阅读说明：本技术 具有美容用治疗性水溶液的牙科矫治器 (Dental appliance with cosmetic therapeutic aqueous solution ) 是由 小戴维·K·齐纳德 乔尔·D·奥克斯曼 王一中 于 2019-09-20 设计创作，主要内容包括：本发明提供了一种系统,该系统包括：牙科矫治器,该牙科矫治器具有聚合物壳体,该聚合物壳体具有用于接纳一颗或多颗牙齿的多个腔；以及在该牙科矫治器的该聚合物壳体的该腔中的生物相容性美容用含水液体。该含水液体包含粘度调节剂、牙齿再矿化剂和水,该粘度调节剂选自水相容性聚合物、多糖、二氧化硅化合物、以及它们的混合物和组合物。该含水液体基本上不含牙齿美白剂和氟化物,并且在室温下具有大于1.3的折射率。(The present invention provides a system comprising: a dental appliance having a polymeric shell with a plurality of cavities for receiving one or more teeth; and a biocompatible cosmetic aqueous liquid in the cavity of the polymeric shell of the dental appliance. The aqueous liquid comprises a viscosity modifier selected from the group consisting of water compatible polymers, polysaccharides, silica compounds, and mixtures and combinations thereof, a tooth remineralizing agent, and water. The aqueous liquid is substantially free of tooth whitening agents and fluoride and has a refractive index greater than 1.3 at room temperature.)

1. A system, the system comprising:

a dental appliance comprising a polymeric shell having a plurality of cavities for receiving one or more teeth; and

a biocompatible cosmetic aqueous liquid in the cavity of the polymeric shell of the dental appliance, the aqueous liquid comprising:

a viscosity-adjusting agent, and a water-soluble polymer,

tooth remineralizing agent, and

the amount of water is controlled by the amount of water,

wherein the aqueous liquid is substantially free of tooth whitening agents and fluoride, and wherein the aqueous liquid has a refractive index greater than 1.3 at room temperature.

2. The system of claim 1, wherein the refractive index of the aqueous liquid is greater than 1.33.

3. The system of claims 1-2, wherein the aqueous liquid has a pH of about 6.0 to about 8.0.

4. The system of claims 1-3, wherein the viscosity modifier is selected from the group consisting of polysaccharides, water compatible polymers, silica compounds, and mixtures and combinations thereof.

5. The system of claims 1-3, wherein the viscosity modifier is a polysaccharide selected from the group consisting of: ethyl cellulose, methyl cellulose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, xanthan gum, agarose, carrageenan, and mixtures and combinations thereof.

6. The system of claims 1-3, wherein the viscosity modifier comprises a water compatible polymer, and wherein the water compatible polymer is a water soluble polymer selected from the group consisting of: polyacrylic acid and salts thereof, polyethylene glycol, ethylene oxide/propylene oxide copolymers, and mixtures and combinations thereof.

7. The system of claims 1-3, wherein the viscosity modifier comprises a silica compound and the composition comprises no greater than 3 wt.% of a silica-containing viscosity modifier.

8. The system of claims 1-7, wherein the aqueous liquid further comprises a buffer selected from the group consisting of phosphates, carbonates, citrates, and mixtures and combinations thereof.

9. The system of claims 1-8, wherein the tooth remineralizing agent comprises a calcium compound, wherein the compound optionally comprises calcium phosphate.

10. The system of claims 1-9, wherein the aqueous liquid comprises a surfactant of formula I:

HOCH₂-(CHOH)_n-CH₂NR¹R²(I)

wherein R is¹And R²Independently selected from hydrogen atom, alkyl group, C (O) R³And SO₂R⁴；R³And R⁴Independently selected from alkyl groups, aryl groups and aralkyl groups;

and n is an integer from about 2 to about 5.

11. The system of claim 10, wherein the surfactant of formula I is present in the aqueous liquid at no greater than 4 wt% based on the total weight of the composition.

12. The system of claims 1-11, wherein the aqueous liquid prevents, inhibits, or disrupts the formation or maintenance of a biofilm in a region in contact with the aqueous liquid, or has any combination of preventing, inhibiting, and disrupting effects.

13. A system, the system comprising:

a dental appliance comprising a polymeric shell having a plurality of cavities for receiving one or more teeth, wherein the polymeric shell is a polymeric material selected from the group consisting of: polyurethanes, polyesters, polyethylene terephthalate, glycol-modified polycyclohexanedimethanol terephthalate, poly (meth) acrylates, and mixtures and combinations thereof; and

a biocompatible cosmetic aqueous liquid in at least some of the cavities of the polymeric shell of the dental appliance, the aqueous liquid comprising:

from about 0.1 parts by weight to about 60 parts by weight of a viscosity modifier selected from the group consisting of polysaccharides, water compatible polymers, silica compounds, and mixtures and combinations thereof;

about 40 to about 95 parts by weight of a buffer comprising a phosphate compound;

up to about 1 part by weight of a tooth remineralizing agent comprising a calcium compound; and

water;

wherein the aqueous liquid is substantially free of tooth whitening agents and fluoride, and wherein the refractive index of the aqueous liquid is greater than 1.3.

14. The system of claim 13, wherein the refractive index of the aqueous liquid is greater than 1.33.

15. The system of claim 14, wherein the water compatible polymer is a water soluble polymer selected from the group consisting of: polyacrylic acid, polyethylene glycol, ethylene oxide/propylene oxide copolymers, and combinations thereof, and wherein the water soluble polymer is present in the aqueous liquid at about 0.5 parts by weight to about 60 parts by weight.

16. The system of claim 13, wherein the silica compound comprises no greater than 3 wt% of the viscosity modifier, the silica compound comprising fumed silica.

17. The system of claims 13-16, wherein the aqueous liquid has a pH of about 7.1 to about 7.35 and a viscosity at 20 ℃ of about 0.001Pa s at a shear rate of 1/s to about 10Pa s at a shear rate of 1/s.

18. The system of claims 13-17, wherein the aqueous liquid further comprises about 0.1 to about 10 parts by weight of a fragrance comprising a polyol sugar alcohol.

19. The system of claims 13-18, wherein the polymeric housing and the aqueous liquid transmit at least 60% of incident light having a wavelength of about 400nm-750 nm.

20. A kit, the kit comprising:

a dental appliance comprising a polymeric shell having a plurality of cavities for receiving one or more teeth; and

a biocompatible cosmetic aqueous liquid comprising:

a viscosity modifier;

a tooth remineralizing agent; and

water;

wherein the aqueous liquid is substantially free of tooth whitening agents and fluoride, and wherein the refractive index of the aqueous liquid is greater than 1.3.

Background

Orthodontic treatment repositions misaligned teeth and improves bite configurations to improve appearance and dental function. Repositioning the teeth by applying a controlled force to the teeth for an extended period of time.

For each treatment stage of orthodontic treatment, the teeth may be repositioned by placing a polymer incremental position adjustment appliance (commonly referred to as an orthodontic aligner or orthodontic aligner tray) over the patient's teeth. The orthodontic alignment tray includes a polymer shell having a plurality of cavities for receiving one or more teeth. The individual cavities in the polymeric shell are shaped to apply a force to one or more teeth to resiliently and incrementally reposition a selected tooth or group of teeth in the upper or lower jaw. A series of orthodontic aligner trays are provided for sequential and alternating wearing by a patient during each stage of orthodontic treatment to gradually reposition teeth from one tooth arrangement to a successive tooth arrangement to achieve a desired tooth alignment condition. Once the desired alignment condition is achieved, an aligner tray or series of aligner trays may be periodically or continuously used in the patient's mouth to maintain tooth alignment.

Further, the orthodontic retainer tray can be used for an extended period of time to maintain tooth alignment after initial orthodontic treatment. Mouth guards and night guards may also be used to temporarily protect teeth during athletic activities or to prevent damage caused by tooth-to-tooth contact or friction.

The use of orthodontic treatment or retainers or protective mouth guards may require that the orthodontic appliance remain in the mouth of the patient for up to 22 hours each day for extended periods of days, weeks, months or even years.

Saliva is the primary defense of the oral cavity against tooth decay. Healthy saliva flow helps prevent tooth decay by physically removing bacteria from the mouth before they can adhere to tooth and tissue surfaces and form a protected biofilm. The flow of saliva also helps to dilute sugars and acids introduced by ingestion of food and beverages. The buffering capacity of saliva neutralizes acids and aids in the digestive process.

Disclosure of Invention

Placing a dental appliance (e.g., orthodontic aligner tray, retainer tray, mouth guard, night guard, etc.) on a patient's teeth can impede the natural flow of saliva around the teeth, which in some cases can increase the risk of tooth decay, particularly if the patient fails to consistently follow the recommended protocol for tray cleaning and brushing.

In addition, the functional nature of the orthodontic appliance dictates that the individual cavities in the polymeric shell are intentionally designed to not fit perfectly around the selected teeth of the patient, as such non-fit causes the orthodontic aligner tray to flex and apply a corrective force to those selected teeth that are the target of realignment. This mismatch creates an air gap between the orthodontic appliance and some of the patient's teeth. Even if the orthodontic appliance is made of a transparent polymeric material, air, patient-consumed liquid, saliva, and air bubbles entrained in the liquid, all of which reside in the air gap, can result in the aligner tray being more easily visible in the patient's mouth, which creates a non-ideal aesthetic appearance. Orthodontic appliances that are substantially invisible on the teeth during treatment are most desirable for patients.

In general, the present disclosure relates to a system that includes a dental appliance, such as an orthodontic aligner tray, an orthodontic retainer tray, a mouth guard, a night guard, and the like, that includes a polymeric shell having tooth retention cavities. At least some of the tooth holding cavities contain a biocompatible cosmetic therapeutic aqueous liquid. In some embodiments, the aqueous liquid has a chemical composition selected to maintain or improve the oral health of a patient, such as, for example, tooth remineralizing agents, buffers, and mixtures and compositions thereof. In some embodiments, the aqueous liquid at least partially occupies the air gap between the orthodontic aligner tray and the teeth as having a chemical composition with an index of refraction selected to make the orthodontic aligner tray less visible in the mouth of the patient. In some embodiments, the aqueous liquid can provide at least one of tooth remineralization, buffering, and aesthetic benefits to the patient.

In one aspect, the present disclosure is directed to a system comprising a dental appliance having a polymeric shell having a plurality of cavities for receiving one or more teeth; and a biocompatible cosmetic aqueous liquid in the cavity of the polymeric shell of the dental appliance. The aqueous liquid comprises a viscosity modifier selected from the group consisting of water compatible polymers, polysaccharides, silica compounds, and mixtures and combinations thereof, a tooth remineralizing agent, and water. The aqueous liquid is substantially free of tooth whitening agents and fluoride and has a refractive index greater than 1.3 at room temperature.

In another aspect, the present disclosure is directed to a system comprising a dental appliance having a polymeric shell having a plurality of cavities for receiving one or more teeth, wherein the polymeric shell is a polymeric material selected from the group consisting of: polyethylene terephthalate, glycol-modified polycyclohexanedimethanol terephthalate, and mixtures and combinations thereof; and a biocompatible cosmetic aqueous liquid in at least some of the cavities of the polymeric shell of the dental appliance. The aqueous liquid comprises from about 0.1 parts by weight to about 60 parts by weight of a viscosity modifier selected from the group consisting of polysaccharides, water compatible polymers, silica compounds, and mixtures and combinations thereof; about 40 to about 95 parts by weight of a buffer comprising a phosphate compound; up to about 1 part by weight of a tooth remineralizing agent comprising a calcium compound; and water. The aqueous liquid is substantially free of tooth whitening agents and fluoride.

In another aspect, the present disclosure is directed to a method in which a tooth is inserted into a cavity in a polymeric shell of a dental appliance to adjust the tooth from an maloccluded position to a desired position. The method comprises administering a biocompatible cosmetic aqueous liquid in the cavity, the biocompatible cosmetic aqueous liquid comprising: a viscosity modifier selected from the group consisting of polysaccharides, water compatible polymers, silica compounds, and mixtures and combinations thereof; a tooth remineralizing agent; and water. The aqueous liquid is substantially free of tooth whitening agents and fluoride and has a refractive index greater than 1.3.

In another aspect, the present disclosure is directed to a kit comprising a dental appliance having a polymeric shell having a plurality of cavities for receiving one or more teeth; and a biocompatible cosmetic aqueous liquid. The cosmetic aqueous liquid contains: a viscosity modifier selected from the group consisting of polysaccharides, water compatible polymers, silica compounds, and mixtures and combinations thereof; a tooth remineralizing agent; and water. The aqueous liquid is substantially free of tooth whitening agents and fluoride and has a refractive index greater than 1.3.

The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.

Drawings

Fig. 1 is a schematic top perspective view of a system including a dental appliance and an aqueous cosmetic solution.

Fig. 2 is a schematic top perspective view of a method for using a dental alignment tray placed in a patient's mouth to cover teeth.

Figure 3 is a schematic illustration of components of a kit including a dental appliance and a cosmetic aqueous liquid.

Fig. 4 is a schematic view of a reclosable storage unit and dispenser configured to hold a dental appliance and dispense an aqueous cosmetic liquid into a tooth holding cavity in the dental appliance.

In the drawings, like numbering represents like elements.

Detailed Description

In one embodiment, the system 10 includes a dental appliance 100 as shown in fig. 1 that includes a thin polymeric shell 102 having tooth retention cavities 104 configured to fit over one or more of the teeth in a patient's upper or lower jaw. In the embodiment shown in fig. 1, the dental appliance 100 is an orthodontic aligner tray, but in other embodiments the dental appliance can be, for example, an orthodontic retainer tray, mouth guard, or night guard. In the embodiment of fig. 1, the tooth holding cavity 104 is shaped to receive and resiliently reposition one or more teeth from one tooth arrangement to a successive tooth arrangement. In other embodiments, the dental retainer tray may include tooth holding cavities 104 shaped to receive and hold the position of one or more teeth previously realigned, while the mouth guard or night guard includes tooth holding cavities 104 shaped to protect the teeth during athletic activities or to prevent teeth in the upper and lower jaws from rubbing against each other and causing premature wear to the tooth surfaces.

The system 10 includes a dental appliance 100 in which at least some of the tooth holding cavities 104 of the polymeric shell 102 contain a biocompatible cosmetic aqueous liquid 108. The term Cosmetic herein refers to compositions such as those described in Federal Food, Drug and Cosmetic Act, article 201(i) (Federal Food, Drug and Cosmetic Act, sec.201 (i)). In this application, the term cosmetic means that the aqueous liquid is not intended for use as a medicament for curing or treating a disease in a patient's mouth, but includes components intended for use in the polymeric shell 102 and in the patient's mouth to clean, beautify or promote the attractiveness of teeth, alter the appearance of teeth, or reduce the visibility of the polymeric shell 102 when placed on teeth. In various embodiments, the term "biocompatible" means that the aqueous liquid comprises components that are suitable for use in a patient's mouth and do not react toxicologically, harmfully, or physiologically with body fluids in the mouth or with exposed surfaces of teeth, and do not adversely react with commonly consumed foods and beverages.

The disclosed aqueous liquid composition 108, one or more components of the composition, or both, may be characterized as edible. By a component or composition being edible, it is meant that the particular ingredient or composition is safe for daily long-term ingestion at the recommended level of use. In some embodiments, the GRAS (generally recognized as safe) list of the U.S. Food and Drug Administration (FDA) may be used to determine whether a component is edible at the levels used in the composition.

The aqueous liquid 108 in the alignment system 10 comprises: a viscosity modifier selected from the group consisting of water compatible polymers, polysaccharides, silica compounds, and mixtures and combinations thereof; a tooth remineralizing agent; and water, and is biocompatible. The aqueous liquid is at least substantially free of tooth whitening agents and fluoride.

By substantially free of tooth whitening agents and fluoride, in this application, it is meant that the aqueous liquid 108 contains no more than about 1% by weight of tooth whitening agents or fluoride, based on the total weight of the aqueous liquid. Non-limiting examples of suitable fluorides include inorganic fluoride sources such as sodium fluoride, sodium monofluoride, stannous fluoride, calcium fluoride, and the like, and organic fluoride sources such as tetraalkylammonium tetrafluoroborate and amine hydrofluorate, and mixtures and combinations thereof. Examples of tooth whitening agents, also not intended to be limiting, include hydrogen peroxide, carbamide peroxide, calcium peroxide, and mixtures and combinations thereof. In some embodiments, the aqueous liquid is substantially free of tooth whitening agents and fluoride, meaning that the aqueous liquid contains no more than about 0.1% by weight of tooth whitening agents or fluoride. In some embodiments, the aqueous liquid is completely free of tooth whitening agents and fluoride, meaning that the aqueous liquid contains no more than about 0.01% by weight of tooth whitening agents or fluoride.

In some embodiments, the aqueous liquid 108 in the system 10 has a refractive index selected to minimize the difference in refractive index between the polymeric shell of the dental appliance and the air gap between the patient's tooth and the dental appliance occupied by the aqueous liquid. This index matching enhances the optical characteristics of the system 10 by reducing glare and reflections at the surface of the patient's teeth. Glare is defined herein as the average reflection in the range of 450 nm to 650 nm, and reflection is defined herein as the process in which a portion of the radiant flux incident on a surface returns to the same hemisphere, the bottom of which is the surface and contains the incident radiation (see Handbook of Optics, second edition, McGraw-Hill press 1995 (Handbook of Optics, 2)^nd ed.,McGraw-Hill,Inc.,1995))。

In some embodiments, the refractive index of the aqueous liquid 108 is selected to minimize both the appearance of air bubbles entrained in the aqueous liquid and the appearance of the dental appliance 100 covering the patient's teeth. The selection of the refractive index of the aqueous liquid 108 depends at least in part on the refractive index of the polymeric material of the polymeric shell 102. In various exemplary embodiments, which are not intended to be limiting, the polymer shell 102 is a polymer material having a Refractive Index (RI) in the range of 1.48 to 1.65. For example, polymethyl (meth) acrylate (PMMA) has an RI of 1.489; the polycarbonate had an RI of 1.585; and polyethylene terephthalate (PET) has an RI of 1.64. In some non-limiting embodiments provided by way of example only, if the polymeric shell is PET having an RI of about 1.6, then to minimize the appearance of the dental appliance on a patient's tooth, the refractive index of the aqueous liquid without visible air bubbles should be greater than about 1.3, or greater than about 1.33, or greater than about 1.34 (+ -0.01) at room temperature from about 20 ℃ to about 25 ℃. The refractive index of the aqueous liquid 108 can be measured by, for example, a refractometer such as those available from Bausch & Lomb, Rochester, NY, Bausch & Lomb. Where aesthetic appearance is not of particular concern or secondary to other medical considerations (e.g., if the housing is a mouth guard or intended for nighttime wear only), the aqueous liquid need not have a refractive index greater than 1.3.

In some embodiments, the aqueous liquid 108 optionally comprises nanoparticles selected to modify the refractive index of the components of the composition and provide the aqueous liquid 108 with desired aesthetic properties. By utilizing nanoparticle fillers, such as metal oxide nanofillers, dispersed in the aqueous solution 108, the refractive index can be increased, which can provide a material that is much more optically transparent or translucent, or a material that has a more closely matched refractive index.

Suitable nanoparticle fillers may include, but are not limited to: silicon dioxide; zirconium oxide; oxides of titanium, aluminum, cerium, tin, yttrium, strontium, barium, lanthanum, zinc, ytterbium, bismuth, iron, and antimony; and combinations thereof. More typical nanofillers may include zirconia (ZrO)₂) (ii) a Oxides of titanium (e.g. TiO)₂) And ytterbium oxide (e.g., Y)₂O₃) (ii) a And other metal oxides having a high refractive index. Titanium dioxide and zirconium oxide are particularly useful nanofillers because they have very high refractive indices and require less material weight to properly match the refractive indices than lower refractive index materials.

The nanofiller typically has an average particle size of at most 100 nanometers and more typically at most 50 nanometers. Such nanofillers typically have an average particle size of at least 2 nanometers, more typically at least 5 nanometers, and even more typically at least 10 nanometers. In some embodiments, the nanofiller is in the form of nanoclusters, typically at least 80% by weight of nanoclusters. In other embodiments, the nanofiller is in the form of a combination of nanoparticles and nanoclusters. A portion of the nanofiller surface is typically silane treated or otherwise chemically treated to provide one or more desired physical properties. Suitable nanofillers are disclosed in U.S. Pat. No. 6,387,981(Zhang et al) and U.S. Pat. No. 6,572,693(Wu et al) as well as International publications WO 01/30305(Zhang et al), WO 01/30306(Windisch et al), WO 01/30307(Zhang et al) and WO 03/063804(Wu et al). The filler components described in these references include nanoscale silica particles, nanoscale metal oxide particles, and combinations thereof.

In some embodiments, the aqueous liquid 108 of the system 10 is substantially colorless and transparent to visible light having wavelengths of 400nm to 750nm, and thus appears substantially invisible to the patient's teeth when free of visible bubbles. In some embodiments, the polymeric housing 102 and the aqueous liquid 108 of the system 10 transmit at least 60%, or at least 80%, or at least 90% of incident light having a wavelength of about 400nm-750nm, which may render the system 10 substantially invisible when the polymeric housing 102 is positioned on a patient's teeth.

To provide the desired viscosity for a particular application, the aqueous liquid 108 in the system 10 comprises: a viscosity modifier selected from the group consisting of water compatible polymers, polysaccharides, silica compounds, and mixtures and combinations thereof. In various embodiments, the viscosity modifier may be bacteriostatic and have a low odor. Alternatively, a bacteriostatic or deodorant agent may be added to the aqueous liquid.

Water compatible polymers suitable for use as viscosity modifiers in the aqueous liquid 108 include water soluble polymers, water dispersible polymers, and mixtures and combinations thereof.

The water soluble polymer dissolves, disperses or swells in water and thus alters the physical characteristics of the aqueous liquid 108 to provide characteristics such as, for example, gelling, thickening or emulsification/stabilization. Suitable biocompatible water-soluble polymers include, but are not limited to, polyacrylic acid and salts thereof, polyethylene glycol, ethylene oxide/propylene oxide copolymers, and mixtures and combinations thereof, and polymeric materials such as dextran, hydroxypropyl cellulose, and polystyrene sulfonic acid and salts thereof.

When mixed with additional compounds such as, for example, anionic or nonionic surfactants, acids or bases, the water compatible polymers dissolve, disperse or swell in water and thereby alter the physical characteristics of the aqueous liquid 108 to provide characteristics such as, for example, gelling, thickening or emulsifying/stabilizing. Suitable water compatible polymers include, but are not limited to, synthetic polymers, modified natural polymers and natural polymers such as, for example, chitosan, neutralized chitosan, modified chitosan, partially chitosan, acrylate polymers having pendant amine groups such as those available under the trade name EUDRAGIT, specifically EUDRAGIT E PO Ready Mix available from Evonik Nutrition & Care GmbH, and mixtures and combinations thereof.

In some embodiments, the aqueous liquid 108 comprises one or more surfactants. In some embodiments, useful surfactants may include those of formula I:

HOCH₂-(CHOH)_n-CH₂NR¹R² (I)

wherein R is¹And R²Independently selected from hydrogen atom, alkyl group, C (O) R³And SO₂R⁴；R³And R⁴Independently selected from alkyl groups, aryl groups and aralkyl groups; and n is an integer from about 2 to about 5.

In formula I, the radical R¹And R²Independently selected from the group consisting of: a hydrogen atom, an alkyl group, C (O) R³And SO₂R⁴。R¹And R²May be a hydrogen atom, R¹And R²Each of which may be an alkyl group, R¹And R²May be C (O) R³Or R is¹And R²May be SO₂R⁴. In some embodiments, R¹May be a hydrogen atom, and R²May be an alkyl group, C (O) R³Or SO2R⁴. In other embodiments, R¹May be an alkyl group, and R²May be C (O) R³Or SO₂R⁴. In other embodiments, R¹May be C (O) R³And R is²May be SO₂R⁴. When R is¹And R²When either or both are alkyl groups, the alkyl groups may comprise about one carbon atom, more than about two carbon atoms, more than about four carbon atoms, more than about six carbon atoms, more than about eight carbon atoms, more than about ten carbon atoms, more than about twelve carbon atoms, more than about fourteen carbon atoms, more than about sixteen carbon atoms, or more than about eighteen carbon atoms. In some embodiments, the alkyl group includes less than about thirty carbon atoms, less than about twenty-six carbon atoms, or less than about twenty carbon atoms. In some embodiments, the alkyl group comprises a straight chain alkyl group. In other embodiments, the alkyl group comprises a branched alkyl group. In other embodiments, the alkyl group comprises a cycloalkyl group. When R is¹And R²When each of (a) includes an alkyl group, R¹And R²May contain the same alkyl groups, or R¹And R²Different alkyl groups may be included. Non-limiting examples of alkyl groups include methyl, ethyl, 1-propyl, isopropyl, butyl, isobutyl, sec-butyl, pentyl, isopentyl, neopentyl, hexyl, 2-ethylhexyl, octyl, decyl, undecyl, dodecyl, tetradecyl, pentadecyl, octadecyl, cyclohexyl, 4-methylcyclohexyl, cyclohexylmethyl, cyclopentyl, and cyclooctyl.

Radical R³And R⁴Independently selected from alkyl groups, aryl groups and aralkyl groups. When R is³Or R⁴When either or both are alkyl groups, the alkyl groups may comprise about one carbon atom, more than about two carbon atoms, more than about four carbon atoms, more than about six carbon atoms, more than about eight carbon atoms, more than about ten carbon atoms, more than about twelve carbon atoms, more than about fourteen carbon atoms, more than about sixteen carbon atoms, or more than about eighteen carbon atoms. In some embodiments, the alkyl group includes less than about thirty carbon atoms, less than about twenty-six carbon atoms, or less than about twenty carbon atoms. In some embodiments, the alkyl group comprises a straight chain alkyl group. In other embodimentsIn one embodiment, the alkyl group includes a branched alkyl group. In other embodiments, the alkyl group comprises a cycloalkyl group. In a compound of formula I or a pharmaceutically acceptable salt thereof, when R³And R⁴When both radicals are present, and when R is present³And R⁴When each of (a) includes an alkyl group, R³And R⁴May contain the same alkyl groups, or R³And R⁴Different alkyl groups may be included. Non-limiting examples of alkyl groups include methyl, ethyl, 1-propyl, isopropyl, butyl, isobutyl, sec-butyl, pentyl, isopentyl, neopentyl, hexyl, 2-ethylhexyl, octyl, decyl, undecyl, dodecyl, tetradecyl, pentadecyl, octadecyl, cyclohexyl, 4-methylcyclohexyl, cyclohexylmethyl, cyclopentyl, and cyclooctyl.

When R is³Or R⁴When either or both are aryl groups, the aryl group may contain one aromatic ring or more than one aromatic ring. The aromatic ring may include up to six carbon atoms, up to eight carbon atoms, up to ten carbon atoms, up to twelve carbon atoms, up to fourteen carbon atoms, up to sixteen carbon atoms, or up to eighteen carbon atoms. The aromatic ring may contain heteroatoms such as nitrogen, oxygen or sulfur. If more than one aromatic ring is present, the aromatic rings may be fused together, or they may be linked by chemical bonds. In a compound of formula I or a pharmaceutically acceptable salt thereof, when R³And R⁴Both are present, and when R is³And R⁴When each of (a) includes an aryl group, R³And R⁴May contain the same aryl groups, or R³And R⁴Different aryl groups may be included. Non-limiting examples of aryl groups include substituted and unsubstituted phenyl, 1-naphthyl, 2-naphthyl, 9-anthracenyl.

When R is³Or R⁴When either or both are aralkyl groups, the aralkyl group may contain one aromatic ring or more than one aromatic ring. An aralkyl group may contain up to six carbon atoms, up to eight carbon atoms, up to ten carbon atoms, up to twelve carbon atoms, up to fourteen carbon atoms, up to sixteen carbon atomsCarbon atoms, up to eighteen carbon atoms or up to twenty carbon atoms. If more than one aromatic ring is present on the aralkyl group, the aromatic rings may be fused together, or they may be joined by chemical bonds. The aromatic ring may contain heteroatoms such as nitrogen, oxygen or sulfur. In a compound of formula I or a pharmaceutically acceptable salt thereof, when R³And R⁴When both radicals are present, and when R is present³And R⁴When each of (a) includes an aralkyl group, R³And R⁴May contain the same aralkyl groups, or R³And R⁴Different aralkyl groups may be included. Non-limiting examples of aralkyl groups include benzyl, 1-phenylethyl, 2-phenylethyl, 3-phenylpropyl, 2-naphthylethyl and 9-anthracenemethyl.

In formula I, n is an integer from about 2 to about 5. In some embodiments, the dental composition comprises a compound of formula I, or a pharmaceutically acceptable salt thereof, wherein n is an integer having a value of about 5, about 4, about 3, or about 2. In some embodiments, n is an integer having a value of 5, or 4, or 3, or 2. It is to be understood that the dental composition may comprise more than one compound of formula I or a pharmaceutically acceptable salt thereof, and that the compounds may be represented by formula I having different integer values of n. In these embodiments, the average value of n for the composition may be a non-integer.

Pharmaceutically acceptable salts of the compounds of formula I may also be used and may include ammonium salts. In some embodiments, the dental compositions of the present invention comprise an ammonium salt. The ammonium salt may be represented as the reaction product of an acid with an amine, or as the reaction product of an amine with an alkylating agent such as, for example, methyl iodide, ethyl bromide, or benzyl bromide. Ammonium salts include protonated amine compounds, e.g. wherein NR¹R²A compound of formula I wherein R is a group which has been protonated by an inorganic or organic acid¹And R²The groups are independently selected from hydrogen atoms and alkyl groups. Ammonium salts include alkylated amine compounds, e.g. wherein NR¹R²A compound of formula I wherein R is a group which has been alkylated with an alkylating agent¹And R²Independently selected from hydrogen atoms and alkyl groups.

The ammonium salt comprising at least one counterionThe counter ion may be an inorganic anion, an organic anion, or a combination of anions. Combinations of anions include combinations of more than one inorganic anion, combinations of more than one organic anion, or combinations of inorganic and organic anions. Inorganic ions include, for example, halides (fluoride, chloride, bromide, and iodide), nitrates, sulfates, tetrafluoroborates, and tetrakis (aryl) borates. The tetra (aryl) borate salt comprises a compound having the formula Z₄B^-Wherein Z is an aromatic group, such as a substituted or unsubstituted phenyl group. Examples of tetrakis (aryl) borates include, but are not limited to, tetraphenyl borate, tetrakis (4-methylphenyl) borate, tetrakis (2-methylphenyl) borate, tetrakis (1,3, 5-trimethylphenyl) borate, tetrakis (4-fluorophenyl) borate, tetrakis (pentafluorophenyl) borate, and tetrakis (4-trifluoromethylphenyl) borate. Organic anions include, for example, alkanoates (such as, for example, acetate, propionate, and butyrate), benzoate, fumarate, maleate, tartrate, ascorbate, benzene sulfonate, toluene sulfonate, and citrate. In some embodiments, the pharmaceutically acceptable salt is free of unsubstituted or substituted tropolone.

In certain embodiments, the ammonium salt may be formed by protonating a compound of formula I with a mineral acid, an organic acid, or a combination of a mineral acid and an organic acid, wherein R is¹And R²Independently selected from hydrogen atoms and alkyl groups. In another embodiment, the ammonium salt may be formed by alkylating a compound of formula I, wherein R is¹And R²Independently selected from hydrogen atoms and alkyl groups. In another embodiment, the ammonium salt may be formed by an ion exchange or metathesis reaction with a previously formed ammonium salt.

In some embodiments, R¹Comprises an alkyl group, and R²Is C (O) R³Wherein R is³Including alkyl groups. In certain embodiments, R¹Including an alkyl group having from about one to about four carbon atoms, and R³Including alkyl groups having from about four to about sixteen carbon atoms. In some embodiments, R¹Comprises a first partRadical of a radical, and R³Including alkyl groups having seven, eight, or nine carbon atoms. In some embodiments, the dental composition includes a compound of formula II, formula III, or formula IV below.

The disclosed aqueous liquid composition 108 may comprise no greater than 5 wt% of one or more surfactants based on the total weight of the composition, no greater than 4.5 wt% of one or more surfactants based on the total weight of the composition, or no greater than 4 wt% of one or more surfactants based on the total weight of the composition. In some embodiments, the disclosed compositions may comprise not less than 0.5 wt% of one or more surfactants based on the total weight of the composition, not less than 0.4 wt% of one or more surfactants based on the total weight of the composition, or not less than 0.3 wt% of one or more surfactants based on the total weight of the composition.

The polymer used to form the aqueous liquid 108 can be prepared by polymerizing the above-described monomers by conventional polymerization methods. Typical polymerization methods that can be used include thermal and/or photochemical polymerization as well as bulk and solution polymerization.

In some embodiments, the viscosity modifier for the aqueous liquid 108 is a polysaccharide, such as, for example, methylcellulose, carboxymethylcellulose, hydroxypropylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose, gellan gum, agarose, carrageenan, and mixtures and combinations thereof. In some embodiments, the aqueous liquid 108 may also optionally include a gelling initiator or accelerator, such as a monovalent or divalent salt.

In some embodiments, the viscosity modifier for the aqueous liquid 108 is a silica compound. Suitable silica compounds include, but are not limited to, fumed silica or precipitated silicas such as those available under the trade name AEROSIL from Evonik Industries, Parsippany, NJ, and CAB-O-SIL from Cabot Corp, Alpharetta, GA, Alpharetta, Kyowa. In some embodiments, which are not intended to be limiting, the aqueous liquid 108 comprises no greater than about 3 wt.%, or no greater than 2 wt.%, or no greater than 1 wt.% of a silica-containing viscosity modifier.

In some embodiments, the viscosity modifier is present in an amount sufficient to cause the aqueous liquid 108 to form a gel, which in this application refers to a flexible, viscous, liquid, colloidal material that tends to adhere to the dental appliance 100 such that a substantial portion of the gel remains in the tooth holding cavities 104 until displaced by the patient's teeth. In some embodiments, the gel is capable of swelling upon contact with body fluids (or fluids similar to body fluids, such as physiological saline) in the mouth, but is insoluble in water. Gels are substantially continuous, i.e., structures lacking micropores or voids (although minor amounts of defects, such as entrapped air bubbles or fractures, may be present), and are therefore typically in solid or semi-solid form. The term "gel" is used regardless of the state of hydration.

In some embodiments, the gel has a viscosity selected to prevent rapid drainage of aqueous liquid from the tooth retention cavity 104 of the polymeric shell 102 when the dental appliance 100 is inserted into the mouth of a patient and the tooth retention cavity 104 is positioned to cover the patient's teeth. For example, suitable discharge-resistant aqueous liquids having gel-like properties have been found to have viscosities of from about 0.001Pa s at a shear rate of 1/s to about 10Pa s at a shear rate of 1/s at room temperature. In other embodiments, the gel has a viscosity selected to facilitate insertion of the dental appliance 100 into the mouth of a patient or positioning of the dental appliance 100 on the teeth of a patient. For example, an aqueous liquid suitable for easy insertion into a dental appliance is a gel having a viscosity at room temperature of about 0.001Pa s at a shear rate of 1/s to about 10Pa s at a shear rate of 1/s.

In various embodiments, the viscosity modifier in the aqueous liquid 108 is present in about 0.1 parts by weight to about 60 parts by weight.

In various embodiments, the aqueous liquid 108 in the system 10 also comprises a tooth remineralizing agent, either alone or in combination with one or more minerals that may be useful or beneficial for ingestion or oral health.

Exemplary optional minerals that may be included in the disclosed composition of the aqueous liquid 108 may include calcium (Ca), phosphorus (P), magnesium (Mg), iron (Fe), strontium (Sr), zinc (Zn), potassium (K), or combinations thereof. In some embodiments, which are not intended to be limiting, some minerals may be formed by including magnesium chloride (MgCl)₂) Calcium chloride (CaCl)₂) Strontium chloride, zinc gluconate, potassium nitrate, and dipotassium hydrogen phosphate (KH)₂PO₄) Or a combination thereof.

In some embodiments, calcium salts and phosphate salts provide a continuous opportunity for remineralization of dental enamel, which can reverse or attenuate the tooth decay process.

For example, in some embodiments, suitable tooth remineralizing agents include, but are not limited to, those comprising Ca²⁺An ionic calcium compound. Suitable calcium compounds include, but are not limited to, calcium chloride, calcium carbonate, calcium caseinate, calcium chloride, calcium citrate, calcium glubionate, calcium glucoheptonate, calcium glycerophosphate, calcium gluconate, calcium hydroxide, calcium hydroxyapatite, calcium lactate, calcium oxalate, calcium oxide, calcium pantothenate, calcium phosphate, calcium polycarbophil, calcium propionate, calcium pyrophosphate, calcium sulfate, and mixtures and combinations thereof. These compounds have been found to minimize demineralization of calcium hydroxyapatite on the surface of a patient's teeth.

In some embodiments, the tooth remineralizing compound comprises a phosphate compound. Suitable phosphate compounds include, but are not limited to, aluminum phosphate, bone phosphate, calcium orthophosphate, anhydrous calcium hydrogen phosphate, calcium phosphate-bone ash, calcium hydrogen phosphate dihydrate, anhydrous calcium hydrogen phosphate, calcium hydrogen phosphate dihydrate, tribasic calcium phosphate, dibasic calcium phosphate dihydrate, dicalcium phosphate, neutral calcium phosphate, tribasic calcium phosphate, tricalcium phosphate, precipitated calcium phosphate, tricalcium phosphate, whitlockite, magnesium phosphate, potassium phosphate, dipotassium hydrogen phosphate, dipotassium monophosphate, dipotassium hydrogen phosphate, potassium dihydrogen phosphate, potassium acid phosphate, potassium dihydrogen orthophosphate, potassium hydrogen phosphate, sodium phosphate, anhydrous sodium phosphate, disodium hydrogen orthophosphate, disodium hydrogen phosphate dodecahydrate, disodium hydrogen phosphate, disodium phosphate, and mixtures and combinations thereof.

In some embodiments, the calcium compound, the phosphate compound, or both are sufficient to Ca-coat the aqueous liquid 108 with Ca²⁺Ions and PO₄ ^3-At least one of the ions is present in the aqueous liquid 108 in a saturated amount. In some embodiments, the aqueous liquid 108 saturated in at least one of calcium ions or phosphate ions can substantially reduce or prevent demineralization or enhance remineralization, or both, on the surface of the patient's teeth.

In various embodiments, the tooth remineralizing agent in the aqueous liquid 108 is present in an amount of up to about 1 part by weight, or up to about 2 parts by weight, or up to about 5 parts by weight.

In some embodiments, the disclosed compositions of the aqueous liquid 108 may include one or more preservatives to render the composition microbiologically stable, increase its microbiologic stability, or some combination thereof. In some embodiments, useful preservatives include those that function at neutral pH, do not adversely affect taste, are edible, are effective against multiple pathogens, or combinations thereof. Specific exemplary useful preservatives can include, for example, those commercially available under the trade name GEOGARD from LONza (Basel, Switzerland), as well as salicylic acid, benzyl alcohol, sodium benzoate, potassium sorbate, parabens, natural preservatives, polyglyceryl esters, monolaurin, 1, 2-octanediol, caprylic/capric triglyceride, dehydroacetic acid (DHA), aloe vera, potassium sorbate, cetylpyridinium chloride (CPC), polyhexamethylene biguanide (PHMB), chlorhexidine gluconate (CHG), vitamin E, triethyl citrate, ethylenediaminetetraacetic acid (EDTA).

The disclosed composition of the aqueous liquid 108 may have different characteristics. In some embodiments, the disclosed compositions can be described by their pH, their viscosity, their stability, various other characteristics, or combinations thereof.

In various embodiments, the aqueous liquid 108 in the system 10 has a pH suitable for use in the mouth of a patient, and can be selected to help neutralize oral acids from food and bacteria present in the mouth of the patient. In various embodiments, for example, the aqueous liquid is buffered to have a pH of about 4.5 to about 9.5, or about 6.0 to about 8.0(± 0.1), or about 7.1 to about 7.35, or about 7.1. The composition may naturally have such a pH, or may be buffered to have a pH in a useful, e.g., "neutral," range.

In some embodiments, the disclosed compositions can have desirable stability characteristics. The stability of the composition can include microbial stability, physical stability, or a combination thereof. In some embodiments, the disclosed compositions are microbiologically stable for at least 6 months, in some embodiments for 1 year, in some embodiments for greater than 2 years.

In some embodiments, the aqueous liquid comprises a buffer to maintain a desired pH range. Suitable buffers include, but are not limited to, phosphates, carbonates, citrates, and mixtures and combinations thereof. In one embodiment, a suitable phosphate compound is Na₂HPO₄. In another embodiment, the water soluble polymer, alone or in combination with the above-described buffering agents, can be selected to provide both viscosity adjustment and buffering to maintain the pH of the aqueous liquid within a selected range.

In various embodiments, the aqueous liquid 108 comprises from about 40 parts by weight to about 95 parts by weight, or up to about 98 parts by weight of a buffering agent.

The disclosed composition of the aqueous liquid 108 may also optionally contain additional components such as, for example, sweeteners, humectants, mineral salts, buffering components, flavorants, preservatives, or combinations thereof. Other optional beneficial ingredients may also be included at appropriate levels, such as aloe vera (multi-benefit), folic acid (associated with B12), hyaluronic acid (lubricating, healthy skin), ceramides (healthy skin), arginine, betaine or oxidized triglycerides, vitamin E (antioxidants and preservatives), vitamin B12 (healthy skin, etc.), EDTA, cetylpyridinium chloride, chlorhexidine, other preservatives, and combinations thereof.

In some embodiments, the aqueous liquid 108 of the system 10 further comprises 0.1 to about 10 parts by weight of a fragrance. Suitable flavoring agents can vary widely, but particularly useful flavoring agents have a pleasant taste and are not metabolized to acids at the tooth surface. Examples of suitable flavoring agents include, but are not limited to, polyol sugar alcohols such as xylitol, erythritol, glycerol, sorbitol, and mixtures and combinations thereof.

In some embodiments, suitable flavoring agents include, but are not limited to, peppermint, strawberry, butter, vanilla, coconut, almond, bubble gum, berry, juice drink, creamy candy, caramel, or combinations thereof. In some embodiments, some flavors such as mint, citrus, and the like may also be advantageous because they stimulate saliva production when used in the compositions. Artificial sweeteners (e.g., stevia, aspartame, sucralose, neotame, acesulfame potassium (Ace-K), saccharin, and high sweeteners (advatame)) may also be used. In some embodiments, the disclosed compositions may comprise one or more sweeteners, including, for example, non-cariogenic polyols or sugar substitutes (e.g., sucralose). In some embodiments, the disclosed compositions may comprise non-cariogenic polyol sweeteners, such as xylitol, sorbitol, maltitol, erythritol, isomalt, or combinations thereof. In compositions comprising the optional sweetener, the sweetener may be present in an amount of not less than 2.5 wt% based on the total weight of the composition or not less than 1 wt% based on the total weight of the composition. In some embodiments, the optional sweetener may be present in an amount of no greater than 20% by weight based on the total weight of the composition or no greater than 15% by weight based on the total weight of the composition.

In some embodiments, the aqueous liquid 108 in the system 10 may optionally include a dye or pigment to provide a desired color, which may be decorative or selected to improve the appearance of the patient's teeth, for example.

In some embodiments, the disclosed composition of the aqueous liquid 108 is capable of preventing, inhibiting, or disrupting the formation or maintenance of a biofilm in the area in contact with the composition. The area of contact may be in vivo or in vitro. In some embodiments, the composition can prevent, inhibit, or disrupt the formation or maintenance of a biofilm in the mouth where the composition is applied to the user's mouth (e.g., by spraying the composition into the mouth) when compared to the mouth without the composition applied.

In some embodiments, the aqueous liquid 108 can prevent, inhibit, or disrupt the formation or maintenance of a biofilm in a container in which the biofilm is present when compared to a container to which the composition is not applied, and the composition is applied to the container by pouring, spraying, or the like. Some combinations that prevent, inhibit or disrupt biofilm formation or maintenance or achieve prevention, inhibition and disruption can be measured using a modified version of the MBEC assay (described in ASTM E2799) that measures disruption of streptococcus mutans (strep mutans) biofilms grown on special spikes in microtiter plates. Biofilms grown on the pins were treated by periodic immersion in the test material, followed by washing in saliva and water. The biofilm remaining on each nail after treatment can be quantified by measuring the amount of fluorescently labeled bacteria that elute from the nail at the end of the treatment cycle. In some embodiments, the disclosed compositions can affect the accumulation of plaque in the area contacted with the composition. The area of contact may be in vivo or in vitro. In some embodiments, the composition can reduce plaque accumulation on at least one tooth in the mouth when the composition is applied to the mouth of a user (e.g., by spraying the composition into the mouth) when compared to the mouth without the composition applied. In some embodiments, the composition can reduce the accumulation of plaque in containers in which plaque can form when compared to containers in which the composition is not applied, and the composition is applied to the container by pouring, spraying, or the like. Reduced plaque accumulation can be measured by a variety of in vivo methods, including, for example, plaque nicking, plaque staining, and the like.

In some embodiments, the disclosed composition of the aqueous liquid 108 may affect the lubricity or lubricity of the area in contact with the composition. The lubricating ability may facilitate easy insertion and removal of the dental appliance 100 into and onto the mouth and teeth of a patient, while not adversely affecting the force exerted by the dental appliance in a particular location to gradually move the teeth to a new configuration. In some embodiments, the composition may maintain or increase lubricity. In some embodiments, the composition may, for example, provide the same or a higher degree of lubricating properties to the mouth than saliva can provide. The ability to lubricate or provide lubricating properties can be measured by the coefficient of friction against a suitable substrate. A low coefficient of friction (compared to saliva) is desired.

In some embodiments, the disclosed compositions of the aqueous liquid 108 may combine a number of desirable benefits, such as aesthetic appearance, remineralization, lubrication, caries prevention, moisturization, pH buffering to neutralize potential acids produced by oral biofilms. The search for an ingestible biocompatible cosmetic aqueous liquid to achieve all the desired benefits requires extensive experimental research, which is very important and requires more than routine optimization. In addition, some of the disclosed compositions also achieve desirable physical stability (desirable product shelf life and commercial utility). Surprisingly, some of these formulations also have antiplaque properties, as demonstrated by in vitro anti-biofilm studies using Streptococcus mutans, a well-known biofilm-forming bacterium that causes plaque.

In an exemplary embodiment, the aqueous liquid 108 comprises: from about 0.1 parts by weight to about 60 parts by weight of a viscosity modifier selected from the group consisting of polysaccharides, water compatible polymers, silica compounds, and mixtures and combinations thereof; about 40 to about 95 parts by weight of a buffering agent; up to about 1 part by weight of a tooth remineralizing agent comprising a calcium compound; optionally from about 0.1 parts by weight to about 10 parts by weight of a fragrance; and water. The aqueous liquid is substantially free of tooth whitening agents and fluoride, and wherein the refractive index of the aqueous liquid is greater than 1.3, or greater than 1.33, or greater than 1.34.

In another embodiment, the aqueous liquid 108 comprises: 0.5 to about 60 parts by weight of a water soluble polymer selected from the group consisting of polyacrylic acid, polyethylene glycol, ethylene oxide/propylene oxide copolymers, and combinations thereof; about 40 to about 95 parts by weight of a buffering agent; up to about 1 part by weight of a tooth remineralizing agent comprising a calcium compound; optionally from about 0.1 parts by weight to about 10 parts by weight of a fragrance; and water. The aqueous liquid is substantially free of tooth whitening agents and fluoride, and wherein the refractive index of the aqueous liquid is greater than 1.3, or greater than 1.33, or greater than 1.34.

The shell 102 of the orthodontic appliance 100 is an elastic polymeric material that generally conforms to the patient's teeth and may be transparent, translucent, or opaque. In some embodiments, the housing 102 is a light transmissive or substantially transparent polymeric material, which may include, for example, one or more of an amorphous thermoplastic polymer, a semi-crystalline thermoplastic polymer, and a transparent thermoplastic polymer. In some embodiments, the housing 102 comprises a material selected from the group consisting of: polyurethanes, polycarbonates, acrylics, polysulfones, polypropylenes, polyesters, copolyesters, polypropylene/ethylene copolymers, cyclic olefin polymers/copolymers, poly-4-methyl-1-pentene or polyester/polycarbonate copolymers, styrenic polymeric materials, polyamides, polymethylpentene, polyether ketones, and combinations thereof. In another embodiment, the housing 102 may be selected from light-transmissive or substantially transparent semi-crystalline thermoplastics, and composites such as polyamides, polyethylene terephthalate, polybutylene terephthalate, polyester/polycarbonate copolymers, polyolefins, cyclic olefin polymers, styrenic copolymers, polyetherimides, polyetherketones, polyethersulfones, polytrimethylene terephthalate, and mixtures and combinations thereof. In some embodiments, the housing 102 is a polymeric material selected from the group consisting of: polyethylene terephthalate, glycol-modified polyethylene terephthalate (PETg), glycol-modified polycyclohexanedimethylene terephthalate, poly (meth) acrylates (which include polymethacrylates and polyacrylates), polyurethane polymethacrylates, and mixtures and combinations thereof. One example of a commercially available material suitable as the resilient polymeric material of the housing 102 is PETg, which is not intended to be limiting. Suitable PETg resins are available from a variety of commercial suppliers, such as, for example, Eastman Chemical (Kingsport, TN), inc; SK Chemicals (Irvine, CA)) in deluxe, california; dow DuPont chemical company of Midland, Mich.Mich. (Dow DuPont, Midland, Mich.); pacur corporation of Oishikosh, Wisconsin (Pacur, Oshkosh, Wis); and Scheu Dental technology of Itulon, Germany (Scheu Dental Tech, Iserlohn, Germany).

In some embodiments, the housing 102 may be made of a single polymeric material, or may include multiple layers of different polymeric materials.

In one embodiment, the housing 102 is a substantially transparent polymeric material. In this application, the term "substantially transparent" refers to materials that pass light in the wavelength region (about 400nm to about 750nm) to which the human eye is sensitive, while rejecting light in other regions of the electromagnetic spectrum. In some embodiments, the reflective edge of the polymer material selected for the housing 102 should be above about 750nm, well outside the sensitivity of the human eye.

The orthodontic appliance 100 can be manufactured using a variety of techniques. A plurality of cavities 104 can be formed in the substantially flat sheet of polymeric material to form the orthodontic appliance 100, wherein the cavities are configured to receive one or more teeth. The cavity 104 may be formed by any suitable technique, including thermoforming, laser machining, chemical or physical etching, and combinations thereof.

In another embodiment, the shell orthodontic appliance 100 can be formed using a three-dimensional (3D) printing process (e.g., additive manufacturing) such as stereolithography and inkjet printing. Suitable resins for use in three-dimensional printing processes include, for example, those described in international publications WO2019/023009(Parkar et al), WO2019/103855(Parkar et al), WO2018/119026(Parkar et al), and WO2018/005501(Franke et al).

Referring now to fig. 2, the shell 102 of the orthodontic appliance 100 generally conforms to the patient's teeth 200, but is slightly misaligned with the patient's initial maloccluded tooth configuration. In some embodiments, the shell 102 may be one of a set or series of shells having substantially the same shape or mold, but formed of different materials to provide different stiffness or elasticity as needed to move the patient's teeth. As such, in one embodiment, the patient or user can alternatively use one of the orthodontic appliances during each treatment stage, depending on the patient's preferred time of use or desired treatment time period for each treatment stage.

Wires or other means for retaining the shell 102 on the teeth 200 may not be provided, but in some embodiments it may be desirable or necessary to provide a separate anchor on the teeth with a corresponding receptacle or aperture in the shell 102 so that the shell 102 can exert a retaining force or other directed orthodontic force on the teeth, which would not be possible without such an anchor.

The shell 102 may be customized, for example, for daytime and nighttime use, during functional or non-functional (chewing or non-chewing), during social (where appearance may be more important) and non-social (where aesthetic appearance may not be an important factor), or based on the patient's desire to accelerate tooth movement (by optionally using a more rigid appliance for a longer period of time at each stage of treatment, rather than using a less rigid appliance).

For example, in one aspect, a patient may be provided with a transparent orthodontic appliance that may be used primarily to maintain tooth position and an opaque orthodontic appliance that may be used primarily to move teeth for each treatment stage. Thus, during the day, the patient may use the transparent appliance in a social setting, or in other words in an environment where the patient is more keenly aware of the physical appearance. Further, during the evening or night, in non-social situations, or otherwise when in an environment where physical appearance is less important, the patient may use an opaque appliance that is configured to apply a different amount of force during each treatment stage or otherwise have a stiffer configuration to accelerate tooth movement. The method can be repeated such that each of the pair of appliances is used alternately during each treatment stage.

Referring again to fig. 2, the orthodontic appliance 100 and the aqueous solution 108 form a dental alignment system. For example, for each treatment stage of orthodontic treatment, the patient may be provided with a series of multiple incremental orthodontic appliances 100, each formed of the same or different materials. The orthodontic appliance may be configured such that each successive member of the series incrementally repositions a single tooth 200 in the patient's upper or lower jaw 202 from an maloccluded position to a desired unoccluded position. In some embodiments, the cavity 104 is configured such that selected teeth will be repositioned while other teeth will be designated as bases or anchor regions for holding the repositioned appliance in place when the repositioned appliance applies a resilient repositioning force to the tooth or teeth to be repositioned.

The aqueous solution 108 is applied to some or all of the cavities 104 in the polymeric shell 102 prior to placing the elastic orthodontic appliance 100 on the teeth. The aqueous solution 108 is applied in the cavity 104 in a sufficient amount such that when the orthodontic appliance 100 is placed on a tooth, the aqueous solution occupies and remains in the air gap between the polymeric shell 102 and the tooth.

As described above, in some embodiments, the aqueous solution is a gel and has a viscosity selected such that all or a substantial amount of the gel remains in the cavity 104 when the polymeric shell 102 is placed on a tooth and the tooth is inserted into the cavity 104. As the teeth enter the cavity 104, a portion of the gel is displaced, but enough gel remains to substantially fill the air gap between the polymer shell 102 and the teeth. As described above, in various embodiments, a gel may be used to facilitate insertion and placement of the polymeric shell 102 on the tooth.

In some embodiments, the aqueous solution 108 may be dispensed from a collapsible tube container, syringe, or applicator and manually applied to the cavity 104 prior to inserting the polymeric shell 102 onto the tooth. In another embodiment, an automated dispenser may be used to dispense a controlled amount of the aqueous liquid 108 into the chamber 104.

Placing the elastic dental appliance 100 over the teeth 200 applies a controlled force at a particular location to gradually move the teeth into a new configuration. Repeating this process with successive dental appliances having different configurations eventually moves the patient's teeth through a series of intermediate configurations to a final desired configuration.

Referring to fig. 3, in various embodiments, the system can be provided in the form of a kit 300 that includes a dental appliance 301 and an aqueous solution 308. In one embodiment, the aqueous solution 308 may be provided in a container 320, such as a squeezable bottle or collapsible tube, along with instructions 322 for proper application to the dental appliance 301. In another embodiment, the aqueous solution 308 can be provided in a dispenser 330, wherein the dispenser 330 includes, for example, a syringe, trigger operated gun, or pump 332 configured to dispense a predetermined amount of the aqueous solution 308 for each insertion of the dental appliance 301 into the mouth of a patient. In another embodiment, the dispenser 330 may be configured to automatically dispense a predetermined amount of the aqueous solution 308 for each insertion of the dental appliance 301. In another embodiment, the kit may optionally include additional items, such as, for example, a storage box 340, which may be used as a holder or an automated cleaning device for temporarily storing the dental appliance 301 when it is not in the mouth of the patient; a liquid cleaning or sanitizing solution or water-soluble solid tablet 350 for storage in a cartridge or an automated cleaning device; a charger for an automatic dispenser or cleaning device; instructions for use, and the like.

As shown in fig. 4, in one exemplary embodiment, the reclosable storage unit and dispenser 430 includes a foam applicator pad 450 that is shaped to hold a shell-like dental appliance 401 that includes a tooth holding cavity 404. The storage unit and dispenser 430 also includes an opening 454 in a hinged cover 456. As aqueous liquid (not shown in fig. 4) is dispensed into the reservoir 458, for example, in the bottom 460 of the dispenser 430 or directly onto the applicator pad 450, the aqueous liquid collects in the reservoir 458. The foam applicator pad 450 absorbs aqueous liquid from the reservoir 458. When the cover 456 is closed and engages the bottom 460 of the dispenser 430, the dental appliance 401 is pressed against the foam applicator pad 450. The foam applicator pad 450 dispenses a predetermined measured amount of aqueous liquid into the cavity 404 of the dental appliance 401.

The system of the present disclosure will now be further described in the following non-limiting examples.

Examples

Four solutions were prepared as described in table 1 below:

TABLE 1

pH measurement

After calibration, pH tests were performed on a standard pH meter. The pH meter is an ACCUMET type 15 pH meter from Fisher Scientific. The pH measurement was performed by inserting a pH probe into the solution, waiting 2 minutes, and recording the pH value. The pH values are listed in the examples table.

Solution preparation and application

Solutions are prepared by mixing the necessary ingredients that provide certain desired functions, such as moistening the teeth, providing pH buffering to neutralize potential acids produced by oral biofilms, providing calcium phosphate to simulate saliva, and providing some flavor. Xylitol is added for flavoring and preventing dental caries. The solutions in the following examples contain water soluble polymers, phosphate buffer, xylitol, calcium phosphate and water for cosmetic application in a transparent tray aligner to provide wetting and reduce light scattering, which can reduce the visibility of the transparent aligner polymer film on the patient's teeth.

Preparation of buffer solution

pH 7.3 buffer

3.84 grams of citric acid was dissolved in 200mL of DI water. 28.4 g of Na₂HPO₄Dissolved in 1000mL DI water. Once both solutions were prepared, 130mL of citric acid solution was added to 1000mL of Na₂HPO₄In solution. The pH of the final combined solution was 7.33。

Buffer pH 6.4

1.92 grams of citric acid was dissolved in 100mL of DI water and the procedure was repeated to form 200mL of citric acid solution. 14.2 g of Na₂HPO₄Dissolved in 500mL DI water. Once the two solutions were prepared, 335mL of Na was added₂HPO₄The solution was added to 150mL of citric acid solution. The pH of the final solution was 6.39.

CARBOPOL polymer buffer

DI water was added to the glass jar, followed by triethanolamine and disodium hydrogen phosphate, and the components were mixed thoroughly to form a solution. CARBOPOL 974P NF was then added to the glass jar and mixed well to form a viscous solution. The detailed formulation of CARBOPOL polymer buffer is set forth in table 2 below, and the pH is measured at 7.0.

TABLE 2

Components	Mass (gram)	Mass%
			DI water	773	96.38
CARBOPOL 974PNF	8	1.00
			Triethanolamine	10	1.25
Na2HPO4	11	1.37
			Total of	802	100

Aligner aqueous liquid preparation

Various examples of aqueous liquids are set forth below. To prepare the liquid, the chemical components listed in the table below were added to a glass jar and mixed thoroughly to form a solution. The pH of the different solutions was measured with a pH meter and probe.

Aqueous liquids example 1

The formulation of aqueous liquid example 1 is shown in table 3 below.

TABLE 3

Components	Mass (gram)
		CARBOPOL Polymer buffer solution pH 7.0	49
Buffer pH 7.33	49
		Xylitol, its preparation method and use	1.95
Calcium dihydrogen phosphate hydrate	0.05
		Total of	100

The aqueous liquid example 1 had a pH of 7.11.

Aqueous liquid example 2

The formulation of aqueous liquid example 2 is shown in table 4 below.

TABLE 4

Components	Mass (gram)
		PEG3350	20
Buffer pH 6.40	30
		Xylitol, its preparation method and use	1
Calcium dihydrogen phosphate hydrate	0.025
		Total of	50

The pH of the aqueous liquid example 2 was 7.17.

Aqueous liquid example 3

The formulation of aqueous liquid example 3 is shown in table 5 below.

TABLE 5

Components	Mass (gram)
		KOLLIPHOR P407	10
Buffer pH 7.33	84.975
		Xylitol, its preparation method and use	5
Calcium dihydrogen phosphate hydrate	0.025
		Total of	100

The pH of the aqueous liquid example 3 was 7.33.

Aqueous liquids example 4

The formulation of aqueous liquid example 4 is shown in table 6 below.

TABLE 6

Components	Mass (gram)
		HFC Natrosol 250HHX pharm	0.8
Buffer pH 7.33	94.175
		Xylitol, its preparation method and use	5
Calcium dihydrogen phosphate hydrate	0.025
		Total of	100

The pH of the aqueous liquid example 4 was 7.25.

The aqueous liquid was inserted into a transparent dental aligner tray and mounted on orthodontic operation training mold models with and without solution. This solution reduces the appearance of occlusal edges and dark areas near the cusps, which makes the aligner tray less visible.

Detailed description of the preferred embodiments

Embodiment a. a system, comprising:

a dental appliance comprising a polymeric shell having a plurality of cavities for receiving one or more teeth; and

a biocompatible cosmetic aqueous liquid in the cavity of the polymeric shell of the dental appliance, the aqueous liquid comprising:

a viscosity modifier selected from the group consisting of water compatible polymers, polysaccharides, silica compounds, and mixtures and combinations thereof,

tooth remineralizing agent, and

the amount of water is controlled by the amount of water,

wherein the aqueous liquid is substantially free of tooth whitening agents and fluoride, and wherein the aqueous liquid has a refractive index greater than 1.3 at room temperature.

The system of embodiment a, wherein the polymeric shell is a polymeric material selected from the group consisting of: polyurethanes, polyesters, polyethylene terephthalate, glycol-modified polycyclohexanedimethanol terephthalate, poly (meth) acrylates, and mixtures and combinations thereof.

The system of embodiments a and B, wherein the refractive index of the aqueous liquid is greater than 1.33.

The system of embodiments a and B, wherein the refractive index of the aqueous liquid is greater than 1.34.

The system of any one of embodiments a-D, wherein the aqueous liquid has a pH of about 6.0 to about 8.0.

The system of any one of embodiments a-D, wherein the aqueous liquid has a pH of about 7.1 to about 7.35.

The system of any of embodiments a-F, wherein the polysaccharide is selected from the group consisting of ethyl cellulose, methyl cellulose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, xanthan gum, agarose, carrageenan, and mixtures and combinations thereof.

The system of embodiment G, wherein the polysaccharide is hydroxyethyl cellulose.

The system of embodiment G, wherein the polysaccharide is ethylcellulose.

The system of any one of embodiments a-I, wherein the water compatible polymer comprises a water soluble polymer.

The system of embodiment J, wherein the water soluble polymer is selected from the group consisting of polyacrylic acid and salts thereof, polyethylene glycol, ethylene oxide/propylene oxide copolymers, and mixtures and compositions thereof.

The system of any one of embodiments a-K, wherein the silica compound comprises fumed silica.

The system of any of embodiments a-L, wherein the composition comprises no greater than 3 wt.% of a silica-containing viscosity modifier.

The system of any one of embodiments a-M, wherein the aqueous liquid further comprises a buffer selected from the group consisting of phosphates, carbonates, citrates, and mixtures and compositions thereof.

The system of embodiment N, wherein the phosphate compound is Na₂HPO₄。

The system of any one of embodiments N and O, wherein the buffer further comprises a water-soluble polymer.

The system of any one of embodiments a-P, wherein the tooth remineralizing agent comprises a calcium compound.

The system of embodiment Q, wherein the calcium compound comprises calcium phosphate.

The system of any one of embodiments a-R, wherein the aqueous liquid further comprises a fragrance.

The system of embodiment S, wherein the fragrance is a polyol sugar alcohol.

The system of embodiment T, wherein the polyol sugar alcohol is selected from the group consisting of xylitol, erythritol, glycerol, sorbitol, and mixtures and combinations thereof.

The system of embodiment U, wherein the polyol sugar alcohol comprises xylitol.

The system of any one of embodiments a-V, wherein the aqueous liquid comprises a surfactant of formula I:

HOCH₂-(CHOH)_n-CH₂NR¹R² (I)

wherein R is¹And R²Independently selected from hydrogen atom, alkyl group, C (O) R³And SO₂R⁴；R³And R⁴Independently selected from alkyl groups, aryl groups and aralkyl groups;

and n is an integer from about 2 to about 5.

The system of embodiment W, wherein the surfactant of formula I is present in the aqueous liquid at no greater than 4 wt% based on the total weight of the composition.

The system of any of embodiments a-X, wherein the aqueous liquid further comprises a sweetener, a humectant, a mineral salt, a buffering component, a flavor, a preservative, or a combination thereof.

The system of any one of embodiments a-Y, wherein the aqueous liquid further comprises aloe vera, folic acid, hyaluronic acid, ceramide, arginine, betaine, or oxygenated triglyceride, vitamin E, vitamin B12, EDTA, cetylpyridinium chloride, chlorhexidine, other preservatives, or combinations thereof.

The system of any one of embodiments a-Z, wherein the aqueous liquid is sprayable.

Embodiment BB. the system of any one of embodiments a-Z, wherein the aqueous liquid prevents, inhibits or disrupts the formation or maintenance of a biofilm in the area in contact with the aqueous liquid, or has any combination of preventing, inhibiting and disrupting effects.

Embodiment CC a method of preventing, inhibiting or disrupting biofilm formation or maintenance in oral tissue or any combination thereof, comprising contacting oral tissue with an aqueous liquid according to any of embodiments a to CC.

Embodiment DD. the system of any one of embodiments a-BB wherein at least one cavity in the polymeric shell of the dental appliance is configured to adjust a tooth from a maloccluded position to a desired position.

Embodiment ee a system, comprising:

a dental appliance comprising a polymeric shell having a plurality of cavities for receiving one or more teeth, wherein the polymeric shell is a polymeric material selected from the group consisting of: polyurethanes, polyesters, polyethylene terephthalate, glycol-modified polycyclohexanedimethanol terephthalate, poly (meth) acrylates, and mixtures and combinations thereof; and

a biocompatible cosmetic aqueous liquid in at least some of the cavities of the polymeric shell of the dental appliance, the aqueous liquid comprising:

from about 0.1 parts by weight to about 60 parts by weight of a viscosity modifier selected from the group consisting of polysaccharides, water compatible polymers, silica compounds, and mixtures and combinations thereof;

about 40 to about 95 parts by weight of a buffer comprising a phosphate compound;

up to about 1 part by weight of a tooth remineralizing agent comprising a calcium compound; and

water;

wherein the aqueous liquid is substantially free of tooth whitening agents and fluoride, and wherein the refractive index of the aqueous liquid is greater than 1.3.

Embodiment FF. the system of embodiment EE, wherein the refractive index of the aqueous liquid is greater than 1.33.

Embodiment gg. the system of embodiment EE, wherein the refractive index of the aqueous liquid is greater than 1.34.

Embodiment HH. the system of any one of embodiments EE-GG, wherein the water compatible polymer is a water soluble polymer selected from the group consisting of: polyacrylic acid, polyethylene glycol, ethylene oxide/propylene oxide copolymers, and combinations thereof, and wherein the water soluble polymer is present in the aqueous liquid at about 0.5 parts by weight to about 60 parts by weight.

The system of any of embodiments EE-HH, wherein the silica compound comprises no greater than 3 weight percent of the viscosity modifier, the silica compound comprising fumed silica.

The system of any one of embodiments EE-II, wherein the aqueous liquid has a pH of about 6.0 to about 8.0.

Embodiment KK. the system of any one of embodiments EE-II, wherein the aqueous liquid has a pH of about 7.1 to about 7.35.

Embodiment LL. the system of any one of embodiments EE-to KK, wherein the aqueous liquid has a viscosity at 20 ℃ of about 0.001Pa s at a shear rate of 1/s to about 10Pa s at a shear rate of 1/s.

Embodiment MM. the system of any one of embodiments EE to LL, wherein the aqueous liquid further comprises from about 0.1 to about 10 parts by weight of a fragrance comprising a polyol sugar alcohol.

Embodiment NN. the system of any one of embodiment MM, wherein the polyol sugar alcohol comprises xylitol.

Embodiment OO. the system of any one of embodiments EE-to NN, wherein the calcium compound comprises calcium phosphate.

Embodiment PP. the system of any one of embodiments EE-to-OO, wherein the polymeric shell and the aqueous liquid transmit at least 60% of incident light having a wavelength of about 400-750 nm.

Embodiment QQ. the system of any one of embodiments EE to PP, wherein the aqueous liquid is substantially transparent to visible light having a wavelength of 400nm to 750 nm.

Embodiment RR. the system of any one of embodiments EE to QQ, wherein the aqueous liquid comprises no more than 4 wt.% based on the total weight of the composition of a surfactant of formula I:

HOCH₂-(CHOH)_n-CH₂NR¹R² (I)

wherein R is¹And R²Independently selected from hydrogen atom, alkyl group, C (O) R³And SO₂R⁴；R³And R⁴Independently selected from alkyl groups, aryl groups and aralkyl groups;

and n is an integer from about 2 to about 5.

Embodiment SS. the system of any one of embodiments EE-RR, wherein the aqueous liquid is sprayable.

Embodiment TT. the system of any one of embodiments EE to SS, wherein the aqueous liquid prevents, inhibits, or disrupts the formation or maintenance of a biofilm in a region that is in contact with the aqueous liquid, or has any combination of preventing, inhibiting, and disrupting effects.

A method of preventing, inhibiting or disrupting biofilm formation or maintenance in oral tissue or any combination thereof, comprising contacting oral tissue with an aqueous liquid according to any of embodiments EE to TT.

The system of any of embodiments EE-UU, wherein at least one cavity in the polymeric shell of the dental appliance is configured to adjust a tooth from a malocclusal position to a desired position.

Embodiment WW. A method wherein a tooth is inserted into a cavity in a polymeric shell of a dental appliance to adjust the tooth from an maloccluded position to a desired position, the method comprising administering a biocompatible cosmetic aqueous liquid comprising: a viscosity modifier selected from the group consisting of polysaccharides, water compatible polymers, silica compounds, and mixtures and combinations thereof; a tooth remineralizing agent; and water; wherein the aqueous liquid is substantially free of tooth whitening agents and fluoride, and wherein the refractive index of the aqueous liquid is greater than 1.3.

Embodiment XX. is the method of embodiment WW, wherein the refractive index of the aqueous liquid is greater than 1.33.

Embodiment YY. the method of embodiments WW and XX, wherein the water compatible polymer is a water soluble polymer selected from the group consisting of: polyacrylic acid, polyethylene glycol, ethylene oxide/propylene oxide copolymers, and combinations thereof, and wherein the water soluble polymer is present in the biocompatible aqueous liquid at about 0.5 parts by weight to about 60 parts by weight.

Embodiment ZZ. the method of any one of embodiments WW to YY, wherein the silica compound comprises fumed silica.

The method of any one of embodiments WW to ZZ, wherein the aqueous liquid has a pH of about 7.1 to about 7.35.

The method of any one of embodiments WW to AAA, wherein the aqueous liquid has a viscosity at 20 ℃ of about 0.001 Pa-s at a shear rate of 1/s to about 10 Pa-s at a shear rate of 1/s.

The method of any one of embodiments WW to BBB, wherein the aqueous liquid further comprises from about 0.1 to about 10 parts by weight of a flavorant comprising xylitol.

The method according to any one of embodiments WW to CCC, wherein the calcium compound comprises calcium phosphate.

The method of any of embodiments WW-DDD, wherein said polymeric shell and said aqueous liquid transmit at least 60% of incident light having a wavelength of about 400nm-750 nm.

The method of any one of embodiments WW to EEE, wherein the aqueous liquid is substantially transparent to visible light having a wavelength of 400nm to 750 nm.

The method according to any one of embodiments WW to FFF, wherein the aqueous liquid comprises not more than 4 wt. -%, based on the total weight of the composition, of a surfactant of formula I:

HOCH₂-(CHOH)_n-CH₂NR¹R² (I)

wherein R is¹And R²Independently selected from hydrogen atom, alkyl group, C (O) R³And SO₂R⁴；R³And R⁴Independently selected from alkyl groups, aryl groups and aralkyl groups;

and n is an integer from about 2 to about 5.

The method according to any one of embodiments WW to GGG, wherein the biocompatible aqueous liquid comprises:

from about 0.1 parts by weight to about 60 parts by weight of a viscosity modifier selected from the group consisting of polysaccharides, water-soluble polymers, water-dispersible polymers, fumed silicas, and mixtures and combinations thereof;

about 40 to about 95 parts by weight of a buffer comprising a phosphate compound;

up to about 1 part by weight of a tooth remineralizing agent comprising a calcium compound;

about 0.1 to about 10 parts by weight of a fragrance; and

and (3) water.

Embodiment iii. the method according to any one of embodiments WW to HHH, wherein the polymeric shell is a polymeric material selected from the group consisting of: polyethylene terephthalate, glycol-modified polycyclohexanedimethanol terephthalate, and mixtures and combinations thereof.

Embodiment jjj. a kit comprising:

a dental appliance comprising a polymeric shell having a plurality of cavities for receiving one or more teeth; and

a biocompatible cosmetic aqueous liquid comprising:

a viscosity modifier selected from the group consisting of polysaccharides, water compatible polymers, silica compounds, and mixtures and combinations thereof;

a tooth remineralizing agent; and

water;

wherein the aqueous liquid is substantially free of tooth whitening agents and fluoride, and wherein the refractive index of the aqueous liquid is greater than 1.3.

The kit of embodiment jjjj further comprising an applicator for applying the aqueous liquid to the dental appliance.

The kit of embodiments jjjj and KKK further comprising instructions for applying the aqueous liquid to the dental appliance.

The kit of any one of embodiments JJJ-LLL, further comprising a reclosable tray for holding the polymeric shell.

The kit of any one of embodiments JJJ to MMM, further comprising a dispenser for dispensing the aqueous liquid into the dental appliance.

Implementation ooo. the kit according to implementation NNN, wherein the dispenser is automated.

The kit of any one of embodiments JJJ to OOO, further comprising a cleaning composition for periodically cleaning the polymeric tray.

Embodiment qq. the kit of embodiment PPP, wherein the cleaning composition comprises a cleaning and disinfecting liquid.

The kit of embodiments PPP and QQQ, wherein the cleaning composition comprises a water-soluble solid tablet.

The kit of any one of embodiments JJJ to RRR, wherein the refractive index of the aqueous liquid is greater than 1.33.

The kit of any of embodiments JJJ to SSS, wherein the viscosity modifier is a water compatible polymer selected from: polyacrylic acid, polyethylene glycol, ethylene oxide/propylene oxide copolymers, and combinations thereof, and wherein the water soluble polymer is present in the biocompatible aqueous liquid at about 0.5 parts by weight to about 60 parts by weight.

The kit according to any one of embodiments JJJ to TTT, wherein the silica compound comprises fumed silica.

The kit according to any one of embodiments JJJ to UUU, wherein the aqueous liquid has a pH of from about 7.1 to about 7.35.

The kit according to any one of embodiments JJJ to VVV, wherein the aqueous liquid has a viscosity at 20 ℃ of about 0.001Pa s at a shear rate of 1/s to about 10Pa s at a shear rate of 1/s.

Embodiment xxx. the kit of any one of embodiments JJJ to WWW, wherein the calcium compound comprises calcium phosphate.

The kit of any one of embodiments JJJ-XXX, wherein the polymeric shell and the aqueous liquid transmit at least 60% of incident light having a wavelength of from about 400nm to 750 nm.

The kit of any one of embodiments JJJ to YYY, wherein the aqueous liquid is substantially transparent to visible light having a wavelength of 400nm to 750 nm.

The kit according to any one of embodiments JJJ to ZZZ, wherein the aqueous liquid comprises no more than 4 wt% of a surfactant of formula I, based on the total weight of the composition:

HOCH₂-(CHOH)_n-CH₂NR¹R² (I)

wherein R is¹And R²Independently selected from hydrogen atom, alkyl group, C (O) R³And SO₂R⁴；R³And R⁴Independently selected from alkyl groups, aryl groups and aralkyl groups;

and n is an integer from about 2 to about 5.

The kit of any one of embodiments JJJ to AAAA, wherein the aqueous liquid comprises:

from about 0.1 to about 60 parts by weight of a water-soluble polymer;

about 40 to about 95 parts by weight of a buffer comprising a phosphate compound;

up to about 1 part by weight of a tooth remineralizing agent comprising a calcium compound;

about 0.1 to about 10 parts by weight of a fragrance; and

and (3) water.

The kit of any one of embodiments JJJ to BBBB, wherein the polymeric shell is a polymeric material selected from the group consisting of: polyurethanes, polyesters, polyethylene terephthalate, glycol-modified polycyclohexanedimethanol terephthalate, poly (meth) acrylates, and mixtures and combinations thereof.

The kit of any one of claims JJJ to CCCC, wherein at least one cavity in the polymeric shell of the dental appliance is configured to adjust a tooth from an maloccluded position to a desired position.

Various embodiments of the present invention have been described. These and other embodiments are within the scope of the following claims.