CA2226585A1 - Chewing gum composition - Google Patents

Abstract

A chewing gum composition which can help reduce dental decay, and dentinal hypersensitivity. To achieve these results the consumer begins by masticating this new chewing gum composition in order to produce excess saliva. This operation loosens much of the food particles left in the mouth and permits them to be easily swallowed. Many of these particles are also assimilated into the chewing gum composition and so removed as harmful agents. Excess saliva will also begin to dilute the acids produced by dental plaques but by employing, into the chewing gum composition, one or more water soluble alkaline compounds significantly more will be neutralized. Moreover, a chewing gum composition containing sodium bicarbonate or other abrading agent and or a peroxide based compound will gently scrub teeth and so help minimize the accumulation of bacterial plaques. Sodium bicarbonate also has the ability to absorb odours and, therefore, the effects of halitosis can be reduced by its use. Odours are not just masked but are absorbed, thus, providing a much more effective solution than that of odour masking. Masticating a chewing gum composition containing a peroxide based compound will release significant amounts of oxygen thereby lessening the quantity of oral plaques. In turn, the unpleasant odours sporadically exhibited by these plaques will be reduced also. Finally, the further incorporation of a fluoride based compound and or a dental desensitizing agent will notably reduce dental decay and or dentinal hypersensitivity, respectively. This product, therefore, provides an effective, convenient, inexpensive, and safe solution in helping reduce dental plaques, oral odours, and dentinal hypersensitivity.

Description

CA 02226~8~ 1998-03-16 1 Case-5 3Patent Application of 4Robert V. Marcon 53471 Sinnicks Avenue, Niagara Falls, Ontario, Canada, L2J 2G6 6A citizen of Canada 11 TITLE OF THE lN ~/hNllON

CROSS-REFERENCE
16 This application claims priority from U.S.A. Provisional 17 Application, serial number 60/040,935, filed 17 March 1997 STATEMENT REGA~:)ING FEDERALLY SPONSORED R~.~ARCH OR DEVELOPMEN~
21 Not Applicable.

24 REFERENCE TO A ]!IICROFICHE APPENDIX
Not Applicable.

28 BACKGROUND OF T]~IE lNV~:NllON
29 This inveni_ion relates to chewing gums and, specifically, to chewing gum compositions which reduce dental decay, and 31 dentinal hypersensitivity.
32 The chewing of gum has for many years been a desirable 33 pleasure for the general population~ It has also utilized many 34 different ingredients in its manufacture in order to provide different tastes, textures, sensations, and flavour life. Though CA 02226~8~ 1998-03-16 36 many recipes were used, most contained a general gum base, a 37 flavouring agent, and sugar. These chewing gums, therefore, 38 produced a pleasant tasting and inexpensive consumer product for 39 the mass market.
Unfortunately, the inevitable result of frequently chewing 41 gum laden with sugar was the formation of carious lesions or 42 caries in teeth Dental decay of this type, along with various 43 others, genera]ly stem from the various bacteria that form 44 plaques on the surfaces of ~eeth. These plaques, which can contain 250 or more separate microbial species, use sugars and 46 other fermentable carbohydrates to produce polymers which bind 47 the organisms to the tooth surface and acids which cause its 48 demineralization. In the first stages a carious lesion does not 49 contain an act:ual cavity but with prolonged and repeated demineralization by the plaque created acids a cavity will form.
51 Thus, each time something sweet is consumed plaques can produce 52 at least 20 miLnutes of acid in the mouth which, in turn, 53 seriously contributes to dental demineralization.
54 Furthermore, plaque, if not removecL will in time form calculus, and calculus is the mineralized bacterial plaque 56 deposits found on the teeth or other solid oral structures such 57 as restorations. Calculus is invariably covered by a film of 58 plaque, the organisms of which also occupy its porous structure.
59 Hence, its composition is generally made up of seventy percent organic salts and thirty percent micro-organisms and organic 61 material. Morec)ver, its formation is always preceded by plaque 62 accumulation w]~lich serves as an organic matrix for the 63 subsequent mineralization of the deposit. The precipitation of 64 mineral salts in plaque can start at any time from the second to the fourteenth cLay of plaque formation, but some individuals can 66 begin to calcify plaque in four to eight hours. Initially, 67 small crystals develop close to bacteria; gradually the 68 intermicrobial matrix becomes entirely calcified and eventually 69 the bacteria also become mineralized. The calcification occurs in layers, which vary in their degree of calcification and have CA 02226~8~ l998-03-l6 71 resting lines between them. As a result, the presence of 72 calculus makes effective oral hygiene impossible and therefore 73 its prevention and or removal to help control the inception or 74 progression of inflammatory periodontal disease is of great importance 76 In consequence to these problems sugar has been largely 77 replaced by artificial sweeteners in order to stem the 78 increasing incidence of dental decay. Since these sweeteners 79 rendered substantial improvements over sugar they have been quickly accepted by many consumers even though their tastes 81 were, at times, less pleasing than sugar.
82 There has also been in the past other avenues of 83 experimentation which have incorporated compounds such as urea 84 peroxide, fluo:ride, or chlorophyll into some chewing gum compositions. Urea peroxide, being a peroxide based compound, 86 offered some bactericidal effects as well as loosening 87 particulate material and cleaning debris. Unfortunately, it 88 also possesses a slight odour and is incompatible with certain 89 enzymes, metallic ions, alkalis, sunlight, and heat. Fluoride, though extensively used in dentifrices and mouthwashes to 91 prevent dental decay has not been, as yet, adequately studied 92 for its therapeutic effectiveness when used in a chewing gum 93 form. Consequently, results remain unproven. Chlorophyll, 94 however, has been extensively studied but to date no conclusive evidence has b,een obtained to demonstrate either a caries 96 preventive action or a therapeutic effect on gingival disease.
97 Chewing gums have also been used in the past as a breath 98 freshener by utilizing chlorophyll or the chewing gum's 99 flavouring agent to mask many undesirable oral odours. These 100 practises, while only marginally successful, have been eagerly 101 adopted because of the general lack of viable alternatives to an 102 immediate and sensitive social problem.
103 It has alsc~ been discovered that chewing regular sugarless 104 gum after a mea]L helped reduce the formation and progression of 105 carious lesions. These observations are due to the fact that CA 02226~8~ l998-03-l6 106 the mouth produces excess saliva when chewing gum, thus helping 107 to loosen, and then swallow, many iEood particles which may be 108 harmful. Acids" created by bacterial plaques were also somewhat 109 more diluted thereby decreasing the rate of dental llO demineralization accordingly. Some chewing gum manufactures 111 have capitalized on these observations to promote the chewing of 112 gum after meals as a method of practising good dental hygiene.
113 It provides a good alternative to brushing where brushing is 114 impractical.
115 It has also been estimated that as many as one in seven 116 people of the populace have suffered from dentinal 117 hypersensitivity at some time. However, recognized treatments 118 are currently only available from professional dental 119 practitioners, certain dentifrices or mouthwashes.
120 Unfortunately, most of these methods also require a convenient 121 place, such as a clinical office, bathroom or washroom, for 122 their use. Most also require additional equipment, such as 123 various dental t:ools, toothbrushes, towels, and water along with 124 a sink to dispc~se of any oral refuse. Moreover, professional 125 dental personnel are invariably expensive and generally require 126 prearranged appointments. As a result, there is presently a 127 very great need in the general public for a convenient, 128 effective, and inexpensive solution to alleviate the pain 129 associated with dentinal hypersensitivity.
130 With these thoughts in mind it becomes increasingly clear 131 that there is a large deficiency in contemporary chewing gums in 132 providing satisfactory remedies to the aforedescribed problems.
133 In consequence, the invention detailed within this disclosure 134 can provide a more effective and optimal solution than can be 135 currently achieved.

13 8 OBJECTS AND ADVi~NTAGES
139 The invent:ion disclosed herein overcomes many of the 140 drawbacks listed in the prior art, while also providing a more CA 02226~8~ 1998-03-16 141 effective solution and improved performance over presently used 142 chewing gums.
143 In addition, some of the objects and advantages associated 144 with this invention, or its various versions, are described 145 below. Others w:ill become apparent as the description proceeds.

147 OBJECTS:

149 (1) To reduce dentinal hypersensitivity.
150 (2) To reduce the various dental problems caused by oral 151 plaques.

153 ADVANTAGES:

155 (1) The incorporation of one or more dental desensitizing 156 agents into the chewing gum composition can help 157 dimin:ish dentinal hypersensitivity.
158 (2) Fluor:ide based compounds may be used, in the chewing 159 gum composition, to significantly reduce the incidence 160 of derltal decay.
161 (3) Some of the ingredients utilized herein can also 162 produce a gentle scrubbing or cleansing action upon 163 the t~_eth and gums which will not only reduce the 164 bacterial plaques found in the mouth but will also 165 tend 1o cosmetically whiten teeth. Moreover, cleaner 166 ename:l surfaces will increase the therapeutic 167 performance of fluorides and dental desensitizing 168 agents.
169 (4) The chewing gum compositions herein disclosed may 170 contaiin one or more water soluble alkaline compounds 171 which can be used to decrease the demineralizing 172 effect.s caused by oral acids.
173 (5) Some of the ingredients that may be utilized herein 174 possess very good odour absorbing qualities, thus, 175 helping to reduce the effects of halitosis.

CA 02226~8~ 1998-03-16 176 (6) Professional dental personnel are not required nor is 177 the cumbersome use of toothbrushes and mouthwashes.
178 This not only reduces time and cost but also 179 eliminates the need for special equipment, places, 180 water or the awkward disposal of oral refuse.
181 (7) The ingredients employed by the chewing gum 182 composition of this disclosure are cost competitive 183 with t_hose presently used by manufacturers.
184 (8) The cost and mechanics of incorporating into the 185 chewing gum composition the various ingredients 186 disclosed herein are both inexpensive and technically 187 favourable.

190 SU~MAl~Y OF THE lNV~!;N'l'lON
191 The invenlion disclosed herein details a chewing gum 192 composition which can be utilized in reducing the effects 193 produced by dent:al plaques and the pain associated with dentinal 194 hypersensitivit~y. To begin, dental plaques, which can contain 195 250 or more separate microbial species, use sugars and other 196 fermentable carbohydrates to produce polymers which binds them 197 to the tooth surface and acids which cause dental 198 demineralization. In time, these plaques will produce caries and 199 form calculus. The establishment of calculus can seriously 200 irritate gum tissues and so promote the advance of periodontal 201 disease. Do to its porous structure calculus can also harbour 202 a multitude of bacterial plaques and so promote its continued 203 spread. This makes effective oral hygiene impossible. Dental 204 plaques are also capable of producing various offensive odours 205 which, while not harmful, are self-evident in their 206 undesirability.
207 In addition to plaques, dentinal hypersensitivity is a very 208 painful disorder which, by current estimates, as many as one 209 person in seven will at some point bear. The principle theory 210 to explain this mechanism of pain transmission from the dentine CA 02226~8~ l998-03-l6 211 to the pulp is called the, Hydrodynamic Theory". It is a theory 212 based upon the observation that fluid within the dentinal 213 tubules of the dentine can flow either inward or outward 214 depending on the pressure variations in the surrounding tissues.
215 Pain is, therefore, created by the rapid movement of fluid in 216 the open dentinal tubules that stimulate, at the dentinal-pupal 217 junction, the free nerve endings from the pulp.
218 In response to the~e problems, the invention disclosed 219 herein utilizes a chewing gum composition in order to administer 220 various highly effective ingredients or compounds to the mouth 221 and teeth. To achieve these results the consumer simply begins 222 by masticating this new chewing gum composition in order to 223 produce excess saliva. This operation loosens much of the food 224 particles left in the mouth and permits them to be easily 225 swallowed. Many of these particles are also assimilated into 226 the chewing gum composition and so removed as harmful agents.
227 Excess saliva will also facilitate the dilution of oral acids 228 but the further utilization of one or more water soluble 229 alkaline compourlds will neutralize significantly more.
230 Moreover, if included in the chewing gum composition, an 231 abrading agent or peroxide based compound will help provide a 232 gentle scrubbing action upon the teeth and gums which greatly 233 helps in reducing any accumulated bacterial plaques. Sodium 234 bicarbonate, a mild abrading agent, also has the ability to 235 absorb odours and, therefore, the effects of halitosis can be 236 reduced by its use. Odours are not just masked but are 237 absorbed, thus, providing a much more effective solution than 238 that of odour masking. Masticating a chewing gum composition 239 containing a peroxide based compound will release significant 240 amounts of oxygen thereby lessening the quantity of oral 241 plaques, and the unpleasant odours sporadically exhibited by 242 them. As a result, consumers can freshen their breath quickly 243 and effectively without undue mess or inconvenience. Finally, 244 the further use of a fluoride based compound and or a dental 245 desensitizing agent will notably diminish dental decay and CA 02226~8~ 1998-03-16 246 dentinal hypers,ensitivity, respectively.
247 A chewing gum composition containing one or more of these 248 ingredients will, therefore, render many benefits to its users.
249 It can diminish dental plaques and other related dental 250 diseases. Cosmetically, teeth will tend to be whiter and appear 251 healthier. Halitosis as well as the pain or discomfort 252 associated with sensitive teeth can also be noticeably reduced 253 and, in final summation, all of this can be accomplished 254 effectively, conveniently, inexpensively, and safely.

258 Not Applic,able.

261 DE~ATT~T~n DESCRIPTION OF THE lNV~N'l'lON
262 The present invention pertains to a chewing gum composition 263 which can be used to help reduce the incidence or the effects 264 associated with one or more of the following manifestations:

266 (1) Dentinal hypersensitivity.
267 (2) DentaL plaques.

269 While thesle objectives are obviously desirable they are 270 achieved in a most unique and novel manner by including, in the 271 chewing gum composition, various specialized ingredients. These 272 ingredients can work alone or in conjunction with others but in 273 all cases herein disclosed they shall be incorporated into a 274 chewing gum composition. The reasons why this method of use is 275 preferred over c7ther possible avenues are listed below.

277 (1) The physical act of masticating the chewing gum 278 composition produces excess saliva which loosens food 279 partic~les in the mouth and allows them to be easily 280 swallc7wed. Many of these particles are also CA 02226~8~ 1998-03-16 281 assimilated into the chewing gum composition and so 282 thereby removed as harmful agents.
283 (2) Excess saliva not only helps dilute the acids produced 284 by plaques it also helps rebuild teeth.
285 (3) The process of physically masticating the chewing gum 286 composition will help scrub teeth cleaner and so allow 287 the specialized ingredients of the chewing gum 288 composition to be applied more effectively to the 289 denta:L surfaces than is possible with mouthwashes.
290 (4) Physical mastication, will apply the specialized 291 ingredients of the chewing gum composition more 292 aggressively to the teeth than is possible with 293 mouthwashes.
294 (5) In general, consumers will orally masticate a chewing 295 gum ,~omposition longer than for other means of 296 administration thus, giving the specialized 297 ingreldients of the chewing gum composition a longer 298 and so more effective treatment period upon the teeth.
299 (6) Most consumers do not brush after each meal or snack 300 because it is inconvenient and time consuming. This 301 significantly increases the rate of dental decay.
302 Howev,er, this new chewing gum composition provides a 303 very convenient method of dental care and so will 304 appre,-iably increase the overall dental health of the 305 conswrner.
306 (7) By us:Lng dental desensitizing agents in this fashion 307 professional dental personnel are not required nor is 308 the cumbersome use of dentifrices, toothbrushes, and 309 mouthwashes. This not only reduces time and cost but 310 also eliminates the need for special equipment, 311 place~, water or the awkward disposal of oral refuse.

313 The disclo-,ure will now begin with the base of the chewing 314 gum composition which is, in general, the starting point for 315 most chewing gums. The disclosure will then progress, and CA 02226~8~ 1998-03-16 316 finally detail ihe specialized ingredients which may be used to 317 render one or more of the above benefits.
318 To begin, therefore, the term, "chewing gum composition", 319 used herein inc]Ludes regular chewing gums, non-tack gums, bubble 320 gums, and other-,. They may also possess hard edible shells, gel 321 or liquid centres, or various other traits or characteristics, 322 alone or in combination. A chewing gum composition also 323 conventionally consist of two basic portions which may be termed 324 gustatory and masticatory. The gustatory portion provides 325 sweetness and flavour while the masticatory portion or chewing 326 gum base provides the viscoelastic properties essential to the 327 "chewability" o~ the gum.
328 The masticatory portion of the chewing gum composition used 329 herein may, therefore, utilizes any commercially acceptable 330 chewing gum base, the quantity of which, may range as high as 331 ninety-nine decimal nine (99.9) weight percent of the final 332 chewing gum composition. The chewing gum base may also comprise 333 many varied substances which can provide regular, non-tack, 334 hard, soft or alternate attribute and may even employ natural or 335 synthetic ingredients alone or in combination. As a result, the 336 chewing gum base may comprise a combination of one or more 337 elastomers, colouring or pigmenting agents, dental abrasives or 338 abrading agents, anti-odorants, fluoride based compounds, 339 humectants, soft:eners, plasticisers, emulsifiers, bulking agents 340 or fillers, preservatives, acidulants, anti-oxidants, anti-341 sticking agents, alkaline agents, water, and other miscellaneous 342 compounds in order to achieve the various specific qualities, 343 characteristics or textures desired. It is, however, not 344 mandatory that all of the ingredients listed above be used. Only 345 those required to make the chewing gum base desired need be 346 added.
347 Examples of some suitable elastomers may, therefore, 348 include, but are not limited to, chicle, jelutong, balata, 349 namaquland rubber, almeidana gum, abba rubber, guttapercha, and 350 the various gutl::a rubbers. The elastomer may also be made from CA 02226~8~ 1998-03-16 351 resins such as cumarone resins, copal gum, kauri gum, ~mm~r 352 gum, sweet bay gum, spruce gum, and balsams. Others may also 353 consist of synthetic elastomers such as polyisobutylene, 354 polyisoprene, and copolymers of butadiene and styrene.
355 Hydrogenated or partially hydrogenated vegetable oils such as 356 soy bean oil, cottonseed oil, corn oil, peanut oil, and palm or 357 animal fats such as tallow and lard can also be used. Cocoa 358 butter, paraffin, beeswax, carnauba, petroleum wax, 359 polyethylenes, and polyvinyl polymers are other examples of 360 materials which can be used.
361 As stated previously the chewing gum base may contain one 362 or more colouring or pigmenting agents. These pigmenting agents 363 may be obtained from either natural or synthetic sources, or a 364 combination thereof. Thus, by way of example and not 365 limitation, some common available colouring agents may include 366 FD and C-type ~lyes and lakes, fruit ancl vegetable extracts, 367 titanium dioxid,e, and the like.
368 The pigmeIIting agent titanium dioxide is particularly 369 useful because of its brilliant opaque white colour and its 370 extremely small particle size. Though a larger size may be used 371 the titanium dioxide particles most useful in the present 372 chewing gum compositions have an approximate size of between 0.1 373 and 1.5 microns and most preferably have a particle size between 374 0.1 and 0.2 microns. A pigmenting agent having this approximate 375 size allows the pigmenting agent to be absorbed by the enamel of 376 the teeth and so occupy the space between the hydroxyapatite 377 crystals or prisms that make up the enamel layer of the teeth.
378 Thus, this pigment competes with the substances that tend to 379 attack, stain or discolour teeth by filling the space between 380 the prisms with an inert white material instead of an 381 undesirable substance or colouring. A further benefit of 382 titanium dioxide as the pigmenting agent is its ability to also 383 function as a polishing or abrading agent when it is being used.
384 One or more polishing or abrading agents may also be 385 utilized in the chewing gum base. The type of abrading agents CA 02226~8~ 1998-03-16 386 employed are nol:: restricted to any specific types or quantities.
387 This effectively allows the abrading compounds used to suit the 388 final effects dLesired. In any case, their incorporation will 389 help clean and polish teeth and so help produce a smooth and 390 shiny dental surface that will resist discoloration, bacterial 391 accumulation, and retention. This will reduce the amount of 392 oral acids produced by plaques and so, in turn, reduce dental 393 demineralizatiol~. Moreover, as dental surfaces become cleaner 394 the therapeutic performances of other ingredients such a 395 fluorides or dental desensitizing agents will notably increase.
396 Examples of a mild or low abrasive may include titanium dioxide, 397 sodium bicarbonate, calcium carbonate, dicalcium phosphate 398 dihydrate, a mixture of tricalcium phosphate and calcium 399 carbonate, aluminum oxide or hydrated silica dicalcium 400 phosphate. Examples of a moderate abrasive may include a mixture 401 of silica gels, a mixture of egg shell powder and dicalcium 402 phosphate dihydrate, a mixture of hydrated aluminum and dibasic 403 calcium phosphate dihydrate, a mixture of insoluble sodium 404 metaphosphate and dicalcium phosphate, or a mixture of hydrated 405 silica and alum;num oxide. Other compounds and mixtures are, of 406 course, availab:Le.
407 While sodium bicarbonate is a mild abrading agent its 408 usefulness doe~i not end here. It can, for instance, also 409 function as an anti-odorant and so provide significant odour 410 absorbing capahilities in order to minimize the effects of 411 halitosis. Being a water soluble alkaline compound it also has 412 the ability to neutralize significant quantities of oral acid 413 and so diminish yet again, the acidic effects of plaque.
414 Sodium bicarbonate is also quite inexpensive and generally 415 available in powdered form. Thus, it can be used to coat a 416 chewing gum or it can be easily added, mixed, blended, or 417 otherwise incor~porated into the chewing gum composition in most 418 stages of its manufacture. It can readily be incorporated into 419 or onto the chewing gum base, sweetening agent, flavouring 420 agent, hard exterior shell or gel or liquid centre as a powder CA 02226~8~ 1998-03-16 421 or mixed into any compatible substance or liquid used therein.
422 The ease with ~hich sodium bicarbonate may be introduced into 423 the chewing gum composition offers the manufacturer lower 424 production as wlell a shorter implementation costs for equipment 425 already in service may be readily utilized or adapted to handle 426 it.
427 The amount of sodium bicarbonate used in the chewing gum 428 formulation may be adjusted to suite any specific taste, 429 texture, struct:ural feature, chewability, odour absorbing or 430 acid neutralizing characteristic. In some recipes it may even 431 be desirable to omit its use altogether or conversely, the 432 manufacturer may employ copious quantities to amplify its 433 effects. The chewing gum composition may even comprise a chewing 434 gum base to wh-lch sodium bicarbonate is only added or it may 435 also include a sweetening or flavouring agent alone or in 436 combination. As a result, the amount of sodium bicarbonate used 437 is given great latitude and can, therefore, range from 438 approximately eighty (80) weight percent, of the final chewing 439 gum composition, all the way to zero (0)~ While the level of 440 alkalinity provided by sodium bicarbonate is not set at any 441 specific measure and thus, can vary between compositions the 442 maximum values c)f both quantity and oral alkalinity must always 443 be of a safe level. The edicts of safety and non-toxicity must 444 be absolutely observed for all ingredients when formulating 445 these types of chewing gums or any of their alternate versions 446 or variations.
447 While sodium bicarbonate is a preferred compound there may 448 be instances where it may be necessary or desirable to 449 substitute one or more alternate compounds in place of sodium 450 bicarbonate. Such times may arise when, for example, a formula 451 for a chewing gum composition may conflict with sodium 452 bicarbonate. Another example may result from the need to 453 restrict high sodium diets. In any event, these substances, 454 though less preferable than sodium bicarbonate, must also be 455 water soluble and alkaline in nature and possess chemical traits CA 02226~8~ l998-03-l6 456similar to those found in sodium bicarbonate. Such a compound 457may, therefore, include potassium bicarbonate. The exact 458solubility and alkalinity of potassium bicarbonate will vary 459from that provided by sodium bicarbonate but this can be 460compensated by varying the respective amount used in the chewing 461gum composition. Potassium bicarbonate can also be used alone 462or in combination with other ingredients as well as being 463blended or ot:herwise incorporated into the chewing gum 464composition in a fashion similar to or like that used with 465sodium bicarbonate.
466Another substance which the chewing gum base may utilize is 467a fluoride based compound. These compounds, also called 468fluorides, have in the past been found to help prevent the 469incidence of carious lesions or caries. Caries are caused when 470teeth demineralize at a rate faster than they remineralize and 471most demineralization is caused by acid producing dental 472plaques. Remine~alization, however, is promoted by calcium and 473phosphate and these elements are the chief remineralizing agents 474found in saliva. Fluoride based compounds, therefore, provide 475protection from carious lesions or caries by acting as a 476catalyst to speed the precipitation of calcium phosphate, in the 477form of a hydroxy apatite, onto or into teeth. However, this is 478not fluoride's only role. It is also able to inhibit the 479activity of some bacterial enzymes and their acid producing 480processes, and at extremely high concentrations it can also kill 481some plaque bacl_eria. Even more important, it tends to become 482incorporated in1::o the apatite, as a fluoridated hydroxy apatite, 483or "fluorapatit~e", creating a mineral that is appreciably less 484dissolvable by acid.
485Hence, the chewing gum base may contain one or more 486fluoride based compounds. Their assimilation into the chewing 487gum base can be likened to, but not limited to, that used by 488sodium bicarbonate. The fluoride compounds used may also be 489slightly solublle in water or may be fully water soluble. They 490are, however, foremost characterized by their ability to release -CA 02226~8~ l998-03-l6 491 fluoride ions in water and by freedom from undesired reaction 492 with other compounds of the chewing gum composition. Among these 493 materials are numerous fluoride based compounds which can 494 comprise inorgal~ic fluoride salts such as soluble alkali metal, 495 alkaline earth metal salts, and others. Examples of such 496 include sodium I-luoride, potassium fluoride, ammonium fluoride, 497 a copper fluoride such as cuprous fluoride, zinc fluoride, 498 sodium fluorosilicate, ammonium fluorosilicate, sodium 499 fluorozirconate, barium fluoride, calcium fluoride, sodium 500 monofluorophospl~ate, sodium silicofluoride, aluminum mono- and 501 di-fluorophosphate, and fluorinated sodium calcium 502 pyrophosphate. However, alkali metal and tin fluorides, such as 503 sodium and stannous fluorides, sodium monofluorophosphate (MFP), 504 amine fluoride, and mixtures thereof, are preferred.
505 The amount of fluorine based compound used is dependent to 506 a large extenl upon the type of fluorine compound, its 507 solubility, and the formulation of the final chewing gum 508 composition but it must always be a nontoxic amount. Thus, the 509 amount can range to about four ( 4) weight percent and preferably 510 to about one and one half (1.5) weight percent of the final 511 chewing gum composition.
512 Optimizing the effects and benefits of fluorides is also of 513 prime importance and one way of accomplishing this is to provide 514 as plaque free a dental enamel surface as possible. All 515 fluoride compounds will tend to function better when given a 516 cleaner dental surface on which to work. In this respect, the 517 incorporation into the chewing gum composition of one or more 518 abrading agents, peroxide based compounds or other similar 519 scrubbing or cleaning ingredients can render markedly improved 520 results for these substances tend to attack and remove plaques.
521 As these plaques diminish the fluoride's effect upon the teeth 522 Wi 11 be much more effective and useful.
523 To foster greater consumer appeal the gustatory portion of 524 the chewing gum composition may also contain one or more 525 sweetening and or flavouring agents. Sweeteners include, for CA 02226~8~ 1998-03-16 526 example, both natural and artificial compounds and combinations 527 thereof in order to provide any sensorially acceptable blend.
528 Examples of some common available sweeteners include sucrose, 529 lactose, dextr~se, maltose, dextrin, dried inverted sugar, 530 fructose, levu]Lose, galactose, corn syrup and their solids, 531 sorbitol, mannitol, xylitol, hydrogenated starch hydrolysates, 532 maltitol, sucralose, aspartame, salts of acesulfame, alitame, 533 saccharin and its salts, cyclamic acid and its salts, 534 glycyrrhizin, clihydrochalcones, thaumatin, monellin, and the 535 like. Though any type of sweetener may be used artificial 536 compounds are p]eferred for they reduce the potential for dental 537 decay. Xylitol, an artificial sweetener, is particularly useful 538 for it is incapable of nourishing bacteria and has demonstrated, 539 in certain clinical studies, the ability to inhibit the growth 540 of bacteria evell in the presence of sugar.
541 The chewing gum composition may also utilize one or more 542 flavouring agents. They may comprise essential oils, synthetic 543 flavours, or mixtures thereof including, but not limited to, 544 oils derived from plants and fruits such as citrus oils, fruit 545 essences, mint, peppermint oil, spearmint oil, clove oil, oil of 546 wintergreen, anise, sassafras, sage, eucalyptus, marjoram, 547 c;nn~ on, lemon, orange, banana, cherry, apple, pineapple, 548 grape, strawberry, blueberry, tutti frutti, methyl salicylate, 549 and the like. Those skilled in the art will recognize that 550 natural and artificial flavouring agents may be used 551 independently or combined in any sensorially acceptable blend.
552 All such flavours and flavour blends are contemplated by the 553 present invention.
554 Chewing gwrn compositions have, in the past, also utilized 555 hard coated gums or shells such as that disclosed by Michael A.
556 Reed and Ulesses P. Orr in their United States Patent 5,270,061 557 which issued 14 December 1993. Chewing gum compositions such as 558 these, or others that may contain a liquid centre such as that 559 disclosed by Su}:)raman R. Cherukuri, Steven M. Faust and Kenneth 560 P. Bilka in their United States Patent 4,980,178 which issued 25 CA 02226~8~ 1998-03-16 561 December 1990 can also benefit from the introduction, into their 562 compositions, of the ingredients herein specified by this 563 disclosure. T]hey may be deployed into one or all of their 564 individual elements. Those elements being the hard outer shell, 565 the interior or exterior soft or hard gum portions or the liquid 566 centre itself.
567 Various chewing gum compositions, ingredients, and 568 components are also disclosed in the examples given below. These 569 examples, the cLisclosures of which are hereby incorporated by 570 reference into this specification, provide additional 571 information on chewing gum bases, compositions, preparations, 572 and characteristics thereof. They also provide examples of 573 various sweetening and flavouring agents which can be used in 574 the gustatory portion of the chewing gum composition.

576 (1) U.S.A. Patent: Number 5,336,509 577 Invenl_ed by: Gordon McGrew and 578 Steven P. Synosky.
579 Issued: 9 August 1994.
580 (2) U.S.A. Patent: Number 5,334,397 581 Invented by: Ronald L. Ream, Christine L.
582 Corriveau and William J. Wokar.
583 Issue~d: 2 August 1994.
584 (3) U.S.A. Patent: Number 5,270,061 585 Invenl_ed by: Michael A. Reed and 586 Ulesses P. Orr.
587 Issued: 14 December 1993.
588 (4) U.S.A. Patent: Number 5,110,607 589 Invenl_ed by: Robert K. Yang.
590 Issue,1: 5 May 1992.
591 (5) U.S.A. Patent: Number 5,087,459 592 Invenled by: Michael S. Chun, Albert H.
593 Chapdelaine, and Mansukh M. Patel.
594 Issued: 11 February 1992.
595 (6) U.S.A Patent: Number 4,980,178 CA 02226~8~ 1998-03-16 596 Invented by: Subraman R. Cherukuri, Steven 597 M. Faust and Kenneth P. Bilka.
598 Issued: 25 December 1990.
599 (7) U.S.A. Patent: Number 4,265,877 600 Invented by: Louis T. Tenta.
601 Issued: 5 May 1981.

603 The aforedisclosed information details some of the 604 compositions and commonly available ingredients presently used 605 in making chewing gums. However, the disclosure will now detail 606 various specialized ingredients which can be used to provide 607 improved resullts over presently manufactured chewing gums.
608 These ingredienl_s can also be used alone or in combination with 609 each other and their individual procurement may be derived, 610 where possible, from either natural or synthetic sources.

613 The chewing gum composition may also make use of one or 614 more peroxide based compounds such as, but not limited to, 615 calcium peroxide, and sodium carbonate peroxide. Their use will 616 help remove del~tal plaques and whiten teeth and so thereby 617 reduce the incidence of dental caries and other related 618 diseases. Thi~, ability to reduce dental decay stems from the 619 fact that oxygen is released during their decompositions. Thus, 620 when a peroxide based compound is masticated in the mouth the 621 decomposal rele!ase of oxygen will vigorously attack all oral 622 bacteria and p:Laques and also bleach or whiten teeth. Over 623 time, as these plaques and their acidic byproducts are reduced 624 the progression of carious lesions and that of calculus 625 accumulation upon the teeth is also substantially curtailed.
626 Peroxide based compounds being mostly alkaline in nature 627 will also facilitate the neutralization of oral acids. The 628 level of alkalinity is not set at any specific figure or amount 629 and thus can be suitably adapted to the chewing gum composition 630 desired. The concentration of the peroxide based compound will CA 02226~8~ l998-03-l6 631 also vary to some extent upon the type of peroxide compound 632 employed and the formulation of the final chewing gum 633 composition but both the quantity as well as the level of 634 alkalinity must be of a safe level. As a result, the amount 635 used, though it may in some instances be higher, will preferably 636 comprise twenty-five (25) weight percent or less of the final 637 chewing gum composition. Assimilation of these substances into 638 the chewing gum composition can also be in a fashion similar to, 639 but not limited to, that used by sodium bicarbonate.
640 Another beneficial aspect of peroxide based compounds is 641 their ability 1o reduce halitosis. Peroxide based compounds 642 reduce the odours produced by certain oral bacteria not by the 643 absorbtion or the masking of odours but by the eradication of 644 the bacteria itself. As previously mentioned, peroxide based 645 compounds when masticated in the mouth release oxygen and oxygen 646 being a disinfectant will quickly attack any bacteria or plaques 647 that it finds. Thus, with repeated use bacterial or plaque 648 created odours a!re m; n; ; zed. If, however, odours are of a non-649 bacterial nature then ingredients, as previously revealed, that 650 absorbed or masked odours should be used instead.
651 Finally, when a calcium containing peroxide compound such 652 as calcium peroxide is masticated in the mouth it not only 653 provides a peroxide component but a calcium one as well. This 654 confers a notable supplementary benefit for calcium is a 655 component of sa]iva and one of the chief remineralizing elements 656 used by the bod~ in rebuilding teeth. As a result, the consumer 657 would be the beneficiary of yet another important factor for 658 optimizing dental care.

660 DENTAL DES]ENSITIZING AGENTS
661 It has been estimated that as many as one in seven people 662 have suffered from dentinal hypersensitivity at some time. In 663 the United Stat,es this figure has ranged as high as forty (40) 664 million adults of which ten (10) million of these endure chronic 665 hypersensitivity. Hypersensitivity is most common among CA 02226~8~ l998-03-l6 666 patients aged twenty to forty years with the affliction peaking 667 in the thirties. The condition has also been reported to occur 668 slightly more often in females than males, however, this finding 669 has not been statistically significant. These figures, 670 therefore, clearly demonstrate the magnitude of this affliction 671 and the scope of suffering manifested by it.
672 Dentinal hypersensitivity is an affliction which can be 673 simply defined as an adverse reaction or pain in one or more 674 teeth resulting from a thermal, chemical, or mechanical 675 stimulus. However, microscopic examination of clinically 676 hypersensitive surfaces has shown that areas where the dentine 677 has been exposecIby gingival recessions, defective restorations, 678 caries, periodontal therapy, loss of enamel through poor diet, 679 fractures, toothbrush abrasion, occlusal wear, and 680 parafunctional]labits, or cementum loss from abrasion or erosion 681 can promote sensitivity. Bulimics may also experience extreme 682 dentinal hypers,ensitivity because of the significant enamel 683 destruction caused by stomach acids during periods of induced 684 vomiting. In all cases mentioned above the tubules in these 685 areas, of which there are millions, have been shown 686 microscopically to be wider and more numerous than in 687 nonsensitive areas. Moreover, hypersensitive dentine is found 688 almost exclusively on the facial surfaces of teeth at the 689 cervical margins with the relative sensitivity frequency of 690 individual teel_h being reported as follows: premolars 38 691 percent, incisors 26 percent, canines 24 percent, and molars 12 69 2 percent.
693 Medically, the principle theory to explain the mechanism of 694 pain transmission from the dentine to the pulp is called the, 695 "Hydrodynamic Theory", and it was originated by Kramer and later 696 expounded on by Alfred Gysi. Briefly stated, the theory is 697 based upon the observation that dentine consists of hollow 698 tubules which are filled with fluid secreted by the pulp. These 699 fluids are not static and so can flow either inward or outward 700 depending on the~pressure variations in the surrounding tissues.

CA 02226~8~ 1998-03-16 701 Moreover, each dentinal tubule contains a cytoplasmic cell 702 process that exL-ends from the odontoblast cell body at the edge 703 of the pulp. In young teeth, the process extends to the 704 dentinoenamel or dentinocemental jurLction. In older teeth, the 705 processes may have withdrawn thus helping explain why younger 706 people experience more pain. In addition, the odontoblast cell 707 bodies lie side by side, at the dentinal-pulpal junction, with 708 nerve endings from the pulp. Some of these nerve endings will 709 also extend short distances into the dentinal tubules. When, 710 therefore, any surface simulation causes a rapid flow of fluid 711 within these tubules it may subsequently stimulate the free 712 nerve endings from the pulp and so elicit a painful sensation.
713 Such stimuli, which can include thermal, chemical or mechanical, 714 Will further increase the sensation of pain if enamel 715 thicknesses have been reduced or portions of dentine have been 716 uncovered to expose the dentinal tubules. The theory of 717 hydrodynamics, thus, clarifies how so many different stimuli can 718 elicit the same pain response.
719 If, then, the greatest pain sensations are felt when fluid 720 in the dentinal tubules flows either inward or outward then the 721 occlusion of t]hese tubules should significantly reduce fluid 722 flow in either direction and so diminish the sensation of pain 723 accordingly. Alternately, desensitizing the free nerve endings 724 at the dentinal-pulpal junction should also cause a reduction in 725 pain.
726 With this in mind the invention disclosed herein will 727 endeavour to achieve a reduction in the pain associated with 728 dentinal hypersensitivity by the incorporation of one or more 729 dental desensitizing agent into the chewing gum composition.
730 These desensiti~ing agents will strive to occlude the dentinal 731 tubules or desensitize the free nerve endings from the pulp.
732 Furthermore, th~se ingredients should be safe, inexpensive, easy 733 to use and apply, non-irritating, painless, require minimum 734 application time, and present no danger to the body, teeth or 735 soft tissues of the mouth nor create any discolourment in their CA 02226~8~ 1998-03-16 736 appearance.
737 As a resul~::, suitable desensitizing agents may include, but 738 are not limitecL to, nitrate based compounds such as potassium 739 nitrate, sodium nitrate, lithium nitrate, magnesium nitrate, 740 calcium nitrate, strontium nitrate, and others. Additional 741 desensitizing a~gents may include strontium chloride, sodium 742 citrate, calcium hydroxide, dibasic calcium phosphate, dibasic 743 sodium citrate, strontium acetate and sodium 744 monofluorophosphate, formaldehyde and the like.
745 While desensitizing agents can be used alone or in 746 combination with others the actual quantity of dental 747 desensitizing agent used will inevitably depend to a large 748 extent on the type of desensitizing agent employed and the 749 formulation of Ihe final chewing gum composition. As a result, 750 the amount used, though it may in some instances be higher, will 751 preferably comprise thirty-five (35) weight percent or less, and 752 more preferably comprise fifteen (15) weight percent or less, of 753 the final chewing gum composition. In any event, it must be a 754 safe amount. I-ts integration into the chewing gum composition 755 can be accomplished in a fashion similar to, but not limited to, 756 that used by sodium bicarbonate.
757 As is the case with fluoride, desensitizing agents will 758 render notably improved results if dental enamels are cleaner.
759 Consequently, one or more scrubbing or cleaning agents can be 760 incorporated inl:o the chewing gum composition. Such substances 761 may include, by way of example and not limitation, titanium 762 dioxide, sodium bicarbonate, and other abrading agents or 763 peroxide based compounds such as calcium peroxide, sodium 764 carbonate perox:ide, and the like.

767 The following references, the disclosures of which are 768 hereby incorporated by reference into this specification, 769 further elaborate and detail other ingredients, procedures, and 770 information which may be of use in the disclosure herein.

CA 02226~8~ 1998-03-16 771 (1) Accepted Dental Therapeutics, 39th Edition, 772 Copyright 1982, by the American Dental Association, 773 211 E. Chicago Ave., Chicago, Illinois, U.S.A., 60611 774 Library of Congress Number: 74[2]-MCAT
775 (2) Comprehensive Dental Hygiene Care, 4th Edition, 776 Writt,sn by: Irene R. Woodall, 777 Copyright 1993, by Mosby - Year Book, Inc., 778 11830 Westline Industrial Drive, St. Louis, Missouri, 779 U.S.A., 63146.
780 ISBN Number: 0-8016-7019-5 781 (3) Fenaroli's Handbook of Flavour Ingredients, 782 Written by: Prof. Dr. Giovanni Fenaroli, 783 Copyright 1971, by the Chemical Rubber Company, 784 18901 Cranwood Pkwy., Cleveland, Ohio, U.S.A., 44128.
785 Library of Congress Number: 72-152143 786 (4) Flavor Technology, Profiles, Products, Applications, 787 Written by: Henry B. Heath, M.B.E., B.Pharm.(London), 788 Copyright 1978, Avi Publishing Company Incorporated, 789 Westport, Connecticut, U.S.A
790 ISBN Number: 0-87005-258-9 792 Additional information regarding the subject of this 793 invention can be found in the many books available to the public 794 at libraries and technical centres or in the many patents and 795 government publications currently available today.
796 In conclusion, therefore, the preceding description 797 contains many specificities that should not be construed as 798 limiting the scope of the invention but as merely providing 799 illustrations oi-~ some of the presently preferred embodiments of 800 this invention and thus, the scope of the invention should be 801 determined by t:he appended claims and their legal equivalents 802 rather than by 1_he examples given.

Claims (21)

1. An orally administrable chewing gum composition comprising a chewing gum base and at least one dental desensitizing agent.

2. The chewing gum composition as recited in claim 1 to further comprise at least one sweetening agent, flavouring agent or mixtures thereof.

3. The chewing gum composition as recited in claim 2 wherein the constitution or formulation of the chewing gum composition is selected from the group consisting of regular chewing gums, soft chewing gums, hard chewing gums, non-tack gums, bubble gums, hard edible shells, edible gel centres, edible liquid centres, and combinations thereof.

4. The chewing gum composition as recited in claim 1 wherein the chewing gum composition includes at least one ingredient selected from the group consisting of elastomers, colouring or pigmenting agents, dental abrasives or abrading agents, anti-odorants, fluoride based compounds, humectants, softeners, plasticisers, emulsifiers, bulking agents or fillers, preservatives, acidulants, anti-oxidants, anti-sticking agents, alkaline agents, peroxide based compounds, water, and mixtures thereof.

5. The chewing gum composition as recited in claim 4 to further comprise at least one sweetening agent, flavouring agent or mixtures thereof.

6. The chewing gum composition as recited in claim 4 wherein the constitution or formulation of the chewing gum composition is selected from the group consisting of regular chewing gums, soft chewing gums, hard chewing gums, non-tack gums, bubble gums, hard edible shells, edible gel centres, edible liquid centres, and combinations thereof.

7. The chewing gum composition as recited in claim 6 to further comprise at least one sweetening agent, flavouring agent or mixtures thereof.

8. The chewing gum composition as recited in claim 1 wherein the dental desensitizing agent is selected from the group consisting of nitrate based compounds, potassium nitrate, sodium nitrate, lithium nitrate, magnesium nitrate, calcium nitrate, strontium nitrate, strontium chloride, sodium citrate, calcium hydroxide, dibasic calcium phosphate, dibasic sodium citrate, strontium acetate and sodium monofluorophosphate, formaldehyde, and mixtures thereof.

9. The chewing gum composition as recited in claim 8 to further comprise at least one sweetening agent, flavouring agent or mixtures thereof.

10. The chewing gum composition as recited in claim 9 wherein the constitution or formulation of the chewing gum composition is selected from the group consisting of regular chewing gums, soft chewing gums, hard chewing gums, non-tack gums, bubble gums, hard edible shells, edible gel centres, edible liquid centres, and combinations thereof.

11. The chewing gum composition as recited in claim 8 wherein the chewing gum composition includes at least one ingredient selected from the group consisting of elastomers, colouring or pigmenting agents, dental abrasives or abrading agents, anti-odorants, fluoride based compounds, humectants, softeners, plasticisers, emulsifiers, bulking agents or fillers, preservatives, acidulants, anti-oxidants, anti-sticking agents, alkaline agents, peroxide based compounds, water, and mixtures thereof.

12. The chewing gum composition as recited in claim 11 to further comprise at least one sweetening agent, flavouring agent or mixtures thereof.

13. The chewing gum composition as recited in claim 11 wherein the constitution or formulation of the chewing gum composition is selected from the group consisting of regular chewing gums, soft chewing gums, hard chewing gums, non-tack gums, bubble gums, hard edible shells, edible gel centres, edible liquid centres, and combinations thereof.

14. The chewing gum composition as recited in claim 13 to further comprise at least one sweetening agent, flavouring agent or mixtures thereof.

15. An orally administrable chewing gum composition comprising a chewing gum base, calcium peroxide or sodium carbonate peroxide, and mixtures thereof.

16. The chewing gum composition as recited in claim 15 to further comprise at least one sweetening agent, flavouring agent or mixtures thereof.

17. The chewing gum composition as recited in claim 16 wherein the constitution or formulation of the chewing gum composition is selected from the group consisting of regular chewing gums, soft chewing gums, hard chewing gums, non-tack gums, bubble gums, hard edible shells, edible gel centres, edible liquid centres, and combinations thereof.

18. The chewing gum composition as recited in claim 15 wherein the chewing gum composition includes at least one ingredient selected from the group consisting of elastomers, colouring or pigmenting agents, dental abrasives or abrading agents, anti-odorants, fluoride based compounds, humectants, softeners, plasticisers, emulsifiers, bulking agents or fillers, preservatives, acidulants, anti-oxidants, anti-sticking agents, alkaline agents, water, and mixtures thereof.

19. The chewing gum composition as recited in claim 18 to further comprise at least one sweetening agent, flavouring agent or mixtures thereof.

20. The chewing gum composition as recited in claim 18 wherein the constitution or formulation of the chewing gum composition is selected from the group consisting of regular chewing gums, soft chewing gums, hard chewing gums, non-tack gums, bubble gums, hard edible shells, edible gel centres, edible liquid centres, and combinations thereof.

21. The chewing gum composition as recited in claim 20 to further comprise at least one sweetening agent, flavouring agent or mixtures thereof.