Toothpaste with phytic acid for iron-related tooth discolorations

Abstract

Health authorities recommend the use of iron drops as a supplement for each infant at the age of 6 months and encourage and monitor their use until the age of 2 years. In addition, the use of iron drops becomes a long-term necessity in all systemic conditions that cause iron deficiency. Iron discoloration is quite common in children, especially in the infant period (0- 2 years) due to the structure of the milk teeth and the incomplete oral flora. The developed toothpaste for infants and children comprising phytic acid will eliminate iron-related discoloration of milk teeth.

Description

[0001] DESCRIPTION

[0002] TOOTHPASTE WITH PHYTIC ACID FOR IRON-RELATED TOOTH DISCOLORATIONS

[0003] Technical Field

[0004] Relates to a toothpaste comprising phytic acid and used to remove iron-related discoloration in milk teeth.

[0005] State of The Art

[0006] The World Health Organisation recommends that infants should receive iron supplements from 6 to 24 months of age. Accordingly, family physicians / pediatricians worldwide and in our country started to use iron drops as a supplement for each infant at the age of 6 months, and encourage and monitor their use until the age of 2 years. In addition, the use of iron drops becomes a long-term necessity in all systemic conditions that cause iron deficiency. Iron discoloration is quite common in children, especially in the infant period (0-2 years) due to the structure of the milk teeth and the incomplete formation stage of the oral flora. These discolorations, which cannot be removed by home oral care methods (brushing / wiping), can only be removed by mechanical scraping with hand / rotary instruments in the clinical environment of a dental practice, but after a while they reappear with deeper and stronger bonds due to the worn surfaces caused by the instruments used. It is quite difficult and time consuming to perform this procedure on infants and young children. There are no effective ingredients developed to chemically prevent the formation of iron discoloration.

[0007] Black discoloration is the discoloration of milk and permanent teeth in the form of a dotted, thin line or wide band running parallel to the gum line. The black material is a ferric sulphide- like compound formed by the interaction of hydrogen sulphide produced by bacteria and iron in saliva or gum fluid. Black discoloration is distinguished from other forms of dental plaque by comprising insoluble iron salts and high levels of calcium and phosphate. The use of iron preparations and chromogenic bacteria are at the forefront of the etiology of external staining seen in both milk and permanent dentition in children. Studies investigating the bacteria responsible for black discoloration have suggested the Actinomyces group, the Prevotella group and Porhyromonas gingivalis, although this is not certain. Since many of the chromogenic bacteria that cause these discolorations grow in the presence of iron, the likelihood of discolorations is increased in children taking iron preparations. The most common discoloration that parents consult a dentist about is the black discoloration of milk teeth. Although polishing with polishing paste appears to be the most effective method of removing external black stains, it has been reported that the heat released during polishing can cause pulp necrosis, especially in milk teeth with large pulps, and that polishing removes the fluoride-rich outer layer of enamel. This is particularly important in children with high levels of caries.

[0008] Therefore, polishing should be avoided in these patients unless absolutely necessary and the need for treatment should be carefully assessed. Removing stains with toothpaste, which is one of the methods that can be used at home, is more comfortable for the patient and parents. Today, there is a wide range of toothpastes on the market, especially for the removal of external stains associated with the pellicle. They contain high levels of abrasives and are contraindicated for use in paediatric patients. By adding active ingredients to toothpastes, pellicle proteins can be dissolved and stains can be removed. Sodium phytate is a polyphosphate, and the ability of polyphosphates to bind to tooth surfaces has been shown to inhibit protein adsorption.

[0009] Although there are many pastes for tooth discoloration in adults; there is no paste specific for iron discoloration that can be used in infants. The discoloration of iron compounds begins to develop in children, especially between the ages of 6 months and 2 years. Given the need for iron supplementation for every baby and the financial and moral difficulties of treating new and recurrent iron discolorations, preventing discolorations before they occur is the most rational, simple and sustainable option.

[0010] A toothpaste for infants and children has been developed with the addition of a plant-based 'Phytic acid' to break down compounds that cause iron discoloration on the tooth surface.

[0011] Phytic acid, the source of phosphorus in plant seeds and bran, is a sixfold dihydrogen phosphate ester of inositol, also known as inositol hexaphosphate, inositol hexakisphosphate or inositol polyphosphate, IP6 (Formula 1). Phosphates are partially ionised to form the phytate anion at physiological pH. This agent has a high negative charge. It provides effective chelation of multivalent cations such as calcium, magnesium and iron. As a result of animal studies, karyostatic properties of phytic acid have been proven. The karyostatic effect of phytic acid is due to its inhibition of the dissolution of calcium phosphate and tooth enamel. Mouthwashes, cements and many dental products have been commercially manufactured on the basis of these caryostatic properties. However, there is no product available to use the iron chelating capacity of Phytic Acid to remove iron discoloration in infants.

[0012] CN106581159A relates to a toothpaste comprising Magnolia officinalis for children between the ages of 9 and 12.

[0013] CN106473936 A relates to a toothpaste for children comprising silicon dioxide, xylitol, sodium lauroyl sarcosinate, fluoride, deionised water, and essence. It is designed to help prevent tooth decay and delayed tooth development.

[0014] US20130017158 relates to an oral care composition comprising a tin ion source and / or a zinc ion source and phytic acid or a phytic acid salt.

[0015] WO 2007 / 076001 discloses oral care compositions essentially comprising a water-insoluble zinc compound and phytate.

[0016] US Patent No. 4,335,102 discloses the use of phytic acid in a tin-comprising oral care composition for caries prophylaxis.

[0017] EP2057978 discloses the use of chelates, including phytic acid, in a formulation comprising tin and further comprising zinc ions, a fluoride ion source and a silica abrasive.

[0018] Applications for oral care compositions comprising phytic acid do not disclose the use of phytic acid to remove discoloration caused by iron drops in infants. Disclosure of Invention

[0019] A formulation with the addition of Phytic acid or its salt has been developed that can bind the iron-bound compound that causes discoloration on the tooth surface with toothpaste for infant / child use. In the developed formulation, phytic acid or its salt is 0.5-1.5% w / w, preferably 0.85% w / w. Phytic acid salts are alkali, alkaline earth and ammonium salts; for example, sodium phytate, potassium phytate or mixtures can be used. In the description, the term phytic acid refers to phytic acid and its salts.

[0020] In the present invention, infants refer to individuals aged between 0 and 2 years, children refer to young children aged between 3 and 6 years and older children aged between 7 and 11 years. The term ‘toothpaste for infants and children’ should refer to toothpaste for use in the 0-2, 2- 6 and 7-11 age groups which is intended to remove discoloration caused by iron drops in infancy.

[0021] Moisturising agents are used to prevent toothpaste formulations from hardening in the tube or when exposed to air. Short-chain polyalcohols such as glycerol, sorbitol, propylene glycol, polyethylene glycol can be used for this purpose. In the developed formulation, polyethylene glycol between 20-40% w / w, preferably 25% w / w, and sorbitol between 10-40% w / w, preferably 19%, were selected as moisturisers.

[0022] Binding agents can be used to prevent the separation of liquid and solid phases in toothpaste formulations. For this purpose, cellulose derivatives such as methylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, polysaccharides such as sodium alginate, carrageenan, xanthan gum, polymers such as sodium polyacrylate, clay compounds such as bentonite, laponite can provide a suitable viscoelastic structure. In the formulation 2-3% w / w, preferably 2.5% w / w sodium carboxymethyl cellulose was used as a binder.

[0023] Surfactants (surface-active substances) can be used in toothpaste formulations to make it easier for the ingredients to contact the teeth, dissolve plaque and make it easier to clean the teeth. Sodium lauryl sulphate, sodium lauryl sarcosinate, sodium alkylsulfo succinate, sodium cocomonoglyceride, sodium lauroyl glutamate, cocoyl propyl betaine, sodium N-methyl cocoyl taurate, poloxamer, sulphonate and sucrose fatty acid esters can be used for this purpose. In the developed formulation, 0.5-2% w / w, preferably 1-1.5% w / w, more preferably 1.45% w / w sodium lauryl sulphate was selected as surfactant.

[0024] Toothpaste formulations may contain flavouring agents to make the taste soft and pleasant. Sorbitol and glycerol are used as sweeteners in the formulation. In addition, sodium saccharin, xylitol can be used for this purpose. In the developed formulation, 0.15-0.25% w / w, preferably 0.2% w / w of sweetener can be used.

[0025] Water-insoluble essential oils such as peppermint, eucalyptus and menthol, or combinations thereof, may be used at 0.5-1.5% w / w, preferably 1% w / w, to give toothpaste formulations a refreshing flavour.

[0026] Toothpaste formulations may contain abrasive substances that clean teeth. For this purpose, substances such as silica, calcium carbonate, calcium phosphate, calcium pyrophosphate, sodium bicarbonate, sodium pyrophosphate, aluminium hydroxide can be used. In the developed formulation, calcium carbonate was selected as the abrasive in a ratio of 15-55% w / w, preferably 50% w / w.

[0027] Toothpaste formulations may contain therapeutic agents such as sodium fluoride, potassium nitrate, strontium salts, triclosan, pyrophosphates, antimicrobial preservatives such as alcohols, sodium benzoate, parabens, coloring agents such as titanium dioxide to reduce caries and sensitivity. However, since the formulation developed is intended for infants and young children, the use of these substances has been avoided.

[0028] The properties of the formulation as described above are given in the table below.

[0029] The developed toothpaste does not contain preservatives and is safe to use. Thus, a stable, smooth, glossy, tasty and safe formulation was developed. The formulation has sufficient foam and is easy for children to clean. Example 1. Infant / child toothpaste has been prepared according to the following formulation.

[0030] Advantages:

[0031] With the toothpaste developed, the product that can provide a solution to tooth discoloration caused by iron drops, the use of which is deemed necessary' by health authorities, will prevent the formation of iron-rel ted discoloration and will provide the breakdown of the discoloration compounds formed . The developed toothpaste formulation will prevent the formation of iron compounds on the surface of the teeth during the process of supplementation with iron- comprising drops through the parental brushing / cleaning method at home as part of daily oral hygiene habits, and will ensure the breakdown of the formed compounds.

[0032] The invention of a toothpaste to prevent iron discoloration in infants has the following advantages:

[0033] • The advantage of home-type application is provided to current solution of iron discoloration on tooth surface requiring clinical environment and mechanical technological tools.

[0034] It will be possible to prevent discoloration of the teeth of infants before it occurs with daily use at home. It prevents iron discoloration of baby teeth caused by the iron drops that babies use every day from 6 months to 2 years of age, and can remove discoloration that has already occurred.

[0035] • The stress that the dental clinic environment and the equipments to be used will cause for the baby and the family will not be experienced with the home-type daily application.

[0036] ■ The possible injury' risks that the dental clinic environment and the equipments to be used may cause for the baby will not be experienced with the home-type daily application.

[0037] ■ There will be no financial cost to the family for the dental intervention.

[0038] Families will start to apply daily oral dental hygiene to their babies from 6 months of age (when the first milk teeth erupt).

[0039] • Daily oral and dental health habits that start early in life will last a lifetime and prevent oral and dental diseases. The perspective of 'developing dental care awareness when toothache occurs', which is common in our country and worldwide, can be changed to 'dental care awareness before the pain symptom occurs', starting from infancy.

[0040] • The family physicians / paediatricians who follow up infant patients will gain a perspective and awareness of oral dental health.

[0041] On the other hand, the toothpaste developed will be a new medical and cosmetic protective / preventive / treatment product that is easy to use, highly effective, economical, has a long shelf life and can be used in all kinds of platforms such as Mother and Child Health Centres, family physicians and kindergartens in terms of public health.

Claims

CLAIMS1- A toothpaste for use in infants and children, characterised in that it comprises phytic acid or its salt at the rate of 0.5-1.5% w / w, preferably 0.85% w / w, and is used for the removal of iron-related discoloration of infant milk teeth.2- The toothpaste for use in infants and children according to claim 1, characterised in that polyethylene glycol is used as a moisturiser in an amount of 20-40% w / w, preferably 25% w / w, and sorbitol in an amount of 10-40% w / w, preferably 19% w / w.3- The toothpaste for use in infants and children according to claim 1, characterised in that sodium carboxymethylcellulose of 2-3% w / w, preferably 2.5% w / w, is used as a binder.4- The toothpaste for use in infants and children according to claim 1, characterised in that sodium lauryl sulphate of 0.5-2% w / w, preferably 1-1.5% w / w, more preferably 1.45% w / w is used as a surfactant.5- The toothpaste for use in infants and children according to claim 1, characterised in that sweetener of 0.15-0.25% w / w, preferably 0.2% w / w is used as a sweetener.6- The toothpaste for use in infants and children according to claim 1, characterised in that water-insoluble essential oils such as peppermint, eucalyptus and menthol, or combinations thereof, are used as flavouring in an amount of 0.5-1.5% w / w, preferably 1% w / w.7- The toothpaste for use in infants and children according to claim 1, characterised in that calcium carbonate of 15-55% w / w, preferably 50% w / w is used as an abrasive.8- The toothpaste for use in infants and children according to claim 1, characterised in that it does not comprise any substance for therapeutic purposes, an antimicrobial preservative, colouring agent.

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