Oral care agent with dimethylglycine

Abstract

The present invention relates to an oral care agent, in particular an oral care agent for use in the oral cavity, containing dimethylglycine and / or a salt thereof. In addition, the invention relates to use of such an oral care agent for wound healing and / or the prevention and treatment of gum inflammation and / or for the regeneration and vitalisation of the gums and / or for the prevention and treatment of gum bleeding and / or to care for the oral mucosa and / or the gums and / or to stimulate the flow of saliva. In particular, the invention relates to the use of such an oral care agent as a cosmetic.

Description

[0001] Oral care products with dimethylglycine

[0002] The present invention relates to an oral care product, in particular an oral care product for use in the oral cavity, containing dimethylglycine and / or a salt thereof. Furthermore, the invention relates to the use of such an oral care product for wound healing and / or the prevention and treatment of gingivitis and / or the regeneration and revitalization of the gums and / or the prevention and treatment of bleeding gums and / or the care of the oral mucosa and / or the gums and / or the stimulation of saliva flow. In particular, the invention relates to the use of such an oral care product as a cosmetic.

[0003] The gums (Latin: gingiva) are part of the oral mucosa. Among other things, they surround the teeth cervially. The gums surround the neck of the tooth, sealing the point where the tooth enters the jawbone of the oral cavity. The gums thus serve, among other things, to protect and support the tooth.

[0004] The different parts of a natural tooth are the crown, neck, and root, each of which is made up of several layers. Of these layers, only the outer enamel is normally visible, which surrounds the dentin and other layers. Enamel is very hard, making it ideal for biting or grinding food, for example. It consists of approximately 97% by weight hydroxyapatite, which has the following molecular formula: Cas(PO4)3(OH). Dentin is also considered the hard substance of the tooth and is also composed of approximately two-thirds hydroxyapatite. In addition to hydroxyapatite, dentin contains proteins and water and is therefore not as hard as enamel.

[0005] Healthy gums are pale pink and show no signs of bleeding. However, tender, reddish, and swollen gums may indicate disease. Bleeding after flossing or brushing can also be a sign of changes in the oral mucosa.

[0006] In many cases, poor oral hygiene leads to bleeding gums. Bacteria nest in the oral cavity, especially between the teeth and gums, and can lead to inflammation, which manifests as bleeding gums.

[0007] The most common causes of bleeding gums include gingivitis, periodontitis, necrotizing periodontal diseases such as necrotizing ulcerative gingivitis (NUG) and necrotizing ulcerative periodontitis (NUP), hormonal changes during puberty, pregnancy, or menopause, and the use of anti-epileptic medication, immunosuppressants, or antihypertensive drugs. Bleeding gums can also occur as a side effect of diseases such as diabetes mellitus, HIV infection, leukemia, or hemophilia, or can be caused by fungal or viral infections, as well as malnutrition. For example, a vitamin C deficiency can promote bleeding gums, as can a protein deficiency. A lack of fluids can also cause bleeding gums, resulting in less saliva being produced, an imbalance in the oral flora, and a subsequent predisposition to inflammation.

[0008] In gingivitis, bacteria accumulate and multiply in hard-to-reach areas of the mouth. A bacterial coating, also known as plaque, forms on the teeth, causing inflammation, accompanied by bleeding gums and often bad breath.

[0009] If gingivitis is left untreated, the disease can lead to periodontitis, also known colloquially as "periodontal disease." Periodontitis is a bacterial inflammation of the gums that can result in irreversible destruction of the periodontal ligament. It is also triggered by a bacterial coating known as plaque. This usually tenacious bacterial coating or film can also be referred to as biofilm. A hallmark of periodontitis is detectable bone loss, which is reported to be triggered by enzymes designed to destroy the bacterial biofilm. However, these enzymes also lead to the destruction of the body's own tissue, among other things. This can lead to the loss of connective tissue and bone.

[0010] Careful oral hygiene and thorough cleaning with conventional oral care products are not always successful in inhibiting the underlying inflammation and swelling that cause bleeding gums, or in reducing or eliminating them altogether. Furthermore, conventional oral care products cannot improve damage to the periodontal ligament and jawbone caused, for example, by periodontitis.

[0011] US 2004 / 0121025 A1 describes a composition for the systemic treatment of bone loss, comprising a vanadium salt, ipriflavone, at least one homocysteine ​​inhibitor, and an absorbable calcium salt in a pharmaceutically acceptable carrier. The homocysteine ​​inhibitor is intended to block the harmful effects of homocysteine ​​on bone tissue in order to increase the effectiveness of the components for preventing bone loss and promoting bone formation (i.e., vanadium salt and ipriflavone). The homocysteine ​​inhibitor can be dimethylglycine.

[0012] Based on this, the object of the present invention was to provide an agent that can reduce the occurrence of bleeding gums, regenerate and revitalize the gums, and combat gingivitis, and that is suitable for the (cosmetic) care of the oral mucosa and / or gums. Furthermore, this composition should be applicable orally in the oral cavity and overcome the disadvantages of the compositions known from the prior art.

[0013] This object was surprisingly achieved by the composition according to claim 1 and its use according to claims 8-11. Preferred embodiments are set out in the dependent claims.

[0014] According to the invention, the object is achieved by providing an oral care product, in particular an oral care product for use in the oral cavity, which contains dimethylglycine and / or a salt thereof.

[0015] Accordingly, the present invention relates to an oral care product, in particular for use in the oral cavity, containing dimethylglycine and / or a salt thereof.

[0016] The oral care product is a cosmetic, pharmaceutical or medicinal preparation, in particular a cosmetic preparation.

[0017] An oral care product within the meaning of the present invention is understood to mean a solid, semi-solid, or liquid preparation intended for application in the oral cavity and / or pharynx to achieve a local effect there. For the purposes of the present invention, application in the oral cavity and / or pharynx is also referred to as oral application. Accordingly, the oral care product according to the invention is not intended to be swallowed. No significant amounts, and preferably no amount at all, of the oral care product according to the invention should enter the gastrointestinal tract.

[0018] Solid or semi-solid preparations are preferred because they remain in the oral cavity for a longer time than liquid preparations.

[0019] Solid preparations for use in the oral cavity include tablets, in particular chewable tablets, sublingual, buccal and adhesive tablets, as well as chewable capsules and chewing gum.

[0020] Semi-solid preparations for use in the oral cavity include ointments, gels (e.g. mouth gels, gels for periodontal pockets), creams and pastes (e.g. toothpaste).

[0021] Liquid preparations for use in the oral cavity include mouthwashes, gargles, mouth rinses, solutions for application to the gums, solutions and suspensions for use in the oral cavity, drops for use in the oral cavity, sprays for use in the oral cavity and sublingual sprays.

[0022] The oral care agent of the present invention preferably acts only (locally) in the oral cavity.

[0023] The oral care product is preferably in the form of a toothpaste, mouthwash, tablet, chewing gum, oral gel / oral gel, gel for periodontal pockets, or mouthwash. The oral care product is particularly preferably in the form of a toothpaste, mouthwash, or oral gel / oral gel.

[0024] A toothpaste, also called toothpaste, can be used for mechanical tooth cleaning and is a soft or semi-solid composition for oral use, especially on the teeth.

[0025] A mouthwash, also known as mouth rinse, is a liquid that can be used, among other things, to prevent tooth decay and other diseases in the mouth.

[0026] A tablet for (local) application in the oral cavity includes chewable tablets, sublingual tablets, buccal tablets and adhesive tablets.

[0027] A mouth gel is a gel-like composition that can be used to treat discomfort / pain, for example, in the oral mucosa, gums, and lips, or to combat dry mouth. The mouth gel is usually applied to the painful area, such as in the case of mouth ulcers.

[0028] Essentially the same applies to a gel for periodontal pockets as to a mouth gel, whereby the gel for periodontal pockets is essentially applied to or applied to the gums and into the pockets formed between the gums and the neck of the tooth.

[0029] In a particularly preferred embodiment, the oral care product according to the invention is in the form of a toothpaste.

[0030] In a further particularly preferred embodiment, the oral care product according to the invention is in liquid form, in particular as a mouthwash. In liquid form, the oral care product according to the invention can be both sprayed and gargled. The liquid oral care product wets the oral mucosa and thus ensures moistening. In a further particularly preferred embodiment, the oral care product according to the invention is in the form of a mouth gel / oral gel. A mouth gel / oral gel has a thick consistency, which has the advantage that it can be applied to the mucous membranes like a protective film and also remains there. This means that the formulation and the active ingredients remain active for an extended period. A mouth gel / oral gel is therefore particularly suitable for overnight use.

[0031] It has surprisingly been shown that the oral care product according to the invention containing dimethylglycine and / or a salt of dimethylglycine exhibits excellent efficacy in gum care and in the prevention and treatment of gum diseases. In particular, the oral care product according to the invention reduces bleeding gums, inhibits inflammation and swelling, regenerates and revitalizes the gums, and stimulates saliva flow. In addition, the oral care product according to the invention containing dimethylglycine and / or a salt of dimethylglycine protects against infections, relieves irritation of the oral mucosa, and promotes wound healing and tissue regeneration.

[0032] The oral care product according to the invention is thus excellently suited for wound healing and / or prevention and treatment of gingivitis and / or for regenerating and revitalizing the gums and / or for preventing and treating bleeding gums and / or for caring for the oral mucosa and / or gums and / or for stimulating saliva flow, even in patients with dry mouth.

[0033] Dimethylglycine (7V,A-dimethylglycine) is found in plants, animals, and humans, although it is only produced in very small amounts in humans. It is formed as an intermediate in a multi-step biosynthesis of glycine from choline through the transamination of betaine with betaine homocysteine ​​methylase.

[0034] A,A-Dimethylglycine, also (dimethylamino)acetic acid, is represented by the following chemical formula 1:

[0035] formula 1

[0036] According to the present invention, it has surprisingly been found that dimethylglycine and / or a salt of dimethylglycine, as a component of an oral care product for use in the oral cavity, is excellently suited for gum regeneration and gum revitalization, as well as for gum care and for the prevention and treatment of gum diseases such as gingivitis or periodontitis, and in particular reduces gum bleeding, inhibits inflammation and swelling, and contributes to wound healing. Furthermore, it has surprisingly been found that dimethylglycine and / or a salt of dimethylglycine can stimulate salivation.

[0037] This was particularly surprising because dimethylglycine and / or a salt of dimethylglycine had not previously been described in the field of dental care / gum care / oral care.

[0038] The invention relates not only to the use of dimethylglycine, but also to its salts, solvates, and hydrates. These are preferably pharmaceutically or cosmetically acceptable salts of dimethylglycine. The salt is particularly preferably a water-soluble salt with a solubility in water of at least 10 g / l at 20°C.

[0039] In a preferred embodiment, the salt of dimethylglycine is an alkali, alkaline earth or ammonium salt of dimethylglycine.

[0040] Examples include sodium, potassium, calcium, magnesium, and ammonium salts. In the ammonium salts, the ammonium cation carries one to four alkyl groups, each independently containing 1 to 4 carbon atoms. Preferred are the sodium and potassium salts of dimethylglycine, especially the sodium salt of dimethylglycine, namely sodium dimethylglycinate (sodium V, A-dimethylglycinate).

[0041] In an alternative preferred embodiment, the salt of dimethylglycine may be the salt of an inorganic and / or organic acid with dimethylglycine.

[0042] Examples of salts of dimethylglycine with an inorganic acid are the hydrochloride, hydrobromide, hydroiodide, hydrogen sulfate, sulfate, hydrogen sulfite, sulfite, hydrogen carbonate, carbonate, monophosphate, diphosphate, and triphosphate of dimethylglycine, as well as mixtures thereof. Particular preference is given to the hydrochloride of dimethylglycine, namely dimethylglycine hydrochloride (AA-dimethylglycine hydrochloride).

[0043] Examples of salts of dimethylglycine with an organic acid are the acetate, lactate, citrate, succinate, fumarate, maleate and benzoate of dimethylglycine and mixtures thereof.

[0044] According to the invention, the dimethylglycine and / or salt of dimethylglycine is preferably selected from the group consisting of dimethylglycine, sodium dimethylglycinate and dimethylglycine hydrochloride.

[0045] It is believed that dimethylglycine and / or a salt of dimethylglycine leads to gum regeneration according to the invention. The composition according to the invention preferably contains dimethylglycine and / or a salt of dimethylglycine in a proportion of 0.00001 wt.% to 10.0 wt.%, based on the total weight of the oral care product. In a preferred embodiment, the composition according to the invention contains dimethylglycine and / or a salt of dimethylglycine in a proportion of 0.00001 wt.% to 5 wt.%, preferably 0.0001 wt.% to 5 wt.%, preferably 0.0001 wt.% to 2.0 wt.%, more preferably 0.0005 wt.% to 1 wt.%, in each case based on the total weight of the oral care product.

[0046] In a preferred embodiment of the invention, the oral care product according to the invention may contain dimethylglycine and / or a salt of dimethylglycine in a proportion of

[0047] 0.00001 wt%, 0.0001 wt%, 0.0002 wt%, 0.0005 wt%, 0.001 wt%, 0.002 wt% or 0.005 wt% to 10 wt%, 5 wt%, 2 wt%, 1 wt%, 0.5 wt%, 0.2 wt%,

[0048] 0.1% by weight, 0.05% by weight, 0.02% by weight or 0.01% by weight, each based on the total weight of the oral care product.

[0049] In a further preferred embodiment of the invention, the oral care product according to the invention may contain dimethylglycine and / or a salt of dimethylglycine in a proportion of about 0.005 wt.% or about 0.01 wt.% or about 0.1 wt.% or about 0.5 wt.% or about 1.0 wt.% or about 2.0 wt.% or about 2.5 wt.% or about 3.5 wt.%, in each case based on the total weight of the oral care product.

[0050] In a further preferred embodiment of the invention, the oral care product according to the invention is a toothpaste containing dimethylglycine and / or a salt of dimethylglycine in a proportion of about 0.005 wt.% or about 0.1 wt.% or about 1.0 wt.% or about 2.0 wt.%, in each case based on the total weight of the oral care product.

[0051] In a further preferred embodiment of the invention, the oral care product according to the invention is a mouthwash containing dimethylglycine and / or a salt of dimethylglycine in a proportion of about 0.01% by weight or about 0.5% by weight or about 2.5% by weight or about 3.5% by weight, in each case based on the total weight of the oral care product.

[0052] The oral care product according to the invention preferably contains dimethylglycine and / or a salt of dimethylglycine as a pure chemical substance, including the respective solvates and hydrates (e.g., the dihydrate of sodium dimethylglycinate), as this increases the purity of the composition and reduces the occurrence of undesirable side effects. For this reason, the oral care product according to the invention preferably contains the chemical derivatives of dimethylglycine, selected from methylglycine, trimethylglycine, (2-hydroxyethyl)-trimethylammonium, and trimethylhydroxybutyrobetaine, in concentrations of less than 0.01 wt.%, based on the total weight of the composition. Particularly preferably, the compositions according to the invention are completely free of these derivatives.

[0053] In a preferred embodiment, the oral care product according to the invention does not contain N-alkyl derivatives of dimethylglycine.

[0054] In a preferred embodiment, the oral care product according to the invention further contains one or more calcium phosphate compounds.

[0055] The calcium phosphate compound is preferably selected from the group consisting of monocalcium phosphate monohydrate (MCPM), monocalcium phosphate anhydrate (MCPA), dicalcium phosphate dihydrate (DCPD, brushite), dicalcium phosphate anhydrate (DCPA, monetite), octacalcium phosphate (OCP), α-tricalcium phosphate (α-TCP), β-tricalcium phosphate (β-TCP), amorphous calcium phosphate (ACP; also known as CPP-ACP complex = casein phosphopeptide - amorphous calcium phosphate), calcium-deficient hydroxyapatite (CDHA), hydroxyapatite (HA or HAP), tetracalcium phosphate (TTCP), and calcium pyrophosphate. The calcium phosphate compound is particularly preferably hydroxyapatite.

[0056] The calcium phosphate compound, especially hydroxyapatite, remineralizes tooth enamel and is therefore effective in caries prevention. In addition, the calcium phosphate compound, especially hydroxyapatite, protects against sensitive teeth.

[0057] Hydroxyapatite has the chemical formula Cas(PO4)3(OH) and is also known as hydroxyapatite. It is a mineral from the phosphate mineral class that crystallizes in a hexagonal crystal system. Hydroxyapatite is also a member of the apatite group and forms a continuous mixed series with chlorapatite and fluorapatite.

[0058] The hydroxyapatite contained in this oral care product is preferably synthetically produced. This means that the hydroxyapatite used is preferably not obtained by cauterizing the organic components from animal material, such as bone.

[0059] In a preferred embodiment, hydroxyapatite is present in pure form. According to the invention, a pure form is present precisely when the ions contained in the hydroxyapatite (Ca 2+ , PO4 3 and OH') are each less than 1%, preferably less than 0.5%, more preferably less than 0.1% substituted by one or more other ions. For example, in pure hydroxyapatite, the Ca 2+ -ions by, for example, Mg 2+ or Zn 2+ and the OH' ions are substituted, for example, by fluoride or chloride to less than 1%, preferably less than 0.5%, more preferably less than 0.1%.

[0060] Thus, the composition according to the invention comprises (pure) hydroxyapatite (Cas(PO4)3(OH)) as the sole apatite component. It has been shown that by using hydroxyapatite as the apatite component, the addition of fluorides such as CaF2 and / or fluorapatite, which have previously been used, for example, to harden tooth enamel and combat caries, can be dispensed with in the present oral care product. This completely avoids the negative effects currently being discussed in connection with fluoride-containing dental care and oral products. One of these negative effects is cited as fluorosis, which results from excessive fluoride intake and triggers symptoms such as nausea, vomiting, and diarrhea.Further examples include bone fluorosis, which is characterized by thickening of the outer bone layer and the associated loss of bone elasticity and resilience, and enamel fluorosis, which is recognizable by the appearance of whitish enamel spots on the tooth surface. It has also been reported that swallowing high-dose dental care products, especially in children, can trigger acute fluoride poisoning, which can occasionally even be fatal. Furthermore, it has been reported that the WHO is unable to establish a daily fluoride requirement because fluoride is not an essential trace element, and therefore there are no diagnostic parameters and no evidence for the existence of clinical symptoms of "fluoride deficiency."

[0061] Furthermore, the oral care product according to the invention comprises the calcium phosphate compound, in particular hydroxyapatite, preferably in a particulate form, i.e., the calcium phosphate compound, in particular the hydroxyapatite, is preferably present in particulate or particle form. It is preferably a micro- and / or nanoparticulate calcium phosphate compound, preferably micro- and / or nanoparticulate hydroxyapatite.

[0062] The Xso value of the volume-based particle size distribution Qs(x) of hydroxyapatite is 1 to 100 nm in the case of nanoparticulate hydroxyapatite and more than 100 nm in the case of microparticulate hydroxyapatite, whereby the Xso value of the volume-based particle size distribution is measured by laser diffraction. Preferably, the Xso value of the volume-based particle size distribution Qs(x) of the hydroxyapatite is 1.0 nm to 100.0 pm, preferably 10 nm to 10 pm, more preferably 50 nm to 5 pm, particularly preferably 100 nm to 5500 nm. Very particular preference is given to microparticulate hydroxyapatite with a volume-based particle size distribution of 1.0 to 15.0 pm, in particular 1.2 to 12.0 pm or 1.5 to 10.0 pm, and most preferably 2.0 to 5.0 pm, wherein the Xso value of the volume-based particle size distribution is measured by means of laser diffraction.

[0063] For this purpose, a hydroxyapatite sample is first subjected to ultrasonic irradiation in an ultrasonic homogenizer with an energy output of 96 W for 9 minutes, followed by a further 3 minutes in a sample preparation device. The subsequent particle size distribution measurement (laser diffraction) is performed in a particle size determination instrument at a temperature of 25°C ± 0.3°C, and the corresponding values ​​are calculated according to Mie theory. All measuring instruments used are commercially available. In a preferred embodiment of the invention, the hydroxyapatite has a hexagonal crystal lattice in which the length of the a-axis is 0.930 to 0.950 nm, preferably 0.933 to 0.948 nm, particularly preferably 0.936 to 0.945 nm and the length of the c-axis is 0.680 to 0.700 nm, preferably 0.682 to 0.696 nm, particularly preferably 0.685 to 0.692 nm.The a-axis and c-axis lengths are determined by Rietveld analysis of the corresponding X-ray powder diffractograms. The X-ray powder diffractograms themselves are obtained by measurement with a conventional powder diffractometer at routine settings.

[0064] It is further preferred that the hydroxyapatite used according to the invention has a largely spherical crystal morphology. In particular, it is preferred that the hydroxyapatite does not have a needle-shaped crystal morphology. Such a needle-shaped crystal morphology could entail undesirable disadvantages, similar to those of asbestos.

[0065] In a preferred embodiment, the hydroxyapatite is present in aggregated form. Aggregation in this case refers to the aggregation of molecules or particles into a larger structure, the aggregate. This aggregation or aggregate is caused and held together by various forces and / or bonding types, such as ionic bonds, van der Waals forces, intermolecular forces, or other chemical bonding types. The degree of aggregation and the size of the aggregate can be determined using scanning electron microscopy. It is preferred that no nanoparticles can be detected in hydroxyapatite in aggregated form, even after high energy input. Nanoparticles are defined as particles with a size of less than 100 nm.With regard to nanoparticles, it is not yet known whether they can have an adverse effect on humans, for example after possible penetration of the intestinal wall.

[0066] A hydroxyapatite suitable according to the invention is described, for example, in the application DE 10 2016 114 189.5.

[0067] A hydroxyapatite suitable according to the invention is available, for example, under the name KALIDENT 100 1st B (PF210715G1) or KALIDENT POWDER 100-B (PF210715G4) from Kalichem Italia srl, Rezzato, Italy.

[0068] The oral care product according to the invention preferably contains one or more calcium phosphate compound(s), preferably hydroxyapatite, in an amount of 0.01 to 40% by weight, preferably 0.1 to 30% by weight, more preferably 0.5 to 20.0% by weight, based on the total weight of the oral care product according to the invention.

[0069] In a preferred embodiment of the invention, the oral care product according to the invention can contain one or more calcium phosphate compound(s), preferably hydroxyapatite, in a proportion of 0.01 wt.%, 0.02 wt.%, 0.05 wt.%, 0.1 wt.%, 0.2 wt.%, 0.5 wt.%, 1.0 wt.%, 1.5 wt.%, 2.0 wt.%, 5.0 wt.%, 10.0 wt.%, 15.0 wt.%, 20.0 wt.%, 25.0 wt.%, 30.0 wt.%, 35.0 wt.% or 40 wt.%, in each case based on the total weight of the oral care product.

[0070] It is known that the amount of calcium phosphate compound(s), preferably hydroxyapatite, can also depend on the form in which the oral care product (toothpaste, mouth gel, etc.) is present. For example, a toothpaste may contain a larger amount of calcium phosphate compound(s), preferably hydroxyapatite, than a mouthwash.

[0071] In a preferred embodiment of the invention, the oral care product according to the invention is a toothpaste containing dimethylglycine and / or a salt of dimethylglycine in a proportion of approximately 0.005 wt.%, based on the total weight of the oral care product. This oral care product preferably contains no calcium phosphate compound, preferably no hydroxyapatite.

[0072] In a preferred embodiment of the invention, the oral care product according to the invention is a toothpaste containing dimethylglycine and / or a salt of dimethylglycine in a proportion of about 0.1% by weight and a calcium phosphate compound, preferably hydroxyapatite, in a proportion of 20% by weight, in each case based on the total weight of the oral care product.

[0073] In a preferred embodiment of the invention, the oral care product according to the invention is a toothpaste containing dimethylglycine and / or a salt of dimethylglycine in a proportion of about 1.0% by weight and a calcium phosphate compound, preferably hydroxyapatite, in a proportion of 10% by weight, in each case based on the total weight of the oral care product.

[0074] In a preferred embodiment of the invention, the oral care product according to the invention is a toothpaste containing dimethylglycine and / or a salt of dimethylglycine in a proportion of about 2.0% by weight and a calcium phosphate compound, preferably hydroxyapatite, in a proportion of 1.0% by weight, in each case based on the total weight of the oral care product.

[0075] In a further preferred embodiment of the invention, the oral care product according to the invention is a mouthwash containing dimethylglycine and / or a salt of dimethylglycine in a proportion of about 0.01% by weight and a calcium phosphate compound, preferably hydroxyapatite, in a proportion of 0.1% by weight, in each case based on the total weight of the oral care product.

[0076] In a further preferred embodiment of the invention, the oral care product according to the invention is a mouthwash containing dimethylglycine and / or a salt of dimethylglycine in a proportion of about 0.5% by weight and a calcium phosphate compound, preferably hydroxyapatite, in a proportion of 5.0% by weight, in each case based on the total weight of the oral care product.

[0077] In a preferred embodiment of the invention, the oral care product according to the invention is a toothpaste containing dimethylglycine and / or a salt of dimethylglycine in a proportion of approximately 2.5 wt.%, based on the total weight of the oral care product. This oral care product preferably contains no calcium phosphate compound, preferably no hydroxyapatite.

[0078] In a preferred embodiment of the invention, the oral care product according to the invention is a toothpaste containing dimethylglycine and / or a salt of dimethylglycine in a proportion of approximately 3.5 wt.%, based on the total weight of the oral care product. This oral care product preferably contains no calcium phosphate compound, preferably no hydroxyapatite.

[0079] In a preferred embodiment, the oral care product according to the invention may further contain one or more surfactants.

[0080] Surfactants are amphipathic molecules and consist of an oil-soluble and a water-soluble part. In other words, surfactants have a lipophilic and a hydrophilic part. Surfactants are classified based on the hydrophilic part and its charge. There are three classes of surfactants: nonionic, cationic, anionic, and amphoteric.

[0081] The hydrophilic part of a nonionic surfactant is not charged. A nonionic surfactant does not contain a dissociable group, but instead contains one or more polar groups such as ethers, ketones, and alcohols. Commonly used nonionic surfactants include polyalkylene glycol ethers.

[0082] Cationic surfactants have a positive charge in their hydrophilic part. Most cationic surfactants are quaternary ammonium compounds with halides as the counterion, such as distearyldimethylammonium chloride.

[0083] The hydrophilic moiety of an anionic surfactant is negatively charged. These anionic surfactants often contain carboxyl, alkoxy, sulfonate, or sulfate groups with alkali or alkaline earth ions as counterions. An example of an anionic surfactant is sodium lauryl sulfate.

[0084] Depending on the pH, the hydrophilic part of an amphoteric surfactant comprises at least one group that is or can become positively charged and at least one group that is or can become negatively charged. The group that is or can become positively charged is, for example, an amine or ammonium group. The group that is or can become negatively charged is, for example, a carboxy, alkoxy, sulfonate, or sulfate group. Examples of amphoteric surfactants are amphoacetates, amphodiacetates, amphopropionates, amphodipropionates, sulfobetaines, and hydroxysultaines.

[0085] In a preferred embodiment, the surfactant contained in the oral care product according to the invention is an anionic or an amphoteric surfactant.

[0086] Preferably, the surfactant is selected from sodium lauryl sulfate, sodium cocoamphopropionate, cocamidopropyl betaine, sodium methyl cocoyl taurate, sodium cocoyl glycinate, sodium myristoyl sarcosinate, cocamidopropyl hydroxy sultaine and sodium cocoamphoacetate or mixtures thereof.

[0087] In a preferred embodiment, the oral care product according to the invention does not contain sodium lauryl sulfate.

[0088] Preferably, the surfactant is selected from the group consisting of betaines, glycinates, sarcosinates, sulfates and taurates.

[0089] Preferably, the oral care product according to the invention contains one or more surfactants in an amount of 0.05 to 5 wt.%, more preferably 0.07 to 4 wt.%, in particular 0.1 to 3 wt.%, based on the total weight of the oral care product.

[0090] In a preferred embodiment, the oral care product according to the invention may contain one or more pharmaceutical or cosmetic excipients. These pharmaceutical or cosmetic excipients are described, for example, in Toothpastes, Monographs in Oral Science, Vol. 23, 1st edition, 2013.

[0091] According to the invention, the pharmaceutical or cosmetic excipients are preferably antimicrobial (in particular antibacterial) substances, pH regulators, cleaning agents (also known as abrasives), flavorings, gelling agents, emulsifiers or care active ingredients.

[0092] Antimicrobial substances are substances that can kill microorganisms, such as bacteria, or significantly reduce their proliferation. In addition to antimicrobial substances with a non-specific defense against bacteria and fungi, there are also antimicrobial substances that are effective only against specific bacteria, for example. The use of antimicrobial substances can also be used to combat bad breath, for example. Antimicrobial substances can preferably be contained in the oral care product according to the invention in an amount of 0.01 to 1.0 wt.%, more preferably 0.05 to 0.5 wt.%. Examples of antimicrobial, particularly antibacterial, substances used in oral care are zinc compounds such as zinc chloride, zinc citrate, and zinc PCA, as well as chlorhexidine, triclosan, cetylpyridinium chloride, and tin chloride.Antimicrobial, particularly antibacterial substances preferred according to the invention include zinc compounds such as zinc chloride, zinc citrate and zinc PCA, lactoferrin and lysozyme.

[0093] In a preferred embodiment, the oral care product according to the invention does not contain chlorhexidine. In a further preferred embodiment, the oral care product according to the invention does not contain any quaternary ammonium compounds, in particular no cetylpyridinium chloride. pH regulators are substances that can adjust a specific pH range, preferably a neutral range of pH 6.5 to 7.5. An overly acidic composition would pose a risk of demineralization of the tooth structure (erosion). Examples of pH regulators are sodium hydroxide (NaOH) or phosphoric acid (H3PO4), which can be used depending on the desired pH. To raise a pH that is too low, sodium hydroxide can be added, while phosphoric acid can be added if the pH is too high.

[0094] Alternatively, a mixture of sodium phosphate and disodium phosphate can be used. A particular advantage of this buffer system lies in the use of phosphate, which is also a component of the hydroxyapatite in tooth enamel and can be incorporated there for stabilization. Furthermore, the solubility equilibrium is shifted toward remineralization. The mixture of sodium phosphate and disodium phosphate is preferably present in a ratio of 1:1. Therefore, in a preferred embodiment, the preparation according to the invention comprises a mixture of sodium phosphate and disodium phosphate, preferably in a ratio of 1:1.

[0095] Abrasives, also known as cleaning agents, cleaning substances, or grinding agents, usually work together with the toothbrush to remove plaque and harmful bacteria from the tooth surface during the tooth cleaning process and can also whiten teeth. Abrasives can be contained in the oral care product according to the invention, preferably in an amount of up to 10 wt.% based on the total weight of the oral care product. Examples of abrasives are whiting, marble powder, and / or silicate compounds such as silica. In a preferred embodiment, the oral care product according to the invention contains no silicate compound, in particular no silica.

[0096] Flavorings can give the oral care product according to the invention the desired flavor. Flavorings can also stimulate saliva production, whereby the moisture of saliva can have a positive influence on tooth remineralization. An example of a saliva-stimulating flavoring is pellitorin, especially trans-pellitorin. Other examples of flavorings include mint and / or citrus flavoring, preferably mint and citrus flavoring, more preferably mint and citrus flavoring in a ratio of 1:1. Gelling agents are responsible for the formation of a stable gel and give the oral care product, such as toothpaste, a pleasant texture and sufficient flowability so that it can be easily applied or spread onto the mucous membranes or gums.In general, all gelling agents known in the pharmaceutical and / or cosmetic field for producing stable gel formulations can be used within the scope of the invention. Hydrophilic gelling agents are preferably used. Examples of suitable gelling agents are natural gelling agents such as pectin, agarose, gelatin, and casein, or modified natural gelling agents such as cellulose derivatives including methylcellulose, hydroxymethylcellulose, hydroxyethylcellulose (HEC), hydroxymethylpropylcellulose (HPMC), and carboxymethylcellulose, or fully synthetic gelling agents such as polyvinyl alcohols, poly(meth)acrylic acids, polyacrylamide, polyvinylpyrrolidone, polypropylene glycol, polyethylene glycol, and poloxamers. Cellulose derivatives and poloxamers are preferred due to the higher stability and appropriate viscosity of the resulting gels. Poloxamers are most preferred for reasons of gel stability and their function as solubilizers.Suitable poloxamers are poloxamer 407 (e.g. trade name Pluronic F 127; Kolliphor P 407), or poloxamer 188 (e.g. trade name Pluronic F 68; Kolliphor P 188).

[0097] Depending on the amount used, gelling agents can also generally function as thickeners. Cellulose derivatives, in particular, are also used as thickeners in toothpastes and mouthwashes.

[0098] Suitable emulsifiers which may be contained in the oral care product according to the invention correspond to the surfactants mentioned herein and include, for example, PEG-40 Hydrogenated Castor Oil.

[0099] Suitable care active ingredients that can be contained in the oral care product according to the invention include allantoin, bisabolol, hyaluronic acid and panthenol.

[0100] In a further preferred embodiment, the oral care product according to the invention further contains caffeine.

[0101] Furthermore, dental care compositions often contain fluoride compounds, such as sodium fluoride, amine fluoride, or zinc fluoride. In a particularly preferred embodiment, the oral care product according to the invention contains no fluoride compound and is thus fluoride-free.

[0102] In a further preferred embodiment, the oral care product according to the invention does not contain titanium dioxide.

[0103] In a particularly preferred embodiment, the oral care product according to the invention contains no fluoride compound, no chlorhexidine, no titanium dioxide, no sodium lauryl sulfate, no silicate compound, in particular no silica, and / or no quaternary ammonium compound, in particular no cetylpyridinium chloride.

[0104] In a preferred embodiment, the oral care product further contains antibacterial substances and / or cleaning agents.

[0105] Exemplary and inventively preferred pharmaceutical or cosmetic excipients include 1,2-hexanediol, 1,2-octanediol, allantoin, bisabolol, purified water, glycerin, houseleek extract (Sempervivum Tectorum extract), hyaluronic acid, hydroxyacetophenone, hydroxyethylcellulose, lactoferrin, lysozyme, panthenol, PEG-40 hydrogenated castor oil, propylene glycol, sorbitol, stevia extract (Stevia Rebaudiana extract), xylitol, and zinc salts or zinc compounds.

[0106] 1,2-Hexanediol and / or 1,2-octanediol primarily have a moisturizing and conditioning effect, but also exhibit a preservative effect. A mixture of 1,2-hexanediol and 1,2-octanediol, for example, is commercially available under the trade name SymDiol 68® from Symrise.

[0107] According to the invention, allantoin has a soothing, regenerative, and healing effect on tissue. This can prevent cracks in the tongue, lips, and palate.

[0108] Bisabolol has an anti-inflammatory effect on skin and mucous membranes and is used for skin regeneration and wound healing.

[0109] According to the invention, glycerin (propanetriol) serves both as a solvent and as a humectant. In a preferred embodiment, the oral care product according to the invention for use in the oral cavity comprises 86.5% glycerin.

[0110] Houseleek extract is also known as Sempervivum tectorum extract. Houseleek extract also has a soothing, regenerative, and healing effect on tissue, making it a good care product for the oral mucosa. Houseleek extract is available commercially under the trade name Houseleek Bio Extract 'CG (CH) P-00025259' from Botanica GmbH.

[0111] According to the invention, hyaluronic acid (hyaluronan, HA) or a salt thereof is used for moisturizing, gum care, and for the prevention and treatment of gum disease. Hyaluronic acid is a natural protein found as a component of the connective tissue of the human body. Hyaluronic acid or a salt thereof protects against infections, soothes irritations of the oral mucosa, promotes wound healing, and tissue regeneration. Hyaluronic acid or a salt thereof also reduces bleeding gums and inhibits inflammation and swelling. In a preferred embodiment, the preparation according to the invention for use in the oral cavity comprises the sodium salt of hyaluronic acid, also known as sodium hyaluronate.

[0112] Hydroxyacetophenone has antioxidant properties. It also has preservative properties. Hydroxyacetophenone is commercially available, for example, under the trade name SymSave H®.

[0113] Hydroxyethylcellulose acts as a viscosity regulator, thus creating the preferred viscous or gel-like consistency of the preparation for oral application. Alternatively, carboxymethylcellulose, alginates, xanthan gum, and / or carrageenan can be used as viscosity regulators.

[0114] Lactoferrin has both antiviral and antimicrobial properties and is effective in the treatment of chronic periodontitis.

[0115] Lysozyme, also known as muramidase, is an enzyme found in animals and humans as part of the innate immune system and has antibacterial properties.

[0116] Panthenol, also known as dexpanthenol, pantothenol, D-panthenol, or provitamin B5, is converted into pantothenic acid (vitamin B5) in the body. Pantothenic acid is a component of coenzyme A and thus plays an essential role in dermatological metabolism. Panthenol plays an important role in skin wound healing. Panthenol also has anti-itch and anti-inflammatory effects.

[0117] PEG-40 Hydrogenated Castor Oil is an emulsifier.

[0118] Propylene glycol is a humectant and therefore serves to moisten the oral mucosa.

[0119] Xylitol, sorbitol, and stevia extract (Stevia rebaudiana extract) are sweeteners used to enhance the flavor of the preparation according to the invention. Stevia extract is known as E 960, sorbitol as E 420, and xylitol as E 967 according to Regulation (EU) No. 231 / 2012.

[0120] In addition, xylitol also serves as a humectant. Furthermore, xylitol stimulates saliva production and promotes the neutralization of microbially produced acids as well as the remineralization of teeth. Xylitol can minimize the number of caries bacteria and inhibit their growth. It therefore also supports caries prevention. The oral care product according to the invention can contain xylitol in an amount of 0.1 to 10 wt.%, preferably 0.7 to 8 wt.%, based on the total weight of the oral care product. In addition to xylitol, the oral care product according to the invention can contain other sugar alcohols such as sorbitol. Zinc salts / zinc compounds act as antimicrobial, particularly antibacterial substances, and preferably comprise zinc chloride, zinc citrate, or zinc PCA, i.e., the compound of zinc with pyrrolidonecarboxylic acid (PCA). They reduce plaque and prevent tartar formation and bad breath.

[0121] In a particularly preferred embodiment, the preparation according to the invention for use in the oral cavity has a pH value of 5.0 - 7.5 and comprises the following ingredients:

[0122] The oral care product according to the invention can be produced by known methods. The present invention further relates to the use of the oral care product described herein. The use is in particular a cosmetic or medicinal use, preferably a cosmetic use.

[0123] The oral care product according to the invention is thus preferably used as a cosmetic. In one aspect, the present invention relates to the use, in particular the cosmetic use, of the oral care product described herein for the care of oral and pharyngeal soft tissues, in particular for the care of gums, periodontal pockets, tongue, cheek, throat, and palate. The term "care" here encompasses the cleaning of gums, periodontal pockets, tongue, cheek, throat, and palate, as well as the application (with / without rinsing) to gums, periodontal pockets, tongue, cheek, throat, and palate.

[0124] In a further aspect, the present invention relates to the use of the oral care product described herein for the prevention and / or treatment of oral diseases selected from gingivitis, periodontitis, mucositis, peri-implantitis, peri-implant mucositis, aphthous ulcers, fungal thrush, oral fistulas, receding gums, bad breath, ulcers and saliva deficiency.

[0125] The present invention thus encompasses an oral care product as described herein for use in the prevention and / or treatment of oral diseases selected from gingivitis, periodontitis, mucositis, peri-implantitis, peri-implant mucositis, canker sores, fungal thrush, oral fistulas, receding gums, halitosis, ulcers and salivary deficiency.

[0126] In yet another aspect, the present invention relates to the use, in particular the cosmetic use, of the oral care product described herein for improving oral soft tissue, in particular the oral mucosa and / or the gums. The term "improvement of oral soft tissue" refers, among other things, to gum regeneration, gum revitalization, reduction of bleeding gums, and reduction and healing of gum inflammation with respect to the gums (soft tissue).

[0127] Finally, the present invention also relates to the use of the oral care product described herein for the prevention and / or treatment of a bacterial and / or viral infection and / or mycoses.

[0128] The present invention thus encompasses an oral care product as described herein for use in the prevention and / or treatment of a bacterial and / or viral infection and / or mycoses.

[0129] In one embodiment of the uses, the oral care product according to the invention remains in the oral cavity after application (leave-on product).

[0130] In a further embodiment of the uses, the preparation according to the invention is applied as often as required.

[0131] The following examples are intended to illustrate the invention without, however, wishing to restrict it to the specific formulations.

[0132] Short description of the figures Figure 1

[0133] Figure 1 shows cell viability after 24 h, 48 h, and 72 h of cultivation, demonstrating a significant increase with the addition of DMG after 48 h and 72 h. Cell viability was determined using the MTT assay. Absorbance was measured in quadruplicate and normalized to the 24-h control. The mean value with standard deviation is given.

[0134] Figure 2

[0135] Figure 2 shows cell proliferation after 24 h, 48 h, and 72 h of cultivation, demonstrating a significant increase with the addition of DMG after 48 h and 72 h. Cell proliferation was determined using the CyQUANT assay. Fluorescence was measured in triplicate and normalized to the 24 h control. The mean value with standard deviation is given.

[0136] Figure 3

[0137] Figure 3 shows migration over time using different DMG concentrations. Migration and wound closure are significantly faster with DMG compared to the control without DMG. The wound was created at 0 h, and images were taken after 16 h, 20 h, and 24 h of cultivation, respectively. Based on the images, the cultivation surface area that was not yet colonized with cells was determined using ImageJ software. The measured values ​​are normalized to the time point 0 h (maximum wound size) and expressed as a percentage.

[0138] Figure 4

[0139] Figure 4 shows the gene expression of VEGF after 24 hours of cultivation, demonstrating a significant increase in gene expression upon addition of DMG. The relative gene expression of VEGF determined by qRT-PCR (triplicate determination, normalized to the respective gene expression of a constitutively expressed gene; GAPDH - glyceraldehyde-3-phosphate dehydrogenase) is shown. The mean value with standard deviation is given.

[0140] Figure 5

[0141] Figure 5 shows the gene expression of IL-6 after 24 h of cultivation. The relative gene expression determined by qRT-PCR is shown (triple determination, normalized to the respective gene expression of a constitutively expressed gene; GAPDH - glyceraldehyde-3-

[0142] Experimental Section The following compositions were prepared using methods known to those skilled in the art. The amount of the components was chosen so that their weight proportions in the premix corresponded to the stated weight proportions. Example 1

[0143] Examples of the composition of oral care products according to the invention in the form of toothpastes (in wt.%):

[0144] Further embodiments of the composition of oral care products according to the invention in the form of toothpastes correspond to the above-mentioned formulations of embodiments 1-4, but contain the same amount of amorphous calcium phosphate instead of hydroxyapatite.

[0145] Example 2

[0146] Examples of the composition of oral care products according to the invention in the form of mouthwashes (in wt.%):

[0147] Further embodiments of the composition of oral care products according to the invention in the form of mouthwashes correspond to the above-mentioned formulations of embodiments 1-4, but contain the same amount of amorphous calcium phosphate instead of hydroxyapatite.

[0148] Example 3

[0149] In an application study, the effect of a toothpaste containing dimethylglycine was investigated compared to a dimethylglycine-free placebo toothpaste with regard to the occurrence of bleeding gums.

[0150] The composition of the toothpaste with dimethylglycine corresponded to the formulation of Example 1 from Example 1 with 20% hydroxyapatite; the dimethylglycine-free placebo toothpaste contained demineralized water instead of dimethylglycine.

[0151] In a 12-week double-blind study, 50 adult subjects aged 40-75 years with bleeding gums were enrolled. The subjects brushed twice daily (morning and evening) for 2 minutes with their assigned toothpastes using an electric round-head toothbrush (25 subjects: active treatment; 25 subjects: control). Supplementary mouthwashes, toothpastes, etc., were not permitted during the study period. Only subjects with at least 10 naturally healthy teeth and non-smokers were included. Subjects with severe periodontal disease were excluded. The primary study parameter was the "bleeding on probing index."

[0152] The results at baseline and after 12 weeks of continuous use are presented below:

[0153] In a user study, the use of a toothpaste containing dimethylglycine resulted in a significant reduction in gum bleeding compared to a dimethylglycine-free placebo toothpaste. A questionnaire administered to volunteers after 12 weeks showed that the toothpaste containing dimethylglycine was widely accepted in terms of taste, tolerability, and mouthfeel after brushing.

[0154] Example 4: In an in vitro study, the effect of sodium dimethylglycinate was investigated in a cell culture model using human horn-forming keratinocytes. For this purpose, HaCaT cells were cultured for 1, 3, 5, and 7 days in DMEM medium (including fetal calf serum and an antibiotic-antimycotic mix). Among other things, cell viability, proliferation, and migration were determined using appropriate measurement methods, as well as the expression of growth factors relevant to cell growth.

[0155] Proof of viability:

[0156] For this measurement, a so-called MTT assay was used to determine cellular metabolic activity as an indicator of cell viability and cytotoxicity. This colorimetric assay is based on the reduction of a yellow tetrazolium salt (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, or MTT) to violet formazan crystals by metabolically active cells.

[0157] Human epidermal keratinocyte cells (HaCaT) were seeded in a 96-well plate at a cell density of 5,000 cells / well and cultured in medium (DMEM with 10% FBS, 1% penicillin-streptomycin, 0.5% Fungizone). The next day, and after further 24 h, 48 h, and 72 h of cultivation at 37°C and 5 vol% CO2, the cell culture medium was changed without (control) or with the active ingredient concentrations of sodium dimethylglycinate (DMG) already present. The measurement was carried out analogously to previously published studies in BI Toth, N. Dobrosi, A. Dajnoki, G. Czifra, A. Oläh, AG Szöllosi, I. Juhäsz, K. Sugawara, R. Paus, T. Biro, J Invest Dermatol 2011, 131, 1095-1104.

[0158] Figure 1 shows cell viability after 24 h, 48 h, and 72 h of cultivation, demonstrating a significant increase with the addition of DMG after 48 h and 72 h. Cell viability was determined using the MTT assay. Absorbance was measured in quadruplicate and normalized to the 24-h control. The mean value with standard deviation is given.

[0159] Evidence of proliferation:

[0160] To measure proliferation, a so-called CyQUANT assay was performed. In this fluorescence-based assay, the fluorescent dye used binds to DNA (deoxyribonucleic acid), whereby the cellular DNA content is a direct measure of the number of cells within a sample.

[0161] Human epidermal keratinocyte cells (HaCaT) were seeded in a 96-well plate at a cell density of 5,000 cells / well and cultured in medium (DMEM with 10% FBS, 1% penicillin-streptomycin, 0.5% Fungizone). The next day, and after a further 24 h, 48 h, and 72 h of cultivation at 37°C and 5 vol% CO2, the cell culture medium was changed without (control) or with the respective active ingredient concentrations. The measurement was performed analogously to previously published studies in A. Oläh, BI Toth, I. Borbirö, K. Sugawara, AG Szöllösi, G. Czifra, B. Pal, L. Ambras, J. Kloepper, E. Camera, The Journal of Clinical Investigation 2014, 124, 3713-3724.

[0162] Figure 2 shows cell proliferation after 24 h, 48 h, and 72 h of cultivation, demonstrating a significant increase with the addition of DMG after 48 h and 72 h. Cell proliferation was determined using the CyQUANT assay. Fluorescence was measured in triplicate and normalized to the 24 h control. The mean value with standard deviation is given.

[0163] Proof of migration:

[0164] To measure migration, a so-called wound healing assay was performed, based on previously published studies in T. Kawabata, T. Otsuka, K. Fujita, G. Sakai, R. Matsushima-Nishiwaki, O. Kozawa, H. Tokuda, International Journal of Molecular Medicine 2018, 42, 3149-3156. The principle is based on measuring the migration of cells onto an uncolonized culture surface over time. For this purpose, 20,000 cells were seeded into two adjacent wells or cavities separated by a silicone insert (with standardized width) and cultured in medium (DMEM with 5% FBS, 1% penicillin-streptomycin, 0.5% Fungizone) for 48 h at 37°C and 5 vol% CO2. The plastic insert was then removed (“creation of the wound”) and cell migration was documented over time by determining the non-cell-populated cultivation surface using images.In parallel, the cell culture medium was changed without (control) or with the respective active ingredient concentrations of DMG immediately after removal of the plastic insert (0 h) and after a further 24 h. The image analysis and determination of the culture surface not colonized by cells were performed using specific software (Image J).

[0165] Figure 3 shows migration over time using different DMG concentrations. Migration and wound closure are significantly faster with DMG compared to the control without DMG. The wound was created at 0 h, and images were taken after 16 h, 20 h, and 24 h of cultivation, respectively. Based on the images, the cultivation surface area, which was not yet colonized by cells, was determined using ImageJ software. The measured values ​​are normalized to the time point 0 h (maximum wound size) and expressed as a percentage. Detection of VEGF gene expression:

[0166] VEGF (Vascular Endothelial Growth Factor) promotes the growth and formation of new blood and lymph vessels. Gene expression was measured using a standard method called quantitative real-time PCR (qRT-PCR).

[0167] Human epidermal keratinocyte cells (HaCaT) were seeded in a 6-well plate at a cell density of 140,000 cells / well and cultured in medium (DMEM with 10% FBS, 1% penicillin-streptomycin, 0.5% Fungizone) at 37°C and 5 vol% CO2. The next day, the cell culture medium was changed without (control) or with the respective drug concentrations already present, and the cells were harvested after 24 h. Gene expression was measured using qRT-PCR based on previously published studies in BV Diaz, M.-C. Lenoir, A. Ladoux, C. Frelin, M. Demarchez, S. Michel, Journal of Biological Chemistry 2000, 275, 642-650.

[0168] Figure 4 shows the gene expression of VEGF after 24 hours of cultivation, demonstrating a significant increase in gene expression upon addition of DMG. The relative gene expression of VEGF determined by qRT-PCR (triplicate determination, normalized to the respective gene expression of a constitutively expressed gene; GAPDH - glyceraldehyde-3-phosphate dehydrogenase) is shown. The mean value with standard deviation is given.

[0169] Surprisingly, it was shown that DMG had a positive effect on the growth-relevant parameters of HaCaT cells and that the expression of the growth factor VEGF was significantly increased compared to the treatment of HaCaT cells without DMG.

[0170] Detection of gene expression of interleukin 6:

[0171] Interleukin-6 (IL-6) is a peptide hormone of the immune system belonging to the group of proinflammatory interleukins and plays a key role in the nonspecific, innate immune response. Gene expression was measured using a standard method known as quantitative real-time PCR (qRT-PCR).

[0172] Human epidermal keratinocyte cells (HaCaT) were seeded in a 6-well plate at a cell density of 140,000 cells / well and cultured in medium (DMEM with 10% FBS, 1% penicillin-streptomycin, 0.5% Fungizone) at 37°C and 5 vol% CO2. The next day, inflammation of the cells was induced by cytokine treatment (25 ng / ml tumor necrosis factor alpha (TNFa) and 25 ng / ml interferon gamma (IFNγ)). After treatment, cells were treated with different DMG drug concentrations (inflammation induction + DMG 0.005% - 0.00005%) or without DMG (positive control for inflammation induction). In parallel, cells were treated without any treatment (control) or only with the different DMG drug concentrations (DMG 0.005% - 0.00005%), and the cells were harvested after 24 hours for gene expression analysis. Gene expression was measured using qRT-PCR based on previously published studies by BV Diaz, M.-C. Lenoir, A. Ladoux, C. Frelin, M. Demarchez, S.Michel, Journal of Biological Chemistry 2000, 275, 642-650.

[0173] Figure 5 shows the gene expression of IL-6 after 24 h of culture. The relative gene expression of IL-6 determined by qRT-PCR (triplicate determination, normalized to the respective gene expression of a constitutively expressed gene; GAPDH - glyceraldehyde-3-phosphate dehydrogenase) is shown. The mean value with standard deviation is given.

[0174] Surprisingly, it was shown that the expression of interleukin-6 induced by cytokine treatment was reduced in a dose-dependent manner by the addition of DMG compared to the positive control of inflammation induction.

Claims

Claims 1. An oral care product, characterized in that the oral care product contains dimethylglycine and / or a salt thereof.

2. Oral care product according to claim 1, characterized in that the oral care product contains dimethylglycine and / or a salt thereof in an amount of 0.00001 to 10.0 wt.%, preferably 0.0001 to 2.0 wt.% and particularly preferably 0.0005 to 1 wt.%, in each case based on the total weight of the oral care product.

3. Oral care product according to one of the preceding claims, characterized in that the oral care product further contains a calcium phosphate compound.

4. Oral care product according to claim 3, characterized in that the calcium phosphate compound is in particulate form and / or that the calcium phosphate compound is selected from the group consisting of monocalcium phosphate monohydrate (MCPM), monocalcium phosphate anhydrate (MCPA), dicalcium phosphate dihydrate (DCPD, brushite), dicalcium phosphate anhydrate (DCPA, monetite), octacalcium phosphate (OCP), α-tricalcium phosphate (α-TCP), β-tricalcium phosphate (β-TCP), amorphous calcium phosphate (ACP), calcium-deficient hydroxyapatite (CDHA), hydroxyapatite (HA or HAP), tetracalcium phosphate (TTCP) and calcium pyrophosphate and / or wherein the calcium phosphate compound is preferably hydroxyapatite.

5. Oral care product according to claim 3 or claim 4, characterized in that the oral care product comprises the calcium phosphate compound in an amount of 0.01 to 40.0 wt.%, preferably 0.1 to 30.0 wt.%, particularly preferably 0.5 to 20.0 wt.%, based on the total weight of the oral care product.

6. Oral care product according to one of the preceding claims, characterized in that the oral care product further comprises a surfactant, wherein the surfactant is preferably selected from the group consisting of betaines, glycinates, sarcosinates, sulfates and taurates.

7. Oral care product according to one of the preceding claims, characterized in that the oral care product further comprises antibacterial substances and / or cleaning agents.

8. Use of the oral care product according to any one of claims 1 to 7 for the care of oral and pharyngeal soft tissues.

9. Use of the oral care product according to any one of claims 1 to 7 for the prevention and / or treatment of oral diseases selected from gingivitis, periodontitis, mucositis, Periimplantitis, peri-implant mucositis, canker sores, fungal thrush, oral fistulas, receding gums, bad breath, ulcers, saliva deficiency.

10. Use of the oral care product according to any one of claims 1 to 7 for improving oral soft tissue.

11. Use of the oral care product according to any one of claims 1 to 7 for the prevention and / or treatment of a bacterial and / or viral infection and / or mycoses.

12. Oral care product according to any one of claims 1 to 7, characterized in that the Oral care products available in the form of toothpaste, tablets, chewing gum, mouth gel, gel for periodontal pockets, mouthwash or mouth rinse.

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