ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS FOR FULL MAINTENANCE OF ORAL HEALTH, PROCESS FOR OBTAINING AND USES THEREOF

Abstract

This invention describes an oral composition, the variations, uses and production method thereof, wherein it is an acidified bioactive complex obtained from association of salts, organic compounds, silicon compounds and phosphates which, when in the mouth, is electrochemically attracted by the tooth, bonding to it and causing ionization of calcium from the dental structures, due to its acidic characteristics. Once bonded to the tooth, the complex gathers dispersed particles in the buccal medium, condensing them and, mainly from calcium, forming a hybrid layer containing silicon-enriched hydroxyapatite. This hybrid layer remineralizes the tooth enamel surface, functioning as a protective shield over the tooth, protecting against the everyday acidic challenges, when the dentin is exposed, this layer obliterates the dentin tubules, relieving the pain caused by dental sensitivity. The layer formation occurs in a self-etching manner, in other words, each application of the oral composition forms a new three-dimensional layer on top of the previous one; Thus, the formation of minerals in acidic medium, exactly in the same medium where mineral loss occurs, enables the formation of the hybrid layer, which enables the product to provide full maintenance of oral health.

Claims

1. ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, wherein it features in its constitution, spread into three phases (phase 1, phase 2 and phase 3) and with the possibility of combination into three variations (variation 1, variation 2 and variation 3) the following components: Moistener: at a 40 to 70% m/m proportion of the composition; selected among PEG 600, PEG 400, glycerin, sorbitol, in isolation or combined; Thickener: at a 5 to 30% m/m proportion of the composition; selected among carboxymethylcellulose, xanthan gum, thickening silica, in isolation or combined; Deionized water: at a 0.1 to 7% m/m proportion of the composition; Fluorides: at a 0 to 1% m/m proportion of the composition; selected among: stannous fluoride, sodium fluoride, potassium fluoride, sodium monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate, amine fluoride (for example, N′-octadecyltrimethylendiamine-N, N, N′-tris (2-ethanol)-dihydrofluoride), ammonium fluoride, titanium fluoride, hexafluorosulfate and combinations thereof; Sweeteners: at a 0.5 to 5% m/m proportion of the composition; selected between sodium saccharine and xylitol; Preservative: at a 0.1 to 1% m/m proportion; selected among sodium Benzoate, methylparabens, parabens; preferably sodium Benzoate; Remineralizing salts, desensitizers and catalysts: at a 0.1 to 10% m/m proportion of the composition; selected among sodium, calcium, potassium, iron, zinc, tin, magnesium, titanium, aluminum and/or copper ions. Abrasive: at a 3 to 18% m/m proportion of the composition; selected between calcium carbonate, sodium, silica; Surfactant: at a 5 to 15% m/m proportion of the composition; selected among sodium laureth sulfate, sodium alkyl sulfate, sodium lauroyl sarcosinate, cocamidopropyl betaine and polysorbate and combinations thereof; preferably, sodium laureth sulfate; Antiseptic: at a 0.1 to 1% m/m proportion of the composition; selected among halogenated diphenyl ether, triclosan, herb extracts, essential oils, rosemary extract, tea extract, magnolia extract, thymol, menthol, eucalyptol, geraniol, carvacrol, citral, hinokitol, catechol, methyl salicylate, epigallocatechm gallate, epigallocatechm, gallic acid, miswak, sea-buckthorn extract, biguanide antiseptics, chlorhexidine, alexidine or octenidine, quaternary ammonium composites, cetylpyridinium chloride (CPC), benzalkonium chloride, tetradecyl pyridinium chloride (TPC), N-tetradecyl-4-ethylpyridinol chloride, N-tetradecyl-4-ethylpyridinol chloride, octenidine, sanguinarine, Povidone-iodine, delmopinol, salifluorine, tin salts, copper salts, iron salts, sanguinarine, propolis and oxigenating agents, hydrogen peroxide, buffered sodium peroxoborate or peroxocarbonate, phthalic acid and its salts, monopertallic acids and its salts and esters, ascorbyl stearate, oleoylsarcosine, alkyl sulfate, dioctyl sulfossuccinate sulfate, salicylanilide, domiphen bromide, delmopinol, octapinol and other piperidine byproducts, nicin preparations, chlorite salts or any mixtures between any aforementioned substances; preferably, triclosan; Flavoring agent: at a 1 to 5% m/m proportion of the composition, selected among essential oils (mint, peppermint, spearmint, lemon grass, clove, salvia, strawberry, grape, eucalyptus, marjoram, cinnamon, lemon, rosemary—pepper, orange), as well as aldehydes, esters, alcohols and similar flavoring materials; Pigments/dyes: at a 0.1 to 10% m/m proportion of the composition; may be organic or inorganic, selected among peroxides, superoxides, oxygen forming agents and ingredients for optical bleaching as all dyes and pigments, organic and inorganic, which act within the blue to violet light spectrum to reflect white light, such as mica and silicon compounds; pH corrector: at a 0.5 to 40% m/m proportion of the composition; selected among basics (mono- and di-sodium phosphates) and acids (phosphoric, citric, maleic); Calcium sources: at a 0.001 to 10% m/m proportion of the composition; selected among: calcium glycerophosphate, calcium carbonate and tricalcium phosphate, from organic sources or not; Amino acids: at a 0 a 10% m/m proportion of the composition; selected among arginine, lysine, citrulline, ornithine, creatine, histidine, diaminobutanoic acid, diaminopropionic acid, salts and/or combinations thereof, or even any amino acids with a carboxyl group and a water soluble amino group and available in aqueous solution with a pH around 7 or lower, preferably arginine; Orthophosphoric acid: at a 0 to 40% mm proportion of the composition; Tetrasodium pyrophosphate, at a 0.5 to 40% m/m proportion of the formulation.

2. ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to claim 1, wherein phase 1 comprises: Carboxymethylcellulose, at a 0.7 to 1.0% m/m proportion of the formulation; Glycerin, at a 45 to 55% m/m proportion of the formulation; Sodium fluoride, at a 0 to 1% m/m proportion of the formulation; Sodium saccharine; at a 0.5 to 5% m/m proportion of the formulation; Sodium benzoate, at a 0.1 to 1% m/m proportion of the formulation; Xylitol, at a 0.5 to 5% m/m proportion of the formulation; Tetrasodium pyrophosphate, at a 0.5 to 40% m/m proportion of the formulation; Sorbitol, at a 40 to 70% m/m proportion of the formulation; PEG-600, at a 40 to 70% m/m proportion of the formulation; Thickener silica, at a 7 to 15% m/m proportion of the formulation; Abrasive silica, at a 7 to 15% m/m proportion of the formulation; Sodium laureth sulfate, at a 5 to 15% m/m proportion of the formulation; Triclosan, at a 0.1 to 1% m/m proportion of the formulation; Menthol, at a 1 to 5% m/m proportion of the formulation.

3. ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to claim 1, wherein phase 2 comprises: Carboxymethylcellulose, at a 0.7 to 1.0% m/m proportion of the formulation; Glycerin, at a 45 to 55% m/m proportion of the formulation; Sodium saccharine, at a 0.5 to 5% m/m proportion of the formulation; Sodium benzoate, at a 0.1 to 1% m/m proportion of the formulation; Xylitol, at a 0.1 to 5% m/m proportion of the formulation; Citric acid at a 2 to 5% m/m proportion of the formulation; Sorbitol, at a 40 to 70 m/m proportion of the formulation; Peg-600, at a 40 to 70% m/m proportion of the formulation; Thickener silica, at a 7 to 15% m/m proportion of the formulation; Mixture of microlyzed calcium carbonate at 70 to 80% and tricalcium phosphate at 20 to 30%, at a 0.5 to 5% m/m proportion of the formulation; Sodium laureth sulfate, at a 5 to 15% m/m proportion of the formulation; Triclosan, at a 0.1 to 1% m/m proportion of the formulation; Menthol, at a 0.5 to 3% m/m proportion of the formulation; pH corrector, which may be monobasic phosphate, dibasic phosphate or citric acid, as needed, at a 2 to 5% m/m proportion of the formulation.

4. ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to claim 1, wherein phase 3 comprises: Carboxymethylcellulose, at a 0.7 to 1.0% m/m proportion of the formulation; Glycerin, at a 45 to 55% m/m proportion of the formulation; Thickener silica, at a 5 to 25% m/m proportion of the formulation; Blue dye, at a 0.1 to 0.3% m/m proportion of the formulation; Phosphoric acid, at a 5 to 40% m/m proportion of the formulation.

5. ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to any one of claim 1, 2, 3 or 4, wherein its three variations are: Variation 1: professional use variation, comprising phases 1, 2 and 3, namely: 0.01 to 30% of phase 3+0.5 to 40% of phase 2+30 to 60% of phase 1; Variation 2: domestic and professional use variation, comprising phases 1 and 2, namely: 0.5 to 70% of phase 2+30 to 99.5% of phase 1; Variation 3: variation for domestic and daily use, comprising only phase 1, namely: 100% phase 1.

6. ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to claim 5, wherein its variations comprise pH ranging from 2 to 5.5.

7. ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to any one of claim 1 or 5, wherein the constituents may be presented in a microlyzed form, in nanometric scale.

8. ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to any one of claim 1 or 5, wherein, after application, in a completely acidic medium, said composition is electrochemically attracted by the tooth, bonding to it and causing ionization of the calcium present in its structures, thus gathering dispersed particles in the buccal medium, and condensing from calcium and other ions present in the medium, creating a hybrid layer containing silicon-enriched hydroxyapatite.

9. ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to claim 8, wherein, after application, it creates an in situ hybrid layer, containing silicon-enriched hydroxyapatite which bonds with dental structures.

10. ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to claim 8, wherein its action occurs in aqueous medium (mouth), with a pH between 5.5 and 7.5 in situ.

11. ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to any one of claim 1 or 5, wherein it is alternatively supplemented with calcium salts, using a proportion of 0.001 to 10% m/m of the composition, preferably with calcium glycerophosphate, calcium carbonate and tricalcium phosphate.

12. ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to any one of claim 1 or 5, wherein, alternatively, they are used as silicon sources: amorphous silica, bioglasses, silicates, mesoporous silica, functionalized silica, especially developed silica.

13. ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to any one of claim 1 or 5, wherein its components are presented in a single phase; phases separated by physical barriers, within a same recipient or encapsulated; or even in separated recipients.

14. ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to any one of claim 1 or 5, wherein it may be presented as: powder, liquid, cream, gel or foam dentifrice; mouthwash; drops or chewing gum.

15. PROCESS FOR OBTAINING AN ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to claim 1, wherein it is performed independently for each one of the phases (phase 1, phase 2 and phase 3); therefore, after separation and weighing of components, carboxymethylcellulose at a 0.7 to 1.0% m/m proportion of the composition is added to glycerin, at a 45 to 55% m/m proportion of the composition, under slow stirring for a period of 10 to 30 minutes and speed between 45,000 and 200,000 at 25° C., obtaining the glycerin+CMC base; then the full load of deionized water is added to the reactor, at 0.1 to 7% m/m in relation to the total composition volume, activating turbine, anchor and impeller; afterwards, the remaining components of each one of the phases are added to the reactor and the process follows with minor particularities, arising out of the components used in each one of them: phase 1: salts sodium fluoride at a 0 to 1% m/m proportion of the formulation; sodium saccharine at a 0.5 to 5% m/m proportion of the formulation; sodium benzoate at a 0.1 to 1% m/m proportion of the formulation; xylitol at 0.5 to 5% m/m of formulation; tetrasodium pyrophosphate at a 0.5 to 40% m/m of the formulation, followed by homogenization for 5 to 20 minutes in the conditions previously described; followed by addition of moisteners, sorbitol, at a 40 to 70% m/m proportion of the formulation, and PEG-600 at a 40 to 70% m/m proportion of the formulation, and the previously prepared glycerin+CMC base at a 50 to 55% m/m proportion of the formulation. A vacuum application is then performed at 600 mmHg, followed by homogenization for 5 to 20 minutes in the conditions previously described; after homogenization with the vacuum turned on, the thickener silica is slowly added in a 10 to 15 minute interval at a 7 to 15% m/m proportion of the formulation; then abrasive silica is added the same way, at a 7 to 15% m/m proportion of the formulation; with the vacuum still on, homogenization is carried out for a period of 1 to 3 hours; after this period, with the vacuum still on, the sodium laureth sulfate is added at a 5 to 15% m/m proportion of the formulation; followed by homogenization for a period of 5 to 20 minutes; then triclosan is added at a 0.1 to 1% m/m proportion of the formulation, previously dissolved in menthol at a 1 to 5% m/m proportion of the formulation; followed by homogenization for a period of 5 to 20 minutes; lastly, the orthophosphoric acid is added at a 0.8 to 1.5% m/m proportion of the formulation, also with the vacuum turned on, followed by homogenization for a period of 3 to 5 hours, after which the process for obtaining phase q is finished; phase 2: sodium saccharine at a 0.5 to 5% m/m proportion of the formulation; sodium benzoate at a 0.1 to 1% m/m proportion of the formulation; xylitol at a 0.5 to 5% m/m proportion of the formulation; citric acid at a 2 to 5% m/m proportion of the formulation, followed by homogenization for 5 to 20 minutes in the conditions previously described; afterwards, moisteners and sorbitol are added at a 40 to 70 m/m proportion of the formulation, and PEG-600 at a 40 to 70% m/m proportion of the formulation, and the previously prepared glycerin+CMC base at a 50 to 55% m/m proportion of the formulation; a vacuum application is then performed at 600 mmHg, followed by homogenization for 5 to 20 minutes in the conditions described; after homogenization with the vacuum turned on, the thickener silica is slowly added in a 10 to 15 minute interval at a 7 to 15% m/m proportion of the formulation, then the calmix, at a 0.5 to 5% m/m proportion of the formulation. With the vacuum still on, homogenization is carried out for a period of 1 to 3 hours. After this period, with the vacuum still on, the sodium laureth sulfate is added at a 5 to 15% m/m proportion of the formulation; followed by homogenization for a period of 5 to 20 minutes. Then triclosan is added at a 0.1 to 1% m/m proportion of the formulation, previously dissolved in menthol at a 0.5 to 3% m/m proportion of the formulation; followed by homogenization for a period of 5 to 20 minutes. Lastly, the pH corrector is added, which may be monobasic phosphate, dibasic phosphate or citric acid, as needed, at about 2 to 5% m/m proportion of the formulation, also with the vacuum on, to adjust around a pH of 4.5 to 5.5 followed by homogenization for a period of 0.5 to 1 hour, after which the process for obtaining phase 2 is finished; phase 3: after homogenization with the vacuum turned on, the thickener silica is slowly added in a 10 to 15 minute interval at a 5 to 25% m/m proportion of the formulation, then the blue dye, at a 0.1 to 0.3% m/m proportion of the formulation. With the vacuum still on, homogenization is carried out for a period of 1 to 2 hours; lastly, phosphoric acid is added at a 5 to 40% m/m proportion of the formulation, also with the vacuum turned on, for adjustment around a pH value of 2, followed by homogenization for a period of 0.5 to 1 hour, after which phase 3 is obtained.

16. PROCESS FOR OBTAINING AN ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to claim 15, wherein the acidification of the composition occurs in pH between 2.0 and 5.5, through addition of pH correctors selected among mono- and di-sodium phosphates, phosphoric acid, citric acid and maleic acid.

17. PROCESS FOR OBTAINING AN ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to claim 15, wherein it uses a very low volume of deionized water (A), between 0.1 and 7%.

18. USE OF ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to claim 1 or 5, wherein it is applied for full maintenance of oral health.

19. USE OF ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to claim 18, wherein it is applied as an anti-demineralizing agent.

20. USE OF ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to claim 18, wherein it is applied as a protective agent against cariogenic and microbial processes, and exposure to acids even in pH below 4.5.

21. USE OF ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to claim 18, wherein it is applied as a restorative agent.

22. USE OF ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to claim 18, wherein it is applied as an optical, chemical and mechanical whitening agent.

23. USE OF ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to claim 18, wherein it is applied as a protective agent against erosive processes and relief of dental sensitivity, through obliteration of dentin tubules.

24. USE OF ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to claim 18, wherein it is applied as protection against dental corrosion.

25. USE OF ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, according to claim 18, wherein it is day-to-day acidic attacks.

Description

DESCRIPTION OF THE DRAWINGS

[0035] The invention will be described in a preferred embodiment; thus, for better understanding, references will be made to the following figures:

[0036] FIG. 1: A. EDS results of the composition of the invention, note the formation of the complex pattern. B. Enlarged section of the actual image, where: Strong purple—sodium; Violet—fluorine; Green—oxygen; Blue—silicon; Red—carbon; Yellow—phosphorus;

[0037] FIG. 2: EDS results of the use of the composition of the invention. A. Actual image; B. Enlarged image. Note the formation of the mineral pattern—calcium (blue) phosphate (pink), enriched with silicon (yellow):

[0038] FIG. 3: Image demonstrating the formation of the hybrid layer, in situ;

[0039] FIG. 4: Images of the process taking place inside the tooth—inside dentin tubules, illustrating the closure of the tubules;

[0040] FIG. 5: Enamel surface without applying the invention (left) and enamel surface brushed with the composition pleaded for one week;

[0041] FIG. 6: Illustrative chart of pain reduction from use of the oral composition and the Novamin® technology;

[0042] FIG. 7: Scheme illustrating the visual analog pain scale (EVA);

[0043] FIG. 8: Illustrative chart of pH variation in relation to use;

[0044] FIG. 9: Cross-section of enamel showing the area without brushing This invention, and the area brushed with This invention, respectively;

[0045] FIG. 10: Images of the surface of tooth samples: Sound dentin open tubules simulating pain by dentin sensitivity and dentin treated with This invention, respectively;

[0046] FIG. 11: Comparison of the percentage of remineralization (% SMHR) of dentifrices between groups (Different letters indicate statistically significant difference between groups, ANOVA, P<0.01);

[0047] FIG. 12: Absolute values and standard deviation of sound lesion depth for cavity and sound for treated cavity (Different letters indicate statistically significant between groups, ANOVA, P<0.01);

[0048] FIG. 13: Images of the surface of tooth samples: sound enamel, enamel treated with MCBS, enamel treated with This invention, respectively;

[0049] FIG. 14: Images of the surface of tooth samples: sound enamel, enamel treated with regenerative agent, enamel treated with This invention, respectively;

[0050] FIG. 15: Images of Scanning Electron Microscopy of silica-based, lab-synthesized hybrids, with up to 60,000× amplification. A. synthesized in acidic medium; B. synthesized in basic medium;

[0051] FIG. 16: Image of tooth sample depth with highlight to the formed layer. Note that the scale is 1 micrometer, divided into 10 parts (100 nanometers each), not possible to notice any pores, only holes due to the displacement of material during cutting;

[0052] FIG. 17: Image that demonstrates formation of layers, both on dentin and on enamel (B). After the brushing period, a blue whitening tone was verified (A);

[0053] FIG. 18: Cross-sectional image showing tooth sample depth with highlight to the formed layer. Note a layer that varies between 4 and 8 micrometers with only four applications of 5 minutes of the pleaded composition in 2 phases, one containing the original formulation and another adding the entry calcium supplement—6% calcium glycerophosphate;

[0054] FIG. 19: Image of enamel surface treated with This invention in 2 phases, one containing the original formula and another adding 2 sources of extra nanoparticulated calcium supplement (tricalcium phosphate and 5% calcium carbonate+F. Detail for filling of grooves by layer formation. This embossing thus favors retention of adhesive restorations/cementum. Result obtained from four applications;

[0055] FIG. 20: Image of enamel surface treated with the composition described in this invention for one week. Half of the sample was not brushed where it is possible to show the grooves (left side). On the brushed side, the grooves were filled with the mineral layer, showing the regenerative effect of This invention;

[0056] FIG. 21: Image of cross section of treated dentin with the composition described in This invention in 2 phases, one containing the original formula and another adding 2 sources of extra nanoparticulated calcium supplement (tricalcium phosphate and 5% calcium carbonate). Detail of tubule filling through a robust layer formation (up to 10 micrometers). Without calcium, a layer up to 3 micrometers was attained. Result with four application of 05 minutes;

[0057] FIG. 22: Image of dentin surface treated with This invention without fluorine. Detail of tubule filling;

[0058] FIG. 23: Images of the construction of a new enamel-like layer after one week of use. Images above show the worn tooth without using the technology, image below show the brushing and reconstruction of mineral loss, with around 40% mineral recovered after one week of use.

DETAILED DESCRIPTION OF THE INVENTION

[0059] This invention refers to a composition in three variations, provided in a single phase or phases separated by physical barriers, inside a single container or encapsulated, or yet in separated recipients with components included in smaller sizes or in nanometric scale. The presentation form may be, but not limited to dentifrice (cream, gel, foam, liquid, or powder), mouthwash, drops and chewing gums. Below are the proposed variations, application examples, as well as its processes for obtaining:

[0060] Variation 1: Variation for professional use, comprising phases 1, 2 and 3, with 0.01 to 30% of phase 3+0.5 to 40% of phase 2+30 to 60% of phase 1;

[0061] Variation 2: Variation for domestic and professional use, comprising phases 1 and 2, with 0.5 to 70% of phase 2+30 to 99.5% of phase 1;

[0062] Variation 3: Variation of domestic and daily use, comprising only phase 1, with 100% of phase 1.

[0063] For the application of variation 1, the dentist, while in possession of the three phases, shall start application by dispensing phase 3 directly onto the tooth through a syringe with applicator, wait 10 to 20 seconds and subsequently washing the tooth surface with water for 20 to 60 seconds. Afterwards, phases 2 and 1 shall be applied, previously mixed in the doctor's office, at a ratio that may vary between 1/2, 1/1, 2/1, not limited to said ratios, directly on the tooth with the help of a spatula or other application instrument. For application of variation 2, the patient opens the recipient containing phase 2 and spreads it over the toothbrush, in an amount the size of a pea. Subsequently repeat the process with the recipient containing phase 1. Immediately after application of both phases to the toothbrush, brushing is to be carried for 1 to 3 minutes, expelling foam and all excess material; mouth rinsing is not required. For application of variation 3, the patient opens the recipient and spreads its contents over the toothbrush, in an amount the size of a pea. Immediately after application of both phases to the toothbrush, brushing is to be carried for 1 to 3 minutes, expelling foam and all excess material; mouth rinsing is not required. In one application form, the oral composition with synergistic association of organic and inorganic components may comprise three phases, which are physically separated by layers, and/or encapsulation, and/or yet in distinct packaging, so that components do not interact before the activity time in the mouth, in other words, components are not neutralized becoming inactive:

[0064] Phase I: main base composition, with or without fluorine, containing an acidified bioactive complex, with or without pigments, dyes, silicon sources, with or without whitening effect;

[0065] Phase II: mixture of organic and/or inorganic accelerator such as calcium (micro and/or nanoparticles); and/or other agents, such as: antimicrobial agent, remineralizer (arginine), bleacher; phase with acidulated to slightly alkaline pH, struck by the addition of acids and/or phosphates or even other pH regulating agents;

[0066] Phase III: acidified gel and thickened with silica, pH 2 to 4.

[0067] Considering that variation 3 of the composition, presented in a single recipient, must be physically separated by an inert layer, for example, of glycerin or a single composition with or without active fluorine; or, yet, due to encapsulation of phases 1 and 2, which will be dispersed in an inert matrix, with or without active fluorine.

[0068] In order to obtain the composition, components may or may not be in the nanometric scale, considering that, initially, all components of the composition are separated and weighed, according to table 4, as follows:

TABLE-US-00004 TABLE 4 Components used to obtain the oral composition. Components Quantity % Moistener 40 to 70 (Selected among, but not limited to: PEG 600, PEG 400, glycerin, Sorbitol in isolation or in association). Thickener 5 to 30 (Selected among, but not limited to: carboxymethylcellulose, xanthan gum, thickening silica, in isolation or in association). Deionized Water 0.1 to 7 Fluorides 0 to 1 (Selected among, but not limited to: stannous fluoride, sodium fluoride, potassium fluoride, sodium monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate, amine fluoride (for example, N′- octadecyltrimethylendiamine-N,N,N′-tris(2- ethanol)-dihydrofluoride), ammonium fluoride, titanium fluoride, hexafluorosulfate and combinations thereof). Sweeteners 0.5 to 5 (Selected among, but not limited to: sodium saccharine and xylitol). Preservatives (Selected among, but not limited to 0.1 to 1 sodium benzoate, methylparabens, parabens) Remineralizing salts, desensitizers, catalysts 0.1 to 10 (Selected among, but not limited to: sodium ions, calcium, potassium, iron, zinc, tin, magnesium, titanium, aluminum and/or copper) Abrasive 3 to 18 (Selected among, but not limited to: calcium carbonate, sodium, silica). Surfactant 5 to 15 (Selected among, but not limited to: sodium laureth sulfate, sodium alkyl sulfate, sodium lauroyl sarcosinate, cocamidopropyl betaine and polysorbate and combinations thereof. Preferably, sodium laureth sulfate). Antiseptic 0.1 to 1 (Selected among, but not limited to: halogenated diphenyl ether, triclosan, herb extracts, essential oils, rosemary extract, tea extract, magnolia extract, thymol, menthol, eucalyptol, geraniol, carvacrol, citral, hinokitol, catechol, methyl salicylate, epigallocatechm gallate, epigallocatechm, gallic acid, miswak, sea-buckthorn extract, biguanide antiseptics, chlorhexidine, alexidine or octenidine, quaternary ammonium composites, cetylpyridinium chloride (CPC), benzalkonium chloride, tetradecyl pyridinium chloride (TPC), N-tetradecyl-4- ethylpyridinol chloride, N-tetradecyl-4- ethylpyridinol chloride, octenidine, sanguinarine, Povidone-iodine, delmopinol, salifluorine, tin salts, copper salts, iron salts, sanguinarine, propolis and oxigenating agents, hydrogen peroxide, buffered sodium peroxoborate or peroxocarbonate, phthalic acid and its salts, monopertallic acids and its salts and esters, ascorbyl stearate, oleoylsarcosine, alkyl sulfate, dioctyl sulfossuccinate sulfate, salicylanilide, domiphen bromide, delmopinol, octapinol and other piperidine byproducts, nicin preparations, chlorite salts or any mixture thereof). Flavoring agent (Selected among, but not limited to: 1 to 5 essential oils (mint, peppermint, spearmint, lemon grass, clove, salvia, strawberry, grape, eucalyptus, marjoram, cinnamon, lemon, rosemary - pepper, orange), as well as aldehydes, esters, alcohols amd similar flavoring materials). Dyes/pigments 0.1 to 10 (May be organic or inorganic, selected among, but not limited to: peroxides, superoxides, oxygen forming agents and ingredients for optical bleaching as all dyes and pigments, organic and inorganic, which act within the blue to violet light spectrum to reflect white light, such as mica and silicon compounds). pH corrector 0.5 to 40 (Selected among, but not limited to: basic (sodium mono- and di-phosphates) and acids (phosphoric, citric, maleic)). Calcium Sources 0.001 to 10 (Which are alternatively employed and selected among, but not limited to: calcium glycerophosphate, calcium carbonate and tricalcium phosphate, may be organic sources or not). Silicon source 0.1 to 40 (Which are alternatively employed and selected among, but not limited to: amorphous silica, bioglasses, silicates, mesoporous silica, functionalized silica, especially developed silica). Amino acids 0 to 10 (Which are alternatively employed and selected among, but not limited to: arginine, lysine, citrulline, ornithine, creatine, histidine, diaminobutanoic acid, diaminopropionic acid, salts and/or combinations thereof, or even any amino acids with a carboxyl group and a water-soluble amino group and available in aqueous solution with a pH around 7 or lower. Preferably, arginine). Orthophosphoric acid 0 to 40 Tetrasodium pyrophosphate 0.5 to 40

[0069] Below are some examples of formulations and the process for obtaining each of the phases that comprise the three variations of the pleaded composition.

[0070] Table 5 below describes an example of formulation of phase 1 of the composition, and the process for obtaining it.

TABLE-US-00005 TABLE 5 Components present in the formulation of phase 1. Component Proportion Moisteners (PEG 600, Glycerin, Sorbitol) 40 to 70 Thickener (Carboxymethylcellulose) 1 to 5 Deionized Water 0.1 to 30 Sweeteners (Sodium saccharine, xylitol) 0.1 to 1 Sodium Fluoride 0 to 1% Preservative (Sodium Benzoate) 0.1 to 1 Silica Thickener 7 to 15 Abrasive Silica 7 to 15 Tetrasodium pyrophosphate 0.5 to 40% Surfactant (Sodium laureth sulfate) 3 Aroma 0.5 to 3 Antiseptic (Triclosan) 0.1 to 0.3 Orthophosphoric acid 0.8 to 1.5

[0071] In order to obtain the formulation of phase 1 of the composition, a pre-mix is prepared, where the glycerin+CMC base is obtained, and for such the following components are used:

[0072] Carboxymethylcellulose, at a 0.7 to 1.0% m/m proportion of the formulation;

[0073] Glycerin, at a 45 to 55% m/m proportion of the formulation.

[0074] Carboxymethylcellulose is added to glycerin, in slow agitation, for 10 to 30 minutes at a speed of 45,000 to 200,000 rpm at 25° C., to avoid formation of lumps, obtaining the glycerin+CMC base. Afterwards, the full load of deionized water is added to the reactor, at 0.1 to 7% regarding the total volume of the composition, activating turbine, anchor, and impeller. Then the following salts are added to the reactor: sodium fluoride at a 0 to 1% m/m proportion of the formulation; sodium saccharine at a 0.5 to 5% m/m proportion of the formulation; sodium benzoate at a 0.1 to 1% m/m proportion of the formulation; xylitol at a 0.5 to 5% m/m of formulation; tetrasodium pyrophosphate at a 0.5 to 40% m/m of the formulation, followed by homogenization for 5 to 20 minutes in the conditions previously described.

[0075] Afterwards, moisteners and sorbitol are added at a 40 to 70% m/m proportion of the formulation, and PEG-600 at a 40 to 70% m/m proportion of the formulation, and the previously prepared glycerin+CMC base at a 50 to 55% m/m proportion of the formulation. A vacuum application is then performed at 600 mmHg, followed by homogenization for 5 to 20 minutes in the conditions described above. After homogenization with the vacuum turned on, the thickener silica is slowly added at a 10-to-15-minute interval at a 7 to 15% m/m proportion of the formulation; then the abrasive silica is added the same way, at a 7 to 15% m/m proportion of the formulation. With the vacuum still on, homogenization is carried out for a period of 1 to 3 hours.

[0076] After this period, with the vacuum still on, the sodium laureth sulfate is added at a 5 to 15% m/m proportion of the formulation; followed by homogenization for a period of 5 to 20 minutes. Then triclosan is added at a 0.1 to 1% m/m proportion of the formulation, previously dissolved in menthol at a 1 to 5% m/m proportion of the formulation; followed by homogenization for a period of 5 to 20 minutes. Lastly, the orthophosphoric acid is added at a 0.8 to 1.5% m/m proportion of the formulation, also with the vacuum turned on, followed by homogenization for a period of 3 to 5 hours, after which the process for obtaining phase 1 is finished, which may be applied in isolation, as the variation 3 of the composition.

[0077] Table 6 below describes an example of formulation of phase 2 of the composition, which contains calcium, followed by the process for obtaining it.

TABLE-US-00006 TABLE 6 Components present in the formulation of phase 2. Component Proportion Moisteners (PEG 600, Glycerin, Sorbitol) 40 to 70 Thickener (Carboxymethylcellulose) 1 to 5 Deionized Water 0.1 to 30 Sweeteners (Sodium saccharine, xylitol) 0.1 to 1 Preservative (Sodium Benzoate) 0.1 to 1 Abrasive (Silica Thickener) 7 to 15 Calcium Source (Microlyzed 70 to 80% 5 calcium carbonate/20 to 30% tricalcium phosphate) Surfactant (Sodium laureth sulfate) 3 Aroma 0.5 to 3 Antiseptic (Triclosan) 0.1 to 0.3 pH corrector (Monobasic Phosphate, 2 to 5 dibasic Phosphate, citric acid)

[0078] In order to obtain the formulation of phase 2, initially, a pre-mix is prepared, where the glycerin+CMC base is obtained, and for such the following components are used:

[0079] Carboxymethylcellulose, at a 0.7 to 1.0% in/in proportion of the formulation;

[0080] Glycerin, at a 45 to 55% in/in proportion of the formulation.

[0081] Carboxymethylcellulose is added to glycerin, in slow agitation, for 10 to 30 minutes at a speed of 45,000 to 200,000 rpm at 25° C., to avoid formation of lumps, obtaining the glycerin+CMC base. Afterwards, the full load of deionized water is added to the reactor, at 0.1 to 7% m/m proportion of the formulation, activating turbine, anchor, and impeller. Then the following salts are added to the reactor: sodium saccharine at a 0.5 to 5% m/m proportion of the formulation; sodium benzoate at a 0.1 to 1% m/m proportion of the formulation; xylitol at a 0.5 to 5% m/m proportion of the formulation; citric acid at a 2 to 5% m/m proportion of the formulation, followed by homogenization for 5 to 20 minutes in the conditions previously described. Afterwards, moisteners and sorbitol are added at a 40 to 70 m/m proportion of the formulation, and PEG-600 at a 40 to 70 m/m proportion of the formulation, and the previously prepared glycerin+CMC base at a 50 to 55% m/m proportion of the formulation. A vacuum application is then performed at 600 mmHg, followed by homogenization for 5 to 20 minutes in the conditions described above. After homogenization with the vacuum turned on, the thickener silica is slowly added at a 10-to-15-minute interval at a 7 to 15% m/m proportion of the formulation, and the mixture of 70% to 80% calcium carbonate and 20 to 30% microlyzed tricalcium phosphate is added at a 0.1 to 5% m/m proportion of the formulation. With the vacuum still on, homogenization is carried out for a period of 1 to 3 hours. After this period, with the vacuum still on, the sodium laureth sulfate is added at a 5 to 15% m/m proportion of the formulation; followed by homogenization for a period of 5 to 20 minutes. Then triclosan is added at a 0.1 to 1% m/m proportion of the formulation, previously dissolved in menthol at a 0.5 to 3% m/m proportion of the formulation; followed by homogenization for a period of 5 to 20 minutes. Lastly, the pH corrector is added, which may be monobasic phosphate, dibasic phosphate or citric acid, as needed, at about 2 to 5% m/m proportion of the formulation, also with the vacuum on, to adjust around a pH of 4.5 to 5.5 followed by homogenization for a period of 0.5 to 1 hour, after which the process for obtaining phase 2 is finished, which may be applied in association with phase 1, as a variation 2 of the composition, or in association to phases 1 and 2, as variation 1.

[0082] Table 7 below describes an example of formulation of phase 3 of the composition, which contains calcium, followed by the process for obtaining it.

TABLE-US-00007 TABLE 7 Components present in the formulation of phase 3. Component Proportion Moisteners (PEG 600, Glycerin, Sorbitol) 40 to 70 Thickener (Carboxymethylcellulose) 1 to 5 Deionized Water 0.1 to 30 Abrasive (Silica Thickener) 7 to 15 Blue dye 0.1 to 0.3 Citric acid 5 to 40

[0083] In order to obtain phase 3, wherein it is composed of a phosphoric acid gel, a pre-mix is prepared, where the glycerin+CMC base is obtained, and for such the following components are used:

[0084] Carboxymethylcellulose, at a 0.7 to 1.0% m/m proportion of the formulation;

[0085] Glycerin, at a 45 to 55% m/m proportion of the formulation.

[0086] Carboxymethylcellulose is added to glycerin, in slow agitation, for 10 to 30 minutes at a speed of 45,000 to 200,000 rpm at 25° C., to avoid formation of lumps, obtaining the glycerin+CMC base. Afterwards, the full load of deionized water is added to the reactor, at 0.1 to 7% m/m proportion of the formulation, activating turbine, anchor, and impeller. After homogenization with the vacuum turned on, the thickener silica is slowly added in a 10-to-15-minute interval at a 5 to 25% m/m proportion of the formulation, then the blue dye, at a 0.1 to 0.3% m/m proportion of the formulation. With the vacuum still on, homogenization is carried out for a period of 1 to 2 hours. Lastly, the citric acid is added at a 5 to 40% m/m proportion of the formulation, also with the vacuum turned on, followed by homogenization for a period of 0.5 to 1 hour, after which phase 3 is obtained, which may be applied by a professional, in association with phases 1 and 2, and as variation 1 of the composition.

[0087] Table 8 below shows a summary board with the characteristics of the pleaded oral composition, in any one of its three variations.

TABLE-US-00008 TABLE 8 Characteristics of the oral composition obtained, in any of its variations. Proposed oral composition In tube −−Water (Formulation) ++Acidic +Phosphate +Na, K, Zn +Silica ±Fluorine Silicon-based complex pH 4.7 - acidified at pH 2.0 to 5.5 In mouth +Phosphate pH 5.5 to 6.5 ++FCa2 Phosphate ++Hybrid Layer: Si, P, Ca, proteins (with or without fluorine) On tooth ++Enamel permeability/++Ca availability +Silicon-based complex ++Mineral precipitation Hybrid Layer: Si, P, Ca, proteins (with or without fluorine) Formation of microporous layer - acidic medium Active layer (molecule release and adhesion) Results +Remineralization +Hybrid layer (protection/adhesion) +Hybrid layer anti-dental erosion +Antimicrobial Whitening +Desensitization

[0088] In this description, except otherwise provided, the use of the singular form also includes the plural. For example, “a sodium ion source” also comprises the case in which more than one source of sodium ions may be used, in addition to its complex or ionized form. The term “non-aqueous” referred herein in this invention relates to the use of small amounts of water, or no water at all, in its formulation; this explanation is required in order to distinguish the term aqueous (oral environment) where the invention operates. Examples of formulations described for each one of the phases are illustrative and non-limiting, and such formulations may eventually feature other components, such as fluorine. In addition, it should be emphasized that any of the three variations may still, alternatively, be supplemented with calcium salts, using up a proportion of 0.001 to 10% m/m of the composition, preferably with calcium glycerophosphate, calcium carbonate and tricalcium phosphate. The oral composition described herein follows the process for obtaining silicon-based polymers in its structure, in acidic medium and with little to no water. It refers to the use of all compounds containing silicon, preferably all forms of silica and, preferably, among silicas, amorphous silica, due to its low cost. The process is considered low cost, since other more expensive processes and silicon compounds are used in the state of the art, such as: bioglasses, silicates, mesoporous silica, functionalized silica, especially developed silica, among others. Obtaining these oral compositions, silicon-based complexes, happens through addition, or not, of metallic salts during preparation, as well as organic compounds that are part of the formulation. Through an EDS (Energy-Dispersive Spectroscopy) mapping analysis (FIG. 1) it is possible to notice the formation of the silicon-based complex. Immediately after the variations come into contact with the oral cavity (aqueous medium), their action starts. In further detail, the reaction takes place inside the dental structure, where, when applying This invention, acidification of the medium and the tooth is provoked, causing an acidic attack which releases tooth components, more specifically calcium and phosphates. The silicon-based complex is electronically attracted by the tooth surface, adhering to it and promoting increase of the polymeric chain, capturing negative and positive ions, as well as organic and inorganic molecules. This “capturing” process, mainly for calcium, increases the interface pH to alkaline levels, favoring the “maturing” of calcium phosphates and, consequently, mineral condensation and formation. This “maturing” of calcium phosphates is known by the formation of hydroxyapatite, which is confirmed by the Ca/P relation in the EDS around 1.64 at the atomic number, very close to optimal at 1.67. However, the formed hydroxyapatite is not pure; otherwise, it would be soluble in acidogenic challenges with a pH around 5.5. Thus, the formation of an insoluble complex occurs in This invention, enriched with silicon and maybe containing fluorine (FIG. 2). The continuous use of This invention promotes, on the dental structure (in situ) the formation of an increasingly robust, active, compact, low porosity layer, resistant to the challenges of the harmful effects caused to teeth (FIG. 3). This is only possible because continuous formation of the layer only takes place due to “polishing/preparation” of the layer that has been deposited previously. The reaction is caused by rubbing the composition over the already existing structure, in other words, through application of the composition that is acidified and highly reactive, with the help of a toothbrush or other means. Basicity is higher between the tooth and the formed layer, and the medium precipitates the layer even further due to its acidity. This probably occurs because the free calcium present on the tooth and saliva accelerates polymerization/condensation of the layer, in addition to increasing pH on the interface.

[0089] As the layer condensation depends on calcium and phosphates available in the medium, the main source of these components in the buccal medium is the enamel. In this sense, higher layer thicknesses were found about this tissue (around 6 to 20 micrometers). The dentin, on the other hand, layers up to 3 micrometers were found before the use of the pleaded composition. The lack of supplementation for layer formation on the dentin was overcome by the supplementation of calcium and phosphate layers. Calcium and phosphate salts were added in the composition during preparation of phase II, so that the compounds would not react before application. The result was the increase in layer thickness to around 6 to 10 micrometers (FIG. 5). As the composition is used, a hybrid layer is formed with bonding capacity for organic/inorganic layers, which are released only if needed. These components are comprised by antimicrobial agents, boosters, remineralizers and desensitizers. The adhesion to the organic part of the layer is given by the carbon-bearing compounds, which are incorporated through formula ingredients, among which are PEG, and may also be bonded to surfactants (for example, sodium laureth sulfate), responsible for providing elasticity and stability.

[0090] Below are some trials carried out with the oral composition (C) described above and pleaded in This patent application.

Clinical Trials

[0091] A randomized double-blind clinical trial was carried out to evaluate the capacity of pain relief on a patient with dentin sensitivity and need for periodontal treatment. Where T1: pain before the periodontal treatment; T2: after periodontal treatment; T3: 1 week of use of the oral composition (C); T4: 2 weeks of use; T5: 3 weeks of use, and; T6: 4 weeks of use; preliminary results did not yield statistically significant differences between the groups, however, as the pain level of the sample that used This invention started higher and ended up equal to the patients that used the product Novamin®, it may be stated that This invention was capable of reducing pain further than the commercially available product (FIG. 6). A 12-year-old child suffering from MIH—Molar Incisor Hypomineralization, reporting severe pain caused by dental sensitivity, used the product Elmex Sensitive® for 30 days and experienced pain reduction from a 10 to a 7, in a pain scale from 0 to 10. The same child began using This invention and, after 30 days of use, its average initial pain level dropped from 8 to 1, as per FIG. 7. A pH analysis was carried out to verify the behavior of compositions throughout the use, both for the oral composition and another composition of similar acidic pH were used. In the study, patients used gels and took notes of pH variation during teeth brushing. Results obtained are observed in FIG. 8, where blue shows that the gel described in the prior art BR102013006807-1, with acidic pH at 4.5, does not remain acid for extended periods, and is rapidly neutralized by saliva. The orange bar, on the other hand, demonstrates that the use of the oral composition (C), described in This invention, had a progressive increase in pH, ending slightly acidic with 1 minute, still below baseline data. The result obtained is highly desired, in view of the polymer precipitation reaction followed by subsequent condensation and formation of hybrid layer, takes place in an aqueous and acidic medium.

Laboratory Studies

[0092] Bovine enamel blocks were prepared and demineralized. Half a portion of each was then covered with enamel and the exposed area was brushed with the oral composition, described in This invention. Analysis of Scanning Electron Microscopy—SEM and Energy-Dispersion Spectroscopy—EDS (FIG. 8) have validated the deposition and composition of the hybrid layer, formed by the oral composition described. Tables 8 and 9 show the composition of enamels before and after application of the oral composition. The same study was carried out using bovine dentin (FIG. 9), demonstrating the same effect.

TABLE-US-00009 TABLE 8 EDS - Demineralized Enamel. Element % Weight % of atomic number C 18.17 26.77 He 53.58 59.26 Na 0.60 0.46 Mg 0.22 0.16 P 9.61 5.49 Ca 17.82 7.87 Total: 100.00 100.00

TABLE-US-00010 TABLE 9 EDS- Enamel brushed with the oral composition (C) - composition of hybrid layer. Element % Weight % of atomic number C 39.31 54.14 He 31.09 32.14 Na 0.62 0.45 Mg 0.29 0.20 Al 0.38 0.24 Si 0.68 0.40 P 8.38 4.48 S 0.37 0.19 Cl 0.40 0.19 K 0.33 0.14 Ca 17.84 7.36 Fe 0.29 0.09 Total: 100.00 100.00

[0093] In another study, 10 blocks of bovine enamel previously prepared and demineralized for each of the groups (Regenerate®, Sensodyne Repair® in Protect, Colgate Reparação Diária® and the oral composition (C), described in This invention) simulated the mouth environment for 1 week.

[0094] During the experiment, the surface hardness level of blocks before demineralization (baseline) was measured, and afterwards the blocks were demineralized, and a new hardness measurement was carried out. After the second measurement the blocks were brushed for a week in the brushing machine with each of the toothpastes. After this process was finished, a third hardness measurement was carried out after the blocks were brushed. The oral composition, described in This invention, was vastly superior to other toothpastes regarding remineralization levels in only 1 week, as observed in FIG. 10. A second measurement was performed with the QLF device which quantifies minerals through light. Results have also shown a large remineralization of demineralized dental tissues for the oral composition, still greatly superior to other toothpastes, recovering around 50% of the lost minerals in only 1 week of use (FIG. 12). In another study, with unique results in the state of the art, the protection capacity of dental enamel was evaluated. The mesoporous calcium silicate biomaterial-based toothpaste was used for one week (Regenerate® dental gel) and the oral composition, described in This invention. Both products formed a protective layer at the end of one week of use (FIG. 13). After treatment, the samples were immersed in citric acid at 50% for 2 minutes, in order to simulate the dental erosion process. This erosion challenge promoted by citric acid is the same acid found in lemon juices, oranges, etc. The process was validated, since the sound dental enamel clearly was worn similarly to erosion, after the challenge. The enamel treated with the Regenerate® dental cream attained a limited protection of enamel structure, possibly verified through FIG. 14, where it clearly did not withstand the challenge.

[0095] Differently than what occurred with the dental enamel brushed with the oral composition (C) described in This invention, where practically no changes to the layer structure were observed, and the enamel below it remained intact (FIG. 14). The hybrid layer (FIG. 15A) formed by This invention, is a thicker and higher layer, more resistant, unique, formed in acidic medium, microporous, and hard to penetrate. Differently from the enamel treated with Regenerate®, which formed a mesoporous layer (FIG. 15B), with larger diameter pores, with less thickness and smaller, which probably enabled the penetration of acid and degradation of said layer and the enamel. Therefore, gelation in acidic medium leads to chains that join to form polymeric gels (FIG. 16), that after drying give rise to a compact matrix with low pore volume and size generally smaller than 2 nm of diameter, called micropores (Benvenutti, 2009). In another study, bovine enamel and dentin blocks were prepared and brushed for 1 week with This invention, with while silica substituted by blue silica.

[0096] Layers formed both on the dentin and on the enamel. After the brushing period, a blueish tone and bleaching was verified (FIG. 17A). It was possible to verify the clarifying effect caused to the tooth through the spectrophotometer, confirming the positive result. Thus, it is possible to state, based on results, that a layer has formed, even if capable of providing an optical whitening effect (FIG. 17B). FIGS. 18 to 22 show the details of the hybrid layer formed with the use of the oral composition and FIG. 23 demonstrates the construction of a new enamel-like layer with one week of use of the oral composition.

[0097] This way, this invention is an acidified bioactive complex obtained from association of salts, organic compounds, components including silicon and phosphates. When the product is being used, in the mouth, it lowers the pH of the mouth cavity to around 5.5, due to its acidic composition. Thus, this invention creates an acidic condition in the dental structure to release mainly calcium and phosphate ions into the buccal medium, whilst the bioactive complex is electrochemically attracted by the tooth, bonds to it and gathers dispersed particles and ions, precipitating them and transforming into a hybrid layer containing silicon-enriched hydroxyapatite.

[0098] It should be highlighted that the hybrid layer may also be formed by all types of ions and calcium phosphate-based compounds, especially apatites. The hybrid layer remineralizes the dental enamel surface, functioning as a protective shield over the tooth, which mimics the original enamel, an “enamel-like” which functions against the acidic day-to-day challenges when the dentin is exposed, this layer obliterates the dentin tubules and relieves the pain caused by dentin sensitivity, and in addition, the composition is also a protective agent against cariogenic and microbial processes and exposure to acids even in pH below 4.5. The formation of a layer takes place in a self-etching manner, in other words, after each use of the oral composition variations, a new layer is formed on top of the previous one.

[0099] The inventive step of this application lies precisely in the formation of minerals in acidic medium, exactly in the same environment in which minerals are lost, for example, the solubilization of hydroxyapatite occurs in pH 5.5 or lower, enabling the formation of a hybrid layer, which allows the product to act upon full maintenance of oral health.

[0100] In face of the foregoing, it is observed that the ORAL COMPOSITION WITH SYNERGISTIC ASSOCIATION OF ORGANIC AND INORGANIC COMPONENTS, its PROCESS FOR OBTAINING and USES THEREOF deserve the privilege of an invention patent.