%, or less than 80%, 70%, 60%, 50%, 40%.

In some embodiments, the dental appliance is adapted to fit over one or more teeth and at least a portion of the gums, wherein the portion of the dental appliance covering at least a portion of the teeth exhibits a whitening effect and the portion covering the gums is substantially transparent.

In some embodiments, a differential electrical field (differential electric field) may be applied to the teeth and/or underlying tissue to facilitate tooth movement. In some embodiments, the electrical conductivity of MA1 is higher than MA 2. In some embodiments, the electrical conductivity of MA1 is lower than MA 2. In some embodiments, one or more materials have a different piezoelectric activity than another material.

In some embodiments, the dental appliances described herein are used for orthodontic treatment while providing a form of dental/periodontal treatment or cosmetic treatment. Traditionally, such treatments have been provided using various accessories (accesses) and devices that are applied when the repositioning appliance is removed from the patient's mouth.

The bleaching tray is used to maintain a tooth whitening agent (typically hydrogen peroxide or carbamide peroxide) near the surface of the teeth. However, since these trays are trimmed below (beyond) the gum line, the gum area is subjected to irritating bleaching agents, which can cause irritation or damage to the gum tissue.

In some embodiments, the dental appliances described herein incorporate a tooth/periodontal or cosmetic treatment form into or onto the innermost component of the dental appliance. In some aspects of this embodiment, as exemplified in fig. 5A and B, the dental appliance comprises a laminate structure in which the second or outermost polymeric material is trimmed about 2mm beyond the gum line, conforms to the margin of the tooth, or has a generally straight margin and extends beyond the gum line, but does not directly conform to the contour of the tooth.

In some embodiments, the dental/periodontal or cosmetic treatment form is provided in a form that must be activated in order for it to be effective.

In some embodiments, the dental appliance includes a dental/periodontal or cosmetic treatment form in the form of a decomposition catalyst.

The decomposition catalyst activity is for decomposing the peroxide compound and is present in the innermost portion of the dental appliance that conforms to the teeth or conforms to the teeth and gums.

In some embodiments, the dental appliance comprises a single material comprising a decomposition catalyst, and the material (a) is not trimmed; (b) trimming to a gum line; or (3) trimmed about 2mm beyond the gum line, conforming to the edge of the tooth, or having a generally straight edge and extending beyond the gum line, but not directly conforming to the contour of the tooth.

In some embodiments, the dental appliance comprises more than one material containing a decomposition catalyst, and the material (a) is untrimmed, (b) is trimmed to the gum line, or (3) is trimmed about 2mm above the gum line, conforms to the edge of the tooth, or has a substantially straight edge and extends beyond the gum line, but does not directly conform to the contours of the tooth.

In some embodiments, the catalytic activity is derived from Zeolite Socony Mobil-5 (Zeolite SM-5), an aluminosilicate Zeolite belonging to the pentasil family of zeolites. Has a chemical formula of Na_nAl_nSi_96–nO₁₉₂·16H₂O(0<n<27) And it can be obtained from a number of sources. The zeolite is insoluble, non-toxic, and is known to catalyze the decomposition of peroxides (peroxides), such as hydrogen peroxide, to produce oxygenated species including hydroxyl radicals. See, for example, Gabriel Ovejero et al, Ind. Eng. chem. Res.,2001,40(18), 3921-.

In some embodiments, the catalytic activity is derived from one or more of an iron compound, a nickel compound, or a manganese compound.

In some embodiments, the catalytic activity is derived from heterogeneous catalysts or magnetically separable iron mixed oxides such as co (ii) ferrite, cu (ii) ferrite, mn (ii) ferrite, and magnetite.

In some embodiments, the dental appliance includes a dental/periodontal or cosmetic treatment form in the form of a photocatalyst.

The photocatalyst is present in the innermost portion of the dental appliance that conforms to the teeth or to the teeth and gums.

In some embodiments, the dental appliance comprises a single material comprising a photocatalyst, and the material (a) is untrimmed, (b) trimmed to the gum line, or (3) trimmed about 2mm above the gum line, conforms to the edge of the tooth, or has a substantially straight edge and extends beyond the gum line, but does not directly conform to the contours of the tooth.

In some embodiments, the dental appliance comprises more than one material, and the photocatalyst-containing material (a) is untrimmed, (b) is trimmed to the gum line, or (3) is trimmed about 2mm above the gum line, conforms to the edge of the tooth, or has a substantially straight edge and extends beyond the gum line, but does not directly conform to the contours of the tooth.

In some embodiments, the photocatalyst comprises finely divided titanium dioxide, CuO-SnO₂ZnS-CdS, ZnO or Nb₂O₅Or other known photocatalysts.

In some embodiments, catalytic activity is provided by anatase titanium dioxide (photocatalytic semiconductor material). Anatase is known to produce hydroxyl radicals and other oxidizing species in the presence of UVA (400nm) light. Biochemical properties

In some embodiments, the dental appliance includes a dental/periodontal or cosmetic treatment form in the form of a component having antibacterial activity. In some embodiments, the antibacterial activity of MA1 is greater than the antibacterial activity of MA 2.

In some embodiments, the calcium binding capacity of MA1 is greater than the calcium binding capacity of MA 2. In some embodiments, MA1 has greater mineralization activity than MA 2. In some embodiments, the calcium transport properties of MA2 are better than the calcium transport properties of MA 1.

The dental appliance or housing may vary in fluid permeability. This can be optimized by varying the diameter and density of the holes. The hole density and diameter may be uniformly or non-uniformly distributed throughout the dental appliance or housing. The dental appliance or housing may vary in oxygen permeability and/or fluid permeability.

In some embodiments, MA2 has an oxygen permeability greater than MA 1. In some embodiments, the speed of salivary transport of MA1 is greater than MA 2.

In some embodiments, the dental appliance includes at least a first or innermost component and a second or outermost component.

In some embodiments, the first or innermost component of the dental appliance or housing more closely tracks the configuration of the (track) tooth than the second or outermost component. In some embodiments, the first or innermost component has a thinner wall thickness than the second or outermost component.

In some embodiments, the innermost component and the outermost component comprise similar or identical materials.

In some embodiments, at least a portion of the innermost component that fits over the teeth is trimmed to the gum line so that the gums are barely covered. In some embodiments, substantially all of the innermost material is trimmed to the gum line above the area readily visible to an observer when the appliance is worn. In some embodiments, some of the innermost material is not trimmed to the gum line above areas that are not readily visible to an observer when wearing the appliance (e.g., the back of the teeth). In some cases, the innermost component that fits over the tooth includes more than one layer or more than one material and has a thickness as shown in table 3.

TABLE 3 exemplary thickness ranges for the innermost component of the dental appliance.

Minimum (mm)	Maximum (mm)
		0.0125	0.75
0.0125	0.5
		0.0125	0.25
0.0125	0.05
		0.025	0.75
0.025	0.5
		0.025	0.25
0.025	0.125
		0.025	0.05
0.125	0.5
		0.125	0.25

In some embodiments, the second or outermost component of the dental appliance or housing has a smaller profile (i.e., less conformal) than the first or innermost component. In one embodiment, the outer component is not coextensive with the teeth, may be transparent or translucent, and has a thickness as shown in table 4.

TABLE 4 exemplary thickness ranges for the outermost components of the dental appliance.

Minimum (mm)	Maximum (mm)
		0.125	1
0.25	1
		0.375	1
0.5	1
		0.75	1
0.125	0.75
		0.25	0.75
0.375	0.75
		0.5	0.75
0.125	0.5
		0.25	0.5
0.375	0.5

In some embodiments, the second or outermost component of the dental appliance is one or more of thicker, stronger, and more transparent than the first or innermost component of the dental appliance.

In some embodiments, components of the dental appliance are attached or laminated to one another.

In some embodiments, the outermost component is not trimmed to the gum line and extends beyond the gum line, e.g., 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 10mm, 1 to 3mm, 2 to 4mm, 4 to 6mm, 5 to 6mm, 6 to 7mm, 7 to 8mm, 8 to 9mm, or 9 to 10mm beyond the gum line.

In some embodiments, the components of the dental appliance may or may not be multi-layered, and the material extending beyond the gum line is different from the material covering the teeth.

In some embodiments, the components of the dental appliance may or may not be multi-layered, and the material extending beyond the gum line is the same as the material covering the teeth.

In some embodiments, the dental appliance housing has a variable thickness, for example, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1.0mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 0.2mm to 0.6mm, 0.4mm to 0.8mm, 0.6mm to 1.0mm, 0.8mm to 1.2mm, or 1.0mm to 1.4 mm. The thickness of the different parts of the dental appliance or housing may vary due to design or due to the manufacturing process.

In some embodiments, the polymer in the material used to make the dental appliance or housing is a homopolymer, or a random, block or graft copolymer. The composition may comprise a single polymer, or a mixture of two or more polymers. Typically, the polymer is substantially transparent. In some embodiments, the optical properties of the dental appliance or housing are controlled by optical additives mixed with the polymer. In some embodiments, the polymer is a semi-crystalline polymer that scatters light.

The devices described herein may be made from any suitable plastic or polymeric resin, examples of which are listed in table 5. The housing material may be a thermoplastic resin or a thermosetting resin.

In some embodiments, the polymer may optionally have one or more of the following properties (i.e., either one of the following properties alone or any possible combination of two or more of the following properties).

In some embodiments, the polymer comprises a thermoplastic polymer.

In some embodiments, the polymer comprises a thermoset polymer.

In some embodiments, the polymer is an elastomer, preferably an elastomer having an elongation at break greater than 200% and a 100% modulus of less than 25 MPA.

TABLE 5 exemplary polymers for making dental appliances.

In some embodiments, the dental appliance or shell is prepared by thermoforming one or more materials of uniform or non-uniform thickness, for example by thermoforming one or more materials over a model of the tooth to which the dental appliance is to be fitted.

The polymeric material in the dental appliance may comprise two or more different polymeric materials, such as the polymers disclosed above, and one or more additives.

In some embodiments, the material, e.g., elastomeric polyurethane, is provided in the form of a uniform sheet having a thickness of 0.5mm, 0.625mm, 0.76mm, 1.0mm, 0.40 to 0.55mm, 0.55 to 0.65mm, 0.65 to 0.76mm, 0.76mm to 1.0mm, or 1.0mm to 1.1 mm. In other cases, the material is provided in the form of a disc, square, triangle, or other shaped material having a thickness of 0.5mm, 0.625mm, 0.76mm, 1.0mm, 0.40 to 0.55mm, 0.55 to 0.65mm, 0.65 to 0.76mm, 0.76mm to 1.0mm, or 1.0mm to 1.1 mm.

In some embodiments, a material, such as rigid polyurethane (e.g., Zendura a, Bay materials llc), is provided in the form of a uniform sheet having a thickness of 0.5mm, 0.625mm, 0.76mm, 1.0mm, 0.40 to 0.55mm, 0.55 to 0.65mm, 0.65 to 0.76mm, 0.76mm to 1.0mm, or 1.0mm to 1.1 mm. In other cases, the material is provided in the form of a disc, square, triangle, or other shaped material having a thickness of 0.5mm, 0.625mm, 0.76mm, 1.0mm, 0.40 to 0.55mm, 0.55 to 0.65mm, 0.65 to 0.76mm, 0.76mm to 1.0mm, or 1.0mm to 1.1 mm.

In some embodiments, a material, such as polymethylpentene (e.g., TPX) or polyethylene terephthalate glycol (PETG), is provided in the form of a uniform sheet or a disc, square, triangular, or other shaped material having a thickness of 0.4mm, 0.5mm, 0.625mm, 0.76mm, 1.0mm, 0.3 to 0.4mm, 0.4 to 0.5mm, 0.5 to 0.6mm, 0.6 to 0.7mm, or 0.7mm to 1.0 mm. (perhaps we can condense to a "polymer" and the thickness is an essentially independent variable.)

In some embodiments, it is preferred that the teeth be of natural appearance and as white as desired by the patient or individual whose teeth are being treated. In such cases, it is preferred that a material used to make the dental appliance contain one or more additives that provide the appropriate color to the tooth.

In some embodiments, materials, such as rigid polyurethane containing pigments, are provided in the form of uniform sheets, or discs, squares, triangles or other shaped materials having a thickness of 0.0125mm, 0.025mm, 0.05mm, 0.125mm, 0.25mm, 0.5mm, 0.125mm to 0.5mm, 0.05 to 0.5mm, 0.125 to 0.5 mm.

In some embodiments, the material, e.g., polyurethane treated with anatase, zeolite, or other agents, is provided in the form of a uniform sheet, or a disc, square, triangle, or other shaped material having a thickness of 0.125mm, 0.25mm, 0.3mm, 0.35mm, 0.4mm, 0.45mm, 0.5mm, 0.125 to 0.3mm, 0.25 to 0.4mm, or 0.4 to 0.5 mm.

The polymeric materials described herein can be prepared by conventional methods well known to those skilled in the art of polymer technology. Typically, polymeric dental appliances are produced by shaping (profiling), e.g. thermoforming, a polymeric sheet of the selected material over a model of the tooth. In some cases, one or more additional materials are thermoformed over the model of the teeth, resulting in a laminate (laminate). In some embodiments, the dental appliance is a composite material. In some embodiments, the dental appliance is 3D printed. In some embodiments, the dental appliance is produced by spraying a polymer solution or dip coating on a model.