Tooth whitening and enamel remineralization compositions and methods of use

Abstract

The present application relates to the field of tooth whitening, and particularly relates to a tooth whitening and enamel remineralization composition and a use method thereof, the tooth whitening and enamel remineralization composition comprising a CPIC gel and an HP gel; the CPIC gel comprising a composite CPIC, an HP activator and a first pH regulator; the composite CPIC comprising calcium ions, phosphate ions and weakly reducing metal ions; the HP activator comprising a transition metal complex for promoting HP decomposition; the first pH regulator being used for controlling the pH value of the CPIC gel in a weak alkaline range; the HP gel comprising HP, an HP stabilizer and a second pH regulator; the HP stabilizer being used for combining the weakly reducing metal ions in the HP gel to prevent HP decomposition; and the second pH regulator being used for controlling the pH value of the HP gel within 4-6. The composition in the present application comprises the CPIC gel and the HP gel, and can simultaneously realize tooth whitening and enamel remineralization.

Description

Technical Field

[0001] This invention relates to the field of teeth whitening technology, specifically to a teeth whitening and enamel remineralization composition and its application method. Background Technology

[0002] In the field of oral health, teeth whitening and enamel protection are issues of great concern. Hydrogen peroxide (H2O2) is a commonly used active ingredient in current teeth whitening products. As a strong oxidant, it releases highly reactive free radicals (such as hydroxyl radicals and superoxide anions) that react with pigment molecules (such as coffee stains, tea stains, tetracycline deposits, etc.) on the tooth surface and deep layers, breaking them down into colorless or light-colored small molecules, thereby achieving a whitening effect. Hydrogen peroxide can also penetrate the microporous structure of enamel, altering the organic components and moisture content of the enamel surface, reducing the enamel refractive index, and making teeth appear whiter. Simultaneously, hydrogen peroxide can penetrate deep into the dentin through dentinal tubules to oxidize and decompose pigment deposits therein, reducing intrinsic staining.

[0003] However, hydrogen peroxide (HP) has some drawbacks in the whitening process. On the one hand, it breaks down the proteins that bind enamel minerals, causing enamel prism mineral crystals to loosen and be lost, damaging the natural hard tissue protective layer of teeth, namely enamel. On the other hand, HP breaks down the organic matrix that acts as a barrier in exposed dentinal tubules, increasing the permeability of dentinal tubules and causing dentin hypersensitivity. Therefore, although HP bleaching can remove stains, it inevitably damages the enamel mineralization layer, making it loose and rough, increasing the risk of plaque adhesion and restaining, significantly weakening tooth wear resistance, and after tooth bleaching, the tooth surface is prone to forming an acquired biofilm covering in the oral environment, which weakens the mineralization function of saliva.

[0004] In existing technologies, calcium phosphate ion clusters (CPICs) are ion clusters formed by stabilizing them with triethylamine under ethanol or non-aqueous media conditions. These ion clusters are highly mineralizing and active materials for enamel regeneration and repair. Chinese patent CN107343857B discloses a method for preparing enamel-like hydroxyapatite using calcium phosphate ion clusters as a precursor mineralizing material to form an ACP mineralization front on the enamel surface. This material can be used to repair enamel in superficial caries, and the repaired structure and mechanical properties are consistent with natural enamel. Chinese patent 201980034288.5 discloses an oral care composition based on calcium phosphate polyion clusters, which enhances the repair ability of CPICs on teeth with glycerin. Based on this, CPICs could potentially address the problems caused by HP bleaching.

[0005] Based on the characteristics of HP and CPIC, when used together, HP promotes the bonding of more CPICs to the tooth structure by decomposing acquired biofilms and pigments on the tooth surface. This accelerates remineralization of the tooth surface by constructing a biomimetic mineralization front, forming a dense mineralized film. However, HP is only stable in a weakly acidic system, which dissolves CPICs, rendering their mineralization function ineffective. Conversely, the weakly alkaline environment suitable for CPICs catalyzes the decomposition of HP, resulting in insufficient shelf stability and making it difficult to use the two together. If HP is used first followed by CPICs, the restorative effect of CPICs on the tooth structure is relatively limited.

[0006] Therefore, how to overcome the shortcomings of the existing technology is the subject of this invention. Summary of the Invention

[0007] The purpose of this invention is to provide a teeth whitening and enamel remineralization composition and its method of use.

[0008] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0009] Teeth whitening and enamel remineralization compositions, including CPIC gel and HP gel;

[0010] The CPIC gel comprises a composite CPIC, an HP activator, and a first pH adjuster;

[0011] The composite CPIC includes calcium ions, phosphate ions, and weakly reducing metal ions;

[0012] The HP activator includes a transition metal complex for promoting HP decomposition;

[0013] The first pH adjuster is used to control the pH value of the CPIC gel within a weakly alkaline range;

[0014] The HP gel comprises HP, an HP stabilizer, and a second pH adjuster;

[0015] The HP stabilizer is used to bind the weakly reducing metal ions in the HP gel to prevent HP decomposition.

[0016] The second pH adjuster is used to control the pH value of the HP gel within 4-6.

[0017] Unless otherwise stated, all percentages and proportions in this application refer to weight percentages and weight ratios.

[0018] As used in this application, the term "polymer" or "polymers" refers to polymers prepared from monomeric compounds through polymerization reactions. The term "ionic cluster" refers to a compound or aggregate of ions composed of combinations of cations and anions. Ionic clusters are similar to polymers, but they are formed by ionic bonds and are entirely composed of ions. Specifically, calcium phosphate ion clusters (CPICs) refer to compounds that exist in solution as calcium ions (Ca... 2+ ) and phosphate ions (PO4) 3- CPIC is an ion aggregate mainly composed of calcium phosphate (ACP). It is an important intermediate in the formation of calcium phosphate minerals (such as amorphous calcium phosphate (ACP) and hydroxyapatite (HAP)). Amorphous calcium phosphate (ACP) is an early precursor phase in the biomineralization crystallization process, exhibiting short-range order and long-range disorder, and is thermodynamically unstable, readily transforming into crystalline forms such as hydroxyapatite. CPIC can form ACP mineralization fronts on hard tissue surfaces, thereby biomimeticly repairing enamel and dentin in the oral environment.

[0019] The ratio of CPIC gel to HP gel is not limited and can be adjusted according to actual needs.

[0020] Preferably, the proportion of HP stabilizer in HP gel is <1%, so that HP stabilizer can only play a role in HP gel, and the proportion of HP is at least 6%-40%.

[0021] The first pH adjuster is used to control the pH value of the CPIC gel within a slightly alkaline range. The specific range is not limited, and you can refer to the following examples for understanding.

[0022] The preparation process of conventional CPIC can be carried out according to the method disclosed in Chinese Patent CN110157132B. For example, it can be prepared by the following method: dissolving 2 g of CaCl2·2H2O in 0.8 L of ethanol; then, at room temperature, adding 38 mL of triethylamine (TEA) to the above solution under magnetic stirring, and stirring for 30 minutes; next, at room temperature, adding a phosphoric acid ethanol solution (0.7 mL of phosphoric acid (85 wt%) dissolved in 200 mL of ethanol) to the above solution under magnetic stirring, and stirring; then, centrifuging at 8000 rpm to obtain a gel, and washing several times with ethanol to obtain conventional CPIC, wherein the molar ratio of calcium (Ca) to phosphorus (P) is 0.9-2.0.

[0023] The preparation process of composite CPICs is an improvement upon the conventional CPIC preparation process. In the conventional CPIC synthesis process described above, 0.001-1 g of MnCl2·4H2O is added as a manganese source to the calcium source, generating manganese-containing CPICs (composite CPICs) to enhance the HP activation function of conventional CPICs without affecting their mineralization function. Based on the knowledge of HP activation, the manganese source here can also be replaced or supplemented with 0.001-1 g of other weakly reducing metal ions with similar functions, such as iron, cobalt, nickel, copper, and tin sources. Alternatively, after the conventional CPIC synthesis, weakly reducing metal ion sources such as iron, cobalt, nickel, copper, and tin can be added for doping.

[0024] The molecular formula of the composite CPIC is: Ca x M y H z (PO4) a N b Where M is an inorganic cation, such as Mn 2+ Fe 2+ Co 2+ Ni 2+ Cu + Sn 2+ Mg 2+ Zn 2+ Na + K + etc.; N is an inorganic anion, such as OH- - Cl - F - Carbonate, sulfate, acetate, and citrate, etc., x, y, z, a, and b are reduced real numbers not exceeding 3 and represent the relative proportions of the components that make up the ion cluster. The ranges of x and a are 1-3, and the ranges of y, z, and b are 0-1.

[0025] The composite CPIC has the following chemical properties: the product is neutral or weakly alkaline (pH 6.5-9.5), insoluble in water, soluble or slightly soluble in acid, and can combine with dental calcium phosphate minerals and promote the formation of mineralized layers.

[0026] Composite CPIC has the following physical properties: it is a white or colored gel-like substance with a solid content between 5% and 50% and a certain degree of fluidity. It can be formed into a bulk material through solvent evaporation.

[0027] The difference between this and a regular CPIC is that the composite CPIC introduces Mn. 2+ Fe 2+ Co 2+ Ni 2+ Cu + Sn 2+Weakly reducing metal ions can promote the decomposition of HP, forming HP-activated CPIC.

[0028] HP activators are used to activate HP, promoting its decomposition to form reactive oxygen species. HP activators include transition metal complexes that promote HP decomposition, such as manganese EDTA or cobalt gluconate. Preferably, the transition metal complex is cobalt gluconate.

[0029] The first pH adjuster can be triethanolamine (TEA), sodium tripolyphosphate, sodium bicarbonate, sodium citrate, disodium hydrogen phosphate, etc., which can control the pH of CPIC gel under weakly alkaline conditions to ensure the storage stability of CPIC gel. When CPIC gel and HP gel are mixed to form a composition, the second pH adjuster can be used to adjust the pH of the composition to neutral (pH≈7.0–7.4), so that the combined activity of CPIC component and HP component is optimal.

[0030] The second pH adjuster can be citrate or phosphate, which is used to control the pH of HP gel within 4-6 to ensure the stability of HP storage.

[0031] HP stabilizers can be composed of EDTA salts, phosphates, or polyphosphates. Preferably, the HP stabilizer is an EDTA salt. The function of the HP stabilizer is to bind residual trace amounts of weakly reducing metal ions in the components to prevent HP decomposition and improve the shelf stability of HP gel products.

[0032] The CPIC component in CPIC gel (regular CPIC) and the HP component in HP gel have a synergistic effect, specifically as follows: On the one hand, HP can break down acquired biofilms and pigments on the tooth surface, thereby exposing tooth minerals and promoting the binding of CPIC to the tooth, thus activating the mineralization of the tooth in the saliva environment; on the other hand, after CPIC promotes the formation of a dense mineralized film on the tooth surface, it can prevent pigment redeposition, thereby consolidating the whitening effect of HP, that is, the two promote each other.

[0033] The HP stabilizer in HP gel and the weak reducing metal ions in CPIC gel have a synergistic effect, as follows: On the one hand, the HP stabilizer can bind to the small amount of weak reducing metal ions remaining in the HP gel components, preventing HP decomposition during shelf storage and maintaining the product's long-lasting bleaching activity; on the other hand, when CPIC gel and HP gel are mixed, the weak reducing metal ions in HP-activated CPIC (composite CPIC) can reactivate HP, promote the release of reactive oxygen species on the tooth surface through the enrichment of CPIC on the tooth surface, and improve the utilization of active substances for pigment decomposition. This combination of components can achieve teeth whitening and remineralization simultaneously.

[0034] The second pH adjuster in HP gel and the first pH adjuster in CPIC gel have a synergistic effect, as follows: The second pH adjuster can control the pH value of HP gel within 4-6 to ensure the stability of HP storage; the first pH adjuster can control the pH of CPIC gel under weakly alkaline conditions to ensure the stability of CPIC gel storage; the second and first pH adjusters can adjust the pH of the composition to neutral (pH≈7.0–7.4) when CPIC gel and HP gel are mixed to form a composition, so that the combined activity of CPIC component and HP component is optimal. At this time, the decomposition process of HP is activated, and CPIC binds to the tooth, activating the mineralization of the tooth in the salivary environment.

[0035] In summary, the composition, comprising CPIC gel and HP gel, simultaneously achieves teeth whitening and enamel remineralization. The activated calcium phosphate ion clusters in the CPIC gel act as catalysts (primarily weakly reducing metal ions) to catalyze the decomposition of HP, while also fusing with the tooth surface to continuously generate reactive oxygen species, thereby removing pigments and impurities from enamel and dentin more quickly and effectively. Simultaneously, HP, by decomposing acquired biofilms and pigments on the tooth surface, promotes the binding of more CPIC gels to the tooth, accelerating remineralization by constructing a biomimetic mineralization front, forming a dense mineralized film. The combined use of CPIC gel and HP gel allows for teeth whitening while simultaneously repairing them, preventing rapid re-staining after whitening.

[0036] Additional notes regarding HP-activated CPIC and HP activator:

[0037] HP activators are additional activators added to the components (such as manganese EDTA and cobalt gluconate), and their molecular form and function are not entirely the same as those of activated CPICs. Taking manganese source as an example, the manganese in HP-activated CPICs is fixed in the form of manganese ion doping inside and on the surface of the CPIC. Its mechanism of action is to decompose HP through the solid-phase catalysis of manganese ions on the surface of the CPIC. In contrast, HP activators are molecular / free manganese, and their function is to decompose HP through molecular catalysis.

[0038] HP-activated CPIC can bind to tooth structure, promoting mineralization and the decomposition of HP near the tooth surface, thereby increasing the concentration of reactive oxygen species near the tooth surface. The combined use of HP-activated CPIC and HP activator can have a synergistic bleaching effect: HP-activated CPIC can specifically increase the concentration of highly reactive free radicals around the tooth, making HP more efficient at degrading organic stains and improving bleaching efficacy; while HP activator mainly increases the concentration of reactive free radicals in the gel itself, preventing the concentration of reactive free radicals on the tooth surface from decreasing due to diffusion into the bulk phase, thus prolonging the bleaching effect. The two complement each other and synergistically enhance the effect.

[0039] HP activators can also prevent HP stabilizers (such as EDTA salts, phosphates, or polyphosphates) in HP gel components from decomposing CPIC. According to chemical principles, HP stabilizers can coordinate with calcium ions and variable-valence metal ions, thereby dissolving CPIC and causing it to lose its mineralization-inducing activity. HP stabilizers are essential components in HP gel components, and their purpose is to coordinate with residual iron, cobalt, and nickel ions introduced by the solvent or production process, "passivating" them and thus significantly slowing down their catalytic decomposition rate of HP. By introducing HP activators, according to Le Chatelier's principle, introducing products into the system will shift the reaction equilibrium in a direction unfavorable to product production, thereby preventing HP stabilizers from destroying CPIC.

[0040] In a further technical solution, the CPIC gel also includes at least one of surfactants, thickeners, wetting agents, tooth desensitizers, preservatives, and flavoring agents;

[0041] The HP gel also includes at least one of a foam stabilizer, a thickener, a wetting agent, and a preservative.

[0042] The ingredients of a tooth desensitizing agent can be potassium nitrate and sodium fluoride. Tooth desensitizing agents are used to reduce tooth sensitivity caused by the exposure of dentinal tubules during the whitening process.

[0043] The surfactant can be anionic surfactant, such as C8 to C96. 18 Sodium, magnesium, ammonium, or ethanolamine salts of alkyl sulfates (e.g., sodium lauryl sulfate), C8 to C96 salts. 18 Sodium, magnesium, ammonium, or ethanolamine salts of alkyl sulfosuccinic acids (e.g., sodium dioctyl sulfosuccinate), C8 to C945 salts. 18 Sodium, magnesium, ammonium, or ethanolamine salts of alkyl sulfonates (e.g., sodium lauryl sulfonate), C8 to C94 salts. 18 Sodium, magnesium, ammonium, or ethanolamine salts of alkyl sarcosine (e.g., sodium lauryl sarcosine), C8 to C8 salts. 18Sodium, magnesium, ammonium, or ethanolamine salts of alkyl phosphates (optionally containing up to 10 ethylene oxide and / or propylene oxide units) and sulfated glycerol monoesters. Surfactants may also include nonionic surfactants, such as optional polyoxyethylene sorbitan fatty acid esters, ethoxylated fatty acids, polyethylene glycol esters, ethoxylated monoglycerides and diglycerides of fatty acids, and ethylene oxide / propylene oxide block polymers. Other suitable surfactants include amphoteric surfactants, such as betaine or sulfobetaine. Mixtures of any of the above materials may also be used. Preferably, the surfactant is sodium lauryl sulfate.

[0044] The role of surfactants is to reduce the interfacial tension between CPIC clusters and particles in the gel, ensuring stable dispersion of the colloid; and to improve the wettability of the gel on the tooth surface, enabling CPICs to adhere more tightly to the dentin and enamel surfaces.

[0045] The thickener may consist of: sodium carboxymethyl cellulose (CMC), hydroxyethyl cellulose, methyl cellulose, ethyl cellulose, tragacanth gum, gum arabic, carrageenan, sodium alginate, carrageenan, guar gum, xanthan gum, starch, modified starch, silica-based thickeners (including silica aerogels), magnesium aluminum silicate (such as Veegum), carbomer (crosslinked acrylate), and mixtures thereof. Preferably, the thickener is carbomer 940.

[0046] The role of thickeners is to form a three-dimensional network structure in the gel system, provide the required viscosity and thixotropy, prevent the components from separating or settling; ensure controllable flowability when the gel is extruded or brushed, so that the gel can be quickly fixed on the dental tray and tooth surface after use.

[0047] The wetting agent may be composed of glycerin, ethylene glycol, propylene glycol, polyethylene glycol (PEG), etc. Preferably, the wetting agent is glycerin.

[0048] The functions of humectants are: to moisturize, preventing the gel from drying out too quickly in the oral environment and under light conditions; to improve taste and reduce irritation to soft tissues; to synergistically improve the adhesion and moisturizing properties of the gel, prolonging the residence time of active ingredients on the tooth surface; and to promote penetration, helping CPIC to fully contact enamel fissures and preventing tooth dehydration.

[0049] Preservatives can be parabens, potassium sorbate, sodium benzoate, clove oil (containing eugenol), etc. Preservatives are used to ensure the gel remains stable at room temperature and in the oral microbial environment to prevent expiration.

[0050] Fragrance agents can be menthol or natural peppermint oil. Fragrance agents can enhance the user experience and help alleviate mild irritation that HP may cause.

[0051] Foam stabilizers can be composed of silica and polymeric surfactants, such as polyoxyethylene-polyoxypropylene-polyoxyethylene block copolymers (Pluronic / Poloxamer series), PEG-150 distearate, acrylic acid / ammonium acrylate copolymers (Carbomer series) derivatives, polyacrylamide / isohexadecane copolymers, and cocamidopropyl betaine. When HP decomposes, the reactive oxygen free radicals formed combine to form oxygen, and the continuous release of oxygen leads to a decrease in the utilization rate of HP's reactive oxygen free radicals. Foam stabilizers can control the state of oxygen bubbles formed in the gel, making the bubbles finer and more stable, and ensuring they are more uniform and smaller, preventing them from growing larger, breaking, and escaping, thus preventing a decrease in HP utilization due to oxygen escape.

[0052] The thickeners, wetting agents, and preservatives in HP gels are the same as those in CPIC gels.

[0053] The method of using the teeth whitening and enamel remineralization composition includes:

[0054] Step 1: Store the CPIC gel and HP gel separately in the initial storage area;

[0055] Step 2: Transfer portions of the CPIC gel and HP gel from the initial storage area to the intermediate mixing area to obtain the first composition;

[0056] Step 3: Transfer at least a portion of the remaining CPIC gel and the remaining HP gel from the initial storage area to the transfer mixing area to obtain a second composition, which is capable of expelling at least a portion of the first composition from the transfer mixing area.

[0057] Initially, CPIC gel and HP gel are stored separately to avoid mutual interference, allowing for the creation of suitable storage environments for each. The initial storage area can include two completely isolated first and second storage areas to store CPIC gel and HP gel respectively.

[0058] In step two, the first composition may fill or nearly fill (e.g., fill more than 90%) the transfer mixing region. The CPIC gel and HP gel are compounded in the transfer mixing region to form the first composition for synergistic cooperation during subsequent use.

[0059] The first composition needs to be used after it is formed. Therefore, the second composition is formed in step three, and the second composition pushes the first composition out of the transfer mixing area. This not only makes it convenient to use the first composition, but also avoids the first composition occupying the transfer mixing area and hindering the formation of subsequent compositions.

[0060] Understandably, by observing the total remaining amount of CPIC gel and HP gel in the initial storage area, both can be added to the initial storage area to replenish it.

[0061] Understandably, the amount of the second composition formed determines whether the entire first composition is removed from the transit mixing zone.

[0062] In a further technical solution, during the transfer phase of CPIC gel and HP gel in step two, the start and end times of the transfer are the same for both, meaning that their transfer time periods overlap. This simplifies the control of the transfer process and makes operation easier.

[0063] In a further technical solution, in step two, a mixing structure is used to mix the CPIC gel and HP gel entering the intermediate mixing area to accelerate the formation speed of the first composition and the second composition. This can improve the mixing degree of CPIC gel and HP gel in the first composition and the second composition, ensuring that CPIC gel and HP gel can work together synergistically during subsequent use.

[0064] The mixing structure can be an existing stirring structure (such as including stirring blades), and there are no specific restrictions.

[0065] An application device for a teeth whitening and enamel remineralization composition includes:

[0066] The receiving portion includes a first cavity and a second cavity for receiving CPIC gel and HP gel, respectively;

[0067] A mixing section, connected to the receiving section, includes a mixing chamber communicating with both the first cavity and the second cavity, the mixing chamber being used to provide space for mixing the CPIC gel and the HP gel to form a composition; the mixing section has an outlet for discharging the composition;

[0068] A propulsion section is movably disposed in the receiving section for pushing the CPIC gel and the HP gel into the mixing chamber.

[0069] Initially, the CPIC gel is stored in the first chamber, and the HP gel is stored in the second chamber. Next, the propulsion unit gradually pushes the CPIC gel and HP gel into the mixing chamber, causing them to mix and form a composition. Subsequently, under normal circumstances, the majority of the composition is gradually ejected from the mixing chamber by the subsequently formed composition for use.

[0070] The arrangement of the first and second chambers within the container allows for the separate storage of CPIC gel and HP gel, preventing mutual interference and enabling the creation of suitable storage environments for each. It is understood that the first and second chambers can be completely separated, which is a standard configuration. The volume ratio of the first to second chambers can be set to 1:1 to 1:4 to facilitate the design of different component formulations.

[0071] The mixing section comprises only a single mixing chamber that provides space for the formation of the composition, and the composition can be discharged through the outlet.

[0072] The propulsion unit provides the driving force for the transfer of CPIC gel and HP gel, enabling the two to achieve the transfer in the aforementioned processes.

[0073] In summary, the application device can effectively mix HP gel and CPIC gel evenly, allowing the components to work synergistically to achieve the aforementioned teeth whitening and remineralization effects.

[0074] In a further technical solution, the receiving portion includes two first tubes and a second tube arranged side by side in a first direction, the first tube and the second tube having the same length and both extending along a second direction; the first direction and the second direction are orthogonal.

[0075] The first cavity penetrates the first tube along the second direction; the second cavity penetrates the second tube along the second direction.

[0076] The first tube, the second tube, the first cavity, and the second cavity can all be cylindrical. The radial dimensions of the first cavity and the second cavity can be different or the same, depending on the actual needs.

[0077] The arrangement of the first and second tubes completely separates the first and second cavities, allowing CPIC gel and HP gel to be stored completely independently.

[0078] The first tube and the second tube are of the same length, which makes it easy for the receiving part to be adapted to the mixing part and the propulsion part. For example, the contact surface between the mixing part and the receiving part can be a plane. The mixing part can use an existing mixing device with a frustum-shaped structure without modification to adapt to the receiving part.

[0079] In summary, this application employs a dual-tube design, allowing the CPIC active component and the HP active component to be stored separately in optimal weakly alkaline and weakly acidic environments in gel form. Before use, the mixing of the two components transforms the gel medium into a neutral environment. Combined with the catalytic effect of CPIC, this activates HP, enabling its rapid decomposition and releasing reactive oxygen species to degrade pigment molecules on the tooth surface, enhancing its whitening activity. Simultaneously, during HP bleaching, it removes the organic contamination layer from the tooth surface and activates tooth minerals (exposing high-energy surfaces and increasing interfacial energy), facilitating the mineralization effect of CPIC. This allows for the rapid formation of a mineral layer on the tooth surface, and through subsequent continuous mineralization, a dense mineralized layer is formed on the tooth surface. This layer repairs micro-damage to the tooth caused during the bleaching process and forms a dense protective layer to prevent the re-deposition of pigments and bacteria, thus ensuring the stability of the teeth whitening effect and maintaining tooth health. Through this dual-component formulation design, combined with the accompanying device, the dual effects of whitening and remineralization can be achieved, overcoming the shortcomings of existing whitening technologies.

[0080] In a further technical solution, the propulsion unit includes:

[0081] The first push rod extends along the second direction, with one end sealed and movable within the first cavity;

[0082] The second push rod extends along the second direction, with one end sealed and movable within the second cavity.

[0083] A push plate is connected to the end of the first push rod away from the mixing part and the end of the second push rod away from the mixing part;

[0084] The first push rod and the second push rod are of the same length.

[0085] Taking the first pusher as an example, the first pusher is inserted into the first cavity to push the CPIC gel. The first pusher can be adapted to the size of the first cavity to prevent the CPIC gel from bypassing the first pusher and leaking out. The first pusher and the first cavity are actually in a dynamic sealing relationship.

[0086] When in use, push the push plate, which will drive the first push rod and the second push rod.

[0087] The first and second pushers are of the same length. During the transfer phase of CPIC gel and HP gel, while controlling the initial injection volume of both, the start and end times of the transfer can be the same, meaning their transfer time periods can overlap. This simplifies the transfer process, making operation easier and allowing for simultaneous control of their output volumes. Understandably, to control the proportion of both entering the mixing chamber per unit time, the cross-sectional dimensions of the first and second chambers can be adjusted.

[0088] The mixing section may include a mixing section, a guiding section, and an output section connected sequentially along a second direction. The mixing section is connected to the receiving section, the mixing chamber is located within the mixing section, and the discharge port is located within the output section. Along the direction from the propulsion section toward the mixing section, the dimensions of the mixing section and the output section may gradually decrease (e.g., in a frustum shape). The guiding section may be cylindrical. An existing stirring structure (or mixing structure) may be provided within the mixing section. The guiding section and the output section may be bent to form a curved conveyor head.

[0089] The terms "first," "second," etc., used in this article do not specifically refer to order or sequence, nor are they intended to limit this case; they are merely used to distinguish components or operations described using the same technical terms.

[0090] The terms "connection" or "positioning" as used in this article can refer to two or more components or devices making direct physical contact with each other, or making indirect physical contact with each other, or to two or more components or devices operating or moving with each other.

[0091] The terms “include,” “including,” and “have” used in this article are all open-ended, meaning they include but are not limited to.

[0092] Unless otherwise specified, the terms used herein generally have their ordinary meaning in the context of the art, the subject matter, and the specific context. Certain terms used to describe this case will be discussed below or elsewhere in this specification to provide additional guidance to those skilled in the art in describing this case.

[0093] The terms “front,” “back,” “up,” “down,” “left,” and “right” used in this article are directional terms. In this case, they are only used to describe the positional relationship between the structures and are not intended to limit the specific direction of the protection scheme or its actual implementation.

[0094] The working principle and advantages of this invention are as follows:

[0095] The CPIC component in CPIC gel (regular CPIC) and the HP component in HP gel have a synergistic effect, specifically as follows: On the one hand, HP can break down acquired biofilms and pigments on the tooth surface, thereby exposing tooth minerals and promoting the binding of CPIC to the tooth, thus activating the mineralization of the tooth in the saliva environment; on the other hand, after CPIC promotes the formation of a dense mineralized film on the tooth surface, it can prevent pigment redeposition, thereby consolidating the whitening effect of HP, that is, the two promote each other.

[0096] The HP stabilizer in HP gel and the weak reducing metal ions in CPIC gel have a synergistic effect, as follows: On the one hand, the HP stabilizer can bind to the small amount of weak reducing metal ions remaining in the HP gel components, preventing HP decomposition during shelf storage and maintaining the product's long-lasting bleaching activity; on the other hand, when CPIC gel and HP gel are mixed, the weak reducing metal ions in HP-activated CPIC (composite CPIC) can reactivate HP, promote the release of reactive oxygen species on the tooth surface through the enrichment of CPIC on the tooth surface, and improve the utilization of active substances for pigment decomposition. This combination of components can achieve teeth whitening and remineralization simultaneously.

[0097] The second pH adjuster in HP gel and the first pH adjuster in CPIC gel have a synergistic effect, as follows: The second pH adjuster can control the pH value of HP gel within 4-6 to ensure the stability of HP storage; the first pH adjuster can control the pH of CPIC gel under weakly alkaline conditions to ensure the stability of CPIC gel storage; the second and first pH adjusters can adjust the pH of the composition to neutral (pH≈7.0–7.4) when CPIC gel and HP gel are mixed to form a composition, so that the combined activity of CPIC component and HP component is optimal. At this time, the decomposition process of HP is activated, and CPIC binds to the tooth, activating the mineralization of the tooth in the salivary environment.

[0098] In summary, the composition, comprising CPIC gel and HP gel, simultaneously achieves teeth whitening and enamel remineralization. The activated calcium phosphate ion clusters in the CPIC gel act as catalysts (primarily weakly reducing metal ions) to catalyze the decomposition of HP, while also fusing with the tooth surface to continuously generate reactive oxygen species, thereby removing pigments and impurities from enamel and dentin more quickly and effectively. Simultaneously, HP, by decomposing acquired biofilms and pigments on the tooth surface, promotes the binding of more CPIC gels to the tooth, accelerating remineralization by constructing a biomimetic mineralization front, forming a dense mineralized film. The combined use of CPIC gel and HP gel allows for teeth whitening while simultaneously repairing them, preventing rapid re-staining after whitening. Attached Figure Description

[0099] Figure 1 This is a before-and-after comparison of the shade of teeth treated with the teeth whitening and enamel remineralization composition of this invention.

[0100] Figures 2-3 Electron micrographs of teeth (tooth body) before whitening using the teeth whitening and enamel remineralization composition in this embodiment of the invention;

[0101] Figures 4-5Electron micrographs of teeth after whitening using the teeth whitening and enamel remineralization composition in this embodiment of the invention.

[0102] Figures 6-7 Electron micrographs of teeth after whitening and 6-hour mineralization treatment using the teeth whitening and enamel remineralization composition described in this embodiment of the invention.

[0103] Figures 8-9 Electron micrographs of teeth after whitening and 24-hour mineralization treatment using the teeth whitening and enamel remineralization composition described in this embodiment of the invention.

[0104] Figure 10 Electron micrograph of the enamel surface after whitening and 24-hour mineralization treatment of teeth using the teeth whitening and enamel remineralization composition in this embodiment of the invention.

[0105] Figure 11 Microscopic image of CPIC attached to the surface of natural teeth;

[0106] Figure 12 Electron micrographs of teeth treated with a teeth whitening and enamel remineralization composition that removes HP activator.

[0107] Figure 13 This is a flowchart illustrating the method of using the teeth whitening and enamel remineralization composition in an embodiment of the present invention.

[0108] Figure 14 This is a schematic diagram of the application device for the teeth whitening and enamel remineralization composition in an embodiment of the present invention.

[0109] In the above figures: 1. Receiving part; 11. First tube body; 12. Second tube body;

[0110] 2. Mixing section; 21. Discharge port; 22. Mixing segment; 23. Guiding segment; 24. Output segment;

[0111] 3. Propulsion section; 31. First push rod; 32. Second push rod; 33. Push plate. Detailed Implementation

[0112] The present invention will be further described below with reference to the accompanying drawings and embodiments:

[0113] Example: The present invention will be clearly described below with illustrations and detailed description. Any person skilled in the art who understands the examples of the present invention can make changes and modifications based on the technology taught in the present invention without departing from the spirit and scope of the present invention.

[0114] The terminology used herein is for the purpose of describing specific embodiments only and is not intended to limit the scope of this work. Singular forms such as “a,” “this,” “this,” “the,” and “the” as used herein also include plural forms.

[0115] Teeth whitening and enamel remineralization compositions, including CPIC gel and HP gel;

[0116] The CPIC gel comprises a composite CPIC, an HP activator, and a first pH adjuster;

[0117] The composite CPIC includes calcium ions, phosphate ions, and weakly reducing metal ions;

[0118] The HP activator includes a transition metal complex for promoting HP decomposition;

[0119] The first pH adjuster is used to control the pH value of the CPIC gel within a weakly alkaline range;

[0120] The HP gel comprises HP, an HP stabilizer, and a second pH adjuster;

[0121] The HP stabilizer is used to bind the weakly reducing metal ions in the HP gel to prevent HP decomposition.

[0122] The second pH adjuster is used to control the pH value of the HP gel within 4-6.

[0123] Unless otherwise stated, all percentages and ratios in this embodiment refer to weight percentages and weight ratios.

[0124] As used in this embodiment, the term "polymer" or "polymers" refers to polymers prepared from monomeric compounds through polymerization reactions. The term "ionic cluster" refers to a compound or aggregate of ions composed of combinations of cations and anions. Ionic clusters are similar to polymers, but they are formed by ionic bonds and are entirely composed of ions. Specifically, calcium phosphate ion clusters (CPICs) refer to compounds that exist in solution as calcium ions (Ca... 2+ ) and phosphate ions (PO4) 3- CPIC is an ion aggregate mainly composed of calcium phosphate (ACP). It is an important intermediate in the formation of calcium phosphate minerals (such as amorphous calcium phosphate (ACP) and hydroxyapatite (HAP)). Amorphous calcium phosphate (ACP) is an early precursor phase in the biomineralization crystallization process, exhibiting short-range order and long-range disorder, and is thermodynamically unstable, readily transforming into crystalline forms such as hydroxyapatite. CPIC can form ACP mineralization fronts on hard tissue surfaces, thereby biomimeticly repairing enamel and dentin in the oral environment.

[0125] The ratio of CPIC gel to HP gel is not limited and can be adjusted according to actual needs.

[0126] Preferably, the proportion of HP stabilizer in HP gel is <1%, so that HP stabilizer can only play a role in HP gel, and the proportion of HP is at least 6%-40%.

[0127] The first pH adjuster is used to control the pH value of the CPIC gel within a slightly alkaline range. The specific range is not limited, and you can refer to the following examples for understanding.

[0128] The preparation process of conventional CPIC can be carried out according to the method disclosed in Chinese Patent CN110157132B. For example, it can be prepared by the following method: dissolving 2 g of CaCl2·2H2O in 0.8 L of ethanol; then, at room temperature, adding 38 mL of triethylamine (TEA) to the above solution under magnetic stirring, and stirring for 30 minutes; next, at room temperature, adding a phosphoric acid ethanol solution (0.7 mL of phosphoric acid (85 wt%) dissolved in 200 mL of ethanol) to the above solution under magnetic stirring, and stirring; then, centrifuging at 8000 rpm to obtain a gel, and washing several times with ethanol to obtain conventional CPIC, wherein the molar ratio of calcium (Ca) to phosphorus (P) is 0.9-2.0.

[0129] The preparation process of composite CPICs is an improvement upon the conventional CPIC preparation process. In the conventional CPIC synthesis process described above, 0.001-1 g of MnCl2·4H2O is added as a manganese source to the calcium source, generating manganese-containing CPICs (composite CPICs) to enhance the HP activation function of conventional CPICs without affecting their mineralization function. Based on the knowledge of HP activation, the manganese source here can also be replaced or supplemented with 0.001-1 g of other weakly reducing metal ions with similar functions, such as iron, cobalt, nickel, copper, and tin sources. Alternatively, after the conventional CPIC synthesis, weakly reducing metal ion sources such as iron, cobalt, nickel, copper, and tin can be added for doping.

[0130] The molecular formula of the composite CPIC is: Ca x M y H z (PO4) a N b Where M is an inorganic cation, such as Mn 2+ Fe 2+ Co 2+ Ni 2+ Cu + Sn 2+ Mg 2+ Zn 2+ Na + K + etc.; N is an inorganic anion, such as OH-- Cl - F - Carbonate, sulfate, acetate, and citrate, etc., x, y, z, a, and b are reduced real numbers not exceeding 3 and represent the relative proportions of the components that make up the ion cluster. The ranges of x and a are 1-3, and the ranges of y, z, and b are 0-1.

[0131] The composite CPIC has the following chemical properties: the product is neutral or weakly alkaline (pH 6.5-9.5), insoluble in water, soluble or slightly soluble in acid, and can combine with dental calcium phosphate minerals and promote the formation of mineralized layers.

[0132] Composite CPIC has the following physical properties: it is a white or colored gel-like substance with a solid content between 5% and 50% and a certain degree of fluidity. It can be formed into a bulk material through solvent evaporation.

[0133] The difference between this and a regular CPIC is that the composite CPIC introduces Mn. 2+ Fe 2+ Co 2+ Ni 2+ Cu + Sn 2+ Weakly reducing metal ions can promote the decomposition of HP, forming HP-activated CPIC.

[0134] HP activators are used to activate HP, promoting its decomposition to form reactive oxygen species. HP activators include transition metal complexes that promote HP decomposition, such as manganese EDTA or cobalt gluconate. Preferably, the transition metal complex is cobalt gluconate.

[0135] The first pH adjuster can be triethanolamine (TEA), sodium tripolyphosphate, sodium bicarbonate, sodium citrate, disodium hydrogen phosphate, etc., which can control the pH of CPIC gel under weakly alkaline conditions to ensure the storage stability of CPIC gel. When CPIC gel and HP gel are mixed to form a composition, the second pH adjuster can be used to adjust the pH of the composition to neutral (pH≈7.0–7.4), so that the combined activity of CPIC component and HP component is optimal.

[0136] The second pH adjuster can be citrate or phosphate, which is used to control the pH of HP gel within 4-6 to ensure the stability of HP storage.

[0137] HP stabilizers can be composed of EDTA salts, phosphates, or polyphosphates. Preferably, the HP stabilizer is an EDTA salt. The function of the HP stabilizer is to bind residual trace amounts of weakly reducing metal ions in the components to prevent HP decomposition and improve the shelf stability of HP gel products.

[0138] The CPIC component in CPIC gel (regular CPIC) and the HP component in HP gel have a synergistic effect, specifically as follows: On the one hand, HP can break down acquired biofilms and pigments on the tooth surface, thereby exposing tooth minerals and promoting the binding of CPIC to the tooth, thus activating the mineralization of the tooth in the saliva environment; on the other hand, after CPIC promotes the formation of a dense mineralized film on the tooth surface, it can prevent pigment redeposition, thereby consolidating the whitening effect of HP, that is, the two promote each other.

[0139] The HP stabilizer in HP gel and the weak reducing metal ions in CPIC gel have a synergistic effect, as follows: On the one hand, the HP stabilizer can bind to the small amount of weak reducing metal ions remaining in the HP gel components, preventing HP decomposition during shelf storage and maintaining the product's long-lasting bleaching activity; on the other hand, when CPIC gel and HP gel are mixed, the weak reducing metal ions in HP-activated CPIC (composite CPIC) can reactivate HP, promote the release of reactive oxygen species on the tooth surface through the enrichment of CPIC on the tooth surface, and improve the utilization of active substances for pigment decomposition. This combination of components can achieve teeth whitening and remineralization simultaneously.

[0140] The second pH adjuster in HP gel and the first pH adjuster in CPIC gel have a synergistic effect, as follows: The second pH adjuster can control the pH value of HP gel within 4-6 to ensure the stability of HP storage; the first pH adjuster can control the pH of CPIC gel under weakly alkaline conditions to ensure the stability of CPIC gel storage; the second and first pH adjusters can adjust the pH of the composition to neutral (pH≈7.0–7.4) when CPIC gel and HP gel are mixed to form a composition, so that the combined activity of CPIC component and HP component is optimal. At this time, the decomposition process of HP is activated, and CPIC binds to the tooth, activating the mineralization of the tooth in the salivary environment.

[0141] In summary, the composition, comprising CPIC gel and HP gel, simultaneously achieves teeth whitening and enamel remineralization. The activated calcium phosphate ion clusters in the CPIC gel act as catalysts (primarily weakly reducing metal ions) to catalyze the decomposition of HP, while also fusing with the tooth surface to continuously generate reactive oxygen species, thereby removing pigments and impurities from enamel and dentin more quickly and effectively. Simultaneously, HP, by decomposing acquired biofilms and pigments on the tooth surface, promotes the binding of more CPIC gels to the tooth, accelerating remineralization by constructing a biomimetic mineralization front, forming a dense mineralized film. The combined use of CPIC gel and HP gel allows for teeth whitening while simultaneously repairing them, preventing rapid re-staining after whitening.

[0142] Additional notes regarding HP-activated CPIC and HP activator:

[0143] HP activators are additional activators added to the components (such as manganese EDTA and cobalt gluconate), and their molecular form and function are not entirely the same as those of activated CPICs. Taking manganese source as an example, the manganese in HP-activated CPICs is fixed in the form of manganese ion doping inside and on the surface of the CPIC. Its mechanism of action is to decompose HP through the solid-phase catalysis of manganese ions on the surface of the CPIC. In contrast, HP activators are molecular / free manganese, and their function is to decompose HP through molecular catalysis.

[0144] HP-activated CPIC can bind to tooth structure, promoting mineralization and the decomposition of HP near the tooth surface, thereby increasing the concentration of reactive oxygen species near the tooth surface. The combined use of HP-activated CPIC and HP activator can have a synergistic bleaching effect: HP-activated CPIC can specifically increase the concentration of highly reactive free radicals around the tooth, making HP more efficient at degrading organic stains and improving bleaching efficacy; while HP activator mainly increases the concentration of reactive free radicals in the gel itself, preventing the concentration of reactive free radicals on the tooth surface from decreasing due to diffusion into the bulk phase, thus prolonging the bleaching effect. The two complement each other and synergistically enhance the effect.

[0145] HP activators can also prevent HP stabilizers (such as EDTA salts, phosphates, or polyphosphates) in HP gel components from decomposing CPIC. According to chemical principles, HP stabilizers can coordinate with calcium ions and variable-valence metal ions, thereby dissolving CPIC and causing it to lose its mineralization-inducing activity. HP stabilizers are essential components in HP gel components, and their purpose is to coordinate with residual iron, cobalt, and nickel ions introduced by the solvent or production process, "passivating" them and thus significantly slowing down their catalytic decomposition rate of HP. By introducing HP activators, according to Le Chatelier's principle, introducing products into the system will shift the reaction equilibrium in a direction unfavorable to product production, thereby preventing HP stabilizers from destroying CPIC.

[0146] In this embodiment, the CPIC gel further includes at least one of surfactants, thickeners, wetting agents, tooth desensitizers, preservatives, and flavoring agents;

[0147] The HP gel also includes at least one of a foam stabilizer, a thickener, a wetting agent, and a preservative.

[0148] The ingredients of a tooth desensitizing agent can be: potassium nitrate (concentration can be 1-5 wt%) + sodium fluoride (concentration can be 0.2 wt%). Tooth desensitizing agents are used to reduce tooth sensitivity caused by exposure of dentinal tubules during the whitening process.

[0149] The surfactant can be anionic surfactant, such as C8 to C96. 18Sodium, magnesium, ammonium, or ethanolamine salts of alkyl sulfates (e.g., sodium lauryl sulfate), C8 to C96 salts. 18 Sodium, magnesium, ammonium, or ethanolamine salts of alkyl sulfosuccinic acids (e.g., sodium dioctyl sulfosuccinate), C8 to C945 salts. 18 Sodium, magnesium, ammonium, or ethanolamine salts of alkyl sulfonates (e.g., sodium lauryl sulfonate), C8 to C94 salts. 18 Sodium, magnesium, ammonium, or ethanolamine salts of alkyl sarcosine (e.g., sodium lauryl sarcosine), C8 to C8 salts. 18 Sodium, magnesium, ammonium, or ethanolamine salts of alkyl phosphates (optionally containing up to 10 ethylene oxide and / or propylene oxide units) and sulfated glycerol monoesters. Surfactants may also include nonionic surfactants, such as optional polyoxyethylene sorbitan fatty acid esters, ethoxylated fatty acids, polyethylene glycol esters, ethoxylated monoglycerides and diglycerides of fatty acids, and ethylene oxide / propylene oxide block polymers. Other suitable surfactants include amphoteric surfactants, such as betaine or sulfobetaine. Mixtures of any of the above materials may also be used. Preferably, the surfactant is sodium lauryl sulfate.

[0150] The role of surfactants is to reduce the interfacial tension between CPIC clusters and particles in the gel, ensuring stable dispersion of the colloid; and to improve the wettability of the gel on the tooth surface, enabling CPICs to adhere more tightly to the dentin and enamel surfaces.

[0151] The thickener may consist of: sodium carboxymethyl cellulose (CMC), hydroxyethyl cellulose, methyl cellulose, ethyl cellulose, tragacanth gum, gum arabic, carrageenan, sodium alginate, carrageenan, guar gum, xanthan gum, starch, modified starch, silica-based thickeners (including silica aerogels), magnesium aluminum silicate (such as Veegum), carbomer (crosslinked acrylate), and mixtures thereof. Preferably, the thickener is carbomer 940.

[0152] The role of thickeners is to form a three-dimensional network structure in the gel system, provide the required viscosity and thixotropy, prevent the components from separating or settling; ensure controllable flowability when the gel is extruded or brushed, so that the gel can be quickly fixed on the dental tray and tooth surface after use.

[0153] The wetting agent may be composed of glycerin, ethylene glycol, propylene glycol, polyethylene glycol (PEG), etc. Preferably, the wetting agent is glycerin.

[0154] The functions of humectants are: to moisturize, preventing the gel from drying out too quickly in the oral environment and under light conditions; to improve taste and reduce irritation to soft tissues; to synergistically improve the adhesion and moisturizing properties of the gel, prolonging the residence time of active ingredients on the tooth surface; and to promote penetration, helping CPIC to fully contact enamel fissures and preventing tooth dehydration.

[0155] Preservatives can be parabens, potassium sorbate, sodium benzoate, clove oil (containing eugenol), etc. Preservatives are used to ensure the gel remains stable at room temperature and in the oral microbial environment to prevent expiration.

[0156] Fragrance agents can be menthol or natural peppermint oil. Fragrance agents can enhance the user experience and help alleviate mild irritation that HP may cause.

[0157] Foam stabilizers can be composed of silica and polymeric surfactants, such as polyoxyethylene-polyoxypropylene-polyoxyethylene block copolymers (Pluronic / Poloxamer series), PEG-150 distearate, acrylic acid / ammonium acrylate copolymers (Carbomer series) derivatives, polyacrylamide / isohexadecane copolymers, and cocamidopropyl betaine. When HP decomposes, the reactive oxygen free radicals formed combine to form oxygen, and the continuous release of oxygen leads to a decrease in the utilization rate of HP's reactive oxygen free radicals. Foam stabilizers can control the state of oxygen bubbles formed in the gel, making the bubbles finer and more stable, and ensuring they are more uniform and smaller, preventing them from growing larger, breaking, and escaping, thus preventing a decrease in HP utilization due to oxygen escape.

[0158] The thickeners, wetting agents, and preservatives in HP gels are the same as those in CPIC gels.

[0159] See Figure 13 The method of using the teeth whitening and enamel remineralization composition includes:

[0160] Step 1: Store the CPIC gel and HP gel separately in the initial storage area;

[0161] Step 2: Transfer portions of the CPIC gel and HP gel from the initial storage area to the intermediate mixing area to obtain the first composition;

[0162] Step 3: Transfer at least a portion of the remaining CPIC gel and the remaining HP gel from the initial storage area to the transfer mixing area to obtain a second composition, which is capable of expelling at least a portion of the first composition from the transfer mixing area.

[0163] Initially, CPIC gel and HP gel are stored separately to avoid mutual interference, allowing for the creation of suitable storage environments for each. The initial storage area can include two completely isolated first and second storage areas to store CPIC gel and HP gel respectively.

[0164] In step two, the first composition may fill or nearly fill (e.g., fill more than 90%) the transfer mixing region. The CPIC gel and HP gel are compounded in the transfer mixing region to form the first composition for synergistic cooperation during subsequent use.

[0165] The first composition needs to be used after it is formed. Therefore, the second composition is formed in step three, and the second composition pushes the first composition out of the transfer mixing area. This not only makes it convenient to use the first composition, but also avoids the first composition occupying the transfer mixing area and hindering the formation of subsequent compositions.

[0166] Understandably, by observing the total remaining amount of CPIC gel and HP gel in the initial storage area, both can be added to the initial storage area to replenish it.

[0167] Understandably, the amount of the second composition formed determines whether the entire first composition is removed from the transit mixing zone.

[0168] In this embodiment, in step two, during the transfer phase of CPIC gel and HP gel, the start and end times of the transfer are the same for both, meaning that their transfer time periods overlap, which simplifies the control of the transfer process and makes operation more convenient.

[0169] In this embodiment, in step two, a mixing structure is used to mix the CPIC gel and HP gel entering the intermediate mixing area to accelerate the formation speed of the first composition and the second composition. This can improve the mixing degree of CPIC gel and HP gel in the first composition and the second composition, and ensure that CPIC gel and HP gel can work together in subsequent use.

[0170] The mixing structure can be an existing stirring structure (such as including stirring blades), and there are no specific restrictions.

[0171] See Figure 14 An application device for a teeth whitening and enamel remineralization composition, comprising:

[0172] The receiving part 1 includes a first cavity and a second cavity for receiving CPIC gel and HP gel, respectively;

[0173] The mixing section 2, connected to the receiving section 1, includes a mixing chamber that communicates with both the first cavity and the second cavity. The mixing chamber is used to provide space for mixing the CPIC gel and the HP gel to form a composition. The mixing section 2 has an outlet 21 for discharging the composition.

[0174] The propulsion unit 3 is movably disposed in the receiving unit 1 for pushing the CPIC gel and the HP gel into the mixing cavity.

[0175] Initially, the CPIC gel is stored in the first chamber, and the HP gel is stored in the second chamber. Next, the pusher 3 gradually pushes the CPIC gel and HP gel into the mixing chamber 2, causing them to mix and form a composition. Subsequently, under normal circumstances, the majority of the composition is gradually ejected from the mixing chamber by the subsequently formed composition for use.

[0176] The arrangement of the first and second chambers in the housing 1 allows CPIC gel and HP gel to be stored separately to avoid mutual interference and to create suitable storage environments for each. It is understood that the first and second chambers can be completely separated, which is a standard configuration. The volume ratio of the first to second chambers can be set to 1:1 to 1:4 to facilitate different component formulation designs.

[0177] The mixing section 2 includes only a single mixing chamber that provides space for the formation of the composition, and the composition can be output through the discharge port 21.

[0178] The propulsion unit 3 provides the driving force for the transfer of CPIC gel and HP gel, enabling the two to achieve the transfer in the above processes.

[0179] In summary, the application device can effectively mix HP gel and CPIC gel evenly, allowing the components to work synergistically to achieve the aforementioned teeth whitening and remineralization effects.

[0180] In this embodiment, the receiving part 1 includes two first tubes 11 and second tubes 12 arranged side by side in a first direction. The first tubes 11 and second tubes 12 have the same length and both extend along the second direction. The first direction and the second direction are orthogonal.

[0181] The first cavity penetrates the first tube 11 along the second direction; the second cavity penetrates the second tube 12 along the second direction.

[0182] For the first and second directions, please refer to the appendix respectively. Figure 14 The distribution direction of the first tube body 11 and the second tube body 12, and the extension direction of the first tube body 11 and the second tube body 12.

[0183] The first tube 11, the second tube 12, the first cavity, and the second cavity can all be cylindrical. The radial dimensions of the first cavity and the second cavity can be different or the same, and can be adjusted according to actual needs.

[0184] The arrangement of the first tube 11 and the second tube 12 completely separates the first cavity from the second cavity, allowing CPIC gel and HP gel to be stored completely independently.

[0185] The first tube 11 and the second tube 12 are of the same length, which makes it easy for the receiving part 1 to be adapted to the mixing part 2 and the propulsion part 3. For example, the contact surface between the mixing part 2 and the receiving part 1 can be a plane. The mixing part 2 can use an existing mixing device with a frustum-shaped structure without modification to adapt to the receiving part 1.

[0186] In summary, this embodiment employs a dual-tube design, allowing the CPIC active component and the HP active component to be stored separately in optimal weakly alkaline and weakly acidic environments in gel form. Before use, the components in both tubes are mixed, transforming the gel medium into a neutral environment. Combined with the catalytic effect of CPIC, this activates HP, enabling its rapid decomposition and releasing reactive oxygen species to degrade pigment molecules on the tooth surface, enhancing its whitening activity. Simultaneously, during HP bleaching, it removes the organic contamination layer from the tooth surface and activates tooth minerals (exposing high-energy surfaces and increasing interfacial energy), facilitating the mineralization effect of CPIC. This allows for the rapid formation of a mineral layer on the tooth surface, and through subsequent continuous mineralization, a dense mineralized layer is formed on the tooth surface. This layer repairs micro-damage to the teeth caused during the bleaching process and forms a dense protective layer, preventing the re-deposition of pigments and bacteria, thus ensuring the stability of the teeth whitening effect and maintaining tooth health. Through this dual-component formulation design, combined with the accompanying device, the dual effects of whitening and remineralization can be achieved, overcoming the shortcomings of existing whitening technologies.

[0187] In this embodiment, the propulsion unit 3 includes:

[0188] The first push rod 31 extends along the second direction, with one end sealed and movable in the first cavity;

[0189] The second push rod 32 extends along the second direction, with one end sealed and movable in the second cavity;

[0190] Push plate 33 is connected to the end of the first push rod 31 away from the mixing part 2 and the end of the second push rod 32 away from the mixing part 2;

[0191] The first push rod 31 and the second push rod 32 are of the same length.

[0192] Taking the first push rod 31 as an example, the first push rod 31 is inserted into the first cavity to push the CPIC gel. The first push rod 31 can be adapted to the size of the first cavity to prevent the CPIC gel from bypassing the first push rod 31 and leaking out. The first push rod 31 and the first cavity are actually in a dynamic sealing relationship.

[0193] When in use, push the push plate 33, which in turn drives the first push rod 31 and the second push rod 32.

[0194] The first pusher 31 and the second pusher 32 are of the same length. During the transfer phase of CPIC gel and HP gel, while controlling the initial injection volume of both, the start and end times of the transfer can be the same, meaning their transfer time periods can overlap. This simplifies the control of the transfer process, making operation easier and allowing for simultaneous control of their output volumes. It is understandable that to control the proportion of both entering the mixing chamber per unit time, the cross-sectional dimensions of the first and second chambers can be adjusted.

[0195] The mixing section 2 may include a mixing section 22, a guiding section 23, and an output section 24 connected sequentially along a second direction. The mixing section 22 is connected to the receiving section 1, the mixing chamber is disposed within the mixing section 22, and the discharge port 21 is disposed within the output section 24. Along the direction from the propulsion section 3 toward the mixing section 2, the dimensions of the mixing section 22 and the output section 24 may gradually decrease (e.g., in a frustum shape). The guiding section 23 may be cylindrical. An existing stirring structure (or mixing structure) may be provided within the mixing section 22. The guiding section 23 and the output section 24 may be bent to form a curved conveyor head.

[0196] The following provides specific embodiments and comparative examples for illustration:

[0197] Example 1

[0198] A. Clean the user's teeth to remove food debris and other impurities from the tooth surface.

[0199] B. Mix CPIC gel and HP gel to form a composition, then apply the composition to the teeth or squeeze it into the dental tray. For the latter, place the dental tray in the user's mouth to allow the composition to fully react with the user's teeth.

[0200] C. Wait 15 minutes.

[0201] D. Results are shown in Figure 1 The teeth's shade improved from 1M2 to 0M1, an improvement of four shades. This demonstrates that the combination of CPIC gel and HP gel can quickly whiten teeth.

[0202] Example 2

[0203] A. Mix CPIC gel and HP gel to form a composition, and then apply the composition to the tooth.

[0204] B. Wait 20 minutes.

[0205] C. Repeat AB once, see Figures 2-5 We can conclude that:

[0206] Before whitening, the fish-scale structure of tooth enamel is tightly arranged with clear boundaries. Some areas are covered by an organic staining layer, while crystal clusters are visible in other areas, and rod-shaped crystals are intact.

[0207] After two whitening treatments, the organic staining layer was removed, the fish-scale-like features of the enamel were destroyed, and the microscopic magnification revealed that the rod-shaped crystal features were destroyed after whitening, forming granular substances.

[0208] It can be concluded that HP charges organic matter through active oxidation, thereby increasing its water solubility, causing the organic stain layer to detach from the enamel surface. In addition, the bleaching effect of HP degrades the protein molecules that act as adhesives between enamel minerals, resulting in the destruction of the mineral structure after whitening, which in turn leads to the overall loosening of the enamel structure.

[0209] D. After whitening, the teeth are mineralized in simulated saliva.

[0210] E. Wait 6 hours, see Figure 6 , Figure 7 We can conclude that:

[0211] Through the whitening effect of HP (ingredient), CPIC (ingredient) fuses with the tooth body and activates the surface. After soaking in simulated saliva for 6 hours, a thin mineralized layer is formed on the surface of the enamel. Although the fish-scale structure of the enamel is still faintly visible, the original loose mineral features have been replaced by the mineralized layer structure. The grooves and gaps of the original fish-scale structure have been basically filled by the mineral layer, making the overall enamel structure smoother and denser.

[0212] As HP removes the organic contamination layer, CPIC can more easily bind directly to the enamel, thereby activating the tooth surface. Under the mineral deposition and mineralization effect of saliva, a mineralized layer gradually forms on the tooth surface.

[0213] F. Continue mineralizing the tooth structure in simulated saliva;

[0214] G. Wait 18 hours, see Figure 8 , Figure 9 We can conclude that:

[0215] After whitening, the teeth are soaked in simulated saliva for 24 hours, and a dense mineralized layer forms on the surface of the enamel. The fish-scale structure of the enamel disappears, and the enamel structure becomes smooth and dense.

[0216] See Figure 10 The cross-sectional structural features of the dense mineralized layer show that the mineralized layer is about 3 micrometers in size and is composed of columnar characteristic crystals similar to hydroxyapatite. The crystals are arranged in a tight overall manner, that is, through the early induced crystal overgrowth and spatial competition growth of the mineralized layer, a dense mineral layer is eventually formed on the tooth surface.

[0217] Comparative Example 1

[0218] With other factors kept constant, one portion of the teeth was first whitened with HP gel and then remineralized with CPIC gel. Another portion of the teeth was treated with a combination of HP gel and CPIC gel for both whitening and remineralization. The results are shown in the table below:

[0219]

[0220] The table above shows that, compared with the traditional operation (whitening first and then mineralizing), the two-component whitening / remineralization synergistic design can reduce the whitening level of the dental X-ray from 1M2 to 0M1 from 5 whitening treatments to 2, which can greatly shorten the treatment time. On the other hand, the total time from whitening damage to the formation of a 3-micron mineralization layer is reduced from 4 days to 1 day.

[0221] See Figure 11 Further investigation into the microstructure of CPIC adhesion on the natural tooth surface revealed that CPIC does not readily adhere to areas with organic contamination layers, but rather deposits in the mineral regions of the enamel. This explains why the whitening / remineralization synergy is more effective: on the one hand, after the whitening treatment removes organic contaminants, the exposed tooth minerals are more easily deposited, thus promoting tooth mineralization; on the other hand, CPIC deposited on the tooth surface can catalyze the formation of reactive oxygen species, which is more conducive to the degradation of surrounding organic matter. The synergistic effect of these two factors allows the product (composition) to achieve a dual enhancement in both whitening and mineralization.

[0222] Comparative Example 2

[0223] HP gel and CPIC gel are combined into a composition, in which HP activator is removed from the first composition and HP activator is retained in the second composition;

[0224] With other factors kept constant, one portion of the teeth was treated with the first composition for whitening and remineralization, while another portion was treated with the second composition for whitening and remineralization. The results are shown in the table below:

[0225]

[0226] The table above shows that without the presence of HP activator, the whitening effect of HP is not fully realized, and the teeth whitening effect is greatly reduced, requiring 20 treatments to improve the color from 1M2 to 1M1. Furthermore, due to the presence of contaminants, the mineralization of the tooth surface exhibits an uneven state (see...). Figure 12 ).

[0227] The above embodiments are only for illustrating the technical concept and features of the present invention, and are intended to enable those skilled in the art to understand the content of the present invention and implement it accordingly. They should not be construed as limiting the scope of protection of the present invention. All equivalent changes or modifications made in accordance with the spirit and essence of the present invention should be covered within the scope of protection of the present invention.

Claims

1. A teeth whitening and enamel remineralization composition, characterized in that: Including CPIC gel and HP gel; The CPIC gel comprises a composite CPIC, an HP activator, and a first pH adjuster; The composite CPIC comprises calcium ions, phosphate ions, and weakly reducing metal ions; the molecular formula of the composite CPIC satisfies Ca... x M y H z (PO4) a N b Where M is an inorganic cation selected from Mn 2+ Fe 2+ Co 2+ Ni 2+ Cu + Sn 2+ Mg 2+ Zn 2+ Na + and K + Either of the following, where N is an inorganic anion selected from OH. - Cl - F - Any one of carbonate, sulfate, acetate and citrate, x, y, z, a and b do not exceed 3, x and a are in the range of 1-3, and y, z and b are in the range of 0-1; The HP activator includes a transition metal complex for promoting HP decomposition, the transition metal complex being selected from either manganese EDTA or cobalt gluconate. The first pH adjuster is used to control the pH value of the CPIC gel within a weakly alkaline range; The HP gel comprises HP, an HP stabilizer, and a second pH adjuster; The HP stabilizer is used to bind the weakly reducing metal ions in the HP gel to prevent HP decomposition; the HP stabilizer is selected from any one of EDTA salts, phosphates, and polyphosphates. The second pH adjuster is used to control the pH value of the HP gel within 4-6.

2. The teeth whitening and enamel remineralization composition according to claim 1, characterized in that: The CPIC gel further includes at least one of surfactants, thickeners, wetting agents, tooth desensitizers, preservatives, and flavorings; The HP gel also includes at least one of a foam stabilizer, a thickener, a wetting agent, and a preservative.

3. The method of using the teeth whitening and enamel remineralization composition, characterized in that: The method of using the teeth whitening and enamel remineralization composition according to any one of claims 1-2 includes: Step 1: Store the CPIC gel and HP gel separately in the initial storage area; Step 2: Transfer portions of the CPIC gel and HP gel from the initial storage area to the intermediate mixing area to obtain the first composition; Step 3: Transfer at least a portion of the remaining CPIC gel and the remaining HP gel from the initial storage area to the transfer mixing area to obtain a second composition, which is capable of expelling at least a portion of the first composition from the transfer mixing area.

4. The method of using the teeth whitening and enamel remineralization composition according to claim 3, characterized in that: In step two, during the transfer phase of CPIC gel and HP gel, the start and end times of transfer are the same for both.

5. The method of using the teeth whitening and enamel remineralization composition according to claim 3, characterized in that: In step two, a mixing structure is used to mix the CPIC gel and HP gel that enter the intermediate mixing area.

6. The method of using the teeth whitening and enamel remineralization composition according to claim 3, characterized in that: This is achieved through an application device, which includes: The receiving part (1) includes a first cavity and a second cavity for receiving CPIC gel and HP gel respectively; The mixing section (2), connected to the receiving section (1), includes a mixing chamber that communicates with both the first chamber and the second chamber. The mixing chamber is used to provide space for mixing the CPIC gel and the HP gel to form a composition. The mixing section (2) has an outlet (21) for discharging the composition. The propulsion part (3) is movably disposed in the receiving part (1) for pushing the CPIC gel and the HP gel into the mixing cavity.

7. The method of using the teeth whitening and enamel remineralization composition according to claim 6, characterized in that: The receiving part (1) includes two first tubes (11) and second tubes (12) arranged side by side in a first direction. The first tubes (11) and the second tubes (12) have the same length and both extend along the second direction. The first direction and the second direction are orthogonal. The first cavity penetrates the first tube (11) along the second direction; the second cavity penetrates the second tube (12) along the second direction.

8. The method of using the teeth whitening and enamel remineralization composition according to claim 7, characterized in that: The propulsion unit (3) includes: The first push rod (31) extends along the second direction, with one end sealed and movable in the first cavity; The second push rod (32) extends along the second direction, with one end sealed and movable in the second cavity; Push plate (33) is connected to the end of the first push rod (31) away from the mixing part (2) and the end of the second push rod (32) away from the mixing part (2); The first push rod (31) and the second push rod (32) are of the same length.

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