Technical Field

This invention relates to an antibacterial, anti-inflammatory and anti-mutagenic toothpaste which does not contains any harmful and toxic chemical, consists of natural cleansing products, provides overall oral hygiene and cleaning, including teeth, gingiva and palate, is suitable for oral flora, reduces the microorganism activities in dental and gingival tissues and supports the treatment in case of a disease.

Specifically, the invention describes a toothpaste which comprises a composition containing Rosa Damascena (Isparta rose oil) as a therapeutical agent, and a method of production thereof.

State of the Art

Today, the use of toothpastes is common all over the world to destroy all bacteria, viruses and similar microbes in the mouth, including teeth, gingiva and palate, to ensure oral hygiene, and to clean teeth and gingiva. Abrasives, cleansing agents, binders, flavoring sweeteners, preservatives and cleansing agents for preventing dental caries are used in the toothpastes.

However, various chemicals used in the toothpastes are accumulated in the body and lead to significant health problems. In particular, as young children do not rinse their mouths well, some of these harmful chemicals in the toothpastes may be swallowed, or the chemicals may pass into their bodies through their tongue and oral mucosa.

Sodium lauryl sulfate (SLS), sodium lauryl ether sulfate (SLES), paraben, titanium dioxide (T1O ₂ ) and colorant chemicals present in the toothpastes in the market are toxic substances.

SLS, a very cheap foaming agent, is known to prevent eye development in children. In addition, SLS used in toothpastes may increase the incidence of mouth sores. It is known to cause mouth sores to increase their incidence by changing the nature of the epithelial cells. Studies show that the toothpastes containing SLS and SLES support and increase the formation of mouth ulcers. In addition, as SLS and SLES are carcinogenic, they are known to remain as residues in organs such as brain and eyes, and cause diseases in later ages.

Paraben used in toothpastes in the art is also known specifically as methyl paraben (E218), propylparaben (E216), ethylparaben (E214), butylparaben, benzylparaben and heptylparaben (E209) and is a chemical which is generally used to prolong shelf life by preventing bacteria and fungi that may occur in cosmetic and care products. As it is absorbed by the skin, it may mix with the whole body, all tissues, even blood and urine. Paraben is a carcinogenic substance and leads to substantial and serious damage to the endocrine system and reproductive systems.

In order to overcome the above-mentioned problems, the world, and the health and cosmetics sectors have sought to produce natural products rapidly in line with the demands of their customers. In addition to the high cleaning effect of a toothpaste, consumers are looking for equivalent products which contain natural contents, do not leave bad odor, do not go bad quickly, do not leave a bad taste in the mouth, and do not adversely affect human health.

The leading companies of these fields currently produce products with natural content, but they use chemicals in the excipients in order to achieve the desired stability values and to prevent the rapid degradation of natural products. In addition, chemical contents are commonly used in order to improve odor and taste characteristics and reduce costs.

These drawbacks in the state of the art encouraged the inventor to develop a new toothpaste formulation with a natural content, which is not harmful to health, does not contain toxic chemical additives, but has also a high cleansing effect and supports the healing/treatment of the oral tissues. The inventor intends to develop a new toothpaste formulation containing Isparta rose oil and Isparta rose water, and fluoride, which has optimum cleaning properties and is free of harmful chemicals.

In the state of the art, the invention of the Chinese patent application entitled “Rose healtcare toothpaste” with publication no. CN 105708783(A) discloses a toothpaste prepared, by weight, from 7-20 units of rose extract, 2-8 units of fructus lycii extract, 2- 4,5 units of chrysanthemum extract, 5-10 units of five-bladed motherwort extract, 5-10 units of radix angelica sinensis, 3-10 parts of brown sugar oil, 9-45 parts of sodium bicarbonate, 0.6-4 parts of acyloxy sodium sulfonate, 3-20 parts of glycerin, 0.3-3 parts of propolis and 0-0.2 parts of sodium benzoate. The toothpaste has the effects of regulating qi, relieving depression, stimulating blood circulation, dissipating blood stasis, regulating menstruation, relieving pain and delaying aging. However, a new formulation containing Isparta rose oil and rose water according to this invention is completely different from the formulation content in the state of the art. Although both formulations have herbal contents, the therapeutic agents used, composition ratios and technical effects are different. The cumulative cleansing effect of Isparta rose extracts and fluoride, and the therapeutic effect of Isparta rose extracts, the moisturizing property of Isparta rose extracts and these superior technical effects when combined with other components were studied in the toothpastes of the present invention.

Description of the Invention

The object of the invention is to develop an antibacterial, anti-inflammatory and anti- mutagenic toothpaste which does not contains any harmful and toxic chemical, consists of natural cleansing products, provides overall oral hygiene and cleaning, including teeth, gingiva and palate, is suitable for oral flora, reduces the microorganism activities in dental and gingival tissues and supports the treatment in case of a disease.

Another object of the invention is to develop an antioxidant, anticarcinogenic, anti inflammatory, anti-mutagenic, anti-bacterial, anti-aging toothpaste formula with natural contents, which has useful pharmacological effects for human health and scavenges free radicals.

Another object of the invention is to prevent the composition from going bad and to provide a prolonged shelf life by combining it with Isparta rose (Rosa Damascena) oil used as a cleansing agent.

Another object of the invention is to produce a new toothpaste which is effective against caries, effective in tooth sensitivity, contributes to gingival and gingival mucosal health, is effective against all inflammations and diseases that may be possibly present in the soft tissues and tongue in the mouth and supports treatment. In addition, the object is to shorten the soft tissue healing time by contributing to wound healing after dental applications.

Detailed Description of the Invention

The invention is an antibacterial, anti-inflammatory and anti-mutagenic toothpaste which provides overall oral hygiene and cleaning, including teeth, gingiva and palate, is suitable for oral flora, reduces the microorganism activities in dental and gingival tissues and supports the treatment in case of a disease, wherein it comprises, in the composition, 0.1 %-1 % by weight of the oil of Isparta oil rose (Rosa Damascena) and 2- 8% by weight of Isparta rose (Rosa Damascena) water as a therapeutic agent, 20%- 30% by weight of water, 5-15% by weight of an abrasive, 1 -4% by weight of a foaming agent, 0.5-3% by weight of a thickener and/or stabilizer, 0.1 -0.3% by weight of fluoride, 0.1 -0.5% by weight of pine oil as a preservative, and 5-10% by weight of bentonite clay.

Plants are also used for oral hygiene, in addition to human health in many areas. Rosa Damascena oil, which belongs to the family of flowering plants and whose is produced mainly in Isparta worldwide, has its own characteristics. Owing to the strong antibacterial and strong antioxidant characteristic of the products of Isparta oil rose (Damascena), this has been discovered to help in oral and teeth cleaning. Various components (geraniol, citronellol and nerol which are monoterpene alcohols) have been detected in an extract of Isparta oil rose (Rosa Damascena oil). These have been observed to inhibit different microorganisms.

Positive effects of rose on oral and dental health have been achieved. Studies show that rose has an important place in the maintenance of oral and dental health both by preventing caries formation and gingival diseases. In addition, it may be used in the prevention of viral and fungal diseases due to its antiviral and antifungal activity.

In the formulation of the invention, the extracts and oil of Rosa Damascena oil (Isparta oil rose) are used as therapeutic agents. Optimum rates were determined during the studies, and the product of the invention plays an active role in the healing of oral wounds. Preferably, in the toothpaste of the invention, the composition comprises 6% by weight of oil of Rosa Damascena (Isparta oil rose), 4% by weight of Rosa Damascena water (Isparta rose water), 29.7% by weight of water, 8% by weight of an abrasive, 1.5% by weight of a foaming agent, 1% by weight of a thickener and/or stabilizer, 0.3% by weight of fluoride, 0.2% by weight of pine oil as a preservative, and 7% of bentonite clay.

Corrosive agents are used in the toothpastes for preventing the plaque accumulation and mechanic and chemical removal of dental discolorations. In the art, all of abrasives used in the toothpastes may be used in this invention, but preferably, calcium carbonate, or sodium bicarbonate is used. Furthermore, the abrasiveness of a toothpaste may be determined depending on the hardness, shape and size of the particles, as well as pH value. Therefore, sodium bicarbonate is used in this invention. In the invention, sodium bicarbonate neutralizes the acids formed by providing a basic environment at pH= 8.5 in the mouth, ensuring the intraoral pH balance.

Foaming agents help the cleaning process by allowing the formulation to foam. In the art, all of foaming agents used in the toothpastes may be used in this invention, but preferably, sodium coco sulfate is used.

In toothpastes, thickeners and/or stabilizers are used to control stability and consistency. In said invention, xanthan gum is used to achieve favorable viscosity.

Another feature of the invention is the use of fluoride, which reduces the acid production in the mouth by interfering with the bacterial enzyme activity, prevents the growth of bacteria and provides an antimicrobial effect.

When all components in the current formulation are combined, the moisturizing effect and the therapeutic effect of the oil of Rosa Damascena oil (Isparta oil rose) which is used as an active ingredient have been observed to be increased.

In particular, when it is combined with fluoride, it has been observed to provide remineralization of the demineralized zones on a dental tissue and to increase the negative effect on the cycle of caries formation of the microorganisms. Thus, the harmful effect of the chemical is reduced and optimized, while providing a high therapeutic effect. A factor that provides this technical effect is the weight ratio of the oil of Isparta oil rose (Rosa Damascena), Isparta rose (Rosa Damascena) water and fluoride used in the invention.

Although vegetable glycerin is used as a humectant in the invention, Isparta rose (Rosa Damascena) oil has also been observed to contribute to the moisturizing effect in this composition. It helps preventing the hardening of the toothpaste by preventing the moisture loss which may occur in the toothpaste structure.

In addition, as Rosa Damascena extracts (rose oil and rose water) are used, there is no need to add any chemical sweetener or essence to the composition of the invention.

In addition to the moisturizing and sweetening effects given above, the more antioxidant, free radical scavenger, anti-carcinogenic, anti-inflammatory, antimutagenic, antibacterial, anti-aging, pharmacological effects of Isparta rose (Rosa Damascena) oil than expected when combined with other components have been observed to provide a superior effect for the composition.

Another feature of the toothpaste of the invention is that it comprises 0.1%-0.5%, preferably 0.2%, by weight of a flavoring agent. Here, essential peppermint oil is used as a flavoring agent, which gives a natural aroma and an aromatic effect.

The toothpaste of the invention also contains 1-5%, preferably 2%, by weight of natural oil which cleans the gingiva, strengthens the structure of the teeth and reduces the risk of infection. In the invention, coconut oil is ised as a natural oil.

The toothpaste of the invention also contains 15-20%, preferably 17.5%, by weight of a humectant which retains moisture and acts as a preservative. Preferably, vegetable glycerin is present in the invention.

Furthermore, the toothpaste of the invention contains 10-20%, preferably 15%, by weight, of a first strengthening agent. In the invention, tricalcium phosphate which has a strengthening effect on tooth enamel, is preferably used as the first strengthening agent. Furthermore, the toothpaste of the invention contains 8-18%, preferably 13%, by weight, of a second strengthening agent. In the invention, xylitol is used as the second strengthening agent.

Table 1 : An exemplary composition of the toothpaste of the invention

The production method of the toothpaste composition of the invention essentially comprises the following process steps:

Firstly, phase A and phase B are formed separately,

During formation of phase A: - Mixing the foaming agent and water, then heating this mixture to 80°C,

- Cooling the solution obtained in the previous step and adding the abrasive and second strengthening agent thereto,

- Making the mixture homogeneous by stirring,

- Adding oil of Isparta (Rosa Damascena) oil rose, pine oil, flavoring agent, natural oil, During formation of phase B:

- swelling the thickener and/or stabilizer in the humectant,

- adding natural Isparta rose (Rosa Damascena) water,

During formation of phase C:

- Combining the phases A and B formed according to the process steps given above in a vessel,

- Adding bentonite clay, fluoride and first strengthening agent,

- Stirring the mixture until homogeneous.

An exemplary implementation of the production method of the toothpaste according to the invention is provided below:

In the process, the toothpaste is produced during 3 phases.

Phase A: Water is taken, Sodium Coco Sulfate is added thereto, and the resulting solution is heated to 80°C by stirring. The solution is cooled down and Sodium Bicarbonate and Xylitol are added thereto. Rose Oil, Pine Oil, Peppermint Oil and Coconut are added to the mixture which is still homogeneous.

Phase B: The xanthan gum is swelled in glycerin. Natural rose water is added to the mixture.

Phase C: Phases A and B are combined in a vessel. Then, bentonite clay, fluoride and Tricalcium Phosphate are added. The mixture is stirred until homogeneous.

As no chemical reaction, or high thermal treatment is applied in the production process, the components do not lose their effectiveness and work more efficiently.

The effectiveness tests, stability and microbiological tests of the toothpaste of the invention described in the detailed description above are performed by Natural Products Application and Research Center (SUDUM) of Suleyman Demirel University. As the test course of the products is ongoing, they could not be included in the scope of the specification.

Moreover, a product suitable for oral flora has been developed by considering the pH and intraoral alkaline balance of the toothpastes in the present invention.