A bioactive cavity disinfectant

Abstract

The invention relates to a gel-structured chemical composition containing tannic acid as an active ingredient, which aims to effectively and successfully clean / disinfect bacteria and residues that may remain in the environment following the mechanical removal of dental caries.

Description

[0001] A BIOACTIVE CAVITY DISINFECTANT

[0002] Field of the Invention

[0003] The invention relates to a bioactive cavity disinfectant.

[0004] The invention relates to a chemical composition in an active gel structure that aims to effectively and successfully clean / disinfect the remaining bacteria and residues that may be present in the surface following the mechanical removal of dental caries.

[0005] State of the Art

[0006] Cavity preparation of dental caries is a restoration procedure performed to remove infected dentin from restorative dentistry stages and create space for restoration (dental filling) material. After the cavity preparation with rotary tools called burs, a 2 m thick debris layer consisting of residue such as dental tissue particles, bacteria and bacterial residues is formed on the dentin surface. The name given to this layer is the smear layer. The success of the cavity preparation procedure in dentistry depends on the effective removal of the infected layer of carious dentin tissue before application and the disinfectant materials applied by the physician to the cavity remaining in the area of application without dispersion and not dispersing by showing a local effect.

[0007] Among the current applications, the closest to ideal cavity disinfectant is thought to be chlorhexidine applied in 2% concentration. (1 ,2) However, it is known that chlorhexidine leads to microleakage by affecting the restorative material from bonding to the dental tissues. (3,4,5). Chlorhexidine 2% products used in the routine also contain ethanol.

[0008] Considering the medical use of tannic acid as an active ingredient, its use as an agent that improves skin quality in cosmetic cream formulation was observed in the national patent application numbered TR2015 / 02477; and its use as an active ingredient in wound burn material was observed in the national patent application numbered TR2016 / 11293. However, there are no studies in the literature on the use of tannic acid as an active ingredient in dental cavity disinfectant in gel structure.

[0009] As a result, due to the aforementioned issues and the inadequacy of existing solutions, it has become necessary to make advancements in the relevant technical field.

[0010] The Objective of the Invention

[0011] The object of the invention is to solve mentioned disadvantages by being inspired from the current conditions.

[0012] The main object of the invention is to provide a cavity disinfectant that displays bioactivity and does not contain alcohol, which provides effective and successful cleaning / disinfection of bacteria and their residues based on the antioxidant effect that can be found in the environment following the mechanical removal of tooth caries with the active substance content of tannic acid.

[0013] An object of the invention is to provide a cavity disinfectant that thanks to its gel structure, the disinfectant materials applied to the cavity by the physician can remain undispersed in the applied area and do not disperse by showing a local effect.

[0014] An object of the invention is to provide a cavity disinfectant which by showing synergistic effect with adhesive restorative materials during the dental filling stage does not disrupt the bonding of the restorative materials to the dental tissues and thus does not lead to microleakage.

[0015] An object of the invention is to provide a cavity disinfectant which has a pH value applicable to the exposed dentin surface. In order to fulfil the above-mentioned objects, the invention is a chemical composition in an active gel structure developed for use in dentistry, which aims to effectively and successfully clean / disinfect the remaining bacteria and residues that may be present in the environment following the mechanical removal of dental caries, and comprises; standardized tannic acid homogeneously dissolved in citric acid solvent, at least one thickener and distilled water.

[0016] The structural and characteristic features and all the advantages of the invention will be understood more clearly thanks to the detailed description given below, and therefore the evaluation should be made by taking this detailed description into consideration.

[0017] Detailed Description of the Invention

[0018] In this detailed description, the composition and the preferred embodiments of the invention are described only for a better understanding of the subject.

[0019] The invention is an alcohol-free chemical composition with an active gel structure which is developed for use in dentistry, which aims to effectively and successfully clean / disinfect the remaining bacteria and residues that may be present in the environment following the mechanical removal of dental caries, and comprises standardized tannic acid, citric acid, at least one thickener and distilled water.

[0020] According to an embodiment of the invention, the mentioned thickener is Hydroxy ethyl cellulose and / or methyl cellulose, preferably hydroxy ethyl cellulose.

[0021] The active ingredient of the invention, tannic acid, belongs to the polyphenol group which can be extracted from various plant leaves and seeds. Due to its antioxidant activity, its antibacterial effect varies depending on the type of plant it is extracted from, harvest time and harvest type (6). While the tannic acid used in the mixture which is the subject of the invention is standardized absolutely, it also has a specific CAS value.

[0022] The active ingredient of the invention, tannic acid, has been proven to have significant positive effects on dentin collagen, which is an important component of the hybrid layer, and its stability (7). Unlike chlorhexidine, which is currently used, it increases the mechanical properties and stability of the dentin matrix and can prevent microleakage that may occur with this property.

[0023] The active pH value of the gel chemical composition which is the subject of the invention is between 1 .8-2.7 and is preferably pH 2.21 .

[0024] In the embodiment of the invention, the main active ingredient tannic acid is a poorly soluble component in distilled (pure) water, showed sufficient and high quality dissolution in water with a pH value reduced with citric acid. In the literature, the effectiveness of different solvents in removing the "smear layer" on the dentin surface and protecting dentin plugs without causing postoperative sensitivity has been measured and the superior properties of citric acid have been revealed (8). Therefore, citric acid solvent is one of the basic ingredients that should be present for the invention.

[0025] In the literature, it has been reported that the bioactivity of polyphenols such as tannic acid is increased by ultrasonication (9). The fact that the mixture subject to the invention was mixed with ultrasonic methods (sonication) was effective in homogenizing the solution and increasing its bioactivity.

[0026] For foods with halal properties: any product derived from or contaminated with the carcass of dead animals; coagulated or flowing blood; pork and its byproducts; animals slaughtered without the name of Allah; animals killed in a way that prevents their blood from being completely drained from their bodies; those who contain alcohol, carnivorous animals such as lions, dogs, wolves or tigers; birds with sharp claws such as hawks, eagles, owls or vultures; terrestrial animals such as frogs and snakes and products other than their products are considered halal (10). The formulation which is the subject of the invention is "halal" in that it does not contain alcohol (10).

[0027] The phenomenon called thixotropic effect in dentistry means that the materials applied by the physician into the patient's mouth can remain undispersed in the applied area and do not disperse by showing a local effect. The inventors revealed that the gel disinfectants obtained during the research and development studies provide a thixotropic effect in the dental cavity with the synergistic effect of the compositions within the scope of the prescriptions given in Table 1 .

[0028] Table 1 contents of the composition which is the subject of the invention

[0029] The method of the invention comprises the following process steps in its most basic form within the scope of the prescriptions provided in Table 1 :

[0030] - Dissolving citric acid with distilled water and homogenizing it by adding distilled water up to the predetermined amount,

[0031] - Adding standardized 99.9% pure tannic acid in powder form to the prepared base component and homogenizing, preferably resting; - Homogenizing by adding a predetermined amount of thickener to the solution, preferably resting the obtained gel product.

[0032] In the method of the invention, preparations should be carried out at room temperature, preferably in the range of 20-22<C. Ea ch stage of the addition of tannic acid-citric acid solution and hydroxy ethyl cellulose should be homogenized by being subjected to ultrasonic sonication at 10,000-24,000 rpm for 1 -10 minutes.

[0033] In the method of the invention, it is important to store Tannic acid under appropriate storage conditions, to have the purity of the water and tannic acid used at 99.9% and above, to prepare the solution fresh and to pay attention to the appropriate rotation speed and rpm during the sonication stage.

[0034] EXAMPLE 1 :

[0035] The citric acid which is an organic acid derivative (1 ,2,3-tricarboxylic-2- hydroxypropane; 2-hydroxypropanetricarboxylic acid) compound was dissolved in 5 ml of distilled water at room temperature and the base component was completed with 100 ml of distilled water.

[0036] Tannic acid component CAS Number: 1401 -55-4; Molecular weight: 1701.20 FEMA No: 3042 2gr. Was weighed on precision scale.

[0037] 2 grams of tannic acid at 99.9% purity in powder form was added to 100 ml. of the base component.

[0038] The mixture was homogenized by being subjected to ultrasonic sonication at 10.000-24.000 rpm for 1 -10 minutes.

[0039] The mixture was kept in an amber coloured bottle in a dark environment at room temperature for 48 hours.

[0040] Gelling property forming thickeners were added and the final product was obtained after kept for 24 hours.

[0041] Tannic acid can be dissolved in acetic acid or phosphoric acid which another organic acid. However, according to pH measurements repeated 3 times, the pH values of tannic acid preparations dissolved in water solutions of Acetic acid, citric acid, and phosphoric acid were detected to be 3.24, 2.21 , and 1.74, respectively on the Mettler Toledo / Seven Compact Duo S214 model pH gadget. However, tannic acid did not dissolve in the phosphoric acid solution at the desired concentration and showed precipitation / clouding. Although the pH values of dental agents applied to the open dentin surface differ from product to product in the literature, it was found to be 2.7 for Single Bond Universal; 1 .8 for Gluma Bond Universal; and 2.5 for Prime&Bond Elect (11 ). In this case, citric acid, which dissolves at the desired concentration and has a pH value in accordance with the literature, is a suitable solvent for disinfection of the smear layer (complex structure comprising bacterial residues and dentin shavings) formed on the dentin surface. The fact that the invention is an agent suitable for professional use by dentists for disinfection on the enamel / dentin surface distinguishes it from all other preparations containing tannic acid. In addition, methyl cellulose can be added instead of Hydroxy ethyl cellulose.

[0042] REFERENCES

[0043] 1. Singla M, Aggarwal V, Kumar N. Effect of chlorhexidine cavity disinfection on microleakage in cavities restored with composite using a self-etching single bottle adhesive. J Conserv Dent. 2011 ;14(4):374-377. doi:10.4103 / 0972- 0707.87201

[0044] 2. Siwinata M, Zubaidah N, Soetojo A. The effectivity of cavity cleanser chlorhexidine gluconate 2% and saponin 0.78% of mangosteen peel. Conservative Dentistry Journal. 2020; 10(1 ): 19-22

[0045] 3. Ipek A, Ozgul B, Tamer T, Fatih E, Aykut C, Mehmet KF. The effects of cavity disinfection on the nanoleakage of compomer restorations: an in vitro study. Eur Oral Res 2020; 54(1 ): 16-24.

[0046] 4. Tulunoglu O, Ayhan H, Olmez A, Bodur H. The effect of cavity disinfectants on microleakage in dentin bonding systems. J Clin Pediatr Dent 1998;22(4):299-305.

[0047] 5. Jones CG. Chlorhexidine: is it still the gold standard? Periodontol 2000 1997;15(3):55-62.

[0048] 6. Xuan Cuong D, Xuan Hoan N, Huu Dong D, Thi Minh Thuy L, Van Thanh N, Thai Ha H, Thi Thanh Tuyen D, Xuan Chinh D. 2019. Tannins: extraction from plants. In: Aires A, editor. Tannins - structural properties, biological properties and current knowledge. London, UK ntechOpen.

[0049] 7. Bedran-Russo AK, Yoo KJ, Ema KC, Pashley DH. Mechanical properties of tannic-acid-treated dentin matrix. Dent Res. 2009;88(9):807-811 . doi:10.1177 / 0022034509342556

[0050] 8. Benderli Y, Yucel T. Qe§itli Qbzucu Ajanlarm Dentin Yuzey Etkilerinin Degerlendirilmesi-The Evaluation Of Surface Treatment Effects Of Various Acid Solutions On Dentine Surface. J Istanbul Univ Fac Dent. Temmuz 2013;29(4):227-234. 9. Bartzoka, E.D., Lange, H., Crestini, C. (2015). Ultrasound Functionalization of Polyphenols. In: Ashokkumar, M. (eds) Handbook of Ultrasonics and Sonochemistry. Springer, Singapore, https: / / doi.org / 10.1007 / 978-981 -287-470- 2_21-1 10. Saha T, Rifat T, Shimanto S. Prospects of Halal Pharmaceuticals. Asian

[0051] Journal of Ethnopharmacology and Medicinal Foods. 2019; 5(2): 17-23.

[0052] 11 . Ugurlu M. Bonding of a resin-modified glass ionomer cement to dentin using universal adhesives. Restorative Dentistry & Endodontics 2020; 45(3): e36

Claims

CLAIMS1. An alcohol-free chemical composition with active gel structure which is developed to be used in dentistry, which aims to clean / disinfect bacteria and their residue effectively and successfully following the mechanical removal of dental caries, characterized by comprising; standardized tannic acid, citric acid, at least one thickener and distilled water.

2. The composition according to claim 1 , characterized by comprising; 99,9% purity standardized tannic acid 0.78-20% by weight , citric acid 1 - 5% by weight, thickener 0.5-5% by weight, distilled water 10-95% by weight.

3. The composition according to claim 1 and 2, characterized by comprising; standardized tannic acid with a purity of 99.9% at a ratio of 2% by weight, citric acid at a ratio of 1%, thickener at a ratio of 4%, distilled water at a ratio of 93%.

4. The composition according to any claims 1 to 3, characterized in that; the mentioned thickener is Hydroxy ethyl cellulose and / or methyl cellulose.

5. The composition according to claim 4, characterized in that; the mentioned thickener is Hydroxy ethyl cellulose.

6. The composition according to any claims 1 to 5, characterized in that; the pH value is between 1 .8-2.7.

7. The composition according to claim 6, characterized in that; the pH value is 2.21 .

8. A method for producing mentioned composition according to any preceding claims, characterized by comprising; the following process steps: i. Dissolving citric acid with distilled water and homogenizing it by adding distilled water up to the predetermined amount, ii. Adding standardized 99.9% pure tannic acid in powder form to the prepared base component and homogenizing, preferably resting; iii. Homogenizing by adding a predetermined amount of thickener to the solution, preferably resting the obtained gel product.

9. The method according to claim 8, characterized in that; the process steps i-iii are carried out at a range of 20-22<C.10.The method according to claim 8, characterized in that; homogenization process of process steps i-iii are carried out by being subjected to ultrasonic sonication at 10.000-24.000 rpm for 1 -10 minutes.

11. The method according to claim 8, characterized in that, the resting processes of process steps ii-iii are carried out in a dark environment for 24-48 hours.

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