Intraoral device, system, and method for oral care based digital imaging

Abstract

An intraoral device (10, 50, 70, 100) for use in systems and methods oral care based digital imaging is provided. The intraoral device (10, 50, 70, 100) includes a mouthpiece (12) and a shroud (28, 72). The mouthpiece includes a flange (16, 86, 102), and the shroud (28, 72) extends from the mouthpiece (12). The shroud (28, 72) defines a channel (34) extending between a distal opening (30) and a proximal opening (32). The intraoral device (10, 50, 70, 100) is not configured to couple to an image-capturing device. A system and a method are provided for oral care based digital imaging.

Description

[0001] INTRAORAL DEVICE, SYSTEM, AND METHOD FOR ORAL CARE BASED DIGITAL

[0002] IMAGING

[0003] TECHNOLOGICAL FIELD

[0004] The present technology relates to an intraoral device for use in systems and methods oral care based digital imaging. In particular, the present technology relates to a system and a method for oral care based digital imaging.

[0005] BACKGROUND

[0006] Typically, consumers visit a dental health professional two or fewer times a year. Thus, many consumers purchase oral care products to treat a variety of oral health conditions, such as stained teeth, gum irritation, tartar buildup, among other oral health conditions. However, it can be difficult for consumers to evaluate the effectiveness of the oral care product over a defined period of time by only casual visual observation.

[0007] Current systems of tracking performance, such as simply taking a self-photograph of one’s own oral cavity with a mobile phone, do not provide the consistency in photo location, room lighting, and / or photo quality that is required to effectively track an oral care regimen impact on the oral cavity and / or provide updated recommendations for improving oral health. Existing intraoral adaptors, which attempt to correct for this lack of consistency, are coupled to mobile phones during use and may be uncomfortable and complex to use.

[0008] Accordingly, there is a need for improved systems and methods for oral care based digital imaging.

[0009] BRIEF DESCRIPTION OF THE DRAWINGS

[0010] FIG. l is a perspective view of an intraoral device according to an embodiment.

[0011] FIG. 2 is a bottom perspective view of the intraoral device of FIG. 1.

[0012] FIG. 3 is a front view of the intraoral device of FIG. 1.

[0013] FIG. 4 is a top view of the intraoral device of FIG. 1.

[0014] FIG. 5 is a perspective view of an expandable intraoral device according to an embodiment.

[0015] FIG. 6 is a bottom perspective view of the expandable intraoral device of FIG. 5.

[0016] FIG. 7 is a front view of the expandable intraoral device of FIG. 5 in an expanded configuration. FIG. 8 is a front view of the expandable intraoral device of FIG. 5 in a collapsed configuration.

[0017] FIG. 9 is a top view of the expandable intraoral device of FIG. 5.

[0018] FIG. 10 is a front perspective view of an expandable intraoral device according to an embodiment.

[0019] FIG. 11 is a front perspective view of the expandable intraoral device of FIG. 10 in a collapsed configuration.

[0020] FIG. 12 is a perspective view of an intraoral device according to an embodiment.

[0021] FIG. 13 is a bottom perspective view of the intraoral device of FIG. 12.

[0022] FIG. 14 is a front view of the intraoral device of FIG. 12.

[0023] FIG. 15 is a top view of the intraoral device of FIG. 12.

[0024] FIG. 16 is a perspective view of an example calibration chart.

[0025] FIG. 17 is a top view of the expandable intraoral device of FIG. 5 positioned against a mobile phone.

[0026] DETAILED DESCRIPTION

[0027] Embodiments of the present invention relate to an intraoral device and related systems and methods for evaluating one oral health condition of at least one person depicted in a digital image. The user may position the intraoral device inside the oral cavity (e.g., with the lips around the intraoral device) and, without coupling the intraoral device to an image-capturing device, capture a digital image. The digital image may be an oral cavity image of a person that may comprise one or more oral cavity features, which may include mouth, teeth, gum, gingiva, tongue, cheek, or combinations thereof. Capturing the digital image without coupling the intraoral device to the image-capturing device allows for greater accessibility. Otherwise, the intraoral device may not be compatible with certain image-capturing devices depending on dimensions or other features.

[0028] As described herein, a user can use the disclosed intraoral device, systems, and methods to diagnose certain oral health conditions with or without the guided help of a dental health professional, and / or track and / or evaluate the effectiveness of an oral care product and / or regimen of oral care products using digital images of the oral cavity or manipulated images of the oral cavity to more clearly show the changes in certain attributes of the oral cavity to the user.

[0029] Oral health conditions that can be diagnosed and treated with the disclosed methods, apparatus, and systems include, without limitation, the whiteness / yellowness of teeth, gum recission, periodontal disease, appearance of dental plaque, tartar build up, caries, erosion, and / or combinations thereof.

[0030] Definitions

[0031] "Person", as used herein, means a human being depicted in a digital image.

[0032] "Oral cavity feature", as used herein, is an element of the mouth and may include but is not limited to oral cavity soft tissue, gums, teeth, including, for example, as determined or detected by the pixel data or otherwise pixels of one or more corresponding digital image(s).

[0033] "Oral health condition", as used herein, means all cosmetic dental attributes that provide an oral health effect on an area of the oral cavity or impact appearance and / or feel thereof. Some non-limiting examples of a cosmetic dental attribute may include gum inflammation / redness, gum firmness, gum bleeding, gum sensitivity, yellowness, lightness, front surface staining, interproximal (IP) staining in between adjacent teeth, marginal staining (around the gum line), opacity, shine, interproximal plaque, surface plaque, a misaligned tooth, or a missing tooth.

[0034] "Convolutional neural network", as used herein, refers to a type of feed-forward artificial neural network where the individual neurons are tiled in such a way that they respond to overlapping regions in the visual field.

[0035] "Oral care product", as used herein, refers to a product that includes an oral care active or regulates and / or improves a cosmetic dental attribute condition. An oral care product may include but is not limited to, toothpaste, mouth rinse, dental floss, whitening strips, gel, emulsion, brushes (manual or power), new oral care implements like mouth guards or the like.

[0036] "Digital image", as used herein, refers to a digital image formed by pixels in an imaging system including but not limited to standard RGB, or the like and under images obtained under different lighting conditions and / or modes. Non-limiting examples of a digital image include color images (RGB), monochrome images, video, multispectral image, hyperspectral image or the like. Non-limiting light conditions include white light, blue light, UV light, IR light, light in a specific wavelength, such as for example light source emitting lights from 100 to 1000 nm, from 300 to 700 nm, from 400 to 700 nm or different combinations of the upper and lower limits described above or combinations of any integer in the ranges listed above. Common wide spectral band light together with the hyperspectral camera. These Digital images can be taken by standard consumer smart phones. A digital image may be a single photograph or a single frame in a series of frames defining a video. "Image obtaining device", as used herein, refers to a device configured for obtaining images, including but not limited to a digital camera (standalone or part of a mobile phone), a photo scanner, a computer readable storage medium capable of storing digital images, and any electronic device including picture taking capabilities.

[0037] "User", as used herein, refers to a person who uses at least the features provided herein, including, for example, a device user, a product user, a system user, and the like.

[0038] "Treat" or "Treating", as used herein, refers to providing a product recommendation, customized instructions, use of a recommended product for improving oral health conditions of a subject depicted in a digital image. The subject is a person.

[0039] Intraoral Device

[0040] Disclosed herein is an intraoral device. In use, the intraoral device can provide a view of the oral cavity of a subject. An image-capturing device can be used to capture an image of at least a portion of the oral cavity of the subject without being coupled to the intraoral device. Thus, the intraoral device is not configured to be coupled with an image-capturing device. For example, the intraoral device does not include a strap or band, adhesive, clip, clamp, magnet, hook, bracket, holder, hook-and-loop tape, or other corresponding feature that would removably or permanently couple the intraoral device to an image-capturing device (e.g., a mobile phone). Instead, in some embodiments, the intraoral device may be spaced apart from the image-capturing device during use. In other example embodiments, the intraoral device may abut the image-capturing device during use. For example, a user may hold the intraoral device and image-capturing device against each other. Generally, the intraoral device may be considered a hands-free device in use, but the image capturing device is held by the user or an independent support.

[0041] Referring to FIGS. 1-4, in an embodiment, an intraoral device 10 is shown. The intraoral device 10 includes a mouthpiece 12 and a platform 14. The mouthpiece 12 may be considered a distal end of the intraoral device 10, and the platform 14 may be considered the proximal end of the intraoral device 10. The mouthpiece 12 may include a flange 16 configured to be inserted into the user's mouth such that the flange is located between the user's lips and the teeth or gums. The flange 16 may be curved (e.g., to correspond to the dental arch of a user). For example, the left and right sides of the flange 16 may be distal of the front and back sides of the flange 16. In use, the user may place their lips around the flange 16. The mouth interface 12 may also include one or more bite wings 18. The distal end of the bite wings 18 may extend distally of the flange 16. The proximal end of the bite wings 18 may extend to the flange 16 or may be proximal of the flange 16. The bite wings 18 may be substantially parallel or may be inclined relative to each other. The distal end of the bite wings 18 may be rounded.

[0042] The platform 14 may include an upper surface 20, a lower surface 22, and a sidewall 24 extending between the upper and lower surfaces 20, 22. The upper surface 20 may include a depression 26 or other tactile indicator. The user may position a finger against the depression 26 when holding the intraoral device 10 against the image-capturing device. The lower surface 22 may be configured to abut the image-capturing device. The lower surface 22 may be flat. The cross-section of the platform 14 may vary and may be, for example, a rectangle (with straight or rounded comers), an oval, a circle, a pill (or a stadium), etc.

[0043] The intraoral device 10 may include a shroud 28 extending from the mouth interface 12 to the platform 14. For example, the shroud 28 may extend between the flange 16 and the upper surface 20 of the platform 14. The shroud 28 may define a distal opening 30, a proximal opening 32, and a channel 34 extending therebetween. The flange 16 may extend axially away from the distal opening 30. The axial distance of the flange 16 from the distal opening 30 may vary. For example, the axial distance of the flange 16 at the left and right sides of the flange may be greater than the axial distance at the front and back of the flange 16. The proximal opening 32 may be coplanar with the lower surface 22 of the platform 14. The distance of the sidewall 24 of the platform 14 from the proximal opening 32 may vary. For example, as shown in FIG. 2, one side (e.g., a right side) of the platform 14 may extend further from the proximal opening 32.

[0044] The channel 34 may be defined be a sidewall 36 of the shroud 28. The sidewall 36 may be straight or tapered. For example, the sidewall 36 may have a first, proximal width (e.g., adjacent the proximal opening 32) that is wider than a second, distal width (e.g., adjacent the distal opening 30). The cross-sectional shape of the shroud 28 may vary and may be, for example, a rectangle (with straight or rounded corners), an oval, a circle, a pill (or a stadium), etc. The cross- sectional shape of the shroud 28 may vary along a height thereof or may be fixed. In an embodiment, the distal opening 30 may be pill-shaped, and the proximal opening 32 may have the shape of a rounded rectangle. Further, the distal opening 30 may be curved (e.g., to correspond to the dental arch of a user), while the proximal opening 32 may be flat. The proximal opening 32 may assist in aligning the image-capturing device with the intraoral device 10. For example, some mobile phones include a raised wall around the camera lenses. The proximal opening 32 may be sized to fit around the camera features of the image-capturing device. Thus, in use, a portion of the image-capturing device may extend into the channel 34 of the intraoral device 10. In various embodiments, the intraoral device 10 may include a feature to assist in calibrating the digital image. For example, the intraoral device 10 may include one or more calibration charts, such as a color calibration chart, a translucence calibration chart, a scale calibration, or a combination thereof. The calibration chart may make it possible, for each digital image, to correct errors in colors by their hue or shade of color and luminance, intensity, or overall brightness. Such errors may be specific to each image-capturing device. Additionally, the calibration chart enhances the determination of the exact colors and translucence of features of the oral cavity, such as the teeth or gums. The calibration chart may be coupled to or integral with the intraoral device. An example calibration chart 35 is shown in FIG. 16.

[0045] In various embodiments, the calibration chart may be positioned within the channel 34 of the shroud 28. Referring to FIGS. 1 and 4, the sidewall 36 of the shroud 28 may include an inner surface 38 and an outer surface 40. One or more protrusions 42 may extend inwardly from the inner surface 38 of the sidewall 36. The calibration chart may be positioned on the distal surface of the protrusion 42 such that the calibration chart is captured in the digital image along with the oral cavity of the user. For example, as shown in FIG. 4, two protrusions 42 are positioned at a left and right side of the channel 42. The protrusion 42 may extend around a perimeter of the channel 34 (FIGS. 10-13) or may be discontinuous (FIG. 4). The protrusions may have an angled edge (FIG. 4) or curved edge (FIG. 9). An inner edge of the bite wings 18 may extend from the protrusions 42.

[0046] Referring now to FIGS. 5-9, in an embodiment, an expandable intraoral device 50 is shown. The intraoral device 50 is configured to transition between an expanded configuration (FIG. 7) and a collapsed configuration (FIG. 8). The collapsed configuration allows for easier storage and shipping of the intraoral device 50. The intraoral device 50 may include one or more living hinges to allow for the intraoral device 50 to be collapsed and expanded. The living hinge(s) may be between sections or tiers of the shroud 28. For example, the shroud 28 may include a first, proximal living hinge 52 and a second, distal living hinge 54. The should 28 may include a proximal section 56 extending from the proximal opening 32, a distal section 58 extending from the distal opening 30, and a middle section 60. The proximal and middle sections 56, 60 are separated by the first living hinge 52, and the distal and middle sections 58, 60 are separated by the second living hinge 54. Depending on the number of living hinges, the shroud may include no middle section or more than one middle section.

[0047] In an embodiment, the distal, middle, and proximal sections may be generally tapered. For example, the distal section may have a smaller cross-sectional area than the middle section, and the middle section may have a smaller cross-sectional area than the proximal section. In the collapsed configuration, as shown in FIG. 8, the distal section 58 is positioned within the middle section 60, and the middle section 60 is positioned within the proximal section 56. Additionally, in the collapsed configuration, the flange 16 may remain distal of the proximal section 56. Where more than one living hinge is present, the intraoral device 50 may have more than one collapsed configuration. For example, if living hinge 52 is collapsed but living hinge 54 is not, the intraoral device 50 may be in a first collapsed configuration. When both living hinges 52, 54 are collapsed, the intraoral device 50 may be in a second configuration. This provides multiple possible configurations that may improve compatibility for different image-capturing devices. For example, different lenses may have different focal lengths, and the distance between the mouthpiece 12 and the proximal opening 32 can be chosen based on the focal length of the respective lens.

[0048] With reference to FIGS. 10 and 11, in an embodiment, an expandable intraoral device 70 is shown. The intraoral device 70 includes a shroud 72 with more than one type of living hinge. The intraoral device 70 includes a proximal indented living hinge 74 and distal indented living hinge 76. The intraoral device 70 also includes a proximal continuous living hinge 78 and a distal continuous living hinge 80. The outer surface 40 of the shroud 28 is discontinuous at the indented living hinges 74, 76, while the outer surface 40 may be continuous at the living hinges 78, 80. In other words, the continuous living hinges 78, 80 may allow for a smooth transition from one section to another. The proximal indented living hinge 74 may separate a proximal section 82 and a middle section 84. The distal indented living hinge 76 may separate the middle section 84 and a distal section 86. The sections may be partitioned by a living hinge. For example, the middle section 84 includes an upper tier 88 and lower tier 90 separated by the proximal continuous living hinge 78. The distal section 86 may include an upper tier 92 and lower tier 94 separated by the distal continuous living hinge 80. The upper and lower tiers may taper inwardly towards the continuous living hinge. When collapsed, the indented living hinges 74, 76 form a sharp edge, as shown in FIG. 11. In comparison, the continuous living hinges 78, 80 may form a rounded edge like the edge formed by the living hinges 52, 54 as shown in FIG. 8. The shroud 72 may have a zigzag shape. For example, the cross-sectional area of the proximal continuous living hinge 78 may be less than the cross-sectional area of one or both of the indented living hinges 74, 76. The cross-sectional area of the distal continuous living hinge 80 may be less than that of the proximal continuous living hinge 78. In the fully collapsed configuration shown in FIG. 11, the flange 86 may be partially proximal of and partially distal of the proximal indented living hinge 74. The living hinges may be formed using a flexible material, such as silicone. The thickness of the shroud may vary. For example, the thickness of the shroud at the living hinge may be smaller than the thickness of one or more of the proximal, distal, and middle sections. The cross- sectional shape of the living hinges and the shroud sections may vary and may be, for example, a rectangle (with straight or rounded corners), an oval, a circle, a pill (or a stadium), etc. As shown in FIG. 5, in an embodiment, the living hinges 52, 54 may have a cross-section of a rounded rectangle.

[0049] Referring now to FIGS. 12-15, in an embodiment, an intraoral device 100 is shown. The intraoral device 100 is configured to be spaced apart from the image-capturing device during use. Accordingly, the shroud 28 of the intraoral device 100 is shorter than the shroud 28 of the intraoral devices 10, 50. The intraoral device 100 may, in an embodiment, not include a platform. The intraoral device 100 may include a proximal flange 102 extending radially outward from the proximal opening 32. The proximal flange 102 may be curved. The curves of the flange 16 and the proximal flange 102 may be the same or may be different. As shown in FIG. 14, in an embodiment, the radius of curvature of the proximal flange 102 may be greater than that of the flange 16. As described above, the protrusion 42 may extend continuously around the inner perimeter of the channel 34.

[0050] In use, biting on the intraoral device (e.g., the bite wings) can keep it in place comfortably during use. Further, the bite wings function to keep the upper and lower teeth at a fixed distance from each other, which can allow for a more precise imaging for lower teeth. Further, the bite wings may keep people from pushing their tongue against teeth to help keep the intraoral device in place. In another embodiment, the imaging can also be completed without using the bite wings. For example, capturing a lingual image may require the user to open their mouth. Also, it may be important for the person to manually rotate the intraoral device to capture different parts of the oral cavity.

[0051] The dimensions of the intraoral device may vary. In various embodiments, a height of the intraoral device may be in a range of about 30 mm to about 200 mm, from about 30 mm to about 50 mm, from about 35 mm to about 40 mm, from about 100 mm to about 150 mm, from about 100 mm to about 120 mm, or may be about 38 mm or about 110 mm. The width of the intraoral device may vary. For example, the width or the greatest width of an intraoral device with a platform may be from about 50 mm to about 120 mm, from about 90 mm to about 110 mm, or may be about 99 mm. The depth of the intraoral device may be from about 30 mm to about 100 mm, from about 30 mm to about 50 mm, or from about 60 mm to about 80 mm, or may be about 40 mm or about 69 mm. Additionally, the dimensions of the proximal and distal openings may vary. For example, the length of the distal opening may be, for example, in a range of from about 20 mm to about 45 mm, about 25 mm to about 35 mm, about 30 mm to about 35 mm, or about 32 mm. The width of the distal opening may be, for example, in a range of from about 30 mm to about 60 mm, about 40 mm to about 60 mm, about 45 mm to about 55 mm, or about 42 mm or about 49 mm.

[0052] The material of the intraoral adaptor may vary. In an embodiment, the intraoral adaptor may include more than one material. For example, the material of the mouthpiece (e.g., the bite wings and flange) may be softer than the material for the platform. The material may be, for example, a plastic, a rubber, or a combination thereof. An example material is silicone or a thermoplastic elastomer.

[0053] System

[0054] Disclosed herein is a system including an intraoral device, as described herein, and an image-capturing device. The system may be used by a user having a certain oral health condition. The intraoral device can be paired with a computer-based application to help a user evaluate or diagnose at least one oral health condition and / or track and / or evaluate the effectiveness of an oral care product and / or regimen of oral care products. An example computer-based application is described in WIPO WO 2021 / 236616, which is herein incorporated by reference in its entirety. The system may also include one or more oral care products.

[0055] Methods of use of the intraoral device in combination with an image-capturing device and, optionally, a computer-based application are also described herein.

[0056] Referring to FIG. 17, a system 150 may include an intraoral device, such as intraoral device 50, and an image-capturing device 152, such as a mobile phone, having a lens 154. The method may include a user positioning their lips around the flange 16 (or, if no flange is present, around a distal end of the shroud 28). To keep the intraoral device in place, the method may include the user biting on the bite wings 18. Before or after positioning their lips around the intraoral device, the method may include aligning the image-capturing device such that the lens is positioned to capture the channel 34. In an embodiment, the method may include holding the image-capturing device against the intraoral device while capturing an image. This may prevent light from the exterior of the shroud 28 from entering the channel 34 through the proximal opening 32. In another embodiment, the image-capturing device may remain spaced apart from the intraoral device (e.g., intraoral device 100) during use. Thus, the method may include holding the image- capturing device away from the image capturing device while capturing an image. The user may capture a digital image of their oral cavity through the channel 34. The digital image may also include the calibration chart. The method may include repositioning the intraoral device to capture a second image of a different portion of the oral cavity.

[0057] Oral Health Conditions

[0058] The system, as disclosed herein, can be configured to detect, diagnose, and / or identify certain oral health conditions. Suitable oral health conditions that can be detected, diagnosed, and / or identified through use of the intraoral device, described herein, include gum inflammation / redness, gum firmness, gum bleeding, gum sensitivity, yellowness, lightness, front surface staining, interproximal (IP) staining in between adjacent teeth, marginal staining (around the gum line), opacity, shine, interproximal plaque, surface plaque, misalignment, missing teeth, and / or combinations thereof.

[0059] In particular, disclosed herein, are methods to detect, diagnose, and / or identify certain oral health conditions that can be treated or improved by oral care products. Suitable oral health conditions include stained teeth and / or teeth that are not of the desired shade of white, accumulation of plaque and / or tartar, gingivitis, gum irritation, and / or gum bleeding, gum recission, tooth and / or gum sensitivity, caries in at least one tooth, and / or combinations thereof. Alignment of teeth in the oral cavity can be another oral health condition that can be improved.

[0060] Additionally, the intraoral device and associated systems and methods can be used to track and evaluate an oral care product and / or oral care product regimen that is applied by a user to improve the oral health condition of interest.

[0061] For example, a user may be interested in changing the shade of white of their teeth, such as through the application of an oral care product comprising a whitening agent. The intraoral device and associated disclosed methods can be used to track progress in whitening or bleaching their teeth.

[0062] Method to Evaluate Oral Care Product Effectiveness

[0063] Oral care digital imaging computer-implemented methods are described in U.S. Patent Application Publication No. 2023 / 0215009, which is herein incorporated by reference in its entirety.

[0064] Disclosed herein is an oral care digital imaging computer-implemented method to evaluate the effectiveness of an oral care product and / or oral care regimen on improving the oral health condition in the oral cavity of a user. It can be difficult for consumers to evaluate the effectiveness of the oral care product over a defined period of time by only casual visual observation. Thus, the disclosed method can help a user recognize the improvement of the oral health condition over a period of time.

[0065] The user can obtain a first digital image at a first or initial time. The first digital image can be defined by pixel data. The user can be instructed to insert an intraoral device into their mouth without coupling the intraoral device to an image-capturing device. For example, the user can be instructed to place their lips over a flange of the intraoral device. The image-capturing device may be positioned such that a clear line of sight is available from a lens of the imagecapturing device to the oral cavity of the user (i.e., through the intraoral device). The user can then operate the image-capturing device to obtain a first digital image. The user may be instructed to hold the image-capturing device against the intraoral device while obtaining the first digital image. This temporary abutment of the image-capturing device and intraoral device is not considered coupling the image-capturing device and intraoral device. In that regard, the intraoral device and image-capturing device would fall apart from each other without the user holding them together. Further, an orientation where one device is resting atop the other is not considered coupling as, for example, a plate is not coupled to the table on which it merely rests.

[0066] The first digital image can be used to identify an oral health condition. The oral health condition can be identified virtually by a dental health professional by providing the dental health professional with the first digital image. The dental health professional can then provide a remote diagnosis of the oral health condition, such as described in U.S. Patent Application Publication No. 2021 / 0282634. The oral health condition can also be identified automatically through various other algorithms, such as those described in WIPO WO 2021 / 236616. The oral health condition may be assigned a value, such as a level, and / or location, which may be displayed to the user. The user can be directed to apply a particular oral care product that is expected to improve the oral health condition or an oral care product that has been recommended by a dental health professional or the computer-based application to improve the oral health condition.

[0067] The user can then obtain a second digital image at a second time. The second digital image can be defined by pixel data. To be able to discern a difference in the oral health condition between the first time and the second, the user can wait a defined period of time, such as at least about 24 hours, at least about 1 day, at least about 3 days, at least about 7 days, at least about 14 days, at least about 30 days, or at least about 1 month from the first time to the second time.

[0068] The user can then be presented in a graphical user interface a first digital image or a modified first digital image and a second digital image or a modified second digital image. Additional digital images, such as third, fourth, fifth, sixth, etc. digital image, can be provided by the user. The user can be periodically reminded through in-application reminders or push notifications to periodically obtain a subsequent digital image. Obtaining additional digital images can allow the user to continually track progress and / or allow the application to track compliance with the oral care regimen.

[0069] Oral Care Product

[0070] Oral care products that can be used in association with the disclosed methods and system include one or more active agents that can treat a desired oral health condition. Suitable active agents include whitening agents, anticaries agent, gum health compound, antiplaque agent, anti sensitivity agent, and / or combinations thereof. A particular compound can fall within more than one category. For example, stannous fluoride can fall within "anticaries agent", "gum health compound", and / or "anti sensitivity agent." The active agent can also include other inactive ingredients.

[0071] The oral care product can also include implements or devices to mechanically or physically treat the oral health conditions, such as a manual and / or electric toothbrush, floss, floss picks, and the like.

[0072] Whitening Agent

[0073] The oral care product may comprise from about 0.1% to about 10%, from about 0.2% to about 5%, from about 1% to about 5%, or from about 1% to about 15%, by weight of the oral care product, of whitening agent.

[0074] The whitening agent can be a compound suitable for whitening at least one tooth in the oral cavity. The whitening agent may include peroxides, metal chlorites, perborates, percarbonates, peroxyacids, persulfates, dicarboxylic acids, as described herein, and / or combinations thereof. Suitable peroxides include solid peroxides, hydrogen peroxide, urea peroxide, polyvinylpyrrolidone peroxide complex, cross-linked polyvinylpyrrolidone peroxide complex, calcium peroxide, benzoyl peroxide, sodium peroxide, barium peroxide, inorganic peroxides, hydroperoxides, organic peroxides, and mixtures thereof. Suitable metal chlorites include calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, and potassium chlorite. Other suitable whitening agents include sodium persulfate, potassium persulfate, peroxydone, 6-phthalimido peroxy hexanoic acid, Pthalamidoperoxycaproic acid, dicarboxylic acids, such as oxalic acid, malonic acid, methylmalonic acid, or mixtures thereof. The whitening agent can comprise dicarboxylic acid. The dicarboxylic acid comprises a compound with two carboxylic acid functional groups. The dicarboxylic acid can comprise a compound or salt thereof defined by Formula I.

[0075] Formula I. Dicarboxylic acid

[0076] R can be null, alkyl, alkenyl, allyl, phenyl, benzyl, aliphatic, aromatic, polyethylene glycol, polymer, O, N, P, and / or combinations thereof.

[0077] The dicarboxylic acid can comprise oxalic acid, malonic acid, succinic acid, glutaric acid, adipic acid, pimelic acid, suberic acid, azerlaic acid, sebacic acid, undecanedioic acid, dodecanedioic acid, brassylic acid, thapsic acid, japanic acid, phellogenic acid, equisetolic acid, malic acid, maleic acid, tartaric acid, phthalic acid, methylmalonic acid, dimethylmalonic acid, tartronic acid, mesoxalic acid, dihydroxymalonic acid, fumaric acid, terephthalic acid, glutaric acid, salts thereof, or combinations thereof. The dicarboxylic acid can comprise suitable salts of dicarboxylic acid, such as, for example, monoalkali metal oxalate, dialkali metal oxalate, monopotassium monohydrogen oxalate, dipotassium oxalate, monosodium monohydrogen oxalate, disodium oxalate, titanium oxalate, and / or other metal salts of oxalate. The dicarboxylic acid can also include hydrates of the dicarboxylic acid and / or a hydrate of a salt of the dicarboxylic acid.

[0078] The oral care product can comprise from about 0.01% to about 10%, from about 0.1% to about 15%, from about 1% to about 5%, or from about 0.0001 to about 25%, by weight of the oral care product, of dicarboxylic acid.

[0079] Anticaries Agent

[0080] The oral care product can include an anticaries agent in a therapeutic or subtherapeutic dose, such as described in U.S. Patent Application Publication No. 2021 / 0093528, which is herein incorporated by reference in its entirety. The anticaries agent can be active against caries through one of these four mechanisms: i) suppressing acid formation via antibacterial action; ii) reducing enamel solubility through a calcium co-ion effect; iii) reducing enamel solubility through a fluoride co-ion effect; and iv) reducing enamel solubility through surface adsorbed stabilizers. Thus, the anticaries agent can be an antibacterial agent, a calcium ion source, a fluoride ion source, a surface adsorbed stabilizer. However, a compound can fall within more than one of these categories, such as, for example, stannous chloride, which can be an antibacterial agent and a surface adsorbed stabilizer or stannous fluoride, which can be an antibacterial agent, a fluoride ion source, and a surface adsorbed stabilizer.

[0081] Suitable antibacterial agents include hops acids, such as hops alpha acids, hops beta acids, hydrogenated hops acids, and / or combinations thereof. Suitable hops beta acids can include lupulone, adlupulone, colupulone, and / or mixtures thereof. Other suitable antibacterial agents include metal ion sources, such as tin ion sources, zinc ion sources, copper ion sources, and / or combinations thereof. Other suitable antibacterial agents include triclosan, extracts from any species within the genus Magnolia, extracts from any species within the genus Humulus. Other suitable antibacterial agents include hops acids, tin ion sources, benzyl alcohol, sodium benzoate, menthylglycyl acetate, menthyl lactate, L-menthol, o-neomenthol, chlorophyllin copper complex, phenol, oxyquinoline, and / or combinations thereof. Other suitable antibacterial agents include one or more amino acids, such as basic amino acids. The oral care product can comprise from about 0.01% to about 10%, from about 1% to about 5%, or from about 0.5% to about 15% of an antibacterial agent.

[0082] Suitable surface adsorbed stabilizers include metal ion sources, such as tin ion sources, zinc ion sources, copper ion sources, aluminum ion sources, titanium ion sources and / or combinations thereof. Other suitable surface adsorbed stabilizers include bioactive materials, amino acids, and / or combinations thereof.

[0083] The oral care product can comprise fluoride. Fluoride can be provided by a fluoride ion source. The fluoride can comprise one or more fluoride containing compounds, such as stannous fluoride, sodium fluoride, titanium fluoride, calcium fluoride, calcium phosphate silicate fluoride, potassium fluoride, amine fluoride, sodium monofluorophosphate, zinc fluoride, and / or mixtures thereof. The oral care product can comprise a fluoride ion source capable of providing from about 50 ppm to about 5000 ppm, and preferably from about 500 ppm to about 3000 ppm of free fluoride ions. To deliver the desired amount of fluoride ions, the fluoride ion source may be present in the oral care producr at an amount of from about 0.0025% to about 5%, from about 0.01% to about 10%, from about 0.2% to about 1%, from about 0.5% to about 1.5%, or from about 0.3% to about 0.6%, by weight of the oral care composition.

[0084] The oral care product of the present invention can comprise calcium, such as from a calcium ion source. The calcium ion source can be any suitable compound or molecule that can provide calcium ions in an oral care composition and / or deliver calcium ions to the oral cavity when the oral care composition is applied to the oral cavity. The calcium ion source can comprise a calcium salt, a calcium abrasive, and / or combinations thereof. In some cases, a calcium salt may also be considered a calcium abrasive or a calcium abrasive may also be considered a calcium salt.

[0085] The calcium ion source can comprise a calcium abrasive. The calcium abrasive can be any suitable abrasive compound that can provide calcium ions in an oral care composition and / or deliver calcium ions to the oral cavity when the oral care composition is applied to the oral cavity. The calcium abrasive can comprise one or more calcium abrasive compounds, such as calcium carbonate, precipitated calcium carbonate (PCC), ground calcium carbonate (GCC), chalk, dicalcium phosphate, calcium pyrophosphate, and / or mixtures thereof.

[0086] The calcium ion source can comprise a calcium salt, or a compound that can provide calcium ions in an oral care composition and / or deliver calcium ions to the oral cavity when the oral care composition is applied to the oral cavity that can not act as an abrasive. The calcium salt can comprise one or more calcium compounds, such as calcium chloride, calcium nitrate, calcium phosphate, calcium lactate, calcium oxalate, calcium oxide, calcium gluconate, calcium citrate, calcium bromide, calcium iodate, calcium iodide, hydroxyapatite, fluorapatite, calcium sulfate, calcium glycerophosphate, and / or combinations thereof.

[0087] The oral care product can comprise from about 5% to about 70%, from about 10% to about 50%, from about 10% to about 60%, from about 20% to about 50%, from about 25% to about 40%, or from about 1% to about 50% of a calcium ion source.

[0088] Gum Health Compound

[0089] The active agent can comprise a gum health compound. The gum health can decrease gum irritation, prevent gingival recession, stop gingival recession, reverse gingival recession, decrease gum recession, increase gingival barrier protection, promote collagen synthesis, promote extracellular matrix synthesis, increase gum resilience protection, increase epidermal thickness and / or promote fibrillin synthesis, and / or combinations thereof in an oral cavity of a user.

[0090] Suitable gum health compounds include metal ion source, vitamin, such as retinoid compound, gum strengthening polyol, or combinations thereof.

[0091] As used herein, "vitamin" includes all natural and / or synthetic analogs of vitamins, vitamers, compounds and / or derivatives that exhibit the biologically activity of vitamins, isomers of these compounds, stereoisomers of these compounds, salts of these compounds, or combinations thereof.

[0092] Suitable vitamins for gum health can include Vitamin A, such as retinoid compound, Vitamin B, including Vitamin Bl (thiamine), Vitamin B2 (riboflavin), Vitamin B3 (niacin), Vitamin B5 (pantothenic acid), Vitamin B6, Vitamin B7 (biotin), Vitamin B9 (folic acid and / or folate), Vitamin B12 (cyanocobalamin), Vitamin C, Vitamin D, Vitamin E, Vitamin K, and / or combinations thereof. Vitamins can also include other vitamin-like compounds, such as choline, carnitine, or combinations thereof. The oral care product can comprise from about 0.0001% to about 10%, from about 0.01% to about 5%, or from about 0.01% to about 2%, by weight of the composition, of vitamin.

[0093] The gum health compound can comprise one or more retinoid compounds. As used herein, "retinoid compound" includes all natural and / or synthetic analogs of Vitamin A or retinol-like compounds that possess the biological activity of Vitamin A in the skin as well as the geometric isomers and stereoisomers of these compounds. The retinoid compound can, for example, be retinol, retinyl esters (e.g., C-C alkyl esters of retinol, including retinyl palmitate, retinyl acetate, retinyl propionate), retinal, and / or retinoic acid (including all-trans retinoic acid and / or 13-cis- retinoic acid). In some embodiments, retinoids other than retinoic acid are used. These compounds are available in the art and are commercially available from several sources, e.g., Sigma Chemical Company (St. Louis, Mo.), and Boehringer Mannheim (Indianapolis, Ind.). Other suitable retinoids are tocopheryl -retinoate, tocopherol ester of cis- or trans-retinoic acid, adapalene (6-3-(l-adamantyl)- 4-methoxyphenyl-2-naphthoic acid), and tazarotene (ethyl 6-2- (4.4-dimethylthiochroman-6-yl)-ethynylnicotinate). Desirable retinoids include retinol, retinoic acid, retinyl palmitate, retinyl acetate, retinyl propionate, retinal, and combinations thereof.

[0094] The retinoid compound may be included as the substantially pure material, or as an extract obtained by suitable physical and / or chemical isolation from natural (e.g., plant) sources. The retinoid compound can be substantially pure, or essentially pure. The compositions of this invention may contain a safe and effective amount of the retinoid compound, such that the oral care product is safe and effective for regulating or improving the condition of keratinous tissues and accidental ingestion since applied to the oral cavity.

[0095] The retinoid compound can comprise retinol, retinyl ester, retinal, retinoic acid, tocopheryl -retinoate, tocopherol ester of cis- or / ra / z.s-retinoic acid, isotretinoin, alitretinoin, etretinate, acitretin, adapalene, bexarotene, tazarotene, or combinations thereof. The retinoid compound can be pharmaceutical grade, USP, or the like grade, due to use in the oral cavity. The retinoid compound and / or the retinol can have a purity of at least about 95%, at least about 97%, at least about 99%, at least about 99.5%, or at least about 99.9%. The oral care product can comprise from about 0.0001% to about 10%, from about 0.01% to about 5%, or from about 0.01% to about 2%, by weight of the composition, of retinoid compound. The oral care composition can comprise from about 1 ppm to about 10,000 ppm, from about 500 ppm to about 5000 ppm, from about 750 ppm to about 5000 ppm, from about 1000 ppm to about 2500 ppm, about 1500 ppm, or about 2250 ppm of retinoid compound. Amounts of retinoid compound that are greater than about 5000 ppm are thought to lead to toxicity concerns for formulating with oral care compositions, which would not be present in skin care compositions.

[0096] The retinoid compound can comprise retinol comprising cis- and / or trans- alkene functional groups. The retinol can comprise at least about 80%, at least about 90%, at least about 95%, and / or at least about 99% of / ra / rs-alkene functional groups. The retinoid compound can also comprise surfactant, such as anionic surfactant, cationic surfactant, and / or nonionic surfactant, which can improve gum barrier permeability. Suitable surfactants can include polysorbate.

[0097] The gum health compound can comprise a metal. The metal can be provided by a metal ion source. The metal ion source can comprise tin, zinc, copper, or combinations thereof. The metal can provide a gum health benefit. The oral care product can comprise from about 0.01% to about 5%, from about 0.1% to about 10%, from about 0.001% to about 1%, from about 0.2% to about 1%, from about 0.5% to about 1.5%, or from about 0.3% to about 0.6%, by weight of the oral care product, of the metal and / or metal ion source.

[0098] The metal can comprise tin, which can be provided by a tin ion source. The tin ion source can be any suitable compound that can provide tin ions in an oral care composition and / or deliver tin ions to the oral cavity when the dentifrice composition is applied to the oral cavity. The tin ion source can comprise one or more tin containing compounds, such as stannous fluoride, stannous chloride, stannous bromide, stannous iodide, stannous oxide, stannous sulfate, stannous sulfide, stannic fluoride, stannic chloride, stannic bromide, stannic iodide, stannic sulfide, and / or mixtures thereof. Preferably, the tin ion source can comprise stannous fluoride, stannous chloride, and / or mixture thereof.

[0099] The oral care product can comprise from about 0.01% to about 5%, from about 0.1% to about 10%, from about 0.001% to about 1%, from about 0.2% to about 1%, from about 0.5% to about 1.5%, or from about 0.3% to about 0.6%, by weight of the oral care product, of the tin and / or tin ion source.

[0100] The metal of can comprise zinc, which can be provided by a zinc ion source. The zinc ion source can comprise one or more zinc containing compounds, such as zinc fluoride, zinc lactate, zinc oxide, zinc phosphate, zinc chloride, zinc acetate, zinc hexafluorozirconate, zinc sulfate, zinc tartrate, zinc gluconate, zinc citrate, zinc malate, zinc glycinate, zinc pyrophosphate, zinc metaphosphate, zinc oxalate, and / or zinc carbonate.

[0101] The oral care product can comprise from about 0.01% to about 5%, from about 0.1% to about 10%, from about 0.001% to about 1%, from about 0.2% to about 1%, from about 0.5% to about 1.5%, or from about 0.3% to about 0.6%, by weight of the oral care product, of the zinc and / or zinc ion source.

[0102] Antiplaque Agent

[0103] The active agent can comprise antiplaque agent. Suitable antiplaque agents can include abrasives, polyphosphates, pyrophosphate, chlorhexidine, quaternary ammonium compounds, and / or combinations thereof.

[0104] The antiplaque agent can comprise polyphosphate, which can be provided by a polyphosphate source. A polyphosphate source can comprise one or more polyphosphate molecules. Polyphosphates are a class of materials obtained by the dehydration and condensation of orthophosphate to yield linear and cyclic polyphosphates, such as phytic acid, of varying chain lengths. Thus, polyphosphate molecules are generally identified with an average number (n) of polyphosphate molecules, as described below. A polyphosphate is generally understood to consist of two or more phosphate molecules arranged primarily in a linear configuration, although some cyclic derivatives may be present.

[0105] Preferred polyphosphates are those having an average of two or more phosphate groups so that surface adsorption at effective concentrations produces sufficient non-bound phosphate functions, which enhance the anionic surface charge as well as hydrophilic character of the surfaces. Preferred in this invention include the linear polyphosphates having the formula: XO(XPOs)nX, wherein X is sodium, potassium, ammonium, or any other alkali metal cations and n averages from about 2 to about 21, from about 2 to about 14, or from about 2 to about 7.

[0106] Some examples of suitable polyphosphate molecules include, for example, pyrophosphate (n=2), tripolyphosphate (n=3), tetrapolyphosphate (n=4), sodaphos polyphosphate (n=6), hexaphos polyphosphate (n=13), benephos polyphosphate (n=14), hexametaphosphate (n=21), which is also known as Glass H. Polyphosphates can include those polyphosphate compounds manufactured by FMC Corporation, ICL Performance Products, and / or Astaris.

[0107] The oral care product can comprise from about 0.01% to about 15%, from about 0.1% to about 10%, from about 0.5% to about 5%, from about 1 to about 20%, or about 10% or less, by weight of the oral car eproduct, of the polyphosphate source. Alternatively, the oral care product can be essentially free of, substantially free of, or free of polyphosphate. The oral care product can be essentially free of, substantially free of, or free of cyclic polyphosphate. The oral care producr can be essentially free of, substantially free of, or free of phytic acid, which can lead to insoluble tin and / or zinc compounds.

[0108] Antisensitivity Agent

[0109] The active agent can comprise anti sensitivity agent. Suitable anti sensitivity agents include potassium nitrate, dicarboxylic acid, such as oxalic acid, tin, and / or combinations thereof.

[0110] Oral Care Product Forms

[0111] Suitable compositions for the delivery of the active agent include emulsion compositions, such as the emulsions compositions of U.S. Patent Application Publication No. 2018 / 0133121, which is herein incorporated by reference in its entirety, unit-dose compositions, such as the unitdose compositions of U.S. Patent Application Publication No. 2019 / 0343732, which is herein incorporated by reference in its entirety, leave-on oral care compositions, jammed emulsions, such as the jammed oil-in-water emulsions of U.S. Patent No. 11,096,874, which is herein incorporated by reference in its entirety, dentifrice compositions, mouth rinse compositions, mouthwash compositions, tooth gel, subgingival gel, mouth rinse, mousse, foam, mouth spray, lozenge, chewable tablet, chewing gum, tooth whitening strips, floss and floss coatings, breath freshening dissolvable strips, denture care products, denture adhesive products, or combinations thereof. The active agent can also be placed on a non-dissolvable strip, such as the delivery system of U.S. Patent No. 5,891,453, which is herein incorporated by reference in its entirety.

[0112] Methods of Applying Oral Care Product

[0113] The oral care product comprising active agent, as described herein, can lead to the improvement of oral health conditions, such as the whitening of teeth, removing stain from teeth, and / or preventing the accumulation of stain from teeth when applied to the oral cavity. For example, a user can dispense at least a one-inch strip of a suitable oral care product, as described herein, onto an oral care implement, such as a toothbrush, applicator, and / or tray, and apply the oral care product to the oral cavity and / or teeth.

[0114] If a toothpaste or dentifrice composition is used, the user can be instructed to brush teeth thoroughly for at least 30 seconds, at least one minute, at least 90 seconds, or at least two minutes at least once, at least twice, or at least three times per day. The user can also be instructed to expectorate the oral care product after the completion of the brush procedure.

[0115] The user can also be instructed to rinse with a mouthwash composition comprising active agent and / or mouth rinse composition comprising active agent after the completion of the brush procedure or instead of the brush procedure. The user can be instructed to swish the oral care composition thoroughly for at least 30 seconds, at least one minute, at least 90 seconds, or at least two minutes at least once, at least twice, or at least three times per day. The user can also be instructed to expectorate the oral care product after the completion of the procedure.

[0116] The oral care product of the present invention can be used to provide a whitening benefit, such as the whitening of teeth, removing stain from teeth, and / or preventing the accumulation of stain from teeth. The oral care product can include primary packaging, such as a tube, bottle, and / or tub. The primary package can be placed within secondary package, such as a carton, shrink wrap, or the like. Instructions for use of the oral care composition can be printed on the primary package and / or the secondary package. The scope of the method is intended to include instructions provided by a manufacturer, distributor, and / or producer of the oral care composition.

[0117] If the oral care composition is a toothpaste, the user can be instructed to dispense the toothpaste from the toothpaste tube. The user can be instructed to apply a portion of the toothpaste onto a toothbrush. The portion of the toothpaste can be of any suitable shape, such as strip, a peasized amount, or various other shapes that would fit onto any mechanical and / or manual brush head. The user can be instructed to apply a strip of the toothpaste that is at least about 1 inch, at least about 0.5 inch, at least 1 inch, and / or at least 0.5 inch long to the bristles of a toothbrush, such as soft-bristled toothbrush.

[0118] The user can be instructed to brush their teeth for at least about 30 seconds, at least about 1 minute, at least about 90 seconds, at least about 2 minutes, at least 30 seconds, at least 1 minute, at least 90 seconds, and / or at least 2 minutes.

[0119] The user can be instructed to brush their teeth thoroughly and / or as directed by a dental health professional. The user can be instructed to brush their teeth after each meal. The user can be instructed to brush their teeth at least once per day, at least twice per day, and / or at least three times per day. The user can be instructed to brush their teeth no more than three times a day, such as to prevent cationic antimicrobial induced staining. The user can be instructed to brush their teeth in the morning and / or in the evening prior to sleeping.

[0120] The user can be instructed to not swallow the toothpaste composition due to the inclusion of ingredients that are not suitable for ingestion, such as fluoride. The user may be instructed to expectorate (or spit out) the toothpaste composition after the cessation of the brushing cycle.

[0121] If the oral care composition is a mouth rinse, the user can be instructed to dispense the mouth rinse from a bottle containing the mouth rinse. The user can be instructed to use the mouth rinse at least once a day, at least twice a day, and / or at least three times a day. The user can be instructed to use the mouth rinse composition after the use of toothpaste and / or floss.

[0122] The user can be instructed to swish a portion of rinse in the oral cavity, such as between the teeth, for a period of time. The user can be instructed to vigorously swish a portion of the rinse.

[0123] The user can be instructed to use be from about 5 mL to about 50 mL, from about 10 mL to about 40 mL, 10 mL, 20 mL, 25 mL, 30 mL, 40 mL, 2 teaspoonfuls, and / or 4 teaspoonfuls of mouth rinse.

[0124] The user can be instructed to swish the mouth rinse for at least about 30 seconds, at least about 1 minute, at least about 90 seconds, at least about 2 minutes, at least 30 seconds, at least 1 minute, at least 90 seconds, and / or at least 2 minutes.

[0125] The user can be instructed to not swallow the mouth rinse composition due to the inclusion of ingredients that are not suitable for ingestion, such as fluoride. The user may be instructed to expectorate (or spit out) the mouth rinse composition after the cessation of the rinse cycle.

[0126] The usage instructions for the oral care product, such as for a toothpaste composition and / or a mouth rinse composition, can vary based on age. For example, adults and children that are at least 6 or at least 2 can have one usage instruction while children under 6 or under 2 can have a second usage instruction.

[0127] Suitable medicaments include oral care compositions, toothpaste compositions, mouth rinse compositions, floss coatings, chewing gums, and / or other suitable compositions to be applied in the oral cavity.

[0128] Oral Care Regimen

[0129] If multiple active agents are used, such as for example, a whitening agent and an anti sensitivity agent, each active agent can be delivered in a single composition or in two separate compositions. For example, a first composition can comprise tin and / or fluoride and a second composition and or device, such as a whitening strip, can comprise peroxide. The first and second composition can be delivered simultaneously, such as in a dual-phase composition or sequentially from discrete compositions.

[0130] An oral care kit can include the first composition comprising tin and / or fluoride and the second composition comprising peroxide. The oral care kit can also include instructions directing a user to apply the first composition to an oral cavity of the user followed by applying the second composition to the oral cavity of the user. The instructions can accompany the kit or be provided in one or more computer-implemented methods. The first composition can be expectorated prior to the application of the second composition or the second composition can be applied prior to the expectoration of the first composition from the oral cavity.

[0131] The entire oral care regimen can have a duration of from one minute to about three minutes with each application step having a duration of from about 30 seconds to about 2 minutes or about 1 minute.

[0132] The components can be delivered to the oral cavity simultaneously or sequentially. The simplest case is simultaneous, continuous delivery of equal amounts of the two components or a constant ratio of the components during a single oral care session. The two components may be provided separately, such as in a dual-phase composition in two separate compositions, and then delivered simultaneously to the oral cavity. Brushing duration is sufficiently short so that the components will not be inactivated. Another use for simultaneous, continuous delivery is systems that include two components that react relatively slowly, and that will remain in the oral cavity after brushing to be absorbed by the teeth and or gums.

[0133] In the case of sequential delivery, both components may be delivered during a single oral care session, e.g., a single brushing session or other single treatment session (single use, start to finish, by a particular user, typically about 0.1 to 5 minutes), or alternatively the components may be delivered individually over multiple oral care sessions. Many combinations are possible, for example delivery of both components during a first oral care session and delivery of only one of the components during a second oral care session.

[0134] Sequential delivery during a single oral care session may take various forms. In one case, two components are delivered in alternation, as either a few relatively long duration cycles during brushing (A B A B), or many rapid-fire alternations (A B A B A B A B A B . . . . A B).

[0135] In another case, two or more components are delivered one after the other during a single oral care session, with no subsequent alternating delivery in that oral care session (A followed by B). For example, a first composition comprising fluoride and / or tin can be delivered initially, to initiate brushing and provide cleansing, followed by a second composition comprising peroxide.

[0136] Other steps can also be included in the regimen, such as peroxide activation via electromagnetic radiation, flossing, and / or manual removal of stain and / or plaque through one or more dental instruments.

[0137] The dimensions and values disclosed herein are not to be understood as being strictly limited to the exact numerical values recited. Instead, unless otherwise specified, each such dimension is intended to mean both the recited value and a functionally equivalent range surrounding that value. For example, a dimension disclosed as "40 mm" is intended to mean "about 40 mm."

[0138] Every document cited herein, including any cross referenced or related patent or application and any patent application or patent to which this application claims priority or benefit thereof, is hereby incorporated herein by reference in its entirety unless expressly excluded or otherwise limited. The citation of any document is not an admission that it is prior art with respect to any invention disclosed or claimed herein or that it alone, or in any combination with any other reference or references, teaches, suggests or discloses any such invention. Further, to the extent that any meaning or definition of a term in this document conflicts with any meaning or definition of the same term in a document incorporated by reference, the meaning or definition assigned to that term in this document shall govern.

[0139] While particular embodiments of the present invention have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention.

Claims

CLAIMSWhat is claimed is:

1. An intraoral device comprising: a mouthpiece, the mouthpiece comprising a flange; and a shroud extending from the mouthpiece, wherein the shroud defines a channel extending between a distal opening and a proximal opening, wherein the intraoral device is not configured to couple to an image-capturing device.

2. The intraoral device of claim 1, wherein the intraoral device is free from a strap or band, adhesive, clip, clamp, magnet, hook, bracket, holder, and hook-and-loop tape.

3. The intraoral device of claim 1 or 2, wherein the mouthpiece further comprises bite wings extending distally of the flange.

4. The intraoral device of any one of the preceding claims, wherein the shroud is configured to transition between an expanded configuration and a collapsed configuration.

5. The intraoral device of claim 4, wherein the shroud comprises a proximal section, a distal section, and a living hinge separating the proximal section and the distal section.

6. The intraoral device of claim 5, wherein the living hinge and the proximal opening have a same cross-sectional shape.

7. The intraoral device of claim 5 or 6, wherein, in the collapsed configuration, the flange is distal of the proximal section.

8. The intraoral device of any one of the preceding claims, further comprising a calibration chart, preferably wherein the shroud further comprises an inner surface and a projection extending from the inner surface, and wherein the calibration chart is positioned on a proximal surface of the projection.

9. The intraoral device of any one of the preceding claims, wherein a cross-section of the distal opening is pill-shaped, and a cross-section of the proximal opening is a rounded rectangle.

10. The intraoral device of any one of claims 1-9, wherein a cross-section of the distal opening is pill-shaped, and a cross-section of the proximal opening is pill-shaped.

11. The intraoral device of any one of the preceding claims, further comprising a platform, wherein the shroud extends between the mouthpiece and the platform, preferably wherein the platform comprises an upper surface, a lower surface, and a depression on the upper surface.

12. The intraoral device of claim 11, wherein the proximal opening of the shroud is coplanar with the lower surface of the platform.

13. The intraoral device of any one of the preceding claims, wherein the flange is a distal flange, and the intraoral device further comprises a proximal flange, preferably wherein the proximal flange has a radius of curvature greater than a radius of curvature of the distal flange.

14. A system for digital imaging of an oral cavity, the system comprising: the intraoral device of any one of the preceding claims; and the image-capturing device comprising a lens, preferably wherein the proximal opening of the shroud is configured to extend around the lens of the image-capturing device or wherein, when the intraoral device is positioned against the image-capturing device, a portion of the image-capturing device extends into the channel.

15. A method for digitally imaging an oral cavity of a user using the image-capturing device, the method comprising: positioning lips of the user around the intraoral device of any one of claims 1-13; aligning a lens of the image-capturing device and the channel of the intraoral device, preferably wherein aligning the lens of the image-capturing device includes holding the imagecapturing device against the intraoral device or holding the image-capturing device spaced apart from the intraoral device; and capturing an image of the oral cavity without coupling the image-capturing device and the intraoral device.

Images