Oral compositions with a synergistic association of organic and inorganic components for the maintenance of complete oral health, processes for their manufacture and use - Patent Application 20070122999

Abstract

Oral compositions with a synergistic association of organic and inorganic components for the maintenance of complete oral health, processes for their manufacture and methods of use The present invention relates to oral compositions, their variations, uses, and methods of manufacture, characterized by an acidified bioactive complex obtained from the association of ingredients including salts, organic compounds, silicon, and phosphates. When placed in the mouth, this complex electrochemically attracts and adheres to teeth, causing calcium ionization from the tooth structure due to its acidic nature. Once attached to the teeth, the complex begins to collect dispersed particles in the oral environment, condensing primarily calcium and forming a hybrid layer containing silicon-rich hydroxyapatite. This hybrid layer remineralizes the surface of tooth enamel and acts as a protective shield for the teeth, acting against the acidic challenges of everyday life. When exposed, this layer obliterates dental tubules and relieves pain caused by tooth sensitivity. The layer formation occurs in a self-etching manner, meaning that each time the oral composition is applied, a new three-dimensional layer is formed on top of the previous one. Thus, mineral formation in an acidic medium, the exact same environment in which mineral loss occurs, allows the hybrid layer to form, enabling the product's action to promote the integrity of oral health.

Description

[Technical Field]

[0001] BRIEF DESCRIPTION OF THE INVENTION This patent application describes an unprecedented "oral composition, manufacturing process, and use involving a synergistic association of organic and inorganic components for the complete maintenance of oral health," involving the interaction of salts, acids, silicon-based compounds, and other compounds, including carbon, in a medium containing low concentrations of 0.1-7% water at an acidified pH range of 2-5.5. Upon contact with the oral environment, the composition exhibits a strong affinity for dental tissues, and during use, it is able to acidify the oral environment, favoring the maintenance of a slightly alkaline oral pH (intraoral pH ranges from 5.00-7.5, potentially higher at the tooth / reaction interface). This accelerates mineral binding, formation, and deposition, and more precisely, the in situ formation of a microporous (organic and inorganic) hybrid biomaterial layer with pores less than 2 nanometers in diameter in the tooth structure. The layer formed is insoluble in water at oral temperature, its formation occurs independently of fluoride ions, and its deposition process on dental structures (enamel, dentin, cementum) is initiated by the connection of a silicon-based composite fabricated and packed into a single-phase and / or multi-phase container. The components constituting the present invention may or may not be microdegraded (at the nanometer scale). The hybrid biomaterial layer formed through the use of the composition promotes the integrity of oral health. In restorative treatment, it promotes better adhesion of dental adhesives and dental cements used to restore teeth. In preventive and cosmetic dentistry, the hybrid layer formed has a positive effect on protection and functional and aesthetic restorations. These effects are known for remineralization, protection against cariogenic and microbial processes, and delayed release of active substances. Teeth whitening, both optically by the adhesion of particles to the layer and chemically and mechanically by removing pigments, and by blocking dentin tubules, protection against erosion processes, protection against corrosion, acid attack, and relief of tooth sensitivity.

[0002] [Application field of the invention] The present invention belongs to the section of human needs in the field of dentistry and hygiene.More specifically, for dental preparations, as it describes an oral composition, which includes the synergistic relationship of its components, and from the use of the composition, gives teeth an active action in better adhesion, protection and restoration of dental adhesives, in addition to functional and aesthetic restoration.

[0003] [Invention Instructions] Modern social behaviors, such as the consumption of sugary and acidic foods, stress, dental tension, and the use of orthodontic appliances, are directly related to the emergence of oral problems. Among these, the most common are caries, erosion, and tooth sensitivity. Currently, oral care regimens must adapt to the realities of social behavior. Facing challenges, this field requires constant technological improvement: prevention, protection, and restoration against decay, tooth erosion, and other oral problems, while aiming to relieve and prevent tooth pain and sensitivity. Furthermore, patients increasingly demand aesthetics and functionality / durability from dental treatments from specialists in this area.

[0004] Despite the various technologies already developed, recent studies have demonstrated the inefficiency of bioactive toothpastes in relation to the challenges of modern life. According to Joao-Souza et al. (2017), toothpaste alone cannot solve tooth erosion or tooth sensitivity. In this context, Lonta et al. (2019) also argue that anti-erosion toothpastes do not fulfill such a function. Regarding destructive processes of dental tissue (demineralization), such as caries and erosion, fluoride (F) has become the main asset incorporated into products used to combat these problems.

[0005] However, several studies have shown that previously widely used products for preventing such problems, such as fluoride, have limited effectiveness. According to Schmidlin et al. (2016), given the limitations of fluoride, the action of bioactive agents, such as those incorporated into toothpaste, is often necessary to promote remineralization. Another current issue worth highlighting is the significant increase in the prevalence of HMI in children—a condition in molars and incisors where enamel deformities promote the development of cariogenic processes and exposure of adjacent tissues to enamel and dentin, resulting in hypomineralization. This exposure leads to extremely painful processes through direct communication with the dental pulp via dentinal tubules in the oral environment. Related to this issue, so-called desensitizing toothpastes do not or only minimally relieve pain in children, necessitating more expensive professional procedures, such as the application of sealants and desensitizing agents. In some cases, more drastic alternatives, such as tooth restoration or extraction, are necessary. In light of the above, the present invention provides a formulation that fully meets the needs of maintaining oral health. Its characteristics and constituents have a long history of research, making it unparalleled. According to the most recent review on the subject (Leal & Takeshita et al., 2019 - Pediatric Restorative Dentistry), the mechanism by which fluoride acts on demineralization and remineralization of enamel and dentin is already well established and is known to depend on the availability of oral calcium and phosphate ions in the presence of fluoride. Phosphate and calcium-based agents have been investigated alone or in combination with fluoride to enhance the remineralization effect, mainly by replacing pure hydroxyapatite with less soluble ones, resulting in stronger protection and prevention against disease. Hydroxyapatite (Ca 10 (PO4)6(OH)2) is the original mineral in teeth that can be transformed to become more insoluble in the face of the daily challenges teeth suffer. Table 1 shows the possible modifications of hydroxyapatite according to Da Silva et al. (2012).

[0006] [Table 1] Table 1: Examples of apatite substitution.

[0007] The primary modification of hydroxyapatite widely recommended in dentistry is the addition of F to the A site, converting it into a poorly soluble mineral known as fluoroapatite and / or fluoridated apatite. Generally speaking, hydroxyapatite is a calcium phosphate compound. Phosphate compounds aid in tooth remineralization and reduce solubility. Several of these compounds are used as sources of calcium and phosphate to enhance the saturation of the oral environment relative to hydroxyapatite. These include: nanohydroxyapatite, bioactive glass containing sodium phosphate and calcium (Novamin®), a dual-chamber system in which calcium salts are separated by plastic compartments from sodium phosphate and fluoride salts (Enamelon), dehydrated dicalcium phosphate (DCPD), caseinophosphopeptide (CPP), amorphous calcium phosphate (ACP) (Recaldent), and functionalized tricalcium phosphate and calcium glycerophosphate. Therefore, an ideal formulation should combine the ability to improve remineralization with the reduction of mineral loss, erosive wear, and dentin hypersensitivity (Leal & Takeshita et al., 2019: Pediatric Restorative Dentistry). Biomaterials have always been used to replace, repair, and regenerate dental hard tissues. As research progresses, significant developments have been observed in the field of dental materials, with new materials becoming available and existing materials improving in performance. Unlike the development of bioinert materials, recent research on hard tissues has witnessed the development and subsequent application of bioactive materials, the main feature of which has been the development of bioactive glass. First discovered in 1969, bioactive glass provided a reliable alternative to inert implant materials due to its ability to form stable bonds with host tissues and, specifically, induce remineralization of dental hard tissues.(Khalid 2017 - Bioactive Glasses and Their Applications in Dentistry). Several studies in the literature have employed silicon-based materials as precursor materials or even as materials for direct surface coating. Therefore, silicates, bioglass, and other silicon sources have been extensively studied and used. According to Da Silva et al. (2012), literature data indicate that incorporating silicon into the HA-hydroxyapatite structure increases the bioactivity of the material. SiHA-based ceramics can form a new layer of biological apatite phase on their surfaces in contact with physiological fluids more quickly than pure HA. Studies involving cell culture have demonstrated that bone cell proliferation and differentiation are more significant on the surface of SiHA than on HA. One silicon-based material is silica. Silica is an inorganic polymer with siloxane groups (Si-O-Si) inside and silanol groups (Si-OH) on its surface. Silica forms one of the most widely used classes of inorganic materials for supporting various systems in a variety of applications. Its main studied properties are related to its surface, sparking interest in studying its molecular or ionic adsorption properties. For Benvenutti et al. (2009), the development of new, innovative materials and the improvement of existing materials are part of the daily challenges of scientific evolution. The combination of organic and inorganic components leads to new materials known as organic-inorganic hybrids. These materials associate their own unique physicochemical properties, and by combining them, they synergistically form highly promising materials, taking advantage of the strengths of each. Hybrids containing silica as the inorganic component, also known as silica-based hybrids, are the most important, studied, and technologically applied, presenting several applications such as catalysis, drug carriers, and protective coatings, among others.

[0008] Among silica particles, amorphous silica stands out for its exceptional advantages, including ease of surface modification, low cost, and low toxicity. As such, they have been used in many applications, including cosmetics, food, and medical diagnostics. Silica polymerization and precipitation occur in a variety of environmental and industrial processes: ceramic and catalytic applications, water heater sizing, biomineralization, and coating applications to improve adhesion and wettability. Silica polymerization has become a highly researched topic. Due to the nature of its applications, studies of polymerization and silica precipitation refer to polymerization in slightly acidic to basic solutions, where silica polymerization begins with the condensation of cyclic oligomers, which grow into three-dimensional polymer particles (Gorrepati, 2010). Gorrepati's (2010) study demonstrated silica polymerization at pH 7 (neutral) and found a relationship between salt and silica polymerization rate. The authors cite an exponential increase in polymerization with increasing acid concentration and the addition of salt. These findings are in agreement with Crear et al. (1981), who confirmed an increase in the rate of silicon polymer growth with the addition of salt. In dentistry, the use of fluoride is widely recommended in the prevention of dental caries due to its performance associated with the formation of calcium fluoride and fluorapatite.

[0009] However, another important and widely used function of the fluoride anion is its function as a reaction catalyst. It can be used in either acidic or basic media and has been shown to be a highly efficient catalyst for the gelation process of silica-based hybrids. While its mechanism of action is not fully understood, there is consensus that fluoride, being a very small anion and easily diffusible in the system, initiates the process through nucleophilic attack on silicon, then cooperates with the silicon to promote subsequent reactions. Fluoride is commonly used in the form of HF. In its salt form, as NaF, it has been observed that the metal cation interacts electrostatically with the alkoxide groups, inhibiting the polycondensation process (Bevenutti et al., 2009). In this study, the exact opposite was proposed, using sodium fluoride (NaF) to prevent polycondensation. Therefore, the absence of polycondensation is known to result in hybrid layers that are less organic, more microporous, and more resistant to acid attack. This effect is evident in the work of Pavan et al. (2003), where the presence of Na+ (when NaF was used) resulted in a decrease in the final organic content of the material. This effect is probably due to the interaction of Na and SiO in the hydrolyzed organosol. - This was interpreted as an inhibition of organosilane polycondensation due to interactions with the hydroxyl groups. Silica solubility is constant in the pH range of 2-9, with the ideal pH for silica precipitation as a colloid being close to 4.5 (Gomes, 2018). The colloidal and tribological behavior of silica plays a key role and is known to be much more complex than expected for materials with smooth, chemically inert surfaces (Donose et al., 2005). Furthermore, according to Donose et al. (2005), adsorption of hydrated cations may also play an important role in adhesive interactions between surfaces. Many authors have studied the adhesion of silica to dental structures and demonstrated its strong bond with teeth (Addy et al., 1989, Perdigao et al., 1994, Lee et al., 2007).

[0010] In a classic study, Lee et al. (2007) demonstrated the ability of a dentifrice formulation containing n-CAP (microdissolved carbonate apatite) and silica to occlude dentin tubules. In another classic study, Perdigao et al. (1994) showed that acids thickened with silica, used to prepare tooth structures for restoration bonding, left strong bonds between the silica and the tooth that could not be removed even after washing. It is still possible to say that silica adhered to both enamel and dentin did not affect bond strength. On the contrary, there was a slight increase in bond strength, indicating a strong bond of silica to the dental structure. A study by Giordano et al. (2016) showed that the classic sol-gel deposition, hydrolysis, or condensation of silicon alkoxides occurs under acidic or alkaline conditions, respectively. All chemical species are hydrolyzed in the early stages of the reaction, and can therefore condense to form small oligomeric species with reactive Si-OH groups. Under these conditions, reactions at the terminal silicon atoms are promoted, resulting in the formation of polymeric gels. That is, the small aggregates undergo a condensation reaction with each other, forming a polymer-like network with small pores. In their experiments, the authors used EADS - electro-assisted deposition of sol-gel - OH - or H3O + The device triggers the kinetics of the sol-gel reaction based on the local electrochemical generation of . This means that other parameters, such as the cell geometry, operating potential, and ionic conductivity, must be taken into account. In particular, the selection of the initial solution is a key point in the electroforming process, as reactants are known to play different roles during deposition. Once the EADS are activated by the local reduction of a moderately acidic electrolyte, polycondensation occurs at the surface of the electrolyte electrode due to a local increase in the OH concentration (alkali catalysis). OH- ions are converted into H 3 O and / or HO, except H 3O and HO are not only involved in the reduction reaction at the surface of the working electrode, but are also important variables in the sol-gel process. In fact, water promotes the polycondensation of silica gel, while HO allows for faster hydrolysis of alkoxide groups. Therefore, HO +The concentration of phosphate should be kept as low as possible, resulting in the need for electrolytes to dampen the ohmic drop in solution. In this context, the small amount of water present in the present invention stabilizes the complex, leaving it ready for precipitation and the formation of hybrid layers upon contact with saliva, calcium, and proteins. Fowler et al. (2005) described the ability of surfactants to influence the crystallization, nucleation, and mineral growth processes of calcium phosphate. Among the surfactants studied was sodium lauryl sulfate. The conclusion was that the significant influence of organic aggregates on the formation of calcium phosphate materials was found. Polyphosphates with film-forming properties have also been reported in the literature. In a study by Morsh et al. (2018), polyphosphates, including pyrophosphate, function by forming a protective surface film on pipes to prevent corrosion. Functionalization of hybrid layers is also possible through the use of polyethylene glycol (PEG), which has a variety of relevant properties, including insolubility in water at high temperatures, the formation of complexes with metal cations, high mobility with large excluded volume forces in water, and precipitability for proteins and nucleic acids. Once attached to other molecules, PEG quickly undergoes chemical modification, binding to other molecules and surfaces. PEG modulates the solubility and increases the size of the attached molecule. Benvenutti (2009) observed that PEG macromers can be easily functionalized in the preparation of silica-based hybrid materials. This process involves the addition of new components, which increase the complexity of the system, i.e., molecular precursors of organic components. In addition to other functions, the present invention is still in bleaching. In the composition, dyes are incorporated into a silicon-containing matrix, thus allowing for molecular distribution. As a result, the dyes are distributed within the silica matrix, maintaining optical properties such as increased luminescence intensity (Benvenutti et al., 2009) and functioning as optical brighteners, promoting the emission of white light across the color spectrum.

[0011] It is therefore observed that the claimed composition solves in an innovative way the problems present in the state of the art with regard to proposing an oral composition that is able to fully meet and promote the maintenance of oral health.From the above, it can be noted that the present invention is the result of extensive research to develop an effective and innovative product, as well as its manufacturing process, that synergistically combines the properties of its components in the composition with a remineralizing effect, to protect against cariogenic, acidic, microbial and erosive processes, to whiten and to alleviate tooth sensitivity.

[0012] The current state of the art includes prior art describing dentin hypersensitivity compositions aimed at improving tooth sensitivity and remineralization. However, none have been found that promote the overall maintenance of oral health through a synergistic combination of organic and inorganic compounds that promotes the restoration of already demineralized areas while still providing desensitization and whitening. Research into acidifying dentifrices has a long history, with studies conducted over 40 years demonstrating the action of acidifying dentifrices in conjunction with fluoride, as acidification makes fluoride more reactive and improves performance. In this sense, inventions describing acidified compositions always present their main active agent with fluoride. Regarding pH control in conventional compositions, it should be noted that it has proven most appropriate to provide it through phosphoric acid, as this is essential for the demineralization and remineralization processes (Leal & Takeshita et al., 2018).

[0013] In Table 2 below, some priorities existing in the state of the art are presented, and further priorities are commented on and compared with the compositions claimed in the present invention.

[0014] [Table 2] TIFF0007725025000003.tif156154 TIFF0007725025000004.tif109148 Table 2: Toothpaste-related research over the past 50 years. Adapted and translated from Pediatric Restorative Dentistry - Leal & Takeshita et al., 2018.

[0015] Prior invention PI0705195-6, also developed by the present inventors and titled "Low Fluoride Acidified Liquid Dentifrice Formulation and Use Thereof," is a formulation with a low fluoride concentration (550 ppm F) and an acidified pH, using approximately 0.25% orthophosphoric acid to adjust the pH. This concentration is justified by the fact that adding higher concentrations of acid would result in a lower-than-ideal pH of 4.5. It is important to note that the product contains approximately 25% water. A previous invention, BR102013006807-1, developed by the same authors of this application and titled "Superfunctional Toothpaste and Use of a Combination of Fluoride Agents and Protease Inhibitors," describes a dentifrice formulation containing a higher concentration of fluoride than the previous one and a protease inhibitor with a reduced pH between 4.3 and 6. This increases the product's effectiveness in inhibiting dental caries, acid erosion, and periodontal disease. Again, the water content is approximately 25%. Another application, PCTBR2018050485, entitled "Multifunctional Fluoride Bisphosphate Toothpaste Composition," also developed by the inventors of this application, describes a toothpaste formulation containing a synergistic association of a small amount of water, a fluoride agent, and two phosphate compounds, which contact tooth minerals to provide the composition with an anti-demineralizing / regenerative effect, preventing the loss of calcium and phosphate that occurs during the demineralization process, while simultaneously promoting the repair of areas already demineralized at the early stage, i.e., at the enamel level.

[0016] This composition also has a desensitizing effect on teeth due to its ability to precipitate CaF2, which destroys dentin tubules. This invention differs from the first two primarily in the amount of fluoride, acid (even lower pH in this invention), and water present, as well as the manner in which the product's action occurs. Regarding the third, both contain a high amount of acid, a low amount of water, and the same amount of fluoride, but the composition is completely different. This invention allows for the unprecedented preparation of silicon-based complexes in a non-aqueous environment (small amounts of water), prepared in acidic solutions and / or obtained by high acid concentrations. The fluoride in this invention has an additional function: in addition to forming fluoride compounds as in the previous one, it also serves as a reaction catalyst for the formation of silicon-rich mineral layers in situ (in the mouth).

[0017] Therefore, the present invention is not "fluoride-dependent" like its predecessors, with its catalytic element replaced by other components. The primary mechanism of action of the aforementioned invention is the formation of calcium fluoride phosphate and fluorapatite (fluorine-rich hydroxyapatite). The mechanism occurring in the present invention is the formation of a hybrid mineral layer (organic and inorganic), the primary component of which is silicon-rich hydroxyapatite. Hybrid mineral layers (organic and inorganic), whose primary component is silicon-rich hydroxyapatite, are more acid-resistant than fluoride-rich hydroxyapatite (fluorapatite), especially at oral pH levels below 4.5, where even fluorapatite dissolves. Current state-of-the-art techniques also include techniques for modifying dentin surfaces. Yang et al. (2014) described dentin surface modification to an "enamel-like" structure as a potential strategy for reducing dentin sensitivity, self-repairing, and improving the durability of restorations and cements. The authors described the histological complexity of dentin. While counteracting the long-term effects of dentin bonding, postoperative sensitivity is likely to occur after conventional adhesive restorations, as is the fragility of the layer formed between the tooth and the restoration / cement adhesive system. In this context, the present invention presents a composition and method for forming enamel-like dentin, simulating enamel structure, in order to obtain satisfactory durability of dentin bonding and achieve good performance in preventing postoperative sensitivity. By applying bidirectional bonding of mesoporous silicon to dentin's own hydroxyapatite and in vitro synthesized hydroxyapatite nanorods, a functional enamel-like layer, "enamel-like," can be formed through ion deposition and modulation. "Enamel-like" layers, as described by Yang et al. (2014), were obtained using equal amounts of MSN (MCM-41) nanoparticle mesoporous silica, separately placed in calcium oxide (CaO) and phosphoric acid (H3PO4), mixed with distilled water, and rubbed evenly onto the deproteinized dentin surface three times to form a paste.After solidification in approximately 10 minutes, the remaining adhesive on the surface was gently washed with a water spray for 30 seconds, leaving a thin white coating on the surface of the deproteinized dentin. During the coating process, Ca. 2+ and HPO4 2+ Ions are easily and quickly released due to the large surface area / volume of MSNs. Consequently, precipitates of CaHPO4·2H2O are formed, which tightly clog the dentinal tubules and act as a barrier preventing the penetration of dentinal tubule fluid at the bonding interface. At the same time, as the pH value increases, the nucleation of CaP also contributes to the adhesion between MSNs and the underlying deproteinized dentin. Last but not least, MSNs tightly bind to the HAP of deproteinized dentin through a chemical reaction resulting in the generation of silicon-stabilized tricalcium phosphate (Si-TCP), forming a silicon-rich layer. In one of their studies, Chiang et al. (2010) described calcium phosphate precipitation as a potential treatment for dentin hypersensitivity due to dentinal tubule blockage. The authors highlighted a novel mesoporous silica biomaterial (nano-CaO@mesoporous silica, NCMS). The inclusion of nano-sized calcium oxide particles mixed with 30% phosphoric acid could effectively occlude dentin tubules and significantly reduce dentin permeability. 2+ and ions HPO4 2+When brushing the dentin surface with NCMS paste containing hydroxyapatite, the ions diffused deep into the dentin tubules, forming precipitates of CaHPO4 ·2H2O up to a depth of 100 μm. Dentin permeability tests showed that the new mesoporous material exhibited a significant reduction in dentin permeability (p < 0.05) compared with other materials previously developed by the same team, such as DP-bioglass and the commercially available desensitizer Seal&Protect®. In this case, the mesoporous silica described here, as reported by the authors, does not function to precipitate and clear the dentin tubules. The mesoporous silica referred to herein is merely a calcium carrier. Prior publication WO1994020064A1, titled "Calcium phosphate hydroxyapatite precursor and methods for making and using the same," describes acidified calcium phosphate compositions, particularly useful and unique for orthopedic and dental cements and remineralization agents, as well as methods for their manufacture and kits for their use. The composition comprises tetracalcium phosphate prepared from a mixture having a calcium to phosphorus ratio of less than 2, and / or prepared and maintained under substantially anhydrous conditions prior to use.

[0018] The composition converts to hydroxyapatite upon hardening, is resorbable, and replaces bone when implanted in contact with living bone tissue. In addition to other properties, it offers distinct advantages in cement strength, hardening time, and reliability. Prior patent US5079298A, titled "Silicon-containing polymer having comb-shape structure," describes a silicone-containing polymer with a comb-shape structure, comprising organopolysiloxane units as the backbone and vinyl polymers as side chains. The polymer has excellent migration properties and is useful as an agent providing water repellency, adhesion, and surface activity. Prior patent WO2013052181A2, titled "Functionalized silicones with polyalkylene oxide side chains," describes silicone polymers with grafted pendant hydrophilic polyalkylene oxide side chains and, optionally, reactive functional end groups. These features make them suitable for use in chemical, marine, biomedical, and industrial applications, particularly those involving surface modification. According to Lippert et al. (2013), virtually all formulations containing sodium phosphates (e.g., pyrophosphates) have basic and non-acidic properties. Such formulations typically have a high pH to avoid hydrolysis of these phosphates, a condition desired by manufacturers of formulations existing in the state of the art. Unlike the products described in the state of the art, the intended effect in this invention is precisely the hydrolysis effect. An acidic pH is essential for the reaction to occur, thus making the phosphate and sodium available. The use of silica and its activation, rendering it bioactive and enabling the formation of polymers applicable to the health sector, is widely known in the state of the art. However, the activation of silica from the proposed process, using NaF and condensed salts as components and the resulting product in an acidic medium, i.e., a composition in which organic and inorganic components are synergistically combined, allows the in situ formation of a microporous hybrid mineral layer with silicon-rich hydroxyapatite, confirming the inventiveness and novelty of the proposed invention.The prior publication, W02008068247A1, titled "Oral care product," anticipates oral care products containing mesoporous calcium silicate biomaterials (MCBS) dispersed in a polymeric matrix. This document explains that current lifestyles have led to increased consumption of acidic beverages and foods, making dental erosion more prevalent and common. This is considered one of the greatest threats to teeth in the 21st century. Acidic foods and beverages, such as fruits and fruit juices, make enamel more fragile and susceptible to acid attack and wear. Therefore, without intervention or effective treatment, dental erosion can lead to severely painful tooth sensitivity. Consider that as the enamel surface wears away, the inner tubules of dentin become exposed. Currently, remineralization generally occurs through the addition of fluoride ions according to the following reaction scheme: Ca5(PO4)3OH → Ca5(PO4)3F. Therefore, in the context of this invention, MCSB is a calcium oxide-silica insoluble composite material: CaO-SiO. 2-This material is characterized by being in a mesoporous state, i.e., a material with pores ranging from 0.4 to 50 microns in diameter. The material can be in an amorphous or crystalline state. The term "insoluble" should be understood to mean insoluble in water at oral temperatures. Typically, "insoluble" materials have a solubility of less than 0.01 mol / L at 25°C. Prior patent WO2012078136A1, entitled "Dentifrice compositions containing calcium silicate," describes oral care compositions containing an effective amount of calcium silicate particles with an average diameter of less than about 5 microns to clog dentin tubules. A method of oral hygiene is also described, which includes applying the composition to a subject's oral cavity to reduce or inhibit tooth sensitivity and achieve other benefits. Prior US9717929B2, titled "Dentifrice compositions containing calcium silicate and a basic amino acid," refers to toothpaste compositions containing calcium silicate and a basic amino acid, in free or saline form, containing an effective amount of calcium silicate particles having an average diameter of less than about 5 microns to clog dentinal tubules. A method of oral hygiene is also described, including applying the composition to a subject's oral cavity to reduce or inhibit tooth sensitivity and achieve other benefits. Prior WO2018033427A1, titled "Oral care composition," refers to oral hygiene compositions and methods for reducing tooth sensitivity and / or remineralizing and / or whitening teeth. The disclosed oral hygiene compositions include 1 to 20% calcium silicate by weight of a potassium phosphate salt, a dentinal tubule blocking enhancer selected from calcium dihydrogen phosphate, calcium sulfate hemihydrate, or a mixture thereof, and a physiologically acceptable carrier. Here, the calcium silicate and potassium phosphate salt are present in a weight ratio of 10:1 to 1:5.

[0019] Prior patent application WO2015167488A1, titled "Oral care composition containing silica and zinc citrate," describes a formulation containing specially prepared silica, a bioadhesive, zinc, and the anticalculus agent tetrasodium pyrophosphate. The use of silica in particular anticipates its use in occluding dentinal tubules, more precisely, the use of silica particles having an average particle size equal to or smaller than the diameter of dentinal tubules for occluding dentinal tubules and treating dentinal hypersensitivity. This was also anticipated and disclosed in prior patent application US2009 / 0092562. This application also uses polyvinyl methyl ether / maleic anhydride ("PVM / MA") as a bioadhesive for immobilizing active substances, for example, the antibacterial activity of zinc and the use of TSPP-tetrasodium pyrophosphate as an antibacterial agent. While the above assumes the use of several components of the present invention, it is clear that no acid is used to facilitate the preparation of the claimed composition at a pH of approximately 2 to 5.5. Furthermore, as described in the present invention, the above does not discuss the reduction of water to a minimum amount near zero, which allows for the production of a highly reactive tooth gel, nor does it mention the need to maintain a low pH throughout the application process. It is also important to note that fluoride is not a necessary condition for the operation of the present invention. While still reactive, the acidified pH in contact with the oral environment (water) makes the claimed composition eager to ionize. This allows it to form a hybrid layer of inorganic elements (calcium, sodium, phosphate, silicon, etc.) and organic elements (proteins, pigments, etc.) when connecting dental structures. There is still an important difference regarding TSPP (tetrasodium pyrophosphate), previously used as an anti-calculus agent. It has a completely different function in the present invention: it is a source of sodium for layer condensation and a source of phosphate for remineralization and hybrid layer formation.The prior patent, WO2012010520A1, titled "Hydroxyapatite-binding Nano- and Microparticles for Caries Prophylaxis and Reduction of Dental Hypersensitivity," refers to nano- and microparticles (labeled nano- and microparticles) functionalized with hydroxyapatite-binding oligopeptides, which can be used to seal cavities, fissures, and dentinal tubules to prevent caries formation and reduce tooth hypersensitivity. The same inventors' previous strategy for caries prevention (pit and fissure sealing) was based solely on the application of an enzyme (silicatein) that binds to the tooth surface and subsequently catalyzes the formation of silica, thereby coating the teeth with a layer of silica.

[0020] While the present invention clearly aims to use silica as a method for preventing the oral health conditions described above, its composition is a silicon complex, not a silica oligopeptide that is activated by an acidic preparation method. It bonds directly to teeth, without requiring prior preparation or reaction with a peptide. Prior publication WO2013052181A2, entitled "Functionalized silicones with polyalkylene oxide side chains," describes silicone polymers with grafted pendant hydrophilic polyalkylene oxide side chains and, optionally, reactive functional end groups.

[0021] These features make bioglass suitable for use in chemical, marine, biomedical, and industrial applications, especially those involving surface modification. Below are some priorities that explain the use of bioglass to achieve the effects claimed by this invention. This uses a silicon source in an acidic medium associated with NaF and condensed salts, resulting in less in situ activation and formation of hybrid layers. Furthermore, it is worth noting that not all prior art reports the bleaching / whitening effect of the compositions provided by this invention. Prior publication WO2011161422A1, titled "Bioactive Glass Composition," describes a bioactive glass composition containing one or more glasses containing SiO2, P2O5, and fluoride (SiO content). The SiO2 content is less than 40 mol%, the P2O5 content is at least 4 mol%, and the fluoride content is greater than 1 mol%. Bioactive glasses or glass-ceramics can be used in a variety of medical applications, including dental applications such as toothpaste.

[0022] The prior art, WO2005063185A1, "Compositions and methods for preventing or reducing plaque and / or gingivitis using a bioactive glass containing dentifrice," describes methods and compositions for preventing and / or reducing dental plaque or gingivitis, plaque buildup, and / or gingivitis. To this end, bioactive glass compositions are provided that prevent or reduce plaque, plaque formation, and / or gingivitis by using low levels of small particles of bioactive glass in amounts of about 0.25 to about 10% by weight in a non-aqueous formulation. The resulting non-aqueous compositions are effective and stable in toothpaste products, meeting ISO standards (International Organization for Standardization). Furthermore, these bioactive glass-containing non-aqueous compositions exhibit unexpectedly high levels of antibacterial activity against oral pathogens. Prior publication WO2019115601A1, titled "Novel composition," describes a non-aqueous dentifrice composition containing a bioactive glass, a humectant such as glycerin, a polymer of hydroxyethylcellulose, and a calcium ion source and a phosphate ion source such as fumed silica. The calcium and phosphate sources together are precursors for the in situ formation of a desensitizing / remineralizing agent in oral teeth. This composition is applicable to tooth remineralization and the treatment of dentin hypersensitivity. Prior publication WO2019034325, titled "Oral care composition," describes an oral care composition containing a bioactive glass, a tubule blockage promoter selected from calcium dihydrogen phosphate, calcium sulfate hemihydrate, or a mixture thereof, a phosphate source, and a physiologically acceptable carrier. wherein the bioactive glass and dentate tubule blockage enhancer are present in a weight ratio of 1:3 to 30:1, and the phosphate source is trisodium phosphate, monosodium dihydrogen phosphate, disodium hydrogen phosphate, ammonium phosphate, diammonium hydrogen phosphate, ammonium dihydrogen phosphate, tripotassium phosphate, dihydrogen monophosphate, dipotassium hydrogen phosphate, or mixtures thereof.Prior patent WO2014154874A2, titled "Chlorine-containing silicate glasses and glass ceramics," describes chlorine-containing silicate glasses containing SiO2, at least 0.5 mol% metal chloride, and at least 10 mol% of a combination of MgO, SrO, BaO, and CaO. Prior patent WO2018118911A1, titled "Whitening dentifrice compositions with zinc core shell silica particles," describes a component used for tooth whitening: a blue silica dye bound to zinc. Accordingly, it relates to whitening dentifrice compositions that do not contain peroxide whitening agents and include a blue colorant, zinc core silica (Zn-CSS) particles, and an orally acceptable carrier, including a solvent, non-aqueous, and aqueous. The blue colorant includes at least one of a blue pigment and a blue dye, and has a blue to blue-purple color with a CIELAB hue angle ranging from 200 to 320 degrees. Zn-CSS particles comprise a silica core and a surface etched with a metal silicate, which is a zinc ion silicate and, optionally, a monovalent metal ion. The prior art, EP0951441B1, entitled "Silicon-substituted apatites and process for the preparation thereof," describes a process for obtaining apatite or substituted hydroxyapatite with synthetic silicon at 0.1% to 5% by weight of the silicon. Unlike the present invention, the prior art concentrates apatite or hydroxyapatite in vitro. However, the claimed oral composition in this invention, upon contact with the oral environment, begins to collect dispersed particles in the oral environment, concentrating primarily from calcium, forming a hybrid layer containing silicon-rich hydroxyapatite. The prior art, JP2012514573A, entitled "Silicate-substituted hydroxyapatite," describes hydroxyapatite substituted with inorganic silicate.Unlike the present invention, the prior art refers to obtaining silicate-substituted hydroxyapatite, but in the present invention, silicon enrichment occurs already in the oral environment upon contact with the oral environment, collecting dispersed particles and condensing them, mainly from calcium, to form a hybrid layer containing silicon-rich hydroxyapatite.

[0023] Although state of the art exists describing dentifrice compositions that can relieve toothache and promote tooth remineralization, none of them result in a formulation that fully satisfies the maintenance of oral health.

[0024] In the following Table 3, a brief comparison is made between the invention described in this application and the dentations present in the state of the art, summarizing their main differences.

[0025] [Table 3] TIFF0007725025000006.tif161154 Table 3: Comparison of the present invention with prior art dentifrices.

[0026] [Object of the Invention] The present invention aims to provide an oral composition containing a synergistic combination of organic and inorganic components that promotes complete oral health by providing remineralization, protection against cariogenic, acidic, microbial and erosive processes, whitening and relief of tooth sensitivity. Summary of the Invention [Problem to be solved by the invention]

[0027] The present invention describes oral compositions, their variations, uses and methods of manufacture.

[0028] This composition is characterized by a synergistic association of inorganic and organic components that occurs during its manufacturing process, more precisely, through the interaction of salts, acids, polymers, and silicon-based compounds in a medium containing a small amount of water. Therefore, at an acidified pH range of 2-5.5, 0.1-7% is considered non-aqueous. Upon contact with the oral environment, the claimed composition has a strong affinity for dental tissues, acidifying them during use and maintaining the oral pH at an acidic to slightly alkaline range (5.0 to pH 7.5). This favors mineral deposition, or more precisely, the in situ formation of a hybrid (organic and inorganic) and microporous (pore size less than 2 nanometers) biomaterial layer. The formed hybrid layer is insoluble in water at oral temperature, its formation is independent of fluoride ions, and its deposition process is initiated by the bonding of silicon-based complexes within tooth structures (enamel, dentin, cementum). The presence of the hybrid layer resulting from the interaction of the composition with elements of the tooth structure allows for the complete maintenance of oral health. In restorative treatment, it promotes better adhesion of dental adhesives as well as dental cements used to restore teeth. In preventive and aesthetic dentistry, the hybrid layer formed has a positive effect on the protection and functional and aesthetic restorations. These effects are known as remineralization, protection against cariogenic and microbial processes (through a physical barrier and delayed release of active substances), tooth whitening (optical - through adhesion to the particle layer and chemical-mechanical - in the removal of pigments), protection against erosion processes and relief of tooth sensitivity due to the occlusion of dentinal tubules. [Effects of the Invention]

[0029] The present invention has the following main advantages: · Providing compositions with remineralizing action, protection against cariogenic and microbial processes (delayed release of active substances), teeth whitening (optical - chemical-mechanical in adhesion to the particle layer and removal of pigments), protection against erosive processes, relief of tooth sensitivity due to occlusion of dentin-like tubules of the teeth; It provides a composition that is active at low pH. This occurs due to the absence of water and the presence of metal cations. In the presence of water from the medium, the repulsive forces are reduced, allowing attraction to the tooth, and the polymerized active form of silicone is ready to react with the cations (calcium); · Presents colloidal silica and provides a composition containing active colloidal silica in an acidic medium, unlike currently available products that have a basic pH; We offer compositions whose activity is independent of fluorine, which, when present, not only improves the action of the active substance but also has the function of accelerating it, if not essential, e.g. sodium pyrophosphate, which also acts as a corrosion inhibitor. To provide a composition whose pH can be further acidified (0.01-30% acidic relative to the original product) without impairing its functionality, by adding a high concentration of acid in a separate tube, e.g. 37%; To provide a process for obtaining an oral composition that can solve a common problem in the technical field, that of hardening the mixture in the reactor and in the product tube itself; We offer a fluoride-independent product, allowing the enamel remineralization process to take place. This action is provided by the silicon present. Thus, when fluoride is present, it also acts as a catalyst for the polymerization reaction of the acidified bioactive complex. Unlike known technologies, especially Novamin®, NR5 offers a product that does not necessarily require elemental calcium in its composition, given that reactions with these elements occur naturally in the oral cavity. However, calcium supplements can improve the reaction, but are not a prerequisite for promoting the formation of the hybrid layer on the teeth. [Brief explanation of the drawings]

[0030] The present invention will now be described in its preferred embodiment, and for a better understanding, reference is made to the drawings in which: [Figure 1]A. Note the complex pattern formed as a result of EDS of the composition of the present invention. B. Magnification of a cut portion of the actual image: light purple - sodium; violet - fluorine; green - oxygen; blue - silicon; red - carbon; yellow - phosphorus. [Figure 2] EDS is a result of application of the present compositions. A. Actual image; B. Enlarged image. Note the formation of a mineral pattern—calcium (blue) phosphate (pink) rich in silicon (yellow). [Figure 3] In situ images showing hybrid layer formation [Figure 4] An image of the process occurring inside the tooth - inside the dentate tubule of a tooth, showing the closure of the dentate tubule. [Figure 5] Enamel surface without application of the invention (left) and enamel surface brushed with the claimed composition for 1 week. [Figure 6] Graph illustrating pain relief with the use of oral compositions and Novamin® technology. [Figure 7] Scheme showing the visual analogue scale (VAS) for pain. [Figure 8] 1 is an exemplary graph of pH variation associated with use. [Figure 9] 1A and 1B are cross-sections of enamel showing an unbrushed tooth surface and a tooth surface brushed using the present invention, respectively. [Figure 10] Surface images of tooth samples: healthy open dentin tubules simulating dentin sensitivity and dentin pain treated with the present invention, respectively [Figure 11] Comparison of remineralization rates (%SMHR) (different letters indicate statistically significant differences between groups ANOVA, P<0.01). [Figure 12] Absolute values and standard deviations of lesion depth from healthy to caries and from healthy to treated (different letters indicate statistically significant differences between groups ANOVA, P<0.01). [Figure 13]Surface images of tooth samples: healthy enamel, enamel treated with MCBS, enamel treated with the present invention, and enamel treated with the present invention, respectively. [Figure 14] Surface images of tooth samples: healthy enamel, enamel treated with a regenerator, and enamel treated with the present invention. [Figure 15] Scanning electron microscope images at 60,000x magnification of silica-based hybrids synthesized in the laboratory. A. Synthesized in acidic medium. B. Synthesized in basic medium. [Figure 16] Depth image of a tooth sample highlighting the layers formed. The scale is 1 micrometer, divided into 10 parts (100 nanometers each), so no pores can be noticed, only holes due to the displacement of the material during cutting. [Figure 17] Image showing the formation of layers on both dentin and enamel (B). After the brushing period, a light bluish hue was observed (A). [Figure 18] Cross-sectional images showing the depth of a tooth sample, focusing on the layers formed. We note the layers in the 4 to 8 micrometer range, one containing the original formulation and the other with the addition of a calcium supplement - 6% calcium glycerophosphate. [Figure 19] Images of enamel surfaces treated with the present invention in phase 2. One contains the original formulation, the other adds two sources of extra nanoparticulate calcium supplements (tricalcium phosphate and 5% calcium carbonate + F). Detailing to fill the grooves by forming a layer. This relief favors the retention of adhesive restorations / cement. Results obtained from four applications. [Figure 20] Image of an enamel surface treated for one week with the composition described in the invention. Half of the sample was not brushed where the grooves were visible (left side). On the brushed side, the grooves were filled with a mineral layer, demonstrating the regenerative effect of the invention. [Figure 21]Cross-section of dentin treated with the composition described in this invention in two stages, one containing the original formulation and the other adding two sources of additional nanoparticulate calcium supplements (tricalcium phosphate and 5% calcium carbonate). Detail showing the filling of the dentin tubules with a robust layer formation (up to 10 micrometers). Up to 3 micrometers was achieved without a calcium layer. Results of four 5-minute applications. [Figure 22] Image of dentin surface treated with the present invention without fluoride. Detail of filling the dentate tubules. [Figure 23] Images of the buildup of a new enamel layer after one week of use. The top image shows a worn tooth without the use of the technique, while the bottom image shows brushing and rebuilding of mineral loss, with approximately 40% of the minerals recovered after one week of use. DETAILED DESCRIPTION OF THE INVENTION

[0031] The present invention relates to three variations of the composition, available in a single phase or in phases separated by a physical barrier. These may be in a single container, encapsulated, or in separate containers, and their components may be present in reduced size or nanometer scale. Presentations may be in the form of, but are not limited to, powder, liquid, cream, gel, mouthwash, tablet, chewing gum, or foaming dentifrice. The three proposed variations, application examples, and their manufacturing processes are described below. · Variation 1: A commercial variation consisting of phases 1, 2, and 3 as follows: 0.01-30% of phase 3 + 0.5-40% of phase 2 + 30-60% of phase 1. · Variation 2: A variation for home and commercial use consisting of phases 1 and 2, with 0.5-70% of phase 2 + 30-99.5% of phase 1. · Variation 3: A variation for home and everyday use that consists of only Phase 1 and is 100% Phase 1.

[0032] For Variation 1 application, a dental professional applies the 3-phase composition directly to the teeth via a syringe with an applicator, waits 10–20 seconds, and then rinses the surface with water for 20–60 seconds. Next, Phase 2 and Phase 1, previously mixed in the dental office, are applied directly to the teeth in ratios ranging from 1 / 2, 1 / 1, or 2 / 1, but not limited to these ratios, using a spatula or other application tool. To apply Variation 2, the patient opens the container containing Phase 2 and dispenses a pea-sized amount onto the toothbrush. This procedure is then repeated with the container containing Phase 1. Immediately after applying the Phase 1 and Phase 2 oral compositions to the toothbrush, the patient should brush for 1–3 minutes, expelling any foam and excess, without the need for rinsing. To apply Variation 3, the patient opens the container and dispenses a pea-sized amount onto the toothbrush. Immediately after applying the Phase 1 and Phase 2 oral compositions to the toothbrush, brush your teeth for 1-3 minutes, expelling any excess foam and excess material without the need for rinsing. In one embodiment, an oral composition with a synergistic association of organic and inorganic components can be composed of three phases. These three phases are physically separated by layers, encapsulation, and / or different packaging so that the components do not interact with each other before becoming active in the mouth. This means that the components are not neutralized and inactivated. Phase I: A main base composition containing an acidified bioactive complex with or without fluoride, pigments, dyes, and silicon sources, which may or may not have a whitening effect. Phase II: A mixture of organic and / or inorganic activators with calcium (micro- and / or nanoparticles) and / or other agents, such as antibacterial agents, remineralizing agents (arginine), bleaching agents; a phase acidified to a slightly alkaline pH by adding acids and / or phosphates or other pH adjusters; Phase III: A gel acidified with acid and thickened with silica, pH 2-4.

[0033] Since composition variation 3 is presented in a single container, it must be physically separated by an inert layer, such as glycerin or a single composition with or without active fluoride, or by encapsulation of phases 1 and 2 dispersed in an inert matrix, with or without active fluoride.

[0034] In the preparation of the oral composition, the components may or may not be on the nanometer scale, first all the components of the oral composition are separated and weighed according to Table 4 below:

[0035] [Table 4] TIFF0007725025000008.tif145148 TIFF0007725025000009.tif166156 Table 4: Ingredients used to obtain the oral composition.

[0036] Below are examples of formulations and processes for obtaining each of the phases that make up the three variations of the claimed composition.

[0037] Table 5 below shows an example of a Phase 1 formulation of the composition and describes the process of obtaining it.

[0038] [Table 5] Table 5: Components present in the Phase 1 formulation.

[0039] To obtain the formulation of phase 1 of the composition, a "premix" is prepared, which results in a glycerin + CMC base. For this purpose, the following ingredients are used: Carboxymethylcellulose in the formulation at a rate of 0.7-1.0% w / w; Glycerin at a ratio of 45-55% w / w of the formula.

[0040] Carboxymethylcellulose is added to the glycerin at 45,000-200,000 rpm at 25°C for 10-30 minutes with slow stirring to prevent lumps from forming, resulting in a glycerin + CMC base mixture. Next, 0.1-7% deionized water is added to the reactor, and the turbine, anchor, and impeller are activated. Salts are then added to the reactor: sodium fluoride at 0-1% w / w; sodium saccharin at 0.5-5% w / w; sodium benzoate at 0.1-1% w / w; xylitol at 0.5-5% w / w; and tetrasodium pyrophosphate at 0.5-40% w / w. The mixture is homogenized under the above conditions for 5-20 minutes.

[0041] Next, add the humectant sorbitol at 40-70% w / w of the formula, PEG-600 at 40-70% w / w of the formula, and the previously prepared base glycerin + CMC at 50-55% of the formula. Then, apply a vacuum at 600 mmHg and homogenize under the above conditions for 5-20 minutes. After homogenization, turn on the vacuum and slowly add the thickening silica at 7-15% w / w of the formula at 10-15 minute intervals, followed by the abrasive silica at 7-15% w / w of the formula. Homogenize with the vacuum on for 1-3 hours.

[0042] After this period, while maintaining the vacuum, add sodium lauryl sulfate at 5-15% w / w of the formula, followed by homogenization for 5-20 minutes. Next, add triclosan, previously dissolved in menthol, at 0.1-1% w / w of the formula, so that it is present at 1-5% w / w of the formula, followed by homogenization for 5-20 minutes. Finally, add orthophosphoric acid at 0.8-1.5% of the formula, again with the vacuum on, followed by homogenization over a period of 3-5 hours to obtain Phase 3, which can be applied separately from Phase 1 of the composition.

[0043] Table 6 below lists an example of a Phase 2 formulation for a calcium-containing composition, followed by a description of the manufacturing process.

[0044] [Table 6] Table 6: Components present in the Phase 2 formulation.

[0045] To obtain phase 2, a "premix" is first prepared, from which a glycerin + CMC base is obtained. For this purpose, the following components are used: Carboxymethylcellulose in the formulation at a rate of 0.7-1.0% w / w; Glycerin at a ratio of 45-55% w / w of the formula.

[0046] Carboxymethylcellulose is added to the glycerin at 45,000-200,000 rpm at 25°C for 10-30 minutes with slow stirring to prevent lumps from forming, resulting in a glycerin + CMC base mixture. Next, 0.1-7% w / w of deionized water is added to the reactor, and the turbine, anchor, and impeller are activated. The following ingredients are then added to the reactor: sodium saccharin (0.5-5% w / w of the formulation); sodium benzoate (0.1-1% w / w of the formulation); citric acid (2-5% w / w of the formulation); and xylitol (0.5-5% w / w of the formulation). The mixture is then homogenized under the above conditions for 5-20 minutes. Next, add the humectant sorbitol at 40-70% w / w of the formula, PEG-600 at 40-70% w / w of the formula, and the previously prepared base glycerin + CMC at 50-55% of the formula. Then, apply a vacuum at 600 mmHg and homogenize under the conditions described above for 5-20 minutes. After homogenization, turn on the vacuum and slowly add the thickening silica at 7-15% m / m of the formula at 10-15 minute intervals. Mix the calcium carbonate mixture with the tricalcium carbonate at 70-80% and the phosphate at 20-30% of the formula at 0.1-5% w / w. Homogenize with the vacuum on for 1-3 hours. After this period, add sodium lauryl sulfate at 5-15% w / w of the formula while maintaining the vacuum. Then, homogenize for 5-20 minutes. Next, triclosan, previously dissolved in menthol, is added at a ratio of 0.1 to 1% w / w of the formulation, or 1 to 3% w / w of the formulation. This is then homogenized for 3 to 20 minutes. Finally, a pH corrector, which can be monobasic phosphate, dibasic phosphate, or citric acid, is added as needed. The ratio is approximately 2 to 5% w / w of the formulation, and the pH is adjusted to 4.5 to 5.5, again with the vacuum turned on, followed by homogenization for 0.5 to 1 hour, completing Phase 2. Composition Variation 2 can be applied in conjunction with Phase 1, or Variation 1 can be applied in conjunction with Phases 1 and 2.

[0047] Table 7 below lists an example of a Phase 3 formulation of a calcium-containing composition, followed by a description of its manufacturing process.

[0048] [Table 7] Table 7: Components present in the Phase 3 formulation.

[0049] To obtain phase 3, characterized as a phosphoric acid gel, a "premix" is prepared in which glycerin + CMC base is obtained, for this purpose the following is used: Carboxymethylcellulose in the formulation at a rate of 0.7-1.0% w / w; Glycerin at a ratio of 45-55% w / w of the formula.

[0050] Carboxymethylcellulose is added to the glycerin at 45,000-200,000 rpm at 25°C for 10-30 minutes while stirring slowly to prevent lumps from forming, resulting in a glycerin + CMC base mixture. Next, 0.1-7% w / w of deionized water is added to the reactor, and the turbine, anchor, and impeller are activated. After homogenization, the vacuum is turned on and thickening silica is slowly added at 5-25% w / w of the formula at 10-15 minute intervals, followed by blue dye at 1-0.3% w / w of the formula. Homogenization continues for 1-2 hours with the vacuum on. Finally, citric acid is added at 5-40% w / w of the formula, and the pH is adjusted to approximately 2, again with the vacuum on. This is followed by 0.5-1 hour of homogenization, forming Phase 3. Composition Variation 1, related to Phases 1 and 2, can be adapted by experts.

[0051] Table 8 below shows a summary of the properties of the oral composition in any of its three variations.

[0052] [Table 8] Table 8: Characteristics of the oral compositions obtained with any of its variants.

[0053] In this description, the use of the singular includes the plural unless otherwise specified. For example, the term "sodium ion source" includes the use of multiple sodium ion sources, as well as their complexes or ionized forms. The term "non-aqueous" used herein refers to the use of little or no water in the formulation; this explanation is necessary to distinguish it from the aqueous (oral environment) in which the present invention operates. The formulation examples described for each phase are illustrative and not limiting; ultimately, such formulations may contain other components, such as fluoride. Furthermore, it is important to note that any of the three variations can be alternatively supplemented with calcium salts, preferably calcium glycerophosphate, calcium carbonate, and tricalcium phosphate, using a proportion of 0.001 to 10% w / w of the composition. The oral compositions described herein follow a process that obtains a silicon-based polymer in its structure that contains little or no water in an acidic medium. This is the use of all silicon-containing compounds, preferably all forms of silica, and preferably amorphous silica among silicas due to its low cost. State-of-the-art processes use silicon compounds such as bioglass, silicates, mesoporous silica, functionalized silica, and specially developed silicas, making this process low-cost. These oral compositions, or silicon-based composites, are obtained by adding metal or nonmetal salts, as well as organic compounds, during their preparation. The formation of silicon-based composites can be detected through mapping analysis using EDS-Energy Dispersive Spectroscopy (Figure 1). Their action begins immediately after the composites come into contact with the oral cavity (aqueous medium). More specifically, the reaction occurs within the tooth structure, and application of this invention triggers environmental and dental acidification, triggering an acid attack that releases tooth components, specifically calcium and phosphate.Silicon-based complexes are electrochemically attracted to the tooth surface, attaching to it and promoting the growth of polymer chains, capturing negative and positive ions, organic and inorganic molecules. This process of "trapping," primarily calcium, raises the pH at the interface to alkaline levels, resulting in the condensation and formation of "ripened" calcium phosphate, a mineral known as calcium phosphate. This "ripening" of calcium phosphate is known as the formation of hydroxyapatite, confirmed by the EDS Ca / P ratio, approximately 1.64 atomic number, very close to the ideal 1.67. However, the formed hydroxyapatite is not pure. If it were, it would dissolve in an acidogenic test, with a pH of approximately 5.5. Therefore, in this invention, the formation of an insoluble complex rich in silicon and likely containing fluoride occurs (Figure 2). Continued use of this invention promotes the formation of an increasingly robust, active, compact, low-porosity, and resistant layer on the tooth structure (in situ) (Figure 3). This is possible because the successive formation of layers is achieved by "polishing / preparing" previously deposited layers. The reaction is accelerated by rubbing the composition onto the existing structure, i.e., by applying an acidified and highly reactive composition with the help of a toothbrush or other means. The basicity is higher between the tooth and the formed layer, while the medium is acidic, further precipitating the layer. This is probably due to the free calcium present in the tooth and saliva, which, in addition to increasing the pH at the interface, also accelerates the polymerization / condensation of the layer.

[0054] Because layer condensation depends on the availability of calcium and phosphate in the medium, the primary source of these components in the oral environment is enamel. In this sense, greater layer thicknesses were found on this tissue (approximately 6–20 micrometers). Even with mineralization, layers up to 3 micrometers thick were found on dentin before the use of the claimed composition. The lack of calcium and phosphate sources for layer formation in dentin was overcome by supplementing the calcium and phosphate sources. Calcium salts and phosphate salts were added to the composition during the preparation of Phase II, so the compounds did not react before application. As a result, the layer thickness increased to approximately 6–10 micrometers (Figure 5). As the composition was used, a hybrid layer with the ability to bind organic / inorganic compounds was formed and released only when needed. These components consist of antibacterial agents, enhancers, remineralizers, and desensitizers. The layer's adhesion to the organic portion occurs through carbon-containing compounds, whose incorporation effect is provided by formulation components, including PEG, which may also be linked to surfactants (e.g., sodium lauryl sulfate), which provide elasticity and stability.

[0055] Below are presented some studies that have been carried out with the above oral composition (C) and are claimed in this application.

[0056] <Clinical research> A double-blind, randomized clinical trial was conducted to evaluate the product's ability to reduce pain in patients with tooth sensitivity and the need for periodontal treatment. T1: pain before periodontal treatment; T2: pain after periodontal treatment; T3: pain after 1 week of oral composition (C); T4: pain after 2 weeks of use; T5: pain after 3 weeks of use; and T6: pain after 4 weeks of use. While preliminary results did not show statistically significant differences between groups, the initial pain level for patients using the present invention was higher, while the pain level for patients using Novamin® was equal. It can be stated that the present invention was more effective at reducing pain than commercially available products (Figure 6). A 12-year-old child with molar incisor hypomineralization (MIH) complaining of frequent pain caused by dentin hypersensitivity used the ElmexSensitive® product for 30 days, and her pain decreased from an average of 10 to 7 on a pain scale (0-10). The same patient also began using the present invention, and after 30 days of use, her initial average pain level decreased from 8 to 1, as shown in Figure 7. To verify the behavior of the compositions during use, pH analysis was performed. Both the oral composition and another composition with the same acidified pH were used. In this study, patients used the gel and noticed a change in pH while brushing their teeth. The results are shown in Figure 8. The blue bar indicates that the gel with an acidified pH of 4.5, as described in BR102013006807-1 above, does not remain acidic for a long period of time but is quickly neutralized by saliva. The orange bar indicates that the use of oral composition (C) described in this invention resulted in a gradual increase in pH, eventually becoming slightly acidic within 1 minute, still below the baseline data. The results are highly desirable considering the polymer precipitation reaction followed by condensation and the formation of a hybrid layer, which occurs in both aqueous and acidic media.

[0057] <Laboratory Research> Bovine enamel blocks were prepared and demineralized. Subsequently, each half was coated with enamel, and the exposed areas were brushed with the oral composition described in this invention. Scanning electron microscopy (SEM) and energy dispersive spectroscopy (EDS) (Figure 8) verified the deposition and composition of the hybrid layer formed by the oral composition described. Tables 9 and 10 show the composition of the enamel before and after application of the oral composition. The same study was performed on bovine dentin (Figure 9) and observed to show the same effect.

[0058] [Table 9] Table 9: EDS-demineralized enamel

[0059] [Table 10] Table 10: Brushed enamel-hybrid layer compositions with EDS-oral composition (C).

[0060] In another study, 10 previously prepared and demineralized bovine enamel samples per group (Regenerate®, Sensodyne Repair® atProtect, Colgate Daily Repair® and oral composition (C) described in this invention) were subjected to a simulated oral environment for 1 week.

[0061] During the experiment, the surface hardness of the blocks was measured before demineralization (baseline), then the blocks were demineralized and a new hardness measurement was performed. After the second measurement, the blocks were brushed with each toothpaste using a brushing machine for one week. After this process, a third hardness measurement was performed after brushing the blocks. As shown in Figure 10, the oral composition described in this invention far outperformed other toothpastes in terms of remineralization levels after just one week. The second measurement was performed using a QLF device that quantifies minerals using light. The results showed that the oral composition significantly remineralized demineralized dental tissue, far superior to other toothpastes, restoring approximately 50% of the lost minerals after just one week of use (Figure 12). Another study, unprecedented results in the state of the art, evaluated its ability to protect dental enamel. A toothpaste based on a mesoporous calcium silicate biomaterial (Regenerate® Tooth Gel) and the oral composition described in this invention were used for one week. Both products formed a protective layer after one week of use (Figure 13). After treatment, samples were immersed in 50% citric acid for two minutes to simulate the process of tooth erosion. This erosive challenge, accelerated by citric acid, is the same acid found in lemons, oranges, etc. After the challenge formed a clear erosion-like abrasion, the process was verified as healthy tooth enamel. The enamel treated with Regenerate® Cream likely achieved limited protection of the enamel structure, as seen in Figure 14, but was clearly unable to withstand the challenge.

[0062] Unlike what happened with tooth enamel brushed with the oral composition (C) described in this study, the layer structure remained virtually unchanged, with the underlying enamel remaining intact (Figure 14). The hybrid layer formed by this study (Figure 15A) is a thicker layer with a higher height, more resistant, and unprecedented. It formed in an acidic medium, is microporous, and therefore difficult to penetrate. Unlike enamel treated with Regenerate®, it formed a larger, thinner, mesoporous layer (Figure 15B) with smaller pore sizes, likely allowing acid penetration and dissolution of the enamel. Thus, upon gelation in an acidic medium, the chains bond to form a polymeric gel (Figure 16). This produces, after drying, a compact matrix known as micropores, with a small pore volume and generally less than 2 nm in diameter (Benvenutti, 2009). In another study, enamel and bovine dentin blocks were prepared and brushed with the present invention for one week, substituting blue silica for the white silica.

[0063] A layer formed on both the dentin and enamel. After the brushing period, a bluish hue and bleaching were confirmed (Figure 17A). The tooth whitening effect could be confirmed using a spectrophotometer, and good results were obtained. Therefore, based on the results, it is possible to confirm that a layer capable of providing optical whitening effects was formed (Figure 17B). In Figures 18-22, details of the hybrid layer formed using the oral composition can be noticed. In Figure 23, the construction of a new enamel-like layer can be observed after one week of using the oral composition.

[0064] Thus, the present invention is an acidifying bioactive complex obtained from the combination of ingredients including salts, organic compounds, silicon, and phosphates. Because it is an acidifying composition, once the product is applied to the mouth, it lowers the oral pH to approximately 5.5. Thus, the present invention acid-etches the tooth structure, releasing primarily calcium and phosphate ions into the oral environment. At the same time, the bioactive complex is electrochemically attracted to the tooth, bonding to it and collecting dispersed particles and ions, precipitating them and transforming them into a hybrid layer containing silicon-rich hydroxyapatite.

[0065] It is important to note that a hybrid layer can still be formed by any type of calcium phosphate-based ion and compound, especially apatites. The hybrid layer remineralizes the tooth enamel surface, acting as a protective shield for the tooth and mimicking the original enamel, acting against the acidic challenges of everyday life when the dentin is exposed. This layer obliterates the dentin tubules, alleviating pain caused by dentin sensitivity. Furthermore, the composition is a protective agent against cariogenic, microbial processes, and acid exposure, even at pH levels below 4.5. The layer formation occurs in a self-regulating manner; each time a variation of the oral composition is used, a new layer forms on top of the previous one.

[0066] The inventiveness of this application lies precisely in the formation of minerals in an acidic medium, exactly the same environment in which minerals are lost, for example, the solubilization of hydroxyapatite occurs at a pH below 5.5, allowing the formation of a hybrid layer and the action of the product to promote the overall maintenance of oral health.

[0067] In view of the above, it is observed that oral compositions having a synergistic association of organic and inorganic compounds, their method of obtaining and use are deserving of the privilege of patent for invention.

Claims

1. 1. An oral composition involving a synergistic association of organic and inorganic components, wherein the components are divided into three phases (Phase 1, Phase 2, and Phase 3) and can be combined in three variations (Variation 1 for professional use, Variation 2 for home and professional use, and Variation 3 for home and daily use), wherein the components are: - humectants: in a proportion of between 40 and 70% w / w of the composition; chosen from PEG 600, PEG 400, glycerin, sorbitol, alone or in combination; - Thickening agents: in a proportion of between 5 and 30% w / w of the composition; including thickening silicas, optionally including carboxymethylcellulose or xanthan gum, alone or in combination; deionized water: in a proportion of between 0.1 and 7% w / w of the composition; Fluorides, in a proportion of 0-1% w / w of the composition, selected from the following: stannous fluoride, sodium fluoride, potassium fluoride, sodium monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate, amine fluorides (e.g., N'-octadecyltrimethyldiamine-N,N,N'-tris(2-ethanol)-dihydrofluoride), ammonium fluoride, titanium fluoride, hexafluorosulfate, and combinations thereof; Sweeteners: in a proportion of 0.5-5% w / w of the composition; selected from sodium saccharin and xylitol. Preservatives: in a proportion of 0.1 to 1% w / w; selected from sodium benzoate, methylparaben, parabens; Remineralizing, desensitizing and catalytic salts: in a proportion of 0.1 to 10% w / w of the composition; selected from sodium, calcium, potassium, iron, zinc, tin, magnesium, titanium, aluminum and / or copper ions. Abrasives: in a proportion of 3 to 18% w / w of the composition; selected from calcium carbonate abrasives, sodium abrasives, silica abrasives. surfactants: in a proportion of 5 to 15% w / w of the composition; chosen from sodium lauryl sulfate, sodium alkyl sulfate, sodium lauroyl sarcosinate, cocoamidopropyl betaine and polysorbates, and combinations thereof; Disinfectants: in a proportion of 0.1-1% w / w of the composition; halogenated diphenyl ethers, triclosan, herbal extracts, essential oils, rosemary extract, tea extract, magnolia extract, thymol, menthol, eucalyptus, geraniol, carvacrol, citral, hinokiitol, catechol, methyl salicylate, epigallocatechum gallate, epigallocatechum, gallic acid, miswak, sea buckthorn extract, bisguanide preservatives, chlorhexidine, alexidine or octenidine, quaternary ammonium compounds, cetyltrilidium chloride (CPC), Benzalkyl chlorides, tetradecylpyridinium chloride (TPC), N-tetradecyl-4-ethypyridinol chloride, N-tetradecyl-4-ethypyridinol chloride, octenidine, sanguinarina, povidone iodide, delmopinol, salifluor, estanoic acid salts, copper salts, iron salts, sanguinarina, propolis and oxygenators, hydrogen peroxide, buffered sodium peroxyborate or peroxycarbonate, phthalic acid and its salts, monoperthalic acid and its salts and esters, ascorbyl stearate, oleoyl sarcosine, alkyl sulfates, dioctyl sulfosuccinate sulfate, salicylanide, domiphen bromide, delmopinol, octapinol and other piperidine derivatives, herring preparations, chlorite serate or mixtures of any of the above; Flavoring agents: in a proportion of 1-5% w / w of compositions selected from essential oils (mint, spearmint, peppermint, lemongrass, clove, sage, strawberry, grape, eucalyptus, marjoram, cinnamon, lemon, rosemary-pepper, orange), as well as aldehydes, esters, alcohols and similar flavoring materials; pigments / dyes: in a proportion of 0.1 to 10% w / w of the composition; may be organic or inorganic, peroxides, superoxides, oxygen-generating agents and ingredients for photobleaching, such as all dyes and pigments, selected from organic and inorganic, acting in the blue-violet spectrum and reflecting white light, mica and silicon-containing compounds; pH correctors: in a proportion of 0.5 to 40% w / w of the composition; selected from basic (sodium phosphate - mono- and di-) and acid (phosphoric acid, citric acid, maleic acid); - calcium source: in a proportion of 0.001 to 10% w / w of the composition; selected from calcium glycerophosphate, calcium carbonate and tricalcium phosphate; Amino acids: in a proportion of 0-10% w / w of the composition; arginine, lysine citrulline, ornithine, creatine, histidine, diaminobutanoic acid, diaminoproprionic acid, salts and / or combinations thereof, or any amino acid having a carboxyl group and a water-soluble amino group available in aqueous solution at a pH of about 7 or less; Orthophosphoric acid: in a proportion of 0-40% w / w of the composition; Tetrasodium pyrophosphate in a proportion of 0.5-40% w / w of the formulation. The phase 1 characterized comprises: - thickening silica in a proportion of 7-15% w / w of the formulation and carboxymethylcellulose in a proportion of 0.7-1.0% w / w of the formulation; - glycerin in a proportion of 45-55% w / w of the formulation, and / or sorbitol in a proportion of 40-70% w / w of the formulation, and / or PEG-600; - sodium fluoride in a proportion of 0-1% w / w of the formulation; sodium saccharin in a proportion of 0.5 to 5% w / w of the formulation, and / or xylitol in a proportion of 0.5 to 5% w / w of the formulation; - sodium benzoate in a proportion of 0.1-1% w / w of the formulation; Tetrasodium pyrophosphate in a proportion of 0.5-40% w / w of the formulation; - abrasive silica in a proportion of 7-15% w / w of the formulation; sodium lauryl sulfate in a proportion of 5-15% w / w of the formulation; Triclosan at a rate of 0.1-1% w / w of the formulation; -Menthol in a proportion of 1-5% w / w of the formula. The phase 2 is characterized by: Carboxymethylcellulose in a proportion of 0.7 to 1.0% w / w of the formulation, and / or thickening silica in a proportion of 7 to 15% w / w of the formulation; - sorbitol, and / or PEG-600, in a proportion of 40-70% w / w of the formulation, and / or glycerin, in a proportion of 45-55% w / w of the formulation; - sodium saccharin, in a proportion of 0.5-5% w / w of the formulation; - sodium benzoate in a proportion of 0.1-1% w / w of the formulation; xylitol in a proportion of 0.1-5% w / w of the formula; - citric acid in a proportion of 2-5% w / w of the formulation; - a mixture of 70-80% calcium carbonate and 20-30% micronized tricalcium phosphate in a proportion of 0.5-5% w / w of the formula; sodium lauryl sulfate in a proportion of 5-15% w / w of the formulation; Triclosan at a rate of 0.1-1% w / w of the formulation; - menthol in a proportion of 0.5-3% w / w of the formulation; pH corrector, which can be monobasic phosphoric acid, dibasic phosphoric acid, or citric acid, at 2-5% w / w of the formulation. The Phase 3 characterization comprises: Carboxymethylcellulose in a proportion of 0.7 to 1.0% w / w of the formulation, and / or thickening silica in a proportion of 5 to 25% w / w of the formulation; - glycerin in a proportion of 45-55% w / w of the formula; - blue dye in a proportion of 0.1-0.3% w / w of the formulation; - Phosphoric acid in a proportion of 5-40% w / w of the formulation. The commercial variation 1 is made up of the phases 1, 2 and 3, the home and commercial variation 2 is made up of the phases 1 and 2, and the home and everyday variation 3 is made up of only the phase 1.

2. The oral composition with a synergistic association of organic and inorganic components according to claim 1, in three variations thereof: Variation 1: A commercial variation consisting of phases 1, 2, and 3 as follows: 0.01-30% of phase 3 + 0.5-40% of phase 2 + 30-60% of phase 1. Variation 2: A variation for home and commercial use consisting of phases 1 and 2, with 0.5-70% of phase 2 + 30-99.5% of phase 1. Variation 3: Consists of Phase 1 only, 100% Phase 1, for home and everyday use Variations in use.

3. An oral composition with a synergistic association of organic and inorganic components according to claim 2, characterized by a pH range of 2 to 5.

5.

4. An oral composition with a synergistic association of organic and inorganic components according to claim 1 or 2, characterized by the components being able to be presented in a micronized form on the nanometer scale.

5. An oral composition with a synergistic association of organic and inorganic components according to claim 1 or 2, characterized in that, in a completely acidic medium, it is electrochemically attracted to the teeth, adheres to them, causes the ionization of calcium present in its structure, starts to collect particles dispersed in the oral environment, condenses from calcium and other ions present in the environment, and gives rise to a hybrid layer containing silicon-rich hydroxyapatite.

6. 6. An oral composition with a synergistic association of organic and inorganic components as claimed in claim 5, characterized in that it produces in situ a hybrid layer comprising silicon-rich hydroxyapatite that adheres to tooth structure.

7. An oral composition with a synergistic association of organic and inorganic components as described in claim 5, characterized by its action in an aqueous medium (mouth) and characterized in that its pH there is between 5.5 and 7.

5.

8. An oral composition with a synergistic association of organic and inorganic components according to claim 1 or 2, characterized in that calcium salts are supplemented using a proportion of 0.001 to 10% w / w of the composition, optionally calcium glycerophosphate, calcium carbonate and tricalcium phosphate.

9. Oral composition with a synergistic association of organic and inorganic components according to claim 1 or 2, characterized in that the following are used as sources of silicon: amorphous silica, bioglass, silicates, mesoporous silica, functionalized silica.

10. An oral composition with a synergistic association of organic and inorganic components according to claim 1 or 2, characterized in that the components are present in a single phase, which may be in the same container or encapsulated, phases separated by a physical barrier or in separate containers.

11. An oral composition with a synergistic association of organic and inorganic components according to claim 1 or 2, characterized in that it can be in the form of a powder, liquid, cream, gel, mouthwash, tablet, chewing gum or foaming dentifrice.

12. The process for producing an oral composition with a synergistic association of organic and inorganic components described in claim 1 is characterized in that each phase (Phase 1, Phase 2, and Phase 3) is carried out independently. After separating and weighing the components, carboxymethylcellulose is added at a rate of 0.7-1.0% w / w of the composition to glycerin at a rate of 45-55% w / w of the composition while stirring. The mixture is stirred at 25°C and a speed of 45,000-200,000 rpm for 10-30 minutes to obtain a base glycerin + CMC mixture. Next, a total amount of deionized water, 0.1-7% of the total amount of the composition, is added to the reactor, and the turbine, anchor, and impeller are activated. The other components of each phase are then added to the reactor, and the process continues, with minor variations resulting from the components used in each phase. Phase 1: Add sodium fluoride salt at 0-1% w / w of the formula, sodium saccharin at 0.5-5% w / w of the formula, sodium benzoate at 0.1-1% w / w of the formula, xylitol at 0.5-5% w / w of the formula, and tetrasodium pyrophosphate at 0.5-40% w / w of the formula, followed by homogenization for 5-20 minutes under the conditions described above. Next, add the humectant sorbitol at 40-70% w / w of the formula, PEG-600 at 40-70% w / w of the formula, and the previously prepared base glycerin + CMC at 50-55% w / w of the formula. Then, apply a vacuum at 600 mmHg and homogenize under the conditions described above for 5-20 minutes. After homogenization, turn on the vacuum and slowly add the thickening silica at 7-15% w / w of the formula at 10-15 minute intervals. Next, add abrasive silica in the same manner at 7-15% w / w of the formula. Homogenize with the vacuum on for 1-3 hours. After this period, add sodium lauryl sulfate at 5-15% w / w of the formula while maintaining the vacuum. Homogenize for 5-20 minutes. Next, add triclosan at 0.1-1% w / w of the formula, previously dissolved in menthol, so that it is present at 1-5% w / w of the formula. Homogenize for 5-20 minutes. Finally, orthophosphoric acid is added at 0.8-1.5% of the formula and homogenized, also with vacuum on, for 3-5 hours to complete Phase 1. Phase 2: Add saccharin sodium at 0.5-5% w / w of the formula, sodium benzoate at 0.1-1% w / w of the formula, xylitol at 0.5-5% w / w of the formula, and citric acid at 2-5% w / w of the formula, followed by homogenization under the above conditions for 5-20 minutes. Next, add the hygroscopic agent, sorbitol, and PEG-600 at 40-70% w / w of the formula, and the base glycerin and CMC at 40-70% w / w of the formula, totaling approximately 50-55% w / w of the formula. Then, apply a vacuum at 600 mmHg and homogenize under the above conditions for 5-20 minutes. After homogenization, turn on the vacuum and slowly add the thickening silica at 7-15% w / w of the formula at 10-15 minute intervals, and add the calcium source at 0.5-5% w / w of the formula. Homogenize with the vacuum on for 1-3 hours. After this period, while maintaining the vacuum, add sodium lauryl sulfate at 5-15% w / w of the formula. Homogenize for 5-20 minutes. Next, add triclosan, previously dissolved in menthol, at 0.1-1% w / w of the formula, so that it is present at 1-3% w / w of the formula. Homogenize for 3-20 minutes. Finally, a pH corrector is added, which can be monobasic phosphoric acid, dibasic phosphoric acid, or citric acid, as needed, at approximately 2-5% w / w of the formula, again with the vacuum on, to bring the pH to 4.5-5.5, followed by 0.5-1 hour of homogenization to complete Phase 2. Phase 3: With the vacuum on, slowly add and homogenize the thickening silica at 5-25% w / w of the formula in 10-15 minute intervals and add the blue dye at 0.1-0.3% w / w of the formula. Homogenize with the vacuum on for 1-2 hours. Finally, phosphoric acid is added at 5-40% w / w of the formulation and adjusted to around pH 2, also with vacuum on, followed by homogenization for 0.5-1 hour to obtain Phase 3.

13. 13. A process for the preparation of an oral composition with a synergistic association of organic and inorganic components according to claim 12, characterized by acidification of the composition occurring at a pH between 2.0 and 5.5 by the addition of a pH corrector selected from mono- and di-sodium phosphate, phosphoric acid, citric acid, and maleic acid.

14. A process for the preparation of an oral composition with a synergistic association of organic and inorganic components according to claim 12, characterized in that it uses a very small amount of deionized water (A) between 0.1 and 7%.

15. Use of an oral composition with a synergistic association of organic and inorganic components according to claim 1 or 2, characterized in that it is for maintaining complete oral health.

16. Use of an oral composition with a synergistic association of organic and inorganic components according to claim 15, characterized in that it is an anti-decalcifying agent.

17. Use of an oral composition with a synergistic association of organic and inorganic components according to claim 15, applied as a protective agent against cariogenic and microbial processes and exposure to acids with a pH below 4.

5.

17. Use of an oral composition with a synergistic association of organic and inorganic components according to claim 15, characterized by being a regenerating / remineralizing agent.

19. Use of an oral composition with a synergistic association of organic and inorganic components according to claim 15, characterized in that it is optical, chemical and mechanical whitening.

20. Use of an oral composition with a synergistic association of organic and inorganic components according to claim 15, characterized in that it is a protector against erosive processes and reduces tooth sensitivity through the occlusion of dentate tubules.

21. Use of an oral composition with a synergistic association of organic and inorganic components according to claim 15, characterized in that it protects against dental decay.

Images