Prophylactic dental compositions

Abstract

A specific particle size distribution of feldspar is employed as both a cleaning and a polishing agent for teeth. It consists initially of a powder that, preferably at the time of use, is mixed with a moistener and becomes a paste to be used by the dentist or dental hygienist. It can be combined with a humectant but in smaller proportions than heretofore. It can be used with or without a dental caries-reducing amount of a fluoride anticariogenic agent, either stannous or sodium fluoride, and is more effective than prior materials though mixed with much smaller quantities. It can be supplied in a sectional kit wherein the initially-separated wet and dry ingredients can be joined at the time of use. It can be used as a self-administered prophylactic paste for mass treatment applications.

Description

FIELD OF THE INVENTION

The present invention relates to the field of dental prophylaxis, and more particularly to prophylactic cleaning and polishing agents wherein both sodium and stannous fluoride systems can be used.

Although food particles, mild stains from tea, tobacco, and coffee can be removed to a large extent from teeth by regular brushing with most commercial dentifrices, good preventive dentistry suggests that exogenous stains, calculus (tartar) and various other accumulated stains must be removed periodically by a dentist or dental hygienist. For maximum results, the prophylactic paste which is used by the dentist or hygienist should be capable of removing the stains which are not removed by daily home use of a commercial dentifrice. Professional dental prophylaxis should result in clean, lustrous teeth, and the polishing agent employed by the dentist or hygienist should accordingly be capable not only of thoroughly cleaning the teeth, but also of polishing the teeth to a high luster without excessive scratching.

Various dental abrasives have been employed for dental prophylactic treatment. Levigated alumina, for example, is an excellent polishing agent but is unduly abrasive to enamel, dentin, and cementum. Precipitated chalk cleans teeth fairly well but produces a rough tooth surface. Flour of pumice, a popular ingredient of dental prophylactic pastes, is a fair cleaner but is abrasive and produces a poor polish.

U.S. Pat. Nos. 3,257,282, 3,330,732 and 3,378,445 are referred to as describing a number of cleaning and polishing agents relating expecially to the improvement consisting of the use of finely-divided zirconium silicate having a specified particle size distribution, the larger particle sizes serving to clean and the smaller sizes to polish the teeth. The use of zirconium silicate in prophylactic dentistry has several drawbacks. First, particle sizes of about 70 microns are required for good cleaning, but such sizes cause undesirably high abrasiveness and do not polish well. To obtain polishing it is necessary to include small sized particles, which have little cleaning effect. This necessary addition of very small particle sizes required for polishing limits the quantity of large particle sizes which can be employed for needed cleaning, and vice versa. Second, although zirconium silicate does not initially greatly reduce the availability of ionizable fluorine from a fluoridecontaining anticariogenic agent such as tin fluoride (U.S. Pat. Nos. 3,257,282 and 3,378,445) such zirconium silicate-fluoride mixtures nonetheless ordinarily contain the fluoride adjuvant in large quantities in order to compensate for the gradual loss in activity of this component in the mixtures. The taste of the zirconium silicate - stannous fluoride adjuvant mixture is nauseating, and 7- 10% of the patients gag and vomit when such compositions are used to clean their teeth.

Zirconium silicate, as used commercially, usually combined with several ingredients to provide a prophylactic paste, is applied to the teeth by means of a rubber "prophy" cup which is rotated by an engine-driven dental handpiece. During this procedure, portions of the abrasive come into contact with the moving metallic parts in the dental handpiece, and cause the same to wear. Further, the glycerin-containing zirconium silicate pastes which are commercially available tend to "sling" during the cleaning operation; that is, due to the centrifugal force on the paste generated by the rapidly rotating prophylactic cup, the paste tends to fragmentize and is hurled outwardly into the mouth from the spinning cup.

It has been found that feldspar in certain size ranges can be used as a combined cleaning and polishing agent, overcoming the above problems of prior art. Tests show that both good cleaning and good polishing results are obtained from a range of particle sizes within given limits, so that all particles participate in both functions, regardless of size. This has been demonstrated with particle sizes from about 40 to 325 mesh, and about 420 to about 37 M. Cleaning and polishing are obtained with less scratching of the surface than with prior materials. Also it has been found that larger particles of feldspar, in contrast to other abrasives, are less abrasive than smaller particles of other materials, which accentuates the advantage.

In addition, with feldspars the amount of anticariogenic agent added can be sharply reduced, and yet superior reduction of enamel solubility is obtained. Such property has, among others, the advantage that repulsive taste is minimized or avoided. And where there are no active caries, the feldspar can be mixed with sodium fluoride instead of stannous fluoride, thereby eliminating the taste problem.

In addition, the material can be supplied as a powder mix, and mixed with liquid at the time of use. This can eliminate at least a major part of the glycerine or other such material familiarly used in these pastes, and thereby improves the effectiveness of the fluoride and reduces slinging and injury to the handpiece. The feldspar can be used with less humectant, thereby providing better cleaning.

It is an object of the present invention to provide a new dental prophylactic cleaner and polisher capable of both effective cleaning and polishing of teeth with minimum enamel Scratching. Another object is to provide a kit for the preparation of such material into a paste. A further object proportioned to provide a dental prophylactic paste that can be proportined to suit cleaning of childrens' or of adults' teeth. It is another object of the invention to provide a prophylactic paste capable of effective cleaning and polishing of teeth, which includes either a stannous or sodium fluoride-containing anticariogenic agent and which is pleasing to the taste.

It is yet another object of the invention to provide a dental prophylactic paste including a fluoride-containing anticariogenic agent in which the quantity of fluoride can be substantially reduced, and yet which can obtain better enamel solubility reduction, which surprisingly is possible with certain of the feldspars as the cleaning and polishing agent.

It is a further object of the invention to provide a method for the effective cleaning and polishing of teeth with simultaneous anticariogenic fluoride treatment, which treatment does not cause gagging or emesis in patients.

It is yet a further object of the invention to provide a dental prophylactic paste adapted for use with a prophylactic cup which does not produce objectionable dental handpiece wear.

The Principal Feldspar Material and Size

Feldspars of various compositions are known, and are basically potassium, sodium, calcium and barium-containing aluminum silicates or mixtures thereof. Reference is made to Searle, A. B. & Grimshaw, R. W., The Chemistry and Physics of Clays and Other Ceramic Materials, Third Ed., Earnest Ernest Benn Ltd., London, 1960, pp. 167- 169, 892. The preferred feldspar employed in the present invention as a cleaning and polishing material is a combination of sodium aluminum silicate and potassium aluminum silicate. The composition by weight may have approximately the following:

Sodium as Na.sub.2 O 3 - 11% Calcium, Al, SiO.sub.2 0 - 3% as CaO Potassium to 15% as K.sub.2 O Si 60 - 70% as SiO.sub.2 (a portion may be alpha quartz to 5% of the feldspar) Al.sub.2 O.sub.3 Balance, or 15 - 25% Impurities 1 - 5%

While a feldspar higher in calcium may be used for cleaning and polishing the teeth, the feldspars should be low in calcium and magnesium ions when combined with fluoride for therapeutic treatment, as will be explained.

A particularly useful feldspar has approximately the following composition by weight:

Silica, SiO.sub.2 66.8% (66.8 - 68.5) Alumina, Al.sub.2 O.sub.3 19.6 (17.5 - 19.6) Iron oxide, Fe.sub.2 O.sub.3 0.04 (.04 - .08) Calcium oxide, CaO 1.7 (0.3 - 1.7) Magnesium oxide, MgO Tr. (Tr.) Sodium oxide, Na.sub.2 O 6.9 (3.0 - 6.9) Potassum oxide, K.sub.2 O 4.8 (4.5 - 10.4)

The parenthetical percentages are ranges of the feldspars that can be used as such or mixed to form the material used. A nepheline syenite may be mixed in also to increase the sodium.

This feldspar of the present invention has a particle size range such that substantially none of the particles is retained on a 20 mesh screen and the size range is essentially between 40 and 325 mesh. Preferably, the feldspar particle size distribution is such that by weight approximately:

0% (841 Microns) retained on a 20 mesh screen; 0-5% (149 Microns) retained on a 100 mesh screen; 0-15% (74 Microns) retained on a 200 mesh screen; 0-25% (44 Microns) retained on a 325 mesh screen; 55-90% (44 Microns) pass through a 325 mesh screen.

The screen sizes referred to herein are of the U.S. Sieve Series, ASTM specification E-11-61. Good cleaning and polishing without serious scratching are pronounced when the feldspar particle size range is such that a majority of the particles by weight pass through a 100 mesh screen. Substantially all are retained on a 600 mesh screen.

The feldspar of the foregoing composition and size ranges can be mixed with water and used as a prophy cleaner and polisher. It should, however, incorporate a binder (0.1- 0.5%) and a small amount (2- 8.0%) of humectant.

The dry ingredients may be provided to dentists and dental hygienists in powder form, to which the professional may add water or a fluoride-containing aqueous solution at the time of use to form a paste conforming to the particular requirements at hand.

Within the indicated size range, the particles are effective for both cleaning and polishing. Hence, it is unnecessary to be meticulous in proportioning large and small particles, so as to obtain a blend that can both clean and polish teeth. The value of this can be further understood by recognizing that for prophylactic cleaning and polishing of children's teeth, very little actual scouring is required, whereas for adults' teeth, stained by tobacco, coffee, eggs and the like, substantial scouring is required. With prior art cleaners, separate mixes of essentially finer sizes are made, where necessary, to avoid excess and unnecessary scratching of the teeth, and other mixes of larger sized particles are made to perform the difficult cleaning adequately.

With the feldspar of the present invention, it is possible to use a single overall size range of particles for both children's teeth or adults'. And importantly, in both cases the scratching is less injurious to the enamel than with the prior art materials. If desired, the present feldspar materials may be used in smaller sizes (such as 170- 350 mesh) for children's teeth, but tests indicate it to be unnecessary.

This product is thus much safer to use than prior art materials, because it cleans and polishes as well or better than prior art materials, with less deleterious abrasion and scratching.

The Pastes

Preferably at the time of use, the powder is made into a paste, that includes 90- 95% of the feldspar as defined above, a binder (that acts also as a dispersing agent) which preferably is hydroxyethyl cellulose, hydroxymethyl cellulose, or mixtures thereof as binders, in amounts of from about 0.1 to about 0.5% by weight, and a humectant such as propylene glycol or glycerine in an amount of from about 2 to about 8% by weight. The binder aids in dispersing the glycerine or other humectant. As noted later, the paste may contain a fluoride anticariogenic agent, and may contain small amounts of bleaching, coloring and flavoring materials as are known in the art.

The above paste has the unusual characteristic of being resistant to "slinging" during cleaning of the teeth with a rubber prophylactic cup. "Slinging" refers to the tendency of a prophylactic paste to be hurled outwardly from the rapidly spinning prophylactic cup into the mouth, which is often times unpleasant to patients. By reducing the slinging tendency of prophylactic paste, patient and operator discomforture is reduced and the amount of paste which is required for a complete treatment is also reduced.

The material also reduces wear on the handpiece.

The Pastes: Humectant Use

Dental pastes in general ordinarily contain an abrasive agent, water (such as an aqueous solution of a fluoride), and a humectant such as glycerine. The purpose of the humectant is to reduce the propensity of aqueous pastes to dry out and become hard. When furnished in pre-packaged form to be used over a long period of time, such as in tubes or jars or the like, the paste of the present invention should contain at least about 25% by weight of a humectant such as glycerine, mannitol, sorbitol, propylene glycol, or other polyhydroxy alcohols. Glycerine and propylene glycol are the usual humectants in tooth pastes.

The humectants, especially glycerine, have the disadvantages of giving an oily taste in the mouth, of reducing the anticariogenic effect of fluoride adjuvants, and of reducing the cleaning effect. Reducing the percentage of humectant improves all of these problem situations.

The reduction of the cleaning characteristics of the finely-divided feldspars described above by larger quantities of humectant is believed to occur because the feldspar particles, as small, sharp-edged platelets, slide across the tooth surface during cleaning, and when large quantities of a humectant are employed, the humectant forms a slippery interface between the tooth surface and the feldspar particles, reducing to some extent the ability of the feldspar particles to effectively remove stains and the like from the tooth surface. It has been found that when no more than about 8% by weight of a humectant is employed, there is substantially no reduction in the cleaning ability of feldspar particles.

This low quantity of humectant is sufficient if the paste is not subject to a long lapse of time before being used. For this reason, for ordinary use on adults, the paste should be made up shortly before use, and the amount of humectant be held to no more than about 8%, instead of having it prepackaged in a form that requires high percentages such as 25% humectant. This low percent of humectant not only gives better cleaning, but it reduces or eliminates the unpleasant oily taste, and as will appear, it improves the effectiveness of the fluoride adjuvants.

For professional prophylactic use for children, it is not desired that the prophylactic paste be highly abrasive; hence, such pastes may be made up in advance and may contain substantial quantities (e.g., above about 20% by weight) of a humectant such as glycerine or the like.

Anti-Cariogenic Agent

A particularly important advantage of the present invention is in dental therapeutics, since the feldspars described are significantly better with fluoride anticariogenic agents that are prior art materials. It is possible to get as good or better anticariogenic effects using the feldspars with much smaller quantites of fluorides than have heretofore been possible, and to have more long-lasting protection from caries. It is also possible to use sodium fluoride as the anticariogenic agent.

Since dental caries is caused, at least in part, by the solution of enamel in biologically produced acids of the oral cavity, a decrease in the solubility of enamel in such acids by treating the enamel with a fluoride can reduce the dental caries incidence. One measure of the ability of a fluoride to decrease enamel solubility due to the fluoride treatment is conveniently termed "ESR", meaning enamel solubility reduction, and will be referred to as such hereinafter. ESR may be measured by the method set forth in U.S. Pat. No. 3,257,282, and the same is incorporated herein by reference.

When used in combination with a fluoride-containing, anticariogenic adjuvant such as sodium fluoride in aqueous solution, the tendency of the present feldspar to "deactivate" the fluoride-containing adjuvant has been substantially nil. Surprisingly, the fluoride (anticariogenic) activity of sodium fluoride when employed in a feldspar paste made up shortly before use is equal to and more persistent or durable in the mouth than that obtained through the use of a sodium fluoride solution alone, and is much greater than that obtained with sodium fluoride in combination with a zirconium silicate or flour of pumice abrasive.

The feldspar used with fluorides should be one low in calcium (preferably below 2.0%). Apparently the high calcium feldspars form insoluble calcium fluorides that reduce the quantity of fluoride that is active in the mouth to reduce caries.

Not only is the anticariogenic effect of the fluoride superior in the present invention, but it can be obtained using much less of the adjuvant by weight than with other prior art dental prophylactic abrasives. This eliminates or at least reduces bad flavor problems and the nauseating effects of conventional larger quantities of fluoride-containing adjuvants, especially stannous fluorides.

Fluoride-containing adjuvants are employed in pastes of the invention in a sufficient concentration to significantly reduce the incidence of dental caries in patients. This concentration may range widely, and depends at least in part upon the nature of the chosen adjuvant. Sodium fluoride is a preferred fluoride-containing anticariogenic adjuvant in many uses of the present invention, but other such adjuvants can be employed in it, such as SnF.sub.2, SnZrF.sub.6, etc.

In general, satisfactory results may be obtained by employing a percentage ratio of stannous fluoride-containing adjuvant to feldspar of from about 1.0 to about 10.0% (all ratios and percentages in this specification are by weight unless otherwise apparent), but a range of about 2.0% to about 6.0% is preferred. With sodium fluoride, a percentage ratio of from about 0.5% to about 1.0% has given good results and is preferred. Other constituents may be as indicated elsewhere herein.

Children's Teeth Treatment

In general, the finer particle size ranges of feldspar (substantially all of which, for example, pass through a 170 mesh screen) may be preferred for use in the treatment of children's teeth, since children's teeth require lighter cleaning because of less persistent stains. An excellent paste low in enamel damage for cleaning and polishing children's teeth and for a highly effective fluoride treatment of the teeth includes feldspar particles, substantially all of which pass through a 170 mesh screen, and a fluoride-containing anticariogenic adjuvant which is preferably sodium fluoride. If this paste is to be used by a professional to clean and fluoride-treat children's teeth, then the paste should be made up shortly before use and should contain less than about 8% by weight of a humectant and a somewhat larger quantity of a fluoride-containing adjuvant. If made long in advance, as for self-administration, it should contain 20-25% or so of humectant. In either case, its principal function is as a carrier for topical application of fluoride.

The Kit

When intended for professional use on adult patients, it is desirable that the prophylactic paste of the invention contain 8% by weight or less of a humectant so that thorough cleaning of the teeth may be effected. This is for reasons above expressed, including the fact that when mixed long in advance, the fluoride tends to become lower in effectiveness, especially when substantial quantities of glycerine are present. When the present mixture is used at the time of mixing, the ESR in the mouth is much better and lasts longer. It is to be noted that the depleting effect of long-term pre-mixing is less with feldspar than with prior art abrasives, and the term of effectiveness in the mouth is longer. However, these factors are further improved by mixing the dry feldspar components with the liquid ones at time of use. The kit separately contains a source of feldspar as described above and an aqueous solution of a fluoride-containing anticariogenic adjuvant. Maintaining the dry and moist components apart eliminates the problems of caking or other undesirable incidents to pre-mixing, as noted herein.

A small disposable measuring spoon (or the like) may be provided in the kit to measure a predetermined quantity of the feldspar (which may be incorporated with other dry ingredients) and a disposable calibrated syringe or pipette (or the like) may be provided for measuring out enough of the solution to be combined with the dry ingredients to provide a paste or suitable consistency which contains a dental caries-reducing amount of the anticariogenic agent.

In a preferred embodiment, the dry paste ingredients, which may include the feldspar particles, binder, flavoring, coloring, bleaching agents, and humectant are disposed in one compartment of a container, and the wet ingredients (including the fluoride-containing anticariogenic adjuvant, water, and the like) are disposed in another compartment of the container. Means normally separating, but providing for communicating the two compartments, are arranged so that the ingredients thereof may be mixed to form the desired paste.

For example, a plastic film packet having two adjacent compartments separated by a rupturable heat seal may contain predetermined quantities of the wet and dry ingredients in the two compartments, respectively. Rupture of the rupturable seal, followed by hand kneading of the contents, will provide a suitable paste. The quantities of wet and dry ingredients are preferably chosen so as to provide sufficient paste for at least a single prophylactic treatment.

The kit affords a flexibility in use in a number of respects. The dry powder may be combined in one packet with stannous fluoride, in another with sodium fluoride. In either case the user can select which adjuvant is desirable, and can add as much as he deems advisable. Indeed, he can omit the fluoride if it is not desired, and can add water to the dry powder to make it a paste for use. In addition, he gets the advantage of mixing at time of use. Also the manufacturer can make up different packet combinations from a small number of variations on the components.

The invention may be more easily understood by reference to the following illustrative, non-limiting examples

EXAMPLE 1

Abrasive slurries made from different particle size ranges of finely-divided feldspar were compared from the standpoint of cleaning and polishing of teeth with flour of pumice and with zirconium silicate slurries.

For the cleaning and polishing evaluations abrasive slurries were prepared using one part of a 1% CMC-7HF (carboxymethyl cellulose) solution to one part of abrasive by weight in order to prevent the abrasive from settling. Commercial prophylactic pastes were analyzed in this respect by diluting three parts of paste with one part of water.

Testing was performed on a machine designed specifically for the purpose. This device has an adjustable constant velocity mandrel to which the prophy cup is attached, the entirety of which can be raised and lowered so that the prophy cup can be adjusted to the desired height. The specimen is contained by four screws in a round cup, which can be revolved at a constant rate and is positioned on an adjustable platform which has a weighted arm that enables the pressure to be set where desired. The prophy cup motor assembly can be lowered onto the specimen until the force is sufficient to balance the weighted arm.

Cleaning evaluations were made on 2.0 .times. 2.0 .times. 0.6 cm black Plexiglas blocks. Tests were run by covering the block with the abrasive slurry and revolving the prophy cup at 500 rpm and the specimen cup at 500 rpm for 2 minutes at a pressure of 273 grams. The prophy cup was lifted every twenty seconds to replenish the supply of paste underneath it in order to simulate activity during a normal prophylaxis.

The amount of Plexiglas removed under identical conditions for each abrasive was taken as an indication of the cleaning ability of each abrasive and was determined both by weight loss and depth measurements on a Bendix Proficorder. For the weight loss method the blocks were thoroughly washed, dried, and vacuum dessicated before and after treatment. The same blocks were read on the Proficorder (accuracy .+-. 0.0000015 inches) to determine the depth of the abrasive scratches made by the prophylaxis treatment. The Proficorder has a diamond stylus tracer that provides a strip chart of the microtopography of the specimen to a very high degree of sensitivity and is a very accurate means of evaluation. The correlation between these two methods of evaluation is good; the greater the weight loss, the greater the degree of cleaning; the deeper the penetration, the greater the degree of cleaning.

Polishing evaluations were made on bovine teeth, mounted in Wood's metal with the labial surfaces exposed, with a prophy cup on the machine described above. The labial surface was leveled on a surface grinder so as to provide a smooth, even area for testing. In this case, the prophy cup, which was revolving at 500 rpms, was lowered onto the specimen which was held stationary, immersed in the abrasive slurry, and maintained in that position for 15 seconds. The degree of polishing was compared to a white carrara glass standard (arbitrarily designated at 100% reflection) on a reflectometer and through an X-Y recorder a print-out, showing the reflectance of the entire tooth surface, was made. The polished area provides peaks on the chart and these are taken as the enamel polish (see tables 1 and 2).

Table 1 shows results of the cleaning tests using five commercial samples and a final sample (IUF 140) of the present invention. Table 2 compares polishing results for two commercial samples and four samples of the present invention. The numbers (-140, -170, -200, -325) in these Tables refer to the screen size through which the particles could pass.

From Table 1 it is seen that the pumices clean rapidly and deeply, but with severe scratching as shown by the last column. Zircate is poorer as a cleaner, and scratches more. The present invention cleans better than zircate, comparably to pumice, and scratches less than most pumices.

From Table 2 it is seen that the present invention polishes better than the other materials.

TABLE 1 __________________________________________________________________________ Plexiglass Cleaning and Enamel Scratching Prophylaxis Paste Plexiglass Cleaning Avg.Wt.Loss Depth of Pene- Avg.Scratch (mgs) tration (.mu.ins.) Depth (.mu.ins) __________________________________________________________________________ Brand A Coarse Pumice 8.7 2675 883 Brand A Medium Pumice 7.1 1913 607 Brand B Pumice 4.1 1067 773 Brand C Pumice 2.9 922 283 Commercial Zirconium Silicate 0.6 66 497 IUF 140* 1.7 512 350 __________________________________________________________________________ * IUF is a paste of the present invention, using -140 mesh feldspar.

TABLE 2 ______________________________________ Enamel Polish Abrasive System Avg. Enamel Polish ______________________________________ Zirconium Silicate 83% Flour of Pumice 83% Feldspar F-4 (-140) 92% Feldspar F-4 (-170) 90% Feldspar F-4 (-200) 95% Feldspar F-4 (-325) 95% ______________________________________

EXAMPLE 2

A test was made to compare cleaning test blocks with feldspars of different particle sizes. The feldspars were mixed 1:1 with a 1% CMC-7HF solution, mechanically tried with prophy cups given a fixed load and operated at a fixed relative speed for a given time. The results, averaging four runs in each case:

-140 mesh feldspar - 4.1 avg. weight loss

-170 mesh feldspar - 4.4 avg. weight loss

-200 mesh feldspar - 4.0 avg. weight loss

-325 mesh feldspar - 3.0 avg. weight loss

These tests show that a wide range of particle sizes gives useful and comparable cleaning results.

Polishing results with the same feldspar mixes developed the following comparisons, each being an average of four bovine teeth tests:

-140 mesh, percent reflectivity 87

-170 mesh, percent reflectivity 87

-200 mesh, percent reflectivity 93

-325 mesh, percent reflectivity 94

These results are all comparable.

In another test for cleaning ability, different particle sizes of feldspar were mixed 1:1 with a 1% CMC-7HF solution, tested with prophy cups on black Plexiglas, the prophy cups being uniformly loaded and operated at a uniform relative rotation speed for uniform time. The results, in each case, show an average dessication weight loss of three samples; in the second column after three days; in the third column after seven days:

-440 mesh feldspar 1.8 2.5 -170 mesh feldspar 1.7 2.2 -200 mesh feldspar 1.6 2.4 -325 mesh feldspar 2.0 2.9

The comparability of these results is evident, and accordingly any of that entire range of particle sizes can be used to obtain good cleaning effect.

EXAMPLE 3

A cleaning test was made to compare cleaning by -140 mesh feldspar, flour of pumice, and zirconium silicate. The cleaning test was conducted similarly to that in Example 1. The results are as follows (in each case an average of three samples):

ZrSiO.sub.2 0.7 weight reduction -140 mesh feldspar 2.8 weight reduction

EXAMPLE 4

A prophylactic paste containing 20.3 of humectant was prepared as follows:

To a mixture of Water 19.5 parts Cabosil (finely-divided silica, a product of Cabot) 0.3 parts Sodium fluoride 2.0 parts and Meta-phosphoric acid 4.0 parts was added a mixture of IUF -140 or -170 49 parts Saccharin 0.3 parts Titanium Dioxide (bleach) 2.0 parts

To the resulting mixture was added the following which had been pre-heated to a temperature of 70.degree.C:

Veegum (magnesum aluminum silicatae as a binder) 0.25 parts and Sorbitol (70%) 2.8 parts and to this was then added, in sequence, a mixture of Propylene Glycol 12.75 parts Peppermint flavoring 0.8 parts and Sodium Lauryl sulfate 0.5 parts Coloring 0.8 parts Carboxy methyl cellulose (CMC-7HF), a product of Hercules) 0.5 parts and Glycerin 4.75 parts The amount of meta phosphoric acid used was that amount required to adjust the pH to 4.5.

TABLE 3 ______________________________________ Enamel Solubility Reduction Paste ESR (%) ______________________________________ Prophy paste for children (20% humectant) (0.91% F-) 23.3 ______________________________________

This paste, which contains only 0.91% of fluoride as NaF, is suitable for use as a prophylactic paste for children. The level of humectant prevents undue erosion of hard tooth structure, but the level of NaF provides a high reduction in enamel solubility (see Table 3).

EXAMPLE 5

In compounding a prophylactic, feldspar-containing powder low in humectant that provided excellent laboratory and clinical results, the following formulation was prepared, amounts being expressed in percent by weight:

To a mixture of -140 Mesh Feldspar F-4 93.5% Titanium Dioxide 1.9 Hydroxyethyl cellulose 0.2 Saccharin 0.25 was added a solution of Propylene glycol 3.7 Peppermint oil 0.5

Four grams of thus-prepared powder were added to 1.0 ml of either a SnF.sub.2 or NaF solution and thoroughly stirred to provide adequate paste for a single prophylaxis. The stannous fluoride solution is prepared fresh by dissolving 0.3 grams of SnF.sub.2 in 1.0 ml of water. The sodium fluoride was used as a stable 4% solution. This provides 1.38% fluoride as SnF.sub.2 (5.66% SnF.sub.2) and 0.36% fluoride as NaF (0.8% NaF).

After thorough mixing, the resulting paste was employed in a prophylactic treatment of a human patient (see Table 4). In comparison with other prophylactic pastes, very little slinging was noted.

TABLE 4 ______________________________________ Enamel Solubility Reduction (ESR) Prophylaxis Pastes with NaF Paste ESR (%) ______________________________________ Commercial Brand Pumice (1.23% F-) 2.0 Commercial Brand Pumice (1.81% F-) 24.1 IUF -140 (0.36% F-) 46.2 Prophylaxis Pastes with SnF.sub.2 IUF -140 (5.7% SnF.sub.2) 72.3 Zirconium Silicate (9% SnF.sub.2) 54.4 ______________________________________

EXAMPLE 6

A test was made to determine whether, with feldspar, the quantity of fluoride could be lowered without seriously reducing the ESR. Treating teeth with a saturated solution of SnF.sub.2 produced ESR's of 91% and 88%. Reducing the amount of SnF.sub.2 by 60%, and 80%, respectively, resulted in ESR's of 99% and 90%, respectively, thus showing that with the feldspar, less fluoride can be used. Other tests have shown comparable results.

EXAMPLE 7

A heat-sealable section of polyethylene film was cut into two segments, each measuring 1 inch by 2 inches. One of the segments was placed on a flat surface and a line was drawn perpendicular to the longest dimension of the sample so as to visually divide the sample into two 1-inch squares. Onto one of the squares was deposited 4.0 grams of the "dry" mixture referred to in Example 5 above, and the second 1-by-2 inch segment of film was then placed upon the first section of film and the edges thereof were heat-sealed together to provide a plastic pouch containing the "dry mixture". A final heat seal between the upper and lower segments of film was placed along the pencil line dividing the lower film sample into two 1-inch sections, this heat seal being one-fourth inch wide except for a portion of its length wherein the heat seal was only 1/16 inch wide. The resulting pouch thus was divided into two compartments, one of which contained the dry material. By means of a hypodermic syringe, 1.0 milliliter of the "wet" mixture of components referred to in Example 5 above was injected into the empty compartment, and upon removal of the syringe, the pin hole therein was heat-sealed to render that compartment watertight. The heat seals about the edges of the two film segments were approximately one-fourth inch in width.

The compartment of the resulting pouch holding the wet mix was then pinched to rupture the one-sixteenth inch heat seal between the compartments permitting the wet mixture to contact the dry mixture. By manipulating the pouch with the fingers, the wet and dry mixtures were thoroughly mixed together to provide a prophylactic paste suitable for use in the cleaning and polishing of teeth.

In some of the foregoing tests, run at Indiana University, artificial surfaces, or bovine teeth, were used. The results are intended to be comparative rather than absolute.

The invention has been described above with reference to certain exemplary embodiments. It will be understood, of course, that modifications and variations of the invention as hereinabove set forth may be made without departing from the spirit and scope of the present invention, which is limited only by the claims which follow.

Claims

What is claimed is:

1. A prophylactic dental cleaner and polisher comprising feldspar in finely-divided state, substantially all of the particles passing through a 20 mesh screen, and the essential particles have a size range of about 37 microns to about 420 microns.

2. The product of claim 1, wherein the size range of feldspar particles is approximately:

0-5% retained on a 100 mesh screen;

0-15% retained on a 200 mesh screen;

0-25% retained on a 325 mesh screen;

55-100% pass through a 325 mesh screen;

90-100% are retained on a 600 mesh screen.

3. The product of claim 1 wherein a majority of the particles pass through a 100 mesh screen.

4. The product of claim 1 wherein the feldspar has a composition substantially as follows:

the feldspar may be alpha quartz

5. The product of claim 4 wherein the feldspar has the composition:

6. The product of claim 1, admixed with a binder and a humectant from the group consisting of glycerine, mannitol, sorbitol, propylene glycol, polyhydroxy alcohol, th humectant being in the ratio of about 2% to at least about 20% by weight of the mix.

7. The product of claim 6, wherein the humectant is in the ratio of about 2-8% by weight of the mix.

8. The product of claim 1, with also an anticariogenic amount of a fluoride adjuvant taken from the group consisting of sodium fluoride and stannous fluoride.

9. The product of claim 1, with the adjuvant stannous fluoride in the amount of about 1-10% by weight of the amount of feldspar.

10. The product of claim 1, with the adjuvant sodium fluoride in the amount of about 0.5% - 5.0% of the amount of feldspar.

11. A prophylactic dental paste comprising a caries-reducing amount of fluoride-containing anticariogenic adjuvant and finely-divided feldspar which analyzes about 65 to about 68% SiO.sub.2, from about 0 to about 15% K.sub.2 O, from about 0 to about 3% CaO, from about 5% to about 10% Na.sub.2 O, and the balance substantially aluminum oxide, and having the following particle size distribution by weight:

said feldspar being free of particles retained on 20 mesh.

12. The prophylactic paste of claim 11 characterized by containing not greater than 8% by weight of a humectant.

13. The prophylactic paste of claim 11 wherein said finely-divided feldspar is substantially free of particles retained on a 170 mesh screen.

14. The prophylactic paste of claim 13 including at least 20% of a humectant

15. The prophylactic paste of claim 11 wherein said fluoride-containing adjuvant is sodium fluoride.

16. The prophylactic paste of claim 12 wherein said fluoride-containing adjuvant is stannous fluoride.

17. A kit for preparing a dental prophylactic paste comprising a first compartment which includes a predetermined quantity of finely-divided feldspar analyzing from about 65-68% SiO.sub.2, less than 15% K.sub.2 O, from 0 to about 3% CaO, from about 5 to about 10% Na.sub.2 O, the balance being substantially aluminum oxide, and having a particle size distribution by weight such that 0 to 5% is retained on a 100 mesh screen, 0 to 15% is retained on a 200 mesh screen, 0 to 25% is retained on a 325 mesh screen, the remainder of which pass through a 325 mesh screen, none of said particles being retained on a 20 mesh screen, and a second compartment which includes a predetermined quantity of an aqueous solution of a fluoride-containing anticariogenic agent and which is adapted to be combined with the contents of the first compartment to provide a prophylactic paste containing a caries-reducing amount of said agent.

18. The kit of claim 17 wherein said compartments together contain not greater than 8% of a humectant.

19. A kit for preparing a dental prophylactic paste in approximate amount for a single dental prophylaxis treatment, comprising a source of finely-divided feldspar analyzing from about 65-68% SiO.sub.2, less than 15% K.sub.2 O, from 0 to about 3% CaO, from about 5 to about 10% Na.sub.2 O, the balance being substantially aluminum oxide, and having a particle size distribution by weight such that 0 to 5% is retained on a 100 mesh screen, 0 to 15% is retained on a 200 mesh screen, 0 to 25% is retained on a 325 mesh screen, the remainder of which pass through a 325 mesh screen, none of said particles being retained on a 20 mesh screen; a source of a fluoride-containing anticariogenic agent in aqueous solution, said sources together containing not greater than 8% of a humectant, feldspar measuring means for measuring out from said finely-divided feldspar sufficient for a single dental prophylaxis treatment therewith, and solution measuring means for measuring out of said solution of anticariogenic agent a predetermined quantity of finely-divided feldspar, to provide a paste containing a caries-reducing amount of said agent.

20. A kit for preparing a dental prophylactic paste comprising a first compartment containing finely-divided feldspar in predetermined amount analyzing from about 65-68% SiO.sub.2, less than 15% K.sub.2 O, from 0 to about 3% CaO, from about 5 to about 10% Na.sub.2 O, the balance being substantially aluminum oxide, and having a particle size distribution by weight such that 0 to 5% is retained on a 100 mesh screen, 0 to 15% is retained on a 200 mesh screen, and to 25% is retained on a 325 mesh screen, the remainder of which pass through a 325 mesh screen, none of said particles being retained on a 20 mesh screen; and a second compartment which includes an aqueous solution of a fluoride-containing anticariogenic agent in predetermined amount adapted to be combined with the contents of said first compartment to provide a prophylactic paste containing a caries-reducing amount of said agent, and means for communicating said compartments to permit the contents thereof to combine to form said paste.

21. The kit of claim 20 wherein said compartments together contain not greater than 8% of a humectant.

22. A therapeutic method for cleaning and polishing the teeth and simultaneously treating them with a fluoride which comprises: scrubbing the teeth with a paste containing finely-divided feldspar analyzing from 65-68% SiO.sub.2, less than 15% K.sub.2 O, from 0 to 3% CaO and from 5-10% Na.sub.2 O with the balance being substantially aluminum oxide, and a caries-reducing amount of a fluoride-containing anticariogenic adjuvant.

23. The method of claim 22 wherein said paste contains at least 20% of a humectant.

24. The method of claim 22 wherein the feldspar, with less than 8% of a humectant, is mixed with the anticariogenic adjuvant at the time of use.

25. The method of claim 24 wherein said humectant is propylene glycol.

26. The method of claim 21 wherein the paste contains from about 0-5% of TiO.sub.2, about 0-0.50% saccharine as a sweetner, and about 0-1.0% flavoring.

27. A material for use on teeth to reduce enamel solubility, comprising finely divided felspar particles and an anticariogenic enamel solubility reducing quantity of a fluoride, the felspar being one low in calcium and magnesium ions.

28. The material of claim 27 wherein the fluoride is from about 1% to about 10% stannous fluoride.

29. The material of claim 27 wherein the fluoride is from about 2% to about 6% stannous fluoride.

30. The material of claim 27 wherein the fluoride is from about 0.5% to 1.0% sodium fluoride.

31. The material of claim 27 wherein substantially all of the felspar particles pass through a 170 mesh screen.

32. The material of claim 27 with a humectant to prevent the material from drying out and becoming hard.

33. The material of claim 32, wherein the humectant is no greater than about 8% by weight.

34. The material of claim 32 wherein the anticariogenic fluoride and other ingredients are separate until the time of use.

35. In a method of preparing a material for treating teeth, the steps of: mixing a material including finely divided felspar low in calcium and magnesium, with an anticariogenic enamel solubility reducing amount of a fluoride, at the time of use, for use thereupon in the mouth of a patient.

36. In a method of claim 34, the further steps of: initially providing the dry material to include a humectant and a binder, in a first separate compartment of a multi-compartment receptacle; and providing liquid material comprising an aqueous solution of the anticariogenic fluoride, in a separate compartment; and joining the said materials from the two compartments at the time of use.