Shapes for tooth whitening strips

Description of the invention

The present invention relates to a strip of tooth whitening material.

The strip of tooth whitening material contains a tooth whitening substance to form the tooth whitening kit with it.

Teeth whitening has become popular in today's culture of life. More and more consumers are looking for the best method to get white teeth. Professional teeth whitening by a dentist is common. Generally, there are two types of professional teeth whitening: in the dental office or outside the dental office. Teeth whitening in a dentist's office usually requires a number of visits to the dentist and the use of a saliva shield and protection of the patient's gums against the effects of whitening agents. Bleaching carried out outside the dentist's office typically requires the use of a device or tray that is made in the dentist's office to fit the patient's teeth. The device is used over and over again and must therefore be strong enough to withstand repeated handling, cleaning, filling, seating and abrasion. Typically, the patient uses the device for periods of time when he or she may avoid social contact.

Currently, there are non-professional programs for people interested in whitening their teeth using commercial products available in pharmacies. The commercial products are supplied in the form of a kit that includes a general purpose device and a reservoir containing the whitening gel. The obvious incentive for this approach is the lower cost of the program. The major disadvantage of this one size fits all general purpose device, compared to a professionally fitted device, is the greater void space between the inside walls of the device and the teeth. Therefore, in order to ensure a close contact of the tooth surface with the bleaching gel, more bleaching gel is required. In addition, a poorer fit means a greater loss of gel on the gums that enters the mouth and is possibly swallowed. Commercially available kits, a program used professionally outside the dentist's office, require the user to clean the device in order to reuse them. As general purpose devices are not tailored to the individual user, they take up much more mouth space than fitted devices and therefore restrict social conversation to a greater extent.

US Patent No. 5,575,654 discloses one attempt to remedy some of the problems associated with commercially available kits. This specification discloses a packaged mouldable dental appliance adapted to fit a wide variety of dental arches of various dimensions. In use, the dental appliance is removed from the package, aligned parallel to the edge of the teeth, and pressed against the teeth towards the periodontal tissue until the tooth surfaces are covered.

Another embodiment is disclosed in US Patent No. 5,310,563. This specification discloses a putty-like material that is formed by pressure towards the teeth. It is held in place by mechanical engagement with the undercut surfaces and the action of friction. The composition contains the active ingredient.

Other methods are disclosed in US Patent No. 5,425,953. This specification discloses a liquid tooth whitening polymer composition. The liquid polymer composition, when applied, forms a film on the teeth. Other patents that disclose the use of an oral film include U.S. Patent No. 4,713,243 and U.S. Patent No. 2,835,628.

It is generally assumed that each user or patient has four anterior teeth, two canines, and additional posterior teeth such as molars. This applies to both the user's upper teeth and the front teeth. The shape of the four front teeth and canines is the same at both the top and bottom, except that the upper teeth are usually larger. Each tooth has an anterior and posterior side, and a tooth tip. The front of the tooth is defined as the side of the tooth visible to others and facing the lips of the mouth. The back of the tooth is usually invisible to others, unless the mouth is wide open. The apex of the tooth is defined as the part of the tooth that is farthest from the gum. Alternatively, the apex may be defined as a crown, apex, spike, or tooth top. The shape of the tips of the four anterior teeth is very different from that of the tips of the canines or the posterior teeth. The four front teeth are usually flat in shape which allows the belt to be easily inserted into the

To whiten the teeth on the tips of the teeth. The apex of the canines is usually pointed or conical in shape. This shape is not suited to a strip that folds or wraps at the apex. The user of the strip of material covering the tip of the tusks may find that the strip does not fit easily and therefore does not stay in place for extended periods of time. Moreover, it is not easy for the user to position the strip of material on top of the tusks. The strip can also tear at the tip of the canine. Typically, it is preferable that the strip of material does not fold or wrap around the molars. The tips of the molars are usually square in shape, which does not allow the belt to fold easily against the tooth. However, depending on the shape of the strip of material, correct folding can be achieved on top of the molars.

There is a need for a cheap, commercially available tooth whitening strip with a perfect shape that is compatible with the appropriate tooth surface and that stays in place during normal daily activities. Additionally, a shape of the tooth whitening strip is needed that does not require the user to excessively manipulate its positioning to ensure that good contact is ensured. Moreover, what is necessary is a space-saving agent containing an active ingredient which will allow the user of the agent to use it in a social conversation without affecting speech and appearance.

US Patent Application Serial Number 09 / 040,000 and US Patent 5,879,691 disclose a tooth whitening kit. The kit includes a strip of elastic material and a tooth whitening agent. The shape of the strip has been described as any shape with rounded corners. The disclosures focus on the properties of the strip, such as flexural stiffness, the material composition of the strip, its draping and the interaction between the strip and the tooth whitening substance to hold the strip in place. The present inventors have now discovered that the shape of the tooth whitening strip is also important. Better shapes of the teeth whitening strip allow the teeth whitening strip and the teeth whitening substance to adhere better to the teeth. The improved shapes allow the teeth whitening strips to remain on the user's teeth without slipping, even for an extended period of time. Additionally, the new shapes make the stripes less noticeable to users.

The tooth whitening material strip containing the tooth whitening material having a shape adapted to fit the teeth of the wearer is characterized according to the invention that the strip substantially covers a portion of the front side of the at least four front teeth of the wearer and the two canines and is foldable over the apexes and on the posterior side of one or more of the four front teeth, without covering the tips of the two canines.

It preferably has first, second, third and fourth sides, with the first and second sides facing each other and the third and fourth sides facing each other.

Preferably the third side is concave and the fourth side is convex.

Preferably, the first and second sides are in the form of a stepped step.

Preferably, the first and second sides have cutouts making the third side shorter than the fourth side.

Preferably it has at least two notches corresponding to the tops of the two canines.

Preferably it has at least two holes or cuts, preferably cross cuts, corresponding to the tops of the two canines.

Preferably, it comprises a fold line extending from the first side to the second side, coinciding in the strip on the user's upper and lower teeth with the apexes of the teeth, the length of the fold line being 0.1 cm to 4 cm in the strip on the lower teeth and the length of the fold line is up to 4.3 cm in the strip placed over the user's upper teeth.

Preferably, it is an elastic material, preferably a polyethylene film with a nominal thickness of less than 0.1 mm, having sufficient flexibility to form curved shapes and easily adaptable to the tooth surfaces and interstitial dental spaces without being permanently deformed when placed over the teeth.

It preferably has flat pockets filled with the substance on the side of the strip of material coated with the substance.

The strip of tooth whitening material according to the invention has a shape adapted to conform to the teeth of the user. Each user has four front teeth, two canines, and additional back teeth such as molars. Each tooth has a front side, apex and posterior side. Belt

The material is shaped such that it substantially covers from the front at least the four front teeth and two canines of the user. The front sides of the extra teeth may be coated. The tooth whitening strip then wraps over the apexes and on the back side of one or more of the four front teeth. The strip material, however, does not cover the tips of the two canines. The material of the strap may be of any shape that allows the tusks to protrude. Possible shapes include a trapezoidal shape with or without stepped, stepped sides or cutouts, and a rectangular shape with cutouts, stepped, stepped, or select sides.

The subject matter of the invention is illustrated in the drawings in which Fig. 1 shows a view of a tooth whitening strip material whose shape is essentially trapezoidal, Fig. 2 shows a top view of a tooth whitening strip whose shape is essentially trapezoidal. and which has stepped, stepped sides, fig. 3 is a top view of a tooth whitening strip which is substantially rectangular in shape and which has stepped, stepped sides, Fig. 4 is a top view of a tooth whitening strip which is substantially rectangular in shape with cutouts on the sides, 5 is a top view of a tooth whitening strip which is rectangular in shape and has two notches, Fig. 6 is a top view of a tooth whitening strip which is rectangular in shape and which has two cross cuts, Fig. 7 is a top view of a tooth whitening strip which is rectangular in shape and which has two openings, Figs 8A and 8B are in top and front views, the six lower front teeth of the user and Figs. 9 is a front view of the tooth whitening strip positioned against the six front teeth of a user before it is wrapped around the back sides of the user's teeth.

In this specification, the abbreviation cm means centimeter and the abbreviation mm means millimeter.

Figure 1 shows a first preferred embodiment of a tooth whitening strip according to the invention which is generally designated by reference numeral 10. Herein, the tooth whitening strip 10 is substantially trapezoidal in shape. The strip 10 has a first side 11, a second side 12, a third side 13 and a fourth side 14. The first side 11 and the second side 12 are straight sides which extend at an acute angle from the fourth side 14 to the third side 13. The third side 13 is concave and shorter than the fourth side 14. The fourth side 14 is convex. The fourth side 14 is positioned close to the lower edge of the user's front side, the lower front teeth. Alternatively, if the strap is applied to the user's upper teeth, the fourth side 14 may be positioned along a portion of the upper side of the user's front, upper, front teeth. The fold line 15 of the strip 10 extends from the first side 11 to the second side 12. The fold line 15 can be placed closer to the third side 13 or the fourth side 14. The fold line 15 is defined by the size of the user's teeth and the position of the teeth whitening strip on the user's teeth. The third side 13 runs along the rear side of the user's teeth after the strap 10 has been folded along the fold line 15.

As shown in Fig. 2, with the example of the strip 20, the material of the tooth whitening strip may have a substantially trapezoidal shape that has stepped, stepped sides. The strip 20 in this example has a first side 21, a second side 22, a third side 23 and a fourth side 24. The third side 23 is concave and shorter than the fourth side 24. The fourth side 24 is convex. The first side 21 and the second side 22 are stepped, stepped sides. The fold line 25 extends from corner 26 to 27, respectively, of a stepped step in the first side 21 and a stepped step of the second side 22. The strip 20 may alternatively be described as two substantially trapezoidal shapes arranged on top of each other. The upper trapezoid is formed by the third side 23, the second side 22 from its corner 27 upwards to the third side 23, the fold line 25 and the first side 21 from its corner 26 to the third side 23. The bottom trapezoid is formed by fold lines 25, the second side 22 from its corner 27 downwards to the fourth side 24, the fourth side 24 and the first side from its corner 26 down to the fourth side 24.

Figure 3 shows another example of a strap 30 according to the present invention. The strip of tooth whitening material is generally rectangular in shape with stepped, stepped sides. The strip 30 in this embodiment has a first side 31, a second side 32, a third side 33 and a fourth side 34. The first and second sides 31 and 32 are both stepped, stepped sides. The fold line 35 extends from corner 36 to 37, respectively, of the stepped step in the first side 31 and the stepped step of the second side 32. The strip 30 can also be described as two rectangles placed on top of each other. The top rectangle is formed by the third side 33, the second side 32 from its corner 37 to the third side 33, the fold line 35 and the first side 31 from its corner 36 to the third side 33. This upper rectangle may be described otherwise as a flap that fits over the back sides of a user's teeth. The bottom rectangle is formed by the fold line 35, the second side 32

From its corner 37 downwards to the fourth side 34, the fourth side 34 and the first side 31 from its corner 36 down to the fourth side 34.

A fold line 35 is placed over the apexes of the user's teeth to allow the strip to fold downward on both the front side and the back side of the user's teeth. The strap is positioned so that the two canines of the user are just outside the corners 36 and 37. The fourth side 34 is positioned near the lower edges of the lower front teeth of the user. Alternatively, if the strap is applied to the user's upper teeth, the fourth side 34 may be positioned along the top of the front side of the user's upper front teeth. The third side 33 is provided along the back side of the user's teeth.

Figure 4 shows in detail a strip of tooth whitening material of a substantially rectangular shape with cutouts on the sides . The strip 40 has a first side 41, a second side 42, a third side 43 and a fourth side 44. The third side 43 and the fourth side 44 are essentially straight sides of the same length. The first side 41 and the second side 42 have cutouts 46 and 47, respectively, so that the tips of the tusks are not covered when the belt is placed on the user's teeth. The fold line 45 extends from a cutout 46 in the first side 41 to a cutout 47 in the second side. As shown, the cutouts 46 and 47 have V-shaped side shapes. The cutouts may be of any shape including rectangular, semicircular, and the like that prevent variation 40 from curling the tips of the canines.

Other embodiments of the strips 50, 60 and 70 are shown in Fig. 5, Fig. 6 and Fig. 7, respectively. The strips 50, 60 and 70 of tooth whitening material are generally rectangular in shape with rounded corners. Each of the strips in these examples has two gaps that allow the fangs to protrude when the tooth whitening strip is placed over a user's teeth. Figure 5 shows the gaps in the form of straight cuts 56 and 57. The cuts 56 and 57 extend from the outer edge of the strip 50 to a point inside the variety. A fold line 55 extends from cut 56 to cut 57. In Figure 6, cuts 66 and 67 are shown which are cross cuts. Cross cuts 66 and 67 are located inside variant 60. Fold line 65 extends from cross cut 66 to cross 67. Belt 70 in the example illustrated in Figure 7 has holes 76 and 77 cut into the strip. The dimensions of the holes 76 and 77 must be properly selected to allow the tips of the canines to protrude. A fold line 75 extends between openings 76 and 77.

Figures 8A and 8B show plan views 81 and front 82, respectively, of the user's lower six front teeth. Top view 81 shows an overall arched shape recreated for six front teeth. The two canines 83 and 84 are positioned on opposite sides of the four front teeth 85. The additional posterior teeth such as molars that are positioned adjacent to each canine are not shown. The front view shows the general shapes including the apexes, the four anterior teeth 85, and the canines 83 and 84.

In Figure 9, a front view 82 of the six front teeth shown in Figure 8 is shown, together with the tooth whitening strip 20 illustrated in the example in Figure 2. The strip 20 is shown positioned along the teeth but not yet curled over the teeth. As shown, the fourth flank 24 extends along the lower portion of the four front teeth 85 and the two canines 83 and 84. The fold line 25 meets the tips of the four front teeth 85 and allows the tips of the canines 83 and 84 to be exposed. The fangs protrude at the corners of 26 and 27 stepped steps. The third side 23 should, in turn, fold down over the posterior side of the four front teeth.

The tooth whitening strip may be called a tooth whitening material strip, a cloth strip or a strip. The strip of tooth whitening material has a shape that is adapted to match the teeth of the wearer. It is preferred that the strap covers substantially the front side of at least four of the user's front teeth and two of the user's canines. These teeth are the most visible teeth in most users. The strip of material may cover the front side of the accessory teeth, such as teeth adjacent to the two canines. This may be desirable when these teeth are visible to others. Essentially means that at least half the surface of the anterior teeth is covered. The tooth whitening strip may cover the entire surface of the front teeth and may also cover part of the gums adjacent to the teeth. Typically, the tooth whitening strip begins to cover at the intersection of the tooth and gingival surfaces.

The tooth whitening strip is suitable for wrapping one or more of the four front teeth over the apex and posterior sides without covering the tips of the two canines. The shape of the strip allows the strip not to cover the tips of the canines. Specify wrap at vertex 6

Pitch means that the strip covers or wraps around the front side of the teeth, on the tips of the teeth, and on the back side of the teeth. Depending on the size of the material strip, the entire posterior side of the teeth including the adjacent gingiva may be covered, or only a portion of the posterior side of the teeth may be covered.

The shape of the tooth whitening strip is critical to be able to cover the front side of the canines without covering the tips of the canines. The shape of the strip can be any shape that produces this result. A tooth whitening strip can take many shapes. The strip may be substantially trapezoidal in shape. Substantially trapezoidal is used to denote any shape having four general sides, the two sides of which are usually parallel or uniformly arched. This can occur when one side is convex and the opposite side is concave. The arched shape can help reduce belt pucker and allow the belt to run more smoothly along the tooth surface. The other two opposite sides are usually parallel. The strip may be substantially rectangular in shape. This name is usually used to denote a shape having four sides, each of the two sides being close to parallel. The term parallel is used broadly to include sides that are arched, not straight and usually not perpendicular. Alternatively, the strip may be of any shape, such as round or oval. The strip may also have a polygonal shape. The shape of the strip is not required to be symmetrical.

Either side or edge of the strip may have cutouts, a stepped step, or a convex. By the term notch is meant that it is a break, notch or some kind of curve. By the term stepped step is meant a side that is not straight and may include one or more step steps. The strip may also include cuts, cross cuts, holes, perforations, or any suitable structure that allows the tangs to protrude through the belt material or allows the tangs to pass by the belt material. Usually, the gap should be approximately 2 cm to allow the tusks to protrude.

Each strip of material should contain a fold line. The fold line is defined as the portion of the strip where the tips of the teeth meet the strip when the strip is folded or folded at the vertices. This line may extend from where one of the gaps, one of the stepped steps, or one of the notches extends furthest from one side of the strip, to where another of the gaps, another step, or another cutout extends farthest from the opposite side of the strip. For example, from a corner of a stepped step or from a cut point. The fold line typically may extend from one side of the strip to the other, parallel side, and along the longer portion of the strip. The fold line can be self-adjusting depending on the size and shape of the belt. In the case of a trapezoidal belt shape, the fold line will be defined depending on the location of the belt on the user's teeth.

Typically, the length of the fold line for a belt to fit over the lower teeth of a user is up to about 4 cm. There is no minimum fold line requirement as long as a portion of the belt is folded over the apex of at least one of the four front teeth. Generally, the fold line is from about 0.1 cm to about 4 cm, preferably from about 0.5 cm to about 3.5 cm, more preferably from about 1 cm to about 3.2 cm, and most preferably from about 2 cm to about 3 cm. , 1 cm. For the user's upper teeth, the length of the fold line is up to about 4.3 cm. The fold line is usually from about 0.1 cm to about 4.3 cm, preferably from about 0.5 cm to about 4 cm, more preferably from about 1 cm to about 3.5 cm, and most preferably from about 2 cm to about 3 cm. 4 cm.

The shape of the strip of material is preferably any shape with rounded corners. The term rounded corners means that there are no sharp angles or places. The strip of the adaptable material is preferably of a size that allows it to be individually adapted to the row of teeth to be whitened. 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 preference of the user of the strip. Generally, the length of the strip of material is from about 2 cm to about 12 cm, preferably from about 3 cm to about 9 cm, and more preferably from about 4 cm to about 6 cm. If the strip of material has stepped steps on its sides or is trapezoidal in shape, the longer side of the strip of material is typically from about 3 cm to about 12 cm, preferably from about 3.1 cm to about 10 cm, more preferably from about 3.5 cm to about 8 cm, and most preferably from about 4 cm to about 6 cm. The short side is from about 0.1 cm to about 12 cm, preferably from about 0.5 cm to about 8 cm, more preferably from about 1 cm to about 5 cm, and most preferably from about 1.5 cm to about 3 cm. The width of the material strip also depends on many factors, including whether or not the material strip folds completely around and covers some or all of the anterior and posterior surfaces of the teeth. 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.

PL 194 880 B1

The strip of material serves as a protective cover, essentially to prevent saliva from coming into contact with the tooth whitening substance and the leaching and / or erosion of the tooth whitening substance from the tooth surface, through the lips, tongue and other soft tissues of the user. In order to maintain the activity of the tooth whitening substance to act on the tooth surface for extended periods ranging from several minutes to several hours, it is important to minimize such washout and / or erosion. The term acts on the meaning herein as causing the desired change. For example, if the substance is tooth whitener, it will whiten colored bodies in order to whiten them.

The strip of material can contain substances such as polymers, natural and synthetic woven materials, nonwovens, foil, paper, rubber, and combinations thereof. The strip of material can be a single layer material or a laminate having more than one layer. Typically the strip of material is substantially water impermeable. The material can be any type of polymer that meets the flexural stiffness requirements and is compatible with tooth whitening active ingredients such as peroxide. The material may consist of a single polymer or a mixture of polymers. Suitable polymers include, but are not limited to, polyethylene, ethylene vinyl acetate, ethylene vinyl alcohol, polyesters such as Mylar® manufactured by DuPont, fluoroplastics such as Teflon® manufactured by DuPont, and combinations thereof. Preferably, the material is polyethylene. The strip of material generally has a thickness of less than 1 mm, preferably less than about 0.05 mm, and more preferably from about 0.001 mm to about 0.03 mm. The thickness of the polyethylene strip of material is preferably less than about 0.1 mm, and more preferably from about 0.005 mm to about 0.02 mm.

The strip of material may include shallow pockets. When the substance is applied to the side of the strip of material coated with the substance, additional substance fills the shallow pockets which then act as a reservoir of additive substance. In addition, the shallow pockets help to give texture to the power pack. The foil preferably has an array of shallow pockets. Typically the shallow pockets have a transverse dimension of approximately 0.4 mm and a depth of 0.1 mm. When shallow pockets are included in the strip of material, and when a layer of material of different thicknesses is applied to the strip, the overall thickness of the feed assembly is typically less than about 1 mm. Preferably, the overall thickness is less than about 0.5 mm.

Flexural stiffness is a material property that is a function of the combination of the strip thickness, its width, and the material's modulus of elasticity. This test is a method of measuring polyolefin film stiffness and stretching. It determines the resistance to bending of the sample by using a strain gauge attached to the end of a horizontal beam. The opposite end of the beam presses transversely on the sample strip to force the strip into a vertical groove in the horizontal plate on which the sample rests. A microammeter wired to a strain gauge is calibrated in grams of deflection force. The stiffness of the sample is read directly from the micro-ammeter and is expressed in grams per centimeter of width of the sample strip. In accordance with the present invention, the flexural stiffness of the strip of material is less than about 5 g / cm as measured with a Handle-O-Meter, model # 211-300 supplied by Thwing-Albert Instrument Co. of Philadelphia, PA in accordance with ASTM D2923-95. Preferably, the strip of material has a flexural stiffness less than about 4 g / cm, more preferably less than 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, a strip of material does not need to be hydrated in order to achieve a low flexural stiffness value within the ranges specified above.

This relatively low stiffness allows the strip of material to cover the shaped surfaces of the teeth with a very low pressure force, i.e., the curvature of the strip-engaging mouth and the gaps between adjacent teeth are kept in line with the material strip having a small residual force which causes the strip to return. to its substantially flat shape. The elasticity of the strip allows the strip of material to contact the adjacent soft tissue for an extended period of time without physical irritation. The strip of material does not require any pressure on the teeth during molding.

The strip of material is held in place on a plurality of adjacent teeth by the adhesive force of the substance. The viscosity and overall tackiness of the substance causes the strip of material to adhere adhesively to a plurality of adjacent teeth without significant slippage due to potential friction from lips, tongue, and other soft tissues rubbing against the strip of material during mouth movement while speaking, drinking, and the like. However, adhesion to the teeth is sufficient

It is small to allow easy removal of the power pack by the user of the power pack by tearing off a strip of material with one of the fingers or a fingernail of the hand. The supply kit is easy to remove from the tooth surfaces without the use of a jig, chemical solvent or excessive friction. Chemical solvents include any organic solvents commonly used in mouth care products, such as alcohol, and other safe solvents, such as water, that can be used to dilute the thickening agent. Excessive friction is described as any type of rubbing with one of the fingers or a soft instrument such as cotton balls, a swab, or gauze pads.

The peel force required is only from about 1 g to about 50 g per 1.5 cm wide strip (approximately 17 g / cm). Preferably, the peel force is from about 5 g to about 40 g and more preferably from about 10 g to about 30 g. Low peel force is desired for consumer handling purposes. It is possible to apply a low peel force due to the non-aggressive nature of the gel substance. Only when the flexural stiffness of the strip is low, the adhesion of the substance may also be low. The adhesion of the stiffer belt should be greater than that of the belt in order to prevent the belt from returning to its flat shape and detaching itself from the multi-tooth shaped surface.

The strip of material can be formed using several manufacturing processes known in the art. Preferably, the polyethylene strip of material is made by a blowing or pouring process. Also applicable are processes such as extrusion and other processes that do not affect the flexural stiffness of the strip of material. Additionally, the substance can be incorporated into the strip during its manufacture. The substance may be a laminate on a strip.

A tooth whitening substance is a composition, compound or mixture capable of influencing or causing a desired change in the appearance and / or surface texture that is in contact with the substance. Examples of changes in appearance and structural changes include, but are not limited to, whitening, whitening stains, removing stains, removing plaque, and removing tartar. Preferably, the active ingredient is for whitening the surface of a tooth.

The strip of material may be coated with a tooth whitening material, the tooth whitening material may be applied by the user, or may be applied by the user to the user's teeth, and then the strip may be applied to the covered teeth. The amount of material applied to the strip of material or the teeth will depend on the size and capacity of the piece of material, the concentration of the active ingredient, and the desired benefit. Typically, less than about 1 gram of substance is required. Preferably, from about 0.05 g to about 0.5 g of material is used, more preferably from about 0.1 g to about 0.4 g of material. The amount of substance per square centimeter of material is less than about 0.2 g / cm, preferably from about 0.005 g / cm to about 0.1 g / cm, and more preferably from about 0.01 g / cm to about 0.04 g / cm. cm².

The substance according to the invention may be in the form of a viscous liquid, paste, gel, solution or any other form which will provide adequate adhesion. Preferably, the substance is in the form of a gel. The viscosity of the substance should be from about 200 cps to about 1,000,000 cps at low shear rates (less than one 1 / s). Preferably, the viscosity ranges from about 100,000 cps to about 800,000 cps, and more preferably from about 400,000 cps to about 600,000 cps.

Bleachable actives include any material that is safe for use in the oral cavity and that bleaches or removes stains. The bleachable actives are selected from the group consisting of peroxides, metal chlorates, perborates, percarbonates, peracids, and combinations thereof. Suitable peroxides include hydrogen peroxide, calcium peroxide, carbamide peroxide, and mixtures thereof. Carbamide peroxide is most preferred. Suitable metal chlorates (III) include calcium chlorate (III), barium chlorate (III), magnesium chlorate (III), lithium chlorate (III), sodium chlorate (III) and potassium chlorate (III). Additionally, active substances for bleaching can be chlorates (I) and chlorine (IV) oxide. The preferred chlorate (III) is sodium chlorate (III).

The weight proportion of the active ingredient in the tooth whitening substance is from about 0.01% to about 40%. If a peroxide is selected as the active ingredient, the weight fraction of peroxide in the tooth whitening substance, based on hydrogen peroxide, should be from about 0.1% to about 20%, preferably from about 0.5% to about 10%, and most preferably from about 1% to about 7%. To provide this amount of hydrogen peroxide equivalent, the weight fraction of the bleach substance

The tooth composition of a peroxide such as carbamide peroxide is from about 0.1% to about 30%, and preferably from about 3% to about 20%.

The active ingredients are usually contained in a water gel. A gel is a high viscosity base made of a gelling agent known in the art. These gelling agents are safe for oral use, are not readily soluble in saliva, and do not react with or inactivate the mouth care compounds incorporated therein. Typically, the gelling agent is a swellable polymer. Moreover, the gel formed by these means gives the film material sufficient adhesion to the target area in the mouth. The level of weight fraction of gelling agent in the tooth whitening material needed to form a gel composition is from about 0.1% to about 15%, preferably from about 1% to about 10%, more preferably from about 2% to about 8%, most preferably from about 0.1% to about 15%. about 2% to about 8%.

Suitable gelling agents for use in the present invention include carboxypolymethylene, carboxymethyl cellulose, carboxypropyl cellulose, poloxamer (polyoxyethylene polyoxypropylene glycol), carrageenan, veegum, carboxyvinyl polymers, and natural gums such as Karaya gum, Xantan gum, Xantan gum, Xantha gum. , gum tragacanth, and mixtures thereof. A preferred gelling agent suitable for use in the present invention is carboxypolymethylene supplied by BF Goodrich Company under the Carbopol tradename. Particularly preferred are Carbopol 934, 940, 941, 956 and mixtures thereof. Carbopol 956 is particularly preferred. Carboxypolymethylene is a weakly acid vinyl polymer containing active carboxyl groups. The normal water concentration of the various carboxypolymethylene resins is less than about 2% according to the manufacturer's information. However, it has been found that by preparing supersaturated carboxypolymethylene compositions whose total concentration is within the ranges defined above, oral gel compositions having a correspondingly high viscosity can be obtained.

In addition to their high viscosity, concentrated carboxypolymethylene gels have a number of important properties. In addition to the amount necessary to achieve high viscosity, a sufficient amount of carboxypolymethylene is added to the oral gel composition such that a substantial amount of saliva or water is required to lower the viscosity to the point where the composition can be diluted or washed out by saliva. The concentrated carboxypolymethylene composition also has a unique tack or viscosity that holds and seals the strip material against the target oral surface to which it is adhered, particularly the tooth surfaces. However, care should be taken to avoid using too much carboxypolymethylene, which can make insertion or removal of the strip of material difficult.

The gel compositions disclosed herein also include water. The water used in the present invention should preferably be deionized and free of organic impurities. The water content of the substance is from about 0.1% to 95% by weight, preferably from about 5% to about 90%, and most preferably from about 10% to about 80%. This amount of water includes free water that is added and water that is introduced with other substances.

A pH adjusting agent may also be added to optimize the storage stability of the gel and to make the substance safe for the tissues of the mouth. These pH adjusting agents or buffers can be any substances capable of adjusting the pH of the substance. Suitable substances include sodium bicarbonate, sodium phosphate, sodium hydroxide, ammonium hydroxide, sodium stannate, triethanolamine, citric acid, hydrochloric acid, sodium citrate, and combinations thereof. The pH adjusting agents are added in a suitable amount to adjust the pH of the gel composition to about 4.5 to about 11, preferably from about 5 to about 8.5, and more preferably from about 5.5 to about 7. Weight fraction of adjusting agents The pH of the substance is usually from about 0.01% to about 15% and preferably from about 0.05% to about 5%.

While the gel described above provides adequate adhesion, additional gelling agents can also be incorporated into the compositions to improve the adhesion of the active ingredients. Suitable agents include both polymers with limited water solubility and water-insoluble polymers. When saliva is combined with a prepared composition, these polymers deposit as a thin film on both the soft tissues of the oral cavity and the hard tissues. Suitable binders with limited water solubility include hydroxyethyl cellulose or hydroxypropyl cellulose. The water-insoluble binders include ethyl cellulose and polyoxy resins. Another possible binder which may be used in the prepared composition is polyvinylpyrrolidone with a weight of

The molecular weight range is from about 50,000 to about 300,000. Yet another possible binder suitable for use in the prepared composition is the combination of Gantrez and a semi-synthetic water-soluble polymer carboxymethylcellulose.

An additional carrier material can also be added to the substance. The carrier materials can be humectants. Suitable humectants include glycerin, sorbitol, polyoxyethylene glycol, propylene glycol, and other edible polyhydric alcohols. The weight fraction of humectants in the substance is usually from about 10% to about 95%, preferably from about 20% to about 80%, and more preferably from about 50% to about 70%. In addition to the above gel materials according to the invention, a variety of other ingredients can be added to the substance. These additional ingredients include, but are not limited to, flavorants, sweeteners, xylitol, opacifiers, colorants, and chelates such as ethylenediaminetetraacetic acid. These additional ingredients can also be used in place of the compounds disclosed above.

The release liner can be formed of any material that has a lower affinity for the substance than the substance has for itself and for the strip of material. The release liner is preferably a rigid sheet of material such as polyethylene, paper, polyester or other material to which the non-stick material is applied. The release liner material may be coated with wax, silicone, a polyester such as Teflon®, fluoropolymers, or other non-stick materials. A preferred removable insert is Scotchpak®, manufactured by the 3M Company. The removable liner may be cut to substantially the same size and shape as the strip of material, or its cut size may be larger than the size of the strip of material to provide a readily accessible means of separating the material from the strip. The removable insert may be formed of a frangible material that breaks when the strip is bent, either multiple pieces of material or a slit piece of material. Alternatively, the removable liner may be in the form of two overlapping pieces, of the adhesive plaster type. For a further description of removable media materials, see the Kirk-Othmer Encyclopedia of Chemical Technology, 4th Edition, Vol. 5 21, pages 207-218.

The strip of material is preferably a piece of polyethylene film 0.009 mm thick. The foil preferably has an array of flat pockets, typically 0.4 mm transversely and 0.1 mm deep. The material strip has a flexural stiffness of about 0.6 g / cm as measured with a Handle-O-Meter, model # 211-300 supplied by Thwing-Albert Instrument Co., Philadelphia, PA, in accordance with ASTM D2923- 95.

An example of a tooth whitener is a gel described as follows: 70% glycerin, 5% carboxypolymethylene, 10% carbamide peroxide and 15% water adjusted to pH 6.5 with sodium hydroxide were combined. The mixture was stirred until the mixture was homogeneous.

Additional examples of an alternative tooth whitening gel are described as follows:

Charge 8% carboxypolymethylene to approximately 84% water, then add 4% sodium hydroxide and sufficient sodium bicarbonate to adjust the pH to about 10. This mixture was dissolved in 3.75% sodium chlorate and stirred until until homogeneous.

60% glycerin, 4.5% carboxypolymethylene, and 5% hydrogen peroxide were combined. Sodium hydroxide (50% solution) was added until the desired pH was obtained, and then the remaining water was added. The mixture was stirred until the mixture became homogeneous.

Combine 56% glycerin, 6% carboxypolymethylene, 10% carbamide peroxide, and 24% water. 4% sodium hydroxide (50% solution) was added to achieve the desired pH value. The mixture was stirred until the mixture was homogeneous.

68% glycerin, 6% carboxypolymethylene, 22% carbamide peroxide, and 4% sodium hydroxide (50% solution) were combined. The mixture was stirred until the mixture was homogeneous.

25% glycerin, 69.7% water, 2% Xantan gum, 3% carboxymethyl cellulose, and 0.3% carbamide peroxide were combined. The mixture was stirred until the mixture was homogeneous.

24% Poloxamer, 20% glycerin, 46% polyoxyethylene glycol, and 10% carbamide peroxide were combined. The mixture was stirred until the mixture was homogeneous.

Commercially available tooth whiteners such as Opalescence and Nu-Pro Gold are also suitable for use with the teeth whitening strip of the present invention.

In practicing the present invention, the user applies a strip of material to the teeth. The tooth side of the material is coated with a tooth whitening substance which is preferably

In a viscous state to deliver not only the active ingredient between the surfaces of the teeth and the strip of material, but also to create a viscous state between the surfaces in order to keep the strip in place for an extended period of time. Alternatively, the user may apply a tooth whitening substance to the teeth or the belt to the teeth prior to applying the tooth strip. The strip of material readily conforms to the teeth by lightly pressing the strip towards the teeth and / or by being gently sucked by the user between the gaps in the teeth. The strip of material is easily removed by the user by tearing it off. Preferably, a fresh strip of material should be used with each subsequent treatment.

There is no need to prepare the tooth surface before using the tooth whitening strip. For example, before applying the strip, the user may or may not choose to brush his teeth or rinse his mouth. It is not required that the tooth surfaces be dry or excessively wetted with saliva or water before a strip of material is applied to them.

Preferably, the strip of material and the substances are substantially transparent so as to be almost imperceptible when applied. The thinning of the assembly allows the higher temperature inside the user's mouth to cause heat to pass through the strip of material to the typically cooler teeth to accelerate the diffusion rate of the active ingredient into the tooth surfaces.

Preferably, a user applies the belt of the present invention to the teeth continuously for a period of from about 5 minutes to about 120 minutes throughout the day, preferably from about 30 minutes to about 60 minutes. Typically, this is done once a day for a period of 7 to 28 days. The amount of time and the number of days depend on a number of factors, including the number of whitening operations required, the user's teeth, and whether initial or maintenance whitening is required. Bleaching is performed to achieve a whitening improvement in the 1-4 range as measured by VITA LUMIN® Vacuum Farbskala Shade Guides, a product of VITA Zahnfabrik, of BadSackingen, Germany.

When the user removes the strip of material from the teeth, some substance may remain on the surface of the teeth. This residual amount should not be large, since the tooth whitening substance has an affinity for both the foil and itself. If substance residues remain on the teeth, they can be easily removed by brushing or rinsing.

While specific examples of the invention have been illustrated and described, it will be apparent to those skilled in the art that various changes and modifications can be made without departing from the spirit and scope of the invention, and all such modifications are within the scope of the invention.