MXPA97005421A - Elastic plastic element to fill the root grapes of teeth and a method to prepare - Google Patents

Abstract

The present invention relates to an elastic plastic element comprising a matrix based on isoprene and at least one filling material, the element is suitable for filling the root canals of teeth of humans or animals and is characterized in that it comprises hydroxide of calcium, incorporated within the matrix, as the filling material. The invention also relates to a method of preparing the element according to the invention.

Description

ELASTIC PLASTIC ELEMENT FOR FILLING THE ROOT CHANNELS OF TEETH AND A METHOD FOR PREPARATION DESCRIPTION OF THE INVENTION The present invention relates to an elastic plastic element comprising an isoprene-based matrix and at least one filling material, the element which is suitable for filling the root canals of human or animal teeth. The invention also relates to a method of preparing the elastic plastic element. In the treatment of the disorder known as pulpitis, the infected pulp is mechanically removed from the root canal of teeth and the root canal of teeth is cleaned and extracted, filled with an elastic plastic element or with a different filling material and then It is sealed. For the prior art, see, for example, Friedman et al., In J. Dent. Ros., 54 (1975) 921-925. Briseno in Philipp J. (Aryans?) And US-A-4 632 977. As filling materials for root canals of teeth, Briseno describes, inter alia, semi-rigid cements based on synthetic resins, zinc oxide, eugenol or in calcium hydroxide. US-A-1 632 977 proposes filling materials based on trans-polyisoprenes, for example based on gutta-percha or balata. The gutta-percha points are commercially available, the standard composition of which is 20% by weight of gutta-percha as a matrix, from 60 to 75% by weight of zinc oxide as filler material, from 1 to 17% by weight of heavy metal sulfates as X-ray contrast agents and 3 to 4% by weight of waxes and resins as plasticizers. The known filling material is inert in the root canal of teeth and therefore does not react with the tissue of the body. During the filling of a root canal of teeth with a known inert filling material, this can not, however, be discarded, for example as a result of germs remaining in the channel, after the filling operation an inflammatory process it can develop slowly which leads to an additional necessary treatment, often resulting in a complete loss of the tooth. In view of the prior art, the problem underlining the present invention is to provide an elastic plastic element for filling root canals of human or animal teeth that can be prepared and processed simply and easily and is not subject to the aforementioned adverse effects. The underlined problem of the present invention is also to provide a method of preparing such an element. This problem is solved according to one embodiment of the invention by an elastic plastic element comprising a matrix based on isoprene and at least one filling material, the element which is suitable for filling root canals of teeth of humans or animals. and which is characterized by calcium hydroxide, incorporated into the matrix, as filler material. Calcium hydroxide can be easily processed with an isoprene-based matrix, such as gutta-percha, which is advantageous for laminating into calcium hydroxide in the form of a powder, which simplifies the preparation process substantially. Since calcium hydroxide has an alkaline action, it is able to act as a regulator of the acids that form an inflammatory process and are able to limit an increase in the pH value. As a result, the healing process is advantageously accelerated and assisted. The insert can remain in the tooth root canal temporarily or for an extended period of time. According to the invention, a matrix based on trans-polyisoprea, gutta-percha or a balata can be provided. The matrix can be characterized by at least 80% by weight of trans-polyisoprene. The elastic plastic element according to the invention can be in the form of a gutta-percha point. The calcium hydroxide used as a filler material according to the invention may be provided in the form of a mixture with an ordinary filler material, different, such as zinc oxide, or may be provided as a filler material alone. Of course, the elastic plastic element according to the invention can additionally comprise a pharmaceutically active ingredient, especially an active ingredient which is soluble or dispersible in an aqueous medium, for example an antibiotic and / or glucocorticoid, and also a contrast agent of ordinary X-rays and ordinary waxes, resins or other excipients. An elastic plastic element according to the invention can be preferably characterized by: (a) from 43.5 to 65.0% by weight of matrix, (b) from 35.0 to 56.5% by weight of filler material, (-c) optionally in additional form up to 8% by weight of the X-ray contrast agent, based on (a) and (b), and (d) optionally, additionally, ordinary components. For example, the elastic plastic element according to the invention can be characterized, for example, by (a) approximately 43.5% by weight of gutta-percha, (b) approximately 56.5% by weight of calcium hydroxide as an inorganic filler material individual, (c) optionally additionally up to 8% by weight of X-ray contrast agent, based on (a) and (b), and (d) optionally in additional ordinary component form. The elastic plastic element according to the invention has, therefore, essentially three components which will be explained in greater detail herein.

Component 1 The mechanical properties of an elastic plastic element according to the invention are determined primarily by the properties of the matrix, which is made, for example, from 43.5 to 65.0% by weight together with 35.0 to 56.5% by weight of the filling material (component 2). The matrix must, otherwise, be elastic in such a way that it can be easily processed and easily introduced into the tooth root canal. Otherwise, it should have plastic properties in such a way that the root canal of teeth can be completely filled in permanently without a fastener that is on the left side of the wall.

In addition, the matrix must be able to extract other components, especially the filling material, easily. For these purposes, a matrix having at least 80% by weight of trans-polyisoprene has been proven advantageous. The gutta-percha can be mentioned as an example form, which is a naturally based matrix, the main component of which is trans-polyisoprene. Of course, other trans-polyisoprenes can also be employed, such as balata, isoprene-based synthetic materials or derivatives of the aforementioned materials.

Component 2 The elastic plastic element according to the invention is characterized by calcium hydroxide as filling material. The filler material is present, for example, in an amount of 35.0 to 56.5% by weight together with 43.5 to 65.0% by weight of the matrix. Calcium hydroxide is a substance that is tolerated by the tissue and by the body and can be mixed with the matrix and further compounded with pharmaceutically active ingredients and ordinary excipients. Calcium hydroxide can be rolled into the powder form in the gutta-percha, which leads to the very simple preparation process.

As already established, calcium hydroxide is able to regulate the pH increase that usually occurs in inflammatory processes. It is therefore desirable to introduce as much calcium hydroxide as possible into the tooth root canal. The amount of calcium hydroxide in the elastic plastic element according to the invention is therefore guided as desired, in another way, and by the ability of the matrix to extract the organic filling material, in the other. An example of an elastic plastic element having a very high content of filling material is a gutta-percha point having a content of approximately .56.5% by weight of calcium hydroxide together with approximately 43.5% by weight of gutta-percha .

Component 3 Another optional (though ordinary) component that may be provided as an X-ray contrast agent, for example a heavy metal sulfate, such as barium sulfate or a bismuth / strontium compound. The component can be provided in an amount of up to 8% by weight, based on the matrix and the filler material. Finally, according to another embodiment of the invention, there is provided a method of preparing an elastic plastic element according to the invention, characterized by: (a) forming a film of an isoprene-based matrix; (b) laminating the matrix film in at least one filler material and optionally also an X-ray contrast agent and further optional ordinary excipients, preferably in the form of a powder or in a form that is not highly viscous; (c) spraying and extruding the film of the compound; and (d) cutting the extruded material and laminating the cut piece to form elastic plastic elements that are suitable for filling root canals of human or animal teeth. The invention will be illustrated herein by an Example.

Example To prepare gutta-percha points, first, the gutter-hanger as a die is laminated between a support roll and a pressure roll such that the gutter-hanger is around the support roll in the form of a thin film or in the way of a skin. Calcium hydroxide in powder form in a weight ratio of 56.5% Ca (OH) 2: 43.5% gutta-percha is subsequently wound onto the film that has been formed, the film is molded from the support roll, and the film is molded, pulverized and extruded to form a thin mesh chain. The chain is then cut and laminated. The resulting elastic plastic elements can easily be inserted into root canals of teeth and are placed without channeling.

Claims (10)

1. An elastic plastic element comprising a matrix based on isoprene and at least one filling material (except in calcium silicate), the element that is suitable for filling the root canals of teeth of humans or animals, characterized by hydroxide of calcium, is incorporated in the matrix, as filler material, and by (a) from 43.5 to 65.0% by weight of matrix, (b) from 35.0 to 56.5% by weight of filler material, (c) optionally in the form of additional up to 8% by weight of the X-ray contrast agent, based on (a) and (b), and (d) optionally additionally ordinary components.

2. The item in accordance with the claim 1, characterized by a matrix based on trans-polyisoprene, gutta-percha or balata.

3. The element according to claim 1 or claim 2, characterized by a matrix containing at least 80% by weight of trans-polyisoprene.

4. The element according to any of the preceding claims, characterized in that it is in the form of a gutta-percha point.

5. The element according to any of the preceding claims, characterized by a mixture of zinc oxide / calcium hydroxide or calcium hydroxide free of zinc oxide as filling agent.

6. The element according to any of the preceding claims, characterized in that it additionally comprises an ordinary pharmaceutically active ingredient, especially an active ingredient that is soluble or dispersible in an aqueous medium.

7. The element according to claim 6, characterized by an antibiotic and / or glucocorticoid as a pharmaceutically active ingredient.

8. The element according to any of the preceding claims, characterized in that it additionally comprises an ordinary wax and / or resin.

9. The element according to any of the preceding claims, characterized in that (a) approximately 43.5% by weight of gutta-percha, (b) about 56.5% by weight of calcium hydroxide as the individual inorganic filler material, (c) optionally additionally up to 8% by weight of X-ray contrast agent, based on (a) and (b), and (d) optionally additionally ordinary components.

10. A method for preparing an elastic plastic element according to any of the preceding claims, characterized by (a) forming a film of an isoprene-based matrix; (b) laminating the matrix film in at least one filling material and optionally also an X-ray contrast agent and further optional ordinary excipients; (c) spraying and extruding the film of the compound; and (d) cutting the extruded material and laminating the cut piece to form elastic plastic elements that are suitable for filling root canals of human or animal teeth.