Method of applying a tooth whitening agent employing a strip of low flexural rigidity

Description of the invention

The present invention relates to a tooth whitening product and a tooth whitening substance. The invention relates to a tooth whitening product in which the substance is prevented from erosion and the action of saliva in the mouth for a time sufficient to whiten the teeth with the active ingredient of the substance. The product contains a strip of material and a bleaching agent. More particularly, the invention relates to a disposable tooth whitening product that is cheap and easy to use.

The toothbrush is the most frequently used device for oral hygiene. The mechanical action of the toothbrush bristles helps to remove food particles, tartar, etc. Toothpaste is usually used with the toothbrush. Prior to about 1955, a typical toothpaste contained a surfactant and an abrasive. Typically these products were intended to be mechanically acted upon by scrubbing.

In 1955, CREST® fluoridated toothpaste was introduced, and the toothbrush combined with the fluoridated toothpaste proved to be an effective agent for fluoridating tooth surfaces. The toothpaste was then supplemented with other active ingredients, such as anti-tartar agents, to provide further oral hygiene benefits. Consumers' attention has also focused on the cosmetic aspects of dental care, such as straightening and whitening.

Following the success of the introduction of chemicals that provide therapeutic oral care benefits, similar success in obtaining cosmetic benefits through regular brushing can be expected. However, people who are seriously interested in whitening their teeth and are discouraged by the effects of whitening only by cleaning, often resort to professional help to whiten their teeth.

Professional teeth whitening programs generally fall into two categories: in-office procedure and out-of-office procedure. The in-office procedure involves multiple visits, each of which begins with the fabrication of a tailored rubber shield inside the mouth to prevent bleaching chemicals, typically hydrogen peroxide, from coming into contact with the soft tissue of the mouth. The use of the shield is dictated by the strength of the peroxide.

The out-of-office whitening procedure consists in applying a bleaching agent with a lower chemical force for several hours a day, for several weeks. In an out-of-office program, pre-fitting in the dental office is typically required with a device that is specific to each patient. The bleaching gel is applied with the help of a device precisely adjusted to the teeth. The patient himself measures and applies aliquots of whitening agent to the surface of the teeth, using the device as a means for delivering and holding the whitening agent.

Due to repeated use, the device must be sufficiently tough to withstand repeated use, cleaning, filling, donning and wearing. They are relatively stiff devices to maintain fit during use. Typically, the patient uses the device at a time when he can avoid social contact.

Currently, there are unprofessional programs available for people interested in whitening their teeth using commercial products sold in pharmacies. Commercial products are a kit containing a universal device and a container of bleaching gel. The main disadvantage of such a "one-size" device is that there is a greater void space between its internal walls and the patient's teeth than in a professionally fitted device. For the direct contact of the bleaching gel with the tooth surface, more gel is needed here. Worse fit furthermore means more loss of bleaching gel on the gums, in the mouth and with possible swallowing. In commercial sets, as in an out-of-office, professionally administered program, the user cleans and repeatedly uses the device. Since universal devices are not individually tailored to each user, they take up more oral space than a fitted device, reducing public approval to a greater extent.

One attempt to overcome the disadvantages of commercial kits is disclosed in U.S. Patent No. 5,575,654 dated. Nov. 19, 1996. It describes a mouldable device suitable for a range of dimensionally varying dentition arches in which a metered amount of medicament or bleach is present. After taking it out of the packaging, the device is aligned with the edges of the teeth on the occlusion and pressed towards the interdental tissue to cover the surface of the teeth.

PL 191 827 B1

Another solution is disclosed in US Patent No. 5,310,563 dated. May 10, 1994, which describes a putty-like material that is formed by being pressed between the teeth. It is held by a mechanical connection on undercuts and by friction. The active ingredients are placed in this material.

Other methods are described in US Patent No. 5,425,953 dated. Jun 20, 1995. It discloses a liquid polymeric composition for teeth whitening. When applied to the teeth, the kit forms a foil. Other descriptions illustrating the use of an oral film are provided in U.S. Patent No. 4,713,243 dated No. December 15, 1987 and U.S. Patent No. 2,835,628 dated May 20, 1958.

There is a need for a low-cost tooth whitening product which has a measured fit to incorporate the minimum amount of whitening substance and which is in compliant contact with the surfaces and interdental spaces for the rapid delivery of the active ingredient of the substance. Furthermore, a product is needed that does not require excessive manipulation to be fitted by the user to ensure good contact. In addition, small overall means for containing the active agent are needed, which enable the user to use the product during social contacts. Also, containment means are needed which will protect the tooth whitening substance from erosion in contact with the inner surfaces of the mouth and saliva.

A tooth whitening product comprising a strip of flexible material coated with a tooth whitening substance, according to the invention, characterized in that the tooth whitening substance constitutes the outer layer of the product and comprises a tooth whitening active ingredient and an adhesive that attaches the substance to the material strip and to the teeth after the application of the product. wherein the strip of material and the tooth whitening substance together have a thickness of less than about 1 mm.

Preferably the strip of material has a flexural stiffness of less than 3 g / cm as measured with a Handle-O-Meter by ASTM D2923-95 method.

Preferably, the strip of material comprises materials that are compatible with the at least one tooth whitening active ingredient, the strip being substantially water impermeable.

Preferably the tooth whitening active ingredient is peroxide.

Preferably, the strip of material with the substance has a peel force of from about 5 to about 30 grams.

Preferably the tooth whitening material comprises carboxypolymethylene in an amount from 0.5% to 12% by weight of the tooth whitening material.

Preferably the product also includes a release liner.

Preferably, the strip of material is a polyethylene film having a nominal thickness of less than 0.1 mm.

Preferably, the tooth whitening substance also contains water.

Preferably, the amount of water is from about 5% to about 90% by weight of the tooth whitening material.

Preferably, the amount of the tooth whitening substance is from about 0.005 g / cm² up to about 0.1 g / cm².

Preferably, the flexible strip of material has a tooth-facing surface and the tooth whitening substance continuously covers the tooth-facing surface.

Preferably, the tooth whitening material comprises a gelling agent.

Preferably, the tooth whitening substance further comprises a humectant selected from the group consisting of glycerin, sorbitol, polyethylene glycol, polypropylene glycol, and other food grade polyhydric alcohols.

Preferably, the flexible strip of material comprises a material selected from the group consisting of polyethylene, polyester ethylene vinyl acetate, ethylene vinyl alcohol, and combinations thereof.

Preferably, the flexible strip of material has a flexural stiffness of less than about 5 g / cm.

Preferably, the amount of the tooth whitening agent is from about 0.05 grams to about 0.5 grams.

Preferably, the strip of flexible material is from about 4 cm to about 9 cm long and from about 1 cm to about 2 cm wide.

Preferably, the flexible strip of material is a laminate.

Preferably, the laminate comprises a non-woven layer.

Preferably the tooth whitening substance is a viscous gel.

Preferably, the flexible strip of material has a flexural stiffness of from about 0.1 g / cm to 1 g / cm.

Preferably, the flexible strip of material has a flexural stiffness of about 0.6 g / cm.

Preferably, the flexible strip of material has an exposed surface.

Preferably, the product comprises a single strip of flexible material.

A tooth whitening product to be applied to the teeth comprising a strip of flexible material coated with a tooth whitening substance, according to the invention, characterized in that the tooth whitening substance comprises many different ingredients, the first ingredient being the active ingredient.

The teeth whitening agent is an adhesive, the second component being an adhesive, the first component being separate from the second component.

Preferably the substance is provided in a form selected from the group consisting of a laminate, a first layer containing the first component and a second layer containing a second component, a first spot containing the first component and a second spot containing a second component, a first strip containing the first component, and a second strip containing the second component, and combinations of them.

Preferably the substance is provided in the form of a laminate.

Preferably, the substance is provided in the form of a first layer containing a first component and a second layer containing a second component.

Preferably, the substance is provided in the form of a first strip containing the first component and the second strip containing the second component.

Preferably, the substance forms a uniform surface that is applied to a plurality of adjacent teeth.

Preferably the tooth whitening active ingredient is peroxide.

Preferably the second component is selected from the group consisting of hydroxyl ethyl cellulose, hydroxyl propyl cellulose, ethyl cellulose, polyoxy resins, polyvinyl pyrrolidone and combinations of carboxymethyl cellulose and Gantrez.

Preferably, the substance also comprises a material selected from the group consisting of glycerin, sorbitol, polyethylene glycol, polypropylene glycol, and other food grade polyhydric alcohols.

Preferably, the substance also contains a gelling agent.

Preferably, the gelling agent is selected from the group consisting of carboxypolymethylene, carboxymethyl cellulose, carboxypropyl cellulose, poloxamer, carrageenan, Veegum, carboxyvinyl polymers, natural gum and mixtures thereof.

Preferably, the tooth whitening product has an overall thickness of less than about 1mm.

Preferably, the tooth whitening product has an overall thickness of less than about 0.5 mm.

Preferably, the flexible strip of material comprises a material selected from the group consisting of polyethylene, polyester ethylene vinyl acetate, ethylene vinyl alcohol, and combinations thereof.

Preferably, the flexible strip of material has a flexural stiffness of less than about 3 g / cm.

Preferably, the flexible strip of material has a flexural stiffness of from about 0.1 g / cm to 1 g / cm.

Preferably, the flexible strip of material has a flexural stiffness of about 0.6 g / cm.

Preferably, the substance also comprises water.

Preferably, the amount of water is from about 5% to about 90% by weight of the substance.

Preferably, the tooth whitening product has a peel force of from about 5 g to about 30 g.

Preferably, the amount of substance (14) is between about 0.05 grams and about 0.5 grams. Preferably, the amount of substance is between about 0.005 g / cm² a about 0.1 g / cm².

Preferably, the tooth whitening product is applied to the back surface of the tooth.

Preferably, the second component adheres the tooth whitening active to the plurality of adjacent teeth when combined with the saliva.

Preferably the tooth whitening product is substantially flat before use.

Preferably, the strip of flexible material is from about 4 cm to about 9 cm long and from about 1 cm to about 2 cm wide.

Preferably, the product also includes a release liner adjacent to the substance.

Preferably, the flexible strip of material has a thickness from about 0.005 mm to about 0.02 mm.

Preferably, the flexible strip of material abuts the front surface of the plurality of adjacent teeth without being permanently deformed.

Preferably, the flexible strip of material provides a protective barrier that does not substantially allow saliva to come into contact with the substance.

Preferably, the flexible strip of material has an exposed surface.

Preferably, the flexible strip of material is a laminate.

Preferably, the laminate comprises a non-woven layer.

Preferably the product has one strip of flexible material.

Preferably, a single strip of flexible material is a non-woven fabric.

The tooth whitening substance to be applied to the teeth according to the invention is characterized in that it comprises a polyoxy resin and a peroxide tooth whitening active ingredient, the tooth whitening substance being formed into a thin layer with dimensions such that it covers a large number of

Adjacent teeth are applied to adjacent teeth when applied to a plurality of adjacent teeth, and the multi-oxygen resin adheres the tooth whitening active to the plurality of adjacent teeth as the multi-oxygen resin combines with the saliva.

Preferably, the substance also comprises a material selected from the group consisting of glycerin, sorbitol, polyethylene glycol, polypropylene glycol, and other food grade polyhydric alcohols.

Preferably, the substance also comprises water.

Preferably, the amount of water is from about 5% to about 90% by weight of the tooth whitening material.

Preferably, the substance also contains a gelling agent.

Preferably, the gelling agent is selected from the group consisting of carboxypolymethylene, carboxymethyl cellulose, carboxypropyl cellulose, poloxamer, carrageenan, Veegum, carboxyvinyl polymers, natural gum and mixtures thereof.

Preferably, the amount of the substance is from about 0.05 g to about 0.5 g.

Preferably, the substance is applied to the posterior surface of the teeth.

Preferably, the material is substantially flat before use.

A tooth whitening product for application to teeth comprising a strip of flexible material coated with a tooth whitening substance, according to the invention, characterized in that the tooth whitening substance comprises a polyox resin and a peroxide tooth whitening active ingredient, and a flexible strip of material conforms to the front surface of a plurality of adjacent teeth. the multi-oxygen resin sticks the peroxide active ingredient whitening the teeth to the front surface, when the polyox resin combines with the saliva.

Preferably, the substance also comprises a material selected from the group consisting of glycerin, sorbitol, polyethylene glycol, polypropylene glycol, and other food grade polyhydric alcohols.

Preferably the tooth whitening material is provided in the form of a laminate.

Preferably, the tooth whitening material is provided in the form of a first layer that includes the first component and a second layer that includes the second component.

Preferably, the product has an overall thickness of less than about 1mm.

Preferably, the product has an overall thickness of less than about 0.5 mm.

Preferably, the flexible strip of material has a flexural stiffness of less than about 3 g / cm.

Preferably, the substance also comprises water.

Preferably, the amount of water is from about 5% to about 90% by weight of the substance.

Preferably, the substance also comprises a gelling agent selected from the group consisting of carboxypolymethylene, carboxymethyl cellulose, carboxypropyl cellulose, poloxamer, carrageenan, Veegum, carboxyvinyl polymers, natural resins and mixtures thereof.

Preferably, the product has a peel strength of from about 5 g to about 30 g.

Preferably, the amount of the substance is from about 0.05 grams to about 0.5 grams. 22

Preferably, the amount of substance is from about 0.005 g / cm² up to about 0.1 g / cm².

Preferably, the product is applied to the posterior surface of the teeth.

Preferably, the product is substantially flat before use.

Preferably, the strip of flexible material is about 4 cm to about 9 cm long and about 1 cm to about 2 cm wide.

Preferably, the product also includes a release liner adjacent to the substance.

Preferably, the flexible strip of material conforms to the front surface of the plurality of adjacent teeth and the spaces between the teeth without permanently deforming.

Preferably, the flexible strip of material provides a protective barrier that substantially prevents saliva from coming into contact with the tooth whitening substance.

Preferably, the flexible strip of material has an exposed surface.

Preferably, the flexible strip of material is a laminate.

Preferably, the flexible strip of material comprises a non-woven layer.

Preferably the product has a single strip of flexible material.

Preferably, a single strip of material is a non-woven fabric.

The tooth whitening substance according to the invention is characterized in that it comprises a first polymer, a second polymer and a tooth whitening active ingredient, the tooth whitening substance having the ability to adhere to a plurality of teeth for a sufficient time for the tooth whitening active ingredient to react with the plurality of teeth. .

Preferably, the first polymer is carboxypolymethylene and the second polymer is a water-swellable polymer.

PL 191 827 B1

Preferably, the first polymer is carboxypolymethylene and the second polymer is polyvinylpyrrolidone.

Preferably, the first polymer is a water-swellable polymer and the second polymer is polyvinylpyrrolidone.

Preferably, the first polymer is a water-swellable polymer and the second polymer is a polyoxy resin.

A tooth whitening product for application to teeth comprising a strip of flexible material coated with a tooth whitening substance, according to the invention, characterized in that the tooth whitening substance comprises a tooth whitening active ingredient which is a peroxide, the tooth whitening product having an overall thickness of less than about 1 mm.

Preferably, the flexible strip of material conforms to the front surface of the plurality of adjacent teeth and the spaces between the teeth without being permanently deformed.

Preferably, the tooth whitening product is applied to the back surface of the teeth.

Preferably, the tooth whitening material comprises a material selected from the group consisting of hydroxypropyl cellulose, hydroxypropyl cellulose, ethyl cellulose, polyvinyl pyrrolidone resins, and combinations of carboxymethyl cellulose and Gantrez.

Preferably, the tooth whitening product has an overall thickness of less than about 0.5 mm.

Preferably, the substance also comprises a material selected from the group consisting of glycerin, sorbitol, polyethylene glycol, polypropylene glycol, and other food grade polyhydric alcohols.

Preferably, the flexible strip of material comprises a material selected from the group consisting of polyethylene, polyester ethylene vinyl acetate, ethylene vinyl alcohol, and combinations thereof.

Preferably, the flexible strip of material has a flexural stiffness of less than about 3 g / cm.

Preferably, the flexible strip of material has a flexural stiffness of from about 0.1 g / cm to 1 g / cm.

Preferably, the flexible strip of material has a flexural stiffness of about 0.6 g / cm.

Preferably, the substance also comprises water.

Preferably, the amount of water is from about 5% to about 90% by weight of the substance.

Preferably, the substance also contains a gelling agent.

Preferably the gelling agent is selected from the group consisting of carboxypolymethylene, carboxymethyl cellulose, carboxypropyl cellulose, poloxamer, carrageenan, Veegum, carboxyvinyl polymers, natural gums and mixtures thereof.

Preferably, the tooth whitening product has a peel strength of from about 5 g to about 30 g. 22

Preferably, the amount of substance is from about 0.005 g / cm² up to about 0.1 g / cm².

Preferably, the amount of the substance is from about 0.05 grams to about 0.5 grams.

Preferably the product is substantially flat before use.

Preferably, the strip of flexible material is from about 4 cm to about 9 cm long and from about 1 cm to about 2 cm wide.

Preferably, the product also includes a release liner adjacent to the substance.

Preferably, the flexible strip of material has a thickness from about 0.005 mm to about 0.02 mm.

Preferably, the tooth whitening material has the ability to stick the product to a plurality of adjacent teeth for a sufficient period of time for the tooth whitening active ingredient to react with the plurality of adjacent teeth.

Preferably, the flexible strip of material provides a protective barrier that does not substantially allow saliva to come into contact with the substance.

Preferably, the flexible strip of material has an exposed surface and the tooth whitening substance continuously covers the flexible strip of material.

Preferably the tooth whitening substance is a viscous gel.

Preferably, the flexible strip of material is a laminate.

Preferably, the laminate comprises a non-woven layer.

Preferably, the flexible strip of material is a non-woven fabric.

Preferably, the product comprises a single strip of flexible material.

Preferably, a single strip of flexible material is a non-woven fabric.

Using the present invention, the user places a strip of material over adjacent teeth. The whitening side of the strip is facing the teeth. The substance is in a viscous state as a gel, ie in addition to the active ingredient, it also builds a stickiness between the tooth surfaces and the material of the strip to hold the strip on the teeth. The compliant material strip has a bone that individually fits the 6-8 front teeth of the upper and lower rows when positioned over the teeth. As a soft and pliable material, the strap makes contact with the gums without causing irritation. The strip of material easily conforms to the teeth by light pressure and gentle suction through the gaps between the teeth. Once applied, the strip of material easily conforms to the shape of the teeth without being permanently deformed. After use, the user can easily remove the strip of material by tearing it off. A fresh strip of material is preferably used in each subsequent treatment.

Due to the relatively thin coating, the tooth whitening substance is present in a small volume compared to the substance in stiff trays, fixed or not. The substance is therefore not wasted, accidentally swallowed and does not irritate the surfaces of the mouth where its presence was not expected. The strip of material and substance are transparent and therefore almost imperceptible when worn.

The product contains a tooth whitening substance applied to a strip of material. When the product is placed on the surface of the teeth, the substance contacts the surface, delivering the active ingredient to that surface. The substance also ensures adhesion between the strip of material and the surface, to keep the product long enough and to act on the surface of the active ingredients. Preferably, the substance is in the form of a gel, which is a continuous homogeneous coating on a strip of material.

Figure 1 shows a substantially flat strip of material with rounded corners in a perspective view, Fig. 2 - an embodiment of the present invention showing the flat strip of Fig. 1 - coated with a tooth whitening substance, in perspective view. 3 shows an example of a flat strip with a thickness less than the substance that covers it, taken along line 3-3 of fig. 2, fig. 4 - an alternative embodiment of the invention, showing shallow pockets in the strip of material that act as reservoirs for additional substance applied to the strip, in cross-section, fig. 5 - adjacent teeth with a strip of material according to the invention fitted and glued to the teeth by a substance placed between the teeth and a strip of material, sectional view, Fig. 6, a tooth and adjacent soft tissue in a vertical section along line 6-6 of Fig. 5 showing the strip according to the invention fitted and glued to the tooth by a substance placed between the tooth and the strip of material, fig. 7 - a strip of the material according to the invention adhered to the teeth and adjacent soft tissue and glued on both sides of the teeth by a substance placed between the teeth and the strip of material, in a cross-section similar to Fig. 5, Fig. 8 - a strip of material according to the invention adhering to the teeth and adjacent soft tissue and adhered on both sides by a substance sandwiched between the teeth and the strip material, in vertical section along the line 8-8 of Fig. 7, Fig. 9 - alternative example of the invention showing a flat coated strip the tooth whitening substance of Fig. 2 with a separation pad in a perspective view, and Fig. 10 an alternative embodiment of the invention showing the separation pad connected to the strip of material by the substance on the strip of material, in section along the line 10-10 of Fig. 9.

Figures 1 and 2 show a first preferred embodiment of the present invention that shows a tooth whitening product 10. The tooth whitening product 10 comprises a strip of material 12 which is initially substantially flat, preferably with rounded corners.

The strip of material 12 is coated with or has a tooth whitening substance 14 applied thereto. Substance 14 is homogeneous and uniformly and continuously covers strip of material 12 as shown in Figure 3. However, alternatively, material 14 may be a laminate or separate layers of components, an amorphous mixture of components, discrete stripes or spots, or yet other patterns of various components, or a combination of these structures comprising a continuous coating of oral care material 14 along the axis of the longitudinal portion of the strip of material 12.

As shown in Fig. 4, in an alternative embodiment, the strip of material 12 may include shallow pockets 18 formed therein. When substance 14 is coated on one side of the strip of material 12, additional material 14 fills the shallow pockets 18 to provide reservoirs of additive 14.

Figures 5 and 6 show a tooth whitening product 24 of the invention applied to a plurality of adjacent teeth and a tooth surface. The teeth 22 are embedded in the adjacent soft tissue 20. Adjacent soft tissue is defined herein as the soft tissue surfaces surrounding the dental structure and including: papilla, marginal gingiva, gingival groove, inner gingiva, gingival structure on the tongue and cheek surfaces, up to the mucogingival junction and palate.

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In both Figures 5 and 6, the tooth whitening product 24 is a strip of material 12 and a material 14, with the material 14 on that side of the strip of material 12 facing adjacent teeth 22. The material 14 may be pre-applied to the strip of material 12, or applied to the strip of material. 12 by the user of the product. In either case, the thickness and flexural stiffness of the strip of material 12 allow it to conform to the contouring surfaces of adjacent teeth 22 and adjacent soft tissue 20. The strip of flexible material has sufficient flexibility to create a curved shape around the plurality of adjacent teeth. The strip of material readily conforms to the tooth surfaces and interstitial dental spaces without being permanently deformed after the product is applied. The product is applied without the need to exert much pressure.

Figures 7 and 8 show the tooth whitening product 24 of the invention applied to the anterior and posterior surfaces of adjacent teeth 22 and to the adjacent soft tissue 20 present on the front surfaces of the teeth. The tooth whitening product 24 comprises a strip of material 12 and a material 14 on the side of the strip that faces adjacent teeth 22.

Figures 9 and 10 show an optional release liner 27 attached to the strip of material 12 for substance 14. Substance 14 is present on the side of the material strip 12 facing the release liner 27. This side is applied to the tooth surface after the release liner 27 has been removed.

Material strip

The strip of material serves as a protective barrier that prevents saliva from reaching the whitening substance and from the teeth whitening substance being washed away or eroded from the tooth surface by the lips, tongue, or other soft tissue. Reducing rinsing or erosion is important due to the effect of the active substance whitening the teeth over a long period of time, from several minutes to several hours. The term "influencing" here means bringing about a desired change. For example, if the substance is a teeth whitener, it will whiten colored bodies leading to whitening.

The strip of material 12 can be formed of materials such as polymers, natural and synthetic fabrics, nonwovens, foil, paper, rubber, and combinations thereof. The strip of material can be a single layer of material or a laminate of more than one layer. Generally the strip of material is impervious to water. The material can be any type of polymer exhibiting the required flexural stiffness and which is compatible with the dentition bleach active ingredients such as peroxide. The material may contain 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. Generally, the thickness of the strip of material is less than 1 mm, preferably less than about 0.05 mm, and even more preferably from about 0.001 to about 0.03 mm. The thickness of the polyethylene strip of material is preferably less than about 0.1 mm, and even more preferably from about 0.005 to about 0.02 mm.

Preferably, the strip of material is of any shape with rounded corners. The term "rounded corners" means no sharp angles or sharp edges. The strip of material that readily adapts is preferably sized individually to match the row of teeth to be whitened. There are generally up to 6-8 front teeth in the upper or lower row of teeth that are visible when smiling. Optionally, the strip of material can fit over the entire top or bottom row of teeth when placed over the teeth.

The size of the strip of material depends on many factors, including the number of teeth to be whitened, the size of the teeth, and the personal preferences of the patient. Generally, the length of the strip of material is from about 2 cm to about 12 cm, and preferably from about 4 cm to about 9 cm. The width of the strip of material will also depend on many factors, including whether the strip of material is wrapped around the tooth and covers both surfaces of the tooth. In general use, the strip of material has a width of from about 0.5 cm to about 4 cm, and preferably from about 1 cm to about 2 cm.

The strip of material may include shallow pockets. As the substance is coated on one side of the strip of material, the extra substance fills the shallow pockets to provide the extra substance reservoirs. Additionally, shallow pockets help to provide texture to the product. The foil will preferably have a shallow pocket pattern. The shallow pockets are approximately 0.4 mm wide and 0.1 mm deep. With shallow pockets present in the strip of material and material deposited thereon of varying thickness, the overall thickness of the product is generally less than about 1mm. Preferably, the overall thickness is less than 0.5mm.

PL 191 827 B1

Bending stiffness is a material property that is a function of the combination of strip thickness, width, and the material's modulus of elasticity. This test is a way to measure polyolefin film stiffness and shear. Here, the bending resistance of the sample is determined with the use of a strain gauge attached to the end of the horizontal beam. The opposite end of the beam transversely presses the sample strip forcing a portion of the strip into a vertical groove in the horizontal platform on which the sample rests. A microammeter connected to the strain gauge circuit was calibrated in grams of deflection force. The stiffness of the sample is read directly on the microammeter as a quantity in grams per centimeter of width of the sample strip.

In the present invention, the flexural stiffness of the strip of material is less than about 5 g / cm as measured on a Handle-O-Meter, Model No. 211-300, supplied by Thwing-Albert Instrument Co., Philadelphia, PA according to the ASTM test method. D2923-95. Preferably, the strip of material has a flexural stiffness below about 4 g / cm, even more preferably below about 3 g / cm, and most preferably from about 0.1 g / cm to about 1 g / cm. Preferably, the flexural stiffness of the strip of material is substantially constant and does not change significantly in normal use. For example, the strip of material does not need to be hydrated to achieve a low flexural stiffness within the above ranges.

This relatively low stiffness allows the strip of material to deform around the contoured surface of the teeth with very little force being exerted; that is, adaptation to the curvature of the mouth and the gaps between adjacent teeth is maintained since there is little residual force inside the strip of material causing it to revert to its substantially flat shape. The flexibility of the strip allows the strip of material to contact adjacent soft tissue for long periods of time without physical irritation. The strip of material does not require pressing against the tooth.

The strip of material is held in place on a plurality of adjacent teeth by the adhesive attachment provided by the substance. The viscosity and overall stickiness of the substance causes the strip of material to adhere to a plurality of adjacent teeth without slippage due to potential friction from lips, tongue and other soft tissue rubbing against the strip of material during mouth movement associated with speaking, drinking, etc. However, this adherence to the teeth is weak enough to allow the user to easily remove the product by peeling the strip of material with his fingers or with a nail. The product can be easily removed from the tooth surface without the use of an instrument, chemical solvent and without excessive friction.

Chemical solvents herein mean any organic solvents commonly used in oral care products such as alcohol and other safe solvents such as water that can be used to dilute the gelling agent. Excessive friction is described as any type of rubbing with a finger or a soft object such as cotton balls, gauze, etc.

All that is needed here is a peel force of about 1 gram to about 50 grams per 1.5 cm of strip width (approximately 17 g / cm). The peeling strength is preferably from about 5 g to about 40 g, and even more preferably from about 10 g to about 30 g. For handling reasons, low peel strength is desirable. The low peeling strength is due to the gentle nature of the gel substance. The adhesion of the substance can only be poor with a low flexural stiffness of the strip. The adhesion of the stiffer belt should be greater in proportion to the stiffness of the belt to prevent the belt from returning to a flat form and detaching from the contour surface of the teeth.

The strip of material can be formed by a number of film making methods known in the art. Preferably, the strip of polyethylene material is made by blow molding or casting. It is also possible to use processes such as extrusion or others that do not affect the bending stiffness of the strip of material. Additionally, a substance may be incorporated into the strip during its manufacture. The substance may be a laminate on a strip.

Teeth whitening substance

A tooth whitening substance is a set of ingredients, a compound, or a mixture capable of altering or causing a desired change in the appearance and / or texture of the surface it comes into contact with.

Examples of changes in appearance and structure include, but are not limited to: surface whitening, stain whitening, stain removal, plaque removal, and tartar removal. Preferably, the active interaction causes whitening of the tooth surface.

The amount of substance applied to the strip of material or to the teeth will depend on the size and capacity of the piece of material, the concentration of the active agent and the effect desired. Generally after10

Less than 1 g of substance is needed. Preferably from about 0.05 g to about 0.5 g and more preferably from about 0.1 g to about 0.4 g of this material is used. The amount of substance per cm² material is less than about 0.2 g / cm², preferably from about 0.005 to about 0.1 g / cm² and more preferably from about 0.01 g / cm² up to about 0.04 g / cm².

The substance according to the invention may be in the form of a viscous liquid, paste, gel, solution or any other form suitable for obtaining sufficient adhesion. Preferably the substance is in the form of a gel. The substance will have a viscosity of from about 0.2 to about 1000 Pa · s (200 to about 1,000,000 cps) at low shear rates. Preferably the viscosity is from about 100 to 800 Pa.s (100,000 to about 800,000 cps), and more preferably from about 400 to about 600 cps (400,000 to about 600,000 cps).

Active whitening agents include any material that is safe for use in the mouth, and that whitens or removes stains. These are peroxides, metal chlorites, perborates, percarbonates, peroxy acids and their combinations. Suitable peroxide compounds include: hydrogen peroxide, calcium peroxide, carbamide peroxide, and mixtures thereof. Carbamide peroxide is most preferred. Suitable metal chlorites include: calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, and potassium chlorite. Additional active bleaching agents may be hypochlorite and chlorine dioxide. The preferred chlorite is sodium chlorite.

The tooth whitening active is present in an amount from about 0.01% to about 40% by weight of the substance. When the active agent is a peroxide compound, the peroxide compound should provide an amount of hydrogen peroxide equivalent to from about 0.1% to about 20%, preferably from about 0.5% to about 10%, and most preferably from about 1% to about 7% by weight of the substance. To provide an equivalent amount of hydrogen peroxide, the peroxide compound, such as, for example, carbamide peroxide, is usually present in an amount from about 0.1% to about 30%, and preferably from about 3% to about 20% by weight of the substance.

The active agents are usually found in an aqueous gel. The gel is a high viscosity matrix made of gelling agents known in the art. These are gelling agents that are safe for oral use, do not dissolve easily in saliva, and do not react with oral care compounds. Generally, the gelling agent is a swellable polymer. The gel produced from these factors furthermore forms a sufficient adhesive attachment of the film material to the target mouth surface. The amount of gelling agent needed to form the gel blend is from about 0.1% to about 15%, preferably from about 1% to about 10%, more preferably from about 2% to about 8%, and most preferably from about 4% to about 7%. % by weight of the substance.

Suitable gelling agents useful in the present invention include: carboxypolymethylene, carboxymethyl cellulose, carboxypropyl cellulose, poloxamer, carrageenan, Veegum, carboxyvinyl polymers and natural gums such as karaya gum, xanthan gum, guar gum, acacia gum, gum and tragacanth mixtures thereof. A preferred gelling agent for use in the present invention is carboxypolymethylene supplied by BF Goodrich Company under the trade name "Carbopol.

Particularly preferred Carpoboli include Carbopol 934, 940, 941, 956, and mixtures thereof. Carbopol 956 is particularly preferred. Carboxypolymethylene is a slightly acidic vinyl polymer with active carboxyl groups. The normal concentration of carboxypolymethylene resins in water, according to the manufacturer, is less than about 2%. However, it has been found that the preparation of supersaturated carboxypolymethylene blends containing concentrations within the ranges given above is suitable for the preparation of high viscosity oral gel blends.

In addition to high viscosity, concentrated carboxypolymethylene gels have many significant advantages. To achieve high viscosity, more carboxypolymethylene is added to the oral formulations than needed, so that reducing the viscosity by diluting the mixtures and washing them with saliva requires a significant amount of saliva or water. The concentrated carboxypolymethylene blend also has exceptional adhesion to hold and seal the strip of material on the target surface of the mouth where it is applied, especially on the teeth. However, too much carboxypolymethylene should be avoided, which would make it difficult to apply or remove the strip of material.

Water is also present in the disclosed gel blends. In the case of the invention, it should be deionized water, free from organic impurities. Water makes up 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 is free water that is added plus the amount introduced with other materials.

PL 191 827 B1

A pH adjuster may also be included to optimize the gel storage stability and to make the substance safe for oral tissue. The pH adjusters, or buffers, can be any material suitable for adjusting the pH of a substance. Such materials include: sodium bicarbonate, sodium phosphate, sodium hydroxide, ammonium hydroxide, sodium stannate, triethanolamine, citric acid, hydrochloric acid, sodium citrate, and combinations thereof. The pH adjusters are added in amounts to bring the pH of the set of gels from about 4.5 to about 11, preferably from about 5 to about 8.5, and more preferably from about 5.5 to about 7. The pH adjusters 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.

While the above-described gel provides sufficient adhesion, additional gelling agents may also be present in the formulation to aid adherence of the active ingredients to oral tissues. Suitable agents include both limited water-soluble polymers and water-insoluble polymers. As saliva combines with the ingredients, they settle in a thin layer on the soft and hard tissues in the mouth. Useful adhesives with limited water solubility are hydroxy ethyl and propyl cellulose. Water-insoluble adhesives include ethyl cellulose and polyoxy resins. Another possible adhesive suitable for use in the instant kit is polyvinylpyrrolidone having a molecular weight of from about 50,000 to about 300,000. Another suitable adhesive for use in the instant kit is the combination of Gantrez and a semi-synthetic water-soluble carboxymethyl cellulose polymer.

An additional carrier material can also be added to the substance. The carrier materials can be humectants. Suitable humectants are: gl glycerin, sorbitol, polyethylene glycol, propylene glycol, and other food grade polyhydric alcohols. Humectants are generally present in an amount from about 10% to about 95%, preferably from about 20% to about 80%, and more preferably from about 50% to about 70% by weight of the substance. In addition to the above inventive gel materials, many other ingredients may also be added to the substance. Additional ingredients include, but are not limited to: flavors, sweeteners, xylitol, darkening agents, coloring agents, and celants such as ethylenediaminetetraacetic acid. Such additional ingredients may also be used in place of the kits of ingredients disclosed above.

Separating insert

The release liner may be made of any material that has a lower affinity for the substance than the substance has for itself and the strip of material. The release liner is preferably formed from a strip of a rigid material such as polyethylene, paper, polyester, etc. which is then covered with a non-adhesive material. The release liner material may be coated with wax, silicone, polyester such as Teflon®, fluoropolymers, or other non-stick materials. A preferred release liner is Scotchpak®, manufactured by 3M.

The release liner is cut to the same size and shape as the strip of material or larger to facilitate separation of the material from the strip. The release liner can be made of a brittle material that breaks when the strip is bent, or multiple pieces of material or cut pieces of material. Alternatively, the release liner may be formed by two overlapping pieces, as in a conventional self-adhesive gauze plaster design. An additional description of materials useful as resolving agents is provided in the Kirk-Othmer Encyclopedia of Chemical Technology, 4th Edition, Vol. 21, pp. 207-218.

Examples

The strip of material is made of polyethylene foil with a thickness of 0.013 mm. The film preferably has an array of shallow pockets 0.4 mm wide and 0.1 mm deep. The flexural stiffness for the strip material is about 0.6 g / cm (measured on the Handle-O-Meter, Model No. 211-300, supplied by Thwing-Albert Instrument Co., Philadelphia, PA, in accordance with the method of ASTM D2923- 95).

An example of a tooth whitener is a gel composed of 70% glycerin, 5% carboxypolymethylene, 10% carbamide peroxide and 15% water, adjusted to pH 6.5 with sodium hydroxide. Stir until a homogeneous blend was obtained.

PL 191 827 B1

Below are other examples of teeth whitening gel:

Combine 8% carboxypolymethylene in about 84% water, with 4% sodium hydroxide and sufficient sodium bicarbonate to obtain about pH 10. The material was then dissolved in 3.75% sodium chlorite and mixed until a homogeneous mixture was obtained.

Combination of 56% glycerin, 6% carboxypolymethylene, 10% carbamide peroxide, and 24% water. Addition of 4% sodium hydroxide (50% solution) to adjust the pH. Stir until a homogeneous blend was obtained.

Combination of 68% glycerin, 6% carboxypolymethylene, 22% carbamide peroxide and 4% sodium hydroxide (50% solution). Stir until a homogeneous blend was obtained.

Combination of 25% glycerin, 69.7% water, 2% xanthan gum, 3% carboxymethyl cellulose and 0.3% carbamide peroxide. Stir until a homogeneous blend was obtained.

Combination of 24% poloxamer, 20% glycerin, 45% polyethylene glycol and 10% carbamide peroxide. Stir until a homogeneous blend was obtained.

Commercial tooth whiteners like Opalescence and Nu-Pro Gold are also possible for use in the product of the present invention.

Application method

The user applies a strip of material to a plurality of adjacent teeth. One side of the material facing the teeth is coated with a tooth whitening substance which is present in a sticky state as an active and adhesive substance between the tooth surfaces and the strip of material to keep the strip in place for an extended period of time. The strip of material readily conforms to the teeth when lightly pressed against the teeth by the user and gently sucked through the gaps between the teeth. The strip of material is easily removed by the user by peeling. Preferably, a fresh strip of material is used in subsequent treatments.

Preparation of the tooth surface before application of the product is not required. For example, the user may or may not brush his teeth, or rinse his mouth or not, at his discretion. The surface of the teeth does not require drying or over-wetting with saliva or water before applying the strip of material.

Preferably, the strip of material and substance are transparent and therefore almost imperceptible when worn. The thinness of the product allows the higher oral temperature to be conducted through the strip of material to the normally colder teeth to accelerate diffusion of the active material into the dentition surface.

Preferably, the user applies the product of the invention continuously from about 5 minutes to about 120 minutes a day, preferably from about 30 to about 60 minutes. Generally, the procedure is performed once a day for about 7 to 28 days. The amount of time and the number of days depend on many factors, including the desired degree of whitening, the user's teeth, and whether it is initial or prophylactic whitening. Bleaching is performed to achieve shade 1-4 as measured by VITA LUMIN®, Vacuum Farbskala Shade Guides (product of VITA Zahnfabrik, BadSackingen, Germany).

After the user removes the belt from the teeth, there may be some substance residue on the surface. This is a small amount because the tooth whitening substance has an affinity for the film and for itself. If any substance residue persists, it can be removed by brushing or rinsing.

While specific embodiments of the invention are provided, many changes and modifications will be apparent to those skilled in the art without departing from the spirit and scope of the invention which is intended to be included in the appended claims.