Patent Publication Number: US-7721376-B2

Title: Oral care implement

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation in part of U.S. patent application Ser. No. 10/869,922, filed Jun. 18, 2004, now U.S. Pat. No. 7,143,462, which is a continuation in part of U.S. patent application Ser. No. 10/601,106, filed Jun. 20, 2003 now abandoned, a continuation in part of co-pending PCT Patent Application Serial No. PCT/US03/030633 (designating the U.S.) filed Sep. 26, 2003, which claims the benefit of U.S. Provisional Application No. 60/414,117, filed Sep. 27, 2002, U.S. Provisional Application No. 60/418,776, filed Oct. 16, 2002, and U.S. Provisional Application No. 60/419,425, filed Oct. 18, 2002, a continuation in part of co-pending PCT Patent Application No. PCT/U.S. 2003/029497 (designating the U.S.), filed Sep. 17, 2003, which claims the benefit of U.S. Provisional Application No. 60/412,290, filed Sep. 20, 2002, a continuation in part of U.S. patent application Ser. No. 29/189,729, filed Sep. 10, 2003, now U.S. Pat. No. D517,812, and a continuation-in-part of co-pending U.S. patent application Ser. No. 10/989,267, filed Nov. 17, 2004, which is a continuation-in-part application of U.S. patent application Ser. No. 29/209,242, filed Jul. 14, 2004, now abandoned and a continuation-in-part of U.S. patent application Ser. No. 29/209,244, filed Jul. 14, 2004, now abandoned. The contents of the above-noted applications are each expressly incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     The present invention pertains to an oral care implement with a cleanser for cleaning soft tissue surfaces in the mouth. 
     BACKGROUND OF THE INVENTION 
     According to the American Dental Association, a major source of bad breath in healthy people is microbial deposits on the tongue, where a bacterial coating harbors organisms and debris that contribute to bad breath. The tongue is a haven for the growth of microorganisms since the papillary nature of the tongue surface creates a unique ecological site that provides an extremely large surface area, favoring the accumulation of oral bacteria. Anaerobic flora and bacteria residing on the tongue play an important role in the development of chronic bad breath commonly called halitosis. In general, the bacteria produce volatile sulfur compounds (VSC). If there is enough buildup of the sulfur compounds, the result can be lead bad breath or oral malodor. 
     Bladed tongue scrapers have been used in the past, but have generally been inadequate in respect to their effectiveness and/or safety. Moreover, notwithstanding the benefits to be gained by any ability to clean the tongue, some users avoid the use of such blades because of lack of comfort on the tongue surface. 
     Hence, there is a need for an oral care implement with a tongue cleanser that provides effective removal of the tongue bacteria and other debris while maintaining comfort to the user. 
     BRIEF SUMMARY OF THE INVENTION 
     The invention pertains to an oral care implement with a tissue cleanser that provides improved cleaning and effective removal of bacteria and microdebris disposed on the oral tissue surfaces. 
     In one aspect of the invention, the tissue cleanser includes a plurality of nubs for cleaning soft tissue surfaces in the mouth and particularly for cleaning between the papillae of the tongue. In a further preferred aspect of the invention, the tissue cleanser includes a plurality of conically shaped nubs. 
     In another aspect of the invention, the tissue cleanser is constructed from an elastomeric material. In one preferred embodiment, the tissue cleanser is formed as an elastomeric pad mounted on the head of the oral care implement for improved cleaning, ease of manufacture, and user comfort. 
     In another aspect of the invention, the tissue cleanser includes at least one projection that protrudes from a base of material extending along the head of the implement. In one embodiment, a plurality of projections extend along the head in a spaced apart relationship along a pad formed as an elongate strip that is fixed to the head. In one construction, the base overlies a generally rigid head structure. Alternatively, the base is integrally formed as part of the head thereby forming a flexible head. 
     In another aspect of the invention, the soft tissue cleanser includes a combination of at least one elongate ridge and a plurality of nubs or other discrete projections having a non-elongate structure. As a result, the tongue and other soft tissue of the mouth are cleaned with the benefit of both kinds of cleanser projections for an enhanced cleaning effect. 
     In another aspect of the invention, the soft tissue cleanser includes a combination of hard and soft projections to clean the tongue and other soft tissue in the mouth. In one construction, the cleanser includes a plurality of soft nubs and at least one elongate ridge of hard material. In this way, the combined benefits of a soft and hard cleanser can be gained in one implement. 
     In another aspect of the invention, the soft tissue cleanser includes at least one projection with a scraping edge to be moved over the tongue or other tissue. The edge is formed by sloped surfaces having different inclinations. In one construction, a steeper slope faces generally toward the handle to provide a more aggressive scraping action as the head is dragged out of the mouth. The shallower surface makes the projection less prone to pushing tongue biofilm farther back in the throat. 
     In another aspect of the invention, the oral care implement includes a seat to facilitate and ease molding of the tissue cleanser to the head. In one preferred construction, the head has one or more protuberances for anchoring the head during molding of the tissue cleanser. The head may also include a basin to further define the outline of the molded tissue cleanser. 
     In another aspect of the invention, an oral care implement includes a tissue cleanser having means for reducing oral volatile sulfur compounds by 35% from a baseline measured two hours after use. 
     In another aspect of the invention, an oral care implement is provided with tooth cleaning elements and a tissue cleanser for a thorough cleaning of the teeth, gums, tongue and oral surfaces of the cheeks and lips. In a preferred construction, the tooth cleaning elements and tissue cleanser are supported on opposite sides of a supporting head. 
     In one other aspect of the invention, an oral care implement which includes tooth cleaning elements and a tissue cleanser forms at least one of the tooth cleaning elements as a unitary member with the tissue cleanser. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       A more complete understanding of the present invention and the advantages thereof may be acquired by referring to the following description in consideration of the accompanying drawings, in which like reference numbers indicate like features, and wherein: 
         FIG. 1  is an exploded assembly perspective view of an oral care implement according to one or more aspects of an illustrative embodiment; 
         FIG. 2  is an enlarged perspective view of a head of an oral care implement of  FIG. 1 ; 
         FIG. 3  is a plan view of the oral care implement of  FIG. 1  illustrating a tongue cleaning feature; 
         FIG. 4  is a partial section view of a head of the oral care implement of  FIG. 1  taken along line  4 - 4  of  FIG. 3 ; 
         FIG. 5  is a plan view of the oral care implement of  FIG. 1  illustrating at least one tooth cleaning configuration; 
         FIG. 6  is a perspective of the view of the oral care implement illustrating example tooth cleaning elements; and 
         FIG. 7  is a section view of an alternative construction of the head of an oral care implement. 
         FIG. 8  is a perspective view of an alternative embodiment of the invention. 
         FIG. 9  is a partial cross-sectional view taken along line IX-IX in  FIG. 8 . 
         FIG. 10  is a partial cross-sectional view of an alternative embodiment of the invention taken along line IX-IX in  FIG. 8 . 
         FIG. 11  is a partial cross-sectional view of another alternative embodiment taken along line IX-IX in  FIG. 8 . 
         FIG. 12  is a partial cross-sectional view of another alternative embodiment taken along line IX-IX in  FIG. 8 . 
         FIG. 13  is a partial perspective view of an alternative oral care implement in accordance with the present invention. 
         FIG. 14  is a partial cross-sectional view taken along line XIV-XIV in  FIG. 13 . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     In the following description, the invention is discussed in terms of a toothbrush. For example, toothbrush  100  is shown as one embodiment in  FIG. 1 , and toothbrush  500  as an alternative embodiment in  FIG. 8 . Nevertheless, the invention could be used in other oral care implements including simply a tissue cleansing implement. Further, it is to be understood that other embodiments may be utilized and structural and functional modifications may be made without departing from the scope of the present invention. 
     As seen in  FIGS. 1-7 , an oral care implement in the form of a toothbrush  100  includes a handle  103  and a head  105  which may be used for cleaning the teeth and soft tissue in the mouth, such as the tongue, interior surfaces of the cheeks, lips or the gums. Handle  103  is provided for the user to readily grip and manipulate the toothbrush, and may be formed of many different shapes and constructions. While the head is normally widened relative to the neck of the handle, it could in some constructions simply be a continuous extension or narrowing of the handle. In the preferred construction, head  105  has a first face  106  that supports tooth cleaning elements  107  ( FIGS. 5 and 6 ) and a second face  108  that supports a tissue cleanser  300  ( FIGS. 2 and 3 ). The first and second faces  106 ,  108  are preferably on opposite sides of head  105 . Nevertheless, tissue cleanser  300  may be mounted elsewhere, such as the proximal end  104  of handle  103 . The tissue cleanser  300  or portions of it may also be located on the peripheral sidewall surface  101  of head  105  or extend farther towards the proximate end  104  of handle  103  than illustrated. 
     The elastomeric material of tissue cleanser  300  may be any biocompatible resilient material suitable for uses in an oral hygiene apparatus. To provide optimum comfort as well as cleaning benefits, the elastomeric material preferably has a hardness property in the range of A8 to A35 Shore hardness. As an example, one preferred elastomeric material is styrene-ethylene/butylene-styrene block copolymer (SEBS) manufactured by GLS Corporation. Nevertheless, SEBS material from other manufacturers or other materials within and outside the noted hardness range could be used. 
     Tissue cleanser  300  is preferably configured with a multiplicity of tissue engaging elements  303  ( FIGS. 1-4 ), which in the preferred construction are formed as nubs. Alternative nub constructions  502 , as discussed below, are also illustrated in alternative constructions in  FIGS. 8-12 . As used herein a “nub” is generally meant to include a column-like protrusion (without limitation to the cross-sectional shape of the protrusion) which is upstanding from a base surface. In a general sense, the nub, in the preferred construction, has a height that is greater than the width at the base of the nub (as measured in the longest direction). Nevertheless, nubs could include projections wherein the widths and heights are roughly the same or wherein the heights are somewhat smaller than the base widths. Moreover, in some circumstances (e.g., where the nub tapers to a tip or includes a base portion that narrows to a smaller projection), the base width can be substantially larger than the height. 
     Such tissue engaging elements  303  are designed to significantly reduce a major source of bad breath in people and improve hygiene. Nubs  303  enable removal of microflora and other debris from the tongue and other soft tissue surfaces within the mouth. The tongue, in particular, is prone to develop bacterial coatings that are known to harbor organisms and debris that can contribute to bad breath. This microflora can be found in the recesses between the papillae on most of the tongue&#39;s upper surface as well as along other soft tissue surfaces in the mouth. When engaged or otherwise pulled against a tongue surface, for example, nubs  303  of elastomeric tissue cleanser  300  provide for gentle engagement with the soft tissue while reaching downward into the recesses of adjacent papillae of the tongue. The elastomeric construction of tissue cleanser  300  also enables the base surface  301  to follow the natural contours of the oral tissue surfaces, such as the tongue, cheeks, lips, and gums of a user. Moreover, the soft nubs  303  are able to flex as needed to traverse and clean the soft tissue surfaces in the mouth along which it is moved. 
     As seen in  FIGS. 2 and 4 , in one preferred arrangement of tissue cleanser  300 , nubs  303  are preferably conically shaped. As used herein, “conically shaped” or “conical” is meant to include true cones, frusto-conically shaped elements, and other shapes that taper to a narrow end and thereby resemble a cone irrespective of whether they are uniform, continuous in their taper, or have rounded cross-sections. With reference to  FIG. 4 , the base portion  305  of each conically shaped tissue engaging element  303  is larger than the corresponding tip portion  307 . In this conically shaped configuration, the base portion  305  has a wider cross-sectional area to provide effective shear strength to withstand the lateral movement of the tissue cleanser  300  along the surface of the tongue or other soft tissue surface. The smaller width or diameter of the tip portion  307  in conjunction with the length of the conically shaped nub  303  enable the nubs to sweep into the recesses of the tongue and other surfaces to clean the microbial deposits and other debris from the soft tissue surfaces. In the preferred construction, nubs  303  are able to flex and bend from their respective vertical axes as lateral pressure is applied during use. This flexing enhances the comfort and cleaning of the soft tissue surfaces. In a preferred construction, the thickness or width of the base of the nub in 0.64 mm, and preferably within the range from about 0.51 mm to about 2.00 mm. Tip  307  of the nubs is 0.127 mm and preferably within a that range from about 0.10 mm to about 0.75 mm for optimal penetration between the recesses of papillae of a user&#39;s tongue. The length or height of nubs  303 , as measured from base surface  301  to tip  307 , is preferably 0.91 mm and preferably within range from about 0.5 mm to about 2.5 mm, and most preferably range between 0.75 mm to 1.5 mm. Nevertheless, nubs of other sizes and shapes outside the given ranges can be used. 
     Alternatively, the tissue cleaning elements  303  may have other shapes. As one example, the tissue cleanser may have a grated form such as described in co-pending U.S. patent application Ser. No. 10/601,106, incorporated herein by reference. 
     In a preferred construction, nubs  303  are disposed on the base surface  301  of tissue cleanser  300  in a high density pattern. Each nub  303  is preferably spaced apart from adjacent nubs  303  between a range of about 0.5 mm to about 3 mm; more preferably the spacing ranges between 0.7 mm to 2.5 mm, and most preferably between 1 mm to 2 mm. Nevertheless, other spacing ranges are possible. The surface density of the nubs  303  on base surface  301  ranges preferably from about 100 to about 600 nubs per square inch. In a more preferred construction of the tissue cleanser, the surface density may range from 200 to 500 nubs per square inch, and most preferably between 300 to 450 nubs per square inch. In one preferred example, tissue cleanser  300  includes about 400 nubs per square inch of surface area. The surface density features in conjunction with the height of the nubs  303  enables the tissue cleanser to provide enhanced cleaning of the soft tissue surfaces with improved comfort. Nonetheless, other surface densities are possible. 
     As seen in  FIG. 3 , nubs  303  are preferably disposed in longitudinal rows in a direction generally parallel to the longitudinal axis a-a. Further, nubs  303  are disposed in transverse rows R 1 , R 2  on an axis parallel to base surface  301  and generally perpendicular to the longitudinal axis a-a. In one preferred construction, adjacent nubs  303  are provided on the base surface  301  in a staggered arrangement. For example, adjacent transverse rows of nubs R 1  and R 2  have nubs  303  that are not directly behind each other. A first nub is said herein to be “directly behind” second nub when it is located within the lateral bounds of the second nub extending in a longitudinal direction. This configuration enables improved cleaning of the soft tissue surfaces by facilitating the removal of microflora and other debris, and especially from the recesses of adjacent papillae of the tongue. Nonetheless, the nubs could be arranged randomly or in a myriad of different patterns. 
     Tongue cleanser  300  is preferably formed by being molded to head  105 , although other manufacturing processes could be used. With reference to  FIGS. 1 and 4 , tissue cleanser  300  is preferably molded within a basin or a receiving cavity  111  in face  108  of head  105 . The receiving cavity  111  has a lower base surface  113  and a peripheral sidewall  115  extending away from the lower base surface  113 . In one mounting arrangement, nubs  303  of the tissue cleanser  300  are exposed for use with the base surface of the tissue cleanser  300  being flush or recessed relative to the surface  114  of the head. Nevertheless, other orientations are possible. Also, base surface  301  of the tissue cleanser could be embedded in head  105  or covered by another layer with nubs  303  projecting through appropriate openings. 
     As can be seen in  FIGS. 1 and 4 , face  108  also preferably includes one or more peg members  117   a - c  disposed within basin  111 . Peg members  117  form anchor points against the opposing mold to prevent the head from moving under the pressure of the injection molding. As a result, tissue cleanser  300  preferably includes one or more complementary apertures  311   a - c  which exposes the tops of peg members  117   a - c . Although, the pegs are illustrated in alignment along the centerline of the head (e.g. longitudinal axis a-a), the pegs could have many different positions. Further, the pegs and basin are preferably both included with head  105 , but either could be used without the other. 
     Alternatively, basin  111  and peg members  117   a - c  may be provided to position and hold a previously molded tissue cleanser, although these constructions are not necessary to use such a previously molded tissue cleanser. 
     Peg members  117   a - c  may take on a variety of shapes and lengths. With continued reference to the  FIGS. 1 and 4 , head  105  includes peg members  117   a - c  extending away from the lower base surface  113  of basin  111  to the height of the peripheral sidewall  115 . The peg members  117   a - c  are shaped in the form of a cylinder, but other shapes and lengths of the peg members  117   a - c  are possible. While the molding process would preferably bond the tissue cleanser to the head, the tissue cleanser could be performed and attached by adhesive or other known means. 
     As shown in  FIGS. 1-4 , tissue cleanser  300  is preferably formed as a pad composed of a soft and pliable elastomeric material for comfortable cleaning and effective removal of bacteria and debris disposed on the surface of the tongue, other soft tissue in the mouth and even along the lips. The tissue cleanser  300  also provides effective massaging, stimulation and removal of bacteria, debris and epithehal cells from the surfaces of the tongue, cheeks, gums or lips. 
     In the preferred construction ( FIGS. 1-6 ), tissue cleansers  300  may rub against the inside surfaces of the cheeks or lips, and on the sides of the tongue while the user brushes his or her teeth, and thus provide a desired massaging, stimulation and cleaning of various soft tissue surfaces within the mouth. For example, during brushing of the facial tooth surfaces, tissue cleanser  300  is disposed on the outer face  108  of head  105  to naturally rub against the oral surfaces of the cheek. As a result, enhanced cleaning is attained without additional cleaning steps. Further, some users may sense a stimulating tingle on the cheek surfaces that leads to a positive user reaction, and even enjoyment of the comfortable feel of the tissue cleanser along the soft tissues surfaces in the mouth. Tissue cleanser  300  may also be additionally rubbed on the cheeks, tongue, etc. as desired for further cleaning aside from the contact that may occur while brushing the teeth. 
     Referring to  FIGS. 5 and 6 , the tooth cleaning elements  107  of head  105  may include a variety of tooth cleaning elements which can be used for wiping, cleaning and massaging the user&#39;s teeth and gums. Any suitable form of tooth cleaning elements may be used. The term “tooth cleaning elements” is used in a generic sense which refers to filament bristles or elastomeric fingers or walls that have any desirable shape. In the illustrated example of  FIG. 5 , tooth cleaning elements  107  include distal tooth cleaning elements  203   a - b  disposed at a distal tip  121  of head  105 , peripheral tooth cleaning elements  205   a - 1 , longitudinal tooth cleaning elements  207   a - c  disposed along longitudinal axis a-a, arcuate tooth cleaning elements  209   a - d  and  211   a - b , and proximal cleaning elements  213   a,b . Tooth cleaning elements  205 ,  207 ,  211  and  213  are preferably provided as tufts of bristles whereas tooth cleaning elements  209  are preferably formed as elastomeric walls. Nevertheless, other forms and types of tooth cleaning elements may be used. 
       FIG. 7  illustrates a sectional view of an alternative arrangement of a head  400  of a toothbrush. Head  400  is similar in construction to head  105 , except that tooth cleaning elements  209   a - d  are integrally formed with tissue cleanser  300 . To accomplish the alternative construction, head  400  has appropriately sized ports or openings  401  to allow the elastomeric material to flow through the head during an injection molding process. In this construction, tooth cleaning elements  209   a - d  and tissue cleaner  300  are formed with the same elastomeric material. Thus, head  400  may include at least one elastomeric tooth cleaning element formed as a unitary member with tissue cleanser  300 . 
     In  FIG. 8 , toothbrush  500  includes a plurality of nubs or other projections  502  protruding from a back side  504  of head  506  as a cleanser  508  of soft tissue in the mouth. Teeth cleaning elements preferably extend from a front side of head  506 . The projections  502  are preferably arranged seriatim along at least one narrow base or pad in the form of a strip  510  fixed to the head  506 . In the illustrated example, a plurality of generally parallel strips  510   a ,  510   b ,  510   c ,  510   d  are fixed in a generally concave shape facing away from the handle. In this one construction, the strips extend along back side  504  of head  506  and each sidewall  511 , although extensions along the sidewalls are not necessary. Any number of strips could be included. The strips could define virtually any shape or orientation on the head. For example, strips  510  could have any of the shapes disclosed for the ridges in co-pending U.S. patent application Ser. No. 10/989,267, filed Nov. 17, 2004, entitled “Oral Care Implement”, which is incorporated herein by reference. In the illustrated construction, strips  510  are interconnected by an axial stem which extends into the handle and forms a part of the grip for the user. Further, this handle extension or even the stem is of course not necessary. 
     In one construction, each projection  502  is generally columnar and formed with a width W of about 1.1 mm and a height H of about 1.7 mm ( FIG. 9 ). The projections are spaced apart from each other along strip  510  a distance of about 1.0 mm. These height, width and spacing dimensions could, however, vary widely. In the illustrated embodiment, projections  502  each includes a peripheral wall  513  protruding outward from base  510 , and an inclined distal end surface  514  at an angle of about 50 degrees to side surface  504  of head  506 . The inclined end surface  514  defines a narrow top edge  516  along a portion of peripheral wall  513 , which is advantageous for cleansing the tongue and other soft tissue. Although the end surfaces  514  are shown to be inclined in the same direction, they could be inclined in different directions. 
     In an alternative construction ( FIG. 13 ), head  506  is additionally formed with at least one elongate ridge  525 . With this arrangement, the user is provided with a cleanser that obtains a beneficial dual cleaning effect by moving the discrete projections  502  and the ridge  525  across the tongue or other tissue. In the illustrated example, ridge  525  is a curved, elongate projection protruding generally outward along the outer edge of the remote end  527  of the head. Nevertheless, other arrangements, locations and shapes are possible. Additional ridges could also be provided. In one preferred construction, ridge  525  is molded as one-piece with the head and formed of a relatively hard plastic such as polypropylene. The ridge, however, could be formed separately from the head and/or composed of other materials that are compatible for oral care implements. 
     In one construction, ridge  525  is, as noted above, formed of a relatively hard material (e.g., polypropylene), while projections  502  are formed of a relatively soft material (e.g., a thermoplastic elastomer). This use of dual materials enables the benefits of both materials to be gained. The cleanser includes the firm engagement of the relatively hard scraper blade in ridge  525  and the relatively soft discrete projections that flex and turn as they dig into the tongue or other tissue. 
     As seen in  FIGS. 13 and 14 , ridge  525  is defined by a pair of opposite sidewalls  533 ,  534  which meet to form a scraper edge  535 . While edge  535  is relatively narrow in this construction, it could be substantially widened. In one embodiment, sidewalls  533 ,  534  are formed with different slopes relative to side  504  of head  506 , though they could have the same slope. In one preferred construction, sidewall  533  is formed with a steeper slope than sidewall  534  to define a more aggressive scraping action as the head is pulled across the tongue by the user. The shallower slope of sidewall  534  facing generally away from the handle, makes the ridge less prone to pushing the tongue biofilm farther back in the throat as the ridge is pushed back toward the throat. In a preferred embodiment, sidewall  533  is oriented at an angle α of 62 degrees relative to side  504 , whereas sidewall  534  is oriented at an angle β of 43 degrees. Other angles could also be used for both sidewalls. 
     In another alternative construction ( FIG. 10 ), each projection  502   a  is provided with an end surface  514   a  having two inclined end face portions  515   a ,  517   a  and a top edge  516   a . As with ridge  525 , end face portion  515   a , generally facing toward the handle, is preferably inclined at a steeper angle relative to side  504   a  than end face portion  517   a , although other arrangements including end face portions having the same inclination can be used. As one example, end face portion  515   a  is oriented at an angle α of 62 degrees relative to side  504   a , and end face portion  517   a  is oriented at an angle β of 43 degrees. The steeper angle of end face portion  515   a  provides a more aggressive scraping action as the head is dragged out of the mouth. The shallower angle of end surface  517   a  makes the projection less prone to pushing the tongue biofilm farther back in the throat. 
     Of course, other projections can be used. For example, each projection could include a non-inclined distal end or an end that tapers to a pointed tip. The projections could have a wide variety of shapes beyond the cylindrical shape shown in  FIG. 8 . For example, the projections could have a conical shape, irregular cross sections, or be inclined to the back side  504 . Moreover, the projections may also be ridge shaped to extend entirely or partially along the length of strip  510 . 
     In a preferred construction, projections  502  and strip  510  are formed as a one piece member molded or otherwise secured to head  506 . The projections and strip are preferably formed as a one-piece member of a resilient thermoplastic elastomer such as styrene-ethylene/butylene-styrene block copolymer (SEBS) manufactured by GLS Corporation, but could be composed of other resilient materials, hard materials, or a combination of materials such as disclosed in U.S. patent application Ser. No. 11/011,605, filed Dec. 15, 2004, entitled Oral Care Implement, incorporated herein by reference. The projections and strips could also be formed of the same substance as head  506  (e.g., polypropylene) but have a different color or the like to define it a different material from the head and thereby create at least a visually appealing brush. 
     In one construction, strips  510  are molded to overlie a generally planar surface  504  of head  506  ( FIG. 9 ). Nevertheless, channels  507  could be formed in side  504  to receive strips  510  therein so that side  504  and the outer surfaces  512  of strips  510  having projections  502  are generally co-planar ( FIG. 11 ). Additionally, the strips of resilient material could be formed as an integral part of the head construction ( FIG. 12 ). More specifically, in this alternative construction, the head includes a plurality of first members  520  joined together by a resilient second member  522  that acts as a living hinge to permit the first members to move relative to each other during use of the toothbrush. The second member also forms the base  510   c  of soft tissue cleanser  506  provided with projections  502 . Additionally, as discussed in regard to toothbrush  400 , projections  502  or  502   a  can be integrally formed as a one-piece member with elastomeric tooth cleaning elements extending in an opposite directions from the head. 
     As various changes could be made in the above methods, compositions and structures without departing from the scope of the invention, it is intended that all matter contained in this application, including all mechanisms and/or modes of interaction described above, shall be interpreted as illustrative only and not limiting in any way the scope of the appended claims. 
     The following examples are set forth as representative of the improved operation of the present invention. These examples are not to be construed as limiting the scope of the invention. 
     EXAMPLE 1 
     The performance nature of a toothbrush can be measured using known oral malodor assessment methods. A study was conducted to evaluate the performance of a toothbrush provided with an elastomeric tissue cleanser having conically shaped nubs, such as the preferred construction of toothbrush  100  discussed above. Human test subjects participated in the study. There was a washout or normalization period prior to testing of about 7 days in which the test subjects brushed twice a day with a fluoride dental cream (see Table 1). After the washout period, the test subjects were asked to refrain from any oral hygiene (brushing, rinsing, and flossing), eating and drinking prior to oral testing. A baseline volatile sulfur compound (VSC) sample was taken from each of the test subjects. In the study for overnight odor control, the test subjects brushed their teeth for one minute with a fluoride dental cream (see Table 1) using toothbrush  100  provided with the above noted tissue cleanser  300 . Subsequently, the subjects cleaned their tongue surface with the tissue engaging elements of the toothbrush for ten seconds. The test subjects slept overnight and returned for post treatment. VSC samples were taken at the ten-hour time point from the previous day cleaning. In the illustrative example, use of the toothbrush reduced oral VSC about 60% verses brushing the teeth alone as measured from a baseline ten hours after use. The VSC readings were obtained by gas chromatography. 
     EXAMPLE 2 
     In another study of the above-noted toothbrush  100 , there was a washout or normalization period prior to testing of about 7 days which the test subjects brushed twice a day with a fluoride dental cream (see Table 1). The test subjects were asked to refrain from any oral hygiene (brushing, rinsing, and flossing), eating and drinking before testing. After the washout period, the test subjects provided a baseline tongue bacteria sample by swabbing a side of the back of the tongue with a sterile cotton swab. The test subjects brushed their teeth with a fluoride dental cream (see Table 1) for one minute with the toothbrush having the above-noted tissue cleanser. Subsequently, the test subjects cleaned their tongue surface with a preferred construction of the tissue engaging elements  300  of the toothbrush  100  for ten seconds. Two hours after the cleaning of the tongue surface, a tongue bacteria sample was taken from a side of the back of the tongue with a cotton swab. In the illustrative example, use of the tissue engaging elements controlled more odor causing tongue bacteria than simply brushing the teeth alone. Use of the tissue cleanser  300  demonstrated a tongue bacteria log reduction of over 0.8 Log colony forming units/ml two hours after use on the tongue. 
     EXAMPLE 3 
     In another study of the above-noted toothbrush, a MT assay was used to examine the viability of the epithelial cells collected from the oral cavity prior to and after the use of the toothbrush with the noted tissue cleanser. The MTT Assay was based on the enzymatic reduction of the tetrazolium salt MTT [3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl-tetrazoliumbromide +++] in living, metabolically active cells. The reaction was carried out in situ in test tubes, and the reaction product, a purple-colored formazan soluble in dimethylsulfoxide, was measured colormetrically using a multiwell plate reader. Advantageously, the MTT Assay offers a high degree of precision, ease of use, and suitability for the purpose for large scale chemosensitivity testing. 
     Following a 7-day washout period, the test subjects reported to a test site without prior eating, drinking, or performing oral hygiene. The test subjects provided salivary rinse samples by rinsing their oral cavity with 9 ml of sterile water for 10 seconds and then discharging the water from the rinse into a tube containing 10× sterile phosphate buffered saline (PBS) solution. The samples were refrigerated for approximately 30 minutes before the MTT Assay was run. The test subjects brushed their teeth under supervision for one minute using a fluoride dental cream (see Table 1) followed by 10 seconds of tongue cleaning with the tongue cleanser  300  of the preferred construction. Approximately 30 minutes after brushing and tongue cleaning, the test subjects provided a rinse sample in the manner described previously. 
     The pre-rinse samples and post-rinse samples were centrifuged for 15 minutes at about 3000 RPM. The supernatant, e.g., clear liquid, was removed and the pellet was resuspended in 2.5 mL of PBS. The samples were vortexed for 5 seconds, then 2.5 ml of MTT Solution was added. The samples were subsequently incubated in a gently shaking waterbath set at 37° C. for 2 hours. Following the 2 hour incubation period, the samples were centrifuged for 15 minutes at about 3000 RPM. The supernatatant was siphoned out and 3 mL of detergent (0.04 N Acid Isopropanol) was added to dissolve purple crystals. An increase or decrease in MTT conversion was spectrophotometrically quantified. From each sample, 200 μl of each was added to 96 well plates and the optical density was measured at 570 nm and compared to a negative buffer control. In the illustrative example, one minute of brushing followed by 10 seconds of use of the tissue cleanser reduced oral epithelial cells about 72% as determined by a MTT assay protocol. 
     EXAMPLE 4 
     In another study, human test subjects provided baseline VSC samples via a Halimeter™ (i.e., a sulfide meter). A Halimeter™ uses an electrochemical, voltammetric sensor which generates a signal when it is exposed to VSC such as, sulfide and mercaptan gases and measures the concentration of hydrogen sulfide gas in parts per billion. The test subjects brushed their teeth under supervision for one minute with the preferred construction of a toothbrush having the above noted tissue cleanser. Then, the test subjects used the noted toothbrush to provide six strokes on the tongue surface. A subsequent VSC sample was taken from the test subjects two hours after the bushing stage. In this illustrative example, use of a toothbrush with the tissue cleanser reduced the measured VSC in the mouth odor over 35% from a baseline measured two hours after use. 
     EXAMPLE 5 
     In one other study, after a washout period, human test subjects rinsed their mouths with sterile water to provide a baseline sample for viable epithelial cell analysis with the MTT assay. The subjects brushed their teeth under supervision for one minute with the preferred construction of the toothbrush having the above-noted tissue cleanser. Then, the test subjects used the tissue cleanser to provide six strokes on the tongue surface. The test subjects provided a post rinse sample for analysis. The samples were tested and analyzed in the manner as discussed with respect to Example 3. In this example, use of the toothbrush reduced oral epithelial cells by about 92% from a baseline as determined by MTT assay protocol. 
     In the above noted examples, the subjects brushed their teeth using a fluoride dental cream with the formulation in Table 1. 
     
       
         
           
               
               
             
               
                 TABLE 1 
               
               
                   
               
               
                 % wt. 
                 Ingredient 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
            
               
                 48.76% 
                 Dicalcium Phosphate Dihydrate 
               
               
                 22.0063% 
                 Water 
               
               
                 22.00% 
                 Glycerin 
               
               
                 4.138% 
                 SO3 Sodium Lauryl Sulfate base - 29% 
               
               
                 1.000% 
                 Sodium CMC - 7MF - Food Grade 
               
               
                 0.89% 
                 105 Dental Cream Flavor 
               
               
                 .76% 
                 Sodium Monofluorophosphate 
               
               
                 .25% 
                 Tetrasodium Pyrophosphate 
               
               
                 .20% 
                 Sodium Saccharin