Toothpaste comprising spherical silica particles and perlite particles

Abstract

The present invention relates to dentifrice compositions having superior cleaning performance. These properties arise from a novel abrasive system.

Description

Technical Field

[0001] This invention relates to the field of dental cleaning compositions, and in particular to improving the cleaning power of dental cleaning compositions. Background Technology

[0002] Insoluble ingredients, often referred to as abrasives, are added to dental cleaning agents to help actually remove stains, plaque, and food particles. These components give the toothpaste the necessary grit to lift stubborn substances from the tooth surface.

[0003] The two most commonly used abrasives in toothpaste are silica and calcium carbonate.

[0004] The level of abrasiveness in dental cleaning agents (and therefore the corresponding dosage) always requires careful balancing. A high level of abrasiveness will effectively clean the tooth surface, but it also carries the risk of causing excessive damage to the enamel itself.

[0005] Designers of dental cleaning products always strive to optimize the balance between cleaning power and enamel protection. Summary of the Invention

[0006] In its broadest aspect, the present invention includes a dental cleaning composition comprising spherical silica particles and perlite particles, wherein the spherical silica particles comprise about 0.1% to about 4.0% by weight, and the perlite particles comprise about 0.1% to about 5.0% by weight; and further, wherein the spherical silica particles possess the following properties:

[0007] a. Pore volume from approximately 0.03 mL / g to less than approximately 0.1 mL / g

[0008] b. Average particle size from approximately 1 μm to approximately 10 μm;

[0009] c. Approximately 50 m 2 / g or smaller BET surface area;

[0010] d. Oil absorption capacity of approximately 20 to 50 ml / 100 g; and

[0011] e. Water content less than approximately 0.2% by weight; and

[0012] The perlite particles described therein have a d50 particle size of less than 50 μm.

[0013] On the other hand, spherical silica particles account for about 0.2% to 1.5% by weight of the dental cleaning composition, and perlite particles account for about 0.25% to about 2.0% by weight of the dental cleaning composition.

[0014] On the other hand, spherical silica particles account for about 0.25% to about 1.0% by weight, and perlite particles account for about 0.75% to about 1.5% by weight.

[0015] On the other hand, the composition also includes at least one surfactant and at least one moisturizer.

[0016] On the other hand, the composition also contains a fluoride source.

[0017] On the other hand, the composition contains additional abrasive.

[0018] On the other hand, the composition contains an anti-allergen.

[0019] On the other hand, anti-allergens include one or more of stannous fluoride, potassium nitrate, or bioglass.

[0020] On the other hand, the composition also comprises:

[0021] a. At least one moisturizer, 50-80% by weight

[0022] b. At least one surfactant, 0.5-5% by weight

[0023] c. At least one gelling polymer, 0.25-2% by weight; and

[0024] d. Fluoride source.

[0025] In another aspect, at least one humectant comprises glycerin and polyethylene glycol; and the gel polymer comprises carbomer.

[0026] In another aspect, the composition further comprises:

[0027] a. At least one moisturizer, 20-55% by weight

[0028] b. Water, 15-45% by weight

[0029] c. At least one surfactant, 0.5-5% by weight; and

[0030] d. Fluoride source.

[0031] On the other hand, at least one moisturizer contains one or more of sorbitol, glycerin, polyethylene glycol, or a mixture thereof.

[0032] On the other hand, at least one surfactant includes sodium lauryl sulfate, cocamidopropyl betaine, and sodium cocoyl methyl taurate, and mixtures thereof.

[0033] In another aspect, the composition comprises one or more minor components, including opaque agents, pH adjusters, preservatives, flavoring agents, coloring agents, or mixtures thereof, wherein the minor component accounts for 0.1% to 5% by weight of the composition.

[0034] In another aspect, the present invention includes the use of a dental cleaning composition according to any of the foregoing aspects for cleaning teeth, wherein the brush may be manual or electric. Detailed Implementation

[0035] Surprisingly, the combination of perlite and spherical silica has been found to provide superior cleaning performance in dental cleaning compositions compared to known commercially available silica abrasives.

[0036] As used herein, the term "non-aqueous" means anhydrous or substantially anhydrous. Individual components of a dental cleaning composition may contain limited amounts of water, as long as the entire composition remains substantially anhydrous.

[0037] As used herein, the term "dental cleaning agent" includes any semi-solid preparation in the form of a paste, cream, or gel used for cleaning all or part of an individual's oral cavity.

[0038] As used herein, the term “oral cavity” refers to an individual’s teeth and gums, including all periodontal areas, from the teeth up to the gum line and / or periodontal pockets.

[0039] It has been found that the combination of perlite and spherical silica forms a highly efficient abrasive system for dental cleaning compositions, combining excellent cleaning performance (as measured by PCR testing) with very low abrasion (as measured by RDA testing).

[0040] Compared to other known abrasives, the specific combination produces a dental cleaning agent with excellent cleaning power (high PCR score) while causing even less wear on tooth enamel (low RDA score).

[0041] Perlite is an amorphous volcanic glass with a relatively high water content, typically formed by the hydration of obsidian. It occurs naturally and possesses the unusual property of expanding dramatically when fully heated. It is a commercial product, useful due to its low density after processing.

[0042] Perlite has also been shown to be effective abrasive for dental cleaning agents, see J Clin Dent 2013; 24(3):88-93.

[0043] Non-limiting commercial examples of perlite particles suitable for use in this invention include ImerCare® PerlWhite 19, provided by Imerys Filtration EMEA.

[0044] Preferably, the perlite particles of the present invention have a pH between 6 and 8 (measured as 10% slurry in water).

[0045] Preferably, the BET surface area of ​​the perlite particles of the present invention is at least 1.0 m². 2 / g, more preferably at least 1.25 m 2 / g, with an optimal value of at least 1.50 m 2 / g.

[0046] Preferably, the oil absorption of the perlite particles of the present invention is at least about 100% of the weight of the perlite, more preferably at least about 120%, and most preferably at least about 140%.

[0047] Oil absorption can be measured according to ISO 19246:2016.

[0048] Preferably, perlite comprises about 0.75% by weight to about 2.5% by weight, more preferably about 1.0% by weight to about 2.0% by weight, and most preferably about 1.5% by weight.

[0049] The perlite particles of the present invention have a d50 particle size of less than 50 μm, more preferably less than 30 μm, and even more preferably less than 20 μm.

[0050] Spherical silica has been shown to have good properties for use as an abrasive in dental cleaning agents. See US 11,246,809, which is incorporated herein by reference.

[0051] Non-limiting examples of spherical silica suitable for use in this invention include NP-30® or Sunsphere’s NP-100 and MFIL-GS® silica, available from Madhu PVT. Ltd.

[0052]

[0053] The silica particles used in this invention have a high degree of sphericity, meaning they are spherical or substantially spherical, as can be seen, for example, by scanning electron microscopy, as illustrated in Example 4 herein. For the avoidance of doubt, substantially spherical silica particles refer to any particle in which the entire particle is substantially round or elliptical. Suitably, the silica particles used in this invention include smooth or substantially smooth surfaces.

[0054] Ideally, at least 90% of the spherical silicone particles are substantially spherical, more preferably 95% of the spherical silicone particles are substantially spherical, and even more preferably 99% of the spherical silicone particles are substantially spherical.

[0055] Suitably, the average particle diameter of the silica gel particles used in this invention is in the range of 1 μm to 10 μm, more preferably in the range of 3 μm to 8 μm. Suitably, the particles generally have a uniform size and a narrow particle size distribution, for example, 1 μm to 15 μm. Particle size can be determined by laser diffraction.

[0056] In one embodiment of the invention, the silica particles used in the invention are non-porous or nearly non-porous, i.e., containing substantially or completely closed surfaces (beyond the detection limit). Porosity can be determined by the method described in Ojeda, Phys. Chem. Soc., 2001, 22, 439-439, or as described herein.

[0057] Compared to other precipitated silica, the suitable silica particles used in this invention are relatively hard materials; therefore, they are more resistant to shear stress and less prone to disintegration under shear. Suitablely, the compressive strength (MPa) of the silica used in this invention is in the range of 1800 to 2000, for example, 1850 to 1950. The compressive strength can be determined using a micro compressive strength tester.

[0058] Suitablely, the silica particles used in this invention have a smaller BET surface area value compared to those observed for known dental abrasives (e.g., commercially available precipitated silica as Zeodent-103 and Zeodent-115). The silica particles used in this invention have a BET surface area (m²) of 50 or less. 2 / g). In one embodiment, the silica particles have a BET surface area of ​​40 or less (m²). 2 / g). In one embodiment, the silica particles have a BET surface area of ​​30 or less (m²). 2 / g). In one embodiment, the silica particles have a BET surface area of ​​20 or less (m²). 2 / g). In one embodiment, the BET surface area (m²) of the silica particles. 2 The BET surface area (m² / g) is 10 or less. In one embodiment, the BET surface area (m² / g) of the silica gel particles is... 2 The value ( / g) is 5 or less. BET surface area measurement is determined by measuring the amount of nitrogen adsorbed on the surface, suitably as described in Brunaur et al., J. Am. Chem. Soc., 2001, 22, 439-439, or as described herein.

[0059] Compared to those observed with known dental abrasives such as Zeodent-109 and Zeodent-119 (which are reported to have oil absorption values ​​of 79.8 and 110.7 (ml / 100 g) respectively and are reported as in WO2010 / 068433), the suitable silica particles used in this invention have low oil absorption capacity.

[0060] The oil absorption capacity (mL / 100 g) of the silica gel particles used in this invention is suitably 20 to 50, more preferably 35 or less, and even more preferably in the range of 25 to 35. The oil absorption capacity can be measured according to the method described in U.S. Patent Application 2007 / 0001037A1, published January 4, 2007.

[0061] The dental cleaning composition of the present invention comprises about 0.1% to about 4% of spherical silica particles and about 0.1% to about 5.0% of perlite based on the weight of the dental cleaning composition.

[0062] Preferably, the spherical silica accounts for about 0.2% to about 2.0% by weight of the dental cleaning composition, more preferably about 0.25% to 1.0% by weight.

[0063] The spherical silica particles of the present invention have the following properties

[0064] a. Pore volume from 0.03 mL / g to less than 0.1 mL / g;

[0065] b. Average particle size from 1 μm to 10 μm;

[0066] c.50 m 2 / g or smaller BET surface area;

[0067] d. Oil absorption capacity of 20 to 50 ml / 100 g; and

[0068] e. Water content less than 0.2% by weight.

[0069] Parameters, including water content, were measured before the dental cleaning agent composition was added.

[0070] Other dental cleaning ingredients

[0071] The dental cleaning composition of the present invention can be aqueous or non-aqueous.

[0072] The non-aqueous carriers used in this invention typically comprise a thickener and one or more formulation solvents. Optionally, the non-aqueous carrier may contain additional dentally acceptable abrasives.

[0073] Advantageously, a thickener may be present in the formulation to give the product rheological properties closer to those of conventional dental cleaning agents. The thickener suitably comprises a carboxyvinyl polymer, such as carbomer. Carbomer comprises a synthetic high-molecular-weight crosslinked acrylic polymer. The polymer chain formed from the repeating acrylic units may be crosslinked with, for example, allyl sucrose to provide a commercially available form of carbomer as Carbopol™ 934; a pentaerythritol ether to provide a commercially available form of carbomer as Carbopol™ 974; or crosslinked with divinyl glycol to provide a commercially available form of carbomer as Noveon™ AA-1. Carbopol™ polymers are manufactured by BF Goodrich.

[0074] In one embodiment, the carboxyvinyl polymer comprises Carbopol TM 974. The content of the carboxyvinyl polymer, based on the weight of the dental cleaning composition, may range from about 0.1% to about 7.5%. In one embodiment, the carboxyvinyl polymer is present in an amount of about 0.3% to about 1.0% based on the weight of the dental cleaning composition.

[0075] The dental cleaning composition according to the present invention may contain at least one surfactant. The composition may contain two or more surfactants.

[0076] Preferably, at least one surfactant includes sodium lauryl sulfate (SLS), or cocamidopropyl betaine (CAPB), or sodium cocoyl glycinate or sodium cocoyl methyl taurate and / or mixtures thereof.

[0077] The total amount of surfactant in the dental cleaning agent of the present invention can account for about 0.1% to about 15% by weight of the dental cleaning agent composition, preferably about 0.5% to about 10% by weight, and most preferably about 1.0% to about 5.0% by weight.

[0078] Surfactants may include any surfactant known in the art for use in oral care. A skilled technician will be aware of many possible suitable surfactants.

[0079] The at least one surfactant may include sodium lauryl sulfate, cocamidopropyl betaine, sodium cocoyl glycinate and sodium cocoyl methyl taurate and mixtures thereof.

[0080] The compositions according to the invention may comprise a surfactant system. The surfactant system may comprise a first surfactant and a second surfactant. In some embodiments, the surfactant system consists of a first surfactant and a second surfactant, wherein the second surfactant consists of a mixture of surfactants.

[0081] Suitable first surfactants belong to a class of compounds known as betaine. Structurally, betaine compounds contain anionic functional groups such as carboxylate functional groups and cationic functional groups such as quaternary nitrogen functional groups separated by a methylene moiety. These include N-alkyl betaines, such as cetyl betaine and betaine, and N-alkylamide betaines, such as cocamidopropyl betaine. In one embodiment, the betaine is cocamidopropyl betaine, commercially available under the trade name Tego Betain. Suitably, the betaine is present in an amount ranging from about 0.05% to about 4% by weight of the dental cleaning composition, for example, from about 0.2% to about 2.0% by weight of the dental cleaning composition.

[0082] The second surfactant in the surfactant system used in the compositions according to the invention is selected from taurine salts or C10-20 alkyl sulfate surfactants. Taurine salt surfactants used in the invention are salts of fatty acid amides of N-methyltaurine. They generally conform to the following structural formula:

[0083] RC(O)N(CH3)CH2CH2SO3M

[0084] Wherein RC(O)- represents a fatty acid group, and M represents sodium, potassium, ammonium, or triethanolamine. Fatty acids with a carbon chain length of 10 to 20 are used, including those derived from coconut oil, palm oil, and tall oil. In one embodiment, the fatty acid is derived from coconut. In one embodiment, a sodium salt is used. In one embodiment, the taurine is sodium cocoyl methyl taurate. This taurine surfactant is sold by Croda under the trademark Adinol CT.

[0085] The taurine surfactant may be present in an amount of about 0.1% to about 10% of the dental cleaning composition. In one embodiment, the taurine surfactant is present in an amount of about 0.1% to about 5% by weight of the non-aqueous composition. In one embodiment, the taurine surfactant is present in an amount of about 0.5% to about 2.0% by weight of the dental cleaning composition.

[0086] The alkyl sulfate surfactant used in this invention has the following structural formula:

[0087] R 1 OSO3M

[0088] R 1 The term indicates the fatty alcohol moiety, where M represents sodium, potassium, ammonium, or triethanolamine. Fatty alcohols with a carbon chain length of about 10 to about 20 include those derived from coconut oil, palm oil, and tall oil. In one embodiment, the fatty alcohol is lauryl alcohol. In one embodiment, a sodium salt is used. In one embodiment, the alkyl sulfate is sodium lauryl sulfate.

[0089] The alkyl sulfate surfactant may be present in an amount of about 0.1% to about 10% of the dental cleaning composition. In one embodiment, the alkyl sulfate surfactant may be present in an amount of about 0.1% to about 5% by weight of the dental cleaning composition. In another embodiment, the alkyl sulfate surfactant is present in an amount of about 0.5% to about 2.0% by weight of the dental cleaning composition.

[0090] In some embodiments, the surfactant system comprises a first surfactant and a second surfactant, wherein the first surfactant is betaine and the second surfactant is a mixture of taurate and C10-20 alkyl sulfate surfactants as described above. In one embodiment, the surfactant system comprises a first surfactant being betaine and a second surfactant being a mixture of sodium cocoyl methyl taurate and sodium lauryl sulfate.

[0091] In one aspect, the compositions according to the invention comprise dental cleaning additives that are unstable or incompatible with aqueous environments. Examples of such additives are bioactive glasses of the types disclosed in WO 96 / 10985, WO 97 / 27158 and WO 99 / 13852.

[0092] In one embodiment, the bioactive glass used in this invention has the following composition: about 45% by weight of silicon dioxide, about 24.5% by weight of sodium oxide, about 6% by weight of phosphorus oxide, and about 24.5% by weight of calcium oxide. Such a bioactive glass is commercially available under the trade name NovaMin®, also known as 45S5 Bioglass®.

[0093] The bioactive glass content is from about 1% to about 20% based on the weight of the dental cleaning composition. In one embodiment, the bioactive glass is present in an amount from about 1% to about 15% based on the weight of the dental cleaning composition. In another embodiment, the bioactive glass in the dental cleaning composition is present in an amount from about 1% to about 10% based on the weight of the dental cleaning composition. In yet another alternative embodiment, the bioactive glass is present in an amount from about 2% to about 8% based on the weight of the dental cleaning composition.

[0094] Suitably, the dental cleaning composition according to the invention may also contain an inorganic thickener, such as thickening silica. Suitably, the thickener is thickening silica, such as colloidal hydrated silica, which is commercially available, for example, as Sident 22S or Syloid 244FP.

[0095] In one possible embodiment, the thickened silica is present in the range of about 0% to about 15% by weight of the dental cleaning composition, suitably from about 5.0% to about 15.0%.

[0096] Moisturizers suitable for use in this invention include glycerin, sorbitol, propylene glycol, polyethylene glycol, or mixtures thereof. In one embodiment, the moisturizer comprises glycerin. It is well known that commercially available glycerin may contain 0.1% to 2.0% by weight of water associated with glycerin. Typically, this amount is ≤0.5% by weight of glycerin, for example, 0.1-0.5% by weight. This small amount of water is bound to glycerin and therefore cannot be utilized by other ingredients. Those skilled in the art will still consider compositions containing glycerin to be non-aqueous.

[0097] In one embodiment, the humectant comprises polyethylene glycol. Suitably, the polyethylene glycol is selected from PEG 300, PEG 400, and mixtures thereof. In one embodiment, the polyethylene glycol comprises PEG 400.

[0098] In one embodiment, the moisturizer comprises a mixture of glycerin and polyethylene glycol.

[0099] The formulation humectant is used to bring the formulation to 100%, and suitably, the total amount of solvent may be in the range of about 20% by weight to about 95% by weight of the dental cleaning composition.

[0100] Suitably, the humectant comprises glycerin present in about 35% to about 75% by weight. In one embodiment, the glycerin is present in about 50% to about 70% by weight of the dental cleaning composition.

[0101] Suitably, the humectant includes polyethylene glycol, which is present in an amount of about 0.1% to about 40% by weight of the dental cleaning composition. In one embodiment, polyethylene glycol is present in an amount of about 15% to about 25% by weight of the dental cleaning composition.

[0102] Suitable of the toothpaste, when it contains water, the humectant may contain sorbitol, glycerin and polyethylene glycol.

[0103] To produce a smooth composition that does not show any signs of stickiness, it is desirable to use a specific ratio of carboxyvinyl polymer to polyethylene glycol.

[0104] Advantageously, the ratio of carboxyvinyl polymer to polyethylene glycol is in the range of about 1:15 to about 1:30.

[0105] The dental cleaning composition of the present invention does not require additional abrasives.

[0106] However, dentally acceptable abrasives may optionally be added to the dental cleaning agent composition. Suitable abrasives for use in dental cleaning agent compositions include, for example, amorphous, gelled, precipitated or fumed silica, zinc orthophosphate, sodium bicarbonate (baking soda), plastic particles, calcium carbonate, calcium pyrophosphate, insoluble metaphosphates, or mixtures thereof.

[0107] Silica abrasives can be natural amorphous silica, such as diatomaceous earth; or synthetic amorphous silica, such as precipitated silica. For example, silica abrasives include those marketed by Huber, De gussa, Ineos, and Rhodia under the trade names Zeodent, Sident, Sorbosil, or Tixosil.

[0108] Suitable, the silica abrasive is present in an amount of up to 25% by weight of the total composition, for example, from 2% to 20% by weight of the total composition, for example, from 5% to 15% by weight.

[0109] Typically, the amount of abrasive used in the non-aqueous or aqueous compositions of the present invention will be determined empirically, based on techniques well known in the art, to provide an acceptable level of cleaning and polishing.

[0110] Fluoride ion sources suitable for the compositions of the present invention include alkali metal fluorides such as sodium fluoride, alkali metal monofluorophosphates such as sodium monofluorophosphate, stannous fluoride, or amine fluoride, provided in amounts of 25 to 3500 ppm, preferably 100 to 1500 ppm of fluoride ions.

[0111] Polyphosphates are known to help delay tartar formation and are examples of anti-tartar agents suitable for use in this invention. Polyphosphates are generally understood to consist of two or more phosphate groups arranged primarily in a linear configuration, although some cyclic derivatives may exist. Polyphosphates used in this invention include pyrophosphates, polyphosphates having three or more polyphosphate groups such as sodium tripolyphosphate, and polyphosphates having four or more polyphosphate groups such as tetrapolyphosphate and hexametaphosphate.

[0112] The dental cleaning composition of the present invention may also contain an alkali metal bicarbonate. The inclusion of such a salt in the dental cleaning composition is beneficial for several reasons, such as providing good plaque removal ability and improving the whitening properties of the dental cleaning agent. Importantly, the bicarbonate provides a clean and fresh feeling in the mouth after brushing and rinsing with water. Suitably, the alkali metal bicarbonate is sodium bicarbonate.

[0113] The dental cleaning compositions of the present invention may contain one or more active agents conventionally used in dental cleaning compositions, such as fluoride sources, desensitizing agents, antibacterial agents, anti-plaque agents, anti-tartar agents, deodorizing agents, anti-inflammatory agents, antioxidants, antifungal agents, wound healing agents, or mixtures of at least two thereof. Such agents may be included at a level that provides the desired therapeutic effect.

[0114] Examples of desensitizers include tubule blockers or neurosensitizers and mixtures thereof, such as those described in WO02 / 15809 (Block). Examples of desensitizers include strontium salts such as strontium chloride, strontium acetate, or strontium nitrate, or potassium salts such as potassium citrate, potassium chloride, potassium bicarbonate, potassium gluconate, and especially potassium nitrate.

[0115] Desensitizing agents such as potassium salts are typically present in amounts ranging from 2% to 8% by weight of the composition, for example, 5% by weight of the composition.

[0116] In another embodiment, the desensitizing agent comprises arginine calcium carbonate. Suitably, the arginine salt is present in an amount of 0.5% to 30% by weight of the composition, for example, 1% to 10% by weight of the composition, or 1% to 10% by weight of the composition, for example, 2% to 8% by weight of the composition.

[0117] In one embodiment, the desensitizing agent comprises a bioactive glass. A suitable bioactive glass consists of 45 wt% silica, 24.5 wt% sodium oxide, 6 wt% phosphorus oxide, and 24.5 wt% calcium oxide. Such a bioactive glass is commercially available under the trade name NOVAMIN, also known as 45S5 BIOGLASS.

[0118] Suitablely, the bioactive glass is present in an amount ranging from 1% to 20% by weight of the composition, such as 1% to 15% by weight of the composition, or 1% to 10% by weight of the composition, or 2% to 8% by weight of the composition.

[0119] In one embodiment, the desensitizing agent comprises a stannous salt, such as stannous chloride or stannous fluoride. The stannous salt forms an insoluble metal salt through hydrolysis and oxidation reactions, which precipitates in the dentinal tubules and on the dentinal surface to provide effective relief from dentin hypersensitivity. Stannous salts also provide beneficial effects against tooth erosion, caries, and plaque / gingivitis.

[0120] The compositions of the present invention may also contain an anti-corrosion agent, such as the polymeric mineral surfactant described in WO 04 / 054529 (Procter & Gamble).

[0121] The compositions of the present invention will contain additional formulations, such as flavoring agents, sweeteners, opacifiers or colorants and preservatives, selected from those conventionally used in the field of oral hygiene compositions for this purpose.

[0122] Typically, optional reagents may be used in small amounts or proportions of the whole formulation. For example, these components are typically present in the dental cleaning composition at about 0.001 to about 5% by weight.

[0123] Dental cleaning compositions typically have a viscosity suitable for application to the oral cavity. The viscosity will vary depending on the type of dental cleaning composition prepared and its end use. Based on the teachings provided herein, those skilled in the art can readily prepare compositions with suitable viscosity for oral use.

[0124] The compositions according to the invention can be prepared by mixing the components in any convenient order and in appropriate relative amounts.

[0125] The present invention is further illustrated by the following embodiments.

[0126] result

[0127] To demonstrate the effectiveness of the novel abrasive system, a comparison was made with typical commercial toothpastes containing known silica abrasives.

[0128] The tested formulations are shown in Table 1.

[0129]

[0130] Table 1

[0131] Example 1 is a commercial Sensodyne formulation.

[0132] Examples 2, 3, and 4 are improved versions of the commercial product, wherein the commercial silica-based abrasive is removed and replaced with the abrasive system of the present invention.

[0133] Example 5 is a modified version of the basic formulation, in which SnF2 is removed and only 1.5% perlite is used instead of the commercially formulated silica abrasive.

[0134] Previous work (US 11,246,809) using spherical silica alone has yielded the following comparative formulations.

[0135]

[0136] Table 2

[0137] Six compositions were tested using known standard methods to compare their cleaning power and abrasion on the tooth surface. The results are shown in Table 3.

[0138] The three embodiments of the present invention demonstrated increased cleaning power compared to commercial products in the plecle cleaning ratio test (PCR). Furthermore, in the radioactive dentin analysis test, all three test samples also showed a significant reduction in tooth abrasion compared to three comparative formulations: the commercial product (Example 1), perlite alone (Example 5), and silica alone (Examples 6 and 7).

[0139]

[0140] Table 3

[0141] Therefore, the combined abrasive system of the present invention is significantly superior to the known silica systems currently in use, as well as to each component of the abrasive system used alone.

[0142] The combination of perlite and spherical silica surprisingly enhances cleaning power while reducing abrasion on the tooth surface.

[0143] The effect was not observed when using a combination of commercially available silica with perlite or spherical silica.

[0144] Test methods

[0145] The enamel cleanliness test (PCR) is used as a measure of the removal of stained enamel from bovine teeth.

[0146] introduce

[0147] Previous studies (J.Dent.Res., 61:1236, 1982) have shown that the results of in vitro PCR tests using dental cleaning slurries can be considered to predict clinical findings with reasonable confidence.

[0148] The ability of the dental cleaning formulation to remove surface stains from bovine tooth enamel was evaluated and compared with similar comparative formulations containing alternative silica abrasives (not included in the scope of this invention).

[0149] Methodology

[0150] Cut the cow's permanent central incisor to obtain approximately 8 × 8 mm. 2 Labial enamel samples were then embedded in self-polymerizing methacrylate resin, exposing only the enamel surface. The enamel surfaces were then smoothed on a lapidary wheel and polished with pumice powder and water, followed by ultrasonic treatment to remove excess debris. They were then lightly abraded (60 seconds in 0.12M HCl, 30 seconds in saturated NaCO3, and 60 seconds in 1.0% phytic acid) to accelerate stain buildup and adhesion. They were then placed on a rotating rod and alternately exposed to a mixture containing gastric mucin as a protein source and coffee, tea, and FeCl3. 36 The staining broth (i.e., 1.35 g coffee, 1.35 g tea, 0.02 g Fe and 1.0 g mucin in 400 ml) with H2O as the staining source was prepared for at least 10 days to ensure that the sample produced sufficient staining.

[0151] The amount of in vitro staining was graded using only laboratory-scale L values ​​via photometry (Minolta 2600d colorimeter). The sample area measured was a 1 / 4-inch diameter circle at the center of the enamel sample. Samples with L values ​​between 30 and 38 were measured (30 being the most deeply stained). Based on these measurements, the samples were divided into groups of 16 samples each, with each group having the same mean baseline measurement.

[0152] The samples were then mounted on a mechanical V-8 cross-brushing machine equipped with soft nylon filament toothbrushes (Oral-B 40 Indicator). The toothbrushes were conditioning by running the machine 1,000 times in deionized water. The tension on the enamel surface was adjusted to 150 g. The dental cleaning agent was used in the form of a slurry prepared by mixing 25 g of dental cleaning agent with 40 ml of deionized water. An ADA reference material was prepared by mixing 10 g of the material with 50 mL of 0.5% CMC solution. The samples were brushed 800 times with a double stroke. To minimize mechanical variables, one sample per group was brushed on each of the eight brush heads. Fresh slurry was applied to each brushed sample. After brushing, the samples were rinsed, blotted dry, and staining was measured again as previously described.

[0153] The difference in stain measurements before and after brushing was determined, and the mean and standard error for the reference group were calculated. The cleaning ratio for the reference material group was designated as a value of 100. The average reduction of the reference group was divided by 100 to obtain a constant value multiple of the reduction for each individual test in the study. The individual cleaning ratio (reduction × constant) for each sample was then calculated. The mean and standard error (SEM) for each group (N=16) were then calculated using the individual cleaning ratios. A higher cleaning ratio indicates a greater amount of surface film of stains removed.

[0154] Using Sigma Stat(3.1) software, statistical analysis of the individual means was performed using a one-way ANOVA model. Since ANOVA indicated significant differences, the Student Newman-Keuls (SNK) test was used to analyze the individual means.

[0155] RDA: Relative dentin abrasion

[0156] The most commonly used industry standard method for measuring how toothpaste is abraded is the procedure described in ISO 11609 and ANSI / ADA Standard No. 130.

[0157] Each test result is relative to a control, and the lower the better.

[0158] The abrasiveness of the dental cleaning formulation was evaluated (by RDA determination) and compared with similar comparative formulations.

[0159] Methodology

[0160] The procedure used was the ISO / ADA recommended procedure for determining the abrasiveness of dental cleaning agents. Dentin samples (8) were placed in a neutron flux under controlled conditions outlined by ISO / ADA. The samples were then fixed in methyl methacrylate to fit them into a V-8 cross-brushing machine. The samples were brushed for 1,500 strokes in a preconditioning run (since the teeth had been previously used) using a slurry consisting of 10 g of ISO / ADA reference material in 50 ml of 0.5% CMC glycerol solution. The brushes used were ISO / ADA specified brushes and had been used in previous studies. The brush tension was 150 g. After the preconditioning run, tests were performed in a sandwich design using 150 g and 1,500 strokes, with each test material slurry (25 g dental cleaning agent / 40 ml water) flanked by a reference material slurry (10 g ADA reference / 50 mL 0.5% CMC).

[0161] Take 1 ml of sample from each reference material slurry, weigh it (0.01 g), and add it to 4.5 ml of scintillation mixture. Mix the sample thoroughly and immediately place it on a scintillation counter for radiation detection. After counting, divide the net count per minute (CPM) value by the weight of the sample to calculate the net CPM per gram of slurry. Then calculate the net CPM / g of the reference material before and after ADA for each test slurry and take the average to calculate the RDA of the test material. Assign a value of 100 to the ISO / ADA material and calculate its ratio to the test material.

[0162] Statistical analysis was performed using Sigma Stat software (13.0) via a one-way ANOVA model. Individual means were analyzed using the Student Newman-Keuls (SNK) test to determine significance.

[0163] Test methods for silica and perlite particles

[0164] Particle size can be determined by laser diffraction.

[0165] The amount of oil absorbed can be measured according to the method described in U.S. Patent Application 2007 / 0001037A1, published on January 4, 2007.

[0166] Surface area and porosity analysis

[0167] The surface area of ​​the silica sample was measured by BET N2 adsorption, and isotherms were also measured to determine pore size and volume.

[0168] instrument:

[0169] The Braun Emmet Teller (BET) surface area calculated from gas adsorption (N2, 77 K) was measured using a Micromeritics 3-Flex gas adsorption analyzer. All powder samples (400–700 mg) were pre-degassed in an oven under vacuum (10⁻³ mbar) at 200 °C for 8 hours, and then degassed again in the 3-Flex analyzer under dynamic high vacuum (10⁻⁶ mbar) at 200 °C for 16 hours prior to analysis.

[0170]

[0171]

Claims

1. A dental cleaning composition comprising spherical silica particles and perlite particles, wherein the spherical silica particles comprise about 0.1% to about 4.0% by weight, and the perlite particles comprise about 0.1% to about 5.0% by weight; and further, wherein the spherical silica particles possess the following properties: a. Pore volume from approximately 0.03 mL / g to less than approximately 0.1 mL / g b. Average particle size from approximately 1 μm to approximately 10 μm; c. Approximately 50 m 2 / g or smaller BET surface area; d. Oil absorption capacity of approximately 20 to 50 ml / 100 g; and e. Water content less than approximately 0.2% by weight; and The perlite particles described therein have a d50 particle size of less than 50 μm.

2. The dental cleaning composition according to claim 1, wherein the spherical silica particles account for about 0.2% to 1.5% by weight of the composition, and the perlite particles account for about 0.25% to about 2.0% by weight of the composition.

3. The dental cleaning composition according to any one of the preceding claims, wherein the spherical silica particles account for about 0.25% to about 1.0% by weight, and the perlite particles account for about 0.75% to about 1.5% by weight.

4. The dental cleaning composition according to any one of the preceding claims, wherein the composition further comprises at least one surfactant and at least one humectant.

5. The dental cleaning composition according to any one of the preceding claims, wherein the composition further comprises a fluoride source.

6. The dental cleaning composition according to any one of the preceding claims, wherein the composition comprises additional abrasive.

7. The dental cleaning composition according to any one of the preceding claims, wherein the composition comprises an antisensitizing agent.

8. The dental cleaning composition according to any one of the preceding claims, wherein the desensitizing agent comprises one or more of stannous fluoride, potassium nitrate, or bioglass.

9. The dental cleaning composition according to any one of the preceding claims, wherein the composition further comprises: a. At least one moisturizer, 50%-80% by weight b. At least one surfactant, 0.5% to 5% by weight c. At least one gelling polymer, 0.25% to 2% by weight; and d. Fluoride source.

10. The dental cleaning composition of claim 9, wherein the at least one humectant comprises glycerin and polyethylene glycol; and the gelling polymer comprises carbomer.

11. The dental cleaning composition according to any one of claims 1 to 8, wherein the composition comprises: a. At least one moisturizer, 20%-55% by weight b. Water, 15%-45% by weight c. At least one surfactant, 0.5% to 5% by weight; and d. Fluoride source.

12. The dental cleaning agent according to claim 11, wherein the at least one humectant comprises one or more of sorbitol, glycerin, and polyethylene glycol, or a mixture thereof.

13. The dental cleaning composition according to any one of claims 9 to 12, wherein the at least one surfactant comprises one or more of sodium lauryl sulfate (SLS), cocamidopropyl betaine (CAPB), and sodium cocoyl methyl taurate, and mixtures thereof.

14. The dental cleaning composition according to any one of the preceding claims, wherein the composition further comprises one or more minor components; the minor components include light-blocking agents, pH adjusters, preservatives, flavoring agents, coloring agents, or mixtures thereof, and wherein the minor component accounts for 0.1% to 5% by weight of the composition.

15. The use of a combination of a dental cleaning composition according to any one of claims 1 to 14 with a brush for cleaning teeth, wherein the brush may be manual or electric.

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