MXPA01001330A - A delivery system for an oral care substance using a permanently deformable strip of material - Google Patents

Abstract

A delivery system for an oral care substance such as a tooth whitening substance includes a strip of material having a yield point and thickness such that the strip of material substantially conforms to a shape of a tooth and its adjoining soft tissue via permanent deformation under a pressure less than about 250,000 Pascals when the delivery system is placed thereagainst. The delivery system also includes an oral care substance applied to the strip of material such that when the delivery system is placed on a surface of the tooth and its adjoining soft tissue, the substance contacts the surface providing an active onto the surface. The substance also provides adhesive attachment between the strip of material and the surface to hold the delivery system in place for a sufficient time to allow the active to act upon the surface. The substance has an extrusion resistance sufficient to withstand a normal force applied to deform the strip of material so that the substance is not substantially extruded from between the strip of material and the surface during manual deformation of the strip of material.

Description

A SUPPLY SYSTEM FOR A SUBSTANCE FOR ORAL CARE THAT USES A STRIP OF MATERIAL PERMANENTLY DEFORMABLE FIELD OF THE INVENTION The present invention relates to a system for the delivery of a substance for oral care such as a substance for whitening teeth in a person's oral tissue, a surface of a tooth, a number of adjacent teeth, or a combination of the same and more particularly to said delivery system wherein the substance is protected from erosion within the mouth for a sufficient time to allow an active provided by the substance to provide a therapeutic benefit. Even more particularly, the present invention relates to the disposable delivery systems used outside the dental office, wherein said delivery systems are inexpensive and are not annoying to be placed without interfering with the normal conversation.

BACKGROUND OF THE INVENTION The most common instrument for dental hygiene is the toothbrush. The mechanical action of the bristles of toothbrushes aids in the removal of food particles, plaque and the like.

Normally, the toothbrush is used with a toothpaste. Prior to 1955, a typical toothpaste consisted of a surfactant and an abrasive material. These products were intended simply to increase the mechanical action of brushing. In 1955, CREST® toothpaste was introduced with fluoride, a trademark of The Procter & The Gamble Company of Cincinnati, OH, and the combination of toothbrush and toothpaste with fluoride proved to be a suitable means of providing fluoride treatment to tooth surfaces. Subsequently, other active ingredients have been added to toothpaste, such as dental scale control agents, to provide additional dental hygiene benefits. Consumers have also paid attention to the cosmetic aspects of dental care, such as strengthening and whiteness of teeth. Due to the success of the assortment of chemical compounds that provide therapeutic benefits for oral care, it is reasonable to expect similar success to achieve the cosmetic benefit with routine brushing. For example, products have been introduced that claim teeth whitening. However, despite the claims, the combination of the low permitted concentration of orally used chemicals and the significant contact time necessary to bleach, effectively prevents significant whiteness by means of a regular brushing program. As a consequence, people who want to whiten their teeth and who have disappointed by the results of whitening dentifrices, they frequently turn to professional help to whiten their teeth. The professional teeth whitening programs provided by dentists generally fall into two categories: an in-office bleaching procedure and an out-of-office bleaching procedure. The procedure in the office involves many visits, each of which begins with the manufacture of a specially adapted rubber dam inside the mouth to prevent bleaching chemicals, especially hydrogen peroxide, from making contact with soft oral tissue. The production of the rubber dam inside the patient's mouth can be both painful and prolonged. However, the concentration of the peroxide bleach requires the use of a dike. The procedure in the office also leaves the teeth sensitive to heat and cold and is very expensive. The out-of-office bleaching program differs in that the patient applies the bleaching agent to their own teeth using a lower concentration chemical for a prolonged period, typically many hours a day for several weeks. The out-of-office program typically requires an initial adaptation in the dental office for an appliance that is specific to the particular patient. The apparatus is a device that is manufactured to precisely fit the patient's teeth and is used to deliver a bleaching product to the patient's teeth, such as a gel containing a urea / peroxide complex. hydrogen. The patient is responsible for measuring and applying the bleaching agent to the surfaces of the teeth using the apparatus as the means to supply and as a means of containment. Since the device is used again, it must be strong enough to withstand repeated handling, cleaning, filling, installation and use. Said apparatuses are relatively rigid to maintain the adaptation during continuous use. As a result, the edge of an appliance is usually rigid, often causing irritation of the gums; and its substantial thickness is generally apparent to the user as well as to other people. Typically, a patient uses the device in periods when social contact can be avoided. There are now non-professional programs available for people interested in whitening their teeth using commercial products available in pharmacies. Commercial products provide equipment that includes a generic device and a bleach gel container. What is most striking is the low cost of the program. A major drawback of this "all size" appliance is the large gap between the interior walls of the appliance and the teeth compared to the professionally adapted appliance. Therefore, to ensure intimate contact of the bleaching gel and dental surfaces, more bleaching gel is required. In addition, a poor adaptation means a greater loss of bleach in the gums, in the oral cavity, and finally ingestion. Commercial teams, like programs professionally administered outside the office, require the user to clean and reuse the device. Since the generic devices do not adapt to the user, they occupy more space in the mouth than the adapted devices and in this way they restrict the normal conversation to a greater degree. An attempt to remedy some of the problems of commercial equipment is described in the U.S. patent. 5,575,654, issued to Fontenot on November 19, 1996. Fontenot discloses a pre-packaged, moldable dental appliance, adapted to fit a wide variety of dental arches of various sizes, containing a previously measured amount of medicating or bleaching agent. In use, the dental appliance is removed from the packing, aligned parallel to the edges of the teeth and pushed over the teeth in the direction of the periodontal tissue until it covers the surfaces of the teeth. The main benefit of the device described by Fontenot is that it eliminates the fact of measuring and filling the device and that it can be discarded after each use. However, it has been observed that the device frequently has volume and adjustment problems. A second solution is described in the U.S. patent: A. 5,310,563, issued to Curtis et al, on May 10, 1994. Curtis et al, describes a material similar to the mastic that is formed by pressing it against the teeth. It is held in place by a mechanical coupling with undercut surfaces and by friction. The composition encapsulates the asset. The active migrates from the composition to the gums and surfaces dental, rather than directly contacting them. In fact, the required usage time increases, which is significantly negative. What is needed is a low cost commercial supply system, having an adjustment adapted for a minimum volume of an asset that provides the substance such as a substance for whitening the teeth, and which is in corresponding contact with the oral surfaces. appropriate for a quick supply of the asset. In addition, what is needed is a means of containing the non-volumetric asset that will allow the user to use the system during normal conversation without interfering with the speech or appearance of the user. Also what is needed is a means of containment that will protect the substance from erosion from contact with the internal surfaces of the mouth.

BRIEF DESCRIPTION OF THE INVENTION In practicing the present invention, the user applies a strip of initially flat material to a portion of a tooth, to the entire tooth, or to a row of adjacent teeth. The side of the material facing the tooth is coated with the substance, or the teeth are coated with the substance and the strip of material is placed on it. In each case, the substance such as a tooth whitening substance is preferably in a too viscous state, such as a gel, to provide not only the active but also tackiness between the tooth surfaces and the material strip for keep the strip of material in place. The strip of adjustable material preferably has a size that adapts individually to all the upper and lower rows of the teeth when placed against them. The strip of material fits easily to the teeth by pressing it lightly against them. The user easily removes the strip of material after using it when detaching it. Each successive treatment uses a new strip of material. Being a relatively thin coating, the substance is in a low volume compared to the substance contained by the rigid trays adjusted or not adjusted. Therefore, the substance is not wasted, and very little of it is ingested accidentally or otherwise irritates the surfaces of the oral cavity, which is what is not intended. In one aspect of the present invention, a delivery system for an oral care substance includes a strip of material having a loosening point and a thickness such that the strip of material substantially conforms to the shape of a tooth and its soft tissue attached by means of permanent deformation under a pressure of less than approximately 250,000 Paséales. The delivery system also includes a substance for oral care applied to the strip of material so that when the delivery system is placed on a surface of the tooth and its soft tissue attached, the substance makes contact with the surface providing an active in the surface. The substance also provides a bond with adhesive between the strip of material and the surface to maintain the system supply in place for a sufficient time to allow the asset to act on the surface. The substance has an extrusion resistance sufficient to withstand the application of a normal force that deforms the strip of material so that the substance is not extruded substantially from between the strip of material and the surface during manual deformation of the strip of material . Preferably, the substance is in the form of a gel, which is a substantially uniform continuous coating on the strip of material. The strip of material is preferably made of wax having a nominal film thickness of about 0.8 mm, which is substantially flat and rectangular with rounded tips, and the strip of material including the substance coated therein has a total thickness less than about 1.5 mm. The strip of material may be of sufficient length to cover a plurality of adjacent teeth while adjusting to the curvature of the user's mouth and spaces between the adjacent teeth. In another aspect of the present invention, a method for delivering an oral care substance to a surface of a tooth and its accompanying soft tissue includes the step of applying the substance to an adjustable material strip having a relax point and a thickness so that the strip of material substantially conforms to the shape of the tooth and its soft tissue attached by means of a permanent deformation under a pressure of less than about 250,000 Pases. Alternatively, this step may include the application of the substance directly to the surface of the tooth and its soft tissue attached. Another step is to apply the strip of adjustable material so that the substance is between the strip of material and the surface. The substance provides an active on the surface and also provides an adhesive bond between the strip of material and the surface to keep the supply system in place for a sufficient time to allow the asset to act on the surface.

BRIEF DESCRIPTION OF THE DRAWINGS Although the specification concludes with the claims that particularly state and claim the present invention differently, it is believed that the present invention will be better understood from the following description of preferred embodiments, taken in conjunction with the accompanying drawings, in which reference numbers identify identical elements and where: Figure 1 is a perspective view of a substantially flat strip of material having rounded tips; Figure 2 is a perspective view of one embodiment of the present invention, which describes the flat strip of Figure 1 coated with a substance for oral care; Figure 3 is a cross-sectional view thereof, taken along section line 3-3 of Figure 2, describing the strip flat that has a thickness less than that of the substance coated therein; Figure 4 is a cross-sectional view showing an alternative embodiment of the present invention, showing shallow cavities in the strip of material, which act as reservoirs for additional substance coated on the strip; Figure 5 is a cross-sectional elevational view of a tooth and soft tissue attached, describing the strip of the present invention fitted and bonded with adhesive to the tooth by means of the substance located between the tooth and the strip of material; Figure 6 is a cross-sectional plan view thereof, showing adjacent teeth having the strip of material of the present invention fitted thereto and adhesively bonding to the teeth by means of a substance located between the teeth and the strip of material; Fig. 7 is a cross-sectional elevational view, similar to Fig. 5, showing the strip of material of the present invention adjusted to both the teeth and the attached soft tissue and attached with adhesive to the teeth by means of the substance located between the teeth and the strip of material; and Figure 8 is a cross-sectional plan view, similar to Figure 6, showing a strip of material of the present invention fitted to the teeth and the soft tissue attached and bonded to the teeth by means of a substance located between the teeth and the strip of material.

DETAILED DESCRIPTION OF THE INVENTION Referring now to the drawings, and more particularly to Figures 1 and 2, a first embodiment of the present invention is shown, which is generally indicated with it number 10. Mode 10 represents a delivery system for a substance for the care oral such as a substance to whiten the teeth. The delivery system 10 has a strip of material 12 which is initially substantially planar with rounded tips. The strip of material 12 can be a single layer of wax, mastic, thin metal foil, or other permanently deformable material or a combination thereof, such as a laminar unit. An oral care substance 14 is applied to or coated on the strip of material 12. Preferably, the substance 14 is a homogeneous fluid, uniformly and continuously coated in the strip of material 12, as shown in Figure 3. However, the substance 14 may alternatively be a laminar unit or separate layers of components, an amorphous mixture of separate components, strips or points or other patterns of different components, or a combination of these structures, which include a continuous coating of substance for the oral care 14 along a longitudinal axis of a portion of the strip of material 12.

The substance 14 preferably contains or is in itself an active, such as a composition, compound, or mixture capable of causing or effecting a desired change in the appearance and / or structure of the surface with which it has contact. Examples of assets include: hydrogen peroxide, carbamide peroxide, sodium fluoride, sodium monofluorophosphate, pyrophosphate, chlorhexidine, polyphosphate, triclosan, and enzymes. Examples of changes in appearance and structure include, but are not necessarily limited to: bleaching, bleaching of spots, stain removal, remineralization to form fluoroapatite, plaque removal, and removal of dental plaque. As an alternative embodiment, a strip of material 16 may have shallow cavities 18 formed therein. When the substance 14 is coated on one side coated with material strip 16, the additional substance 14 fills the shallow cavities 18 to provide deposits of additional substance 14, as shown in Figure 4. Figures 5 and 6 show a delivery system 24 of the present invention applied to a surface of an adjacent tooth or teeth. In the attached soft tissue 20 a tooth 22 is fixed. The tooth 22 is defined herein as a portion of a tooth, an individual tooth, or a group of adjacent teeth. Figure 6 shows, for example, a group of adjacent teeth. The attached soft tissue is defined herein as tissue surfaces surrounding the tooth structure including: gingiva marginal, gingival sulculus, interdental gingiva, structure of the gingival gingiva on lingual and buccal surfaces up to and including a muco-gingival junction and the palate. In both Figure 5 and Figure 6, the delivery system 24 represents the strip of material 12 and the substance 14, the substance 14 on the side of the strip of material 12 facing towards the tooth 22. The substance 14 can be applied previously to the material strip 12, it can be applied to the strip of material 12 by the user's supply system, or applied directly to the tooth 22 and then covered by means of the strip of material 12. In either case, the material strip 12 has a loosening point and a thickness such that the strip of material substantially conforms to the shape of the tooth and its attached soft tissue by means of permanent deformation under a pressure less than about 250,000 Passes. The preferred material strip has visco-elastic properties that allow it to slide as well as to bend to fit across several teeth and around the arc of the user's mouth. It is important that the necessary permanent deformation occurs under a minimum normal force applied by the user. The lower force allows the strip of material to be manually formed on the contour surfaces of the tooth 22 and the attached soft tissue 20 without the substance 14 being extruded substantially from between the strip of material 12 and the surface of the tooth 22 and the tissue soft adjunct 20. "Substantially extruded" means that at least 50% or more of the substance 14 is extruded from between the strip of material 12 and the tooth and the soft tissue surfaces attached. It has been found that users press a strip on each of the teeth using one or more fingertips that have a surface area of about one square centimeter. Typically they apply force to each tooth for a second or less. A typical application pressure varies from around 100,000 Paséales to approximately 250,000 Paséales. The material strip 12 serves as a protective barrier for the substance 14 to substantially prevent the leaching and / or erosion of substance 14 from the surface of the tooth 22 by means of the lips, tongue or other soft tissue of the wearer, and the saliva it makes contact with the substance. For an active in the oral care substance 14 to act on the surface of the tooth 22 for a prolonged time, several minutes or many hours, it is important to minimize such leaching and / or erosion. The term "act on" is defined herein as causing a desired change. For example, if the substance is a peroxide, it whitens the colored bodies inside the tooth to cause whiteness; or if the active ingredient is sodium fluoride, it causes the formation of fluoroapatite in an enamel matrix, changing the enamel matrix into a less acid-soluble material. The material strip 12 is held in place on the tooth 22 by a bond with adhesive provided by the substance 14. The viscosity and general tackiness of the substance 14 causes the strip of material 12 it is bonded with adhesive around tooth 22 without substantially detaching, under the potential friction of the lips and tongue and other soft tissue being rubbed against the strip of material 12 during mouth movements related to talking, drinking , etc. Figures 7 and 8 show a delivery system 26 of the present invention applied to a tooth surface 22 as well as to the attached soft tissue 20. The delivery system 26 represents a strip of material 12 and a substance 14, the substance 14 in the side of the strip of material 12 facing toward tooth 22 and the attached soft tissue 20. Although the strip of material 26 can not be adhesively bonded to the attached soft tissue 20, it can be held in position by bonding with tooth 22. In a particularly preferred embodiment of the invention, substance 14 is a teeth whitening gel containing 30-85% glycerin or polyethylene glycol, 10-22% urea / hydrogen peroxide complex, 0-12% carboxymethylene, 0-1% sodium hydroxide , 0-10% triethanolamine (TEA), 0-40% water, 0-1% flavor, 0-15% sodium citrate, and 0-5% ethylenediaminetetraacetic acid. The preferred gel has a viscosity between 200 and 1,000,000 cps at lower shear rates (less than 1 / seconds). Even more preferably, the tooth whitening agent is a gel containing 70% glycerin, 5% carboxypolymethylene, 10% carbamide peroxide, 15% water adjusted to a pH of 6.5 with sodium hydroxide. This formulation has sufficient resistance to extrusion so that when a coating is applied 0. 25 mm of it, to the strip of material and this is pressed manually against the surface of the tooth under a pressure less than 133,000 Paséales, to deform the strip to the shape of the tooth, less than 50% of the substance to bleach The teeth are extruded from between the strip of material and the tooth surface. Commercial teeth whiteners, such as Opalescence and Nu-Pro Gold are also operated with the delivery system of the present invention. Another oral care product operated with the delivery system of the present invention is a topical fluoride gel having viscosity similar to the preferred embodiment intended for topical application of fluoride to aid protection against caries. dental. The strip of material 12 is preferably a thick 0.8 mm piece of wax, such as # 165 sheet wax formulated and manufactured by Freeman Mfg & Cleveland Supply Co., OH. This particular wax will easily adjust to the shape of the tooth under a pressure of about 133,000 Pases, which is the pressure generated when the user applies a normal force of about 1.36 kg over an area of about one square centimeter. The total thickness of the delivery system is preferably less than about 1.5 millimeters. The thickness of the layer of the substance 14 is preferably around 0.4 mm. Preferably, the delivery system of the present invention is used when applying a tooth whitener to a tooth continuously for 120 minutes a day, once a day, for approximately 7 to 14 days to achieve a whiteness of 1-4 shade guidance improvement as measured by VITA LUMEN Vacuum Farbskala Shade Guides, a product of VITA Zahnfabrik , from BadSackingen, Germany. For an oral care product, such as fluoride gel, the delivery system of the present invention is used when applying the gel to a tooth and / or soft tissue attached continuously for 4 minutes, once a year, to help the prevention of dental caries. When the user removes the strip of material from the tooth and the soft tissue attached, there may be a residue of substance remaining on these surfaces. The residual substance can be easily removed by brushing or rinsing. Although particular embodiments of the present invention have been illustrated and described, it will be apparent 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 that all modifications are intended to be covered in the appended claims. that are within the scope of the invention.

Claims (10)

NOVELTY OF THE INVENTION CLAIMS

1. - A delivery system for an oral care substance characterized by: a) a strip of material having a relax point and a thickness such that the strip of material substantially conforms to a shape of a tooth and its soft tissue attached by means of a permanent deformation under a pressure of less than about 250,000 Pascals when said supply system is placed against it; and b) an oral care substance that is applied to said strip of material so that when said delivery system is placed on a surface of said tooth and its accompanying soft tissue, said substance makes contact with said surface providing an active in said surface, said substance also provides an adhesive bond between said strip of material and said surface to hold the delivery system in place for a sufficient time to allow said active to act on said surface, said substance having a sufficient extrusion resistance to support that a normal force is applied which deforms said strip of material so that said substance does not extrude substantially from between said strip of material and said surface during the manual deformation of said strip of material.

2. - The delivery system according to claim 1, further characterized in that said substance is a substance for whitening the teeth.

3. The supply system according to claim 1 or 2, further characterized in that said substance is a substantially uniform continuous coating on said strip of material.

4. The supply system according to claims 1, 2 or 3, further characterized in that said material strip is made of wax having a nominal film thickness of about 0.8 mm.

5. The supply system according to claims 1, 2, 3 or 4, further characterized in that said strip of material is substantially flat and rectangular with rounded tips, said strip of material includes said substance applied therein that has a total thickness less than about 1.5 mm.

6. The supply system according to claims 1, 2, 3, 4 or 5, further characterized in that said strip of material has a sufficient length to cover a plurality of adjacent teeth while adjusting to the curvature of the mouth of the user and spaces between said plurality of adjacent teeth.

7. A method for supplying a substance for oral care to a surface of a tooth and its soft tissue attached, said method characterized by the steps of: a) applying said substance on an adjustable strip of material having a loosening point and a thickness such that said strip of material substantially adjusts to a shape of the tooth and its attached soft tissue by means of permanent deformation under a pressure of less than about 250,000 Pascals; b) applying said adjustable strip of material with said substance thereto to said surface so that said substance makes contact with said surface, said substance provides an active in said surface, said substance also provides a bond with adhesive between said strip of material and said surface for maintaining said supply system in place for sufficient time to allow said active to act on said surface, said substance having an extrusion resistance sufficient to withstand a normal force being applied which deforms said strip of material in a manner that that said substance is not extruded substantially from between said strip of material and said surface during the manual deformation of said strip of material.

8. The method for supplying a substance for oral care to a surface of a tooth and its attached soft tissue, said method characterized by the steps of: a) applying said substance to said surface of said tooth and its soft tissue attached; b) applying an adjustable strip of material having a point of relaxation and thickness so that the strip of material substantially conforms to a shape of a tooth and its soft tissue attached by means of permanent deformation under a pressure less than about 250,000 Pascals on said substance in said surface, said substance provides an active to said surface, said substance it also provides a bond with adhesive between said strip of material and said surface to hold said delivery system in place for a sufficient time to allow said active to act on said surface, said substance having an extrusion resistance sufficient to withstand being applied a normal force that deforms said strip of material so that said substance does not substantially extrude between said strip of material and said surface during the manual deformation of said strip of material.

9. The method according to claim 7 or claim 8, further characterized in that said substance is a substance for whitening the teeth

10. The method according to claim 7, 8 or 9, further characterized in that said strip of material It is made of wax having a nominal film thickness of approximately 0.8 mm.