JP5550202B2 - Compositions and methods for whitening teeth and reducing sensitivity - Google Patents

Description

Background 1. FIELD OF THE INVENTION This invention relates to compositions and methods for whitening teeth and reducing tooth sensitivity. More particularly, the present invention includes compositions containing both a bleach and a sensitivity reducer. Such a composition is particularly suitable for maximally whitening the tooth and minimizing the sensitivity of the tooth upon prolonged contact with the tooth to be treated.
2. Related Art The natural color of teeth is opaque white to translucent white or slightly yellowish white. However, the use of certain foods and tobacco, the aging process, illness, injury, medication, certain congenital symptoms, and environmental effects can cause tooth discoloration. There is a great demand for dental bleaching compositions because whiter teeth appear to be cosmetically superior to colored or discolored teeth.

Typical tooth bleaches release active oxygen free radicals. Such bleaches include peroxides such as hydrogen peroxide, alkali metal and alkaline earth metal percarbonates and perborates, or complex compounds containing hydrogen peroxide. In addition, it is known that alkali metal or alkaline earth metal peroxide salts, peroxyacetic acid (CH ₃ C═OO—OH), are useful for whitening teeth.

The most commonly used dental bleaching agent is carbamide peroxide (CO (NH ₂ ) ₂ .H ₂ O ₂ ) (also called urea hydrogen peroxide, hydrogen peroxide carbamide and perhydrol-urea). Carbamide peroxide has been used as an oral disinfectant by dental clinicians for several decades. Teeth bleaching was observed to have side effects with long contact times. An over-the-counter composition consisting of 10% carbamide peroxide is available as GLY-OXIDE® by Marion Laboratories and as PROXIGEL® by Reed and Carnrick. An adhesive bleaching gel that can hold a dental tray that is comfortable to wear in place for extended periods of time is available under the trade name OPALESCENCE® from Ultradent Products, Inc., Utah, South Jordan.

  Those who want to whiten teeth typically do so by applying the bleaching composition to the teeth with a dental tray for repeated treatment or they go to the dental clinic 4-10 times Only after receiving the necessary conventional in-hospital bleaching technique, clinically meaningful results were obtained. Clinically meaningful results can be quantified by measuring b * for gray scale (L *) and yellowing or bluening or equivalent methods in a CIE® instrument for color measurement.

  Dental bleaching compositions are useful for removing coloration and apparent discoloration, but are often limited due to the inherent translucency of many human teeth. More precisely, teeth with more translucent enamel are difficult to whiten beyond a certain point. This is because it is difficult to change the yellow-gray color of the underlying dentin by bleaching alone.

  Another disadvantage to the plan for bleaching teeth is that dental bleach tends to be more sensitive when bleach is applied to the teeth over an extended period of time. Thus, attempts to whiten human teeth, including long-term bleaching of excessively translucent teeth, can result in increased tooth sensitivity and can be very serious for certain people.

  From the foregoing, it will be appreciated that what is needed in the art is an improved composition and method for whitening teeth, including an improved composition and method for whitening translucent teeth.

  It will also be appreciated that what is further needed is an improved composition and method for whitening teeth that reduces tooth sensitivity compared to conventional dental bleaching compositions.

Such compositions and methods for whitening teeth while reducing tooth sensitivity are disclosed and claimed herein.
BRIEF SUMMARY OF THE INVENTION The present invention relates generally to dental bleaching compositions and methods for whitening teeth. In addition, the present invention relates to compositions and methods for reducing tooth sensitivity compared to conventional dental bleaching compositions. The composition of the present invention contains a dental bleach and potassium nitrate (KNO ₃ ) in combination with it, which surprisingly has a smaller amount (from about 0.01% to about 2% by weight based on the dental bleaching composition). %) Has been found to both reduce tooth sensitivity and enhance the whitening ability of dental bleaching agents. Although potassium nitrate was known to be effective as an anesthetic to reduce tooth sensitivity, potassium nitrate also enhances whitening of teeth when used in a dental composition in combination with a bleach. It was not known until now.

  Potassium nitrate and bleach are typically dispersed in a liquid or gel carrier. In addition, the whitening composition includes one or more other dental agents such as anti-dental agents for strengthening teeth against caries or anti-microbial agents for treating periodontal disease. Can be contained. The most commonly used anti-rodent agents are fluoride salts, such as stannous fluoride or sodium fluoride, which give teeth whitening compositions even anti-demineralization or even remineralization properties Sometimes. Examples of suitable antimicrobial agents include chlorohexidine, tetracycline, cetylpyridinium chloride, benzalkonium chloride, cetylpyridinium bromide, methyl benzoate, and propyl benzoate.

  The composition is preferably substantially free of abrasive since it typically does not rub the teeth. When using abrasive toothpastes, people typically brush for less than 60 seconds, not enough time to provide a noticeable whitening effect. On the other hand, rubbing teeth with abrasives for a long time can be detrimental to tooth enamel. Thus, the compositions of the present invention preferably do not contain a substantial amount of abrasive so that teeth can be bleached, whitened and opacified for extended periods of time.

  The composition is preferably used with a thin wall, flexible and lightweight dental tray. A suitable dental tray should be maximally comfortable and will cost little if any significant mechanical pressure is applied to the human teeth or gums. When using this type of tray, the tooth whitening composition of the present invention is preferably sufficiently tacky, viscous and resistant to dilution with saliva, acts as a glue-like substance, and has a desired length of time. This ensures that the dental tray is securely adhered and held over the human teeth. Such a dental tray is preferred, but any conventional dental tray can be utilized. The dental composition of the present invention can also be applied directly to human teeth without using a tray. In such a case, it is preferable to use a higher concentration of active bleaching agent in order to increase the speed of the desired bleaching action.

  Ingredients other than active dental agents such as potassium nitrate, bleach, antimicrobial agents and anti-dental agents include “carriers”. If the dental composition is sticky and viscous, the carrier is a combination of a sufficient amount of tackifier such as carboxypolymethylene and one or more solvents such as glycerin, polyethylene glycol, or water. Constitutes an adhesive matrix material to be formed; Preferably, the carrier is formed by a combination of a tackifier and a solvent, although in certain embodiments the carrier can include a solvent without the tackifier. As described below, preferred compositions are relatively viscous and gluey so that a suitable dental tray can be held and maintained for human teeth. Suitable carriers are preferably safe for oral use and are not easily dissolved in saliva and do not react with active dental agents.

  Examples of other suitable tackifiers that can aid other tackifiers in addition to carboxypolymethylene, or thickeners include xanthan gum, tarha gum, tragacanth gum, carboxymethylcellulose, locust bean gum, guar gum , Irish moss gum, Gutty gum, fur celerin gum, carrageenan gum, gum arabic, arginic acid gum, agar gum, alginate gum, proteins like collagen, PEMULEN (registered trademark of BF Goodrich), POLYOX ( (Registered trademark: available from Union Carbide, including a mixture of polyethylene oxide having a molecular weight of 100,000 to 8,000,000, including a high molecular weight polyethylene glycol), or the above-mentioned compound or compound equivalent. PEMULEN® is a patented formulation containing a significant amount of a polyacrylic acid copolymer with slightly hydrophobic ends and strong hydrophilic ends.

  In addition to glycerin, many other polyols act as suitable solvents. The solvent may be water alone or in combination with a polyol. Glycerin is a preferred solvent because it works well to form a sticky gel with carboxypolymethylene. Glycerin also improves some flavor. Some alternatives that can be used in place of glycerin include propylene glycol, polypropylene glycol, polyethylene glycol, erythritol, sorbitol, mannitol, and other polyols. In some embodiments, polyols such as glycerin, low molecular weight polyethylene glycols, polypropylene glycol, propylene glycol, and sorbitol can be used without tackifiers.

  As indicated above, one currently preferred adhesive matrix material includes a mixture of carboxypolymethylene and other suitable mixtures. The term “carboxypolymethylene” is used to refer to a broad category of polymers, particularly copolymers of acrylic acid and polyallyl sucrose. Carboxypolymethylene, which has not been completely neutralized, contains active carboxylic acid groups or components, so carboxypolymethylene can be classified as a weak acid. When dispersed in water, the pH of the carboxypolymethylene can be as low as about 2.5.

  Because highly acidic compositions etch teeth, it is generally preferred to adjust the pH of dental compositions containing carboxypolymethylene or other acids to make the composition less acidic. Accordingly, it is preferred to adjust the pH of the bleaching composition within the range of about 4 to about 9, more preferably within the range of about 5 to about 8. Since the carboxypolymethylene used in the matrix materials and compositions of the present invention is intended to be mixed with a base to increase the pH of the resulting dental composition, the purpose of the specification and claims Thus, the term “carboxypolymethylene” includes carboxypolymethylene in a composition at any pH. Suitable bases used to adjust the pH of the dental composition can include inorganic bases such as sodium hydroxide and ammonium hydroxide. Alternatively, the base can include organic bases such as triethanolamine and other organic amines.

  Since peroxides can cause tooth irritation and greater sensitivity in certain people, the simultaneous inclusion of potassium nitrate can offset the potential negative effects of this peroxide. Thus, potassium nitrate provides both opacification and reduced sensitivity. Although other desensitizing agents, including citric acid, citrate, strontium chloride, etc., can be used to reduce tooth sensitivity, only potassium nitrate has been shown to enhance tooth whitening. Since the present invention allows for prolonged contact through the use of a suitable tray and / or adhesive composition, the potassium nitrate is preferably about 0.01% to about 2% by weight based on the dental composition. In an amount, and more preferably in an amount of from about 0.05% to about 1% by weight. Surprisingly, a dental bleaching composition containing only 0.5% by weight potassium nitrate is far superior to a composition containing 3% by weight potassium nitrate, both in enhancing whitening and reducing tooth sensitivity. Was found to be excellent.

  In a preferred embodiment, a dental bleaching composition within the scope of the present invention has sufficient tack and generally viscosity such that intestinal pressure is necessary to deliver the composition from the container, and gravity Is not enough. Unlike conventional low viscosity compositions such as GLY-OXIDE (manufactured by Marion Laboratories) or PROXIGEL (manufactured by Reed and Carnick according to U.S. Pat.No. 3,657,413 to Rosenthal), preferred in accordance with the present invention The whitening composition is filled into a syringe or squeezable tube, or other similar positive pressure supply.

  A thin wall, flexible and lightweight modified dental tray for holding dental compositions adjacent to human teeth is preferably used in combination with the sticky and viscous dental whitening composition of the present invention. Is done. A general method for producing such a dental tray is as follows. First, an alginate impression that records all tooth surfaces and gingival margins is made, and a stone mold is made from the impression. Any reservoir can be prepared by providing a layer of hard material on the particular tooth surface to be treated. The dental tray is then vacuum formed from the modified mold using a thin flexible plastic sheet material. Once formed, it is preferable to trim the slight gap of the gingival line on both the cheek and lingual surfaces of human teeth. The resulting tray provides a comfortable fit for human teeth with an optional reservoir or space where hard material is placed in a stone mold. The tray can optionally overlap the gingiva if it is desired to provide contact between the dental composition and the human gingiva. The trays of the present invention are much more comfortable and give little or no significant mechanical pressure to the gums of human teeth. Instead, adhesive dental compositions within the scope of the present invention can act as a glue that holds the improved tray in place.

  The amount of tooth whitening obtained by using the compositions and methods of the present invention depends primarily on (1) the length of time each day the tray is installed; and (2) the number of days the tray is installed. The treatment schedule can be tailored to each person's lifestyle or response to treatment, and the human needs can be achieved very frequently to provide effective relief from over-translucent teeth. It has been found that the treatment while sleeping is a good treatment time because there is less mouth activity to reduce the whitening composition pumped from the tray.

  In short, the desensitizing bleaching composition of the present invention typically maintains a dental composition in contact with human teeth, typically for at least about 15 minutes, more preferably for at least about 1 hour. Contains a dental bleaching agent (eg, carbamide peroxide) in an amount to enable human tooth bleaching. They also contain an amount of potassium nitrate that is both a reduced sensitivity that can be caused by contact of human teeth with a dental bleaching agent and an enhancement of the whitening action of the dental bleaching agent. By the comparative studies discussed below, the inventors have shown that potassium nitrate desensitization and whitening enhancement properties are truly reduced when contained at low concentrations (eg, 0.5%) rather than at high concentrations (eg, 3%). We found a surprising but unexpected result of higher.

  In addition, the compositions of the present invention provide large amounts of abrasive (eg, 20% by weight or more) and high concentrations that are intended to contact the tooth daily during brushing (typically 60 seconds or less). It should be contrasted with conventional toothpaste paste compositions that contain less potassium nitrate (eg, up to 10% by weight). Such conventional compositions are formulated to treat past sensitivity rather than the expected dental sensitivity. These compositions do not treat the sensitivity caused by simultaneous contact of teeth with dental bleach. In particular, because of the extremely short contact time, the significant bleaching and sensitivity of human teeth is unlikely to use a peroxide-containing toothpaste.

These and other features of the invention will become more fully apparent from the following description, or may be learned by practice of the invention.
As outlined in the detailed description of the preferred embodiment , the present invention generally provides dental bleaching compositions and methods for bleaching and whitening teeth while minimizing tooth sensitivity. About. At a minimum, the composition of the present invention contains a dental bleach and potassium nitrate, which acts both as a whitening agent and as a desensitizing agent. Bleach and potassium nitrate are delivered to the teeth by a carrier, preferably a carrier that is an adhesive matrix. Potassium nitrate is known as an effective desensitizing agent when used in toothpaste at higher concentrations (eg, 5% or more), but surprisingly it reduces desensitization when used in combination with a dental bleach. It has been found that its effectiveness as an agent actually improves when used at very low concentrations (eg, about 0.01% to about 2%). It more effectively improves the whitening action of the bleaching teeth at such low concentrations, which is also a surprising result. The composition preferably contains no abrasive.

  In a preferred embodiment, the dental whitening composition may be used in conjunction with a thin, flexible and comfortable wearing dental tray to hold the composition against human teeth. Suitable dental trays match the size and shape of the human teeth and apply little or significant mechanical pressure to the human teeth and / or gums. This makes it more comfortable and comfortable to use compared to conventional dental trays. Nevertheless, the dental whitening composition of the present invention can be reliably used with or without conventional dental trays.

  When using thin, flexible dental trays, potassium nitrate, dental bleaching agents and optional dental additives are preferably used for whitening compositions of human teeth without significant mechanical pressure by the tray. Disperse in an adhesive matrix material capable of exhibiting a glue-like action that can be adhered and held in place in the tray. Alternatively, the dental whitening / sensitivity reducing composition can be placed on a direct-dust human tooth without a tray or placed on a conventional dental tray that is held in place by mechanical attachment.

  The amount of potassium nitrate contained in the whitening composition of the present invention can vary depending on the period during which the composition is in contact with human teeth. When used with a dental bleaching composition intended for extended contact with human teeth, such as a dental formulation in which the composition is applied to humans on a daily basis over a long period of time, the potassium nitrate concentration is preferably In an amount of about 0.01% to about 2% by weight, more preferably about 0.05% to about 1%, most preferably about 5% by weight, based on the dental composition. On the other hand, for one-time applications, in particular for shorter times (i.e., within 1 hour), the concentration of potassium nitrate can be increased to 10% or more.

Because of the repeated and prolonged usage, low concentrations of KNO ₃ are better when reducing sensitivity, perhaps because KNO ₃ can be irritating during high doses during low dose anesthesia. Furthermore, the use of lower concentrations of KNO ₃ also has the surprising result of enhancing the whitening effect of the bleach. KNO ₃ appears to increase opacity and thereby reduce the translucency of the tooth enamel.

  In a preferred embodiment, the carrier contains a tackifier and a solvent, which together provide a tacky matrix material, although the solvent can be used alone in certain embodiments. The adhesive matrix material is sufficiently adhesive that a suitable dental tray can be held and maintained against human teeth. Various tackifiers are described below.

  Suitable tacky matrix materials are preferably those that are safe for oral use and do not render potassium nitrate inert. They are preferably viscous and do not dissolve easily in saliva. One currently preferred tackifier used to form a tacky and viscous matrix material is carboxypolymethylene. Carboxypolymethylene can be used to form a glue-like dental whitening composition that can itself act as an adhesive to hold a non-self-supporting dental tray that is comfortable against human teeth. The use of carboxypolymethylene, either alone or in combination with other tackifiers, should be used with a composition that is self-retaining (ie, hard, mechanically interlocks on human teeth or gums and has low tackiness). Eliminates the need to use dental trays, which are typical trays intended).

  Carboxypolymethylene is a broad term for vinyl polymers having active carboxyl groups. A suitable carboxypolymethylene composition is available from B. F. Goodrich Company under the trade name CARBOPOL®. Another trade name for carboxypolymethylene is CARBOMER®. In a common sales form, the pH of carboxypolymethylene can be as low as 2.5. As discussed below, the pH of a composition made using carboxypolymethylene can be increased to obtain a less acidic composition.

  One currently preferred type of carboxypolymethylene resin is known by the trade name CARBOPOL 934P. CARBOPOL 934P is a high purity pharmaceutical grade of CARBOPOL 934, with a molecular weight of approximately 3,000,000. In addition to thickening and suspension, CARBOPOL 934P is used on dry tablets to give sustained release properties. Extensive toxicity studies have been conducted on CARBOPOL 934P and a master file has been established at the Food and Drug Administration. It is listed as CARBOMER 934P in the National Formulary (NF). A more recent preferred carboxypolymethylene is CARBOPOL 974P NF, which is currently superior to CARBOPOL 934P as the choice of carboxypolymethylene. CARBOPOL 974P NF is similar or identical in molecular weight comparable to CARBOPOL 934P, but CARBOPOL 974P NF has been purified to become a more pharmaceutically acceptable material.

  Other carboxypolymethylenes such as CARBOPOL 940 could be used in place of CARBOPOL 934P or CARBOPOL 974P NF. CARBOPOL 934P and CARBOPOL 974P NF are currently preferred because they are available in pharmaceutical grade.

  The amount of carboxypolymethylene in the whitening composition of the present invention can vary depending on the desired degree and type of tack and the amount of other ingredients in the dental composition. In general, the whitening / sensitivity reducing compositions of the present invention are preferably in the range of about 0.5 wt% to about 25 wt%, more preferably about 2 wt% to about 12 wt%, based on the dental whitening composition. And most preferably within a range of about 3% to about 10% by weight carboxypolymethylene. If it is desirable to increase stickiness, viscosity, and resistance to dilution against saliva, the concentration of carboxypolymethylene can be adjusted to achieve any or all of these properties to the desired degree. Increased stickiness helps hold a suitable dental tray against human teeth. Alternatively, if desired, particularly when applied directly without a dental tray, the adhesion and tackiness of the composition can be reduced.

  However, it should be understood that the actual amount of carboxypolymethylene is not critical for obtaining a sticky, viscous dental composition. For example, the adhesive matrix material can contain other tackifying ingredients in combination with carboxypolymethylene or in place of some or all of carboxypolymethylene, suitable for use in place on human teeth. A desired level of dental whitening composition is obtained having the necessary tack to hold a comfortable wearable dental tray. Other synthetic polymers and / or natural rubbers, proteins or other gel-forming mixtures can be used as long as they yield a sticky dental whitening composition.

  To obtain a good dispersion of the carboxypolymethylene resin in the dental whitening composition, the carboxypolymethylene is mixed with a suitable solvent and then other ingredients that are less compatible with carboxypolymethylene, such as water. It is recommended to make an attempt to add. Examples of suitable solvents for use with carboxypolymethylene include glycerin, polyalkylene glycol, other polyols, and the like. Glycerin appears to allow large amounts of carboxypolymethylene to be dispersed in water. The concentration of the glycerin, polyol or substance as used as a solvent in the dental whitening composition is preferably in the range of about 15% to about 85% by weight, more preferably based on the dental whitening composition, Within the range of about 25% to about 75% by weight, and most preferably within the range of about 30% to about 65% by weight.

  Glycerin, other polyols, etc. are inexpensive solvents that work well to form sticky gels using carboxypolymethylene. Glycerin also provides some flavor enhancing properties that are more palatable and do not feel a sweet flavor. Some alternatives to glycerin include propylene glycol, polypropylene glycol, polyethylene glycol, sorbitol, mannitol, erythritol, other polyols, stearyl alcohol, and other alcohols. Ethylene glycol can also act but is not preferred because of its toxicity. In addition to acting as a solvent for tackifiers and thickeners, hydrophilic solvents such as glycerin, polyethylene glycol, polypropylene glycol, propylene glycol, and sorbitol are suitable carriers in the absence of tackifiers. Can also be used.

  Water can also be included as a solvent in the composition of the present invention, but more carboxypolymethylene or other tackiness is added as more water is contained to maintain the same level of tackiness. An imparting agent should generally be included. The amount of water contained in the dental whitening composition of the present invention is preferably in the range of about 0% to about 50% by weight, more preferably about 1% by weight, based on the dental whitening composition. In the range of about 45% by weight, and most preferably in the range of about 2% to about 40% by weight. It will be appreciated that the total weight of water in the dental whitening composition can come from different sources. For example, as an aqueous solution, it can come from several components such as dental additives and bases discussed below.

  Since carboxypolymethylene is a polycarboxylic acid, the pH of the resulting dental whitening composition tends to drop significantly, in some cases to a pH of about 2.5. Although it is generally meaningless to measure the pH in an anhydrous composition, when the anhydrous dental composition is applied to a human tooth, it is associated with a theoretical pH, and the tooth is immersed in water-containing saliva. Based on clinical and in vitro studies, dental whitening compositions with a pH below about 5 are likely to etch enamel. In order to avoid etching the enamel, it is preferred to add a neutralizing agent, i.e., more specifically, the pH of the dental whitening composition of the present invention is within the range of about 4 to about 9, Preferably, a base is added to raise the pH to within the range of about 5 to about 8, and most preferably from about 6 to about 7.

  Inorganic and organic bases can be used to raise the pH, and the use of concentrated aqueous sodium hydroxide (50% NaOH in water) is a currently preferred embodiment. In addition to sodium hydroxide, other inorganic bases such as potassium hydroxide and ammonium hydroxide can be used. Examples of suitable organic bases include alkylamines such as triethanolamine, di-isopropanolamine, and other similar amines. The amount of neutralizing agent or base contained will usually depend on the desired pH and the amount of carboxypolymethylene in the dental whitening composition. Accordingly, the neutralizing agent or base is preferably in the range of about 1% to about 12% by weight, more preferably in the range of about 2% to about 8% by weight, based on the dental whitening composition, Most preferably, it is contained in the range of about 3 wt% to about 7 wt%.

  The term “carboxypolymethylene” is understood to include carboxypolymethylene resins regardless of the overall pH of the dental composition. In other words, the term “carboxypolymethylene” broadly includes resins mixed with bases to raise the pH of the composition. In addition, the term “carboxypolymethylene” refers to carboxypolymethylene or a mixture thereof combined with other ingredients in the dental whitening composition to provide the desired degree of tackiness and viscosity to the final dental whitening composition. As far as given, it broadly includes reacted (complexed) carboxypolymethylene, or else carboxypolymethylene that has been redirected in either direction by other components in the dental whitening composition.

  In addition to carboxypolymethylene, examples of other suitable tackifiers and thickeners include xanthan gum, tarha gum, tragacanth gum, locust bean gum, guar gum, irish moss gum, gatch gum, far sellang gum, carrageenan gum, There are gums such as gum arabic, alginate gum, agar gum, and alginate gum, proteins such as collagen, or cellulose ethers. Another suitable tackifier is the one sold as PEMULEN (registered trademark; B.F. Goodrich branded compound) or a compositional or chemical equivalent thereof. PEMULEN® contains a significant amount of polyacrylic acid copolymer with a small number of hydrophobic ends and a large number of hydrophilic ends. Additional examples of suitable tackifiers include polyethylene oxide such as POLYOX® sold by Union Carbide. These tackifiers can be present in the same ranges as described above with respect to carboxypolymethylene.

  Examples of suitable bleaching agents include aqueous hydrogen peroxide, carbamide peroxide, benzoyl peroxide, glyceryl peroxide, alkali metal and alkaline earth metal salts of percarboxylic acid and perboric acid (eg sodium perborate) and peroxyacetic acid. There is. A significant advantage of using potassium nitrate as an impermeant combined with a bleaching agent in a dental whitening composition is that potassium nitrate simultaneously reduces the sensitivity of the teeth that can result from the use of the bleaching agent. The bleaching agent is preferably in the range of about 0.5 wt% to about 50 wt%, more preferably in the range of 1 wt% to about 30 wt%, and most preferably 3% based on the dental whitening composition. It is contained in the range of wt% to about 20 wt%.

  To protect the stability of the dental whitening composition, it is often included with ion scavengers such as EDTA, EDTA salts such as disodium edetate, oxine EDTA, disodium calcium edetate, and others. preferable. In addition, ion scavengers such as citric acid, succinic acid, adipic acid, tin nitrate and phosphate, and other conventionally used chelating agents can be used. The ion scavenger is preferably in the range of about 0 wt% to about 1 wt%, more preferably in the range of about 0.03 wt% to about 0.5 wt%, and about 0.05 wt%, based on the dental whitening composition Contained in a range of about 0.2% by weight.

  It is also preferred to include other active dental agents to provide other types of teeth and / or gingival treatment. For example, it may be desirable to provide an anti-carious treatment method in conjunction with dental desensitization and / or opacification. Suitable anti-dental and anti-demineralizing agents include fluoride salts, more specifically sodium monofluorophosphate, sodium fluoride, stannous fluoride, and the like. Depending on the degree of fluoride treatment desired, and depending on whether the composition is “over-the-counter” or “medical“ by prescription ””, fluoride is dental It may be contained in the range of about 0% to about 1% by weight, more preferably in the range of about 0.1% to about 0.5% by weight, based on the whitening composition.

  Antimicrobial agents can be included, for example, in conjunction with potassium nitrate or other opacifiers to combat gingival diseases. Examples of useful antimicrobial agents include chlorohexidine, tetracycline, cetylpyridinium chloride, benzalkonium chloride, cetylpyridinium bromide, methyl benzoate, and propyl benzoate. The antimicrobial agent is preferably contained in the range of about 0% to about 15% by weight, more preferably in the range of about 1% to about 5% by weight, based on the dental whitening composition.

  As mentioned above, the dental whitening composition of the present invention preferably does not contain an abrasive. Abrasives treat only the external area of the tooth, but tooth whitening and opacification appear to be achieved by the internal action of bleach and potassium nitrate within the tooth. Preferred embodiments where it is desirable that the whitening composition remain on the teeth for an extended period of time (ie, longer than about 3 minutes) as well as the absence of an abrasive in the composition. Then it is not desirable. In any case, the toothpaste is immediately diluted with saliva, and the paste does not last for a shorter time (ie, about 1 minute or so).

  Other suitable dental sensitivity reducers that can be used in addition to potassium nitrate according to the present invention include citric acid, citrate, strontium chloride, and other sensitivity reducing agents known in the art. The amount of desensitizing agent contained within the dental whitening composition of the present invention can vary according to the concentration of potassium nitrate, the desired strength and the intended treatment time. Accordingly, when included anyway, the other desensitizing agents are preferably in the range of about 0.1% to about 10%, more preferably about 1% to about 7%, based on the dental desensitization composition. It is contained in an amount within the range of% by weight.

  One presently preferred method of supplying sticky and viscous dental whitening compositions within the scope of the present invention is by syringe. A squeezable tube or other similar dispensing device can also be used to deliver the composition. Upon delivery, a suitable dental whitening composition is adequately viscous so that it does not easily collect or spread once delivered, but usually a single extruded strand of dental whitening composition or Stays as beads. Nevertheless, bottles, tubes or other supply means known in the art can be used, especially when the whitening composition is low viscosity, low viscosity and / or thickeners are used. Can be used when not contained.

  Currently, it is preferred to provide a unit dose of the dental whitening composition in a syringe or similar delivery device. In this way, the human can load a precise amount of dental whitening composition onto the dental tray during each treatment period. By using such a delivery device, the dentist can also monitor how much a person has received and used.

  Although not essential, the tacky and viscous dental whitening composition of the present invention preferably works in conjunction with a dental tray that exerts little or no significant mechanical pressure on the human teeth and gums. Used to treat teeth. The result is a more comfortable and comfortable dental tray, unlike conventional dental trays that are generally hard and / or wall-thick, which apply sufficient mechanical pressure that is “self-holding” to the teeth and / or gums. It becomes.

  A common method of making a suitable dental tray according to the present invention is to create an alginate impression that records all tooth surfaces and gingival margins. After that, a stone mold is created from the impression. Trim away excess stones to form an easy operation and dental tray.

  Reference is now made to FIGS. A preferred method for forming a dental tray is obtained by applying a thin coating 10 of hard material to a stone mold 12 corresponding to a tooth for which it is desired to provide more dental whitening composition. One or more reservoirs can be formed in the dental tray. As depicted in FIG. 1, an applicator 14 having a brush tip can be used to apply the coating 10. This coating can be conveniently photocured. If the dental tray is to be trimmed at the bottom of the gingival margin, the covering material is preferably more than about 1 mm away from the gingival line 16 displayed on the stone mold, more preferably the gingival line. Apply to maintain a spacing of 16 to about 1.25 to about 1.5 mm.

  The finished coating has a thickness corresponding to the desired reservoir depth, typically about 0.5 mm. In general, it is preferred that the hard coating material not be applied beyond the stone mold corresponding to the cut edge 18 and occlusal edge 20 of a human tooth. This is to prevent or reduce vertical movement of the tray during use (this movement can act as a pump that can cause the dental whitening composition to leak out of the tray and absorb saliva into the dental tray) This is because the actual human incisal and occlusal ends preferably contact the final tray.

  The dental tray 22 is then vacuum formed from the stone mold using conventional techniques. The dental tray 22 is preferably constructed from a flexible transparent vinyl material having a preformed thickness within the range of about 0.2 mm to about 1.5 mm, more preferably within the range of about 0.25 mm to about 1 mm. Is preferred. The flexible material gives the wearer a more comfortable dental tray. The thickness of the final tray can vary depending on the technique used to make the tray and the size and shape of the human teeth. Thicker or harder materials may be required for those envisioned to crunch or bite. Of course, the user is instructed not to eat or bite the tray using the attached tray.

  Once the dental tray 22 is formed, the dental tray 22 trims a slight gap in the human gingival margin 16 on both the buccal and lingual sides for maximum comfort. Is preferred. When finishing and chamfering the tray perimeter, there should be enough tray material to ensure that the teeth are covered within about 1/4 mm to about 1/3 mm of the gingival boundary. In general, it is preferable that the finished tray is corrugated at the top of the interdental papilla so as not to cover the interdental papilla. Preferably, the edges of the tray are smooth so that the lips and tongue do not feel the edge protrusions. Fine adjustment of the tray can be done by carefully heating and stretching the tray material.

  Reference is now made to FIGS. FIG. 5 depicts the dental whitening / sensitization reducing composition 40 from the syringe 60 being placed in a dental tray. FIG. 6 depicts the insertion of the dental tray 50 into the dental arch row 70 in the user's mouth. FIG. 7 depicts the dental tray 50 in place on the dental arch row. The dental composition can be injected over the entire dental tray in contact with the entire dental arch row, or it can be injected into a portion of the tray that contacts only a portion of the dental arch row. Furthermore, the dental tray can be shaped to contact only a portion of the arch row or only a single tooth. Injecting the dental whitening composition into the dental tray 50 as shown in FIG. 5 is a preferred method, but the dental whitening composition is applied directly to the teeth and the tray 50 is then placed in the arch row. Alternative methods of placing at 70 are also possible.

  In practice, it has been found that the user can experience less tooth discomfort from tray pressure when using a tray with a reservoir provided in the tray described above. At present, this is believed to be due to the fact that the teeth are not held firmly by the tray, and as a result, reduce the “orthodontic” pressure experienced by the tray discrepancy as much as possible. The use of a thin, flexible tray material minimizes the mechanical force on the teeth or gums compared to the harder and thicker plastics known in the art. Taniwa, the reservoir can give more dental whitening composition to the human teeth and can help install a dental tray on the human teeth.

  The thin, flexible dental tray described above is suitable when treating human teeth, but preferably when the dental agent is included to combat gingival disease, the dental tray is Can overlap. Of course, the dental tray can always be configured to overlap the gingiva to the extent that the dental whitening composition does not irritate the gingiva.

  Nevertheless, when trying to treat human teeth rather than gingiva, it was generally found that the user would be more comfortable when the dental tray was trimmed to the gingival margin or below. . Even when the dental tray overlaps human gingiva, the dental tray of the present invention preferably does not apply significant mechanical pressure to the human gingiva.

  Thus, the dental whitening composition ensures the tray on the human tooth without significant mechanical pressure from the dental tray for at least about 1 hour, more preferably at least about 2 hours, and most preferably at least about 4 hours. It is preferable to have a tackiness so that it can be adhered to and retained. Nevertheless, while the above length of time has been shown to provide an accurate measure of the tackiness of the dental whitening composition of the present invention, It should not be construed as a limitation on the actual amount of time that it is desired to use. Certain dental whitening compositions can maintain dental trays against human teeth, for example 10 hours or more, although the composition can be used for any desired time, eg, 15 minutes, 1 hour, or desired Can be reliably used within the scope of the present invention for any length of time.

  The sensitivity-reducing dental whitening composition of the present invention can be used at any time and for any length of time by humans who want to whiten their teeth. The dental whitening composition of the present invention facilitates the use of a flexible thin-walled dental tray that is more comfortable compared to conventional dental trays, but the insertion of any dental tray in the human mouth But it brings some changes in behavior and a reduction in the freedom of the human mouth. Therefore, it is recommended to use a dental tray at night during human sleep to reduce the treatment time as much as possible and alleviate the inconvenience caused by a human oral dental tray.

  It has been found that optimal results can be achieved with cycle exposure times that include repeated exposure over several days or weeks. For example, a treatment plan may require exposure alternately for a time such as one hour without further exposure until the next day. For daytime use, it is recommended to apply the whitening composition for about 1-3 hours. The length of treatment time for night use can vary depending on the sleep pattern of a particular person and can therefore be between about 5-9 hours.

  In order to more clearly illustrate the parameters of the inventive dental bleaching composition within the scope of the present invention, the following examples are given. The following examples are intended to be illustrative and should not be viewed as limiting the scope of the invention.

Example 1
Whitening compositions within the scope of the present invention were prepared by combining the following ingredients in the following proportions measured in weight percent based on the whitening composition.

CARBOPOL 974P NF 6.8%
Glycerin 48.45%
Polyethylene glycol 300 5.5%
Water 20.0%
Sodium hydroxide (50%) 5.4%
KNO ₃ 3.0%
Carbamide peroxide 10.5%
EDTA disodium 0.1%
NaF 0.25%
CARBOPOL 974P NF was obtained from BF Goodrich Company of Cleveland, Ohio. CARBOPOL 974P NF was first combined with glycerin and polyethylene glycol 300 and then mixed with water. By mixing glycerin and polyethylene glycol 300 in CARBOPOL 974P NF, it can be mixed with water more easily. KNO ₃ , carbamide peroxide and disodium EDTA were added to the mixture, and then sodium hydroxide was blended into the homogeneous composition to raise the pH to an acceptable level. Sodium fluoride was then added. The resulting dental whitening composition was found to have opacifying, bleaching, desensitizing and anti-dental properties and applied to human teeth and gums without significant mechanical pressure from the tray. In contrast, the dental tray was sufficiently tacky to reliably hold and maintain the dental tray.

(Example 2)
A suitable dental whitening composition within the scope of the present invention was prepared according to the procedure of Example 1 except that the ingredients were combined at the following weight percent concentrations.

CARBOPOL 974P NF 6.8%
Glycerin 35%
Polyethylene glycol 300 5.5%
Water 20.0%
Sodium hydroxide (50%) 5.8%
KNO ₃ 0.5%
Carbamide peroxide 10.5%
EDTA disodium 0.3%
Peppermint flavor 0.6%
Xylitol 15%
The resulting dental whitening / sensitivity reducing composition was tested and found to be surprisingly superior to a test composition similar to the composition of Example 1 containing 3% potassium nitrate. Compared to the dental whitening / sensitivity reducing composition containing 3% potassium nitrate, the 0.5% agent of Example 2 greatly reduced the sensitivity of the teeth. Sensitivity includes sensitivity to heat and cold, and general sensitivity to gingiva, tongue and throat. The 0.5% formulation of Example 2 also shows a dramatic increase in the ability to whiten teeth compared to a test composition that does not contain potassium nitrate, so that a low concentration of potassium nitrate will whiten the whitening effect of the dental bleaching composition. Surprising results have been established that greatly increase.

(Comparative test)
The subject of the composition of Example 2 is the subject of a comparative study to compare the desensitization and bleaching ability of the composition of Example 2 with the other four dental bleaching compositions. In this study, five dental compositions were labeled as Compositions A to E, respectively, and Composition E was the composition of Example 2. Each dental bleaching composition was applied using a conventional dental tray made to fit each user. Compositions AD were similar to the composition of Example 2 except that different amounts of carbamide peroxide and potassium nitrate and one sample contained different sweeteners.

Composition Carbamide Peroxide KNO ₃ Sweetener
A 10% 0% Xylitol
B 10% 3% Xylitol
C 10% 3% Aspartame
D 15% 3% Xylitol Table 1 lists the results of the comparative study.

  As clearly shown by the data listed in Table 1, comparative studies show that composition E plays in the number of days that the user experienced heat and cold susceptibility compared to compositions AD. Reduction was shown.

  Surprisingly, it was believed that when potassium nitrate was mixed with a dental bleaching agent at a concentration of 3% (composition BD), it would reduce sensitivity at any concentration, but in composition A containing no potassium nitrate. In comparison it actually increased the sensitivity of the user's teeth. This indicates that potassium nitrate does not behave as a sensitivity reducer when blended and used with a dental bleach, but instead increases sensitivity at a constant concentration (e.g. 3%). More surprisingly, composition E resulted in an average Vita tab shading change of 8.6, which resulted in compositions A to B comprising composition D (containing about 50% more bleach than composition E). The surprising result that containing a lower concentration of potassium nitrate than any of D, therefore increasing tooth whitening compared to a composition containing no potassium nitrate or 3% potassium nitrate Indicates.

(Examples 3 to 10)
Within the scope of the present invention according to Example 1, except that the concentration of KNO ₃ was contained in the following amounts of 0.01%, 0.05%, 0.1%, 0.3%, 0.75%, 1%, 1.5% and 2% A dental whitening composition was prepared. The obtained dental bleaching composition exhibits an excellent bleaching action with less sensitivity compared to a dental bleaching composition not containing potassium nitrate. The resulting dental bleaching composition exhibits superior bleaching action with less sensitivity than a dental bleaching composition containing 3% or more potassium nitrate blended with 10% or more carbamide peroxide.

(Example 11)
A dental whitening composition within the scope of the present invention was produced according to Example 2 except that at least a portion of glycerin was replaced with propylene glycol.

(Example 12)
For dental whitening within the scope of the present invention according to Example 2, except that CARBOPOL 974 NF is included in the following amounts of 0%, 0.5%, 2%, 3%, 5%, 10% and 20% A composition was prepared. The concentration of NaOH (50%) was adjusted to maintain approximately the same pH as in Example 2.

(Example 13)
CARBOPOL 974 NF all or part of the following thickeners, xanthan gum, irish moss gum, gucci gum, full selela gum, carrageenan gum, gum arabic, alginate gum, agar gum, alginate gum, tackifying protein, or cellulose A dental whitening composition within the scope of the present invention was prepared according to Example 12 except that it was substituted with at least one ether.

(Example 14)
A dental whitening composition within the scope of the present invention was prepared according to Example 1 except that the ingredients were combined at the following weight percent concentrations.

Glycerin 89%
KNO ₃ 1%
Carbamide peroxide 15%
The foregoing procedure resulted in a dental whitening composition having similar opacifying and desensitizing capabilities compared to the composition of Example 2. However, this composition was less tacky than the composition of Example 2 and had a higher bleaching capacity.

(Example 15)
One or more of the following antimicrobial agents were added to any of the aforementioned dental whitening compositions for the treatment of human gingiva. That is, chlorohexidine, tetracycline, cetylpyridinium chloride, benzalkonium chloride, cetylpyridinium bromide, methyl benzoate, and propyl benzoate. These compositions are preferably used in conjunction with a thin-walled flexible dental tray that overlaps the person's gum for the dental whitening composition for contact with the gum to be treated.

(Example 16)
Any of the aforementioned dental whitening compositions containing a bleaching agent and no bleach stabilizer contain one of the following chelating agents: EDTA, monosodium EDTA, citric acid, succinic acid, and adipic acid. Can be added.

From the foregoing, it will be appreciated that the present invention provides compositions and methods for whitening teeth, including compositions and methods for opacifying excessively translucent teeth.
The present invention further provides a composition for whitening and opacifying teeth while reducing tooth sensitivity compared to conventional dental bleaching compositions.

  The present invention may be implemented in other specific embodiments without departing from the spirit or essential characteristics thereof. The above-described embodiments of the invention are to be considered in all respects as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

  FIG. 2 is a perspective view of a human dental stone type with a coating on the surface of a selected tooth.   FIG. 2 is a perspective view of the stone mold of FIG. 1, wherein a dental tray is formed from the mold and trimmed at the bottom of the gingival margin.   FIG. 3 is a cross-sectional view taken along line 3-3 in FIG. 2, and FIG. 3A is a partially enlarged view within partial line 3A-3A in FIG.   FIG. 4 is a cross-sectional view taken along line 4-4 of FIG.   1 is a perspective view of a bleaching composition dispensed from a syringe in a thin wall, flexible dental tray. FIG.   1 is a perspective view of a thin wall, flexible dental tray filled with a bleaching composition just prior to placement in a human upper arch row. FIG.   1 is a perspective view of a thin wall, flexible dental tray filled with a bleaching composition placed in a human upper arch row. FIG.

Claims (21)

A dental bleaching composition for whitening human teeth and reducing sensitivity,
An amount of at least one dental bleaching agent that exhibits an effect of whitening teeth when in contact with human teeth, comprising at least one peroxide,
To provide a reduction in tooth sensitivity caused by the at least one dental bleach when the dental bleaching composition is in contact with a human tooth for a time sufficient to whiten the tooth in the absence of potassium nitrate. Including potassium nitrate in an amount of 0.01% to 1 % by weight , based on the dental bleaching composition, and a carrier without abrasives that disperses the dental bleaching agent and potassium nitrate;
Here, the carrier contains a solvent and a tackifier,
The dental bleaching composition does not contain an abrasive and is a dental bleaching composition.
The dental bleaching composition according to claim 1, wherein the potassium nitrate is in an amount of 0.05% to 1% by weight, based on the dental bleaching composition.
The dental bleaching composition according to claim 1, wherein the potassium nitrate is in an amount of 0.5% by weight, based on the dental bleaching composition.
The dental bleaching composition according to claim 1, wherein the tackifier is at least one of carboxypolymethylene, gum, or protein.
The dental bleaching composition according to claim 1, wherein the carrier comprises up to 50% by weight of water based on the dental bleaching composition.
The dental bleaching composition according to claim 1, wherein the carrier comprises at least one polyol.
The dental bleaching composition according to claim 6, wherein the polyol comprises at least one of glycerin, propylene glycol, polypropylene glycol, polyethylene glycol, erythritol, sorbitol, or mannitol.
2. The antimicrobial agent of claim 1, further comprising at least one antimicrobial agent comprising at least one of chlorohexidine, tetracycline, cetylpyridinium chloride, benzalkonium chloride, cetylpyridinium bromide, methyl benzoate or propyl benzoate. Dental bleaching composition.
The dental bleaching composition according to claim 1, further comprising at least one anti-cariogenic agent comprising at least one of sodium monofluorophosphate, sodium fluoride, or stannous fluoride.
The dental bleaching composition according to claim 1, wherein the dental bleaching agent comprises at least one of hydrogen peroxide, carbamide peroxide, sodium perborate, benzoyl peroxide, or glycerol peroxide.
The dental bleaching composition according to claim 1, wherein the dental bleaching agent is in an amount of 0.5 wt% to 50 wt% based on the dental bleaching composition.
The dental bleaching composition according to claim 1, wherein the dental bleaching agent is in an amount of 1% to 30% by weight based on the dental bleaching composition.
The dental bleaching composition according to claim 1, wherein the dental bleaching agent is in an amount of 3 wt% to 20 wt% based on the dental bleaching composition.
The EDTA, EDTA salt, adipic acid, succinic acid, citric acid, tin nitrate, or at least one bleach stabilizer comprising at least one of phosphates of tin. Dental bleaching composition.
A dental bleaching composition designed to whiten and reduce sensitivity of human teeth without brushing or scrubbing,
By weight of at least one dental bleaching agent in an amount that results in an effect of whitening teeth human teeth without scrubbing or brushing teeth person with a dental bleaching composition, at least one over- Dental bleaching agents, including oxides ;
Potassium nitrate in an amount of 0.01% to 1 % by weight, based on the dental bleaching composition, and the dental bleaching composition remains stationary in contact with human teeth for a period of at least 15 minutes without brushing or scrubbing Potassium nitrate so as to provide at least one of (i) enhanced tooth whitening effect by dental bleaching agent or (ii) reduced sensitivity that can be provided by dental bleaching agent; and A dental bleaching composition comprising an abrasive-free carrier in which an agent and potassium nitrate are dispersed, the carrier comprising a solvent and a tackifier.
A system for whitening human teeth and reducing sensitivity,
An amount of dental bleaching agent that exhibits an effect of whitening teeth when in contact with human teeth , the dental bleaching agent comprising at least one peroxide ;
Wherein in order to reduce the sensitivity caused by the at least one dental bleaching agent, and potassium nitrate in an amount of dental bleaching composition 0.01% by weight, based on to 1% by weight,
It disperses the dental bleaching agent and potassium nitrate, a carrier that does not contain abrasive, and a carrier comprising a solvent and tackifier, dental bleaching composition containing no abrasive, and a thin, flexible polymer system for containing sheet material, reduce the white to and sensitize human teeth.
The system for whitening and reducing sensitivity of human teeth according to claim 16 , wherein the thin, flexible polymer sheet material is in the form of a dental tray.
17. The system for whitening and reducing sensitivity of human teeth according to claim 16 , wherein the thin, flexible polymer sheet material is a flat sheet suitable for making dental trays therefrom.
The system for whitening and reducing sensitivity of human teeth according to claim 16 , wherein the sheet material is a clear vinyl material with a preformed thickness in the range of 0.2 mm to 1.5 mm.
The system for whitening and reducing sensitivity of human teeth according to claim 16 , wherein the sheet material is a transparent vinyl material with a preformed thickness in the range of 0.25 mm to 1 mm.
17. The system for whitening and reducing sensitivity of human teeth according to claim 16 , further comprising a dental impression material, a stone mold material representing human teeth, and a photocurable molding material.

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