JP5080940B2 - Dental surface treatment agent - Google Patents

Description

  The present invention is applied at the time of root canal treatment, periodontal disease treatment, restoration treatment, etc. in dentistry, and is provided with cutting scraps, so-called smear layers, which are generated on the dentin cutting surface when the tooth is mechanically shaved. The present invention relates to a dental tooth surface treatment agent for dissolving and removing.

  In dental treatment, treatment is carried out to remove infected sources by mechanically cutting infected tooth material, so-called caries and pulp.

  In the repair treatment, which cuts and removes the infected tooth material and fills with artifacts such as metal, ceramics, and resin, when the infection reaches the pulp, the root canal source and root canal dentin are removed. After enlargement, root canal disinfection, root canal treatment that fills the root canal, and periodontal disease treatment that polishes the tooth surface to remove the tartar fixed to the root surface, in each case, the dentin surface is cut. It is known that, when polished, cutting waste called a smear layer is formed on the surface of the dentin, which causes various adverse effects during treatment. (Non-Patent Document 1)

  First, in the case of repair treatment, a tooth requiring treatment is in a state called so-called caries, in which soft tissue is softened and disintegrated due to bacterial infection to form a deep and progressive axilla. This softening and disintegration reaches the enamel-dentin boundary of the tooth, and if it progresses further and the dentin suffers from caries, it becomes dentin caries, and the dentine is in a state where bacteria exist, that is, the caries dentin first layer become. Appropriate treatment for these symptoms is to remove the first layer of carious dentin affected by this bacterial infection using a bar or excavator, etc., and restore the restoration while keeping the cavity inside sterile. Is to fill. However, a smear layer is formed on the cavity wall by mechanical tooth removal at this time. This smear layer not only prevents the adhesion of subsequent restorations, but also causes a so-called secondary caries that will cause caries from below the restorations in the future due to bacteria remaining in the smear layer, and is treated again. You may be forced to receive.

  In the case of root canal treatment, the root canal of the tooth that requires treatment is filled with tissue fragments, necrotic fragments, bacteria and their produced toxins, and spoilage products, and root canal dentin is also inflamed. These sources of infection need to be eliminated because they are contaminated with sexual stimulants. The purpose of this root canal treatment is to prevent sterilization of the root canal and prevent re-infection of the tissues surrounding the apex, and there are three main procedures: root canal enlargement, root canal disinfection, and root canal filling. Separated. In particular, root canal enlargement is an important technique for successful root canal treatment. After the root canal is enlarged, the infection source is eliminated by mechanically cleaning and expanding the root canal using a file, a reamer, or the like. In particular, in the case of infected root canals, bacteria remain in the smear layer, and bacteria have invaded the dentinal tubules immediately below the smear layer. Sterilization within the root canal cannot be achieved, for example, preventing the penetration of the agent, which can adversely affect the prognosis.

  Furthermore, in the case of periodontal disease treatment, a tooth that requires treatment is a state in which a gap between the surface (root surface) of the tooth root and the gingiva, a so-called periodontal pocket, is deepened, and plaque (teeth) is contained in the pocket. ) And tartar, and many bacteria exist in these. For this purpose, plaque and tartar in the periodontal pocket are mechanically cleaned using a scaler (SRP: scaling / root planing), and at the same time, the causative bacteria are eliminated. After that, periodontal pockets are filled with antibacterial agents and anti-inflammatory agents to reduce inflammation according to the symptoms. At this time, there is a smear layer on the tooth surface to which SRP has been applied in the same way, not only preventing the antibacterial agent and anti-inflammatory agent from reaching the affected area, but also fearing that the bacteria remaining in the smear layer may affect the prognosis. It is.

  Thus, the idea that “the smear layer should be removed” has become widespread in any dental treatment, and various drugs and methods for that purpose have been studied.

  At present, as disclosed in Patent Document 1, as a smear layer removing agent, ethylenediamine-4acetic acid (hereinafter referred to as EDTA) reacts with calcium ions in cutting dentin to form soluble calcium chelate. In order to form, it is widely used as being convenient for dissolving and removing the smear layer.

  However, it has been known that the smear layer removing agent using EDTA has a therapeutic problem.

  Depending on the site of application for restoration treatment and periodontal disease treatment, this EDTA preparation will be difficult to apply because it will flow down in liquid form, so that it will be viscous and filled into a tube or syringe-like container to make it easy to collect. Is preferred. In this case, it is necessary to contain a relatively high concentration of EDTA in order to ensure a sufficient smear layer dissolving power even when viscosity is applied. In addition, in order to ensure excellent operability, the obtained tooth surface treatment agent is required to maintain a stable and stable property that can be applied to the affected area without stress, and can be quickly removed from the affected area by washing with water after application. . In this sense, some of the commercial products already have gels or pastes containing EDTA and thickeners such as carbowax and sodium carboxymethylcellulose. By increasing the viscosity, EDTA acts on the tooth surface. Some allow it to stay on the tooth surface for a sufficient time. However, such a commercial product has increased efficiency at the time of application due to thickening, but also has a problem due to the incorporation of a thickener. For example, in a commercial product using carbowax as a thickener, the carbowax pushed into the complex morphological site in the root canal during the enlargement of the root canal is left behind on the root canal wall after washing, and the remaining carbowax Has been pointed out that it may inhibit close root canal filling (Non-patent Document 2). In addition, when a cellulose derivative such as carboxymethylcellulose is selected as the thickener, the resulting tooth surface treatment agent changes with time and becomes hard, ensuring easy extrusion from a container such as a tube or syringe. It has a defect due to the drying of the thickener that cannot be done.

  Furthermore, there are many other examples in which EDTA is thickened. For example, Patent Document 2 uses a method for adjusting the condition during the formation of an orbital sinus by etching for bonding a restoration material to enamel and dentin. An aqueous composition containing EDTA as an ivory portion etchant is disclosed. Further, in Patent Document 3, for use in biological calcification surface conditioning, in particular, tooth root conditioning by selective removal of a portion of the exposed tooth root surface in order to improve the connection after the teeth with periodontal surgery. As a composition in combination with an aqueous matrix or carrier containing an effective amount of EDTA as an active substance. In these compositions, as thickeners, celluloses such as ethyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose and their salts and derivatives thereof, starches and derivatives thereof such as hydroxyethylated starch, plant gums, xanthan gums, Examples include microbial capsular polysaccharides such as curdlan, pullulan and dextran, and algal polysaccharides such as agar, carrageenan and alginic acid. Furthermore, proteins and glycoproteins have been proposed in place of polysaccharides, and include gelatin, modified structural proteins and proteoglycans.

  Furthermore, Patent Document 4 discloses a dental etching composition in a form suitable for etching with an acid to which a viscosity improver is applied. EDTA is selected as one of the acids, and a polyoxyalkylene polymer is selected as the viscosity improver. Patent Document 5 discloses a dental adhesive kit in which EDTA is selected and, if necessary, a polymer compound such as polypyrrolidone, carboxymethyl cellulose, and polyvinyl alcohol, and a viscosity modifier such as highly dispersed silica are blended. It is disclosed.

  As described above, many methods for thickening EDTA have been proposed, but these thickeners are selected to thicken a relatively high concentration of EDTA to form a gel or paste-like tooth surface treatment agent. In this case, separation of the preparation considered to be caused by a high concentration of EDTA occurs, and it cannot be a uniform and stable tooth surface treatment agent. In addition, especially when cellulose and its derivatives are selected as thickeners, the obtained tooth surface treatment agent is filled in, for example, a tube or syringe-like container, and takes a form that can collect an appropriate amount. If an appropriate amount is collected and left in the air as it is, there is a problem that the preparation is dried and solidified at the tip of the container and cannot be collected thereafter. Moreover, since the thing thickened with alginic acid is lacking in water washability, it has a problem that it has big influence on the result of a subsequent treatment.

  Further, inorganic thickeners such as highly dispersed silica are disclosed in, for example, blending into EDTA as an antioxidant in the rough skin preventing agent and cosmetics of Patent Document 6, and are shown as this thickener. Aluminum Magnesium Silicate, Aluminum Silicate, Montmorillonite, Magnesian Montmorillonite, Tetsumontmorillonite, Tetsumagnesian Montmorillonite, Baydelite, Aluminian Bidelite, Sapphire, Aluminian Support Stone, Bentonite, Laponite, This applies to fine silicon oxide and colloidal alumina. When these are selected as thickeners, there is a high possibility that thickener fine particles will remain in the fossa wall and root canal even if washed with water after application, which also has a significant effect on the results of subsequent treatments. Become.

  There are also many techniques related to polyhydric alcohol esters of alginic acid as thickeners. For example, in a composition for inducing binding as disclosed in Patent Document 7, propylene glycol alginate is selected as a carrier, diluent or adhesive added to a protein fraction obtained from an enamel matrix as an active ingredient. Patent Document 8 discloses a preparation intended to gradually release a pharmacologically effective ingredient over a period of several hours as a sustained release preparation composed of propylene glycol alginate. In Patent Document 9, a water-soluble polymer is selected as a therapeutic agent for periodontal disease, and a water-soluble polymer is selected in order to disperse a substance effective for the treatment of periodontal disease based on polymer particles. In addition, propylene glycol alginate is used. Patent Document 10 discloses a viscous preparation containing a basic fibroblast growth factor and contains a thickener in the active ingredient, and propylene glycol alginate is selected as the thickener. ing. Furthermore, Patent Document 11 discloses an alginic acid-containing composition, which contains an alginic acid derivative and boric acid and / or a salt thereof, and enhances the increase in viscosity when contacted with a fluid derived from a living body. Is intended. In addition, Patent Documents 12 to 16 each select propylene glycol alginate for the purpose of thickening.

However, none of these are intended to dissolve the smear layer on the dentin surface, and application to the tooth surface treatment agent is impossible or difficult from the viewpoint of the ability to remove the smear layer, which is also the object of the present invention. is there.
Japanese Patent No. 3463985 JP 10-511638 A JP 10-505859 gazette Special table 2002-529485 gazette Japanese Patent No. 3881431 JP 2002-255728 A Japanese Patent No. 2795667 Japanese Patent No. 2511577 Japanese Patent Publication No. 5-84282 International Publication No. 03/083221 Pamlet JP 2006-348055 A JP-T-2002-504520 Special Table 2002-538211 JP 2007-1112739 A JP 2006-76898 A JP 2006-176479 A The Quintessence, Vol. 15, pp. 446-448 (1996) Dental Diamond, Vol. 24, No. 330, pp. 42-49, 1999

  The problem of the present invention is that it is a gel or paste-form preparation that can be easily applied to a site that was difficult with a liquid drug, while ensuring the ability to dissolve and remove a smear layer equal to or higher than that of a liquid drug. An object of the present invention is to provide a dental tooth surface treating agent having operability superior to that of a dental tooth surface treating agent according to the technology.

  More specifically, a thickening agent is added to a relatively high concentration EDTA aqueous solution to give viscosity, and it is easy to collect, for example, by filling into a tube or syringe-like container, and the affected area is uniform and without stress. It is intended to provide a dental tooth surface treatment agent that has properties that can be applied to the skin, maintains the properties stably, and is washed with water after application and can be immediately removed from the affected area.

  As a result of extensive investigations on thickeners selected as dental tooth surface treatment agents, the present invention increases the viscosity of a relatively high concentration of aminocarboxylic acid with propylene glycol alginate and adjusts the pH to a neutral range. It was found that the prepared composition was excellent in terms of washing performance, operability and property stability, and was completed.

  That is, the dental tooth surface treatment agent of the present invention contains 15 to 30% by mass of a chelating agent composed of an aminocarboxylic acid and 1 to 12% by mass of propylene glycol alginate, and has a pH of 7.0 or more. It is characterized by being adjusted to less than 5.

  Examples of aminocarboxylic acids include ethylenediamine-4-acetic acid (EDTA), hydroxyethylimino-2acetic acid (HIDA), nitrilo-3-acetic acid (NTA), hydroxyethylethylenediamine-3acetic acid (HEDTA), diethylenetriamine-5-acetic acid (DTPA), One or more selected from dihydroxyethylglycine (DHEG) and triethylenetetramine-6acetic acid (TTHA) can be used.

  The concentration of the aminocarboxylic acid in the dental tooth surface treating agent of the present invention is suitably 15 to 30% by mass from the viewpoint of the ability to remove the smear layer. If it is in the form of an aqueous solution, a concentration of less than 15% by mass is effective, but when applied in a paste form, the wettability to the tooth surface is reduced, so a concentration of 15% by mass or more is required. In general, aminocarboxylic acid compounds exhibit higher solubility as the pH value increases. However, in order to avoid problems such as crystal precipitation while keeping the dental surface treatment agent neutral, it is necessary to regulate the concentration of aminocarboxylic acid, which is 30% by mass or less.

  In addition, as the alginate propylene glycol ester contained in the dental tooth surface treatment agent of the present invention, products that meet food additive standards are commercially available, and such products can be used. As the ester, all the carboxyl groups may be esterified or a part thereof may be esterified.

  The concentration of propylene glycol alginate in the dental tooth surface treatment agent influences the viscosity of the dental tooth surface treatment agent to be finally obtained along with the concentration of aminocarboxylic acid and pH value to be blended. In order to obtain a desired viscosity, the blending amount is appropriately adjusted.

  However, the formulation of an excessive amount of propylene glycol alginate is undesirable because it impairs the operability of the resulting dental tooth surface treatment agent, imparts the desired viscosity, and has good operability. In order to obtain an agent, 1 to 12% by mass is a preferable concentration.

  The pH of the dental tooth surface treatment agent needs to be adjusted to a neutral region in consideration of the risk of mucosal adhesion, and the specific value is 7.0 or more and less than 8.5. . The pH may be adjusted as long as it reacts with aminocarboxylic acid and does not inhibit the chelating ability of aminocarboxylic acid. Specifically, alkali metal hydroxide is preferred. In addition, an alkali metal salt of aminocarboxylic acid may be used as a starting material, and in this case, the same effect can be obtained by adjusting the pH.

  The dental tooth surface treatment agent of the present invention is a form that is easy to collect by, for example, filling a tube or syringe-like container by adding a viscosity by adding a thickener to a relatively high concentration EDTA aqueous solution, It has a property that is uniform and can be applied to the affected part without stress, maintains its property stably, and can be washed immediately after application and removed from the affected part immediately. As a result, while having a gel or paste shape that facilitates application to a site that was difficult with a liquid drug, it has the ability to dissolve and remove a smear layer that is equivalent to or better than a liquid drug.

  Hereinafter, an example in which the dental tooth surface treatment agent of the present invention is applied to restoration treatment will be described.

  After forming a cavity according to a conventional method, a dental tooth surface treatment agent (hereinafter simply referred to as “tooth surface treatment agent”) is filled into a syringe, an injection needle is attached to the syringe, and the cavity is filled for 1 minute. After leaving it, it was washed with a water gun and dried by air blow, and the procedure shifted to a repair treatment method using an adhesive repair material.

  Tables 1 and 2 show the compositions and pH values of the tooth surface treating agents of Examples 1 to 7 and Comparative Examples 1 to 12, respectively. Each prepared tooth surface treatment agent was filled in a syringe, and the following test was performed and evaluated.

(Smear layer removal ability and operability)
A cylindrical cavity having a diameter of about 2.0 mm and a depth of about 1.0 mm was formed in the healthy dentin of fresh human-extracted permanent teeth, and each cavity was conditioned using a tooth surface treatment agent for 60 seconds, followed by washing and drying. Thereafter, the tooth surface was subjected to alcohol dehydration, critical point drying, platinum palladium vapor deposition, and SEM observation was performed using Hitachi S-4700. At this time, the “operability” when applied in the cavity, that is, “ease of application to the cavity” was also evaluated.

(Cleanability)
Box cavities (general shape: 6 mm × 6 mm × 3 mm) are formed in the crown of the bovine anterior tooth under water injection, and each tooth surface treatment agent shown in Tables 1 and 2 is applied thereto, and after leaving for 60 seconds, Washed with a gun for 10 seconds. Immerse in the Japanese Pharmacopoeia purified water for 1 hour so that all the cavities formed in the crown after washing with water are immersed, then wash the inside of the cavity and match the washing with the immersion liquid, evaporate all under dry airflow, The mass of the evaporation residue was measured and used as an index of detergency.

(Property stability 1: Dryability)
An appropriate amount of each tooth surface treatment agent shown in Table 1 and Table 2 filled in the syringe was collected by attaching an injection needle (tip diameter: about 1.5 mm). The syringe after collection was left in the room (room temperature 23 ± 1 ° C., relative humidity 50 ± 5%) for 3 hours with the injection needle attached, and then it was confirmed whether or not it could be collected without any problems.

(Property stability 2: Formulation maintenance)
Each tooth surface treatment agent shown in Table 1 and Table 2 filled in the syringe was stored under each storage condition of 25 ° C., refrigeration, and 40 ° C., and the properties were regularly checked.

  Table 3 shows the results of each test. As shown in the table, in Examples 1 to 7, the situation of removing the smear layer on the fossa wall is good, and at the same time, all of the operability, detergency, and property stability (drying properties and formulation maintenance properties) can be satisfied. It was a thing.

  On the other hand, since the comparative example 10 had few blending quantities of EDTA, the satisfactory smear layer removal capability was not obtained. This is thought to be a result of a reduced opportunity for contact with the tooth surface as compared to the liquid form.

  Similarly, Comparative Example 6 does not satisfy the smear layer removing ability. At the same time, Comparative Example 6 had a viscosity that pulled the yarn and did not have a smooth property, so that a good operational feeling was not obtained. It has been found that such properties are based on the nature of the thickener selected and cannot be improved by changing the amount. In addition, even when propylene glycol alginate was selected as a thickener as in Comparative Example 12, it was found that if the blending amount was too large, the operability was impaired.

  Furthermore, in Comparative Examples 2, 3, 7, and 8, although the smear layer could be removed properly, it remained on the tooth surface after being washed with a water gun. If the thickener has low affinity or wettability to water, or if it contains something that does not dissolve in the first place, the treatment agent on the tooth surface cannot be washed off even during the prescribed water washing operation. It is thought that it became. Moreover, in the comparative example 1, when the processing agent was left as it was, it dried, and subsequent use became difficult.

  In Comparative Examples 1, 9, and 11, when the preparation is stored, it changes with time and changes hard, occurrence of solid-liquid separation, precipitation of crystals, and the like are observed. In Comparative Examples 4 and 5, the preparation itself is It was not established, and a defect as a preparation was confirmed.

  Thus, the tooth surface treatment agent of the composition listed in each comparative example has a property that can be applied to the affected area without stress, as in the case of the examples of the present invention, and stably maintains the property, After application, it could not be said to be a tooth surface treatment agent that could be washed with water and quickly removed from the affected area.

Claims (3)

  A dental tooth surface treatment agent for removing a smear layer after dentin surface cutting, containing 15-30% by mass of a chelating agent comprising aminocarboxylic acid and 1-12% by mass of propylene glycol alginate And a dental tooth surface treatment agent having a pH value of 7.0 or more and less than 8.5.   The aminocarboxylic acid is selected from the group consisting of ethylenediamine-4 acetic acid, hydroxyethylimino-2acetic acid, nitrilo-3 acetic acid, hydroxyethylethylenediamine-3 acetic acid, diethylenetriamine-5 acetic acid, dihydroxyethylglycine, triethylenetetramine-6 acetic acid. The dental tooth surface treatment agent according to claim 1, which is either one or two or more.   The dental tooth surface treating agent according to claim 1 or 2, wherein an alkali metal hydroxide is used as the pH adjusting agent.