HRP20150206A2 - Dental formulation - Google Patents

Abstract

The present invention discloses a dental formulation consisting of: - calcium aluminosilicate with a spherical particle shape - CAS i- one or more excipients and optional ingredients required to prepare the desired product in the final form: oral suspension, toothpaste, tooth powder, dental gel, and chewing gum.CAS is characterized by: - specific chemical composition: 0.311 - 0.732 wt. % NaO, 14.712 - 15.360 wt. % CaO, 27,643 - 28,450 wt. % AlO, 33.248 - 35.193 wt. % SiOi 20.446 - 23.273 wt. % HO; - Spherical shape of particles with no clear crystalline surfaces and high surface coarseness: RSP / GSP = 2.58 - 2.81; real specific surface area (RSP) in the range between 2.375 m / g and 4.433 m / g; - external geometric specific surface area (GSP) in the range between 0.9212.375 m / g and 1.593 m / g Due to the above CAS properties, the present invention are effective agents for desensitization, stabilization, mineralization and polishing of the teeth.

Description

The field to which the invention relates

The present invention discloses a dental formulation suitable for the treatment of the teeth and oral cavity. Said dental formulation is suitable for use in case of need for desensitisation, stabilization and remineralization of teeth with various etiologies.

Technical problem

The existing invention solves the technical problem of effective pH control, stabilization and remineralization of hard dental tissues, tooth desensitization, prevention of caries and remineralization of carious lesions, reduction of the number of cariogenic and inflammatory bacteria in the oral cavity, stopping of bleeding in the oral cavity, acceleration of wound healing, prevention of connective tissue degradation oral cavity, prevention and treatment of gingivitis and periodontitis, regulation of salivation, prevention of caries and gingivitis during the wearing of mobile and fixed orthodontic devices, improvement of the condition of the oral cavity caused by the duration of diabetes, improvement of the condition of the oral cavity caused by hormonal changes during pregnancy and menopause, stabilization and remineralization acquired and genetically determined hypomineralization conditions of tooth enamel, prevention of complications on hard and soft tissues of the oral cavity caused by smoking, prevention of pathological changes in soft and hard tissues in the oral cavity of children, filling of natural and acquired morphological defects of hard dental tissues, indirect and direct covering of dental pulp, and root apexification with an open apex.

This was achieved by means of a toothpaste formulation containing calcium aluminosilicate with a spherical particle shape - CAS. Its characteristic is a significantly accelerated and increased release of calcium ions, which enables rapid mineralization of tooth enamel and dentin at optimal pH.

The formulation contains:

(i) calcium aluminosilicate with spherical particle shape (CAS);

(ii) one or more excipients and optional ingredients necessary to achieve the desired final dosage form: oral suspension (mouthwash), toothpaste, dental gel (sticky to the teeth), and chewing gum.

This recipe is especially effective for:

(i) stabilization of hard dental tissues

(ii) remineralization of hard dental tissues

(iii) desensitization of teeth

(iv) polishing teeth

(v) regulation of the pH of the oral cavity

(vi) regulation of salivation

(vii) reduction in the number of pathological flora of the soft and hard tissues of the oral cavity

(viii) prevention of inflammation of the soft tissues of the oral cavity as well as treatment of the aforementioned inflammatory conditions

(ix) accelerating the healing of wounds in the oral cavity.

State of the art

The importance of good oral hygiene is manifested not only in the control of caries, periodontal disease and bad breath, but also in the interdependent action with other systemic conditions such as diabetes, stroke and heart attack, etc.

Underlying the formation of caries and periodontal diseases is dental plaque, which according to WHO (1978) is defined as a biofilm composed of different types of microorganisms in an extracellular matrix made of bacterial metabolic products and components of serum, saliva and blood.

Demineralization is the main process in the development of enamel and dentin caries, which begins with the formation of various organic acids (lactic, acetic, propionic, formic) by plaque bacteria, after exposure to fermentable carbohydrates.

Demineralization is a progressive process, and it is stopped either by reducing acidity or increasing alkalinity in the oral cavity by means of:

(i) application of an orally acceptable neutralizing agent;

(ii) washing; or

(iii) mineralization with a suitable source of calcium (Ca2+) ions, caries will develop.

One of the most important existing tooth decay prevention strategies is frequent tooth brushing with toothpastes that contain fluoride. The effect of fluoride is based on the formation of fluoroapatite [Ca5(PO4)3F] by the reaction of fluoride anions from oral hygiene products and natural hydroxyapatite from tooth enamel. The solubility of fluoroapatite in an acidic environment is about ten times lower than that of hydroxyapatite. In this way, fluorides stabilize tooth enamel and dentin by reducing their solubility in acidic media as well as by having a toxic effect on oral microorganisms [J. M. ten Cate, J. D. Featherstone: Mechanistic aspects of the interactions between fluoride and dental enamel Crit. Rev. Orally. Biol. Honey. 2 (1991) 283-296].

Numerous patents describe the use of fluoride, or phosphate for re-mineralization of teeth, which is based on the formation of fluoroapatite. Likewise, many documents describe oral preparations based on a mixture of phosphates and Ca salts.

US Patent 4,080,440 (1976) discloses a method for re-mineralization of tooth enamel based on a metastable aqueous solution of calcium (0.005-5%) and phosphate (0.005-5%) ions with a Ca:P molar ratio between 0. 01-100 and pH 2.5-4. Re-mineralization occurs with the inclusion of calcium and phosphate ions from the solution on the demineralized surfaces of the teeth.

US Patent 4,083,955 (1976) describes the re-mineralization of tooth enamel using a two-stage wash. At the first, the oral cavity is treated with an aqueous solution of 0.005–10% soluble calcium ions or with an aqueous solution of 0.005–10% soluble phosphate ions. During the treatment (10–30 seconds), calcium ions enter the surface and parts below the surface of the enamel. Then the oral cavity is treated with phosphate ions in the second stage for the same amount of time. During this second treatment, the phosphate ions from the solution react with the calcium ions previously bound to the enamel, forming in both cases hydroxyapatites. The treatment can also be carried out in the opposite way.

US Patent 4,244,931 (1979) discloses the use of calcium hydrogen phosphate dihydrate (CaHPO4•2H2O) with sufficient magnesium phosphate and/or pyrogenic phosphate of improved stability. The formula based on this is useful for re-mineralization and polishing of teeth.

US Patent 4,515,772 (1984) discloses an oral dentifrice composition consisting of 10-70% metaphosphate, aluminum trioxide, polymer gums and amorphous silica as abrasives, 50-3500 ppm fluoride ions (F- ), and at least 1.5% of alkali metal pyrophosphates (source of P2O74- ions).

US Patent 5,614,175 (1996) discloses non-aqueous lesion mineralization agents consisting of 0.0-15% water-soluble calcium salts, 0.05-15% water-soluble phosphate salts.

US Patent 5,645,853 (1995) describes a chewing gum composition for mineralizing lesions, containing 0.01-15% water-soluble calcium salts, 0.01-15% water-soluble phosphate salts, and 10- 95% chewing gum base and encapsulation layer. During chewing, both calcium and phosphate ions are released from the gum and, together with saliva, form a solution of calcium and phosphate ions with a pH between 4 and 7. Phosphate and calcium ions from saliva are deposited on the tooth surface, promoting re-mineralization by crystallization of basic calcium phosphates. (hydroxy-apatite).

Some of the new approaches to mineralization take advantage of the properties of amorphous calcium phosphate (ACP) created from water-soluble calcium and phosphate salts. ACP is quickly converted into crystalline apatite during application in washing and care of teeth with the mentioned recipes [E. D. Eanes in: Z. Amjad (Ed.), Calcium phosphates in biological and industrial systems, Kluwer Academic Pub., Boston, 1998, p.21.; M. S. Tung, US Patent 5,037,639 (1989); M. S. Tung, F. C. Eichmiller: Amorphous calcium phosphates for tooth mineralization, Compend. Cont. Educ. Dent. 25 (2004) 9-13].

Amorphous calcium phosphate (ACP) can be stabilized with pyrophosphates (P2O74-). A supersaturated solution can then be stable for a long time, preventing the crystallization of crystalline forms of calcium phosphate [M. S. Park, E. D. Eanes, J. M. Antonucci, D. Skrtic: Mechanical properties of bioactive amorphous calcium phosphate/methacrylate composites, Dent. Mater. 14 (1998) 137-141].

A similar re-mineralization strategy can be applied to treat lesions and open pores of the dental tubules that would otherwise cause tooth hypersensitivity. [US Patent 6,036,944 (1999)].

One of the best-known preparations for re-mineralization of teeth is based on the use of ACP in sugar-free chewing gum (RecaldentTM). This product contains ACP stabilized by casein (cow's milk protein) [J. D. Bader: Casein phosphopeptide amorphous calcium phosphate shows promise for caries prevention, Evid. Based Dent. 11 (2010) 11-12].

IN

NovaMin Technology Inc. and the University of Maryland (Department of Dentistry, Baltimore, MD, USA) invented a new preparation protected by several patents, NovaMin, based on calcium-sodium phosphate silicate (bio-glass). It was originally designed to treat super-sensitivity by physically filling the dental tubules, and recent research shows the ability of this material to prevent de-mineralization and/or stimulate re-mineralization of the tooth surface. The mode of action of this material is based on the interaction of the said material with aqueous solutions.

When introduced into the oral environment, this material releases sodium, calcium and phosphate ions, which then interact with oral fluids and result in the formation of crystalline hydroxycarbonate apatite (HCA) - a layer that is structurally and chemically similar to natural tooth mineral. [A.K. Burwell, L.J. Litkowski, D.C. Greenspan, Calcium sodium phosphorous silicate (Novamin): Re-mineralization potential, Adv. Dent Res. 21 (2009) 35-39].

According to document EP1620064, a preparation containing the Ca form of zeolite, a source of phosphate ions and matrix proteins is used for the stabilization, recalcification and remineralization of tooth enamel and dentin.

Document EP2438010 discloses calcium aluminosilicate with spherical particle shape (CAS) and its non-medical use. CAS with the same properties as described in the cited document was also used in the present invention.

The above-mentioned methods and corresponding preparations are based either on water-soluble calcium (source of calcium ions) and phosphate salts (source of phosphate ions), or on a common or simultaneous source of calcium and phosphate ions (ACP, bio-glass). The use of water-soluble calcium and phosphate salts as a source of calcium and phosphate ions required for re-mineralization causes certain difficulties related to the control of calcium and phosphate ion concentrations; if the concentrations of the mentioned ions are too low, the required level of re-mineralization cannot be achieved, while on the other hand, too high concentrations of the mentioned ions can cause the formation of defective crystal structures and/or the formation of unwanted deposits on the surface of the teeth. A special problem is the constant change (decrease) in the concentration of calcium and phosphate ions during re-mineralization. Furthermore, water-soluble calcium salts can be a source of various anions (chloride, nitrate, bicarbonate, etc.), which can negatively affect the crystallization of hydroxyapatite and the stability (solubility) of tooth enamel. Finally, the components (calcium and phosphate salts) of re-mineralization agents based on water-soluble salts must be physically separated before use; otherwise, calcium and phosphate ions could instantly react to form different calcium phosphates before use, i.e. during storage.

On the other hand, the application of amorphous calcium phosphate (ACP) and bio-glass in dental care products, which contain water, such as toothpaste, oral solutions (mouthwashes), dental gels, etc., causes another kind of problem; in the presence of water, ACP spontaneously transforms into crystalline, less soluble calcium phosphates, and bio-glass spontaneously dissolves, creating sodium, calcium, phosphate and silicate ions. Mutual reactions of calcium and phosphate ions, created by dissolving bio-glass, result in the formation of amorphous calcium phosphate (ACP), which later turns into crystalline calcium phosphates. In this way, the composition of dental care products is constantly changing during storage, which results in a reduction of its potential for re-mineralization.

Given that the pH of the oral cavity is one of the most important factors for controlling the stability of the mineral parts of the teeth (enamel, dentin) and, therefore, for controlling the development of caries [M.E. Jensen, Cariology 43 (1999) 615], in many of the mentioned methods and corresponding recipes the pH is adjusted by adding bicarbonate and/or carbamide. Bicarbonates in tooth care products reduce acidity (increase pH) and thus increase the stability of the mineral parts of the teeth. The presence of carbonate can cause a negative effect for enamel and dentin. Namely, OH- ions from hydroxyapatite can be replaced with carbonate ions from the solution (saliva), thereby creating carbonate-apatites whose solubility in an acidic environment is significantly higher than the solubility of hydroxyapatite under the same conditions. On the other hand, although carbamide is a neutral compound, in the presence of acids, created by the action of cariogenic bacteria, carbamide hydrolyzes into ammonia and carbon dioxide. The resulting ammonia neutralizes organic acids and thus reduces acidity in the oral cavity. However, comparative studies of chewing gum with or without carbamide have shown that the presence of carbamide has no significant effect on the pH in the oral cavity. Finally, carbon dioxide formed as a product of carbamide hydrolysis can produce carbonate ions. And again, OH- ions from hydroxyapatite can be replaced with carbonate ions thus formed, thus forming carbonate apatites whose solubility in an acidic environment is significantly higher than the solubility of hydroxyapatite under the same conditions.

Taking into account the aforementioned difficulties in pH control as well as the adjustment and control of calcium and phosphate ion concentrations in existing preparations for remineralization, the technical problem of effective mineralization, stabilization and desensitization of teeth is solved in the manner disclosed later in the text. It surprisingly turned out, despite the guidelines of previous research that unequivocally indicate that the optimal preparation for remineralization, recalcification, stabilization and desensitization of teeth should contain sources of phosphate (and/or bicarbonate), and/or fluoride and calcium ions, and/or carbamide, that by using new type of calcium aluminosilicate with spherical particles (CAS) and without the presence of sources of phosphate, bicarbonate, and/or fluoride ions and/or carbamide in the oral preparation achieves remineralization, recalcification, stabilization and desensitization of teeth. Namely, the average expert in the field knows that calcium aluminosilicate cannot regulate pH by itself. For effective pH regulation, it needs a source of phosphate ions and/or bicarbonate ions, and/or carbamide a. In addition, the average expert in the field knows that in oral preparations, phosphate ions are also necessary for the formation of hydroxyapatite - a compound that makes up tooth enamel. for mineralization, stabilization, remineralization and desensitization of teeth. This is precisely one of the most important reasons why previous research has focused on mixtures of sources of Ca and phosphate ions.

The preparation according to the present invention is without a source of phosphate ions, just as without the use of bicarbonate ions and/or carbamide. The preparation maintains the pH at the local level, that is, on the surface of the teeth at an optimal level, average pH=7.6 to 7.8, long after the treatment. The pH on the surface of the tooth treated with the preparation according to EP1620064 is 7.0, while the pH of the surface of the tooth treated with the preparation according to the invention of the University of Maryland - Nova Min tends to values of 10 or more due to the presence of sodium in the bioglass and because a good part of the bioglass is inactivated during storage . A further advantage of the present invention lies in the fact that fluorine is not used in the oral preparation and, as a result, side effects as a result of fluorine toxicity are avoided.

In addition, there are no indications that the remineralization, recalcification, stabilization and desensitization of teeth with the preparation according to the invention lags behind the remineralization, recalcification, stabilization and desensitization of teeth with the preparations according to document EP1620064 and according to the invention of the University of Maryland. Therefore, the subject invention also solves the problem of an alternative method of remineralization, recalcification, stabilization and desensitization of teeth.

Furthermore, if sources of calcium and phosphate ions are present in a preparation such as toothpaste, then Ca and phosphate ions partially dissolve in the water and moisture present in the paste, whereby the final product of this process is an inactive substance such as hydroxyapatite. The subject invention therefore, by removing phosphate ions from the preparation, solves the problem of partial deactivation of preparations for remineralization, recalcification, stabilization and desensitization of teeth, showing better results in this sense.

Furthermore, the present invention uses very small amounts of calcium aluminosilicate, eg zeolite, compared to the prior art. Calcium aluminosilicate, or zeolite, or more specifically the calcium form of zeolite A is present in the preparations according to the subject invention in amounts of 1 to 10 percent by weight. In preferred embodiments, the amount of the above-mentioned calcium aluminosilicate is between 2 and 7%, and in even more favorable embodiments of the invention, 3 to 5%.

Thus, the subject invention also solves the technical problem of effective desensitization, stabilization and mineralization of teeth.

This was achieved using a toothpaste formulation containing calcium aluminosilicate with a spherical CAS particle shape. Its characteristic is a significantly increased release of calcium ions in a shorter time, which enables rapid mineralization of tooth enamel and dentin at optimal pH.

The formulation contains:

(i) calcium aluminosilicate with spherical particle shape (CAS);

(ii) one or more auxiliary ingredients such as excipients and optional ingredients necessary to achieve the desired final dosage form: oral suspension (mouthwash), toothpaste, dental gel (sticky to the teeth), and chewing gum.

This recipe is especially effective for:

(i) desensitization of the teeth;

(ii) mineralization of tooth enamel and dentin;

(iii) stabilization of tooth enamel and dentin; and

(iv) polishing teeth.

Finally, the preparation according to the present invention also has an anti-inflammatory effect, which was found in several individuals in the way that bleeding in periodontitis was visibly reduced, from which it can be concluded that the preparation according to the invention prevents the destruction of collagen fibers and helps in their regeneration.

Presentation of the essence of the invention

The formulation of this invention contains:

(i) calcium aluminosilicate with spherical particle shape (CAS) i

(ii) one or more additives and ingredients necessary to produce the desired final dosage and form: oral suspension (rinse), toothpaste, , dental gel (dental adhesive), and chewing gum.

Short descriptions of the images:

Figure 1.: SEM photograph of CAS particles magnified by 10,000x (a) and 33,000x (b).

Figure 2: Particle size distribution of CAS-P#4. ND is the numerical percentage of particles that have the corresponding diameter D.

Figure 3: Influence of pH on the solubility of hydroxyapatite. CCa is the concentration of calcium ions in the solution, and mHA is the mass of dissolved hydroxyapatite. DE->demineralization; RE->remineralization

Figure 4: SEM photographs of dentinal tubules before (A) and immediately after (B, C) treatment with the preparation containing CAS.

Figure 5.: Average values, Sav, of calcium ion concentration reduction during tooth demineralization in 0.4 M acetic acid solution.

Figure 6: SEM photograph of the tooth surface after treatment with a preparation containing CAS.

Figure 7 SEM photograph of the tooth surface (enamel) before (A) and after (B) treatment with a preparation containing CAS.

Figure 8: SEM photographs of dentinal tubules after treatment with a preparation containing CAS for 6, (A), 12, (B), 18 (C) and 24 h (D).

A detailed description of at least one way of realizing the invention

Synthesis and characteristics of CAS

We found that for some specific chemical compositions of precipitated sodium aluminosilicates, their hydro-thermal treatment results in the formation of sodium aluminosilicates with a spherical shape of particles with an extremely high specific surface area and the ability to replace the original sodium ions with other cations. Sodium aluminosilicate with spherical particle shape was synthesized as follows:

(i) Preparation of sodium aluminosilicate suspension; The suspension is prepared by mixing a sodium aluminate solution (having the appropriate chemical composition with respect to Na2O, Al2O3 and H2O) and a sodium silicate solution (having the appropriate chemical composition with respect to Na2O, SiO2 and H2O) at temperatures (TP) from room temperature ( 20oC) to 90oC. Suspensions prepared in this way contain:

7,586 – 11,695 wt. % Na2O,

4.229 – 9.379 wt. % Al2O3,

3.238 – 7.735 wt. % SiO2 and

72,408 – 84,600 wt. % H2O

(ii) Hydrothermal treatment of aluminosilicate suspensions: The hydrothermal process is performed by heating aluminosilicate suspensions at temperatures (TR) between 65-90oC, with stirring, until the solid phase of the suspension is completely converted into SAS (tR = 60-135 min; depending on the chemical composition of the initial suspension and reaction temperature, TR);

(iii) Product separation (SAS): The SAS, which is obtained by hydrothermal treatment of the suspension, as described under (ii), is separated from the liquid phase (mother) either by centrifugation or vacuum filtration. The separated SAS is subjected to washing with several portions of demineralized water to remove residual reagents (from the mother liquor) adsorbed on the product, until the pH of the filtrate is 9-10.

(iv) Drying of the washed SAS is done at 80-150oC for 24 hours.

(v) Dry SAS is converted to calcium form (CAS) by the process of replacing sodium ions from SAS with calcium ions from calcium chloride (CaCl2) solution, resulting in pure calcium aluminosilicate with spherical particle shape (CAS).

This product (CAS) is characterized as follows:

(i) Chemical analysis of the product (content of Na2O, CaO, Al2O3 and SiO2) is determined by atomic absorption spectroscopy. The water content is determined from the difference in mass before and after calcination at 800oC for 2 hours.

The shape of CAS particles was determined from photographs taken by scanning-electron microscopy (SEM; Fig. 1).

CAS particle size distribution curves were made using a laser light scattering particle size distribution measuring device, Mastersizer 2000 (Malvern Instruments).

The external specific surface areas of the samples (RSP) were measured with a Gemini 2360 (Micromeritics).

Properties of CAS

Chemically, CAS is a hydrated calcium aluminosilicate that has the following chemical composition:

0.311 – 0.732 wt. % Na2O,

14,712 – 15,360 wt. % CaO,

27,643 – 28,450 wt. % Al2O3,

33.248 – 35.193 wt. % SiO2 and

20,446 – 23,273 wt. % H2O,

as determined by chemical analysis. Small variations in chemical composition are caused either by variations in the chemical composition of the initial sodium alumino-silicate suspension or due to expected errors of applied experimental methods, including expected errors during sample preparation. The small amount of Na2O is the result of incomplete replacement of the original sodium ions from SAS with calcium ions from the solution. The calcium ions in CAS are exchangeable and can be exchanged with other cations from the solution.

CAS particles have a size in the range between 0.4 μm and 4 μm (see Fig. 2 ) and an average particle size between 1,237 μm and 1,848 μm.

CAS particles are synthesized as individual particles characterized by the unexpected spheroidal shape of each individual particle. CAS does not consist of aggregates or clusters of particles; see Fig. 1.

Also, unexpectedly, CAS is characterized by pronounced outer surface roughness without recognizable crystal faces (Fig. 1b; SEM, magnification: 30,000x). The high roughness of the outer surface of CAS is also recognizable by the unexpectedly high ratio between the actual specific surface area (RSP), determined by the Brunauer-Emmett-Teller (BET) method, and the geometric specific surface area (GSP) [A. Peiquey et al., Carbon 39 (2001) 507-514; K. Kaneko, C. Ishii, Colloids and Surfaces 67 (1992) 203-212] calculated from the corresponding CAS particle distribution curves (RSP/GSP = 2.58 – 2.81). These RSP/GSP ratio values mean that the specific surface area of CAS is 2.58 – 2.81 times greater than the specific surface area of a material that has the same particle sizes as CAS, but with a smooth surface.

Stabilization ability of CAS

The solubility of the mineral part of the tooth (enamel, dentin), and thus its stability, is highly dependent on the pH in the oral cavity; the solubility of hydroxyapatite, which is the main part of enamel and dentin, decreases with increasing pH (see fig. 3. In this way, pH is one of the most important factors for controlling the stability of the mineral parts of the teeth and therefore, for controlling the occurrence of caries [M.E. Jensen, Cariology 43 (1999) 615].

Due to the hydrolytic reaction:

Ca-alumino-silicate (CAS) + 2H2O � H-alumino-silicate + Ca2+ + 2OH-

the aqueous solution of CAS is alkaline. Depending on the amount of CAS in the suspension, the pH of the suspension is between 8 and 9. This makes it a promising agent for stabilizing teeth.

Mineralizing ability of CAS

The mineralization ability of CAS is related to exchangeable calcium ions in CAS. However, the rate of (re)mineralization is controlled by the rate of "release" of calcium ions from CAS during the exchange of Ca2+ ions from CAS with other cations from saliva. Calcium ions "released" from CAS are incorporated into the surface enamel at an optimal pH (~ 8). This results in the gradual formation of hydroxyapatite on the tooth surface and thus, (re)mineralization of the tooth surfaces without the formation of defective hydroxyapatite crystals and/or crystal clusters. These factors make CAS an ideal source of calcium ions needed for (re)mineralization.

Desensitizing ability of CAS;

Dentin consists of thousands of microscopic tubular structures that extend through the pulp; these dentinal tubules are typically 0.5 to 2 micrometers in diameter (Fig. 4A). Changes in the flow of plasmatic biological fluid, present in the dentinal tubules, can activate the mechanoreceptors present in the nerves, and in this way, cause pain. The mentioned hydrodynamic flow can be increased by cold, air pressure, dryness, sugar, acids, or force applied to the tooth. One of the most effective ways to prevent hypersensitivity is the physical closure of dental tubes with a suitable material. Due to: (i) size (0.4 μm and 50% of particles smaller than 1.5 μm and 90% of particles smaller than 2.5 μm; (Fig. 2), which is comparable to the size of tubules (Fig. 4A), (ii) spherical shape (Fig. 1) which enables the dense packing of CAS particles in the tubes and, in this way, effective sealing of dental particles (Fig. 4B and C) and (iii) chemical composition (matrix of insoluble aluminosilicate and exchangeable calcium ions ) make CAS an almost ideal agent for desensitizing. Unexpectedly, it turned out that all oral preparations effectively close the dental tubules even with a very short action. Therefore, it is not necessary to apply CAS by an expert, but the use of the dental preparation according to the subject invention and the tubule is sufficient will be closed.

Polishing ability of CAS

Due to the principle that tooth polishing should be completed with polishing particles smaller than 12 µm [E. Takanashi, R. Kishikawa, M. Ikeda, N. Inai, M. Otsuki, R.M. Foxton, J. Tagami, Effect of abrasive particles on the surface properties of flow compositions, Dent. Mater. J. 27 (2008) 780-786], CAS is an effective polishing agent due to its particle size.

Excipients and optional ingredients

One or more auxiliary ingredients and optional ingredients (75-99% by weight) are required to prepare the desired final dose and form of the product: oral suspension (mouthwash), toothpaste, gel, (denture adhesive) chewing gum.

These ingredients are selected from the group containing excipients, diluents, fillers, humectants, thickeners (or binders), gum bases, softeners, sweeteners, fragrances, surfactants, (foaming agents and solubilizers), preservatives, antioxidants, stabilizers and other ingredients of your choice .

Diluents in oral suspensions and dental gels are selected from the group containing purified water, ethanol or their mixtures.

Fillers, abrasives and polishing agents can be compounds such as micro-crystalline cellulose, aluminum hydroxide [Al(OH)3], calcium sulfate dihydrate (CaSO4•2H2O), calcium carbonate (CaCO3), calcium pyrophosphate (Ca2P2O7), colloidal hydrated silicon acid (SiO2•xH2O), sorbitol, inulin, kaolin, talc, bentonite, basic magnesium carbonate (MgCO3), basic magnesium carbonate [(4MgCO3•Mg(OH)2•4H2O)], calcium silicate (CaSiO3) and a mixture of two or several listed compounds, with the fact that the listed list of compounds is not complete, and for the purpose of fillers, abrasives and polishing agents, compounds that are not on the list can be used, and which are known to the average expert in the field as fillers, abrasives and polishing agents used in dental preparations. Likewise, mixtures of unlisted compounds as well as mixtures of these compounds with the above-mentioned compounds can be used as abrasives, fillers and polishing agents.

Humectants are selected from the group consisting of glycerol, 1,2-propylene glycol, 1,3-propylene glycol, liquid polyethylene glycol, liquid polyglycerol, aqueous sorbitol solution, or their mixture.

Thickeners, which are also used as binders in the formulations of this invention: dental gel, oral suspension and toothpaste, are selected from the group containing polyacrylic acid, co-polymers, or their sodium or potassium salts; methyl cellulose; sodium caraboxy-methyl-cellulose; 2-hydroxy-ethyl-cellulose; 2-hydroxy-propyl-cellulose; 2-hydroxy-propyl methyl-cellulose, polyglycerol; polyethylene glycol; agar agar; carrageenan, gum arabic; alginic acid and its sodium salt; tragacanth, karaja gum; bentonite, or their mixtures.

Rubber bases as auxiliary substances in the chewing gum recipe from this invention are selected from the following group of compounds: poly-isoprene, (natural rubber), isobutylene-isoprene copolymers (butyl elastomer; Mw = 10,000-100,000); styrene-butadiene copolymers (molar ratio 1:3 to 3:1; Mw = 10,000-65,000), polyvinyl acetate (PVA; Mw = 2,000-90,000); polyethylene; or mixtures thereof.

Softeners as excipients in chewing gums can be, for example, higher fatty acids such as stearic, palmitic or oleic acid; vegetable oils such as coconut oil, canola oil, and sunflower oil; partially hydrogenated vegetable oils such as hydrogenated castor oil, lecithin; mono- and diglycerides such as glyceyl monostearate; waxes such as beeswax, Chinese wax, Candelilla wax, soybean wax, jojoba oil, paraffin wax, microcrystalline wax, lanolin, rosin esters, shellac and mixtures of these substances.

Sweeteners are selected from the group containing sucrose, fructose, glucose, glucose syrup, honey, sodium saccharin, acesulfame potassium, sucralose, sodium or calcium cyclamate, xylitol, sorbitol, erythritol, maltitol, lactitol, glycyrrhizin, licorice extract (Glycyrrhiza glabra L .) root, steviosides, rebaudioside A, Stevia extract (Stevia rebaudiana L.), or their mixtures.

Flavorings and excipients are selected from a group of recognized healthy, edible natural compounds of the class:

(i) organic acids (e.g. citric, malic, tartaric);

(ii) pure turpentine (eg eucalyptol, L-menthol, limonene, camphor, citral, carvone);

(iii) phenols and phenolic esters (eg, thymol, methyl salicylate, eugenol, vanillin, ethyl vanillin, anethole);

(iv) amino acids, usually as flavor enhancers (e.g. sodium glutamate),

(v) Plant dry and liquid extracts, concentrates and essential oils of various plants [eg. peppermint (Mentha piperita L.), thyme (Thymus vulgaris L.), cinnamon (Cinnamomum zeylanicum L.), cloves (Syzygium aromaticum L.), lemon balm (Melissa officinalis L.), lemon (Citrus limonum), sweet orange ( Citrus sinensis), fennel (Foeniculum vulgare L.), anise (Pimpinella anisum L.), caraway (Carum carvi L.), green tea (Camellia Sinensis - Epigalokathehingalat) nutmeg (Myristica fragrans L.), etc.]; and a mixture of these substances. It is known that those who are skilled in the different application of aromas and extracts, when they use them in slightly increased quantities, can also show side effects such as masking unpleasant odors and disinfection (antimicrobial) such as thymol, EGCG, eugenol.

Surface-active substances - (surfactants, ionic and non-ionic) that serve as foaming agents and solvents are selected from the group containing sodium lauryl sulfate, sodium lauryl ethylene glycosulfate, sodium lauryl diethylene glycosulfonate, sodium cocoamphodipropionate, disodium cocoamphodipropionate, dioctyl sodium sulfosuccinate, sodium lauryl sulfoacetate, sodium lauryl sarcosinate, ethoxylates or higher fatty alcohols such as polyoxyethylene (23), lauryl ether, with H.L.B. value ≥10, ethoxylates of higher fatty acids such as polyoxyethylene (23), oleates, with H.L.B. value ≥10; polyglyceryl derivatives of higher fatty acids with H.L.B. value ≥10, polyoxyethylene sorbitan esters of higher fatty acids such as polyoxyethylene sorbitan monostearate, with H.L.B. with a value ≥10, or their mixture.

Preservatives are selected from the group containing methyl 4-hydroxybenzoate, ethyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate, butyl 4-hydroxybenzoate, sorbic acid, potassium sorbate, benzoic acid, sodium benzoate, 2-phenoxyethanol, 4-chloro-m-cresol , thymol, eugenol, or their mixtures.

Antioxidants are selected from the group containing 2,6-di-tert-butyl-4-hydroxytoluene (BHT), tert-butylhydroxyanisole (BHA), EGCG, tocopherol, tocopheryl lactate, ascorbic acid, or mixtures thereof.

Stabilizers are selected from the group consisting of disodium citrate [Na2C(OH)(COOH)(CH2COO)2], disodium ethylenediamine tetraacetate (Na2EDTA•2H2O), or mixtures thereof.

The ingredients selected from the recipes of this invention are used as adjuvants with the aim of achieving additional cosmetic and health effects. Included here are: fluoride sources, antimicrobial agents, and astringents.

Fluorides as caries prevention additives in dental care products are selected from the group containing sodium fluoride (NaF), potassium fluoride (KF), sodium monofluorophosphate (Na2PO3F), tin fluoride (SnF2), or their mixtures.

Antimicrobial agents are selected from the group containing: boric acid or sodium borate, quaternary ammonium compounds such as cetylpyridine chloride, benzalkonium chloride or cetyltrimethylammonium bromide, carbamide, hydrogen peroxide, hexylresorcinal, hexachlorophene, triclosan, chlorhexidine, gluconate or hydrochloride, hexetidine, iodine , sodium N-chloro tosylamide, EGCG, potassium chlorate, and compatible mixtures of these substances.

Astringents are selected from the group containing zinc or aluminum salts, such as zinc phosphate [Zn3(PO4)2], zinc chloride (ZnCl2), zinc iodide, (ZnI2), zinc sulfate heptahydrate (ZnSO4•7H2O), zinc acetate dihydrate [Zn(CH3COO)2•2H2O], aluminum sulfate octadecahydrate [Al2(SO4)3•18H2O], aluminum acetate [Al(CH3COO)3], aluminum acetotartrate [Al(CH3COO)(CH(OH)COO)2], potassium aluminum sulfate dodecahydrate [Al2(SO4)3•12H2O], or mixtures thereof, or pharmaceutically acceptable acids or extracts of plants with a significant percentage of tannins such as oak bark (Cortex Quercus), North American hazel, (Hamamelis virginiana L.), Peruvian balsam (Mynoxylon balsamum L.), common sage (Salvia officinalis L.), walnut leaves (folia Juglandis), Argentina anserina L.

Formulations of the present invention Formulations of the present invention include the desired final dose and form of an oral suspension (mouthwash), toothpaste, gel (denture adhesive) and chewing gum. Formulations are made using conventional procedures known to those skilled in pharmaceutical technology. [J. N. Ingle: Encyclopaedia of Pharmaceutical Technology (2000) Marcel Dekker Inc., USA].

An oral suspension (for rinsing the oral cavity) is obtained by dispersing CAS in purified water or its mixtures with ethanol in the presence of suitable thickeners that stabilize the final suspension, i.e. prevent precipitation. Finally, the oral suspension is stabilized by adding preservatives such as methyl- and propyl-4-hydroxybenzoate, antioxidants (e.g. BHT), stabilizers (e.g. Na2EDTA), and possibly colors (e.g. Brilliant Blue FCF; E133).

Toothpaste is obtained by mixing CAS with one or more fillers and suspending a thickener (which has the function of a binder here) and humectants in purified water. Ingredients of your choice are added to the base thus obtained: antimicrobial agents (e.g. hexetidine) and/or astringents (e.g. zinc phosphate, [Zn3(PO4)2]), sweeteners (e.g. sodium saccharin), flavors (e.g. peppermint oil ), preservatives (e.g. methyl 4-hydroxybenzoate), stabilizers (e.g. disodium citrate, [Na2C(OH)(COOH)(CH2COO)2]) and possibly, permitted colorings.

Dental gel (dental glue) is prepared by vigorously mixing purified water or an aqueous solution of ethanol and a thickener, whereby the base of the gel is formed, to which other ingredients are then added, such as: sweetener, aroma, and, if necessary, antimicrobial agents, and/ or astringent and permitted dyes.

Chewing gum is produced by melting the gum base at 110-120oC, after which CAS, fillers, softeners, sweeteners, flavors, preservatives and antioxidants are added to the melted base. The homogenous mixture prepared in this way is poured into a cooling belt, where larger pieces are formed, which are subsequently processed by extrusion and cutting (or rolling) into the final forms of chewing gum. After that, the resulting chewing gum shapes are coated with a suitable glaze. These are usually various waxes (e.g. paraffin), or mixtures of waxes and permitted dyes.

Formulations from this invention can be performed in various variants, and the working examples do not exhaust the scope of possible embodiments of the invention

EXAMPLES

Worked example 1: Preparation of SAS

Suspensions for synthesis are prepared by mixing solutions of sodium aluminate (which have the appropriate chemical composition with respect to Na2O, Al2O3 and H2O) and sodium silicate (which have the appropriate chemical composition with respect to Na2O, SiO2 and H2O) at temperature Tp. The resulting suspensions contain:

7,586 wt. % Na2O; 4,425 wt. % Al2O3; 3,398 wt. % SiO2 and 84,600 wt. % H2O; Tp = 20-25 oC, for the synthesis of SAS according to procedure P#1 (SAS-P#1)

11,695 wt. % Na2O; 4,229 wt. % Al2O3; 3,238 wt. % SiO2 and 80,838 wt. % H2O; Tp = 65-70 oC, for the synthesis of SAS according to procedure P#2 (SAS-P#2)

10,249 wt. % Na2O; 6,485 wt. % Al2O3; 4,966 wt. % SiO2 and 78,300 wt. % H2O; Tp = 20-23 oC, for the synthesis of SAS according to procedure P#3 (SAS-P#3)

9,945 wt. % Na2O; 8,251 wt. % Al2O3; 5,837 wt. % SiO2 and 75,967 wt. % H2O; Tp = 50-55 oC, for the synthesis of SAS according to procedure P#4 (SAS-P#4)

10,478 wt. % Na2O; 9,379 wt. % Al2O3; 7,735 wt. % SiO2 and 72,408 wt. % H2O; Tp = 50-55 oC, for the synthesis of SAS according to procedure P#5 (SAS-P#5)

Sodium aluminosilicates with spherical particles are obtained by hydrothermal treatment of aluminosilicate suspension at:

TR = 85 – 90 oC for the synthesis of SAS according to procedure P#1 (SAS-P#1)

TR = 70-80 oC for the synthesis of SAS according to procedure P#2 (SAS-P#2)

TR = 65-75 oC for the synthesis of SAS according to procedure P#3 (SAS-P#3)

TR = 70-75 oC for the synthesis of SAS according to procedure P#4 (SAS-P#4)

TR = 75-80 oC for the synthesis of SAS according to procedure P#5 (SAS-P#5)

for:

tR = 135 min for the synthesis of SAS according to procedure P#1 (SAS-P#1)

tR = 60 min for the synthesis of SAS according to procedure P#2 (SAS-P#2)

tR = 120 min for the synthesis of SAS according to procedure P#3 (SAS-P#3)

tR = 90 min for the synthesis of SAS according to procedure P#4 (SAS-P#4)

tR = 60 min for the synthesis of SAS according to procedure P#5 (SAS-P#5)

The product (SAS) was separated from the liquid phase by vacuum filtration and washed with several portions of demineralized water, until the pH value of the filtrate was 9 - 10. The product was dried for 24 hours at 105 oC. After drying, the product appears as a fine white powder.

Working example 2: Preparation of CAS, by replacing SAS with calcium ions AS

About 160 g of dry sample (SAS) was added to a container with a volume of 1500 ml, which contained 800 ml of a 1.1 M CaCl2 solution, preheated to 80o C. The resulting suspension, thermostated at 80o C, was stirred for 2 hours. After that, the solid phase was separated from the solution by centrifugation and washed with several portions of demineralized water. The wet solid phase was again added to a vessel with a volume of 1500 ml, which contained 800 ml of fresh 1.1 M CaCl2 solution, preheated to 80o C. The resulting suspension, thermostated at 80o C, was stirred for 2 hours. Again, the solid phase was separated from the solution by centrifugation and washed with several portions of demineralized water, until a negative reaction for chloride ions. The washed product was dried overnight at 105 oC. CAS prepared in this way appears in the form of a fine white powder.

Worked example 3: Chemical analysis of CAS

Chemical composition of the products (CAS-P#1, CAS-P#2, CAS-P#3, CAS-P#4 and CAS-P#5, obtained by replacing SAS-P#1, SAS-P#2, SAS- P#3, SAS-P#4 and SAS-P#5, procedures, P#1, P#2, P#3, P#4 and P#5) were determined in the following way: Dried samples were kept for 96 hours in a desiccator with saturated NaCl solution.

To determine the total water content, part of the sample was balanced by holding it above a saturated NaCl solution, weighed and annealed for 2 hours at 800 oC. After annealing, the sample was cooled in a desiccator filled with dry silica gel. From the weights of the sample before (mo) and after annealing (mC), the total water content, ((H2O)tot in wt.%), was calculated as:

(H2O)tot = 100(mo – mC)/mo

Determination of the content of calcium (Ca), sodium (Na), aluminum (Al) and silicon (Si) was carried out in the following way: a certain amount of annealed (anhydrous) sample was dissolved in a 1:1 solution of HCl. The solution was diluted with distilled water to the level of concentrations suitable for measuring Na, Ca, Al and Si concentrations by atomic absorption spectroscopy (AAS). The contents of Na, Ca, Al, and Si (in oxide form; Na2O, CaO, Al2O3, SiO2) in the sample were calculated based on the measured concentrations of Na, Ca, Al, and Si in the solution and the amount of annealed sample dissolved in a known volume of solution.

The following results were obtained:

Na2O = 0.411 wt.%; CaO = 15.136 wt.%; Al2O3 = 28.207 wt.%; SiO2 = 33.248 wt.%; H2O = 22.998 wt.% for CAS-P#1,

Na2O = 0.538 wt.%; CaO = 14.712 wt.%; Al2O3 = 27,643 wt.%; SiO2 = 33,870 wt.%; H2O = 23.237 wt.% for CAS-P#2,

Na2O = 0.732 wt.%; CaO = 15.110 wt.%; Al2O3 = 28,670 wt.%; SiO2 = 33.439 wt.%; H2O = 22.049 wt% for CAS-P#3

Na2O = 0.311 wt.%; CaO = 15,360 wt.%; Al2O3 = 28,450 wt.%; SiO2 = 35.193 wt.%; H2O = 20.446 wt.% for CAS-P#4 and

Na2O = 0.431 wt.%; CaO = 15.214 wt.%; Al2O3 = 28.381 wt.%; SiO2 = 33.436 wt.%; H2O = 22.538 wt% for CAS-P#5

Worked example 4: Morphology of CAS

The morphology of CAS particles was determined by scanning electron microscopy (SEM). SEM photographs of CAS particles (representative of all samples prepared as described in Working Examples 1 and 2) show that CAS particles have a spheroidal shape (Fig. 1) without clearly defined and recognizable crystal faces and that, surprisingly and unexpectedly, they appear in a flat spheroid shape and with a large surface roughness (Fig. 1B).

Worked example 5: CAS particle size distribution

CAS particle size distribution curves were determined by the laser light scattering method using the Mastersizer 2000 device (Malvern Instruments). For this purpose, approx. 1% aqueous suspension of CAS. The suspensions were sonicated before determining the particle size distribution. CAS particles have sizes in the micrometer range (about 0.4–4 μm, regardless of the applied synthesis procedure; see the particle size distribution curves in Fig. 2), with:

50% of all particles smaller than 1.45 μm (D50), 90% of all particles smaller than 2.35 μm (D90) and average particle size, Dav = 1.848 μm for CAS-P#1;

50% of all particles smaller than 1.10 μm (D50), 90% of all particles smaller than 1.75 μm (D90) and average particle size, Dav = 1.235 μm for CAS-P#;

50% of all particles smaller than 1.30 μm (D50), 90% of all particles smaller than 2.75 μm (D90) and average particle size, Dav = 1.875 μm for CAS-P#3;

50% of all particles smaller than 1.10 μm (D50), 90% of all particles smaller than 1.64 μm (D90) and average particle size, Dav = 1.20 μm for CAS-P#4;

50% of all particles smaller than 1.00 μm (D50), 90% of all particles smaller than 1.50 μm (D90) and average particle size, Dav = 1.15 μm for CAS-P#5.

Worked example 6: Real (BET) specific surface area of (RSP)CAS:

The external real specific surface (RSP) of the samples was determined by the multiple BET method, using nitrogen as an adsorbent at the temperature of liquid nitrogen (-195.6°C). Before analysis, the samples were dried at 105°C for one hour. The external specific surfaces of the analyzed samples, calculated on the basis of BET isotherms, are:

RSP = 2.375 ± 0.025 m2/g for CAS-P#1;

RSP = 3.562 ± 0.046 m2/g for CAS-P#2;

RSP = 4.433 ± 0.061 m2/g for CAS-P#3;

RSP = 2.970 ± 0.036 m2/g for CAS-P#4 and

RSP = 4,000 ± 0,054 m2/g for CAS-P#5

Working example 7: Geometric specific surface (GSP) of CAS

The corresponding GSP values are determined from the corresponding particle size distributions as:

GSP = [0.524×∑Ni×(Di)2]/[3.145×ρ×∑Ni×(Di)3]

where D is the diameter of CAS particles and Ni is the numerical frequency (%) of particles of size (diameter) D.

The corresponding GPS values are:

GPS = 0.921 m2/g for CAS-P#1;

GPS = 1,269 m2/y for CAS-P#2;

GPS = 1,593 m2/y for CAS-P#3;

GPS = 1,095 m2/y for CAS-P#4 and

GPS = 1,431 m2/y for CAS-P#5

The corresponding values of the ratio RSP (see Work example 6) and GSP are:

RSP/GSP = 2.58 for CAS-P#1;

RSP/GSP = 2.81 for CAS-P#2;

RSP/GSP = 2.78 for CAS-P#3;

RSP/GSP = 2.71 for CAS-P#4 and

RSP/GSP = 2.80 for CAS-P#5;

Working example 8: Preparation of the formulation according to the invention, in the form of an oral suspension

Composition (1000 g of oral suspension): (a) calcium aluminosilicate with spherical particle shape - CAS (20.00 g; 2 wt.%), (b) 2-hydroxyl cellulose (12.00 g; 1.2 wt.%) ), (c) bentonite (20.00 g; 2 wt %), (d) polyoxyethylene sorbitan monostearate (10.00 g; 1 wt %), (e) sodium lauryl sulfate (8.00 g; 0, 8 wt. %), (f) xylitol (15.00 g; 1.5 wt. %), (g) glycerol (25.00 g; 2.5 wt. %), (h) sorbitol (25.00 g of a 70% solution; 2.5% by weight), (i) 1,2-propylene glycol (5.00g; 0.5% by weight); (j) peppermint oil (0.20 g; 0.02 wt %), (k) thymol (0.10 g; 0.01 wt %), (l) methyl salicylate (0.10 g; 0, 01 wt %), (m) brilliant blue (10.00 g of 1% aqueous solution; 1 wt %), (n) chlorhexidine dihydrochloride (0.10 g; 0.01 wt %), (p ) purified water 849.5 g; 84.95 wt. %).

Procedure: Ingredients (d) and (e) were added to (p), and dissolved during 15-minute stirring at room temperature (20-25 oC). The solution thus obtained is heated to about 40-45 oC. Ingredient (b) was added to the thus prepared solution in portions and dissolved during 15-minute mixing. Then ingredients (a) and (c) were added, after which the obtained mixture was homogenized for 5 minutes. Ingredients (f), (g), (h), (m), and (n) were added to the thus obtained mixture, after which the newly obtained mixture was homogenized by mixing for 15 minutes. Finally, separately prepared solutions (j), (k), and (l) in (i) were added to the previously prepared suspension, after which the newly formed suspension was homogenized by mixing for 30 minutes at room temperature. The resulting product is a white aqueous suspension of satisfactory stability with a fresh, pleasant mint taste. The pH of the oral suspension obtained in the previously described manner is 8.6.

Working example 9a: Preparation of the formulation according to the invention, in the form of toothpaste

Composition (1000 g of toothpaste): (a) calcium aluminosilicate with spherical particle shape - CAS (40.00 g; 4 wt. %), (b) silica (100.00 g; 10 wt. %). (c) sodium carboxymethylcellulose (10.00 g; 1 wt. %), (d) sodium lauryl sulfate (12.00 g; 1.2 wt. %), (e) glycerol (400.00 g; 40 wt. %) ), (f) sorbitol (150.00 g of 70% solution; 15 wt. %), (g) peppermint oil (5.00 g; 0.5 wt. %), (h) L-menthol (2 .00 g; 0.2 wt %), (i) methyl salicylate (2.00 g; 0.2 wt %), (j) sodium saccharin (1.20 g; 0.12 wt %) and (k) purified water (277.80 g; 27.78 wt. %).

Procedure: Ingredients (a) and (b) were added to the previously prepared mixture (k), (e), and (f), and mixed for 30 minutes at room temperature. Then ingredient (c) was added, after which the resulting mixture was stirred for 1 hour at room temperature. Ingredients (d), (g), (h), (i), and (j) were added to the thus obtained viscous mixture, after which the thus obtained mixture was further homogenized for 1 hour. The resulting product is in the form of a white paste with satisfactory stability and a pleasant taste. The pH of the toothpaste obtained in the previously described manner is 8.0.

Working example 9b Preparation of the formulation according to the invention, in the form of toothpaste

Composition (1000 g of toothpaste): (a) calcium aluminosilicate with spherical particle shape - CAS (50.00 g; 5 wt. %), (b) glycerin (200.00 g; 20 wt. g%), (c ) carbomer (22.00 g; 2.20 wt. %), (d) xylitol (0.5 g; 0.05 wt. %), (e) sodium lauryl sulfate (14.20 g; 1.42 wt. %), (f) hydrated silica (175.00 g; 17.5 wt %), (g) slicat BLD (30.00 g; 3 wt %), (h) sodium alginate (25.00 g; 2.5 wt %) (i) aroma (7.00 g; 0.70 wt %) (j) purified water (469.5 g; 46.95 wt %) and (k) color and (6 .80, g; 0.68 wt. %)

Glycerine-b is placed in the mixing bowl at room temperature and carbomer-c is added with gentle stirring and is gently mixed until a homogeneous mixture is obtained, after which components -a,h,i,j,k are added to the thus prepared mixture , and all the ingredients are gently mixed until a homogeneous mixture is reached, after that components d, e f, g are added and the mixture is continued to be mixed until a homogeneous paste is obtained. The pH of the toothpaste obtained in the previously described manner is 8.2.

Working example 9c Preparation of the formulation according to the invention, in the form of toothpaste

Composition (1000 g of toothpaste): (a) calcium aluminosilicate with spherical particles - CAS (20.00 g; 2 wt. %), (b) silica (100 g; 10 wt. %). (c) sodium carboxymethylcellulose (10.00 g; 1 wt. %), (d) sodium lauryl sulfate (12.00 g; 1.2 wt. %), (e) glycerol (420.00 g; 42 wt. %), (f) sorbitol (150.00 g of 70% solution; 15% by weight), (g) peppermint oil (5.00g; 0.5% by weight), (h) L-menthol (2.00g; 0.2% by weight), (i) methyl salicylate ( 2.00 g; 0.2 wt %), (j) sodium saccharin (1.20 g; 0.12 wt %), (k) purified water (277.80 g; 27.78 wt % w/w).

Procedure: Ingredients (a) and (b) were added to the previously prepared mixture (k), (e), and (f), and mixed for 30 minutes at room temperature. Then ingredient (c) was added, after which the resulting mixture was stirred for 1 hour at room temperature. Ingredients (d), (g), (h), (i), and (j) were added to the thus obtained viscous mixture, after which the thus obtained mixture was further homogenized for 1 hour. The resulting product is in the form of a white paste with satisfactory stability and a pleasant taste. The pH of the resulting paste is 7.8.

Working example 10: Preparation of the formulation according to the invention, in the form of dental gel

Composition (1000 g of gel): (a) calcium aluminosilicate with spherical particle shape - CAS (50.00 g; 5 wt. %), (b) methyl cellulose (70.00 g; 7 wt. %), (i) sugar (20.00 g ; 20 wt. %), (j) purified water (680.00 g; 68 wt. %).

Procedure: Water (j) is added to the vacuum container, (i) is added to the water while stirring, and then (a) and (b) The mass is then mixed in a vacuum for 20 minutes until all the ingredients are homogenized. The pH of the dental gel obtained in the previously described manner is 8.4.

Working example 11: Preparation of the formulation according to the invention, in the form of chewing gum

Composition (1000 g of chewing gum): (a) calcium aluminosilicate with spherical particles - CAS (20.90 g; 2.09 wt. %), (b) gum base (259.10 g; 25.91 wt. %). (c) sugar (560.00 g; 56 wt. %), (d) glucose syrup (159.00 g, 15.9 wt. %) aroma (1g. 0.1 wt. %)

Procedure: The rubber base is heated to the point where it becomes liquid, and then filtered. (a), (c), (d) and (e) are added to the filtered rubber base with stirring in a vacuum vessel.

All ingredients continue to be mixed until a homogeneous dough-like mass is obtained. The resulting "dough" is placed in an extruding machine or molds where the chewing gum takes its final shape.

Working example 12: pH control

Five (5) people had their pH measured on the surface of their teeth 10 minutes after eating different foods, using strips for measuring pH (Color pH AST, Merck EM Science). In all cases, the measured pH value was between 6.5 and 6.8. 15 min after consuming food, the tested persons treated (brushed) their teeth with the preparation from working example 9b. 5 minutes after the treatment, the pH on the tooth surface was measured again. In all cases, the measured pH value was between 7.6 and 7.8. The measured pH did not change during at least 4 hours after the treatment.

Working example 13: Stabilizing effect

The study of the effect of CAS on tooth enamel stabilization was carried out on 12 intact human molars, extracted for orthodontic reasons. Each tooth sample is divided into 2 parts. One half of each tooth was immersed in 10 ml of the corresponding suspension of CAS (0.1, 1.0 and 10 wt. %) in saliva obtained from healthy volunteers (SZD), thermostated at 37oC, and the other half of the same tooth served as a control. The contact times of the teeth with the suspension were t = 10, 30, 60 and 300 min. The moment of placing the tooth in suspension is marked as the zero time (t = 0) of the treatment. After certain treatment times, the treated halves of the teeth were washed with distilled water and dried. After that, each treated tooth and its other untreated half (control) were treated with 0.4 M acetic acid at 37oC for 12 hours (demineralization) under dynamic conditions. The ratio of the volume of the tooth to the volume of the 0.4 M acetic acid solution was 1:1. After 12 hours of treatment, the tooth samples were separated from the solutions in which they were treated, and after that, the concentrations of calcium ions in the solutions were measured by atomic absorption spectrophotometry. The measurement results, expressed as a percentage reduction (% S) of the concentration of calcium ions in the solution, as a result of the treatment, are shown in Fig. 5. The obtained results unequivocally show that by treating teeth with CAS suspension in SZD, the stability of tooth enamel increases significantly, as determined by the decrease in the concentration of calcium ions in a 0.4 M acetic acid solution as a consequence of decreasing the solubility of tooth enamel after treating teeth with CAS suspension in SZD. The average value of %S gradually increases from %S = 7 for t = 10 min, reaches a maximum value of %S = 23 for t = 60 min and does not change significantly with further treatment. The presented results undoubtedly confirmed that tooth enamel stabilization is a time-dependent process. In other words, the toothpaste in the present invention has a prolonged effect compared to existing and known oral preparations.

Working example 14: (Re)mineralization effect

The remineralization effect of preparations containing CAS was tested by comparing scanning scanning micrographs of demineralized teeth before and after treatment with the preparation.

The intact tooth segment was treated with the preparation from working example 9b, which contained 5% CAS, for 20 seconds. After that, the preparation remained on the tooth for 80 seconds and then the surface of the tooth was washed with demineralized water. This procedure was repeated 4 times. After 4 repetitions of the mentioned procedure, the tooth was washed and dried, and the surface of the treated tooth was analyzed by scanning electron microscopy (SEM). The SEM micrograph in Fig. 6 clearly shows that, after the treatment of the teeth with the preparation, the CAS particles are retained in the cracks on the surface of the teeth and that, in fact, they are completely filled.

A segment of the same tooth was demineralized for 6 hours in 0.4 M acetic acid at 37oC. The surface of such a demineralized tooth segment with visibly damaged enamel is shown in the scanning electron micrograph in Fig. 7A The second segment of the same tooth was immersed in SZD after demineralization and kept in it for 20 minutes. After that, the tooth was treated with the preparation from working example 9a which contained 5% CAS, by rubbing with circular movements of a soft brush for 30 seconds. After that, the preparation remained on the tooth for 80 seconds and then the surface of the tooth was washed with demineralized water. This procedure was repeated 4 times. After 4 repetitions of the mentioned procedure, the tooth was washed and dried, and the surface of the treated tooth was analyzed by scanning electron microscopy (SEM). Sl. 7B clearly shows that the degree of enamel damage is significantly lower after than before treatment (Fig. 7A). The process of "alignment" of the tooth enamel surface is supported by the retention of CAS particles in the cracks on the tooth surface (Fig. 6). This ensures that, in accordance with the mineralizing capacity of CAS, (re)mineralization processes take place even after washing and rinsing the teeth (until the next brushing; see working example 12).

Since the mineralization process is most intense near the CAS particles, it is quite certain that the hydroxyapatite formed during this process is deposited on the surface of the CAS particles, which are located in the intercrystalline spaces and cracks on the surface of teeth as well as natural ones (pits and fissures) and acquired (microfractures) defects of hard tissues. In this way, intercrystalline spaces and cracks are not only filled with frequent CAS but also completely covered with hydroxyapatite.

Working example 15: Desensitizing effect

15.1. The desensitizing ability of Cas was tested in such a way that a segment of a molar tooth was taken and it was hardened and ground so that the tubules of the tooth were exposed and visible. The tooth with open tubules (Figure 4A) was treated with a 2.5% perchloric acid solution, and was then rinsed with demineralized water. After that, the tooth was treated with the preparation from working example 9b, which contained 5% CAS for 20 seconds, then the paste remained on the tooth for 80 seconds, and then the surface of the tooth was washed with demineralized water and dried. After rinsing and drying, the surface of the treated tooth was analyzed by scanning electron microscopy (SEM). The corresponding SEM photographs (Fig. 4B and 4C ) show that the dentinal tubules are filled (occluded) with CAS particles. This largely prevents the irritation of the mechanoreceptors present on the nerves located on the peripheral parts of the pulp. After treatment with the preparation, the tooth was immersed in 5 ml of SZD. After 6, 12, 18 and 24 hours, the teeth were taken out of SZD, the tooth surface was washed with distilled water and dried. After rinsing and drying, the tooth surface was analyzed by scanning electron microscopy (SEM). Sl. 8 clearly shows the gradual formation of hydroxyapatite on the surface of CAS-2 particles and complete mineralization of the tubule opening. This indicates that, after the tubules are filled with CAS particles, some of the calcium ions from the CAS are released into the SZD by the process of ion exchange of calcium ions from the CAS with ions from the SZD. The liberated calcium ions react with SZD components, resulting in the formation of apatites. Due to the alkaline hydrolysis of CSA, the reaction of calcium ions and SZD components takes place in an alkaline environment, which conditions the formation of hydroxyapatite. On the other hand, since the maximum concentration of calcium ions is expected on the surface (or near the surface) of the CSA particles, the formed hydroxyapatite is deposited on the CSA particles located in the tubules. In this way, the tubules are not only filled with CAS particles (Fig. 4), but are completely filled with hydroxyapatite (Fig. 8). It is absolutely certain that the same processes take place in real conditions (oral cavity).

15.2. Five people with pronounced hypersensitivity of teeth to external stimuli (cold, hot) used the preparation according to working example 9b for daily hygiene maintenance of teeth and oral cavity. Two of the mentioned five people felt a significant reduction in hypersensitivity already after the first application of the preparation, and the remaining three people felt a significant reduction in hypersensitivity after one to three days of application of the preparation. In all the cases mentioned, the hypersensitivity of the teeth completely disappeared after a week of using the preparation.

Working example 16: Polishing effect

The polishing effect of Cas can be clearly seen in Fig. 7 from working example 14. Sl. 7A shows a tooth surface with a visibly irregular enamel structure. After the treatment of the tooth with the procedure described in working example 14, the surface of the tooth enamel is not only "flattened" (Fig. 7B ) compared to the surface of the tooth before treatment (Fig. 7A ), but also shows a high degree of smoothness

Work example 17: Stopping bleeding

In the case of damage to the mucous membrane of the oral cavity that resulted in bleeding, after applying the preparation from working examples 8, 9c and 10, the bleeding stopped within 7-10 seconds.

17.1 Person LK bit his tongue. After applying the preparation from working example 10, the bleeding stopped after 10 seconds.

17.2. Person RF injured his gingiva with a toothbrush. After applying the preparation from working example 10, the bleeding stopped after 8 seconds.

15. 17.3. Person OL Injured the palate of the oral cavity by ingesting hard food. After applying the preparation from working example 9a, the bleeding stopped after 7 seconds.

Work example 18: Wound healing

In the case of damage to the epithelial tissue of the mucous membrane of the oral cavity, after applying the preparation from working examples 8 and 10, the healing process of the resulting wounds is shortened to 3 to 6 days.

18.1. Person GN had an aphthous ulceration with a diameter of 3 mm on the mucous membrane of the cheek. After applying the preparation from working example 8, 3 times a day, for 5 days, the ulcerous change was healed.

18.2. In people with FL, damage to the gingiva around a tooth with a ceramic restoration occurred after the dental application of hydrofluoric acid. After applying the preparation from working example 10, 3 times a day, for 3 days, the resulting damage was healed.

Work example 19: Gingivitis and periodontitis

In all 5 examined patients with gingivitis, after applying the preparation from working example 9c, brushing the teeth three times a day, the gingival bleeding index decreased after 3 - 5 days from grade 4 to grade 2; after 5 - 7 days it decreased to grade 1, and after 10 days there was a complete absence of bleeding.

Worked example 20: Regulation of salivation

Hypersalivation is present during pregnancy due to increased secretion of estrogen and progesterone.

There is also a decreased pH and buffering capacity of saliva due to decreased concentration of bicarbonate ions in plasma and increased alpha amylase in saliva.

In pregnant women with pronounced hypersalivation in the first trimester of pregnancy, after using the preparation from working example 9a for 3 weeks, there was a feeling of normal saliva secretion.

20.1 A pregnant woman in her 4th week of pregnancy with a pronounced feeling of hypersalivation, after using the preparation from working example 9 a for 3 weeks, noticed the normalization of saliva secretion.

20.2 A pregnant woman in the 6th week of pregnancy with a pronounced feeling of hypersalivation, after using the preparation from working example 9 a for 3 weeks, noticed the normalization of saliva secretion.

Working example 21 Mobile prosthetic restorations and mobile and fixed orthodontic appliances

The acrylate structure of mobile prosthetic restorations and mobile orthodontic appliances becomes porous and a reservoir for Candida albicans over time, which results in inflammation of the mucous membrane at the point of contact with the acrylate restoration.

21.1 1. Inflammation of the hard palate, prosthetic palatitis, was observed in a 10-year-old patient with a total acrylate mobile prosthesis, porous surface structure.

After applying the preparation from working example 10, for 10 days, 3 times a day, a complete withdrawal of signs of inflammation of the affected area was observed.

21.2. In a child with a mobile orthodontic device, an increased accumulation of dental plaque was observed, especially in the areas of metal brackets. After professional cleaning and daily correct tooth brushing, with the preparation from working example 9a, a complete absence of plaque accumulation was observed during the entire duration of the treatment.

21.3 In the patient with a fixed orthodontic device, who brushed her teeth daily with the preparation from working example 9c, during the entire orthodontic treatment, no increased accumulation of plaque was observed, nor was the formation of carious lesions under the orthodontic brackets.

Worked example 22. Diabetes and oral complications

Periodontitis and D. mellitus are mutually dependent conditions. D. mellitus increases the risk of periodontitis, and inflammatory processes of the periodontium negatively affect the overall picture of D. mellitus.

In patients with a developed picture of D. mellitus type 1 and 2, reduced saliva secretion, a decrease in pH value, an increased number of cariogenic bacteria, an increased number of specific periodontal bacteria, P. intermedia and P. gingivalis, and in this connection an increased incidence of caries, were observed. inflammation and destruction of the periodontium, and increased dentine sensitivity. In addition to the aforementioned local pathological changes, there is also a negative systemic effect on the overall state of D. mellitus.

22.1 In 5 patients with developed D. mellitus type 2, an increased number of S. mutans, decreased pH, decreased saliva secretion, increased dentine sensitivity, and advanced periodontitis with pronounced gingival bleeding were observed. After brushing the teeth with the preparation from working example 9a, for 4 weeks, 3 times a day, a significant improvement of the mentioned symptoms was observed.

22.2 In 5 patients with developed D. mellitus type 1, an increased number of S. mutans, decreased pH, decreased saliva secretion, increased dentine sensitivity, and advanced periodontitis with pronounced gingival bleeding were observed.

After brushing the teeth with the preparation from working example 9a, for 4 weeks, 3 times a day, a significant improvement of the mentioned parameters was observed.

Work example 23. Congenital and acquired hypomineralization conditions of hard dental tissues

In a patient diagnosed with amelogenesis imperfecta, hypomineralization type, with pronounced peeling of enamel, after applying the preparation from working example 9a for 8 weeks, 3 times a day, the cessation of peeling of enamel was observed due to the new process of remineralization of the affected areas.

Working example 24: For smokers

Smoking plays a significant role in the etiopathogenesis of various pathological conditions of the oral cavity. Due to reduced secretion of saliva, reduced pH value of saliva, increased number of pathogenic bacteria (cariogenic and periodontal) and increased accumulation of plaque, caries and periodontal diseases (gingivitis and periodontitis) occur more frequently.

24.1. In male patients (6), symptoms of dry mouth and bad breath were observed. After brushing the teeth with the preparation from working example 9a, for 6 weeks, 3 times a day, a significant improvement of the mentioned symptoms was observed. The dry mouth disappeared after 3 days, and the bad breath was reduced and completely disappeared after 6 days.

24.2. In female patients (7), a slight inflammation of the gums and coating of the tongue with pathological flora was observed. By brushing the teeth with the preparation from working example 9b for a duration of 6 days, the sensation of the tongue was restored, and the inflammatory changes in the gums were alleviated between 7 and 9 days.

Working example 25: Indirect and direct covering of the pulp

25.1. In patient VL with deep caries, after removal of caries-affected dentin, a layer of preparation from working example 10 was applied for 6 weeks, when effective formation of reparative dentin was observed, which avoided endodontic treatment of the tooth.

25.2. In patient BS with a fracture of the crown of the tooth with pulp exposure, a layer of preparation from work example 10 was applied for 8 weeks, a layer of reparative dentin was observed, while the vitality of the tooth was preserved.

Working example 26: Teeth whitening visual effect

In order to prove the effect of brightening and whitening teeth, three groups of tests were performed: In Vivo, In Vitro, SEM The study was conducted with the intention of examining the effect of CAS on the degree of brightness of teeth. For this purpose, in vivo and in vitro tests were performed.

In Vitro

Human teeth were used in the testing. In the in vitro testing, each tooth was sawed into two parts, so that each tooth was also a control in itself. One half of the teeth was treated with the toothpaste from working example 9a, and the other half was not. The starting value of 20 extracted teeth, which were divided into two groups (20 half teeth per group), was measured. The teeth are divided into groups according to the shade of brightness. The shade of brightness was determined by the Vitapan test - Vitapan color key. After the dental plaque was removed, the tooth halves were then embedded in a neutral matrix and brushed with the toothpaste from working example 9a. After brushing for 15 minutes, the brightness was measured again using the Vitapan method, and each treated half of the tooth was compared with the untreated one. After the comparison, it was found that the treated teeth are 2-5 shades lighter than the untreated ones.

In Vivo

The study was conducted on 10 people (subjects), whose teeth brightness was measured at the beginning of the test using the Vitapan test - the Vita Classical color key, which is used to determine the shade (hue), brightness (value) and saturation (chroma) of the teeth. The values thus determined served as initial values. The subjects used the toothpaste from working example 9a, 2 times a day for 3 minutes. during 30 days. After 30 days, the parameters were measured again with the help of the Vitapan color key. The tooth shade was measured as follows:

The teeth to be compared are washed before the measurement,

All strong and bright colors are removed from sight

The examinee is placed at eye level and the teeth are viewed at an angle and in the conditions of everyday social and business activities

The color and shades of the teeth were tested under different light sources, the sun, fluorescent lighting, incandescent lamps

Hue, Value, Chroma are tested

The teeth are cleaned of plaque and surface impurities

The teeth are kept moist during the examination

The distance at which the color is tested is from 90 to 180 cm

In order to exclude eye fatigue and potential visual defects of the examiner, two people look at the teeth, and after the examination, they compare the results

After comparison, before starting to use the paste and after 30 days, it was found that after using the paste from working example 9a, the teeth were 2-7 shades lighter compared to the initial values.

SEM

Teeth from the In Vitro test were observed by scanning electron microscopy (SEM). The images taken show that the CAS particles filled the microcracks of the teeth, and the surface roughness was reduced. Due to reduced unevenness, and thus reduced surface roughness, the teeth are smoother and the reflection of light is more even, and the tooth looks brighter and whiter.

Working example 27: Plaque, Bacterial sticking capability

Ivoclar Vivadent Plaque Test

Dental plaque is a central problem in dentistry because it starts lytic changes on hard dental tissues as well as inflammatory changes on soft tissue, i.e. gingiva. Bacterial plaque not only promotes the development of caries, but also periodontal and peri-implant diseases. The main cause of periodontitis is poor hygiene of the oral cavity, the presence of deposits - plaque on the teeth, and tartar. Plaque bacteria penetrate the periodontal tissue, causing the body's immune response, i.e. inflammation. Plaque Test is a fluorescent indicator-liquid for detecting plaque, which is applied to the tooth surface and illuminated with a polymerization lamp. Only the area of plaque and biofilm spots on the teeth shine under the light.

Method of testing

20 people (respondents) aged between 20 and 40 were selected for the test. At the beginning of the test, the amount of plaque was determined for all subjects by applying Ivoclar fluorescent indicator liquid to the surface of the tooth, which was then illuminated with a polymerization lamp, which showed the area of the tooth affected by plaque. Then their plaque was removed by a standard dental - mechanical procedure. The testing lasted 30 days. All subjects were given identical toothbrushes, which they used to brush their teeth with the paste from working example 9c, 2 times a day for 3 minutes. After thirty days, the area on the teeth affected by plaque was measured again using the same procedure. The test showed that the area of the teeth affected by plaque was 83% smaller after 30 days of using the paste than before using the toothpaste.

Working example 28: Filling resorptive defects of tooth roots

In a patient with pronounced lateral resorption of incisors, after daily treatment of teeth with a present defect using the preparation from working example 9a, after 3 months with X-ray control, good filling of the lesion was observed with a normal lamina dura.

Worked example 29. Apexification of tooth roots

is a procedure that induces the formation of a calcifying barrier and closure of the apex third of the apex of the tooth, in situations where endodontic treatment is required on teeth with incomplete root growth.

31.1. In an 11-year-old girl who needed an endodontic procedure due to trauma to the crown of the upper right central incisor.

After extirpation of the pulp and instrumentation of the canal, the canal is filled with the preparation from Work Example 9b. The cavity is closed with reinforced glass ionomer cement. After 3 months, an x-ray was taken where there was no visible periapical radiolucency, and the tooth showed no signs and symptoms of inflammation. Permanent obturation of the root canal was performed.

Worked example 30. Cariogenic bacteria

CRT Caries Risk Test

In order to test the anticariogenic effect of the toothpaste, the Ivoclar Vivadent AG CRT Test was performed. The CRT test is a scientifically based and generally known method, and it is based on measuring the number of Streptococcus mutans and lactobacillus bacteria in the saliva sample of the subjects.

Method of testing

20 people aged between 20 and 40 were selected for the test. The testing lasted 30 days. All subjects were given identical toothbrushes, which were used to brush their teeth with the paste from working example 9a, 2 times a day for 3 minutes. Everyone had their saliva taken before the start of the test and the initial state was measured, ie the amount and number of bacteria before starting to use the paste. The number of bacteria in the subjects' saliva was determined on day 0, day 15 and day 30 of treatment.

The results obtained after 30 days of using the toothpaste showed an average of 61% less number of Streptococcus mutans bacteria and 38% less number of Lactobacillus bacteria.

From the previous presentations, it is evident that the dental formulation according to the present invention consists of calcium aluminosilicate with spherical particle shape and one or more auxiliary substances and, if necessary, optional auxiliary ingredients necessary for the preparation of the product in its final form, while said dental formulation does not contain any fluoride phosphate ions. CAS is present in the formulation in an amount of 1 to 10% by weight, preferably 2 to 7% by weight, even more preferably 3 to 5% by weight, and most preferably 4% by weight. The pH of the dental formulation according to the present invention, whether it is a toothpaste, tooth powder, gel, suspension, chewing gum or any other form suitable for use in the oral cavity, is set between 7.8 and 8.6, and most preferably 8. The preparation maintains the pH at the local level, that is, on the surface of the teeth at an optimal level, average pH=7.6 to 7.8, long after the treatment. As for the auxiliary substances that are used as part of the dental formulation, they are chosen from the group consisting of excipients, diluents, fillers, thickeners, thickeners (or binders), base gums, softeners, sweeteners, fragrances, surfactants (foaming agents and solvents). , preservatives, antioxidants, stabilizers, or a mixture of one or more of the above. The above group is illustrative in nature and does not exhaust the possibilities of using auxiliary substances that are not listed in it. As such, the dental formulation according to the present invention is used as a medicine. First of all, as a remedy against a number of problems related to the teeth, gums and oral cavity. More specifically, the dental formulation is suitable as a drug used for tooth desensitization, and/or tooth stabilization, and/or tooth mineralization and/or tooth polishing. In more detail, said formulation is used as a medicine for the treatment of inflammation of the teeth and gums. Especially in the case of periodontal disease and caries. Due to its properties, said formulation is suitable for use that requires the formation of reparative dentin in patients with caries. In addition, the formulation according to the present invention is very useful as a means for removing dental plaque, as well as for repairing teeth, stopping bleeding and healing wounds in various indications, especially for healing ulcerative changes and for healing damaged gingiva. Furthermore, the formulation according to the subject invention can also be used for the purpose of salivation regulation during pregnancy.

We should not forget to mention that the formulation according to this invention proved to be very effective in the treatment of inflammatory conditions such as inflammation of the teeth and gums, especially in the case of inflammation caused by the use of prosthetic replacements and mobile and fixed orthodontic appliances. Furthermore, it is very effective as a medicine for the treatment of oral complications resulting from diabetes mellitus type I and/or diabetes mellitus type II such as periodontal disease. It also has a beneficial effect on pathological conditions caused by smoking. In this regard, it is particularly effective in eliminating bad breath and dry mouth. It has been shown to be very effective as a drug used to prevent tooth enamel flaking in amelogensis imperfecta, the hypomineralization type. Furthermore, it is also used for apexification of tooth roots. In addition to the indicated indications and symptoms according to which the dental formulation works very effectively, it can also be used for cosmetic purposes. Primarily for the purpose of teeth whitening. Since the only active ingredient within the dental formulation is calcium aluminosilicate with a spherical particle shape and an average particle size of no more than 1.848 μm, where at least 50% of the particles are smaller than 1.45 μm, and at least 90% of the particles are smaller than 2.35 μm. it can also be used as a medicine for exactly those indications that are listed for the dental formulation according to the subject invention.

Claims (44)

1. Dental formulation, characterized by the fact that it consists of calcium aluminosilicate with spherical particle shape and one or more auxiliary substances and, if necessary, optional auxiliary ingredients necessary for the preparation of the product in its final form, whereby said dental formulation does not contain either fluoride or phosphate ions . 2. Dental formulation according to claim 1, characterized in that calcium aluminosilicate with spherical particle shape is present in an amount of 1 to 10% by weight, preferably 2 to 7% by weight, more preferably 3 to 5% by weight, most preferably 4% by weight. 3. Dental formulation according to claim 2, characterized in that the pH of the formulation is between 7.8 and 8.6. 4. Dental formulation according to claim 3, characterized in that the pH of the formulation is 8. 5. Dental formulation according to any one of claims 1-4, characterized in that the auxiliary substance is selected from the group consisting of excipients, diluents, fillers, thickeners, thickeners (or binders), base gum, softeners, sweeteners, fragrances, surfactants (foaming agents and solvents), preservatives, antioxidants, stabilizers, or a mixture of one or more of the above. 6. Dental formulation according to claim 5, characterized in that said formulation is prepared in the form of oral suspension, toothpaste, dental gel, chewing gum. 7. Dental formulation consisting of calcium aluminosilicate with spherical particle shape and one or more auxiliary substances and, if necessary, optional auxiliary ingredients required for the preparation of the product in its final form, indicated to be used as a medicine. 8. Formulation according to claim 7, characterized in that it is used for tooth desensitization, and/or tooth stabilization, and/or tooth mineralization and/or tooth polishing. 9. Formulation according to claim 7, characterized in that it is used for the treatment of inflammation of the teeth and gums. 10. Formulation according to claim 9, characterized in that it is used for the treatment of periodontal disease and caries. 11. Formulation according to claim 10, characterized in that it is used to create reparative dentin in patients with caries. 12. Formulation according to claim 10, characterized in that it is used to remove dental plaque. 13. Formulation according to claims 8-10, characterized in that it is used for tooth repair, stopping bleeding, healing wounds. 14. Formulation according to claim 13, characterized in that it is used for healing ulcerative changes and for healing damaged gingiva. 15. Formulation according to claim 7, characterized in that it is used to regulate salivation during pregnancy. 16. Formulation according to claim 9, characterized in that it is used for the treatment of inflammation caused by the use of prosthetic replacements and mobile and fixed orthodontic devices. 17. The formulation according to any one of claims 7-10, characterized in that it is used for the treatment of periodontal disease and other oral complications resulting from diabetes mellitus type I and/or diabetes mellitus type II. 18. Formulation according to claim 7, characterized in that it is used to rehabilitate pathological conditions of the oral cavity that arise as a result of smoking. 19. Formulation according to claim 18, characterized by the fact that it eliminates dry mouth, bad breath and restores the sensation of the tongue. 20. Formulation according to any one of claims 7-8, characterized in that it is used to prevent peeling of tooth enamel in amelogensis imperfecta, hypomineralization type. 21. Formulation according to claim 7, characterized in that it is used for apexification of tooth roots. 22. Dental formulation consisting of calcium aluminosilicate with spherical particles and one or more auxiliary substances and, if necessary, optional auxiliary ingredients required for the preparation of the product in its final form, indicated that it is used for teeth whitening. 23. Use of a dental formulation consisting of calcium aluminosilicate with spherical particle shape and one or more auxiliary substances and, if necessary, optional auxiliary ingredients required for the preparation of the product in its final form, indicated by the fact that it is used for teeth whitening. 24. Use of a dental formulation consisting of calcium aluminosilicate with spherical particle shape and one or more auxiliary substances and, if necessary, optional auxiliary ingredients required for the preparation of the product in its final form, indicated to be used as a medicine. 25. Use of the formulation according to claim 24, characterized in that it is used for tooth desensitization, and/or tooth stabilization, and/or tooth mineralization and/or tooth polishing. 26. Use of the formulation according to claim 24, characterized in that it is used for the treatment of inflammation of teeth and gums. 27. Use of the formulation according to claim 26, characterized in that it is used for the treatment of periodontal disease and caries. 28. Use of the formulation according to any one of claims 24-27, characterized in that it is used for the treatment of periodontal disease and other oral complications resulting from diabetes mellitus type I and/or diabetes mellitus type II. 29. A calcium aluminosilicate having a spherical particle shape and an average particle size of at most 1.848 μm, wherein at least 50% of the particles are less than 1.45 μm, and at least 90% of the particles are less than 2.35 μm, for use as a medicine. 30. Calcium aluminosilicate with spherical particle shape according to claim 29, characterized in that it is used for tooth mineralization, calcification, stabilization and desensitization of teeth. 31. Calcium aluminosilicate with spherical particle shape according to claim 29, characterized in that it is used for the treatment of tooth and gum inflammation. 32. Calcium aluminosilicate with spherical particle shape according to claim 29, characterized in that it is used for the treatment of periodontal disease and caries. 33. Calcium aluminosilicate with spherical particle shape according to claim 32, characterized in that it is used to create reparative dentin in patients with caries. 34. Calcium aluminosilicate with spherical particle shape according to claim 32, characterized in that it is used to remove dental plaque. 35. Calcium aluminosilicate with a spherical shape of particles according to claims 30-32, characterized by the fact that it is used for tooth repair, stopping bleeding, healing wounds. 36. Calcium aluminosilicate with spherical particle shape according to claim 35, characterized in that it is used for healing ulcerative changes and for healing damaged gingiva. 37. Calcium aluminosilicate with spherical particle shape according to claim 29, characterized in that it is used to regulate salivation during pregnancy. 38. Calcium aluminosilicate with spherical shaped particles according to claim 31, characterized by the fact that it is used to heal inflammation caused by the use of prosthetic replacements and mobile and fixed orthodontic devices. 39. Calcium aluminosilicate with a spherical shape of particles according to claim 29, characterized in that it is used for the treatment of periodontitis caused as a result of diabetes mellitus type I and/or diabetes mellitus type II. 40. Calcium aluminosilicate with spherical shape of particles according to claim 29, characterized in that it is used to rehabilitate pathological conditions of the oral cavity that occur as a result of smoking. 41. Calcium aluminosilicate with spherical shaped particles according to claim 40, characterized by the fact that it removes dryness of the mouth, unpleasant breath and restores the sensation of the tongue. 42. Calcium aluminosilicate with a spherical particle shape according to any one of claims 29-30, characterized in that it is used to prevent tooth enamel peeling in amelogensis imperfecta, hypomineralization type. 43. Calcium aluminosilicate with spherical particle shape according to claim 29, characterized in that it is used for apexification of tooth roots. 44. Calcium aluminosilicate with a spherical particle shape and an average particle size of no more than 1.848 μm, with at least 50% of the particles smaller than 1.45 μm, and at least 90% of the particles smaller than 2.35 μm, indicated to be used for teeth whitening .