MXPA99011323A - A delivery system for a tooth whitener using a strip of material having low flexural stiffness - Google Patents

A delivery system for a tooth whitener using a strip of material having low flexural stiffness

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Publication number
MXPA99011323A
MXPA99011323A MXPA/A/1999/011323A MX9911323A MXPA99011323A MX PA99011323 A MXPA99011323 A MX PA99011323A MX 9911323 A MX9911323 A MX 9911323A MX PA99011323 A MXPA99011323 A MX PA99011323A
Authority
MX
Mexico
Prior art keywords
strip
substance
teeth
assortment system
dientes
Prior art date
Application number
MXPA/A/1999/011323A
Other languages
Spanish (es)
Inventor
Stanley Dirksing Robert
Albert Sagel Paul
James Rohman Frederick
Original Assignee
The Procter & Gamble Company
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by The Procter & Gamble Company filed Critical The Procter & Gamble Company
Publication of MXPA99011323A publication Critical patent/MXPA99011323A/en

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Abstract

Un sistema para surtir una sustancia blanqueadora de dientes a una pluralidad dientes adyacentes, el sistema de surtido comprende una tira de material flexible que tiene una flexibilidad suficiente para tomar una forma curva sobre una pluralidad de dientes adyacentes y una sustancia blanqueadora de dientes;la tira de material se ajusta fácilmente a las superficies dentales y a los espacios intersticiales de los dientes sin deformación permanente cuando el sistema de surtido se coloca contra los mismos;la sustancia blanqueadora de dientes se aplica a la tira de material de tal manera que cuando el sistema de surtido se coloca sobre la superficie de los dientes, la sustancia hace contacto con la superficie proveyendo un activo sobre la superficie;la sustancia también provee comunión adhesiva entre la tira de material y la superficie para mantener el sistema de surtido en su lugar durante un tiempo suficiente para permitir que el activo actúe sobre la superficie;el método de surtido incluye cubrir previamente la tira de material o hacer que el usuario aplique una sustancia a la tira de material y posteriormente aplicar el sistema de surtido a las superficies de los dientes.

Description

ASSEMBLY SYSTEM FOR A TOOTH WHITENER USING A STRIP OF MATERIAL WHICH HAS A RIGIDITY FLEXURAL BAJA CROSS REFERENCE TO RELATED REQUESTS This application is a continuation in part of the previous application, serial number 08 / 870,330, filed on June 6, 1997, which is still pending.
FIELD OF THE INVENTION The present invention relates to a system for supplying a tooth whitening substance to a plurality of adjacent teeth and in particular to an assortment system where the substance is protected so as not to cause erosion and interaction with the saliva inside the mouth for a while. sufficient to allow an asset provided through the substance to whiten teeth. The assortment system comprises a strip of material and a tooth whitening substance. More particularly, the present invention relates to economical and non-aggressive disposable assortment systems. The present invention also relates to a method for supplying a tooth whitening substance to a plurality of adjacent teeth.
ANTECEDENTS OF THE TECHNIQUE The most common instrument for dental hygiene is the toothbrush. The mechanical action of the bristles of the toothbrush aids in the removal of food particles, plaque, and the like. The toothbrush is normally used with a toothpaste. Prior to about 1955, a typical toothpaste consisted of a surfactant and an abrasive material. These products were simply created to increase the mechanical action of brushing. In 1955 CREST® toothpaste was introduced with fluoride, a registered trademark The Procter & The Gamble Company of Cincinnati, OH, and the combination of toothbrush and toothpaste proved to be suitable means of providing fluoride treatment to dental surfaces. Subsequently, other active ingredients, such as agents for tartar control, have been added to toothpastes to provide other dental hygiene benefits. Consumers have also turned their attention to the cosmetic aspects of dental care, such as straightening and whitening teeth. Given the good success in the assortment of chemicals that provides therapeutic benefits for oral care, a similar result is expected in obtaining the cosmetic benefit through routine brushing. However, people who really want to whiten their teeth and who have been disappointed with the results of whitening dentrification, often turn to professional help to whiten their teeth. The professional teeth-whitening programs that dentists provide generally fall into two categories: in-office bleaching procedure and out-of-office bleaching procedure. The procedure within the office involves many visits, each of which begins with the manufacture of a suitable rubber dam especially inside the mouth to prevent the bleaching chemical compounds, typically hydrogen peroxide, from making contact with the soft oral tissue. The concentration of the peroxide bleach forces the use of the dike. The out-of-office bleaching program differs in that the patient applies the bleaching agent to their teeth using a chemical compound with a lower concentration over an extended period, typically a few hours a day for weeks. The out-of-office program typically requires initial preparation in the dentist's office for a specific device for the particular patient. The device is a device that is manufactured to fit precisely on the patient's teeth and is used to supply the patient's teeth with a whitening gel. The patient is responsible for measuring and applying the bleaching agent on the surface of the teeth using the apparatus as a means of assortment and containment.
Because the appliance is reused, it must be large enough to withstand repeated handling, cleaning, filling, installation and use. Such apparatuses are relatively rigid so that they maintain their shape during repeated use. Typically, a patient uses the device in periods when he can avoid socialization. Now there are non-professional programs for people interested in whitening their teeth using commercial products available in pharmacies. Commercial products provide equipment that includes a general appliance and a bleach gel container. The obvious attraction is the lowest cost of the program. A major disadvantage of this "one-size" appliance is the larger gap between the interior walls of the appliance and the teeth compared to the professionally suitable appliance. In this way, to ensure an intimate contact of the bleaching gel and the surfaces of the teeth, a greater amount of bleaching gel is required. In addition, poor adequacy means a greater loss of bleaching gel in the gums, within the oral cavity, and a probable ingestion. Commercial equipment, as well as professionally managed programs outside the office, require the user to clean and prepare the device to reuse it. Because the general devices are not made for a particular user, they are even more bulky in the mouth than the individually suitable devices, and in this way they restrict socialization to a greater degree.
An attempt to remedy some of the problems of the commercial equipment is described in the patent E.U.A. do not. 5,575,654, issued to Fontenot on November 19, 1996. Fontenot discloses a pre-packaged moldable dental appliance, adapted to fit a wide range of dental arches of various sizes, which contain a pre-measured amount of a medicinal or bleaching agent. In use, the dental appliance is removed from the packing, aligned parallel to the edges of the teeth and pressed on the teeth of the direction of the periodontal tissue until it covers the surfaces of the teeth. Another solution is described in the patent E.U.A. do not. 5,310,563, issued to Curtis et al, on May 10, 1994. Curtis et al. Describes a material in the form of a mass that is formed by pressing against the teeth. This is held in place by a mechanical coupling with undercut and friction surfaces. The composition encapsulates the asset. Other methods are described in the patent E.U.A. no. 5,425,953, issued to Sintov et al, on June 20, 1995. Sintov et al, describes a liquid polymer composition for whitening teeth. The liquid polymer composition forms a film after it is applied to the teeth. Other references describing the use of a film in the oral cavity include U.S. Pat. No. 4,713,243 issued to Schiraldi et al, on December 15, 1987, and the patent of E.U.A. do not. 2,835,628, issued to Saffir on May 20, 1958.
What is needed is a low cost commercial assortment system, which has a customized fit for a minimum volume of a teeth whitening substance, and which is in comfortable contact with the surfaces of the appropriate teeth and in the interstitial spaces of the teeth. teeth for a fast assortment of an active in such a substance. In addition, an assortment system is needed that does not require extensive manipulation of placement by the user to ensure good contact. In addition, what is needed is a medium that is not bulky to contain an asset that will allow the user to use the system during a social discourse without interfering with the user's appearance or speech. A means of containment is also needed that will protect the contact of the teeth whitening substance with the internal surfaces of the mouth and with the saliva avoiding erosion.
BRIEF DESCRIPTION OF THE INVENTION In the practice of the present invention, the user applies a strip of material to a plurality of adjacent teeth. The side of the strip of material facing the teeth is covered with a whitening substance of teeth. The substance preferably has a viscous state, such as gel, such that it not only provides the active, it also provides tack between the surfaces of the teeth and the strip of material to hold the strip of material in place. The strip of adjustable material preferably has a size that is individually fixed to the 6-8 front teeth of the upper or lower rows of teeth when placed against the teeth. Because it is a soft, adjustable material, the strip can be in contact with the user's gums without causing physical irritation. The strip of material is easily adjusted to the teeth by pressing lightly against them and / or causing the user to suck gently between the spaces of the teeth. The strip of material without permanent deformation is easily adjustable to the shape of the teeth when the assortment system is placed on the strip. The user can easily remove the strip of material after using it by detaching it. Preferably, each successive treatment uses a new strip of material. Being a relatively thin coating, the tooth whitening substance has a low volume compared to the substance contained in the suitable rigid trays or not. In this way, no substance is wasted, and a small amount of it can be accidentally ingested or available to irritate the surfaces of the oral cavity for which it was not created. Preferably, the strip of material and the substance are substantially transparent in such a way that they are almost imperceptible during use. The assortment system also includes a tooth whitening substance that is applied to the strip of material. When the assortment system is placed on the surface of the teeth, the substance makes contact with the surface providing an active on the surface. The substance also provides an adhesive fixation between the strip of material and the surface where the assortment system will be maintained for a sufficient time to allow the active to act on said surface. Preferably, the substance is in the form of a gel, which is a substantially uniform continuous coating on the strip of material. In another aspect of the present invention, a method of supplying a tooth whitening substance to the surface of the teeth includes the step of applying the substance onto a strip of adjustable material. This is followed by the application of the strip of adjustable material to the surface of the teeth without permanent deformation of the strip of material. The substance provides an active on the surfaces and also provides an adhesive communion between the strip of material and the surface where the assortment system will be maintained for a sufficient time to allow the active act on the surface.
BRIEF DESCRIPTION OF THE DRAWINGS Although the specification concludes with claims that particularly point out and clearly claim the present invention, it is believed that the present invention will be understood even better from the following description of the preferred embodiments, taken in conjunction with the accompanying drawings, wherein the reference numbers Identify the identical elements and where: Figure 1 is a perspective view of a strip of substantially flat material having rounded corners. Figure 2 is a perspective view of one embodiment of the present invention, which describes the flat strip of Figure 1 coated with a teeth whitening substance. Figure 3 is a cross-sectional view thereof, taken along section line 3-3 of Figure 2, describing an example of the flat strip having a thickness less than that of the substance covering it . Figure 4 is a cross-sectional view showing an alternative embodiment of the present invention, which shows shallow cavities in the strip of material, which act as reservoirs for additional substance coated on the strip. Figure 5 is a cross-sectional view showing the adjacent teeth with the strip of material of the present invention fitted thereon and in adhesive bond with the teeth by means of a substance located between the teeth and the strip of material. Figure 6 is a cross-sectional elevational view of a tooth and the surrounding soft tissue, taken along section line 6-6 of Figure 5, describing the strip of the present invention adjusted and in adhesive communion with the tooth by means of the substance located between the tooth and the strip of material.
Figure 7 is a cross-sectional view similar to Figure 5, showing a strip of material of the present invention adjusted to the teeth and soft tissue and in adhesive communion with both sides of the teeth by means of the substance located between the tooth and the strip of material. Figure 8 is a cross-section elevation view, taken along section line 8-8 of Figure 7, showing the strip of material of the present invention adjusted to both the tooth and the surrounding soft tissue and Adhesive communion with both sides of the tooth by means of the substance located between the tooth and the strip of material. Figure 9 is a perspective view of an alternative embodiment of the present invention, describing the flat strip covered with a tooth whitening substance of Figure 2 with a release liner. Fig. 10 is a cross-sectional view of an alternative embodiment of the present invention, taken along section line 10-10 of Fig. 9, showing a release liner attached to the strip of material by the substance on the strip of material.
DETAILED DESCRIPTION OF THE INVENTION The abbreviation "cm", in the present, means centimeter. The abbreviation "mm", in the present, means millimeter.
Referring now to the drawings, and in particular to Figures 1 and 2, there is shown a first preferred embodiment of the present invention, which is generally indicated as 10. The embodiment 10 represents an assortment system for a tooth whitening substance. The assortment system 10 has a strip of material 12, which initially is substantially flat, preferably with rounded corners. A teeth whitening substance 14 is applied to or coating the strip of material 12. Preferably, the substance 14 is homogeneous, uniformly and continuously covering the strip of material 12 as shown in Figure 3. However, the substance 14 alternately it can be a separate sheet or layers of components, an amorphous mixture of separate components, strips or dots or other patterns of different components, or a combination of these structures including a continuous coating of oral care substance 14 along an axis longitudinal of a portion of strip of material 12. As shown in Figure 4, an alternative embodiment, a strip of material 12 may have shallow cavities 18 formed therein. When the substance 14 covers one side covered by substance from the strip of material 12, an additional substance 14 fills the shallow cavities 18 to provide deposits of additional substance 14. Figures 5 and 6 show an assortment system 24 of the present invention applied to a plurality of adjacent teeth on the surface of a tooth. A plurality of adjacent teeth 22 is included in an adjacent soft tissue 20. The adjacent soft tissue is defined herein as soft tissue surfaces surrounding the structure of the tooth including: papilla, marginal gingiva, gingival sulculus, interdental gingiva, structure gingival gingiva on the lingual and buccal surfaces up to and including the muco gingival junction and the bell. In Figures 5 and 6, the assortment system 24 represents the strip of material 12 and the substance 14, with substance 14 on the side of the strip of material 12 facing the adjacent teeth 22. The substance 14 can be applied previously to the strip of material 12 or applied to the strip of material 12 by the user's assortment system. In any case, the strip of material 12 has a thickness and a flexural stiffness that allows it to fit the contour surfaces of the adjacent teeth 22 and the adjacent soft tissue 20. The strip of flexible material has sufficient flexibility to make a curved shape around of a plurality of adjacent teeth. The strip of material also easily adjusts to the surfaces of the teeth and to the interstitial spaces of the teeth without permanent deformation when the assortment system is applied. The assortment system is applied without great pressure. Figures 7 and 8 show the assortment system 24 of the present invention applied to both the anterior and posterior surfaces of a plurality of adjacent teeth 22, as well as the adjacent soft tissue 20 located on the anterior surface of the tooth. The assortment system 24 represents a strip of material 12 and substance 14, with the substance 14 on the side of the strip of material 12 facing the adjacent teeth 22. Figures 9 and 10 show an optional release liner 27. The lining of detachment 27 is attached to the strip of material 12 by substance 14. The substance 14 is on the side of the strip of material 12 facing the release liner 27. This side is applied to the surface of the tooth once the release liner 27 is removed.
Strip of material The strip of material functions as a protective barrier to substantially prevent the saliva from contacting the teeth whitening substance and causing leaching and / or erosion upon contact with the lips, tongue, and other soft tissue of the wearer. In order for the active substance of the tooth whitening substance to act on the surface of the teeth for a prolonged period, from a few minutes to a few hours, it is important to minimize such leaching and / or erosion. The term "act upon" in the present is defined as providing the desired change. For example, if the substance is a teeth whitening agent, it whitens the bodies with color to provide the desired bleaching. The strip of material may comprise materials such as polymers, natural or synthetic fabrics, nonwovens, metal foils, paper, rubber and combinations thereof. The strip of material may be a single layer of material or a laminate of more than one layer. Generally, the strip of material is substantially impermeable to water. The material can be any type of polymer that has the required flexural rigidity and is compatible with the teeth whitening actives, such as peroxide. The material may comprise a single polymer or a mixture of polymers. Suitable polymers include, but are not limited to, polyethylene, ethyl vinyl acetate, ethyl vinyl alcohol, polyesters such as Mylar® manufactured by Dupont, fluoroplastics such as Teflon® manufactured by Dupont, and combinations thereof. Preferably, the material is polyethylene. The strip of material generally has a thickness of less than about 1 mm, preferably less than about 0.05 mm, and most preferably about 0.001 about 0.03 mm. A strip of polyethylene material preferably has a thickness of less than about 0.1 mm and most preferably from about 0.005 to about 0.02 mm. Preferably, the shape of the strip of material is any shape having round corners, "round corners" being defined as without sharp angles or points. The strip of adjustable material preferably has a size that fits individually to the row of teeth to be bleached. Generally, this is the 6 to 8 anterior teeth of the upper or lower rows of teeth that are visible when the user smiles. Optionally, the strip of material can be adapted to the lower or upper complete rows of teeth when placed on the teeth. The size of the strip of material depends on many factors, including the number of teeth to be bleached, the size of the teeth and the user's personal preference. In general, the length of the strip of material is from about 2 cm to about 12 cm and preferably about 4 cm about 9 cm. The width of the strip of material will also depend on many factors, including whether the strip of material covers the entire tooth and covers both surfaces of the tooth or if it is not. In a general application, the width of the strip of material is from about 0.5 to about 4 cm and preferably about 1 cm about 2 cm. The strip of material may contain shallow cavities. When the substance covers one side covered by substance from the strip of material, additional substance fills the shallow cavities to provide deposits of additional substance. Additionally, the shallow cavities help provide a texture to the assortment system. The film will preferably have a shallow cavity arrangement. Generally, shallow cavities approximately measure 0.4 mm in the transverse direction and 0.1 mm in depth. When the shallow cavities are included in the strip of material and the substances are applied to them in various thicknesses, the overall thickness of the supply system is generally less than about 1 mm. Preferably, the overall thickness is less than 0.5 mm. Flexural rigidity is a property of the material that is a function of a combination of thickness, width of the strip and modulus of elasticity of the material. This test is a method to measure the rigidity of the polyolefin film and its lamination. Determine the flexural strength of a sample using a strain detector placed at the end of a horizontal beam. The opposite end of the beam exerts pressure along a strip of the sample to force a portion of the strip towards a vertical groove on a horizontal platform on which the sample is located. An ammeter, connected to the deformation detector calibrated in grams of deflection force. The stiffness of the sample is read directly from the ammeter and is expressed in grams per centimeter of the width of the sample strip. In the present invention, the strip of material has a flexural stiffness of less than about 5 grams / cm when measured on a Handle-O-Meter meter, model # 21 1-300, available from Thwing-Albert Instrument Co. of Philadelphia, PA , by test method ASTM D2923-95. Preferably, the strip of material has a flexural stiffness less than about 4 grams / cm, most preferably less than about 3 grams / cm, and most preferably from about 0.1 grams / cm to about 1 gram / cm. Preferably, the flexural stiffness of the strip of material is substantially constant and does not change significantly during normal use. For example, the strip of material does not need to be hydrated so that the strip achieves the low flexural rigidity in the ranges specified above. This relatively low stiffness allows the strip of material to wrap the contour surface of the teeth exerting little pressure; that is, according to the curvature of the mouth and the spaces between the adjacent teeth of the user it is maintained because there is very little residual force within the strip of material that causes it to return to its substantially flat shape. The flexibility of the strip allows the strip of material to make contact with the soft tissue for an extended period without causing physical irritation. The strip of material does not require pressure when placing it on the teeth. The strip of material is held in place on a plurality of adjacent teeth by means of an adhesive communion provided by the substance. The viscosity and tackiness of the substance causes the strip of material to be adhesively bonded to a plurality of adjacent teeth without substantial slippage under the potential friction of the lips, tongue and other soft tissues that rub the strip of material during the movement of the mouth associated with talking, drinking, etc. However, this adhesion to the teeth is low enough to allow the user to easily remove the assortment system, detaching the strip of material using his finger or fingernail. The delivery system can be easily removed from the surface of the teeth without the use of instruments, chemical solvents or friction. Chemical solvents include any organic solvent commonly used in oral care products such as alcohol and other safe solvents such as water, which can be used to dilute the gelling agent. Unnecessary friction is described as any kind of rubbing with the finger or a soft instrument, such as cotton, swab or gauze. A peel force of approximately 1 to 50 g for a strip width of 1.5 cm (approximately 17 grams / cm) is all that is required. Preferably, the force to remove it is from about 5 to about 40 grams and most preferably from about 10 grams to 30 grams. A low release force is desired for consumer management purposes. The detachment force is possible because it has a gel substance of a non-aggressive nature. Only when the flexural rigidity of the strip is low can the adhesion of the substance also be low. The adhesion of a harder strip would have to be greater in proportion to the hardness of the strip to prevent the strip from returning to its flat condition and pulling it from the contour surface of a plurality of teeth. The strip of material can be formed by various film making methods known in the art. Preferably, a strip of material made of polyethylene is made by a melting or blowing process. It is also feasible to form the strip by other methods such as extrusion and others that do not affect the flexural rigidity of the strip of material. Additionally, the substance can be incorporated on the strip during the processing of the strip. The substance can be a sheet on the strip.
Teeth Whitening Substance The whitening substance of teeth is a composition, compound or mixture capable of influencing or effecting a desired change in appearance / structure of the surface with which it makes contact. Some examples of changes in appearance and structure include, but are not necessarily limited to, bleaching, bleaching, stain removal, plaque removal, and scale removal. Preferably, the active is to whiten the surfaces of the teeth. The amount of substance applied to the material strip or tooth will depend on the size and capacity of the piece of material, concentration of the asset and the desired benefit. Generally, less than about 1 gram of substance is required. Preferably, it is used from about 0.05 grams to about 0.5 grams and most preferably from about 0.1 grams to about 0.4 grams of the substance. The amounts of substances per cm2 of material is less than about 0.2 grams / cm2, preferably from about 0.005 to about 0.1 grams / cm2, and most preferably from about 0.01 grams / cm2 to about 0.04 grams / cm2. The substance of the present invention can be in the form of a viscous liquid, paste, gel, solution or other suitable form that can provide sufficient addition. Preferably, the substance is in the form of a gel. The substance will have a viscosity of about 200 at about 1,000.00 cps at low shear rates (less than 1 / seconds). Preferably, the viscosity is about 100,000 about 800,000 cps and most preferably about 400,000 to about 600,000 cps. Suitable bleaching assets include any safe material for use in the oral cavity that provides bleaching or stain removal. Suitable actives for bleaching are chosen from the group consisting of peroxides, metal chlorites, perborates, percabonates, peroxyacids, and combinations thereof. Suitable peroxide compounds include hydrogen peroxide, calcium peroxide, carbamide peroxide and mixtures thereof. Carbamide peroxide is preferred. Suitable metal chlorites include calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, and potassium chlorite. Additional bleaching assets can be hypochlorite and chlorine dioxide. The preferred chlorite is sodium ciorite. The tooth whitening active is present in an amount of about 0.01% to about 40% by weight of the substance. If a peroxide compound is chosen as the active, the peroxide compound must provide an amount of hydrogen peroxide equivalent of about 0.1% to about 20%, preferably from about 0.5% to about 10%, and most preferably of about 1% to about 7% by weight of the substance. To provide this amount of equivalent hydrogen peroxide, the peroxide compound, such as carbamide peroxide, is generally present in an amount of about 0.1% to about 30% and preferably from about 3% to about 20% by weight of the substance. The active ingredients are generally contained in an aqueous gel. The gel is a high viscosity matrix formed from gelling agents already known in the art. These gelling agents are safe for oral use, do not dissolve easily in saliva and do not react with or inactivate the oral care compounds incorporated therein. Generally, the gelling agent is a swellable polymer. In addition, the gel formed with these agents provides sufficient adhesive communion of the film material to the target area in the mouth. The level of gelling agent to form the gel composition is from about 0.1% to about 15%, preferably from about 1% to about 10%, most preferably from about 2% to about 8%, and very preferably from about 4% to 7% by weight of the substance. Suitable gelling agents useful in the present invention include carboxypolymethylene, carboxymethylcellulose, carboxypropylcellulose, poloxamer, carrageenan, veegum, carboxyvinylpolymerase, and natural gums such as carayá gum, xanthan gum, guar gum, gum arabic, tragacanth gum, and mixtures thereof. The preferred gelling agent for use in the present invention is carboxypolymethylene, which is obtained from B. F. Goodrich Company under the tradename "Carbopol". Particularly preferred carbopols include carbopol 934, 940, 941, 956 and mixtures thereof. Particularly carbopol 956 is preferred. Carboxypolymethylene is a slightly acidic vinyl polymer with active carboxylic groups. The normal concentration of various carboxypolymethylene resins in water, according to the manufacturer, is less than 2%. However, it has been found that oral gel compositions with high viscosity can be prepared by preparing super saturated carboxypolymethylene compositions having an absolute concentration in the ranges specified above. Concentrated carboxypolymethylene gels have several important characteristics in addition to high viscosity. Sufficient carboxypolymethylene is added to the oral gel compositions in a greater quantity than that required to provide a high viscosity such that a significant amount of saliva or water is required to decrease the viscosity to the point where the composition can be diluted and eliminated with saliva . The concentrated carboxypolymethylene compositions also have a tackiness or adhesion that retains and seals the material of the strip against the surface of the target oral cavity to which it is fixed, particularly the teeth. However, care must be taken to avoid too much carboxypolymethylene causing difficulty in inserting or removing material from the strip. Water is also present in the gel compositions described herein. The water used in the present invention should preferably be deionized and free of organic impurities. Water comprises from about 0.1% to 95%, preferably from about 5% to about 90%, and most preferably from about 10% to about 80%, by weight of the substance. This amount of water includes the free water that is added in addition to the amount that is introduced with other materials. A pH regulating agent can also be added to optimize storage stability of the gel and make substances safe for oral tissues. These adjusting agents or pH regulators can be any suitable material for adjusting the pH of the substance. Suitable materials include sodium bicarbonate, sodium phosphate, sodium hydroxide, ammonium hydroxide, sodium stannate, triethanolamine, citric acid, hydrochloric acid, sodium citrate and combinations thereof. The pH regulating agents are added in amounts sufficient to adjust the pH of the gel composition from about 4.5 to about 1 1, preferably from about 5 to about 8.5, most preferably from about 5.5 to about 7. The pH regulating agents are generally present in an amount from about 0.01% to about 15% and preferably from about 0.05% to about 5% by weight of the substance. Although the gel described above provides sufficient adhesiveness, additional gelling agents can also be included in the formula to help the active ingredients to adhere to the tissues of the oral cavity. Suitable agents include both polymers with limited water solubility, as well as polymers without water solubility. These polymers deposit a thin film in both the soft and hard tissues in the oral cavity when the saliva is combined with the composition herein. Adhesives with suitable limited water solubility include: hydroxyethyl or propylcellulose. Adhesives without water solubility include: ethylcellulose and polyox resins. Other possible adhesives suitable for use in the present composition are polyvinylpyrrolidones with a molecular weight of about 50, 000 to about 300,000. Yet another possible adhesive suitable for use in the present composition is a combination of Gantrez and the water-soluble semi-synthetic carboxymethylcellulose polymer. An additional vehicle can also be added to the substance. The vehicles can be humectants. Such humectants include glycerin, sorbitol, polyethylene glycol, propylene glycol and other possible polyhydric alcohols. Moisturizers are generally present in an amount of from about 10% to about 95%, preferably from about 20% to about 80% and most preferably from about 50% to about 70% by weight of the substance. In addition to the materials indicated above of the gel of the present invention, some other components may also be added to the substance. Additional components include, but are not limited to flavoring agents, sweetening agents, xylitol, opacifiers, coloring agents and chelating agents such as ethylenediaminetetraacetic acid. These additional ingredients can also be used in place of the compounds described above.
Detachment liner The detachment liner may be formed of any material that exhibits less affinity for the substance exhibiting the substance itself and to the strip of material. The release liner preferably comprises a rigid sheet of material such as polyethylene, paper, polyester, or other material which is then covered with an unbondable type material. The release liner material can be covered with wax, silicone, polyester such as Teflon®, fluoropolymers, or other non-bondable type materials. A preferred release liner is Scotchpak®, produced by 3M. The release liner can be cut substantially to the same size and shape as the strip of material or the release liner can be cut longer than the strip of material to provide easily accessible means for separating the material from the strip. The release liner may be formed of a brittle material that breaks when the strip is bent or of multiple pieces of material or a piece of marked material. Alternatively, the release liner may be in two overlapping pieces as a typical adhesive bandage strip design. A further description of suitable materials as release agents is found in Kirk-Othmer Encyclopedia of Chemical Technology, fourth edition, volume 21, pp. 207-218, incorporated herein by reference.
Examples The strip of material is preferably a piece of polyethylene film with a thickness of 0.013 mm. Preferably the film has a shallow cavity arrangement, typically 0.4 mm in length and 0.1 mm in depth. The strip of material has a flexural stiffness of about 0.6 g / cm when measured with a Handle-O-Meter, model number 21 1-300, available from Thwing-Albert Instrument Co. of Philadelphia, PA, by the test method ASTM D2923-95. An example of a tooth whitening agent is a gel described as follows: combination of 70% glycerin, 5% carboxypolymethylene, 10% carbamide peroxide and 15% water with a regulated pH of 6.5 with sodium hydroxide . Mix until it becomes homogeneous. Additional alternative examples of tooth whitening gel are described as follows: combination of 8% carboxypolymethylene in about 84% water, adding 4% sodium hydroxide and sufficient sodium bicarbonate to obtain a pH of about 10. Dissolve in 3.75% sodium chlorite and mix until it becomes homogeneous. Combine 56% glycerin, 6% carboxypolymethylene, 10% carbamide peroxide, and 24% water. Add 4% sodium hydroxide (50% solution) to adjust the pH. Mix until it becomes homogeneous. Combine 68% glycerin, 6% carboxypolymethylene, 22% carbamide peroxide, and 4% sodium hydroxide (50% solution). Mix until it becomes homogeneous. Combine 25% glycerin, 69.7% water, 2% xanthan gum, 3% carboxymethylcellulose, and 0.3% carbamide peroxide. Mix until it becomes homogeneous.
Combine 24% poloxamer, 20% glycerin, 46% polyethylene glycol and 10% carbamide peroxide. Mix until it becomes homogeneous. Commercial teeth whiteners such as Opalescence and Nu-Pro Gold also operate with the assortment system of the present invention.
Method of use In the practice of the present invention, the user applies a strip of material to a plurality of adjacent teeth. The material side facing the teeth is covered with a tooth whitening substance which is preferably in a viscous state to provide not only the active, but also tack between the tooth surfaces and the strip of material to hold the strip in place. its place for a prolonged period. The strip of material easily fits the teeth by gently pressing against the teeth and / or causing the user to suck gently through the spaces between the teeth. The user can easily remove the strip of material by detaching it. Preferably, each successive treatment will use a strip of new material. It is not necessary to prepare the dental surface before applying the assortment system. For example, the user can choose whether or not to brush his teeth or rinse his mouth before applying the assortment system. The surfaces of the teeth do not require drying or being excessively wet with saliva or water before applying the strip of material. Preferably, the strip of material and the substances are substantially transparent in such a way that they are almost imperceptible when used. The thinness of the assortment system allows a higher temperature inside the user's mouth to conduct heat through the strip of material to the normally colder teeth to accelerate the diffusion rate of the active material on the surfaces of the teeth. Preferably, the user applies the assortment system of the present invention to the teeth continuously for about 5 minutes to about 120 minutes a day, preferably from about 30 minutes to about 60 minutes. Generally, this is done once a day for 7 to 28 days. The amount of time and the number of days depend on various factors, including the amount of bleaching desired, the user's teeth, and whether initial or maintenance bleaching is desired. The bleaching is performed to achieve a bleaching benefit of 1 to 4 in a shade guide as measured with VITA LUMIN® Vacuun Farbskala Shade Guides, a product of VITA Zahnafabrik, of BadSackingen, Germany. When the user removes the strip of material from the teeth, there may be residue of substance remaining on the surface. This residue will not be much, since the tooth whitening substance has affinity for both the film and itself. If the residue substance remains, it can be easily removed by brushing or rinsing.
Although the particular embodiments of the present invention have been illustrated and described, it will be obvious to those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the invention, and are intended to be covered in the appended claims. such modifications that are within the scope of the invention.

Claims (10)

1. - An assortment system for providing a tooth whitening substance to a plurality of adjacent teeth, said assortment system comprising: a) a strip of flexible material having sufficient flexibility to make a curved shape on a plurality of adjacent teeth, said strip of material being already adjusted to the surfaces of the teeth and to the interstitial spaces of the teeth without permanent deformation when said assortment system is placed against them; and b) a tooth whitening substance applied to said strip of material such that when said assortment system is placed on a surface of said teeth, said substance makes contact with said surface providing an active on said surface, said substance it also provides adhesive communion between said strip of material and said surface to hold said assortment system in place for a sufficient time to allow said asset to act on said surface.
2. The assortment system according to claim 1, further characterized in that said strip has a flexural stiffness of less than 5 grams / centimeter when measured in a Handle-O-Meter by the test method of ASTM D2923-95 , preferably where said strip of material is capable of recovering from said deformed state in the absence of adhesive forces due to said tooth whitening substance.
3. - The assortment system according to claims 1 and 2, further characterized in that said strip of material comprises materials that are compatible with one or more teeth whitening actives, wherein said strip of material is substantially impermeable to water. 4.- The assortment system in accordance with the claims 1, 2 and 3 further characterized in that said tooth whitening active in said substance is selected from the group consisting of peroxides, metal chlorites, perborates, percarbonates, peroxyacids, and combinations thereof. 5. The assortment system according to claim 1 to 4, further characterized in that said strip of material and said substance applied thereto has a general thickness of less than 1 mm, preferably further characterized in that said strip of material is a polyethylene film having a nominal film thickness less than 0.1 mm. 6. The assortment system according to claims 1 to 5, further characterized in that said strip of material with said substance has a peel force of less than 50 grams, preferably further characterized in that said strip of material with said substance It can be removed from said tooth surface without using an instrument, a chemical solvent or unnecessary friction. 7. The assortment system according to claims 1 to 6, further characterized in that the strip of material has shallow cavities on one side covered with substance from said strip of material, said shallow cavities have a substance located within them. 8. The assortment system according to claims 1 to 7, further characterized in that said substance comprises an amount of carboxypolymethylene from 0.5% to 12% by weight of the substance. 9. The assortment system according to claims 1 to 8, further characterized in that it comprises a release liner. 10. A method for supplying a tooth whitening substance to a plurality of adjacent teeth, said method comprising the steps of: a) applying said substances onto a strip of adjustable material having sufficient flexibility to make a curved shape around a plurality of adjacent teeth and said strip of material being easily adjustable to the tooth surfaces and the interstitial spaces of the teeth without permanent deformation; and b) applying said adjustable strip of material with said substance thereto to said plurality of adjacent teeth without permanent deformation of said strip of material., in such a way that said substance makes contact with said surface, said substance providing an active on said plurality of adjacent teeth, said substance also provides adhesive communion between said strip of material of said plurality of adjacent teeth to maintain said assortment system in its place for a sufficient time to allow said asset to act on said surface.
MXPA/A/1999/011323A 1997-06-06 1999-12-06 A delivery system for a tooth whitener using a strip of material having low flexural stiffness MXPA99011323A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08870330 1997-06-06
US040000 1998-03-17

Publications (1)

Publication Number Publication Date
MXPA99011323A true MXPA99011323A (en) 2001-05-17

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