KR20010106427A - A delivery system for an oral care substance using a permanently deformable strip of material - Google Patents

Abstract

The delivery system of an oral therapeutic material, such as a tooth whitening material, is a yield point that, when deployed, substantially conforms to the shape of the tooth and its adjacent soft tissue through permanent deformation under pressure of up to about 250,000 Pascals and Strip material having a thickness. The delivery system also includes an oral treatment material applied to the strip material such that when the delivery system is disposed on the surface of the tooth and adjacent soft tissue, the material contacts the surface to provide the active on that surface. The material also provides an adhesive bond between the surface and the strip material to maintain the delivery system for a time sufficient for the active to act on the surface. The material has sufficient extrusion resistance to withstand the conventional forces exerted to deform the strip material so that it is not substantially extruded between the surface and the strip material during manual deformation of the strip material.

Description

A system for the delivery of oral treatment materials using permanently deformable strips {A DELIVERY SYSTEM FOR AN ORAL CARE SUBSTANCE USING A PERMANENTLY DEFORMABLE STRIP OF MATERIAL}

The most common tool for dental hygiene is a toothbrush. The mechanical action of the toothbrush bristles helps to remove food fragments and plaque. Toothbrushes are commonly used with toothpaste. Prior to about 1955, conventional toothpastes consisted of surfactants and abrasive materials. Such products were simply to increase the mechanical action of brushing.

In 1955, fluoride-containing toothpaste CREST, a trademark of "The Procter & Gamble Company" of Cincinnati, Ohio This has been introduced and the combination of toothbrush and fluoride toothpaste has proven to be a suitable means of transporting fluoride therapeutics to the surface of teeth. Thereafter, other active ingredients, such as tartar control agents, were added to the toothpaste to provide additional dental hygiene effects. In addition, consumers have turned their attention to the cosmetic aspect of dental treatments such as orthodontics and whitening.

If chemicals that provide oral therapeutic effects are successfully delivered, it is reasonable to expect to achieve cosmetic effects through conventional brushing. For example, products have been introduced that claim to whiten teeth. However, despite the claims, the combination of low permissible strength of the chemicals used in the oral cavity and the contact time necessary for the whitening to occur effectively prevents sufficient whitening through conventional brushing programs. As a result, people who are serious about whitening teeth and who are disappointed by the results of whitening toothpaste often rely on professional help for whitening teeth.

There are two general classes of professional tooth whitening programs offered by dentists. That is, there is a bleaching process in the treatment room and a bleaching process outside the treatment room. The procedure in the clinic involves several visits, each beginning with the manufacture of a rubber dam that is specifically fitted in the mouth to prevent the bleach chemicals, typically hydrogen peroxide, from coming into contact with soft oral tissue. The manufacture of rubber dams inside a patient's mouth is painful and time consuming. However, the use of dams is necessary due to the strength of the peroxide bleach. In addition, the procedure in the office exposes the teeth to high and low temperatures and is very expensive.

Out-of-office bleaching programs differ in that patients apply bleach to their teeth over a long period of time using low intensity chemicals, typically several hours a day for weeks. Out-of-office programs typically require early adaptation at the dentist for instruments specific to a particular patient. The device is a device that is manufactured to precisely fit a patient's teeth and is used to convey bleach products, such as bleach products such as gels containing a urea / hydrogen peroxide complex, to the patient's teeth. It is the responsibility of the patient to measure and apply bleach to the surface of the teeth using the instrument as a transport and maintenance means.

Since the instrument is used, it needs to be sufficiently robust to withstand repeated operations, cleaning, filling, installation and wearing. Such instruments are relatively hard to maintain fit during repeated use. As a result, the edges of the instrument are generally hard and often cause gingival irritation; Its substantial thickness is generally seen by the wearer and others. Typically, patients use the device only during periods of social contact.

There is an unprofessional program available to anyone interested in whitening teeth using commercial products available at pharmacies. Commercially available products provide kits that include containers of common instruments and bleach gels. The obvious appeal is the low cost of the program. The main disadvantage of "single size fit" is the large gap between the teeth and the inner wall of the instrument compared to the professionally adapted instrument. Thus, more bleaching gels are needed to ensure intimate contact of the surface of the teeth with the bleaching gel. In addition, poor fitting results in a large loss of bleach gel into the gingival oral cavity and is eventually ingested. Commercial kits, such as professional care programs outside the office, require the user to clean and reuse the instrument. Since the general apparatus does not fit the individual user, the volume is larger in the mouth than the apparatus that fits, thus limiting the social conversation more.

One attempt to cure some of the problems of commercial kits is disclosed in US Pat. No. 5,575,654, issued to Fontenot on November 19, 1996. Fontnat discloses prepackaged moldable dental instruments adapted to fit over a wide range of dental arches, and includes a premeasured amount of a medicament or bleach. In use, the dental instrument is unpacked, aligned parallel to the edge of the tooth, and pressed against the tooth in the direction of the periodontal tissue until it covers the tooth surface. The biggest advantages of the device disclosed by the Fontnat are the lack of filling and measuring of the instrument and the disposal after each use. However, the device frequently has the problem of large volume and eclectic fitting.

A second solution is disclosed in US Pat. No. 5,310,563 to Curtis et al. On May 10, 1994. Curtis et al. Disclose a putty-like material formed by pressing against a tooth. The material is supported by mechanical engagement and friction with the undercut surface. The composite surrounds the active. The active material migrates from the composite to the gingival and dental surface rather than directly in contact with the gingiva and dental surface. Presumably, the required wear time increases, which is a significant disadvantage.

There is a need for a low cost, commercial delivery system that fits like a custom fit for minimal volume of actives that provide materials such as tooth whitening materials and that is in conformity and shape in contact with a suitable oral surface for rapid delivery of the actives. There is also a need for a small volume active container means that allows the wearer to use the system without disturbing the wearer's words or appearance during social conversations. There is also a need for container means to protect the material from erosion by contact with the inner mouth surface.

Summary of the Invention

In an embodiment of the present invention, the flat strip material is first faced by the wearer to a part of the tooth, ie the entire tooth or adjacent tooth rows. The tooth facing side of the material is coated with the material, or the teeth are coated with the material and the strip material is placed over the material. In each case, a material such as a tooth whitening material is in a highly viscous state, such as a gel, which not only provides the active but also provides adhesion between the strap material and the surface of the tooth to keep the strip material in place. The shape-matching strip member is sized appropriately to fit over the entire upper or lower row of teeth, respectively, when positioned against the tooth. The strip material is easily matched to the shape of the tooth by lightly pressing it against the tooth. The strip material is easily removed by the wearer by peeling after use.

Because of the relatively thin coating, the material has a small volume compared to the material contained by the rigid tray, which may or may not fit. Thus, no substance is lost, and only small amounts of the substance may be ingested accidentally or irritate the oral surface, though not intentionally.

In one aspect of the invention, the delivery system for oral treatment material comprises a strip material having a yield point and thickness such that the strip material substantially conforms to the shape of the teeth and adjacent soft tissues through permanent deformation under pressure of about 250,000 Pascals or less. do. The delivery system also includes an oral treatment material applied to the strip material such that when the delivery system is located on the surface of the tooth and its adjacent soft tissue, the material is in contact with the surface to provide the active on that surface. In addition, the material supports the transport system by providing an adhesive bond between the strip and the surface so that the active can act on the surface for a sufficient time. The material has sufficient extrusion resistance to withstand the conventional forces exerted to deform the strip material such that substantially no material is extruded between the strip material and the surface during manual deformation of the strip material.

Preferably, the material is in the form of a gel, which is a continuous coating that is substantially uniform on the strip material. The strip material is preferably made of wax having a nominal film thickness of about 0.8 mm, which is substantially flat and rounded rectangular in shape, and the strip material comprising the coating material has a total thickness of about 1.5 mm or less. The strip material may have a length sufficient to cover a plurality of adjacent teeth and gaps between adjacent teeth while conforming to the curved shape of the wearer's mouth.

In another aspect of the invention, a method of delivering an oral treatment material to the surface of a tooth and adjacent soft tissue substantially coincides with the shape of the tooth and its adjacent soft tissue through permanent deformation under pressure of about 250,000 Pascals or less. And applying the material to the conformal strip material having a yield point and a thickness that allows it. Alternatively, such steps can include applying the material directly to the surface of the tooth and its adjacent soft tissue. Another step is abutting the strip material such that material is between the strip material and the surface. The material provides an active material to the surface and provides an adhesive attachment between the surface and the strip material to support the delivery system for a time sufficient for the active to act on the surface.

Brief description of the drawings

While the specification includes claims that specifically point out and explicitly claim the invention, the invention will be better understood from the following description of the preferred embodiments made in connection with the accompanying drawings, in which like reference characters designate the same reference signs. Represents an element.

1 is a perspective view of a substantially flat strip material having rounded corners.

Figure 2 is a perspective view of one embodiment of the present invention and discloses the flat strip material of Figure 1 coated with an oral treatment material.

FIG. 3 is a cross-sectional view taken along section line 3-3 of FIG. 2 and discloses a flat strip material having a thickness less than the thickness of the material coated thereon.

4 is a cross-sectional view showing another embodiment of the present invention, showing a shallow pocket serving as a container of additional material coated on the strip.

5 is a front cross-sectional view of a tooth and adjacent soft tissue, and discloses a strip material of the present invention that is matched according to the shape of the tooth and adhesively attached by a material disposed between the tooth and the strip material.

6 is a cross-sectional view showing adjacent teeth in which the strip material of the present invention is matched according to the shape of the tooth and adhesively attached by a material located between the tooth and the strip material.

FIG. 7 is a cross-sectional view similar to FIG. 5 showing the strip material of the present invention matched to the shape of both the tooth and adjacent soft tissue and adhesively attached to the tooth by a material disposed between the strip material and the tooth.

FIG. 8 is a cross-sectional view similar to FIG. 6, showing the strip material of the present invention matched to the shape of the tooth and its adjacent soft tissue and adhesively attached to the tooth by a material located between the tooth and the strip material.

The present invention relates to a system for delivering an oral treatment material, such as a tooth whitening material, to oral tissue, a surface of a tooth, a plurality of adjacent teeth, or a combination thereof, and more particularly an active provided by such material. It relates to a delivery system that is protected from erosion inside the oral cavity for a time sufficient to provide this therapeutic effect. More specifically, the present invention relates to disposable delivery systems for use outside the dentist, which are inexpensive and unobtrusive so that they can be worn without disturbing normal social conversation.

Referring to the drawings, more particularly to FIGS. 1 and 2, there is shown a first preferred embodiment of the invention, generally indicated at 10. Example 10 shows a delivery system for oral therapeutic materials, such as tooth whitening materials. The delivery system 10 has a rounded corner and a substantially flat strip material 12. The strip material 12 may be a wax, putty, thin foil, or a combination thereof, such as a single layer or a layer of permanently deformable material.

An oral treatment material 14 is applied or coated on the strip material 12. Preferably the material 14 is a homogeneous fluid and is uniformly and continuously coated on the strip material 12 as shown in FIG. In other ways, however, the material 14 may be a stacked or separated layer of components, an amorphous mix of components, a separate stripe or spot or other pattern of different components, or a combination of such structures, and the strip material 12 A continuous coating of the oral treatment material 14 along the longitudinal axis of a portion of the.

The material 14 preferably contains the active substance or is itself an active substance, such as a composition, compound or mixture which can cause or influence a desired change in the appearance and / or tissue of the surface in contact. Examples of actives include hydrogen peroxide, carbamide peroxide, sodium fluoride, sodium monofluorophosphate, pyrophosphate, chlorohexidine, polyphosphate, triclosan, and enzymes. Examples of appearance and tissue changes include whitening, stain bleaching, stain removal, mineralization for fluoroapatite formation, plaque removal, and tartar removal.

As another example, the strip material 16 may have a shallow pocket 18 formed therein. When the material 14 is coated on the material coating side of the strip material 16, as shown in FIG. 4, the added material 14 has a shallow pocket 18 providing a container of the additional material 14. To charge.

5 and 6 show the delivery system 24 of the present invention against the surface of a tooth or adjacent teeth. The teeth 22 are buried in the adjacent soft tissue 20. 6 shows an example of an adjacent tooth set. Here, adjacent soft tissue is defined as the tissue surface surrounding the tooth structure, including marginal gingiva, gingival groove, internal tooth gingiva, muco-gingival connection and pallet to it. And gingiva structures of the ball surface.

In FIGS. 5 and 6, the delivery system 24 is represented by the strip material 12 and the material 14, where the material 14 on the side of the strip material 12 faces the tooth 22. The material 14 may be previously applied on the strip material 12 by being applied on the strip material by the user of the conveying system, or directly applied to the tooth 22 and then covered by the strip material 12. In either case, the strip material 12 has a yield point and thickness that allows it to substantially match the shape of the teeth and adjacent soft tissues through permanent deformation under pressure of about 250,000 Pascals or less. Preferred strip materials have viscoelastic properties, which have viscoelastic properties that allow them to bend and bend to conform to their shape around the wearer palate and over some teeth. It is important to allow permanent deformation to occur with minimal conventional forces exerted by the wearer. Without the material 14 being substantially extruded between the surface of the tooth 22 and the adjacent soft tissue 20 and the strip material 12, the strip material is forced to the contour surface and the adjacent surface of the tooth 22 by a small force. It may be formed by hand according to the soft tissue 20. By "substantially extruded" is meant that at least 50% of the material 14 is extruded between the teeth and adjacent soft tissue and the surface of the strip material 12.

The wearer will press the strip on each tooth using one fingertip having a surface area of about one square centimeter. Typical attachment pressures are in the range of about 100,000 Pascals to about 250,000 Pascals.

The strip material 12 acts as a protective barrier for the material 14 and leaks and / or leaks of the material 14 from the surface of the teeth 22 by the wearer's lips, tongue, other soft tissues, and saliva in contact with the material. Substantially prevent erosion. In order for the actives in the oral treatment material 14 to act on the surface of the teeth 22 over a long period of minutes to hours, it is important to minimize such leakage and / or erosion. Here, the term "acts" is defined as causing the desired change. For example, if the substance is a peroxide, it bleaches the pigmented portion of the tooth, causing whitening, and if the active is sodium fluoride, it promotes the formation of fluoroapatite in the enamel matrix and makes the enamel matrix less soluble in acid. .

The strip material 12 is supported on the teeth 22 by adhesive attachment provided by the material 14. The viscosity and stickiness of the material causes the strip material 12 to be adhesively attached around the teeth 22, thereby allowing the strip material 12 to interact with the lips and tongue and other soft tissues while the mouth moves in connection with conversation, drinking, etc. The material does not leak under phosphoric friction.

7 and 8 show the delivery system 26 of the present invention that is attached to the surface of the tooth 22 as well as the adjacent soft tissue 20. The delivery system 26 is represented by the strip material 12 and the material 14, with the material on the side of the strip material 12 facing the teeth 22 and the adjacent soft tissue 20. Although the strip material 26 is not adhesively attached to the adjacent soft tissue 20, it is held in place by adhesive attachment to the teeth 22.

In a particularly preferred embodiment of the invention, material (14) comprises 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% fragrance, 0-15% sodium citrate, and 0-5% ethylenediamineetheracetic acid . Preferred gels have a viscosity between 200 and 1,000,000 cps at low shear rates (up to 1 / second). More preferably, the tooth whitening agent is a gel containing water adjusted to pH 6.5 by 70% glycerin, 5% carboxypolymethylene, 10% carbamide peroxide, sodium hydroxide. Such a composition is such that when the 0.25 mm coating applied to the strip material and the strip material are manually pressed against the tooth surface under pressure of 133,000 Pascals or less, the tooth whitening material is extruded to less than 50% between the strip material and the tooth surface, It has sufficient extrusion resistance to form a strip according to its shape. Commercial toothpaste whitening agents such as Opalescence and Nu-Pro Gold are feasible using the delivery system of the present invention.

Other oral treatment products that are feasible using the delivery system of the present invention are fluoride gels that have a similar viscosity to the preferred embodiment and are intended to apply fluoride for caries protection.

Strip material (12) was developed by Freeman Mfg & Supply Co., Cleverland, Ohio. Preference is given to a 0.8 mm thick piece of wax, such as # 165 sheet wax, which is organized and manufactured by yarn. Such a special wax is easily matched according to the shape of the tooth under a pressure of about 133,000 Pascals, which is the pressure generated when the wearer applies a conventional 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 about 1.5 mm or less. The layer thickness of the material 14 is preferably about 0.4 mm or less.

Preferably, the delivery system of the present invention is applied with a tooth whitening agent to the tooth in order to achieve a whitening effect of 1-4 color swatch improvement as measured by the VITA LUMEN Vacuum Farbskala Shade Guide from VITA Zahnfabrik of BadSackingen, Germany. Used continuously for 120 minutes per day for 7 to 14 days.

In oral care products, such as fluoride gels, the delivery system of the present invention is used by continuously applying the gel to teeth and / or adjacent soft tissue for about 4 minutes once a year to prevent tartar.

As the wearer removes the strip from the teeth and adjacent soft tissue, residues of material may remain on the surfaces of the teeth and adjacent soft tissue. Residual material can be easily removed by brushing or rinsing.

While specific embodiments of the invention have been described and described, it will be apparent to those skilled in the art that various modifications and changes can be made within the scope of the invention, and that all such changes are intended to be within the scope of the invention to cover the appended claims. something to do.

Claims (10)

As a delivery system of oral treatment material, a) a strip material having a yield point and a thickness that, when the delivery system is placed against each other, substantially conforms to the shape of the tooth and its adjacent soft tissue through permanent deformation under pressure of up to about 250,000 Pascals; And b) when the delivery system is disposed on the surface of the tooth and its adjacent soft tissue, comprising an oral treatment material applied to the strip material to contact the surface and provide an active agent on the surface, The material also provides an adhesive attachment between the strip material and the surface to support the delivery system for a time sufficient to allow an active material to act on the surface, the material being typically applied to deform the strip material. And a extrusion resistance sufficient to withstand the force so that it is not substantially extruded between the surface and the strip during manual deformation of the strip. The delivery system of claim 1, wherein the material is a tooth whitening material. The transport system of claim 1 or 2, wherein the material is a substantially uniform continuous coating on the strip material. The transport system of claim 1, wherein the strip material is made of wax having a nominal film thickness of about 0.8 mm. 5. The method according to any one of claims 1 to 4, wherein the strip material is substantially flat and the shape is rectangular with rounded corners, and the strip material comprises the material applied thereon to an overall thickness of about 1.5 mm or less. Characterized by a conveying system. 6. The strip material according to any one of claims 1 to 5, characterized in that the strip member has a length sufficient to cover the plurality of adjacent teeth, coinciding with the gap between the plurality of adjacent teeth and the curved shape of the wearer's mouth. Conveying system. A method of transporting an oral therapeutic substance to the surface of a tooth and its adjacent soft tissue, Applying the material to a conformal strip material having a yield point and thickness that substantially conforms to the shape of the tooth and its adjacent soft tissue through permanent deformation under pressure of about 250,000 Pascals or less; Attaching the conformal strip material formed thereon to the surface such that the material is in contact with the surface to provide an active material on the surface, The material also provides an adhesive attachment between the strip material and the surface to support the delivery system for a time sufficient for the active to act on the surface, the material being typically applied to deform the strip material. A extrusion resistance sufficient to withstand phosphorus forces such that substantially no extrusion is made between the surface and the strip material during manual deformation of the strip material. A method of conveying an oral therapeutic substance to a tooth and its adjacent soft tissue, a) applying the material on the surface of the tooth and its adjacent soft tissue; b) attaching a conformal strip material on the material on the surface having a yield point and thickness that substantially conforms to the shape of the tooth and its adjacent soft tissue through permanent deformation under pressure of about 250,000 Pascals or less; Including; The material provides an active material on the surface, which material also provides an adhesive attachment between the surface and the strip material to maintain the delivery system for a time sufficient for the active material to act on the surface, And the material has extrusion resistance sufficient to withstand the conventional forces applied to deform the strip material so that it is substantially not extruded between the surface and the strip material during manual deformation of the strip material. 9. A method according to claim 7 or 8, wherein the substance is a tooth whitening substance. 10. The method according to any of claims 7 to 9, wherein the strip material is made of wax having a nominal film thickness of about 0.8 mm.