JPH0468281B2 - - Google Patents

Description

[Detailed description of the invention]

B. Field of Industrial Application The present invention is used in dental treatment to provide a dental filling (cement) composition that hardens by mixing a powder or paste mainly composed of calcium hydroxide with a liquid or paste mainly composed of fatty acids. Regarding.
The present invention is characterized in that the concentration of calcium hydroxide is increased in this composition, and a resin such as rosin and other components are blended in order to improve operability in clinical practice. B. Prior art A variety of dental fillings (cements) made from calcium hydroxide have been put into practical use, but all of them are either non-hardening paste-like materials or combinations of zinc oxide (ZnO) and eugenol. Calcium hydroxide is added to the basic composition of As a representative example, Vitapex® (Neo Pharmaceutical Industries) (hereinafter abbreviated as Vitapex) has been put into practical use. Vitapex is made by kneading calcium hydroxide and iodoform into silicone oil to form a paste, and is mainly used for root canal filling. In the dental field, X-rays are often used to confirm the state of filling, and iodoform is used as a contrast agent for X-rays, and Iodoform is used for the same purpose in Vitapex. ing. The special feature of this preparation is that iodoform is prescribed as a contrast agent, and calcium hydroxide is used in paste form to improve operability. In addition, the applicant has a prior invention (patent application
51-78405) revealed the following facts.
That is, the specification of the Japanese Patent Application No. 1978-78405
4394), a cement composition obtained by adding calcium hydroxide to the basic composition of ZoO and eugenol and kneading it with silicone oil has a hardened product that has some elasticity and is difficult to root canal. It has been shown to be suitable for use in fillings and gingival dressings. Direct application of calcium hydroxide to the human body is unique to the field of dentistry. Calcium hydroxide is used in the form of powder or paste in dentistry, and it is said that the higher the concentration of calcium hydroxide, the more effective it is, but in terms of physical properties, it is desirable that it harden (harden) after application. ing. It is also desirable that the area of application (described later) has contrast properties and antibacterial properties. Calcium hydroxide's expected medicinal effects occur when the application site undergoes ossification (osseous scarring: formation of thin, soft membranous bone tissue and healing). Used for the interior (pulp cavity) or the tip of the tooth (root apex). In the center of the tooth, there is a canal (root canal) in which the pulp (blood vessels, lymphatic vessels, nerves) runs, and if a bacterial infection occurs due to caries (cavities), a portion of the pulp may be severed (severed). Sometimes the entire pulp is removed (pulp removal). Both are treatments that leave the fat in place (conservative treatment) without extracting the tooth. In this treatment, the calcium hydroxide preparation must also have the properties of a filler to tightly seal the void created by pulp extraction or pulpotomy, and therefore the conditions for use as a filler are as described above. This condition is as important as the ossification effect of . In addition, by utilizing the effect of the original ossification effect, that is, by applying calcium hydroxide, ossification occurs at the application site, and by utilizing the healing property, it is possible to remove the locally remaining pulp (residual pulp) and pulp fragments during pulp extraction. Filling of the stump surface of the tooth pulp with calcium hydroxide (pulp capping) is performed. Based on these effects, the uses of calcium hydroxide agents include root canal filling of baby teeth, root apex filling of permanent teeth, pulp cutting, and pulp capping. C. Problems to be Solved by the Invention As mentioned above, calcium hydroxide has been used in the field of dentistry for a long time to have properties such as scar ossification and healing in living organisms and a protective effect on dental pulp, and preparations that take advantage of these properties have been developed. It's coming. However, the development of a curing reaction involving calcium hydroxide has not yet borne fruit, nor has it been put to practical use. A typical conventional example of a calcium hydroxide preparation that hardens after application is the idea of adding calcium hydroxide to dental cement, which has been used for a long time.A typical example is zinc oxide Eugene Nord cement. Calcium hydroxide has been prescribed. In this case, the curing mechanism utilizes the reaction and curing of zinc oxide and eugenol after kneading, and calcium hydroxide is mixed in this cured product. The advantages of this idea include that it hardens after application, that the kneading operation is smooth, and that it has X-ray contrast properties.However, the next best thing is that there is a limit to the amount of calcium hydroxide that can be prescribed, so high concentrations are required. These problems include the fact that it cannot be contained, and that there is irritation to living tissue due to Eugenol. On the other hand, there are many examples in the prior art of calcium hydroxide preparations that do not harden after application. Calcium hydroxide is mixed with an aqueous solution, filled into a syringe-like container, and when used, the solution is extruded into droplets through a needle-like tube and applied into the root canal. There are also products that have been devised to be suitable. Another example is one in which silicone oil is used as a base and calcium hydroxide and iodoform (contrast medium and bactericidal agent) are kneaded with this. The product itself is in the form of a paste, and does not require a kneading operation beforehand, so it is filled in a syringe-like container in advance, and when used, the paste is extruded and applied to the affected area. The first characteristic of the uncured product is that it does not harden after application, as is the case with many other prior art products. Therefore, in the case of this product, calcium hydroxide is dissolved and dispersed by body fluids after application, and iodoform is warmed by body temperature and sublimated, and further transported by body fluids and disappears from the local area, so that the desired effect is not achieved. The effect may be difficult to sustain, and the base will shrink due to the disappearance of calcium hydroxide and iodoform, and the contracted void will become a cavity (dead space), which may lead to unfavorable therapeutic results. be. One of the reasons why a preparation containing a high concentration of calcium hydroxide has not been achieved in the prior art is that it is simply an organic acid, as opposed to a powder (A agent) containing calcium hydroxide or calcium hydroxide and a suitable contrast agent. If you just add the liquid agent (Part B) and knead it, the powder and liquid agent will react in a short time and harden too quickly.
This is because the reaction proceeds unevenly. The present inventors conducted research aimed at controlling this rapid reaction and arrived at the present invention. D. Means for Solving the Problems In carrying out the present invention, it was confirmed that glycols can serve this purpose in order to control the above-mentioned premature reaction between the powder and the liquid. However, on the other hand, calcium hydroxide has very poor compatibility (wetting) between the powder surface and the liquid. If the compounding ratio of agent B is increased, it will not be possible to mix it, and if the compounding ratio of agent B is increased to the extent that it can be mixed, it will not become paste-like, but will be slurry-like, which is not only inconvenient for treatment operations, but also difficult to mix with water. It is not possible to prepare preparations with high concentrations of calcium oxide. The present inventors have investigated various additives that can improve the wetting of the A and B agents and maintain a paste-like state during kneading, and have found that rosin, rosin polymers,
Hydrogenated rosin, esterified rosin, metal salts of rosin, Canada balsam, paraffin, and petrolatum may be used alone or in combination with Part A and/or Part B. The objective was achieved and the present invention was completed by blending 0 to 40% by weight in Agent B. That is, in the present invention, it is essential to blend glycols and natural resins or paraffin oils and fats, and only by blending these ingredients can a formulation with a high concentration of calcium hydroxide be made and clinically acceptable. This results in improved operability. In this way, the present invention takes advantage of the fact that calcium hydroxide reacts with certain fatty acids to form a hardened product, and by modifying the formulation, it becomes a suitable dental filling material (cement). As mentioned above, in the present invention, agent A is mainly composed of calcium hydroxide, while agent B is an organic unsaturated fatty acid, an organic saturated fatty acid, or a mixture thereof, with the addition of a polyhydric alcohol, a polyalkylene glycol, or a mixture thereof. Become. Furthermore, a resin or wax is added to the A agent and/or the B agent. The organic unsaturated fatty acid used in the present invention has the general formula
These include oleic acid, erucic acid, and undecylenic acid, which correspond to CnH _2o-1 COOH, linoleic acid, which corresponds to CnH _2o-3 COOH, and linolenic acid, which corresponds to CnH _2o-5 COOH, and these are easily available on the market. Therefore, these can be suitably used. However, in the above formula, n means a numerical value of 1 to 22. Organic saturated fatty acids have the general formula CnH _2o+1 COOH (n~10~
22), such as stearic acid,
These are isostearic acid, palmitic acid, and myristic acid. Examples of polyhydric alcohols used in the invention are propylene glycol or glycerin;
Examples of polyalkylene glycols are polyethylene glycol or polypropylene glycol.
These constitute the composition of B agent which is a curing agent, and the content of organic unsaturated fatty acids in B agent is
50~100% by weight, organic saturated fatty acid content 0~
100% by weight, preferably from 5 to 50% by weight, with a content of polyhydric alcohols or polyalkylene glycols or mixtures thereof from 0 to 50% by weight, preferably 5% by weight.
~50% by weight. In the present invention, when the A agent is a powder and the B agent is a liquid agent, the formulation is easy to set and the production is also simple. In addition, kneading powders and liquids during treatment has the advantage that the consistency of the kneaded product can be adjusted to the desired consistency, but on the other hand, the powder scatters around during kneading, making it difficult to operate. There is a disadvantage that the composition of the kneaded product is also not constant. Therefore, a method has been devised in which the A agent is made into a paste and the B agent is also made into a paste or a liquid preparation.In this method, the kneading operation is easy and the composition of the kneaded product is always almost constant. When part A is a paste, the composition is selected from the group consisting of 40-80% by weight of calcium hydroxide, 0-40% by weight of bismuth subcarbonate, 0-30% by weight of resin, and vegetable oil, mineral oil, silicone oil and similar substances. Additives: 0
~50% by weight, polyhydric alcohol or polyalkylene glycol or mixtures thereof 0~30%
Weight%. Even when the B agent is a paste, the composition obtained by removing calcium hydroxide from the above composition is taken into consideration. The inclusion of a contrast agent in the composition of the invention is not essential. In other words, if the purpose is root canal filling,
This is essential when checking the filling status with X-rays, but is not necessarily required in the case of pulp capping agents. In any case, all contrast agents that have been used in the human body in the prior art can be blended.
Bismuth salt (bismuth subcarbonate, bismuth subnitrate),
Barium sulfate and iodine compounds (iodoform,
Iodinated poppy oil, iodopiracet, etc.) are used. However, each of these has its own advantages and disadvantages; bismuth salt, which has a high X-ray shielding property, can provide sufficient contrast with a small amount, but is expensive, and iodoform is a contrast agent that has both sterilizing and disinfecting properties. However, it has undesirable properties such as a characteristic odor, easy sublimation and volatilization, and lack of storage stability. Therefore, in the present invention, a contrast agent is selected in consideration of prescription constraints and therapeutic use. Next, the case where this agent is used as a root canal filling material will be explained. Root canal filling agents consist of a powder and a liquid, and in order to mix them together and use them clinically, they must have properties that do not harden during operation and harden quickly after filling, with a hardening time of 15 to 60 minutes. is necessary. The cured product is non-irritating and adheres tightly to the tooth structure, completely sealing the gap between the cement margin and the tooth structure over a long period of time (referred to as margin sealing property), completely preventing the invasion of bacteria in the oral cavity. must be prevented. In the present invention, a root canal filling material has been developed which becomes a cured product after application and has appropriate strength, while also having a good sealing point. The following methods are used to measure the sealing property and strength. a Measurement of sealing property A glass tube with an inner diameter of 4 mm and a length of 70 mm was filled with dehydrated copper sulfate powder, one end was sealed with the composition of the present invention, the other end was sealed with silicone rubber, and then placed in hot water at 37°C for 7 days. After soaking for a day, examine the presence or absence of discoloration of copper sulfate in the glass tube. If it is sealed, there will be no discoloration. b Measurement of cement strength (JIS T-6602): A cylindrical test piece with an outer diameter of 6 mm and a length of 12 mm was created using a mold, and after being immersed in hot water at 37°C for 24 hours, it was heated at a speed of 0.25 mm per minute. The test piece is compressed and the compressive strength is measured by a conventional method. The dental root canal filling composition obtained in the present invention is a
Of course it passed the test, and the strength of the cured product was about 25 kg/
It was warm in ^cm2 . The strength within the root canal is not considered to be a major problem clinically. However, fillers (cement) that do not harden cannot be used for semi-permanent fillings because there is a risk that the components of the cement may enter the bloodstream and circulate inside the body, and there is a risk of forming a dead space in the area where it is applied. It is suitable that the filler is non-curable; it is preferable that the filler is curable. Next, the case where the filler composition of the present invention is used as a pulp capping agent will be explained. Current dental treatment tends to preserve as much of the patient's teeth as possible. Therefore, the pulp of the tooth is often left behind, but calcium hydroxide is effective in protecting the pulp.
In clinical practice, calcium hydroxide powder is often applied directly to the area where the dental pulp is exposed (called the exposed pulp surface). This operation, which involves applying to the exposed pulp surface to protect the pulp, is called pulp capping. The cement composition for pulp capping used in the present invention becomes a hardened product after application, has strength, and passes the A test. E. Effect The curing mechanism of the composition in the present invention is thought to be as follows. Calcium hydroxide Fatty acid Fatty acid calcium Glycol compounds are essential as reaction regulators in this mechanism, and furthermore, they can achieve a high concentration of calcium hydroxide, which is required for treatment, and the kneading operation before application is smooth. It is necessary to incorporate a resin such as rosin, balsam or vaseline in order to obtain a composition that becomes a paste of suitable consistency. F. Examples The following examples show examples of the present invention. Example 1 As agent A, calcium hydroxide powder (Japanese Pharmacopoeia) 70g, ester gum (food additive) 15g,
The A agent was produced by mixing 5 g of hydrogenated rosin (Steverite: Hercules Co., Ltd.) and 10 g of barium sulfate (Japanese Pharmacopoeia) and pulverizing the mixture to 150 mesh. B agent is oleic acid (first class reagent) 85
g, propylene glycol (Japanese Pharmacopoeia), 13 g, and Canada balsam, 2 g, were evenly mixed and stirred. The present filler (cement) composition is suitable for root canals. Example 2 Agent A is calcium hydroxide powder (special grade reagent) 70g
and 30g of bismuth subcarbonate (for pharmaceutical manufacturing only). Part B is linoleic acid (first class reagent) 70g, stearic acid (first class reagent) 10g
g, 8 g of rosin dimer (Dimarex: Hercules), 2 g of Vaseline (Japanese Pharmacopoeia), and 10 g of polyethylene glycol #400 were mixed, heated to dissolve, and stirred evenly throughout. .
The composition is suitable as a root canal filling agent or a pulping agent. Example 3 Agent A is calcium hydroxide powder (special grade reagent) 50
g, bismuth subcarbonate (special grade reagent) 30 g, rosin (Memoto Pharmacopoeia) 14 g, and zinc white (Japanese Pharmacopoeia)
It was prepared by mixing 6g and grinding into 150 meshes. B agent is oleic acid (first class reagent) 85
It was produced by uniformly mixing 15 g of propylene glycol (special grade reagent). The filler composition is suitable as a pulp capping agent. Example 4 As part A, take 58 g of calcium hydroxide powder (Japanese Pharmacopoeia), 40 g of silicone oil (silicon polyether copolymer), and 2 g of propylene glycol (Japanese Pharmacopoeia), knead it to make a paste, and put it into a plastic tube. Fill in small portions. For agent B, take 25 g of oleic acid (first-class reagent), 25 g of stearic acid (Japanese Pharmacopoeia), and 20 g of ester gum (food additive), dissolve them while heating to 100°C in a nitrogen stream, and add barium sulfate ( Add 30g of the Japanese Pharmacopoeia to make a paste, and fill small portions into plastic tubes. Effects of the Invention Table 1 shows the values regarding curing time, sealing property, and strength measured for the compositions obtained in Examples 1, 2, and 3 above.

[Table] As mentioned above, in the dental filler composition of the present invention, calcium hydroxide, which is the main component, participates in the curing reaction.
For this reason, a large amount of calcium hydroxide can be included in the formulation, and since agent B mainly contains fatty acids that are less harmful to tissues, it is possible to create a composition that is less toxic to living organisms. Furthermore, the cured product has properties such as having strength, adhering to and covering the tooth structure, and having sufficient sealing properties, and preventing invasion of various bacteria into the oral cavity. Therefore, it is clear that the composition is superior to conventional dental filler compositions, and can greatly contribute to dental treatment.

Claims (1)

[Scope of Claims] 1. A dental filler composition consisting of part A as a powder and part B as a liquid, which hardens by kneading parts A and B, wherein part A is 40 to 40% The group consisting of 100% by weight of calcium hydroxide, 30% by weight or less of rosin, polymers of rosin, hydrogenated products of rosin, esterified products of rosin, metal salts of rosin, Canada balsam, paraffin, petrolatum, and mixtures thereof. A composition comprising a resin selected from the following and optionally 40% by weight or less of a contrast agent, wherein the B agent comprises an organic fatty acid and 50% by weight or less of a polyhydric alcohol and/or polyalkylene glycol. 2. A dental filler composition that is composed of a pasty agent A and a paste or liquid agent B and is hardened by kneading the A agent and the B agent, wherein the A agent is 40%
~80% by weight of calcium hydroxide, 30% by weight or less of rosin, polymers of rosin, hydrogenated products of rosin,
Resin selected from the group consisting of esterified rosin, metal salts of rosin, Canada balsam, paraffin, petrolatum and mixtures thereof, up to 30% by weight of polyhydric alcohol and/or polyalkylene glycol, optionally 50% by weight Contains additives selected from the group consisting of the following vegetable oils, mineral oils, silicone oils and similar substances, with B agent containing organic fatty acids and 40% by weight
The following rosins, rosin polymers, hydrogenated rosins, esterified rosins, metal salts of rosins,
characterized by comprising a resin selected from the group consisting of Canada balsam, paraffin, petrolatum and mixtures thereof, not more than 50% by weight of a polyhydric alcohol and/or polyalkylene glycol, and optionally not more than 40% by weight of a contrast agent. composition.