ES2350745T3 - DENTAL WHITENING COMPOSITIONS OF TWO COMPONENTS. - Google Patents

Abstract

Method for whitening teeth and providing a sensitivity relief comprising: providing a two component tooth whitening system having a first component comprising at least one peroxide compound, at least one phosphate source and at least one gelling agent and a second component comprising at least one source of calcium, strontium or a mixture thereof and at least one foaming or gelling agent; mix the two components; and apply the mixed components to the surface of the teeth.

Description

Two teeth bleaching compositions components.

The present invention relates to a method to whiten teeth and provide relief from sensitivity.

A tooth is composed of a dentin layer internal and an external hard enamel that is coated with a layer protective called the acquired film. The enamel layer is composed of hydroxyapatite crystals that create a surface something porous The film or enamel can get stained or alter its color It is believed that the porous nature of the layer of enamel is what allows staining agents and substances color alteration permeate the enamel and alter the color the tooth.

Many substances they face or a person's teeth come in daily "stain" or reduce the "whiteness" of the teeth. In particular food products, tobacco products and fluids such as tea and coffee consumed tend to stain teeth. So these staining and color alteration substances can permeate the enamel and cause a noticeable color alteration of teeth. At the same time, some of the food and Drinks can cause demineralization of teeth.

One solution to the staining problem is through of teeth whitening. Some toothpastes, such as pastes teeth, gels, and powders, contain whitening agents that release active oxygen or hydrogen peroxide including peroxides, percarbonates and perborates of alkali metals and alkaline earth or complex compounds containing peroxide hydrogen.

The document EP-A-1192933 (Mitsubishi) gives Know photocatalytic tooth whitening compositions.

The document DE-A-1617430 (corresponding to Scheller US-A-3577521) unveils a toothpaste that produces foam using, between others, sodium pyrophosphate peroxyhydrate Na 2 P 2 O 7. 2H 2 O as a source of peroxide of hydrogen.

The document EP-A-0839517 (Unilever) unveils a two component gel based on a peroxide and an activator for the promotion of gum health.

The document US-A-4592487 (Simon) unveils a two component antimicrobial antiplaque toothpaste, containing one of the calcium phosphate components, for example, phosphate of dehydrated dicalcium and tricalcium phosphate.

Teeth whitening can be done using a bucket The amount of bleaching obtained during such teeth whitening depends on

(one)

the length of time the cuvette is worn every day;

(2)

the number of days the bucket;

(3)

the susceptibility of the teeth to the agent of whitening and

(4)

the concentration of active peroxides.

For maximum bleaching, a time is recommended Accelerated treatment of approximately 18-20 hours a day.

A concern with some compositions of whitening is that prolonged treatment with agents highly concentrated whitening present in the composition It can contribute to tooth sensitivity after treatment. Even treatments with compositions that are not known to increase dental sensitivity in most patients can still cause sensitivity in patients more prone to such tendencies of sensitivity

Another concern is aggressive brushing, or any treatment with lower pH bleaching compositions, as indicated in Price et al . (The pH of Tooth-Whitening Products, J Can Dent Assoc , 66: 421-6, 2000), can also lead to further demineralization of the tooth, decreasing its hardness.

Many attempts have been made to provide relief of dentinal sensitivity, sometimes in a separate system from the bleaching system. It has been realized other attempts to use a single system to combat both problems. At the same time, attempts have been made to remineralize the tooth, again in separate systems.

The document US-A-6036944 (Winston) unveils a two component system for dental remineralization that comprises mixing calcium salts, divalent metal compounds other than calcium, and phosphate salts, and apply said mixture to the surface of a tooth, which also discloses that it is also desensitization possible.

The document GB-A-1408922 (corresponding to US-A-4397837 of Blendax-Werke) unveils a system of two components for dental remineralization, providing a component a source of calcium and providing the other component a source of phosphate, and the incorporation of this system into Oral and dental cosmetic products, for example, paste teeth. The two components are applied successively for example, a toothpaste containing a component followed is applied for another toothpaste that contains the other component.

Therefore, there is still a need for a single system approach to solve all problems mentioned above and / or potential problems with which Face the tooth.

The present invention provides a method for whiten teeth and to provide sensitivity relief that it has the characteristics of claim 1 of the attached claims.

Embodiments of the invention may provide a unique system approach to whiten, relieve the sensitivity and for remineralization.

In one embodiment, the system may be a foamable composition

In another embodiment, the first component It may also contain a desensitizing agent.

In one embodiment, the second component may include at least one source of peroxide.

In another embodiment, the second component may include a desensitization agent.

In yet another embodiment, both components They can include a desensitizing agent.

In a further embodiment, the first component can also include a gel stabilizer.

Even in a further embodiment, the first component can be substantially milky, cloudy, opaque or colored, and the second component can be substantially transparent, and vice versa; or both components can be substantially milky, cloudy, opaque or colored.

In yet another embodiment, the two components of the system are adapted to be mixed and applied to teeth from a dental tray for sustained contact.

Still still in a further embodiment, the foamable system can form a foam that deflates, long duration, which has a half-life of at least about 1 hour.

Still in yet another embodiment, the system Foamed can be a foam that deflates, long lasting, which has a half-life of at least about a month.

In other embodiments, they can be provided the two system components in a two-cylinder syringe. In One aspect, the syringe may be provided with a dispensing tip. In another aspect, the dispensing tip may be adapted for foam production In an additional aspect, the tip can Include a mixer.

Still in other embodiments, they can provide the two system components in a container that It has separate compartments for the components. In one aspect, The container can be provided with a dispensing pump.

The present method allows a system approach for bleaching and remineralization. In one embodiment, the system may include a low content bleaching composition in peroxide that has a remineralization effect. In other embodiment, the system may include a bleaching composition of low peroxide content that has a remineralization effect With sensitivity relief. In yet another embodiment, the system may include a bleaching composition of low content in peroxide that has a remineralization effect and treatment with fluoride. In a further embodiment, the system may include a low peroxide bleaching composition having a remineralization effect, fluoride treatment and effect antibacterial In other embodiments, any one can be achieved. of the desired combination effects. In even more embodiments, other agents may be included, including agents antiplate, anti-stain agents, vitamin supplements or others which can be beneficial for teeth, breath or even general health care

The component that contains peroxide system above may include, for example, free peroxide compounds of metal ions. Examples of peroxide compounds free of Suitable metal ions include hydrogen peroxide and organic peroxides including urea peroxide (peroxide carbamide), glyceryl peroxide, benzoyl peroxide and Similar. More for example, peroxides include peroxide of hydrogen, carbamide peroxide and mixtures thereof. He total peroxide present in the bleaching gel ranges, for example, from about 0.5% by weight to about 45% by weight of the gel, more for example, from about 1% in weight up to about 35% by weight of the gel.

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When hydrogen peroxide is used, it usually provides as a 50% aqueous solution. When used alone, the amount of the aqueous peroxide solution of hydrogen in the peroxide gel ranges for example from approximately 1% to approximately 60% (0.5% to 30% in the absence of water); more for example, the amount ranges from approximately 2% to approximately 40% (from 1% to 20% in  absence of water).

On the other hand, when using peroxide carbamide, it is likely to be used in combination with peroxide hydrogen, although it can be used alone.

When used in combination, peroxide carbamide is generally present, for example, in an amount from about 0% by weight to about 40% by weight, and more for example, in an amount of from about 0.5% to about 35% by weight. To the same time, hydrogen peroxide is provided, for example, as a 50% aqueous solution and is generally present in an amount of from about 0.5% to about 30% (from 0.25% to 15% in the absence of water); more for example in an amount of about 1% to about 30% (of 0.5% to 15% in the absence of water).

The peroxide source may be present or either in one or both components of the system. When too is present in the second component, the combined total source of peroxide content is in the same range disclosed previously.

The composition can be a non-composition foamed, foamed or foamable. In general, a foamed composition  may include peroxide concentration equal to or greater than present in an unfoamed composition. On the other hand, a foamable composition may include a peroxide concentration superior in the unfoamed state so that the concentration of peroxide after foam production may be equal to or greater than level present in a typical gel. For foamable compositions, the amounts of peroxide indicated above may represent those of the foamed state.

For a non-foamed gel system, they can additional components are added to form a stable gel. These they can include gelling agents, gel stabilizers, humectants, and other adjuvants may be added to improve the gel consistency, to one or both components.

The gelling agents that can be used in the preparation of bleaching gels include, for example, gums cellulosic, pyrogenic silica, for example, pyrogenic silica CAB-O-SIL provided by Cabot Corporation, and emulsifying waxes such as Polawax ( NF emulsification) or CES Crodafos (cetearyl alcohol (and) phosphate of dicetyl (and) cetyl ether phosphate-10), provided by Croda, Inc., and mixtures thereof, in amounts to provide a stable gel. Some examples of Cellulosic gum may include "Klucel" GF, a Hercules hydroxymethylpropylcellulose.

In addition to the addition of heat, light and / or products chemicals, the amount of bleaching obtained during a procedure Whitening generally depends on (1) the duration of time in which the teeth are in contact with the bleaching agent; (2) the number of days on which the treatment is carried out; (3) the susceptibility of the teeth to the bleaching agent and (4) the concentration of active peroxide, as observed previously. For maximum bleaching, a Long treatment time with a whitening composition highly concentrated, as noted before.

The bleaching activity of a compound of peroxide is usually dictated by the availability of active peroxides, and generally not by the actual concentration of peroxide present in the composition. When the peroxide is present in solution, active peroxides are available easily. However, a dissolution, by its nature, is not easily contained, and / or not suitable for sustained action when applied to a patient's teeth, again because of his difficulty confining it in any desired location during Any length of time. Therefore, a peroxide solution less concentrated that requires a longer contact time for Being effective is not practical in a dissolution environment. A more concentrated peroxide solution, although more effective in the whitening is also not suitable in a dissolution environment because it will not solve the problem of prolonged contact and the confinement. In addition, any concentrated peroxide solution which can come into contact with soft tissue inside the mouth of A patient can potentially cause tissue damage. So, to maintain effective whitening with good containment so that potential tissue damage is minimized, various gelling agents, thickeners, adhesion promoters and / or similar additives, as discussed previously in the system not foamed. These result in the formation of pasta, gels and similar forms, which are effective bleaching systems. It is assumed that some of the additives used, although effective in containment and whitening, may decrease the activity of whitening by inhibiting the availability of active peroxides, especially if the composition contains thickeners or promoters of adhesion derived from acrylic acid polymers (carbomer), thickeners of pyrrolidone analogues, or others. Such additives they can lead to a decrease in the bleaching capacity of peroxides through ionic and covalent interactions within the gel, and act against the desired effect of tooth whitening.

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Foam production can be another way of improve substantivity without some of the additives mentioned previously. Foamed compositions can also provide prolonged contact without high amounts of additives that may tend to inhibit the activity of active peroxides, thus further improving the bleaching activity. Foams with equal or greater amounts of active ingredients and smaller amounts of ingredients inactive In a given volume, smaller amounts of inactive ingredients such as gelling agents, thickeners, adhesion promoters or the like may be present in the foamed state compared to the non-state foamed Without wishing to limit yourself to one theory, the air is supposed to It performs the function of an inactive ingredient such as an gelation, a thickener, an adhesion promoter or mixtures of the same, to provide the substantivity needed; but in general air molecules do not inhibit the availability of active peroxides to the same extent as other ingredients Inactive necessary for substantivity in a non-foamed gel. Therefore, a foamed composition has the substantivity of a composition that has higher amounts of ingredients such as gelling agents, thickeners, adhesion promoters or similar inactive ingredients, but with more availability of active peroxides for the bleaching action even if it is present the same concentration of peroxide. In other words, the foam production can in effect replace air bubbles with gelling agents to create substantivity.

Therefore, a foamed or foamable composition can increase the rate of laundering activity, if desired, without the problems with which the solutions are found. Not only is a manageable foamed composition without confinement problems During use, you can also supply a high concentration of active peroxide by not inhibiting the availability of peroxides assets, and at the same time, you can try to fill the cracks, which sometimes they seep into spaces where spaces are not evident, thus offering an effective bleaching action not only to the front surface of a tooth, but also to the surfaces between the teeth Therefore, foam production can provide potentially all the benefits that are not currently available for other bleaching systems.

In general, foams also have a lower surface tension than its unfoamed counterparts and by both can spread as thin as sheets of a molecule of thickness, while at the same time increasing its surface area, thus covering more area with the same volume of composition of bleaching than their non-foamed counterparts. The ability to Decreasing surface tension can also make stains  They are easier to remove.

Foamed bubbles, through forces of capillary action and decreased surface tension, are also by themselves same good wetting agents, so that a solution of whitening can penetrate through smaller openings, as noted above. Fast penetration into narrower points can also be helped by the distribution of the sizes and shapes of the bubbles. By therefore, foams can even cause more penetration deep active peroxide molecules.

It is also assumed that active peroxides They can also be captured inside the foam bubbles. TO As the bubbles deflate, the active peroxide agent It is released to perform laundering actions.

The foamed or foamable composition not only It has advantages over non-foamed gels, such as tried before, such as those flowing between sticks of the enamel, and that ensure that more active ingredients reach areas that could not be reached before, but also provides better sustained action in an area of use in the home.

For use in the home, a bucket for sustained contact between bleaching composition and the surface of the tooth or teeth for bleaching. Generally, compositions in the art use additives that They have high adhesion strength to help maintain the composition and even the bucket in place. Foams can provide such sustained contact without resorting to the use of the additive class adhesion promoters used in the art. Foams too they can spread more uniformly any tension exerted on the teeth or the bucket. In addition, foamed compositions have a lower density and therefore are more suitable for a sustained contact without gravity friction. Therefore, the foams not only facilitate the action of bleaching but also can facilitate ease of application, penetration into zones Hard to reach, retention and disposal. It is also assumed that active bleaching ingredients can be captured within bubbles and such bubbles can serve as devices of controlled bleaching when dosing the amount of active peroxides that act on the teeth over time as it deflate the bubbles.

In some embodiments, the composition Foamed can be prepared during the manufacture of gels and They can be packaged accordingly. The formation of foam by any shaking or shaking action, use of foaming agents and combinations thereof. Such foams can be prepared to be long lasting with a desired expiration term, for example, of at least approximately one month.

In other embodiments, they may be present. foaming agents to make the foamable composition so that foams are generated just before use. Some foaming agents they can also help in increasing the adhesion of the gel to a solid surface allowing it to spread over a surface area higher.

Still in other embodiments, they can be formed foams just before use by shaking with or without some foaming agent.

Therefore, some compositions include Less a foaming agent. Different categories of foaming agents, and can produce foams in different ways. Suitable foaming agents may include certain surfactants such as anionic, nonionic, amphoteric, zwitterionic, cationic, or mixtures thereof.

Some of these help in the formation of foam and some not. Some surfactants are merely useful for its foaming properties alone, some act only as agents emulsifiers or moistening without foaming, and some They even act to reduce foam production. The functions of the surfactants are not necessarily determined by the category to which they belong.

Anionic surfactants include, but are not limited to water soluble salts of alkyl sulfates having from about 8 to about 20 carbon atoms in the alkyl radical (such as sodium alkyl sulfate), salts water soluble sulfonated fatty acid monoglycerides that they have from about 8 to about 20 atoms of carbon and mixtures thereof. Examples of surfactants anionics include sodium lauryl sulfate, sodium sulphonates of coconut monoglycerides, phospholipids, sarcosinates, such as sodium lauryl sarcosinate, taurates, sodium lauryl sulfoacetate, sodium lauroylisethionate, lauryl ether carboxylate of sodium, and sodium dodecylbenzenesulfonate. Many of these anionic surfactants are disclosed in the patent U.S. 3,959,458.

Nonionic surfactants may include, but not limited to, compounds that include components hydrophilic and hydrophobic (which can be produced by condensation of alkylene oxide groups (hydrophilic in nature) with an organic hydrophobic compound that can be of nature aliphatic or alkylaromatic). Examples of surfactants do not Suitable ionics include low viscosity poloxamers (sold under the trade name Pluronic), hydroxyethylcellulose low viscosity, polysorbates, esters of polyoxyethylene sorbitan (sold under the name Tweens), fatty alcohol ethoxylates, condensates of poly (ethylene oxide) of alkylphenols, products derived from condensation of ethylene oxide with the reaction product of propylene oxide and ethylenediamine, condensates of ethylene oxide of aliphatic alcohols, chain tertiary amine oxides long, long chain tertiary phosphine oxides, long chain dialkylsulfoxides, and mixtures thereof.

Amphoteric surfactants may include, but not limited to, derivatives of secondary and tertiary amines aliphatic in which the aliphatic component can be a chain linear or branched and one of the aliphatic substituents contains from about 8 to about 18 carbon atoms and another contains an anionic water solubilization group, such as carboxylate, sulphonate, sulfate, phosphate, phosphonate, betaines, specifically cocamidopropyl betaine, and mixtures thereof.

Many of these nonionic surfactants and amphoteric are disclosed in U.S. Patent No. 4,051,234.

The surfactants set as an example, when they are used in foamable compositions, they are the ones that not only have certain foam production capabilities, but also those with a certain capacity to act as wetting agents.

In reality, any asymmetric molecule dissolved in water will produce at least one weak surfactant. Normally, such weak surfactants cannot be an agent. Foaming effective, but its effectiveness can be improved if a foam dispenser Asymmetric molecules as used in This document includes those that include a segment hydrophilic and a hydrophobic segment, such as some of the nonionic surfactants mentioned above. One end of the molecule is therefore polar in nature and dissolves in water, while the other end is non-polar in nature and avoids Water. When they are in water, the surfactant molecules will Orient themselves with their polar ends towards the molecules of water, leaving non-polar ends free to attract non-polar molecules It is assumed that in a foamed composition or foamable, non-polar ends help remove stains from the dental surface, allowing them to be removed by washing with the Water.

The amount of foaming agents may range, for example, from about 0.1% to about 5% by weight of the foamable composition, more for example, from about 0.5% to about 3% by weight, even more for example, be less than about 1% in weight.

Still other foaming agents may include reaction products of any base with an acid. These can include, for example, an alkali metal carbonate or bicarbonate, such as sodium bicarbonate, potassium bicarbonate, carbonate sodium or potassium carbonate, or a metal carbonate or bicarbonate alkali such as bicarbonate or magnesium or calcium carbonate. The amount used may range, for example, from about 1% to about 10% by weight, more for example, from about 3% to about 7%, even more for example, from about 3.5 to about 5.5% by weight of the composition. The amount used may also depend of the volume of foam required. Therefore, varying the amount of foaming agents, the amount of foam produced.

Generally, the ratio of acid and base oscillates, for example, from about 1: 0.5 to 1:25, more per example, from about 1: 1 to 1: 4, by weight. Acids Suitable include strong acids such as carboxylic acids soluble in water, phosphoric acids, nitric acids and / or acids sulfuric

Additionally, a foaming agent also It can be a gaseous material. The gaseous material can be any inert gas or a generated gas mixed a solution of basic peroxide with an acid solution.

Since the bleaching activity results when active peroxide comes into contact with the tooth, it may not be necessary for example, that the foams generated just before their use is of too long duration, if the active ingredients are captured inside the bubbles, but have a substantive body so that the amount of liquid formed, is say, deflation of foam bubbles to release active peroxide, can be controlled and balanced. Therefore, the Compositions set as an example are not only foamable, but they can also produce foams that deflate, long duration.

Foams generated by a composition foamable generally have half-lives of, for example, from approximately 1 to 10 hours, more for example, from approximately 2 to 5 hours. A foam that has a half-life of 2 hours means that 50% of the bubbles would deflate to release the encapsulated bleaching agent, or that the volume of the foam is reduced by 50% in about 2 hours after formation, and 75% of all bubbles disappear, or the volume of the foam is reduced by 75% in about 4 hours.

Deflation time or half-lives of the foam depends on several factors. For example, the higher the amount of bubbles formed, the longer the deflation time. Also, the lower the viscosity of the thickeners, and / or others. Inactive ingredients, the shorter the deflation time. He deflation time may also depend on the nature of the other additives of the composition, which have properties surfactants, for example, surfactants or preservatives as well as the environment. For example, a drier environment can contribute to faster deflation of bubbles.

Normally, for foamed compositions, the deflated bubbles have very long half-lives when they are confined in the container, for example, of at least about one month, more for example, of at least about three months. During use, deflated foam bubbles look helped by the environment, such as the loss of water or solvent when environment, and saliva in the patient's mouth. You can design a packed so that a foamed composition can have a term of desired expiration after opening the container or container and the rest have been exposed to the air. A container can also be designed single use only.

For example, an agent of gelation or thickener of lower viscosity. Not likely inhibit the availability of active peroxides to the same extent than a gelling agent of higher viscosity. Viscosity is, for example, generally less than about 10,000 cps, more for example, less than about 8,000 cps, and even more for example, less than about 5,000 cps.

Suitable foaming agents include foamable surfactants including at least some lauryl sulfate of sodium as the primary foaming agent.

As discussed above, the substantivity, that is the ability of a product to persist, It is a desirable property in any bleaching composition. By on the other hand, when the desired property of a product is the ability to eliminate by clearing easily, a foaming surfactant. However, there is a general desire that a bleaching composition can have both substantivity and Easy to remove by rinsing. When this is desired, they can foams generated in a "production pump of foam ", a dispensing tip adapted for the production of foam, or a dispensing tip that includes a mixer adapted for foam production. Such foaming devices they can produce again foams with desirable properties, while using a minimum amount of surfactants, for example,  less than about 0.5%. At the same time, they can also choose some combinations of additives to produce the effect desired, such as by adding other agents sparkling

For remineralization effects, they can be used amorphous calcium compounds. Calcium compounds can be used amorphous such as amorphous calcium phosphate (ACP), amorphous calcium fluoride phosphate (ACPF), amorphous calcium phosphate carbonate (ACCP), amorphous calcium phosphate carbonate (ACCP) and calcium fluoride phosphate carbonate  amorphous (ACCPF) in the remineralization of teeth.

These amorphous compounds are disclosed in the U.S. Patent Nos. 5,037,639, 5,268,167, 5,437,857, 5,562,895, 6,000,341 and 6,056,930.

In addition to amorphous calcium compounds, amorphous strontium compounds such as phosphate of amorphous strontium (ASP), fluoride phosphate amorphous strontium (ASPF), calcium phosphate and amorphous strontium (ASCP), calcium and strontium phosphate carbonate amorphous (ASCCP), fluoride phosphate carbonate amorphous strontium (ASCPF) and calcium fluoride phosphate carbonate and amorphous strontium (ASCCPF) in remineralization, as observed earlier. These compounds are disclosed in the U.S. Patent No. 5,534,244.

Some of the compounds mentioned previously they can also be used in fluoridation of teeth. All the above amorphous compounds or solutions that form amorphous compounds, when applied either on or on dental tissue, can help prevent and / or repair weaknesses Dental such as tooth decay, exposed roots and sensitivity of dentin.

For example, the first component of the system bleaching can include a source of phosphate and the second Component can include a source of calcium or strontium.

For example, the source of phosphate in the first component may include monosodium phosphate (NaH2PO4), disodium phosphate, tetrapotasium pyrophosphate or mixtures of same. As discussed above, the second component may include a source of calcium or strontium, and when both gel components are mixed, can be combined with phosphate to form the various amorphous strontium and / or calcium phosphates.

The phosphate source may be present, for example, in an amount of from about 0.2% to approximately 5% by weight, more for example, between about 0.2% to about 4% by weight.

The source of calcium, strontium or combinations of these in the second component may include, for example, a calcium salt, a strontium salt, or mixtures thereof, more for example, a calcium salt such as calcium nitrate, in an amount of, for example, from about 0.25% by weight up to about 1.5% by weight, more for example, of about 0.3% to about 1% by weight.

In practice, both phosphate can be included as possible or feasible. However, phosphate amounts of monosodium greater than about 4% by weight may tend to affect the stability of the gel.

Surprisingly, the phosphate component present in the first component according to the mentioned intervals previously you can also act to stabilize the gel. TO higher levels, the stabilization effect disappears gradually.

Additionally, phosphate salt can act also to adjust the pH of the first component. System pH it can be, for example, from about 5 to about 8, more for example, from about 5.5 up to about 6.5.

Surprisingly, strontium salts and / or amorphous calcium present in the composition also act as sensitivity relief agents. In fact, those present inventors have discovered that the desensitization effect provided by amorphous calcium phosphate is at least as effective as, if not more effective than, desensitization agents typically used, including some of the treaties to continuation. Therefore, the presence of strontium salts and / or Amorphous calcium can potentially replace agents traditional desensitization.

Agents can also be used. additional desensitization. Desensitizing agents suitable, if added, may include, for example, nitrates alkalines such as potassium nitrate, sodium nitrate and nitrate of lithium; and other potassium salts such as potassium chloride and potassium bicarbonate

The percentage of desensitization agent may be present, for example, up to about 5 per weight percent, more for example, up to about 4 per weight percent, and even more for example, up to about 3 percent by weight.

The desensitizing agent may be present in both system components and the intervals present  Above can represent the total in both components. By example, the desensitizing agent may be present in approximately equal amounts in each component.

Surprisingly, the agent of Desensitization also acts to stabilize the gel.

In addition, such additives can be used as humectants, flavorings, coloring agents, antiplate agents, anti-stain compounds, pH adjusting agents, excipients such as emollients, preservatives, other types of stabilizers such as antioxidants, chelating agents, tonicity modifiers (such as sodium chloride, mannitol, sorbitol or glucose), agents propagation, and water soluble lubricants, such as propylene glycol, glycerol or polyethylene glycol. The concentration of each one can be easily determined by an expert in the technique. Some of these can be contemplated for a system foamed or foamable.

The humectants contemplated for use in Inventive compositions include water, polyols, such as glycerol, sorbitol, polyethylene glycols, propylene glycols, partially hydrolyzed hydrogenated polysaccharides and the like. A single humectant or combination is also contemplated. Generally, they are present in amounts of, for example, up to approximately 85%, more for example, from approximately 15% to about 75% of the formulation. For foamable compositions, the amount of humectant present tends more towards the upper end of the interval.

As mentioned earlier, they can contemplated compositions of lower peroxide content. They can use these low peroxide compositions at home for a longer period of time and can be used as vehicle for the supply of many other agents that can be beneficial for oral and general health. Can also be used these compositions after a whitening treatment in the office To maintain the effect. In addition, a remineralization composition adapted for prolonged use may be beneficial for a tooth or damaged teeth, severe caries, or even bone loss.

In one embodiment, the system includes a low peroxide bleaching composition having a remineralization effect with sensitivity relief. Still in another embodiment, the system may include a composition of low peroxide bleaching that also has an effect of remineralization and fluoride treatment. In one embodiment Additionally, the system may include low bleaching composition peroxide content that also has an effect of remineralization, fluoride treatment and effect antibacterial

Even in more embodiments, they can be included other agents, including anti-plate agents, anti-stain agents, vitamin supplements or others that may be beneficial for teeth, breath or even healthcare general.

The peroxide content may be in the lower end of the interval mentioned above, by example, from about 0.5 to about 5%, more for example, from about 0.5 to about Number 3%. The composition can be foamed or unfoamed.

Although amorphous strontium and / or calcium salts present in the composition also act as relief agents of sensitivity, agents of additional desensitization, such as potassium salts and similar ones mentioned above for an additional effect.

Useful fluoridating agents may include ammonium fluoride or such metal fluoride salts such as sodium fluoride, sodium monofluorophosphate, potassium fluoride, lithium fluoride, stannous fluoride, ammonium and zinc fluoride, tin and ammonium fluoride, calcium fluoride and ammonium fluoride and cobalt, and water soluble amine hydrofluorides. Generally, sodium fluoride and fluoride are preferred. stannous

Some amorphous strontium and calcium salts they can also be useful fluoridating agents and include amorphous calcium fluoride phosphate (ACPF), calcium fluoride phosphate carbonate amorphous (ACCPF) (as disclosed in patents U.S. Nos. 5,037,639, 5,268,167, 5,437,857, 5,562,895, 6,000,341 and 6,056,930), fluoride phosphate of amorphous strontium (ASPF), fluoride phosphate carbonate amorphous strontium (ASCPF) and fluoride phosphate carbonate Calcium and amorphous strontium (ASCCPF) (as disclosed in the U.S. Patent No. 5,534,244). These compounds can have both remineralization and fluoridation effects.

Useful antibacterial agents include, by example, phenolic compounds and salicylamides, and sources of certain metal ions such as zinc, copper, silver and stannous, for example in the form of salt such as zinc chloride, copper and stannous, and silver nitrate. When they are used they are present in small quantities.

In foamed or foamable form, the advantages of the foams mentioned above are also indicated in these bleaching compositions of low peroxide content.

When packing the tooth whitening composition, any convenient way can be used to effect the Separation of the two components before use. For example, a single container can be compartmentalized so that the two components are housed in separate compartments and dispensed simultaneously and mix before application on teeth. Alternatively, the two components can be housed in separate containers from which the components The respective ones are dispensed to be mixed just before use. A exemplary packaging is disclosed in the patents U.S. Nos. 5,819,988, 6,065,645, 6,394,314, 6,564,972 and 6,698,622.

In an exemplary embodiment, provide the two components in separate chambers of a syringe  of two cylinders. In another exemplary embodiment, the two system components are provided in a container that has Separate compartments for components.

In any of the packaging methods described, the syringe or the two compartment container can be provided with a dispensing tip, or a dispensing tip that It includes a mixer. The mixers can be dynamic or static Examples of static mixers may include the also disclosed in U.S. Pat. Nos. 5,819,988, 6,065,645, 6,394,314, 6,564,972 and 6,698,622. Examples of some dynamic mixers may include those disclosed in U.S. Patent Nos. 6,443.61 and 6,457,609; and the U.S. Patent Publication No. 2002/0190082.

Such tips may also be adapted dispensers or mixers for foam production or Syringe or container are provided with a dispensing pump.

Immediately before use, the two components together in a ratio of 1: 2 to 5: 1 (first component with respect to the second component) by operating the syringe or the container. For example, gels or foams can be mixed in the 1: 1 ratio. The mixed bleaching gel or foam is applied to the surface of the teeth directly from the syringe or through of a bucket of teeth whitening. Other are contemplated component combinations, depending on the% variation of the ingredients present in each component.

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Surprisingly, apart from the components for the amorphous compound, such as the phosphate source and the source of calcium, strontium or mixture, the two components They can include approximately the same active ingredients. When the two components of the embodiment are mixed as a For example, the two sources can be combined to form phosphate of calcium. When applied to teeth, calcium phosphate can precipitate on the surface of the teeth where you can incorporated into hydroxyapatite, which helps in remineralization of tooth enamel, as discussed in patents U.S. Nos. 5,037,639, 5,268,167, 5,460,803, 5,534,244, 5,562,895, 6,000,341 and 6,056,930, indicated previously. The activity of the compounds of amorphous calcium and / or strontium, even if the source of peroxide and Other active ingredients are present in both components. This can result in manufacturing efficiency. improved

In addition, to visibly distinguish the two components, the first component can be prepared to be substantially milky, cloudy, opaque or colored, while the second component can be prepared to be substantially transparent, or vice versa. In addition, both can be prepared so that they are substantially milky, cloudy, opaque or colored, and the Distinction is by grade or by color.

Most opacifying agents tend to decrease peroxide stability; for example, TiO_2 or ZnO2 can cause peroxide decomposition, making it Less effective for its intended purposes. Surprisingly, it discovered that CaCO 3 is an effective pigment as well as a mixture of mica and TiO2 stabilized with an EDTA salt. Be discovered that both do not affect peroxide stability, and It was a first white component. Others are also contemplated opacifying agents that have the same effect.

Compositions are also described for use in the present method by the following examples. The B ingredients were mixed in a Kitchenaide mixer until that hydroxymethylpropylcellulose, available from Hercules Incorporated, Aqualon Division, Hercules Plaza (Wilmington, DE) and the Emulsifying wax was dispersed in the propylene glycol. Then, the ingredients in A were added and mixed together before adding the ingredients in C. Subsequently, it added the flavoring and the C-silica to the thickened dispersion with moderate mixing until dispersed. Finally, if it was used, Timica Extralarge Sparkle 11OS (titanium dioxide / mica was added, available from Engelhard Corporation, Iselin, NJ) and mixed under vacuum  to remove all air / foam. On the other hand, when prepare foamed compositions, no such action is necessary foam removal, while at the same time, it is used agitation for the production of additional foam. Also for foamable compositions, foaming agents are added. In compositions either foamed or foamable, may or may not be present a decreased amount of gelling agents, thickeners and / or other inactive ingredients.

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2

3

4

5

6

7

8

9

10

eleven

12

13

14

fifteen

16

17

18

19

twenty

twenty-one

22

2. 3

24

25

26

27

28

29

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To summarize, the ingredient ranges in the first component in the previous examples are as follow:

A 50% hydrogen peroxide solution it is, for example, from about 2% to about 15%, more for example, from about 4% to approximately 12%;

carbamide peroxide is, for example, from about 3% to about 20%, more for example,  from about 4% to about 17.0%;

aerosol, such as Cabosil EH-5, it is, for example, from about 2% to about 5%, more for example, approximately 4.5%;

glycerin is, for example, from about 5% to about 25%, more for example, from about 6% to about 20.0%;

gelling agent such as Klucel GF is, for example, from about 1% to about 40%, more for example, from about 2% to approximately 38%,

Polawax NF is, for example, from about 5% to about 10%, more for example, from about 5% to about 7%;

propylene glycol is, for example, from about 5% to about 15%, more for example,  from about 7% to about 13%, and

Timica / titanium dioxide composition and mica / "Englehard" is, for example, from about 0.2% up to about 1%, more for example, from about 0.25% to about 0.75%.

Other intervals can be used without subtracting value to the invention.

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30

31

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33

3. 4

35

36

37

38

39

40

41

42

43

44

Four. Five

46

47

48

49

fifty

51

52

53

54

55

56

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To summarize, the ingredient ranges in the second component in the previous examples are as follow:

A 50% hydrogen peroxide solution it is, for example, from about 2% to about 15%, more for example, from about 4% to approximately 12%;

carbamide peroxide is, for example, from about 3% to about 15%, more for example,  from about 5% to about 12.0%;

aerosol, such as Cabosil EH-5, it is, for example, from about 2% to about 10%, more for example, from about 4% to approximately 6%, and lower intervals are present for foamed or foamable compositions;

glycerin is, for example, from about 5% to about 25%, more for example, from about 9% to about 22%;

gelling agent such as Klucel GF is, for example, from about 25% to about 50%, more for example, from about 30% to approximately 45%,

Polawax NF is, for example, from about 1% to about 10%, more for example, from about 1% to about 7%;

and propylene glycol is, for example, from about 5% to about 15%, more for example,  from about 7% to about 13%.

Other intervals can be used without subtracting value to the invention.

The foam prepared with any of the previous compositions is of very long duration, for example, more 8 hours, when the amounts of gelling agents e Similar ingredients remain the same as those shown in the previous examples. For some of the compositions of the second component, the foam formed was not as consistent as the foam formed with some of the compositions of the first component due to the lower viscosities of these second components.

Claims (18)

1. Method for teeth whitening and providing a sensitivity relief that includes: provide a tooth whitening system of two components that have a first component comprising the less a peroxide compound, at least one source of phosphate and at less a gelling agent and a second component that comprises at least one source of calcium, strontium or a mixture of the same and at least one foaming or gelling agent; mix the two components; Y apply the mixed components to the tooth surface. 2. Method according to claim 1, wherein said system is provided in a container of two compartments 3. Method according to claim 2, wherein said container comprises a two-cylinder syringe. 4. Method according to any claim above, in which the mixed components are applied to the surface of the teeth from a dental tray. 5. Method according to any claim above, wherein said at least one peroxide compound in the first component comprises hydrogen peroxide and / or a peroxide organic. 6. Method according to claim 5, wherein the organic peroxide comprises urea peroxide, peroxide glyceryl or benzoyl peroxide. 7. Method according to claim 5, wherein said at least one peroxide compound comprises a mixture of urea peroxide and hydrogen peroxide. 8. Method according to any claim above, in which the second component also comprises at least  a peroxide compound. 9. Method according to claim 8, wherein said at least one peroxide compound in the second component It comprises hydrogen peroxide and / or an organic peroxide. 10. Method according to claim 9, wherein the organic peroxide comprises urea peroxide, peroxide glyceryl or benzoyl peroxide. 11. Method according to claim 9, wherein said at least one peroxide compound comprises a mixture of urea peroxide and hydrogen peroxide. 12. Method according to any claim above, in which the source of phosphate in the first component is select from the group consisting of monosodium phosphate (NaH2PO4), disodium phosphate, pyrophosphate tetrapotasio and mixtures thereof. 13. Method according to claim 12, wherein the phosphate source in the first component is present in a amount from 0.2% to 5% by weight. 14. Method according to any claim anterior, in which the source of calcium or strontium, or combinations  thereof in the second component comprises a calcium salt, a strontium salt or a mixture thereof. 15. Method according to claim 14, wherein said source of calcium, strontium or combinations thereof in the second component comprises an amount of from 0.25% in weight up to 1.5% by weight. 16. Method according to claim 14, wherein said source of calcium in the second component comprises nitrate of calcium 17. Method according to any claim above, wherein said second component further comprises a selected component of a group consisting of an agent of additional desensitization, an antibacterial agent, an agent of fluoridation, a vitamin supplement, an anti-stain agent, a antiplaque agent and mixtures thereof. 18. Method according to claim 17, wherein the additional desensitizing agent comprises nitrate of potassium.