JP5725607B2 - Dental treatment composition - Google Patents

Description

The present invention suppresses inflammatory symptoms during infection root canal treatment of deciduous teeth and root unfinished teeth by filling the root canal for a moment with capping or lining of the exposed pulp and spinal cord, Calcium hydroxide or oxidation, such as pulp capping material, root canal paste, and root canal filling composition, which has an excellent effect on the sealing of the root apex or perforation sealing of incomplete teeth and root absorption The present invention relates to a calcium-based dental treatment composition.

Conventionally, root canal pastes for endodontic treatment include roots mainly composed of formaldehyde such as formalin cresol (FC) and formalin ayacol (FG) for the purpose of sterilization and disinfection within the root canal after pulp removal. Tube disinfectants have been used.

Formaldehyde, the main component of this root canal disinfectant, has the effect of coagulating proteins. When FC is applied to the root canal after extraction, various forms of coagulative necrosis due to formaldehyde are formed on the surface of the remaining pulp. Protects living tissues directly from irritation and promotes wound healing.

Thus, although FC is effective as a powerful infectious root canal disinfectant, it is said that it may be inconvenient for the use of formaldehyde itself.

For example, in cases where acute purulent apical periodontitis is diagnosed and accompanied by pulsatile spontaneous pain, and many drains are observed, protein coagulation prevents drainage, increases internal pressure, and symptoms It can get worse. In recent years, there are reports that formaldehyde has strong tissue violence and can cause periodontitis, and there are reports that it is antigenic and activates the cellular immune response, and its use in the body is a problem. Is being viewed.

In response to these problems, calcium hydroxide patch has been widely used in Europe and the United States as an infectious root canal treatment since 40 years ago, and its application as an infectious root canal treatment is now widespread in Japan.

Calcium hydroxide patch has been applied to various endodontic treatments since its application to root canal treatment by Hermann in 1920.

Calcium hydroxide is a white powder, and its aqueous solution is strongly alkaline at pH 12.6. For endodontic treatment, it is kneaded with sterilized purified water, physiological saline, propylene glycol (PG), polyethylene glycol (PEG), etc. Applied.

In particular, it is applied to cases that are expected to promote the addition of hard tissue, such as pulp capping materials, living pulp pulp materials, apical blockage of incomplete root teeth, and blockage of perforations. Yes. In addition, it is used as a root canal patch that is applied for a short period of time to suppress inflammatory symptoms during the treatment of infected root canals.
Of course, it is actively applied to a case of pulpectomy that is interpreted as an infected root canal in a broad sense.

When this calcium hydroxide is applied as a root canal treatment, in addition to less tissue irritation, bactericidal action with strong alkali, soft tissue dissolution action, analgesic action, healing promotion action, leaching solution stopping action, root absorption inhibition action, It is said to have a hard tissue formation-inducing action. In addition to calcium hydroxide, calcium oxide, when brought into contact with water, becomes calcium hydroxide and thus exhibits the same action.

Thus, calcium hydroxide is not just a bactericidal agent, but is considered to be an agent that improves the healing of the inflamed root canal-apical periodontal tissue system. In general, calcium hydroxide is applied as a root canal treatment. Similarly, in the case of medicine, it has been kneaded with sterilized purified water or physiological saline and used as a paste.

As a root canal filling material for deciduous teeth mainly composed of calcium hydroxide, the trade name: Vitapex (Neo Pharmaceutical Industry Co., Ltd.) is known, and its composition is silicon oil (oil base material), iodoform (X-ray contrast). Agent, bactericidal agent) and calcium hydroxide (hard tissue inducer).

However, since the calcium hydroxide-based paste material of the oily base material is difficult to absorb water in the root canal, it does not immediately show strong alkalinity and an immediate effect of calcium hydroxide paste cannot be expected.

Silicon oil, which is an oily base material, has the advantage of maintaining a stable and non-flowing paste mixed with calcium hydroxide, but inhibits the formation of normal new bone because it is non-absorbable in vivo. Disadvantages are known. In addition, iodoform is subject to hydrolysis in the root canal for a long time, and it becomes a vaporizable iodoform and formalin and accumulates in the living body.

As a calcium hydroxide root canal paste that is filled for a short period of time in order to suppress inflammatory symptoms during treatment of infected root canals, it is a requirement to be a hydrophilic or aqueous paste composed of biocompatible components.

Recently, in order to improve the operability of the formulated calcium hydroxide root canal paste, water-based polyhydric alcohols such as propylene glycol, glycerin and polyethylene glycol are blended as a base material, and a paste of calcium hydroxide aqueous solution In addition, paste formulations containing methylcellulose have been put on the market in syringe containers in Europe and the United States.

In Japan, a calcium hydroxide aqueous paste for root canal treatment described in Patent Document 1 is commercially available (trade name: Calcipex II (Nippon Dental Co., Ltd.)), and there is no solid-liquid separation in the formulation, and the root It is widely used as a root sticking agent with good fluidity that can penetrate into apical constrictions.

The technique of Patent Document 1 is a calcium hydroxide aqueous paste with good fluidity that is applied to a normal root canal, and after the paste is stored for a long time, the paste is solid-liquid separated in a syringe container and solidified. It was a technology that solved the problem of not easily coming out of the container.

That is, in order to express a paste with good fluidity, “After each component is sufficiently kneaded with a vacuum defoaming stirrer to form a uniform paste, it is filled into a syringe container and filled one day later. The consistency of the above composition is as follows: 0.1 g of the composition is taken on a glass plate, and a glass plate having a weight of 6.5 g is gently placed on the glass plate, and left for 90 seconds. When the dimension of the smallest part is measured, the spread average value is 5 to 50 mm ".

However, when applying as a root canal paste medicine for deciduous teeth, the root apex is enlarged due to the absorption of the roots. There was a need for further improvements aimed at pastes that did not flow out.

In cases where a large amount of fluid calcium hydroxide paste overflows from the apical foramen, it may cause dysplasia of the successor permanent teeth or, in severe cases, eruption disorders. However, a paste having no fluidity has been desired.

Moreover, in order to expect the reliable antibacterial effect of calcium hydroxide, about 2 weeks are required, and during this period, it is important to stay in the root canal without flowing out of the apical canal.

On the other hand, young permanent teeth often become infected root canals due to dental pulp infection due to severe caries, trauma or central nodule rupture. Young permanent teeth have incomplete roots, and if the pulp becomes inactive, continuous physiological formation of the roots cannot be expected.

Therefore, in this case, by using calcium hydroxide as a long-term root canal paste, a treatment method called apexification is performed in which the apical hole is closed with hard tissue. Apical barrier formation is usually observed after an average of about 6 months.

Since it is important for calcium hydroxide to come into contact with the apical tissue, care must be taken to insert the paste into the apex without any excess. In addition, it is recommended that replacement of calcium hydroxide as a long-term root canaling agent in apexification be performed about one month later and about every three months thereafter until the formation of an apical barrier. However, if the apex lesion is large and calcium hydroxide is absorbed quickly, the exchange interval may be shortened.

Also, in the case of unfinished roots, it is important that the paste does not flow out of the apical canal and stays in the root canal during the long-term root canal paste, Needed.

In addition, pulp capping is a method of protecting the pulp and is classified into indirect pulp capping and direct pulp capping. Indirect pulp capping is aimed at protecting the pulp through dentin by blocking external stimuli, reducing inflammation of the pulp, and promoting the formation of third dentin. Direct pulp capping protects the dental pulp and forms a dentin bridge (dentin bridge consisting of hard tissue) for those that are accidentally exposed in the cavity after removal of the infected dentin, but with a small exposure and no bacterial infection. Attempted for guidance. Calcium hydroxide preparations are also used for this capping (trade names: Calbital (Neo Pharmaceutical Industry Co., Ltd.), Daikal (Dentsu Ply Sankin Co., Ltd.), etc., but conventional calcium hydroxide preparations are made of paste. Since the operability is not always satisfactory because it is easy to stick and the shapeability with dry cotton balls is not always good, a paste that does not flow at all in the pulp capping is required.

A paste that does not flow out can be easily prepared by increasing the blending ratio of powder components such as calcium hydroxide, thickener component (aluminum oxide or titanium oxide ultrafine particles) or X-ray contrast agent component. Since it becomes hard, it cannot be pushed out from the syringe container, or it cannot be pushed out unless a strong pressure is applied to deform or break the syringe plunger.

In paragraph [0075] of Patent Document 1, it is described that the composition in which the amount of calcium hydroxide and the thickener component is increased is solidified in the syringe container after 6 months and cannot be extruded from the syringe container. .

Therefore, when filling into the root canal, it is a paste that can be extruded from the syringe container without applying a strong pressure, and immediately after filling, paste characteristics that do not flow out from the enlarged apical hole are required. In particular, paste characteristics that do not harden during long-term storage are required.

Patent Document 2 describes “one-paste type dental root canal filler composition containing vegetable oil, calcium or magnesium oxide, and X-ray contrast agent or impermeable agent”.

According to paragraph [0021] of the specification, “as a result of a long-term stability test, it is possible to obtain a paste preparation that is stable for a long time by specifying calcium or magnesium as an oxide, not a hydroxide. As a comparative example, it was shown that a paste containing calcium hydroxide and magnesium hydroxide in a vegetable oil solidified in a syringe container after standing for 1 year at 25 ° C. (Comparison Examples 1 and 2).
The result of the comparative example shows that the paste after filling the plastic syringe container absorbs water in the syringe container, causes a saponification reaction, and solidifies in the root canal or the syringe container.

Even when a stable paste is obtained using calcium oxide using the technique shown in Patent Document 2, when used for capping, the formability with a dry swab is poor, and the operation Only inferior ones can be obtained.

Japanese Patent No. 3473879 JP 2002-173409 A

Therefore, the problems to be solved by the present invention are as follows: (1) Even if applied to a root canal where the root unfinished tooth or apex is enlarged for a long time, the paste does not flow out of the apex, and the root canal (2) No stickiness even when pressed with a dry swab ball, etc. (3) Excellent formability as a paste, (4) Extruded without applying high pressure from a syringe container, (5 ) To provide a one-paste type calcium hydroxide or calcium oxide based dental treatment composition that is stable without solidifying in a syringe container.

As a result of diligent research, the present inventors mixed a polyhydric alcohol or an aqueous solution thereof (or an aqueous paste) in which supersaturated calcium hydroxide or calcium oxide was uniformly dispersed in advance with a fatty acid, a salt thereof or an ester thereof to produce a paste. The above problem has been solved by sometimes completing the saponification reaction.

That is, the present invention is as follows.
(1) A dental treatment composition containing calcium hydroxide or calcium oxide, a fatty acid having 7 to 28 carbon atoms or a salt or ester thereof, and a polyhydric alcohol or an aqueous solution thereof.
(2) The dental treatment composition according to (1), wherein the fatty acid is a fatty acid having 15 to 22 carbon atoms.
(3) The composition for dental treatment according to (1) or (2), wherein the fatty acid salt is one or more selected from calcium, lithium, sodium, magnesium, potassium, barium, and zinc salts. object.
(4) The dental treatment composition according to (1) or (2), wherein the fatty acid ester is a fatty acid alkyl ester or a fatty acid glycerin ester.
(5) The dental treatment composition according to (4), wherein the glycerin ester of fatty acid is vegetable oil.
(6) 2 to 70% by mass of calcium hydroxide or calcium oxide, 0.1 to 48% by mass of fatty acid or salt or ester thereof, and 5 to 50% by mass of polyhydric alcohol with respect to the total amount of the composition ( The composition for dental treatment according to any one of 1) to (5).
(7) The composition for dental treatment according to any one of (1) to (6), further comprising one or more selected from calcium silicate glass, MTA (mineral trioxide aggregate), or calcium silicate. object.
(8) The dental treatment composition according to any one of (1) to (7), which is used for endodontic therapy.
(9) The endodontic treatment is a pulp or lining of the pulp or spinal surface, perforation blockage at the root bifurcation or root, root canal filling or reverse root canal filling, or apexification ( The composition for dental treatment as described in 8).
(10) The dental treatment composition according to any one of (1) to (9), which is used for treatment of deciduous teeth or incomplete root teeth.
(11) Any one of (1) to (6), comprising kneading a polyhydric alcohol dispersion of calcium hydroxide or calcium oxide and a fatty acid or a salt thereof or an ester thereof, and allowing to stand until the saponification reaction is completed. A method for producing the dental treatment composition according to claim 1.

The paste of the composition for dental treatment of the present invention (1) Even when applied for a long period of time to an incomplete root tooth or a root canal in which the apex is enlarged, the paste does not flow out of the apex, and the root canal (2) No stickiness even when pressed with a dry swab ball, etc. (3) Excellent formability as a paste, (4) Extruded without applying high pressure from a syringe container, (5 ) Stable and excellent properties without solidifying in the syringe container. Therefore, in pediatric dentistry, the inflammatory symptoms at the time of treatment of infected root canals of deciduous teeth are suppressed, or the root apex of the tooth buds that have caused root resorption and root resorption are blocked or apexified. In addition, the composition is suitable for a dental treatment composition for sealing the pulp or lining of the exposed or spinal surface or perforation. In general endodontic treatment, it can be used as a pulp capping or lining of the pulp and spinal cord, or as a root canal filling material. As a result, it has excellent properties as a root canal filling material for permanent teeth in which the apex is incomplete and the apex hole is opened.

Hereinafter, the present invention will be described in detail.
When the amount of calcium hydroxide or calcium oxide as the main component of the composition is 2 to 70% by mass or 2% by mass or less with respect to the total amount of the composition, it reacts with the root canal exudate and is inactivated. In the case of 70% by mass or more, the paste becomes too hard and difficult to come out of the syringe container.

The fatty acid having 7 to 28 carbon atoms may be anything as long as it causes a saponification reaction with calcium hydroxide or calcium oxide, but preferably has 15 to 22 carbon atoms and is liquid around room temperature. If the number of carbon atoms is 7 to 14, there is no problem in preparation, but the fatty acid itself has a unique and unpleasant irritating odor, which is not preferable.

Examples of fatty acids having 15 to 22 carbon atoms include saturated fatty acids such as palmitic acid, stearic acid, isostearic acid, arachidic acid, behenic acid, and serotic acid, among which branched fatty acids are preferred, and isostearic acid is most preferred. . As the unsaturated fatty acid, oleic acid, linoleic acid, linolenic acid, ricinoleic acid, arachidonic acid, crupanodonic acid and the like are preferable.
Furthermore, without being limited to these free acids, metal salts such as lithium, sodium, magnesium, potassium, barium, and zinc that can exchange ions with calcium ions in the presence of calcium hydroxide or calcium oxide, or esters of fatty acids are also included. It is possible to use.

  The fatty acid ester may be anything as long as it causes a saponification reaction with calcium hydroxide or calcium oxide, and examples thereof include fatty acid alkyl esters and glycerin esters of fatty acids.

  Examples of fatty acid alkyl esters include fatty acid methyl esters, fatty acid ethyl esters, fatty acid propyl esters, and fatty acid butyl esters.

The fatty acid glycerin ester may be a vegetable oil, and any vegetable oil may be used as long as it is derived from natural products, such as olive oil, peanut oil, rapeseed oil, soybean oil, safflower oil, cottonseed oil, corn oil, evening primrose oil, etc. Is mentioned.

For example, the ideal paste consistency as a root canal filling material is a consistency that does not flow in the root canal when the syringe container is filled and a blunt needle is attached and pushed out, so that it does not flow in the root canal. The content of the fatty acid or salt thereof or ester thereof is preferably 0.1 to 48% by mass. In the case where the fatty acid is liquid, it is separated when used in a large amount, and therefore it is preferably about 0.1 to 10.0% by mass.

The polyhydric alcohol is a component for hydrophilizing the entire composition, and is blended so that calcium hydroxide or calcium oxide can be dissociated to exhibit strong alkali when the composition absorbs water. It is also a base material for preparing calcium hydroxide or calcium oxide in a paste form. The polyhydric alcohol may be anything as long as it does not inhibit the effects of calcium hydroxide or calcium oxide, and examples thereof include propylene glycol, polyethylene glycol, polypropylene glycol, and the content is 5 to 50% by mass.

The dental treatment composition of the present invention may contain other additives such as water, thickeners, X-ray contrast agents, and physiologically active substances as other additives.
If water is added, calcium hydroxide or calcium oxide is dissociated to exhibit strong alkali, so that the paste itself can be adjusted to be alkaline from the beginning. As a necessary amount of water concerned about drying during long-term storage, it can be added in a range of up to 30% by mass.

As the thickener, any one of ultrafine aluminum oxide, titanium oxide or silicon dioxide, or a plurality of thickeners can be selected and added to the composition up to 20% by mass.

Examples of the X-ray contrast agent include barium sulfate, bismuth carbonate, zirconia, zinc oxide, or powder glass (for example, lanthanum glass, barium glass, zirconia glass) containing a component having X-ray contrast properties. . Usually, the X-ray contrast medium is an essential component for the composition of the root canal filling material. Furthermore, bioactive glass, bioactive ceramic / cement (for example, calcium silicate glass, MTA (mineral trioxide aggregate), calcium silicate) and the like can be added. After filling, these physiologically active substances gradually react with the phosphate ion component of the contacted tissue fluid to produce hard tissue-like crystals (hydroxyapatite) at the contact interface and improve the sealing performance, using simulated body fluid And confirm. Accordingly, there is no harm to pulp cells, periodontal ligament cells, etc., and preferable sealing properties can be imparted to application interfaces such as pulp capping, perforation sealing, root canal filling, reverse root canal filling, and apexification. The amount of these physiologically active substances added to the composition is 15 to 40% by mass, preferably 20 to 30% by mass.

The composition for dental treatment of the present invention is a method in which a polyhydric alcohol or an aqueous solution thereof (or an aqueous paste) in which supersaturated calcium hydroxide or calcium oxide is uniformly dispersed in advance and a fatty acid, a salt thereof or an ester thereof are uniformly mixed in an automatic mortar. The paste is kneaded and allowed to stand at 40 to 60 ° C. for 24 hours to complete the saponification reaction, and then kneaded uniformly again to prepare a paste having a consistency that does not flow at all.

The paste of the present invention has a consistency that can be easily poured into a root canal directly from a syringe container, and is a good one-part paste that does not become sticky even when pressed with a dry cotton ball.

Moreover, even if this paste is applied to a root canal having an enlarged root apex, it maintains a paste consistency that does not flow out at all.

The composition for dental treatment of the present invention is a paste-like kneaded material produced as described above, and this is filled in a syringe container and provided as a product. At the time of application, an 18-20 gauge blunt needle is attached and filled directly into the root canal. When applied to a case where the root apex is enlarged, it is not necessary to use a thin needle as the blunt needle.

EXAMPLES Hereinafter, although an Example demonstrates this invention further in detail, this invention is not limited by this.
Table 1 shows the compositions of Examples 1 to 20 and Comparative Examples 1 to 5. A paste obtained by kneading each of these components was filled in a 1 ml plastic syringe container, and the following tests were conducted for evaluation.

《Paste flow-out test》
A plastic cylindrical tube (inner diameter: 2 mm) was filled with paste, and left and right at a temperature of 37 ° C. and a relative humidity of 100% in a state where the upper and lower surfaces were pasted, and it was confirmed whether the pasted surface descended (O: Does not flow, x: flows out).

<Extrusion test from syringe container>
Attach a 21-gauge blunt needle to the tip of a plastic syringe container and use a small tabletop precision universal testing machine to displace it to 10 mm at a crosshead speed of 20 mm / min to check whether the paste can easily come out of the syringe container (○: Possible, ×: Impossible).

《Stickness test during pressure contact with dry cotton ball》
A small amount of paste was pressure-contacted with a dry cotton ball, and it was confirmed whether the paste was sticky (O: non-sticky, x: sticky).

《Paste stability maintenance test》
After the paste filled in the plastic syringe container was stored at 40 ° C. for 30 days, the paste properties were visually confirmed (◯: stable, x: unstable).

<< Confirmation of precipitation of hard tissue-like crystals by immersion in simulated body fluid >>
A concave portion having a depth of 0.5 mm was prepared on an acrylic resin plate (15 mm × 15 mm), filled with a paste, and pressure-welded with a PET (polyethylene terephthalate) film. After removing the PET film, it was sealed in a polypropylene sealed container containing 30 ml of a simulated body fluid formulated with the following composition, with the paste surface facing upward, without removing from the acrylic mold, and sealed at a temperature of 37 The mixture was allowed to stand at 30 ° C for 30 days. Thereafter, the operation of immersing and pulling up in fresh water was repeated three times, and then the presence or absence of precipitates was visually confirmed, and the form of surface precipitates was observed with an optical microscope or an electron microscope. Further, the surface precipitate was analyzed with a powder X-ray diffractometer, and the substance of the precipitated crystal was identified (O: Precipitation, X: No precipitation). This test was conducted only for the compositions of Examples 16 to 18 containing a physiologically active substance.
The simulated body fluid was prepared with the composition shown in Table 3 by imitating body tissue fluid.

Table 2 shows the results of each test. As shown in the same table, in Examples 1 to 20, the paste does not flow out and maintains the state immediately after filling, and at the same time, the extrusion from the syringe container, the pressure contact operation with the dry cotton ball, the stable maintenance of the paste Everything was satisfactory. In Examples 16 to 18, a hard tissue-like crystal was precipitated on the surface, and as a result of analysis by a powder X-ray diffractometer, it was confirmed that the crystal was hydroxyapatite.

On the other hand, in Comparative Example 1, the consistency was too low and the paste flowed out, and could not be pressed with a dry swab. This is probably because the saponification reaction with calcium hydroxide does not occur because the fatty acid or its salt or its ester is not blended.

In Comparative Example 2, since there was too much calcium hydroxide, it was not able to prepare in a paste state.

Moreover, since the comparative example 3 had too little polyhydric alcohol, paste consistency was too high and it was difficult to extrude from the plastic syringe container which attached the blunt needle.

Although Comparative Example 4 did not flow out, it was a soft and sticky paste due to too much polyhydric alcohol.

Furthermore, in Comparative Example 5, since there were too many fatty acid salts, it was impossible to extrude from the plastic syringe container which attached the blunt needle.

As described above, the dental treatment compositions listed in the respective comparative examples do not flow out of the apex for a paste consistency that does not flow at all as in the examples of the present invention, and without applying strong pressure from the syringe container. It can be extruded, does not stick even when pressed with a dry swab ball, is excellent in formability, and can not maintain a stable paste state even if left for a long time in a state filled in a plastic syringe container .

Claims (8)

  Spinal or spinal capping or lining, root bifurcation or root containing calcium hydroxide or calcium oxide, C7-28 fatty acid or salt or ester thereof, and polyhydric alcohol or aqueous solution thereof A one-paste type dental treatment composition used for perforation blocking, root canal filling or reverse root canal filling or apexification in a tooth root.   The dental treatment composition according to claim 1, wherein the fatty acid is a fatty acid having 15 to 22 carbon atoms.   The dental treatment composition according to claim 1 or 2, wherein the fatty acid salt is one or more selected from calcium, lithium, sodium, magnesium, potassium, barium, and zinc salts.   The dental treatment composition according to claim 1 or 2, wherein the fatty acid ester is a fatty acid alkyl ester or a fatty acid glycerin ester.   The composition for dental treatment according to claim 4, wherein the glycerin ester of fatty acid is vegetable oil.   2 to 70% by mass of calcium hydroxide or calcium oxide, 0.1 to 45% by mass of a fatty acid or a salt or ester thereof, and 5 to 50% by mass of a polyhydric alcohol based on the total amount of the composition. The dental treatment composition according to any one of -5.   Furthermore, the composition for dental treatment of any one of Claims 1-6 containing the 1 type (s) or 2 or more types chosen from calcium silicate glass, MTA (Mineral Trioxide Aggregate), or calcium silicate.   The polyhydric alcohol dispersion of calcium hydroxide or calcium oxide and a fatty acid or a salt thereof or an ester thereof are kneaded and left to stand until the saponification reaction is completed, according to any one of claims 1 to 6. Of producing a dental treatment composition.