Custom dentures and method of making same
CROSS-REFERENCE TO RELATED APPLICATION 
     This instant application is a continuation-in-part of a co-pending application for U.S. Ser. No. 476,233, filed Mar. 17, 1983, entitled &#34;A Method of Making Custom Dentures and a Dental Module for the Use Therein&#34;. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates generally to custom dentures and, more particularly, to an improved method for the formation and manufacture of custom dentures from synthetic materials. 
     2. Prior Art 
     The increasing longevity of individual life spans throughout much of the world accompanied by a heightened awareness of the need to maintain the ability to masticate a variety of foods throughout the individual&#39;s lifetime in order to provide for his nutritional, bulk and fiber needs has generated an expanding market for dentures. Over the years a host of different devices and a number of various methods of making dentures from synthetic materials have been utilized. 
     The early dentures has no palates. Upper and lower plates were little more than narrow rims constructed of wood, ivory and hippopotamus tusks which were whittled and shaped to conform to the approximate contours of the upper and lower ridges of an oral cavity. Patterns of the mouth were made of paper and cloth and were used as guides for fitting. The dentures were held in place by springs arranged in such a fashion as to push the upper rims against the upper ridge and the lower rims against the lower ridge. 
     Around the beginning of the 19th Century, the art of making plaster casts was developed. Palates were added to the upper plate giving improved retention and function. In the middle of the 19th Century, a composition of amber, linseed oil, guttapercha and sulfur was developed for use as a denture base. However, even with this new material available, denture construction was still tedious and time consuming and, because of this, necessarily expensive. Only the wealthy few could afford the services of a dentist while those of modest means went without. 
     It was not until vulcanite was successfully developed for a denture base material and porcelein as a material for teeth that dentistry was established as a profession that could serve the needs of the majority of people. Although vulcanite was a remarkable denture material for its time, it left much to be desired asthetically. In an attempt to provide more natural looking dentures, a variety of thermoset and thermoplastic resins were tried and ultimately discarded. These resins included such materials as cellulose nitrate, cellulose acetate, phenol formaldehyde, glycols, caseins, and a great many other materials. As did the rubber materials, some of the plastic resins changed their color, became brittle, or generally lost their form. Finally, in 1933, the use of methyl methacrylate (acrylic) was introduced into the making of dentures and today dominates as the most widely used material in the manufacture of dentures. 
     Conventionally, dentures are made by first taking impressions of the patient&#39;s oral cavity. These impressions are then transported to a dental technician who must make molds and castings individually. Teeth must then be set into the molds in preparation for flasking. Next the flask, containing the molding material and teeth, are compressed under high pressure and cured in hot water tanks. The resulting set of dentures are then removed from the flask, cleaned of excess material and sent back to the dentist for ultimate delivery to the dentist. The dentist must then fit the newly made dentures to the patient making adjustments as required. 
     This conventional method of manufacturing dentures suffers from several disadvantages. First, the dentures must individually be detailed by dental technicians. Since the dental technician may be in a location remote from the area of the dentist&#39;s practice, there exists opportunity for distortions in the construction of the conventional denture since the technician has no knowledge of the peculiarities of the patient&#39;s mouth. Additionally, conventional dentures require several visits by the patient in order to develop and fit the dentures properly thus causing inconvenience to the patient and possibly added emotional discomfort. Finally, conventional dentures require from two to four hours of chair time depending upon the specific method being employed by the dentist which is in addition to the several hours of technician time thus adding to the overall cost of the dentures. 
     SUMMARY OF THE INVENTION 
     It is an object of the present invention to provide an improved customized denture. 
     It is a further object of the present invention to provide an improved method of making custom dentures. 
     It is a still further object of the present invention to provide an improved method of making custom dentures wherein the dentures are the product of a master mold which assures that the anatomical detail are transferred onto each set of dentures thus providing greater cosmetic value. 
     Yet another object of the present invention is to provide a method of manufacturing custom dentures which requires less time and therefore results in less cost to the patient. 
     A further object of the present invention is to provide an improved custom denture which is fitted from beginning to end only by the dentist involved who is at all times controlling the development of the denture. 
     Still another object of the present invention is to provide an improved method of providing custom dentures which requires only a single visit to the dentist. 
     Yet another object of the present invention is to provide an improved method of manufacturing custom dentures which requires only a single impression of the oral cavity. 
     A still further object of the present invention is to provide an improved method of providing custom dentures which substantially reduces the amount of time required in a dentist&#39;s chair to approximately one hour. 
     Yet another object of the present invention is to provide an improved method of positioning a plurality of prosthetic teeth in one or more sockets of a denture base. 
     It is a still further object of the present invention to provide an apparatus for maintaining a plurality of prosthetic teeth in a fixed occlusal relationship. 
     It is yet another object of the present invention to provide a preliminary denture device of standard dimensions for later adaptation to a cast representation of at least a portion of an individual oral cavity. 
     According to a broad aspect of the invention there is provided a method for making a denture customized to suit a particular oral cavity which includes manufacturing a denture base in one of a plurality of standard sizes each having at least one socket therein for receiving an array of prosthetic teeth. The array of teeth is positioned in the socket or sockets of the denture base. After the dentist manufactures a representation of his patient&#39;s oral cavity, he selects a denture base having the prosthetic teeth positioned therein is one of the plurality of standard sizes which is most closely accommodated by the oral representation. The dentist then conforms the selected denture base to the surface contours of the representation and finally secures the prosthetic within the sockets. 
     According to a further aspect of the invention there is provided a method of positioning a plurality of prosthetic teeth in at least one socket in a denture base which comprises positioning a plurality of prosthetic teeth in a specific occlusal relationship and providing the plurality of prosthetic teeth with removable appliance means so as to maintain the specific occlusal relationship during subsequent processing. 
     According to a still further aspect of the present invention there is provided an apparatus for maintaining the plurality of prosthetic teeth in a fixed occlusal relationship for insertion into a plurality of sockets in a denture base which comprises a strip of flexible material having a plurality of receiving curves in a major surface thereof. This strip receives each of the plurality of prosthetic teeth which are maintained in position by an adhesive on the major surface. 
     According to yet a further aspect of the present invention there is provided a preliminary denture device of standard dimensions for later adaptation to a cast representation of an individual&#39;s oral cavity comprising a blank of moldable material conforming to the standard dimensions and formed with at least one recess therein. Artificial teeth are adapted for placement in the one recess, the teeth being placed prior to conforming the denture to a cast representation. Means are provided for contacting the teeth and maintaining the occlusal aspects thereof. 
     The above and other objects, features and advantages of the present invention will be more clearly understood from the following detailed description taken in conjunction with the accompanying drawings in which: 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIGS. 1 and 2 are perspective views of mandibulary and maxilary dentures, respectively, manufactured in accordance with the teachings of the present invention; 
     FIGS. 3A and 3B are perspective and cross-sectional views, respectively, of a master mold used in the fabrication of the denture shown in FIG. 2; 
     FIGS. 4A and 4B are perspective and cross-sectional views, respectively, of a master mold used in the fabrication of the denture shown in FIG. 2; 
     FIGS. 5 and 6 are perspective and frontal views, respectively, of a maxilary denture base having sockets therein produced in accordance with the teachings of the present invention; 
     FIG. 7 is a perspective view of a U-shaped appliance for removably securing a plurality of artificial teeth in a fixed occlusal relationship; 
     FIG. 8 illustrates the apparatus from which the U-shaped appliance shown in FIG. 7 is produced; 
     FIGS. 9 and 10 are exploded perspective views illustrating how the dentures shown in FIGS. 1 and 2, respectively, may be packed for shipment; and 
     FIGS. 11 and 12 illustrate alternate embodiments of the present invention. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
     FIGS. 1 and 2 illustrate mandibulary and maxilary dentures 20 and 22 respectively, which are manufactured in accordance with the present invention as can be seen, mandibulary denture 20 includes a base 24 of wax or of a cured or uncured synthetic material and a plurality of artificial or prosthetic teeth 26 fixedly mounted therein. Similarly, maxilary denture 22 includes a base 28 of a wax or of a cured or uncured synthetic material and a plurality of teeth 30. Additionally, base 28 includes a palatal area 32. The mandibulary and maxilary dentures shown in FIGS. 1 and 2 have been conformed to the contours and dimensions of both the endentulus ridge and palatal vault of the individual user. Since the inventive method of manufacturing the dentures shown in FIGS. 1 and 2 is substantially identical for the mandibulary and the maxilary units, the following discussion will be limited to an explanation of the production of a maxilary unit of the type shown in FIG. 2. 
     The production of the inventive dentures first requires that a completely hand crafted denture including an assembly of artificial teeth with an accurate occlusion including a four and one half inch curve of spee or a flat plane occlusal geometry be constructed. The master denture contains the type of teeth that will be used in the mass produced dentures. A stone model is then constructed by taking an impression of the tissue side of the master denture base including the maxilary and mandibular units. This is accomplished by first coating the denture with a thin coat of petroluem jelly such as Vasoline. A thin strip of metal hereinafter referred to as a frame, is positioned around the denture at a fixed distance from the sides of the denture&#39;s periphery. The overlapping area of the metal strip of frame may then be sealed. Next, a heavy mix of dental stone (e.g. of the type available from U.S. Gypsun, Chicago, Ill.) is introduced into the denture so as to fill the denture to its periphery, and the mix of dental stone is slowly vibrated therein. The stone is then smoothed, as for example, with a small spatula, following the contours of the periphery. When the stone is set, it is removed from the metal frame and the denture is removed from the stone. The edges of the stone model may be trimmed; however, the contours of the periphery must be retained. Any voids in the model may then be filled with a small mix of stone. 
     The next step is the creation of a master mold. First, the master denture is set on the stone model and a thin metal strip is snugly positioned around the base of the stone model. The occlusal surfaces of the posterior teeth and the incisal edge of the anterior teeth are then checked to assure that they are below the top of the frame. If this is not the case, the height of the stone model must be altered on a stone trimmer. The metal form is now sealed. Flexane is slowly poured inside the frame, over the teeth roots and palate of the denture until the frame is filled. The Flexane is allowed to cure at room temperature for approximately twenty-four hours at which time the frame, mantle and master may be removed. The Flexane is available from DEVCON CORPORATION, Danvers, Mass. and its use results in a rubber-like urethane master mold. 
     It is next necessary to produce a reproduction of the master mold. To accomplish this, a thin metallic strip is positioned around the master mold. Any space around the seam of the metal strip may be sealed with silicone. This comprises another frame. 
     A set of teeth is inserted into the conforming recess sockets of the master mold of the same type as used in the master denture. The frame is then sealed slab with dental stone and the master mold is placed inside the frame. RTV630 silicone which has been de-aired in a vacuum bell is slowly poured inside the master mold filling the frame to the. The silicone is allowed to cure at room temperature for approximately twenty-four to thirty hours. The resulting silicone reproduction of the master mold may then be removed from the master mold and metal band. RTV is a silicone rubber compound available from General Electric Company, Silicone Products Department, Waterford, N.Y. 
     FIG. 3 illustrates a maxilary master mold having a palatal area 34 and tooth sockets 36. 
     A monothane production mold is then fabricated by slowly pouring heated monothane inside the silicone reproduction. The monothane and the silicone reproduction is preheated to approximately 155° F. for a period of one hour in, for example, a preheating oven equipped with a circulating fan. Once inside the silicone mold, the monothane is cured for a minimum of four hours at a temperature not to exceed 275° F. The monothane production mold may then be removed after it has cooled. A monothane suitable for use is a one component polyurethane rubber, ninety to one hundred durometer and available from Indpol of Cucamonga, Calif. The resulting production mold shown in FIG. 4 includes a palatal area 38 and a plurality of projections 40 corresponding in location and position to sockets 36 in the master mold. 
     FIGS. 5 and 6 are perspective and frontal views of a maxilary denture base constructed from the production mold shown in FIG. 4. As can be seen, the denture base includes a palatal area 42 and a plurality of tooth sockets 44. It should be understood that these dentures will be reproduced in any of the plurality of standard sizes. Obviously, this requires molds of standard sizes produced from master dentures of standard sizes. 
     The denture base shown in FIGS. 5 and 6 may be manufactured from a wax material such as paraffin wax compound or other similar compound known in the art; suitable compound is available from Conoco Chemical Company, Houston, Tex. or Pearsall Chemical Company, Houston, Tex., or may be manufactured from a synthetic resin, preferably methyl methacrylate acrylic available from Eschem Company, Essington, Pa. The denture base resulting from use of the synthetic resin may be cured or uncured. To produce a cured pliable denture base, the production mold shown in FIG. 4 is filled with a mixture of methyl methacrylate acrylic resin (for example type #919S0000). A hydraulic press is used to apply from three to four thousand pounds per square inch of pressure on the flask to insure an exact impression of the master denture. The flask or mold is then removed from the hydraulic press and put in a compress and tightened with an impact wrench. The denture base is then cured in a hot water bath having a minimum temperature of 200° F. and preferably 212° F. for approximately one half hour. The soft and flexible denture base is then removed. 
     To produce an uncured pliable denture base, the production mold is filled with a mixture of, for example, methyl methacrylate acrylic resin, type #139 Standard Denture Polymer that meets ADA specifications, polymerized and formulated to meet the requirements of the dental industry and suitable for conventional flasking and curing in hot water baths. This material is also available from Eschem Company, Essington, Pa. Again, a hydraulic press is used to apply between three thousand and four thousand pounds per square inch pressure on the flask to insure an exact impression of the master denture. The flask is then removed from the hydraulic press, placed in a compress and tightened with an electric impact wrench. The compress and the denture is cooled at approximately 10° F. for approximately twenty four hours. The denture base is then removed. 
     To produce the wax denture base, the mold is filled with the formulated paraffin and bees wax material which has had its temperature elevated to between 101° F. and 130° F. (preferrably 110° F.) at which point it becomes completely moldable. Again a hydraulic press is used to apply pressure on the flask to insure an exact impression of the master denture. The flask is then cooled and the wax denture base is removed. 
     The next step in the manufacture of the dentures shown in FIGS. 1 and 2 is the insertion of artificial or prosthetic teeth identical to those in the master denture into sockets 44 of the denture base. This procedure is greatly simplified by interconnecting the artificial teeth by means of, for example, a removable U-shaped flexible and adhesive appliance which maintains the occlusal aspects of the teeth during subsequent processing. Such an appliance is shown in FIG. 7. As can be seen, appliance 46 is provided with a plurality of receiving curves 48 which correspond in contour and position with a front surface of the master mold and therefore are in alignment with the sockets 44 of the denture base shown in FIGS. 5 and 6. A thin layer of adhesive is provided on the inner surface of the appliance which will contact and removably secure the artificial or prosthetic teeth. If desired, the appliance may have a tapered width; i.e. the appliance is wider in its frontal region and tapers towards the ends thereof. 
     The appliance shown in FIG. 7 may be simply manufactured from a monothane or polyurethane master mold 52 identical to that shown in FIGS. 3A and 3B except that a frontal portion of the mold has been removed such that if artificial teeth 54 were inserted into their corresponding sockets in the mold, they would project a predetermined distance above upper edge 56 of the mold (FIG. 8). Thus, a strip 58 is removed which corresponds to the appliance 46 shown in FIG. 7. The receiving contours are then coated with a pressure sensitive adhesive. 
     It is next necessary to secure the individual artificial or prosthetic teeth to the receiving curves in the U-shaped appliance. This may be accomplished as follows. First, a third master mold is prepared of the type shown in FIGS. 3A and 3B including sockets or cavities 36 and a frontal portion of the mold is removed such that a portion of the front surface of the prosthetic teeth will be exposed after insertion into the cavities or sockets. Next, the palatal area to the rear of the artificial teeth is built up so as to provide rear support. The artificial or prosthetic teeth are then inserted into the cavities or sockets of this mold and the flexible and adhesive U-shaped appliance is applied to the surfaces of the prosthetic teeth. The prosthetic teeth may now be lifted out of the mold removably secured to the appliance as an array of teeth which is ocluded in accordance with the master denture. 
     The array of teeth may now be dropped into the sockets of the denture base and, if desired, a portion of the array may be secured to the denture base by applying a small amount of self-curing resin such as oryl acrylic resin. 
     The denture base having the array of teeth positioned thereon is now ready for shipment to a dentist. During storage and shipment, it is necessary that both the denture base and the array of teeth be adequately protected. This may be accomplished by placing both the mandibulary and maxilary denture bases in a carrier 60 and 62 respectively, and then securing the denture base and carrier in a split mold as shown in FIGS. 9 and 10 respectively. In FIG. 9, the split mold is shown as comprising first and second frontal sections 64 and 66, each having an L-shaped cross section and a rearward or palatal section 68 which is equipped with a lip or projection 70 for adequately securing the denture/carrier assembly. The split mold shown in FIG. 10 also comprises first and second frontal portions 72 and 74 and a rearward palatal section 76 having a contoured surface 78. 
     The split molds shown in FIGS. 9 and 10 may be manufactured from a moldable low density material such as polyester or styrofoam. In the case of uncured acrylic denture bases, it is considered preferable to vacuum pack the denture bases. Having now been properly packed, the denture bases and corresponding arrays of artificial teeth may be shipped to the dentist in a plurality of standard sizes. 
     In order to provide a specific patient with custom dentures, the dentist first makes an impression of the patient&#39;s oral cavity and produces upper and lower casted models from the impression. The dentist further occludes the upper and lower models to establish the occlusal index and derives the occlusal vertical dimension. The dentist then selects a denture base from his inventory of standard size denture bases which most closely accommodates the upper and lower casted models. The denture base selected will have an array of teeth associated therewith as described previously. Each denture is placed on its respective model and the region palate areas are adjusted. The denture base is formed into a closely fitted relationship with the model and the flanges are trimmed to relieve overextension. If the denture base is of the wax variety, the denture base is formed into a closely fitted relationship with the endentulus oral cavity. Next, the wax denture is inserted into a flask and investment casted in the conventional manner. 
     If the denture base selected is of the uncured acrylic resin type, the prosthetic teeth are secured within the sockets by first applying a layer of uncured acrylic resin on the tissue side of the denture base and then curing the denture base and the layer of uncured acrylic resin so as to secure the teeth. The denture is secured by elevating its temperature (e.g. for example in a hot water bath having a temperature of approximately 212° F. for approximately thirty minutes). The final denture module is produced by trimming excess material from the denture module, removing excess material and polishing the module. 
     If the selected denture base is of the cured acrylic resin type, the prosthetic teeth are secured by applying a layer of uncured acrylic resin on the tissue side of the denture base and curing the layer of uncured acrylic resin in the manner described above so as to secure the prosthetic teeth. 
     Regardless of the type of denture base selected, the U-shaped appliance may be removed after the prosthetic teeth are secured to the denture base. 
     FIGS. 11 and 12 illustrate alternate approaches which utilize partial or completely preformed arrays of teeth. For example, FIG. 11 illustrates a combination of a partial preformed array including a number of individual prosthetic 80 fixedly imbedded in a fully detailed and cured base 82. The preformed array is preferably made of the same material utilized in forming base 84. As shown, base 84 contains a plurality of recesses or sockets 86 for receiving individual teeth 88 along with an extended socket 90 which accommodates base 82 of the fixed array. In FIG. 12, base 92 is molded with a single socket 94 along the exposed surface of the endentulus ridge for receiving an integral or segmented array 96 of prosthetic teeth. In this case, the prosthetic teeth are maintained in fixed relationship by a wire 98 extending internally therethrough (not shown) or by forming the array initially as an integral unit. To provide the dentist with an increased ability to shape the denture for a custom fit, the array 96 can be made in three adjacent segments as shown. This permits the dentist to alter the shape of the endentulus ridge to suit the patient. The integral array prevents lateral adjustment of the anterior portion of the ridge. 
     The overall or gross dimensions of the human oral cavity vary greatly throughout the bulk of the population. However, the ability to conform the denture in the present process requires only a limited number, typically three, of different sized dental bases be inventoried by the dentist. The versatility of the present method permits the adjustment of the denture to suit the individual&#39;s oral cavity dimensions and configuration. This adjustment can be made in a short period of time during a single visit. Thus, a custom denture is provided in a single visit. 
     The above description is given by way of example only. Changes in form and details may be made by one skilled in the art without departing from the scope of the invention as defined by the appended claims.