AU2015334960B2

AU2015334960B2 - Dental polishing and cleaning paste

Info

Publication number: AU2015334960B2
Application number: AU2015334960A
Authority: AU
Inventors: Jennifer HARTL; Uwe MUNDIL
Original assignee: Orochemie GmbH and Co KG
Current assignee: Orochemie GmbH and Co KG
Priority date: 2014-10-24
Filing date: 2015-10-21
Publication date: 2018-06-07
Anticipated expiration: 2035-10-21
Also published as: RU2017117877A; AU2015334960A1; WO2016062741A1; ES2714801T3; EP3209386A1; RU2686336C2; RU2017117877A3; EP3209386B1; PL3209386T3; DE102014115518A1; DK3209386T3; JP2017532352A; JP6716554B2

Abstract

The present invention relates to a composition for dental polishing and/or dental cleaning, comprising at least 5 wt.% of a needle-shaped crystalline calcium silicate as a first abrasive body, the needle-shaped crystalline calcium silicate having a length-to-width ratio of 3 : 1 to 20 : 1. The invention further relates to the use of said composition in dental polishing and dental cleaning.

Description

The present invention relates to a composition for dental polishing and/or dental cleaning, comprising at least 5 wt.% of a needleshaped crystalline calcium silicate as a first abrasive body, the needle-shaped crystalline calcium silicate having a length-to-width ratio of 3 : 1 to 20 : 1. The invention further relates to the use of said composition in dental polishing and dental cleaning.

(57) Zusammenfassung: Die vorliegende Erfindung betrifft eine Zusammensetzung zur Dentalpolitur und/oder Dentalreinigung, umfassend mindestens 5 Gew.-% eines nadelformigen kristallinen

Calciumsilikats als ein erster Abrasivkorper, wobei das nadelformige kristalline Calciumsilikat ein LangenBreiten-Verhaltnis von 3 : 1 bis 20 : 1 aufweist. Die Erfindung betrifft femer die Verwendung dieser

Zusammensetzung in der Dentalpolitur und -reinigung.

WO 2016/062741 Al llllllllllllllllllllllllllllllllllllllllllllllllll^

Veroffentlicht:

— mit internationalem Recherchenbericht (Artikel 21 Absatz 3)

WO 2016/062741 A1

DENTAL POLISHING AND CLEANING PASTE

The present invention relates to a composition for dental polishing and/or cleaning, containing a calcium silicate as abrasive body.

For some time now, the dental care treatments that are usually carried out have included the polishing of tooth surfaces and implants in order to obtain smooth and clean teeth, with not only esthetic aspects being important here, but also hygiene-related motives: what are removed by polishing are not only exogenous stains that are caused by consumption of nicotine, tea and red wine, etc., and that do not perse cause tooth disease; supragingival - as well as subgingival - instances of dental plaque can also be removed by appropriate polishing, and this is why they are also used for therapeutic polishing.

The polishing pastes or compositions that are usually used contain abrasive bodies of differing particle size, and it should be noted here that, although a greater cleaning action can be achieved with coarser abrasive bodies, the abrasiveness of said bodies is also increased at the same time. In the worst case, coarser cleaning bodies can even cut scratches into the tooth surface. Conversely, finer cleaning bodies achieve a reduced cleaning action, but preserve the tooth surface.

In this connection, the polishing pastes currently used in tooth cleaning or polishing for this purpose ought to satisfy in particular the following ideal clinical effects, namely a high cleaning efficiency, a low or tooth-gentle abrasiveness, and a high polishing action, the aim of the high polishing action being to provide the tooth surfaces with a “shine”.

However, it has been found in practice that these requirements can only be met with difficulty, since the constituents of the compositions regularly interact and sometimes cancel each other. Also, owing to their high abrasiveness, polishing pastes having high cleaning efficiency sensitize the teeth treated therewith, and this in turn leads to a high sensitivity to pain. Despite efforts to optimize the therapeutic action of the polishing pastes, there is still the problem that polishing inevitably removes parts of the tooth surface.

Currently, various substances are used as cleaning or abrasive bodies in dental cleaning pastes and dental polishing pastes in order to remove stains, plaque and other soft or hard deposits on or from tooth surfaces.

For instance, dicalcium/tricalcium phosphate, calcium pyrophosphate, calcium carbonates and calcium silicates, inter alia, have been and are used in polishing and cleaning pastes as abrasive bodies, and different approaches have been tested in the use of these substances, especially with respect to the mean particle size and the quantitative proportion thereof in the composition. In this connection, dicalcium/tricalcium phosphate and calcium pyrophosphate, in particular, have been found to be too soft.

Thus, further known in the prior art is, for example, US 4,038,380, according to which calcium silicate is used as cleaning and polishing substance in a tooth-cleaning composition, wherein the calcium silicate particles preferably have a size of 2 to 15 pm and a hardness of 4.5 on Moh’s scale.

Furthermore, WO 2013/041419 discloses oral cleaning compositions in which calcium carbonate abrasive bodies are used.

However, the polishing pastes known in the prior art still fail to satisfactorily meet the aforementioned clinical requirements, since they are distinguished by either a high abrasiveness - with simultaneous good cleaning action - or else a low abrasiveness and in turn poorer cleaning action, which leads to insufficient acceptance in correspondingly treated patients.

Thus, there is still the need to find an optimal formulation for a composition which satisfies the clinical requirements without damaging the teeth. It is therefore an object of the present invention to provide such a composition in order to overcome the disadvantages of the prior art.

According to the invention, the object underlying the invention is achieved by a composition comprising at least 5% by weight of an acicular crystalline calcium silicate as a first abrasive body, the acicular crystalline calcium silicate having a length-to-width ratio of from 3:1 to 45:1, preferably from 5:1 to 20:1.

The object is further achieved by the use of the composition according to the invention for dental polishing and/or dental cleaning and also by a corresponding polishing/cleaning method in which the composition according to the invention is used.

The composition according to the invention or the use thereof for polishing and/or cleaning achieves a gentle treatment with, at the same time, a good cleaning action. Advantageously, in this connection, the abrasive bodies are acicular at the start of the tooth cleaning/polishing and therefore have a good removal efficiency, whereas later on in cleaning/polishing the particulate, previously acicular abrasive bodies become highly rounded, i.e., change their particle shape especially with respect to their length; as a result, there is a direct transition from the cleaning process to the polishing process, since the calcium silicate particles that have been made smaller or rounded exhibit no abrasive effect or substantially no abrasive effect or only a slight abrasive effect, but have a good polishing property, and thus achieve a good shine.

Here, as well as in general in the relevant field, an “abrasive body” is understood to mean any particulate substance which, owing to its particulateness, volume and hardness properties, is capable of removing soft and/or hard deposits from tooth surfaces.

The aforementioned definition of acicularness, i.e., the specification of the ratio of the length to the width of the particles of the abrasive body, gives a definition for the abrasive bodies to be used according to the invention. Accordingly, “acicular” means that the length of the abrasive body is always greater than its width, and said abrasive body is at least three times as long as it is wide and, as a result, obtains the shape of a more or less fine and pointed particle, with merely the two ends of the longitudinal side of the particle being understood as “pointed”, it being possible for the diameter of said ends to be smaller than a central region of the needle.

In this connection, the acicular calcium silicates used as abrasive bodies can have an exemplary particle size or particle length (D50) of approximately 5 pm to 40 pm, especially 20-30 pm.

in this connection, according to a preferred embodiment, the composition for dental polishing and/or cleaning comprises from 5 to 70% by weight of the first abrasive body, i.e., of the acicular calcium silicate, preferably from 5 to 30% by weight, and even more preferably from 10 to 20% by weight, and even more preferably approximately 15% by weight.

Experiments relating to the abrasiveness of these compositions have revealed that they have an excellent cleaning action, with low or moderate abrasiveness at the same time, and are thus outstandingly suitable for dental cleaning and polishing. This is due to the fact that the acicular calcium silicate decreases so to speak during the treatment, making possible a simultaneous polishing in one step.

According to a further preferred embodiment of the composition according to the invention, the at least first abrasive body is wollastonite.

Wollastonite, also called Tafelspat, is a colorless mineral and has the chemical composition CaSiO₃, or to be more precise: Ca3[Si₃O₉]. Chemically, it is a naturally occurring calcium silicate or the calcium salt of metasiiicic acid.

According to a further embodiment of the composition according to the invention, said composition contains at least a second, nonacicular abrasive body, preferably selected from feldspar, a silicic acid, pumice or hydroxylapatite, or combination thereof.

Feldspar is part of the group of the silicate minerals of the general chemical composition (Ba,Ca,Na,K,NH₄)(AI,B,Si)₄O₈, where the elements between parentheses can each be reciprocally represented, but are always in the same proportion to the other constituents of the mineral. Silicic acids are oxoacids of silicon having the general chemical formula: [Si(OH)₂-O-]_n, and hydroxylapatite is a mineral from the class of the phosphates, arsenates and vanadates. According to the invention, the aforementioned are used as at least second abrasive body and serve to set the basic abrasiveness. In this connection, the average particle size D50 of the second abrasive body used is between approximately 5 pm and 40 pm, preferably from 20 to 25 pm.

According to a further preferred embodiment, the composition according to the invention further comprises at least one polishing body, it being particularly preferred when the polishing body is hydroxylapatite.

With the addition of hydroxylapatite to the composition according to the invention, a substance of similar hardness to native hydroxylapatite is added in addition to the first abrasive body. This contributes to good polishing properties and to the regeneration of enamel, dentin and cementum, making it possible in turn, as is known, to achieve a desensitization of teeth.

According to the invention, hydroxylapatite which does not cause abrasion is used as polishing body in the embodiment mentioned, in contrast to the use as abrasive body, which exerts an abrasive action on the tooth surfaces and has a corresponding particle shape.

In this connection, it will be clear to a person skilled in the art, from his/her specialist knowledge and on the basis of this disclosure, in which shape and/or particle size a substance, for example hydroxylapatite, acts as abrasive body or as polishing body.

It is self-evident that the composition according to the invention can also comprise further ingredients, such as, for example, one or more of a base, of a humectant, of a thickener, of an emulsifier, of a flavor, of a fluoride, of a pigment and/or of a preservative.

The use of said further ingredients has already been known and tested in the prior art for some time now, and it will be at the discretion of a person skilled in the art to put together the appropriate ingredients in each case on the basis of the invention disclosed herein. An exemplary, nonlimiting list of suitable substances can, for example, be found in EP 2 730178 A1 and in the publications cited therein.

The flavor or the flavoring can in particular be artificial or natural, and is preferably an orange or mint flavor. The fluoride used can be any fluoride suitable in the dental field, with sodium fluoride and potassium fluoride being preferred. The humectant and/or base used can, for example, be glycerol, though polydextrose and/or sorbitol may also be suitable, i.e., any humectant which prevents foodstuffs from drying out, by added water being bound during preparation of the composition. Exemplary thickeners are carrageenan, xanthan gum, and carboxymethylcellulose, though, for example, other celluloses, such as hydroxypropyl(methyl)cellulose, may also be suitable, i.e., any thickener which is suitable for the dental field and which is capable of binding water and of increasing viscosity. The emulsifier used can be any substance/compound which is capable of mixing and stabilizing two fluids which are immiscible or only sparingly miscible with one another to give a finely dispersed mixture (emulsion). By way of example, the emulsifier used can be olefin sulfonate.

Accordingly, one embodiment of the composition according to the invention has the following more specific composition:

from 5 to 70% by weight, preferably from 5 to 30% by weight, even more preferably from 10 to 20% by weight, of wollastonite, from 0 to 50% by weight of a second abrasive body selected from feldspar, silicic acid, pumice or hydroxylapatite or a combination of one or more thereof, from 10 to 50% by weight, preferably from 15 to 30% by weight, even more preferably from 18 to 24% by weight, of glycerol, from 10 to 50% by weight, preferably from 18 to 25% by weight, of water, from 0 to 50% by weight, preferably from 0 to 25% by weight, of a polishing body, selected from hydroxylapatite or feldspar, or mixtures thereof, from 0 to 10% by weight, preferably from 0 to 1% by weight, of an emulsifier, from 0 to 2% by weight of flavor, especially orange flavor or mint flavor, from 0 to 5% by weight, preferably from 0 to 1.5% by weight, of a dye, from 0 to 1% by weight, preferably from 0.5 to 1% by weight, of a preservative, especially phenoxyethanol or a phenoxyethanol/paraben mixture, and from 0 to 0.5% by weight of a fluoride, especially sodium fluoride or potassium fluoride, the sum of all fractions yielding 100% by weight.

Furthermore, the aforementioned composition can also additionally comprise a thickener, for example carboxymethylcellulose, or combinations of two or more different thickeners in an amount of from 0 to 5.0% by weight. Furthermore, said composition can preferably additionally comprise from 20 to 40% by weight of feldspar as second polishing body.

in particular, the present invention also provides the following preferred embodiment of the composition according to the invention:

15% by weight of wollastonite as first abrasive body, from 18 to 24% by weight of glycerol, from 18 to 25% by weight of water, from 0 to 25% by weight of hydroxylapatite as first polishing body, from 20 to 40% by weight of feldspar as second polishing body, from 0 to 1 % by weight of an emulsifier, from 0 to 2% by weight of flavor, especially orange flavor or mint flavor, from 0 to 1.5% by weight of a dye or dye mixture, from 0 to 1% by weight of phenoxyethanol or a phenoxyethanol/paraben mixture as preservative, and from 0 to 0.5% by weight of fluoride, especially sodium fluoride or potassium fluoride, the sum of all fractions yielding 100% by weight.

Lastly, the present invention also provides for the use of a composition according to the invention, as elucidated above, for dental polishing and/or cleaning, especially in professional tooth cleaning/polishing in dental practices or dental hospitals. In this connection, it is self-evident that the applications of the composition according to the invention can also be performed in the private domain, after, if necessary, relevant instruction by personnel trained in dental care.

Here, “dental polishing” is understood to mean any application or use of the composition according to the invention, as part of which dental surfaces are polished or cleaned. Accordingly, the term “tooth surfaces” encompasses here not only the surfaces of natural teeth, but also those of dentures or implants.

in a method according to the invention, the composition according to the invention is, according to the present invention, applied to the tooth surfaces by means of a suitable applicator, for example a brush or rubber cup, optionally after tough dental plaque has been removed beforehand by means of suitable equipment, such as, for example, powder-jet instruments and/or handheld devices. By means of the then applied polishing paste, stains can be additionally removed, and the tooth surface can be “smoothed”, or cracks and holes can be filled, resulting in the tooth surface appearing smooth, i.e., “polished”.

The optionally likewise envisaged addition of a fluoride can quicken the remineralization of the tooth surfaces.

It is self-evident that it is possible to use the features mentioned above and yet to be elucidated below not only in the combination specified in each case, but also in isolation, without departing from the scope of the present invention.

Further advantages are revealed by the following description and by the experiments carried out in relation thereto and exemplary embodiments, and in the figures, in which:

Fig. 1 shows the diagrammatic representation of the course of abrasion over time in the case of application of a composition according to the invention (upper curve) and of a comparative paste “A” (lower curve);

Fig. 2 shows comparative images of ivory plates which had previously been deposited in black tea and which were each treated (polished/cleaned) once with an embodiment of the composition according to the invention (in each case, left part in the plate), or with commercially available comparative pastes (in each case, right part of the ivory plates); A: comparative products “B-1 ”, “B-2” and “C”; B: comparative products “A” and “D”.

Examples

Exemplary embodiments of compositions according to the invention were prepared as follows:

Composition of polishing paste

Constituent	Fraction [%]	Purpose
Wollastonite	15	Abrasive body (acicular)
Glycerol	23-28	Humectant/base
Water	15-20	Base
Hydroxylapatite (HAP)	5-30	Polishing body
Feldspar	20-40	Polishing body

Emulsifier	0-1	Consistency and haptic behavior
Optionally orange or mint flavor	0-2	Flavor + sweetening
Color pigment	0-2	Dye with talc powder
Phenoxyethanol	0.5	Preservation
Sodium fluoride	0-0.5	Fluoridation

The aforementioned compositions were prepared according to customary formulation methods, and compositions without mint and orange flavor were also prepared.

Furthermore, a paste composition comprising the following ingredients was tested: 15% by weight of wollastonite, 20% by weight of glycerol, 0.8% by weight of preservative (mixture of phenoxyethanol and paraben), 0.6% by weight of thickener, 0.15% by weight of emulsifier, 0.15% by weight of sodium fluoride, 5% by weight of hydroxyiapatite, 35% by weight of feldspar, 0.09% by weight of flavor, 1.4% by weight of dye, with the missing % by weight being filled with water as base diluter.

investigations relating to abrasion

The exemplary paste according to the invention and two comparative pastes (product “A”: based especially on perlite, sodium fluoride, titanium dioxide, glycerol, water, flavor, sorbitol, silica; and products “B 1 to 3”: based especially on sorbitol, xylitol, amine fluoride, silicon dioxide, pumice, titanium dioxide, water, dye and flavor; in the abrasion strengths medium, high and low) were used to treat a commerciaiiy available (e.g., from Vita, Bad Sackingen, Germany) ceramic block. As comparison, an untreated ceramic block was additionally used.

The blocks were each treated with the polishing pastes using a commercially available straight/contra-angle handpiece. Polishing is carried out with a likewise commercially available polishing cup under the following conditions: contact pressure 200 g, deflection of the sample table: 10°, polishing time: 15 s at 2000 rpm.

The surfaces were subsequently examined by scanning electron microscopy (SEM) (SEM images not shown).

It was possible to achieve similar results in the case of the treatment of implants (SEM images not shown).

The examinations by scanning electron microscopy revealed that, compared to an untreated surface, no abrasion could be observed for the surfaces treated with one embodiment of the polishing paste composition according to the invention.

Furthermore, Fig. 1 shows a diagrammatic representation of the differences in abrasion between the composition according to the invention and conventional polishing pastes, as measured using a tribometer (on polymethylmethacrylate, PMMA): the upper curve in Fig. 1 shows the course of the abrasion over time in the case of application of the composition according to the invention; the lower curve - and thus a greater abrasion -shows the course of the abrasion over time in the case of application of the comparative product “A”. This showed that the polishing pastes according to the invention are distinctly more tooth-gentle than the two commercially available comparative pastes.

Investigations relating to cleaning action

Subsequently, investigations relating to cleaning action were also carried out; to this end, the cleaning action of the composition according to the invention (“Inv. comp.”) and of two commercially available comparative products was in each case tested on ivory plates (12 x 20 mm) which had been deposited in black tea for 24 hours beforehand. The thus pretreated ivory plates were fixed in a laboratory device.

In each case, 0.1 g of polishing paste was added to a polishing-paste cup (Kerr Hawe soft; Kerrdental, Rastatt, Germany) and said cup was pressed onto the ivory plates at constant contact pressure (200 g) for 20 seconds each time, with the clamping table being moved at a constant angular velocity.

The comparative pastes tested here were products “A” and “B” (having medium abrasiveness “B-1” and high abrasiveness “B-2”), as already mentioned above, and also two further comparative products “C” - based especially on pumice, glycerol, cellulose, titanium dioxide, sodium fluoride, water - and “D” - based on the abrasive minerals pumice, aluminum oxide, calcium carbonate; humectant, binder, flavoring, methylparaben.

The cleaning action, which was determined optically, was found to be sometimes better for the composition/paste according to the invention than for the comparative pastes, but at least equivalent, the results in relation to this being shown in Figs. 2A and 2B: the figures show each of the plates before the treatment, after 20 seconds of treatment and after 40 seconds of treatment, with the left part of each ivory plate being cleaned with one embodiment of the composition according to the invention and the right part of each ivory plate being cleaned with a commercially available comparative product.

Therefore, the results depicted show that the composition according to the invention is distinctly more tooth-gentle, but has at the same time a better cleaning action than the tooth-cleaning or polishing pastes that are commercially available to date.

2015334960 15 May 2018

Claims

Claims

1. A composition for dental polishing and/or cleaning, comprising 5 to 70 % by weight of an acicular crystalline calcium silicate as a first abrasive body, the acicular crystalline calcium silicate having a length-to-width ratio of from 3:1 to 20:1, and wherein the acicular crystalline calcium silicate is wollastonite, and wherein a polishing body is present, which is selected from hydroxylapatite, feldspar, pumice, micaceous iron oxide.
2. The composition for dental polishing and/or cleaning as claimed in claim 1, wherein at least a second, nonacicular abrasive body is present.
3. The composition for dental polishing and/or cleaning as claimed in claim 2, characterized in that the at least second nonacicular abrasive body is selected from feldspar, silicic acid, pumice or hydroxylapatite, or combinations thereof.
4. The composition for dental polishing and/or cleaning as claimed in any of the preceding claims, wherein one or more of a base, of a thickener, of an emulsifier, of a flavor, of a pigment and/or of a preservative are further present.
5. The composition for dental polishing and/or cleaning as claimed in any of the preceding claims, comprising from 5 to 70% by weight of wollastonite as first abrasive body, from 0 to 50% by weight of a second abrasive body selected from feldspar, silicic acid, pumice or hydroxylapatite or a combination thereof, from 10 to 50% by weight of glycerol, from 10 to 50% by weight of water, from 0 to 50% by weight of a polishing body selected from hydroxylapatite and feldspar, or mixtures thereof, from 0 to 10% by weight of an emulsifier, from 0 to 2% by weight of flavor, from 0 to 5% by weight of a dye, from 0 to 1 % by weight of a preservative, or of a mixture of preservatives, and

2015334960 15 May 2018 from 0 to 0.5% by weight of sodium fluoride or potassium fluoride, the sum of all fractions yielding 100% by weight.
6. The composition as claimed in any of the preceding claims, characterized in that it comprises the following:

from 10 to 20% by weight of wollastonite as first abrasive body, from 18 to 24% by weight of glycerol, from 18 to 25% by weight of water, from 0 to 25% by weight of hydroxylapatite as first polishing body, from 20 to 40% by weight of feldspar as second polishing body, from 0 to 1% by weight of an emulsifier, from 0 to 2% by weight of orange flavor or mint flavor, from 0 to 1.5% by weight of a dye, from 0 to 1% by weight of phenoxyethanol or a phenoxyethanol/paraben mixture as preservative, and from 0 to 0.5% by weight of sodium fluoride or potassium fluoride, the sum of all fractions yielding 100% by weight.
7. The composition as claimed in any of claims 1 to 6, characterized in that it comprises approximately 15% by weight of wollastonite as first abrasive body.
8. The use of a composition as claimed in any of the preceding claims for polishing and/or cleaning natural or artificial tooth surfaces.

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