IL141045A - Delivery system for an oral care substance using a permanently deformable strip of material - Google Patents

Description

141045/2 >-»-nn )n» riaijoa Delivery system for oral care substances and tooth whitening substances Procter & Gamble Company A DELIVERY SYSTEM FOR AN ORAL CARE SUBSTANCE USTNG A PERMANENTLY DEFORMABLE STRIP OF MATERIAL FIELD OF THE INVENTION The present invention relates to a system for the delivery of an oral care substance such as a tooth whitening substance to one's oral tissue, a surface of a tooth, a number of adjacent teeth, or a combination thereof, and more particularly to such delivery system wherein the substance is protected from erosion within the mouth for a time sufficient to enable an active provided by the substance to provide a therapeutic benefit. Even more particularly, the present invention relates to disposable delivery systems used outside a dentist office, wherein such delivery systems are inexpensive and unobtrusive so as to be wearable without interfering with normal social discourse.

BACKGROUND OF THE INVENTION The most common implement for dental hygiene is the toothbrush. The mechanical action of the toothbrush bristles 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 intended to augment the mechanical action of the brushing.

In 1955, CREST® toothpaste with fluoride, a Trademark of The Procter & Gamble Company of Cincinnati, OH, was introduced and the toothbrush and fluoride toothpaste combination proved to be a suitable means to deliver a fluoride treatment to the teeth surfaces. Subsequently, other active ingredients, such as tartar control agents, have been added to toothpaste to provide further dental hygiene benefits.

Consumers have also turned their attention to the cosmetic aspects of dental care, such as teeth straightening and whitening.

Given the success of delivering chemicals which provide therapeutic benefits for oral care, it is reasonable to expect similar success in accomplishing the cosmetic benefit via routine brushing. For example, products have been introduced which claim to whiten teeth. However, in spite of the claims, the combination of the low allowable strength of the orally used chemicals and the significant contact time necessary for whitening to occur effectively prevents significant whitening via a regular program of brushing. As a consequence, people who are serious about whitening their teeth and who have been disappointed by the results of whitening dentifrices, often resort to professional help for whitening their teeth.

Professional teeth whitening programs provided by dentists generally fall into two categories: an in-office bleaching procedure and an outside-the-office bleaching procedure. The in-office procedure involves several visits, each of which begins with the fabrication of a specially fitted rubber dam within the mouth to prevent the bleaching chemicals, typically hydrogen peroxide, from contacting the soft oral tissue. The production of the rubber dam within the patient's mouth may be both painful and time consuming. However, the strength of the peroxide bleach mandates the use of the dam. The in-office procedure may also leave the teeth sensitive to heat and cold and is very expensive.

The outside-the-office bleaching program differs in that the patient applies the bleaching agent to his or her own teeth using a lower strength chemical over an extended period of time, typically several hours a day for several weeks. The outside-the-office program typically requires an initial fitting in the dentist's office for an appliance which is specific to the particular patient. The appliance is a device that is fabricated to fit precisely onto the patient's teeth and is used to deliver to the patient's teeth a bleaching product, such as a gel containing urea/hydrogen peroxide complex. The patient is responsible for measuring and applying the bleaching agent to the surfaces of the teeth using the appliance as the means for delivery and containment.

Because the appliance is reused, it must be sufficiently robust to endure repeat handling, cleaning, filing, installation, and wearing. Such appliances are relatively rigid in order to maintain fit during repeat use. As a result, the edge of an appliance is generally stiff, often causing gum irritation; and its substantial thickness is usually apparent to both the wearer and others. Typically, a patient uses the device in time periods when social contact can be avoided.

There are now non-professional programs available to persons interested in whitening their teeth using commercial products available at drug stores. The commercial products provide a kit which includes a generic appliance and a container of bleaching gel. The obvious appeal is the lower cost of the program. A major disadvantage of this "one size fits all" appliance is the greater void between the interior walls of the appliance and the teeth versus the professionally fitted appliance. Hence, in order to insure intimate contact of the bleaching gel and the teeth surfaces, more bleaching gel is required. Furthermore, the poorer fit means a greater loss of bleaching gel onto the gums, into the oral cavity, and eventually ingested. The commercial kits, like the outside-the-oflfice professionally administered program, require the user to clean and to reuse the appliance. Since generic appliances are not fitted to the individual user, they are even more bulky in the mouth than the fitted appliances and thus they restrict social discourse to a greater degTee.

One attempt to remedy some of the problems of the commercial kits is disclosed in U.S. Patent 5,575,654, issued to Fontenot on November 19, 1996. Fontenot discloses a prepackaged moldable dental appliance, adapted to fit a wide range of variously sized dental arches, which contains a premeasured amount of medicinal or bleaching agent. In use, the dental appliance is removed from the packaging, aligned in a parallel fashion to the edges of the teeth and pushed over the teeth in the direction of the periodontal tissue until it covers the teeth surfaces. The primary benefit of the device disclosed by Fontenot is elimination of the measuring and filling of the appliance and the disposability after each use. However, it has been observed that the device frequently has the problems of bulk and compromised fit.

A second solution is disclosed in U.S. Patent 5,3 10,563, issued to Curtis et al. on May 10, 1994. Curtis et al. disclose a putty-like material which is formed by - 4 - 141045/2 pressing against the teeth. It is held in place by mechanical engagement with undercut surfaces and by friction. The composition encapsulates the active. The active migrates from the composition to the gums and tooth surfaces rather than being directly in contact with them. Presumably, the required wearing time is increased, which may be a significant negative.

What is needed is a low cost commercial delivery system, which has a customized fit for a minimal volume of an active providing substance such as a tooth whitening substance, and which is in conformable contact with the appropriate oral surfaces for rapid delivery of the active. In addition, what is needed is a non-bulky active containment means that will permit the wearer to use the system during social discourse without interfering with the wearer's speech or appearance. Also needed is a containment means that will protect the substance from erosion from contact with inner mouth surfaces.

United States Patent No. 5,688,406 describes a pliable support member which is essentially U shaped so as it may fit over a row of human teeth. The support member carries decay-retardant compositions.

United States Patent No. 5,326,685 describes an applicator for spraying a viscus fluid onto the teeth which comprises a flexible backing material of a closed cell material and a flexible dispensing material of an open cell material which can be applied against the teeth.

SUMMARY OF THE INVENTION In some embodiments, this invention is directed to a delivery system for an oral care substance comprising: a strip of material wherein said strip of material substantially conforms to a front surface of a plurality of teeth via permanent deformation under a pressure less than about 250,000 Pascals when said delivery system is placed there against; and an oral care substance applied to said strip of material such that when said delivery system is placed on a surface of the plurality of teeth, said substance contacts said surface providing an active onto said surface.

In some further embodiments, this invention is directed to a delivery system for a tooth whitening substance comprising: - 4a - 141045/2 a strip of material wherein said strip of material comprises a layer of wax or putty and wherein the strip of material substantially conforms to a front surface of a plurality of teeth via permanent deformation under a pressure less than about 250,000 Pascals when said delivery system is placed there against; and a tooth whitening substance applied to said strip of material such that when said delivery system is placed on a surface of the plurality of teeth said substance contacts said surface providing an active onto said surface.

In practicing the present invention, an initially flat strip of material is applied by the wearer to a portion of a tooth, to an entire tooth, or to a row of adjacent teeth. The side of the material facing the tooth is either coated with the substance or the teeth are coated with the substance and the strip of material is placed over the substance. In either case, the substance such as a tooth whitening substance is preferably in a highly viscous state, such as a gel, such that it proves not only the active but also tackiness between the tooth surfaces and the strip of material to hold the strip of material in place. The conformable strip of material is preferably of a size that individually fits the entire upper or lower rows of teeth when positioned against the teeth. The strip of material readily conforms to the teeth by lightly pressing it thereagainst. The strip of material is easily removed by the wearer after use by peeling it off. Each successive treatment uses a fresh strip of material.

By being a relatively thin coating, the substance is low in volume compared to the substance contained by rigid trays fitted or unfitted. Therefore, substance is not wasted, and little of it is accidentally ingested or otherwise available for irritation of oral cavity surfaces for which it 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 yield point and thickness such that the strip of material substantially conforms to the shape of a tooth and its adjoining soft tissue via permanent deformation under a pressure less than about 250,000 Pascals. 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.

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 in shape with rounded corners, and the strip of material including the substance coated thereon has an overall thickness less than about 1.5 mm. The strip of material may have a length sufficient to cover a plurality of adjacent teeth while conforming to the curvature of the wearer's mouth and gaps between the adjacent teeth.

In another aspect of the present invention, a method of delivering an oral care substance to a surface of a tooth and its adjoining soft tissue includes the step of applying the substance onto a conformable strip of material having a yield point and thickness such that the strip of material substantially conforms to the shape of a tooth and its adjoining soft tissue via permanent deformation under a pressure less than about 250,000 Pascals. Alternatively, this step could include applying the substance directly onto the surface of the tooth and its adjoining soft tissue. Another step is applying the conformable strip of material such that the substance is between the strip of material and the surface. The substance provides an active onto the surface and also provides adhesive attachment between the strip of material and the surface to - 6 - 141045/2 hold the delivery system in place for a sufficient time to allow the active to act upon the surface.

Passages of the description which are not within the scope of the claims do not constitute part of the claimed invention.

BRIEF DESCRIPTION OF THE DRAWINGS While the specification concludes with claims which particularly point out and distinctly claim the present invention, 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 like reference numerals identify identical elements and wherein: FIG. 1 is a perspective view of a substantially flat strip of material having rounded comers; FIG. 2 is a perspective view of an embodiment of the present invention, disclosing the flat strip of FIG. 1 coated with an oral care substance; FIG. 3 is a cross-section view thereof, taken along section line 3-3 of FIG. 2, disclosing the flat strip having a thickness less than that of the substance coated thereon; FIG. 4 is a cross-section view showing an alternative embodiment of the present invention, showing shallow pockets in the strip of material, which act as reservoirs for additional substance coated on the strip; FIG. 5 is a cross-section elevation view of a tooth and adjoining soft tissue, disclosing the strip of the present invention conforming to and adhesively attached to the tooth by means of the substance located between the tooth and the strip of material; FIG. 6 is a cross-section plan view thereof, showing adjacent teeth having the strip of material of the present invention conforming thereto and adhesively attached to the teeth by means of a substance located between the teeth and the strip of material; FIG. 7 is a cross-section elevation view, similar to FIG. 5, showing the strip of material of the present invention conforming to both the teeth and the adjoining soft tissue and adhesively attached to the teeth by means of the substance located between the teeth and the strip of material; and 7 FIG. 8 is a cross-section plan view, similar to FIG. 6, showing a strip of material of the present invention conforming to the teeth and the adjoining soft tissue and adhesively attached to the teeth by means of the substance located between the teeth and the strip of material.

DETAILED DESCRIPTION OF THE INVENTION Referring now to the drawings, and more particularly to FIGS. 1 and 2, there is shown a first preferred embodiment of the present invention, which is generally indicated as 10. Embodiment 10 represents a delivery system for an oral care substance such as a tooth whitening substance. Delivery system 10 has a strip of material 12, which is initially substantially flat with rounded corners. Strip of material 12 may be a single layer of wax, putty, thin foil, or other permanently deformable material or a combination thereof, such as a laminate.

Applied or coated onto strip of material 12 is an oral care substance 14. Preferably, substance 14 is a homogeneous fluid, uniformly and continuously coated onto strip of material 12, as shown in FIG. 3. However, substance 14 may alternatively be a laminate or separated layers of components, an amorphous mixture of components, separate stripes or spots or other patterns of different components, or a combination of these structures, including a continuous coating of oral care substance 14 along a longitudinal axis of a portion of strip of material 12.

Substance 14 preferably contains or is itself an active, such as a composition, compound, or mixture capable of influencing or effecting a desired change in appearance and/or structure of the surface it contacts. Example actives include: hydrogen peroxide, carbamide peroxide, sodium fluoride, sodium monofluorophosphate, pyrophosphate, chlorhexidine, polyphosphate, triclosan, and enzymes. Examples of appearance and structural changes include, but are not necessarily limited to: whitening, stain bleaching, stain removal, remineralization to form fluorapatite, plaque removal, and tartar removal.

As an alternative embodiment, a strip of material 16 may have shallow pockets 18 formed therein. When substance 14 is coated on a substance-coated side 8 of strip of material 16, additional substance 14 fills shallow pockets 18 to provide reservoirs of additional substance 14, as shown in FIG. 4.

FIGS. 5 and 6 show a delivery system 24 of the present invention applied to a surface of a tooth or adjacent teeth. In adjoining soft tissue 20 is embedded a tooth 22. Tooth 22 is herein defined as a portion of a tooth, an individual tooth, or a set of adjacent teeth. FIG. 6 shows a set of adjacent teeth, for example. Adjoining soft tissue is herein defined as tissue surfaces surrounding the tooth structure including: marginal gingiva, gingival sulculus, inter dental gingiva, gingival gum structure on lingual and buccal surfaces up to and including muco-ginival junction and the pallet.

In both FIGS. 5 and 6, delivery system 24 represents strip of material 12 and substance 14, with substance 14 on the side of strip of material 12 facing tooth 22. Substance 14 may be pre-applied to strip of material 12, applied to strip of material 12 by the delivery system user, or applied directly to tooth 22 and then covered by strip of material 12. In any of these cases, strip of material 12 has a yield point and thickness such that the strip of material substantially conforms to the shape of a tooth and its adjoining soft tissue via permanent deformation under a pressure less than about 250,000 Pascals. The preferred strip of material has visco-elastic properties which enable it to creep as well as bend in order to conform across several teeth and around the arch of the wearer's mouth. It is important that the necessary permanent deformation occur under minimum normal force being applied by the wearer. The low force enables the strip of material to be manually formed to the contoured surfaces of tooth 22 and to adjoining soft tissue 20 without substance 14 being substantially extruded out from between strip of material 12 and surface of tooth 22 and adjoining soft tissue 20. By "substantially extruded out" is meant at least 50% or more of substance 14 is extruded from between strip of material 12 and the tooth and adjoining soft tissue surfaces.

It has been found that wearers will press a strip onto each tooth using one finger tip having about one square centimeter surface area. They typically apply force at each tooth for one second or less. A typical application pressure ranges from about 100,000 Pascals to about 250,000 Pascals. 9 Strip of material 12 serves as a protective barrier for substance 14 to substantially prevent leaching and/or erosion of substance 14 from the surface of tooth 22 by the wearer's lips, tongue, other soft tissue, and saliva contacting the substance. In order for an active in oral care substance 14 to act upon the surface of tooth 22 over an extended period of time, from several minutes to several hours, it is important to minimize such leaching and/or erosion. The term "act upon" is herein defined as bringing about a desired change. For example, if the substance is a peroxide, it bleaches color bodies inside the tooth to bring about whitening; or if the active is sodium fluoride, it promotes the formation of fluorapatite in an enamel matrix, turning the enamel matrix into a less acid soluble material.

Strip of material 12 is held in place on tooth 22 by adhesive attachment provided by substance 14. The viscosity and general tackiness of substance 14 cause strip of material 12 to be adhesively attached about tooth 22 without substantial slippage under the potential friction of lips and tongue and other soft tissue rubbing against strip of material 12 during mouth movements associated with talking, drinking, etc.

FIGS. 7 and 8 show a delivery system 26 of the present invention applied to a surface of tooth 22 as well as to adjoining soft tissue 20. Delivery system 26 represents strip of material 12 and substance 14, with substance 14 on the side of strip of material 12 facing tooth 22 and adjoining soft tissue 20. Although strip of material 26 may not be adhesively attached to adjoining soft tissue 20, it may be held in position by being adhesively attached to tooth 22.

In a particularly preferred embodiment of the present invention, substance 14 is a tooth whitening gel containing 30-85% glycerin or polyethylene glycol, 10-22% urea hydrogen peroxide complex, 0-12% carboxypolymethylene, 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 low shear rates (less than one 1 /seconds). Even more preferably, a tooth whitener is a gel containing 70% glycerin, 5% carboxypolymethylene, 10% carbamide peroxide, 15% water adjusted to pH 6.5 with sodium hydroxide. This formulation has sufficient resistance to extrusion such that when a 0.25 mm coating of it is applied to the strip of material and the strip of material is manually pressed against a tooth surface under a pressure less than 133,000 Pascals, in order to deform the strip to the shape of the tooth, less than 50% of the tooth whitening substance is extruded from between the strip of material and the tooth surface. Commercial tooth whiteners, such as Opalescence and Nu-Pro Gold are also operable with the delivery system of the present invention.

Another oral care product which is operable with the present delivery system is a fluoride topical gel having similar viscosity to the preferred embodiment which is intended for topical application of fluoride to aid in the protection against dental caries.

Strip of material 12 is preferably a 0.8 mm thick piece of wax, such as #165 sheet wax formulated and manufactured by Freeman Mfg. & Supply Co. of Cleveland, OH. This particular wax readily conforms to the shape of a tooth under a pressure of about 133,000 Pascals, which is the pressure generated when the wearer applies a normal force of about 3 pounds (1.36 kg) over an area of about one square centimeter.

The overall thickness of the delivery system is preferably less than about 1.5 millimeter. Thickness of the layer of substance 14 is preferably about 0.4 mm.

Preferably, the delivery system of the present invention is used by applying a tooth whitener to a tooth continuously for 120 minutes a day, once a day, for about 7 to 14 days to achieve a whitening benefit of 1-4 shade guide improvement as measured by VITA LUMEN Vacuum Farbskala Shade Guides, a product of VITA Zahnfabrik, of BadSackingen, Germany.

For an oral care product, such as fluoride gel, the delivery system of the present invention is used by applying the gel to a tooth and/or adjoining soft tissue continuously for about 4 minutes, once a year, to aid in the prevention of dental caries.

When the wearer removes the strip of material from the tooth and adjoining soft tissue, there may be a residue of substance remaining on the these surfaces. Residual substance may be easily removed by brushing or rinsing. 1 1 While 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 it is intended to cover in the appended claims all such modifications that are within the scope of the invention.

Claims (29)

- 12 - 141045/2 CLAIMS:

1. A delivery system for an oral care substance comprising: (a) a strip of material wherein said strip of material substantially conforms to a front surface of a plurality of teeth via permanent deformation under a pressure less than about 250,000 Pascals when said delivery system is placed there against; and (b) an oral care substance applied to said strip of material such that when said delivery system is placed on a surface of the plurality of teeth, said substance contacts said surface providing an active onto said surface.

2. The delivery system of Claim 1, wherein said oral care substance provides adhesive attachment to hold said delivery system in place for a sufficient time to allow said active to act upon said surface, said substance having an extrusion resistance such that less than 50% of the substance is extruded from between said strip of material and said surface during manual deformation of said strip of material.

3. The delivery system of Claim 1 or 2, wherein said oral care substance comprises: (a) an active component capable of effecting a desired change of the surface it contacts, and (b) an adhesive component providing adhesive attachment between said strip of material and a plurality of teeth.

4. The delivery system of Claim 1 or 2, wherein said oral care substance comprises a tooth whitening substance having a peroxide active.

5. The delivery system of Claim 4, wherein said delivery system has an overall thickness of less than 1.5 mm.

6. The delivery system of Claim 4, wherein the tooth whitening substance is a laminate or separate layers of components, an amorphous mixture of components, separate stripes or spots or other patterns of different components, or a combination of these structures.

7. The delivery system of Claim 4, wherein said strip of material comprises a laminate.

8. The delivery system of Claim 4, wherein said tooth whitening substance comprises a gel. - 13 - 141045/2

9. The delivery system of Claim 4, wherein said strip of material comprises a wax or putty.

10. The delivery system of Claim 9, wherein said wax or putty has a nominal film thickness of about 0.8 mm. 5

11. The delivery system of Claim 4, wherein said strip of material comprises a thin foil.

12. The delivery system according to Claim 4, wherein said strip of material has a length sufficient to cover a plurality of adjacent teeth while conforming to gaps between said plurality of adjacent teeth. 10

13. The delivery system according to Claim 4, wherein said substance is a substantially uniform continuous coating on said strip of material.

14. The delivery system according to Claim 4, wherein said strip of material is further sized to cover a back surface of said plurality of teeth.

15. The delivery system according to Claim 4, wherein said tooth whitening 15 substance is in a layer having a thickness of about 0.4 mm.

16. The delivery system according to Claim 4, wherein the strip of material is initially substantially flat.

17. A delivery system for a tooth whitening substance comprising: (a) a strip of material wherein said strip of material comprises a layer of wax or 20 putty and wherein the strip of material substantially conforms to a front surface of a plurality of teeth via permanent deformation under a pressure less than about 250,000 Pascals when said delivery system is placed there against; and (b) a tooth whitening substance applied to said strip of material such that when 25 said delivery system is placed on a surface of the plurality of teeth said substance contacts said surface providing an active onto said surface.

18. The delivery system of Claim 17, wherein said tooth whitening substance provides adhesive attachment to hold said delivery system in place for a sufficient time to allow said active to act upon said surface, said substrate having an extrusion 30 resistance such that less than 50% of the substance is extruded from between said strip of material and said surface during manual deformation of said strip of material.

19. The delivery system of Claim 17 or 18, wherein said tooth whitening substance comprises a peroxide active. - 14 - 141045/2

20. The delivery system of Claim 19, wherein said tooth whitening substance provides an adhesive attachment between said strip of material and said plurality of teeth.

21. The delivery system of Claim 19, wherein said delivery system is initially substantially flat.

22. The delivery system of Claim 19, wherein said delivery system has an overall thickness of less than about 1.5 mm.

23. The delivery system of Claim 19, wherein the tooth whitening substance is a laminate or separate layers of components, an amorphous mixture of components, separate stripes or spots or other patterns of different components, or a combination of these structures.

24. The delivery system of Claim 19, wherein said strip of material comprises a laminate.

25. The delivery system of Clam 19, wherein said tooth whitening substance comprises a gel.

26. The delivery system of Claim 19, wherein said wax or putty has a nominal film thickness of about 0.8 mm.

27. The delivery system according to Claim 19, wherein said strip of material has a length sufficient to cover a plurality of adjacent teeth while conforming to gaps between said plurality of adjacent teeth.

28. The delivery system according to Claim 19, wherein said tooth whitening substance is a substantially uniform continuous coating on said strip of material.

29. The delivery system according to Claim 19, wherein said strip of material is further sized to cover a back surface of said plurality of teeth. For the Applicants, REINHOLD COHN AND PARTNERS