Abstract:
Tooth whitening compound includes a whitener and a carrier selected for adhering the carrier and whitening composition to a user&#39;s teeth. The whitening compound may be applied by the method including painting, washing, sponging, coating, daubing, spraying, wiping, rubbing, and by any movement relative to a horizontal or vertical axis of the user&#39;s tooth. The whitening compound may be sufficiently viscous to adhere to a user&#39;s teeth, in use, without a mechanical retaining device. The whitening compound may be a semi-solid or a solid compound at ambient temperatures.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application is a continuation of Application No. PCT/US2003/017631, filed Jun. 5, 2003, which is incorporated herein by reference. 
         [0002]    This application relates to applicant&#39;s concurrently filed Application No. [applicant&#39;s ref. 7338-US], entitled “METHOD AND APPARATUS FOR TOOTH WHITENING”, filed Dec. 5, 2005, and which is incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0003]    The invention relates to systems and methods for treating teeth. More specifically, the invention relates to a system (e.g., a novel delivery system) for delivering a tooth whitener to a tooth and a method for whitening teeth. The invention likewise relates to a system and method for whitening teeth without the use of a mouth tray or other retaining device of the type which retains the tooth whitener in place against the teeth during use. 
       BACKGROUND OF THE INVENTION 
       [0004]    Tooth whiteners are known. Conventional tooth whiteners are laborious, unwieldy, and expensive. 
         [0005]    Conventional tooth whitening methods are complicated and expensive, and, hence, are limited to a small portion of the population. 
         [0006]    In one typical method, the user whose teeth are to be whitened must first visit a dentist in order to have a mouth tray made which is molded to fit that user&#39;s teeth from a cast made from an impression. 
         [0007]    After the conventional steps of producing the mouth tray have been completed, then the mouth tray is given to the user, along with the tooth whitening compound(s). 
         [0008]    In some tooth whitening methods, the user then takes the tooth whitening compounds home, and uses them in conjunction with the mouth tray in the privacy of his or her home. 
         [0009]    In use, the mouth tray is at least partially filled by the user with the tooth whitening compound provided by the dental practitioner. 
         [0010]    The user must then take the proper mouth tray for the respective upper or lower jaw and press the mouth tray filled with whitening compound up (or down) against the teeth to be whitened. 
         [0011]    The user then holds the mouth tray filled with the compound in place against the teeth for a specified period of time. 
         [0012]    After the specified period of time, the user removes the mouth tray and the bulk of the compound, and discards the used whitening compound. 
         [0013]    Typically, the whitening procedure is a multi-day procedure. 
         [0014]    U.S. Pat. No. 5,879,691 to Sagel et al. discloses a delivery system for a tooth whitener using a strip of material having low flexural stiffness. 
         [0015]    Some known conventional whitening methods (e.g., the type of methods that utilize either a traditional tray or an adhesive strip) require that the whitening compound be forced on the gingival tissue in the region adjacent to the teeth to be whitened. That forcing whitening compound on the gingival tissue may result in a burning sensation to that tissue. 
         [0016]    Many known whitening compounds have the drawback that they dry out the teeth, in use, owing to the whitening compounds drawing moisture out of the teeth. Such dried out teeth are more sensitive to hot and cold. Accordingly, many prior art whiteners required desensitizers (desensitizing compounds) so that the patients would not be bothered by their temperature-sensitive dried out teeth. 
       OBJECTS AND SUMMARY OF THE INVENTION 
       [0017]    It is an object of the invention to overcome the drawbacks of the prior art methods, compounds, and devices. 
         [0018]    A further object of the invention is to provide a tooth whitening method that is easier to use, more cost effective, and available to a greater percentage of the population. 
         [0019]    A still further object of the invention is to provide a tooth whitening method that eliminates the need for mouth trays which fit the respective upper and lower sets of teeth in the user&#39;s mouth for retaining the whitening compound against the teeth to be whitened, as in the conventional methods. 
         [0020]    Yet another object of the invention is to allow the whitening compound to adhere to the user&#39;s teeth, thus eliminating entirely the need for a mouth tray to retain the tooth whitening compound. 
         [0021]    Yet another object of the invention is to provide a tooth whitening method which is easier to use than the known methods. 
         [0022]    Another object of the invention is to provide a tooth whitening system and method which dries out the user&#39;s teeth less than conventional whitening methods, so that the use of tooth desensitizing agents in the whitening compound may be reduced or eliminated. 
         [0023]    A further object of the invention is to provide a tooth whitener system and method that directly applies a whitening agent onto the surfaces of the user&#39;s teeth, thus eliminating the need for any type of tray or other mechanical retention device to retain the whitening agent on the surfaces of the teeth. 
         [0024]    Another object of the invention is to provide a whitener delivery system which reduces or eliminates the discomfort or burning sensation of the user&#39;s gingival tissue that may occur when using prior art delivery systems. 
         [0025]    Yet another object of the invention is to provide a tooth whitening system in which the whitening compounds are applied substantially directly to the facial and labial surfaces of the teeth to be whitened. 
         [0026]    Another object of the invention is to provide a tooth whitening system and method which reduce or eliminate the annoyance and inconvenience of using and wearing pre-made trays or adhesive-strip type products. 
         [0027]    A still further object of the invention is to provide a tooth whitening system and method which are more effective than known over-the-counter whitening methods requiring the use of boil-and-bite type trays that do not fit the teeth properly and, hence, are often ineffective and result in less than desirable tooth whitening. 
         [0028]    In summary, the invention provides a tooth whitening method which can be performed without the use of a mouth tray for retaining a tooth whitening compound against the user&#39;s teeth. 
         [0029]    It is another object of this invention to have a delivery system where the whitening compound is directly applied onto the tooth in a solid or semi-solid state. The whitening compound may be applied in a manner similar to the use of a tube of lipstick. 
         [0030]    It is further object of the invention to have the whitening compound in a dispenser, which can be utilized without the use of a mirror and without the need for the user to hold the lips away from the teeth any longer than it takes to apply the whitening compound onto the tooth. 
         [0031]    It is a further object of the invention to eliminate the need for whitening mouth trays, applicator brushes, and bottles which hold the whitening compound. 
         [0032]    In summary the invention pertains to delivering a whitening compound against the tooth surface in a solid/semi-solid state in a device resembling a tube of lipstick or a mechanical pencil design. 
         [0033]    It should be understood that relative terms such as up, and down are for convenience only and are not intended to be limiting. 
         [0034]    It should likewise be understood that throughout the specification the features and advantages described in connection with the tooth whitening system apply equally to the features and advantages of the method of whitening teeth described herein. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0035]      FIG. 1  is an elevational view of a tooth whitening system according to the invention; 
           [0036]      FIG. 2  shows the applicator of  FIG. 1  in use; 
           [0037]      FIG. 3  shows a first layer or whitening agent as applied to the user&#39;s teeth, which is a cross sectional view of teeth taken along line  3 - 3  of  FIG. 2 ; 
           [0038]      FIG. 4  illustrates a further container for use with a further embodiment of a tooth whitening system according to the invention; 
           [0039]      FIG. 5  is a cross sectional view of a user&#39;s incisor with a whitening layer on the front surface of the tooth; 
           [0040]      FIG. 6  illustrates a user&#39;s molar with a whitening layer on the front and lower face of the tooth; 
           [0041]      FIG. 7  shows a further embodiment of an applicator for use with the systems according to the invention; 
           [0042]      FIG. 8  shows a still further embodiment of an applicator for use with the systems according to the invention; 
           [0043]      FIG. 9  is a front perspective view of the applicator of  FIG. 8 ; 
           [0044]      FIG. 10  shows another applicator according to the invention; 
           [0045]      FIG. 11  shows the  FIG. 10  applicator, in use; and 
           [0046]      FIG. 12  shows another applicator according to the invention. 
       
    
    
       [0047]    The term painting is intended to cover all manner of applying a layer of the whitening compound to a tooth, the term painting including, but not limited to brushing, sponging, coating, daubing, spraying, wiping, rubbing, and applying by movement relative to the tooth (i.e., any movement relative to a vertical or horizontal axis of a tooth) yielding a layer of whitening compound on the tooth. The movement relative to the tooth is not intended to be limited to movement toward and away from the gum. For example, spraying and daubing may be carried out with little or essentially no movement along an axis that is at an acute angle relative to the longitudinal axis of the tooth (e.g., a central, substantially vertical axis of a user&#39;s tooth). 
       DETAILED DESCRIPTION OF THE INVENTION 
     FIGS.  1 - 9   
       [0048]      FIGS. 1-3  illustrate an embodiment of a tooth whitening delivery system  10  according to a first preferred embodiment of the invention. 
         [0049]    Tooth whitening system  10  includes a container  14  for holding a whitening agent or first whitening compound  60 . Container  14  may be provided with a resealable opening  16  for repeated access to the inside and, hence, the contents of container  20 . 
         [0050]    A brush  20  having a handle  24  and bristles  26  may be provided for applying the whitening agent held in container  20 . 
         [0051]    Bristles  26  may be configured for being held by a user when applying the whitening agent to the user&#39;s teeth by use of bristles  28 . 
         [0052]    Container  20  may be disposable, or may take another form, as described below. 
         [0053]      FIG. 3  illustrates the user&#39;s or user&#39;s jaw  40  including an upper jaw  44  and a lower jaw  48 . 
         [0054]    Teeth  50  include an outer surface  52  and a corresponding inner surface  54 . 
         [0055]    In some cases, only outer surface  52  will be whitened by use of the whitening agent  60 , as it is outer surface  52  which is visible when the user&#39;s lips are drawn back exposing teeth  50 . 
         [0056]      FIG. 2  illustrates how brush  20  is applying the whitening agent on outer surface  52  of teeth  50 . It should be noted that bristles  28  may be configured and sized so as to reach all exposed surfaces of teeth  50 . Preferably, the viscosity of compound  60  is selected so that the whitening agent  60  may be applied directly to all the exposed tooth surfaces which the user desires to whiten. In use, the user may dispense, such as by painting on, a desired quantity of whitening compound  60 , holding brush  20  as shown in  FIG. 1 , and apply sufficient pressure to force whitening compound  60  into crevices  62 , for example, as desired. One or more teeth  50  may have whitening compound  60  applied to them. 
         [0057]    A single coat or multiple coats or layers of whitening agent  60  may be applied. 
         [0058]    Whitening agent  60  is formulated so that it need not be covered, in use, by a device, such as a tray or tape, as the formulation is selected so that the whitening agent  60  adheres to the user&#39;s teeth. 
         [0059]      FIGS. 2 and 3  illustrate the manner in which the whitening agent  60  or the bristles  26  or both are selected so that whitening agent or first layer  60  extends into the exposed crevices  62  between teeth  64 , for example.  FIG. 3  shows whitening agent  62  applied to the outer surfaces  52  of tooth  64 . 
         [0060]    Whitening agent  60  of  FIGS. 1-3  has been successfully used with only one layer of compound  60  as the whitening agent. Of course, the user may apply a thin layer  108  of compound  60 , and then apply more whitening compound  60  to thicken the initial layer, yet both “layers” would be, in effect, a single thicker layer of the same compound  60 . In use, there was no apparent burning or ill effects of whitening agents  60  when whitening agent  60  contacted the mouth tissue. 
         [0061]      FIGS. 4-6  illustrate another preferred embodiment of a whitening system  100  according to the invention. Whitening system  100  includes a container  104  having an opening  106  for providing access to the contents of container  104 . 
         [0062]      FIG. 5  illustrates how one of a user&#39;s incisors  124  is whitened. In the case of incisor  124  the whitening agent  108  may be applied only to the outer surface  52  of incisor 
         [0063]    Typically, a user will find it unnecessary to whiten the inner surfaces  54  of his or her incisors  124 , as the inner surfaces of the user&#39;s incisors  124  are rarely visible to others, for example. 
         [0064]      FIG. 6  illustrates the case where a user would like to whiten the outer surface  52  as well as the lower surfaces of his or her teeth, such as an illustrated molar  64 . In that case, whitening agent  108  is applied to outer surface  52  as well as to the lower surface of the illustrated upper molar  64 . 
         [0065]    In the case where the user would like to whiten the inner surface  54  of molar  64 , the whitening agent  108 , will be applied to inner surface  54  of the molar. 
         [0066]      FIG. 7  illustrates another preferred embodiment of an applicator  150 , according to the invention. 
         [0067]    Applicator  150  includes a handle  154  and a material  156  disposed at one of its ends. The material  156  may be a soft absorbent material such as cotton, and applicator  150  may take the form of a cotton swab. 
         [0068]    Applicator  150  may be disposable. Applicator  150  may be a cotton swab such as a Q-TIP® brand cotton swab. 
         [0069]      FIGS. 8 and 9  illustrate yet another preferred embodiment of an applicator  170  according to the invention. 
         [0070]    Applicator  170  includes a handle  174  and a material  176  disposed at one of its ends. 
         [0071]    Material  176  may be shaped to conform to the shape of the surface of tooth  50  to enhance the application of whitening agent on tooth  50 . 
         [0072]    Material  176  may be made of a foam material, such as cellular foam. 
         [0073]    Applicator  170  may be disposable, in a manner similar to the other applicator embodiments. 
         [0074]    The embodiments of  FIGS. 7-9  may be used with either of the dispensers of  FIGS. 1-3  or  FIGS. 4-6 . In such a case, the user may dispense a desired quantity of solid whitening agent or semi-solid whitening agent  60  or  108  or  110  (or one or more of agents  60  and  108  and  110 ) onto applicator  150  or  170 , respectively, for example. 
         [0075]    The viscosity of one or more of whitening agents  60 , 108  may be varied depending on the intended use, as described in detail below. 
         [0076]    It is contemplated that in any of the embodiments of  FIGS. 1-9  any suitable viscous, solid or semi-solid whitening agent may be used that can whiten without irritating the mouth tissues. 
         [0077]    In a preferred embodiment of the invention, whitening agent  60  may have the following range of compositions. 
         [0000]    
       
         
               
             
               
               
               
               
             
           
               
                   
               
               
                 WHITENING AGENT COMPOSITION A2 
               
               
                 (to yield 100 ml of composition) 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Ethanol (ethyl alcohol) 
                 balance 
                 ml 
               
               
                   
                 Urea Peroxide 
                 .001-40 
                 g 
               
               
                   
                 Resin 
                 .001-30 
                 g 
               
               
                   
                 Hydroxyl propyl cellulose 
                 .001-20 
                 g 
               
               
                   
                 total 
                 100 
                 ml 
               
               
                   
                   
               
             
          
         
       
     
         [0078]    A further preferred embodiment of the whitening agent follows. 
         [0000]    
       
         
               
             
               
               
               
               
             
           
               
                   
               
               
                 WHITENING AGENT COMPOSITION A4 
               
               
                 (total yield 100 ml of composition) 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Ethanol (ethyl alcohol) 
                 balance 
                 ml 
               
               
                   
                 Urea Peroxide 
                 8 
                 g 
               
               
                   
                 Resin 
                 10 
                 g 
               
               
                   
                 Hydroxyl propyl cellulose 
                 .5 
                 g 
               
               
                   
                 total 
                 100 
                 ml 
               
               
                   
                   
               
             
          
         
       
     
         [0079]    Whitening agent  110  of composition A3 may be made with 100% pure undenatured ethyl alcohol and 98% pure urea peroxide. 
         [0080]    Rosin may be substituted for resin in all formulas. 
         [0081]    Urea hydrogen peroxide may be substituted for urea peroxide in all formulas. 
         [0082]    Whitening agents may be formulated as follows: 
         [0000]    
       
         
               
             
               
               
               
               
             
           
               
                   
               
               
                 WHITENING AGENT COMPOSITION A5 
               
               
                 (total yield 100 ml of composition) 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Rosin 
                 .001-30 
                 g 
               
               
                   
                 Urea hydrogen peroxide 
                 .001-40 
                 g 
               
               
                   
                 Hydroxypropyl cellulose 1500 cps 
                 .001-20 
                 g 
               
               
                   
                 Ethyl alcohol (95%) 
                 balance 
                 ml 
               
               
                   
                 Total Volume 
                 100 
                 ml 
               
               
                   
                   
               
             
          
         
       
     
         [0083]    The following is an example of a tooth whitening compound that has been formulated in accordance with the invention. 
         [0084]    The following is the formulation of a procedure for making 100 ml of a Solution No. 16. 
         [0085]    In the following formula, the resin, the urea hydrogen peroxide USP, and the hydroxypropyl cellulose 1500 cps are all expressed as a weight per volume (w/v; i.e., g/100 ml) and the ethanol 95 was added in a quantity as needed (q.s.) to yield the desired 100 ml of whitening agent. 
         [0000]    
       
         
               
             
               
               
               
               
             
           
               
                   
               
               
                 WHITENING AGENT COMPOSITION OF SOLUTION NO. 16 
               
               
                 (total yield 100 ml of composition) 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Rosin 
                 12.5 
                 g 
               
               
                   
                 Urea hydrogen peroxide 
                 8.0 
                 g 
               
               
                   
                 Hydroxypropyl cellulose 1500 cps 
                 0.5 
                 g 
               
               
                   
                 Ethyl alcohol (95%) 
                 balance 
                 ml 
               
               
                   
                 Total Volume 
                 100 
                 ml 
               
               
                   
                   
               
             
          
         
       
     
         [0086]    Solution No. 16 was formulated as follows to yield 100 ml of product:
       1. Dissolve 12.5 g of resin in 75 ml of the ethanol in a beaker having a spin bar therein;   2. The spin bar was spun using the spinning device (stirrer) of an unheated hot plate of the type having a magnetic stirrer disposed therein, the spinning was continued until the unheated rosin and ethanol solution was clear;   3. 8 g of the urea hydrogen peroxide were weighed out and ground into a fine powder using a mortar and pestle, added to the rosin and ethanol solution, and then stirred on the spinning device. A cloudy solution resulted.   4. As the rosin and ethanol solution was spinning, the 0.5 g of hydroxypropyl cellulose was added gradually (sprinkled into the vortex of the spinning solution resulting from the magnetic stir bar) in small amounts at a time. The spinning was continued for about an hour until the solution began to gel. Enough ethyl alcohol (95%) was added q.s. to bring the volume up to 100 ml, and the spinning was continued.   5. The mixed solution was put in a refrigerator (at about 40° F.) and left overnight (i.e., about 19-20 hours) to allow the solution to completely hydrolyze.   6. The refrigerated solution was removed from the refrigerator and again spun at room temperature at about 70° F.) for about 30 minutes to thoroughly mix the solution.
           The prepared solution was then put into the desired containers.   
               
 
         [0094]    It should be noted that in Step 4 of spinning the solution having the rosin, the urea hydrogen peroxide 1500 cps, and the hydroxypropyl cellulose, the added materials may not thoroughly dissolve. It appears that the step of allowing the solution to sit overnight in the refrigerator for a period of time, and then remixing the solution succeeds in yielding a homogeneous solution with the added materials dissolved and dispersed throughout. 
         [0095]    The following is the formulation of a Solution No. 18 that has been made. 
         [0000]    
       
         
               
             
               
               
               
               
             
           
               
                   
               
               
                 WHITENING AGENT COMPOSITION OF SOLUTION NO. 18 
               
               
                 (total yield 60 ml (i.e., 51.43 g) of composition) 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Rosin 
                 7.5 
                 g 
               
               
                   
                 Urea hydrogen peroxide 
                 3.6 
                 g 
               
               
                   
                 Hydroxypropyl cellulose 1500 cps 
                 0.3 
                 g 
               
               
                   
                 Ethyl alcohol (95%) 
                 40.0 
                 g 
               
               
                   
                 Spearmint Extract (1 drop) 
                 0.03 
                 g 
               
               
                   
                 Total Weight 
                 51.43 
                 g 
               
               
                   
                   
               
             
          
         
       
     
         [0096]    Thus, Solution No. 18 can be expressed on a weight per weight (w/w) basis of about 14.6% rosin; 7.0% urea hydrogen peroxide; 0.6% hydroxypropyl cellulose 1500 cps; 77.8% ethyl alcohol; and 0.06% spearmint extract; the total is not exactly 100% owing to the rounding of the percentages to one (1) significant digit. 
         [0097]    Solution No. 18 was prepared in a manner analogous to that as described above in connection with the preparation of Solution No. 16. 
         [0098]    It will be seen that the achievement of a tooth whitening delivery system has been realized that provides for directly applying a whitening agent onto the surfaces of the teeth, thus eliminating the need for any type of tray or other type of carrier. 
         [0099]    In other words, the invention achieves the object of an elegantly simple solution to the problem of expensive laborious and unwieldy tooth whitening systems that made such unavailable to the vast majority of the user population. 
         [0100]    The tooth whitening system achieves the goal of applying and retaining a whitening agent against the user&#39;s teeth without the need for a mouth tray or other retaining wall or retaining means that had previously been necessary. 
         [0101]    The method may be carried out without the use of a mouth tray, mold, or other retaining wall for keeping the whitening agent in place against the teeth. Such trays have previously been required to protect the soft mouth tissue as well. 
         [0102]    The whitening compound in one basic form includes a combined carrier that adheres to the user&#39;s teeth, and a whitening agent. 
         [0103]    The inventive method eliminates the traditional use of any form of mouth trays for teeth whitening. 
         [0104]    The invention further includes a teeth whitener having a novel carrier that temporarily adheres to the tooth for the purpose of whitening the tooth with or without a desensitizing agent. 
         [0105]    The tooth whitener is bound in the resin and is released or is activated by moisture or water from the mouth (i.e., from the saliva in the mouth) rather than by the tooth structure itself. It is believed that owing to the whitening compound being released throughout the thickness of the applied resin, the active layer is against the tooth being whitened, which tooth is buried in the resin. The hydrogen peroxide or peroxide compound against the mouth tissue is neutralized or broken down by the water in the saliva. In that manner, the tissue is unharmed. 
         [0106]    It has been observed that the whitening compound is released (activated throughout the resin for a period of about or about 10-30 minutes). This is seen as an effervescing over the coated tooth surfaces. This can be easily removed by brushing; and additional application(s) of the whitening compounds may be applied. It may be that the whitening compound is activated (released) against the tooth surfaces for a much longer time than the time period during which the effervescence is observed. 
         [0107]    The following formulations are in accordance with the invention. 
         [0108]    A whitening compound suitable for applying to teeth may comprise by weight percent: 
         [0000]    
       
         
               
             
               
               
               
             
           
               
                   
               
               
                 WHITENING AGENT COMPOSITION D1 
               
               
                 A further whitening compound may comprise in weight percent: 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 a) 
                 Ethyl Alcohol 95% is about 15-85% (e.g., 76.36%); 
               
               
                   
                 b) 
                 Synthetic Resin (FORAL NC) is about .001-65% 
               
               
                   
                   
                 (e.g., 13.76%); 
               
               
                   
                 c) 
                 Urea Hydrogen Peroxide or PVP Hydrogen Peroxide is 
               
               
                   
                   
                 about .001-45% (e.g., 8.81%); 
               
               
                   
                 d) 
                 Hydroxypropylcellulose (KLUCEL HF PHARMA) is about 
               
               
                   
                   
                 .001-20% (e.g., .55%); 
               
               
                   
                 e) 
                 Peppermint Oil is about .001-5% (e.g., .15%); 
               
               
                   
                 f) 
                 Menthol is about .001-5% (e.g., .22%); and 
               
               
                   
                 g) 
                 Aspartame ® is about .001-5% (e.g., .15%). 
               
               
                   
                   
               
             
          
         
       
     
         [0109]    Peppermint Oil, Menthol, and Aspartame® all only used for flavoring and do not affect the efficacy of the product. Resin compound can be easily brushed off or it will wear off after several hours. 
         [0110]    Ethyl Alcohol suppliers may include Chemisphere Corp., St. Louis, Mo., U.S.A; 
         [0111]    Synthetic Resin (FORAL NC) suppliers may include Hercules Chemical, PINOVA Division Brunswick, GA, U.S.A.; 
         [0112]    Urea Hydrogen Peroxide or PVP Hydrogen Peroxide suppliers may include Urea Hydrogen Peroxide from American International Chemical, Natick, Mass., U.S.A.; or PVP Hydrogen Peroxide from International Specialty Products, Wayne, N.J., U.S.A.; 
         [0113]    Hydroxypropylcellulose (KLUCEL HF PHARMA) suppliers may include Hercules Incorporated, Aqualon Division, Wilmington Del., U.S.A.; 
         [0114]    Peppermint Oil suppliers may include PCCA, Houston, Tex., U.S.A.; 
         [0115]    Menthol suppliers may include PCCA, Houston, Tex., U.S.A.; and 
         [0116]    Aspartame® suppliers may include PCCA, Houston, Tex., U.S.A. 
         [0000]    
       
         
               
             
               
               
               
             
               
               
               
             
           
               
                   
               
               
                 WHITENING AGENT COMPOSITION D1 
               
               
                 vs. 
               
               
                 CONVENTIONAL BRUSH-ON WHITENING PRODUCT 
               
             
          
           
               
                   
                 TOOTH 
                 CONVENTIONAL 
               
               
                   
                 WHITENING AGENT 
                 BRUSH-ON 
               
               
                   
                 COMPOSITION D1 
                 WHITENING PRODUCT 
               
               
                   
                   
               
             
          
           
               
                 Solution 
                 9% (by weight) 
                 3-4% Carbamide 
               
               
                   
                 Carbamide Peroxide 
                 Peroxide 
               
               
                   
                 (Urea hydrogen peroxide 
               
               
                   
                 or PVP Hydrogen 
               
               
                   
                 peroxide) 
               
               
                   
                 No Carbopol 
               
               
                   
                 No Glycerin 
               
               
                 Ease of 
                 Directly apply 
                 Must first dry 
               
               
                 Application 
                 to teeth 
                 teeth, 
               
               
                   
                   
                 Directly apply to 
               
               
                   
                   
                 teeth 
               
               
                 Mode of Action 
                 Resin overcoat/barrier 
                 Peroxide Gel which 
               
               
                   
                 which yields a 20%-30% 
                 leaves a goo residue 
               
               
                   
                 Peroxide releasing 
                 that is broken 
               
               
                   
                 whitening effect (once 
                 down once moisture 
               
               
                   
                 Alcohol is evaporated) 
                 comes in contact. 
               
               
                   
                   
                 DOES NOT ADHERE 
               
               
                   
                   
                 TO TEETH. 
               
               
                 Time of 
                 20 minute peroxide 
                 Breaks down after 
               
               
                 Effectiveness 
                 releasing compound - 
                 only 
               
               
                   
                 Sustained effervescence 
                 a few minutes once 
               
               
                   
                   
                 moisture contacts 
               
               
                   
                   
                 solution. 
               
               
                 Efficacy (Apply 2 
                 4 shades (up to 8) of 
                 Only 3.2 shades of 
               
               
                 times per day for 
                 whitening using value 
                 whitening 
               
               
                 14 days) 
                 oriented Vita shade 
               
               
                   
                 guide 
               
               
                   
               
             
          
         
       
     
       Superior Whitening Results 
       [0117]    Clinical study of inventive whitening agent obtained whitening results of up to 8 shades (average of 4 shades) in two weeks using a conservative protocol. Other brush-on whitening products do not adhere to the tooth for an extended period of time. These other conventional products typically wash off (wear off) the user&#39;s teeth within five minutes after application. Inventive whitening compound forms a precipitant on the tooth that releases peroxide for about 20 minutes. The conventional whitening product breaks down once moisture is in contact with the whitening compound. 
         [0118]    The preferred composition is composed of about 9% (by weight) Carbamide Peroxide in an alcohol base. Once the whitening composition is applied to the tooth, the alcohol evaporates leaving a precipitant that yields approximately 20%-30% carbamide. 
       Easier to Use 
       [0119]    As the inventive whitening compound utilizes a resin that forms a peroxide releasing precipitant which adheres to the tooth (even when moisture is present), there is no need to dry the teeth prior to use. In contrast, conventional agents use a gel-based compound that forms a “goo”-like layer on the teeth that is removed from the teeth when exposed to moisture. Thus, the user is required to carefully wipe the teeth dry prior to application. 
       Virtually No Tooth Sensitivity 
       [0120]    Based on clinical study using the inventive whitening compound, participants experienced little, if any, tooth sensitivity. In traditional whitening gels and methods, glycerin and the use of a tray to cover the harsh compound dehydrates the tooth thus causing sensitivity. As inventive product does not use a tray or other typical chemicals found in gels, tooth sensitivity will not be present. In the clinical study of the conventional product compared above, tooth sensitivity is similar to other whitening products. 
       Better Chemical Composition 
       [0121]    The inventive compound&#39;s coating, peroxide composition forms a film (resin) that adheres to the teeth. The film can easily be removed from the teeth by brushing or the film will wear off after about 3-4 hours. In contrast, the conventional product compared above uses a chemical composition similar to other gel-based whitening products. 
       Alternative Embodiment of Whitening Compound 
       [0122]    A small heat-emitting hand-held “pen light” may be used to further activate the whitening compound. This light would be used by the user and need not be used by a dentist or other professional to perform this function. Such allows for the resin to be applied in a manner that will create a semi-solid and form a thicker film over the user&#39;s teeth. The user would apply this at night, for example, and brush the whitening compound off in the morning. The peroxide compound may be the heat-actuated whitening agent in this case. 
         [0123]    The resin will create a thick film on the user&#39;s tooth allowing the whitening agent to be released for an extended period of time of about 40 minutes. That extended release period allows the user to apply the whitening compound once per day and achieve the same whitening results as the other formulation. 
       Yet Another Embodiment Application of Whitening Compound 
       [0124]    As the inventive compound utilizes a resin to cause the whitening compound to adhere to the user&#39;s tooth, more resin can be used in the formulation, thus creating a thicker film on the user&#39;s tooth, which film will allow the whitening agent to be released on the tooth for approximately 20-40 minutes or more. This formulation could include: PEG 400, synthetic resin and urea hydrogen peroxide. 
         [0125]    The inventive method also comprises a novel active ingredient imbedded in or carried by a novel carrier that permits sustainable release of the active ingredient and that would be painted on or brushed on the tooth surface and would remain active for a period of time. 
         [0126]    The adhesive or resin may be synthetic or natural. The resin may be a rosin. 
         [0127]    The rosin may be a refined hydrogenated rosin such as supplied by Hercules Chemical, Pinova Division, Brunswick, Ga., U.S.A., as described above. 
         [0128]    The whitening agent may be any peroxide derivative or other chemical component that would whiten teeth. The whitening agent may be provided in varying concentrations depending on the carrier in which the agent is provided, as well as depending on the degree of whitening required, the physical properties of the teeth, and the like. For example, urea hydrogen peroxide, C.A.S. No. 124-43-6, supplied by Professional Compounding Centers of America of Houston, Tex. may be used as described above. 
         [0129]    Other known peroxides may be substituted for the above-described peroxides. 
         [0130]    Sodium bicarbonate may be substituted for peroxide(s) as the whitening agent. 
         [0131]    It is contemplated that the whitening compound will be selected so that the whitening agent and the carrier will yield a release of the whitening agent to the tooth surface over time. This optional time-release mechanism may be for less than a few minutes to ten (10) hours or more. 
         [0132]    The hydroxypropyl cellulose may be as supplied by Professional Compounding Centers of America, Houston, Tex.; e.g., hydroxypropyl cellulose 1500 cps, C.A.S. No. 9004-64-2, part no. 30-1996-100, Lot No. 26855, obtained in a 100 g lot, and used as described above. 
         [0133]    The spearmint oil may be Spearmint Oil N.F (i.e., National Formulary), supplied by Professional Compounding Centers of America (P.C.C.A.), Houston, Tex., Part No. 30-1178-30 used as described above. 
       Embodiments of FIGS.  10 - 12   
       [0134]      FIGS. 10 and 11  illustrate another embodiment of a tooth whitening delivery system  190  according to a first preferred embodiment of the invention. 
         [0135]    Tooth whitening system  190  includes a container  200  for holding a whitening agent or whitening compound  260 . Container  200  may be provided with a resealable opening  216  for repeated access to the inside and, hence, the contents of container  200 . 
         [0136]    An applicator body, such as the illustrated cylinder  226  may be provided for applying the whitening agent held in container  200 . 
         [0137]    Cylinder  226  may be configured for being held by a user when applying the whitening agent to the user&#39;s teeth. 
         [0138]    Container  200  may be disposable, or may take another form, as described below. 
         [0139]    When whitening agent  260  is in its semi-solid or solid state, such as at ambient temperature, a movable actuator  220  provided on body  200  my be actuated to dispense a desired quantity of whitening compound  260  from container  200 . For example, actuator  220  may be in the form of a rotatable actuator which rotates relative to cylinder  260  and forces an amount of whitening compound  260  out of container  200  as a function of the amount of rotation of actuator  22 . Body  200  and actuator  220  may be in the form of conventional lip balm dispenser or the type which dispenses solid lip balm at ambient temperatures. As shown, a quantity  228  of whitening compound  220  has been dispensed thanks to use of actuator  220 , and whitening compound  260  is being applied to a user&#39;s tooth (or teeth) in use. The embodiment of  FIGS. 10 and 11  may be used for dispensing viscous, solid or semi-solid tooth-whitening compound  260  according to the invention. The size and configuration of opening  216  may be varied depending on the intended use and the viscosity of the solid or semi-solid whitening compound to be dispensed, as will be readily appreciated. 
         [0140]    A cap  230  may be provided to cover opening  216  of container  200  when not in use. 
         [0141]      FIG. 11  illustrates the user&#39;s or user&#39;s jaw  40  including an upper jaw  44  and a lower jaw  48 . 
         [0142]    Teeth  50  include an outer surface  52 . 
         [0143]    Outer surface  52  is shown being whitened by use of the whitening agent  260 , as it is outer surface  52  which is typically visible when the user&#39;s lips are drawn back exposing teeth  50 . 
         [0144]      FIG. 11  illustrates how container  200  is used when applying the whitening agent on outer surface  52  of teeth  50 . It should be noted that exposed, dispensed quantity  228  of whitening compound  260  may be configured and sized so as to reach all exposed surfaces of teeth  50 . Preferably, the viscosity of compound  260  is selected so that the whitening agent  260  may be applied directly to all the exposed tooth surfaces which the user desires to whiten. In use, the user may dispense a desired quantity  228  of whitening compound  260 , hold container  200  as shown in  FIG. 11 , and apply sufficient pressure to force whitening compound  260  into crevices  262 , for example, as desired, in a manner analogous to that described above in connection with the other embodiments. One or more teeth  50  may have whitening compound  60  applied to them. 
         [0145]    A single coat or multiple coats or layers of whitening agent  260  may be applied. 
         [0146]    Whitening agent  260  is formulated so that it need not be covered, in use, by a device, such as a tray or tape, as the formulation is selected so that contact of whitening agent  260  with the mouth tissue causes little or no discomfort nor harm to the mouth tissue. 
         [0147]    Whitening agent  260  of  FIGS. 10-11  has been successfully used with only one layer of compound  260  as the whitening agent, as in the embodiments above. 
         [0148]      FIG. 12  illustrates another preferred embodiment of a whitening system  300  according to the invention. Whitening system  300  includes a container  304  having an opening  306  for providing access to the contents of container  304 . Additional openings  306  may be provided, depending on the intended use. 
         [0149]    Container  304  may be provided with a semi-solid viscous whitening material  308  which may differ in viscosity from the first material or whitening agent  260 . The second whitening material or compound  308  may be dispensed in the illustrated flexible container  304 , or may be dispensed in the typically relatively rigid container  200  of  FIGS. 10 and 11 . Threads  312  may be provided to detachably secure a cover for covering hole  306 . 
         [0150]    The second whitening material  308  may be applied to teeth  50  as follows. The user squeezes container  304  sufficiently so as to cause a desired quantity of semi-solid whitening agent  308  to exit opening  306 . 
         [0151]    Typically, a user will find it unnecessary to whiten the inner surfaces  54  of his or her incisors  124 , as the inner surfaces of the user&#39;s incisors  124  are rarely visible to others, for example. 
         [0152]    The embodiments of  FIGS. 7-9  may be used with any of the dispensers of  FIG. 1-6  or  10 - 12 . In such a case, the user may dispense a desired quantity of the respective solid whitening agent or semi-solid whitening agent (or agents) onto applicator  150  or  170 , respectively, for example. 
         [0153]    As will be appreciated, the viscosity of the whitening agent may be selected so that not only is the whitening agent semi-solid or solid at ambient temperatures, but the whitening agent is also at least semi-solid when applied to the users&#39; teeth in the mouth environment. The temperature of the mouth will typically be 37° C. (98.6° F.) 
         [0154]    In use, it is contemplated that the whitening compounds described herein may be applied by hand, such as by applying the whitener to a fingertip then daubing on the whitening compound with the user&#39;s fingertip(s). 
         [0155]    It is contemplated that in any of the above-described embodiments, any suitable viscous, solid or semi-solid whitening agent may be used that can whiten without irritating the mouth tissues. 
         [0156]    The solid or semi-solid whitening compound can be made in several ways. 
         [0000]    
       
         
               
             
               
               
               
             
           
               
                   
               
               
                 WHITENING AGENT COMPOSITION D2 
               
               
                 In one inventive embodiment the whitening compound may 
               
               
                 comprise in weight percent: 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Urea Peroxide 
                   15% 
               
               
                   
                 Rosin 
                   5% 
               
               
                   
                 Wax 
                 79.8% 
               
               
                   
                 Stevia Powder 
                  .15% 
               
               
                   
                 Peppermint Oil 
                 0.05% 
               
               
                   
                   
               
             
          
         
       
     
         [0157]    The urea peroxide and resin can be incorporated in a wax resin formulation and then pressed or extruded into the desirable shape and manufactured in the dispenser. 
         [0158]    The dispensing device would cause the whitening compound to protrude as a solid or semi-solid and the consumer would directly apply the solid or semi-solid compound onto the tooth surface in a manner similar to lip-stick. It may be desirable to provide several shapes and sizes of dispensers or applicators to apply whitening compound to the entire facial surface of the tooth and interproximal areas. If saliva on the tooth hinders the resin-wax whitening compound from sticking to the tooth surface a hydrophilic substance can be incorporated in the compound to absorb the moisture as the whitening compound is being applied. 
         [0159]    With this invention it will be unnecessary to dry the tooth prior to application and will be unnecessary to keep the lips and cheek away from the tooth surface immediately after application, unlike in prior art whitening compounds. 
         [0000]    
       
         
               
             
               
               
             
           
               
                   
               
               
                 WHITENING AGENT COMPOSITION D3 
               
               
                 Another whitening agent composition may comprise: 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Carbamide Peroxide AIC product code: RPLGC30025KBXH 
               
               
                   
                 AIC U.S.A. 
               
               
                   
                 RANGE: .01-30 gm 
               
               
                   
                 Foral NC - Hydrogenated Rosin 
               
               
                   
                 Hercules Chemical, U.S.A. 
               
               
                   
                 RANGE: .01-30 gm 
               
               
                   
                 Stevia 90% powder (sweetener) 
               
               
                   
                 JAJA - Allen Weber, U.S.A. 
               
               
                   
                 RANGE: .001-2.0 gm 
               
               
                   
                 Peppermint Oil 
               
               
                   
                 Rainbow Gardens, U.S.A. 
               
               
                   
                 RANGE: .001-2.0 gm 
               
               
                   
                 KLUCEL HF Pharma hydroxypropylcellulose 
               
               
                   
                 Hercules - Aqualon Division Wilmington, DE, U.S.A. 
               
               
                   
                 RANGE: .001-25 gm 
               
               
                   
                 Ethyl Alcohol 95% 190 proof 
               
               
                   
                 RANGE: 10-50 ml. 
               
               
                   
                   
               
             
          
         
       
     
         [0160]    As an example of viscosity ranges contemplated for the inventive compounds, depending on the intended use, such viscosities being determined in a 25° C. environment as follows. 
         [0161]    Viscosity: Brookfield Viscometer DV1+(RVT) 
         [0162]    Spindle 5 @12 RPM (25° C.) 
         [0163]    Preferred Product Range: 400-800 cps (preferably about 600 cps). 
         [0164]    Upper Range: 3000-5000 cps (semi-solid-gel) to a solid unflowable formulation, i.e., a solid which retains its solid form, such as a stick-like, cylindrical form similar to a conventional cylindrical colored lipstick or a conventional cylindrical lip balm protector, e.g., Chapstick® brand lip balm, A.H. Robbins Co., Richmond, Va., USA). 
       Features of Semi-Solid and Solid Whitening Compounds  According to the Invention  
       [0165]    With the present invention the consumer would simply remove the top of the applicator and then twist the lower part of the applicator and the semi-solid or solid whitening compound would protrude. The consumer would then apply the whitening compound directly onto the surface of the tooth. 
         [0166]    The tooth would not need to be dried prior to application. 
         [0167]    The whitening action would take place in a manner somewhat similar to that of previous brush-on whitening compounds. For example, the peroxide would be released from the solid by the moisture in the saliva along with the salivary proteins. As the compound is a solid rather than a liquid or gel the concentration of peroxide can be substantially increased, increasing the concentration beyond  30 % is contemplated. 
         [0168]    Having the whitening agent in a solid/semi-solid state offers several advantages over current whitening systems to date:
       Ease of consumer application: no mouth trays, adhesive strips, bottles or brushes.   Can be applied anytime, anywhere.   Will not cause any soft tissue irritation; the solid can only be applied to the tooth and will not run onto the soft tissues.   Easy transported; the applicator and semi-solid or solid whitening compound can be carried in a purse or pocket.   Affordable.       
 
         [0174]    While this invention has been described as having a preferred design, it is understood that it is capable of further modifications, and uses and/or adaptations of the invention and following in general the principle of the invention and including such departures from the present disclosure as come within the known or customary practice in the art to which the invention pertains, and as may be applied to the central features hereinbefore set forth, and fall within the scope of the invention or limits of the claims appended hereto.