Prescription tooth-cleansing and gingival therapeutic device
United States Patent Cole [ Apr. 1, 1975 1 PRESCRIPTION TOOTH-CLEANSING AND GINGIVAL THERAPEUTIC DEVICE William Lloyd Cole, Hollywood, Fla.  
 [73] Assignee: Orville N. Greene, New York, NY.  
 ; a part interest 22 Filed: Dec. 6, 1973 21 Appl. No.: 422,179  
 [75] Inventor:  
 Primary Examiner-Robert Peshock Allorney, Agent, or Firm-Greene &amp; Durr [57] ABSTRACT A prescription fitted unitary tooth-cleansing and gingival therapeutic device is disclosed which is fabricated from study models taken by a dentist of a patients individual dentition. The device of the invention includes opposed channels which are formed integrally with a common handle. Each channel is bent into an arcuate shape so as to form an arch which conforms to the exact shape of the teeth and adjacent structures. In addition, the interior of each channel, which is formed of an elastic plastic material, is molded to closely conform to the contour of the teeth and adjacent soft tissue structures of the person utilizing the device. In the interior channel portion of the device are positioned, in two sections, a plurality of bristles or similar projections, which extend generally in a perpendicular direction from the inner walls of the channels. The material of said channels is sufficiently elastic so that when the person chews into the upper and lower channels with his teeth, the projections effectively and exactly clean food particles and bacteria from every surface of every tooth except the interproximal contact areas and interdental C01, and in addition, the device cleanses the area between the teeth and gums known as the Gingival Crevice while also properly massaging and stimulating the Free Marginal Gingival, by reason of the fact that it is provided with ledges beyond the several gingival lines to permit compression of the gingiva.  
 8 Claims, 3 Drawing Figures PATENTED APR 1 I975 CIOW/V %4 WWI/T AW NW 5 WW Z i PRESCRIPTION TOOTH-CLEANSING AND GINGIYAL THERAPEUTIC DEVICE This invention relates to a custom unitary toothcleansing and Gingival therapeutic device, which can be positioned in the mouth of a user and which, when chewed upon, is operable not only to clean the teeth but also the Gingival Crevice and massage the Free Marginal Gingiva.  
 BACKGROUND OF THE INVENTION In 1780, the first toothbrush was produced by William Addis, which, although crude, was essentially like the toothbrushes of today. It had a bone handle and the bristles or hairs thereof were drawn into holes bored in the head and secured with wires. This toothbrush or others similar thereto have been used by millions of people concerned with dental hygiene. However, in order to attempt to clean teeth and prevent both cavities and peridontal disease, the cleaning of teeth by a typical toothbrush has proven to be less than adequate. This is due in a large measure to the difficulty of reaching the many surface areas of the teeth. It is known, for example, that each tooth has generally five surfaces, and that there are 32 adult teeth in the mouth (if none have been extracted), with some surfaces of the teeth being, for all practical purposes, inaccessible to an ordinary toothbrush. Examples of difficult-to-reach areas of the teeth and gums are the fine crevices at the depths of the tiny hilly projections on the chewing surfaces of the back teeth, which crevices are called fissures, the contact points where adjacent teeth touch each other and the crevice between the tooth and the gum edge where the teeth leave the gum, which area is called the Gingival Crevice. It is in these areas that much of the tooth decay and Peridontal disease initiates, and which are not reached by the typical toothbrush utilized today.  
  Thus, it has been reported that expert use of a toothbrush can remove bacteria and foreign particles from approximately 85 percent of the surface of the teeth with little gum massage. However, it is in this 85 percent area where only percent of dental diseases originate. The other 15 percent of the teeth which are typically missed is where 85 percent of all dental diseases occur. Accordingly, present usage of a customary toothbrush has proven to be less than adequate in providing protection for both teeth and gums.  
  Other devices have been untilized, such as dental floss and toothpieks, in combination with a toothbrush to attempt to provide adequate cleaning of the teeth. Dental floss aids in cleaning the contact points between the teeth, but it is not capable of cleaning the remaining portions of the teeth and is less than adequate in providing gum massage to the Free Marginal Gingiva. Toothpicks can be utilized to clean foreign particles fromm between the teeth and around the gums, but once again, cannot be utilized to clean the Gingival Crevice and clean bacteria and other minute particles from the many surfaces of the teeth.  
  More recent developments have included power toothbrushes which provide a rapid back and forth oseillating movement of the bristles thereof. The toothbrushes have not been proven to clean teeth in a more efficient manner than manually operated toothbrushes, nor have they been shown to provide for gum massage in and around the gingival crevice, which massaging is important in preventing Peridontal disease. In addition, power toothbrushes have not been able to clean the contact points between the teeth and reach the small crevices on the chewing surfaces of the back teeth. Accordingly, these power toothbrushes have also not solved the problems of providing an adequate and consistent means for brushing and massaging teeth and gums.  
  Hydraulic teeth cleaning devices have been developed which foree jets of water against the teeth and gums. These cleaning devices are adequate for cleaning particles between the teeth and under bridges, but they require unnatural skill on the part of the person utilizing them.  
  Applicant is also aware of the fact that single or double channel brush devices have been devised for brushing all or a large portion of the teeth simultaneously. Such devices are shown, for example, in U.S. Pat. No. 3,163,874 of Bauer, U.S. Pat. No. 3,109,192 of Sevenson, and British Pat. No. 546,136 (dated June 30, 1942).  
  Generally speaking, the devices of these patents (1) do not allow for the fact that each and every mouth is different and a standard mass-produced brush will not fit all mouths, (2) do not provide for the cleansing of the gingival crevice and the stimulation of the marginal gingiva, and (3) can do harm to tender tissues especially in the event that the user has one or more missing teeth where tender tissues are exposed. It is therefore an object of this invention to provide a custom prescription, tooth-cleansing and gum massaging device made on an exact mold of an individual patients mouth obtained by the dentist through one of several standard impression taking techniques, which therefore closely conforms to and therefore properly cleans substantially the entire surface area of every tooth of user, which cleans the area of the gingival crevice and which compresses and releases and thereby massages the free marginal gingiva without requiring any degree of manual dexterity.  
 SHORT DESCRIPTION OF THE INVENTION According to the process of the invention therefore, a dentist takes an exact impression of the dentition and adjacent soft tissues of a prospective owner of such a cleaning device. The impression will be poured in a suitable stone or plastic material and will duplicate every exposed surface of said dentition and include the Marginal Gingivae and a portion of the tissue lateral to and surrounding the gingival crevice. A mold is made from the dentition and an elastomeric replica of the original impression is made from the mold. The bristles or protuberances are then inserted in the elastomeric replica. If desired, the mold may be altered, e.g., by forming small holes therein, which will then appear as protuberances on the elastomeric relica made from the altered mold.  
  Accordingly, the invention relates to a unitary toothcleansing and gum massaging device made of resilient material so that it can be chewed-on, and having a pair of oppositely directed channels, each of which has a U- shaped configuration to conform to the exact shape of the individual dentition and preferably to the adjacent soft tissue structures. Each side of each channel comprises two distinct areas which have different objectives and functions. The first said area conforms to the adjacent clinical crown areas of the teeth. Scrubbing projections comprising bristles, nipples, or soft abrasive structure are provided on said first areas, the bristles or projections preferably extending generally in the perpendicular direction with respect to the facial, lingual, interproximal and occlusal surface of the teeth respectively. Thus, the entire clinical crown areas of all the teeth are cleaned by making the walls of the channels correspond exactly to the clinical crown areas. The second area of each side of the channels begins with an un dulating line corresponding approximately to the line projected on the clinical crown by the unattached gingival tissue, known as the Free Marginal Gingiva, and has a separate and distinct non-abrasive ridge. This undulating line on the walls of the channels will be called the gingival line. A series of bristles or bristle clusters or similar cleansing projections is provided adjacent to or on the gingival line, for cleansing the gingival crevice when the Free Marginal Gingive is compressed and released by the chewing operation. Beyond the gingival line, the non-abrasive ridge may be flattened out somewhat from a snug fit so as to accommodate the slight lateral expansion of the free marginal gingiva which occurs when the latter is compressed by the gingival line during chewing. Thus, when the device is positioned in the users mouth, and chewed upon, said first areas of the channels cleans the surfaces of the clinical crown of every tooth while said second areas cleanses the area between each tooth and the unattached gingiva and at the same time said second areas compress and release said unattached gingiva to stimulate and massage the same. This is accomplished without any degree of manual dexterity and without harming the gingival tissue, only because the said channels have been prescription molded to the exact form of the users dentition and adjacent soft tissues. The free marginal gingiva is substantially uniformly compressed to about ().52mm, during chewing, by the device of the invention and there is no way that a mass produced item could produce this desired effect.  
  The bristles or ridges or combination thereof of either section of each channel, may be natural or synthetic and may also take the form of protuberances formed integrally with the plastic channels. The bristles or protuberances are not so long that they will be held continuously in collapsed position during chewing. Advantage may be taken of the fact that plastics molded from a melt shrink slightly on cooling so that the channels produced from the impressions made of a persons mouth are still slightly smaller than the actual teeth and will elastically expand on chewing. The walls of the channels are thick enough to form the ridges referred to above, extending away from the gingival lines of the device.  
  The elastic plastic material forming the channels can be of any elastomeric material which does not have an offensive odor or taste and which is relatively inert with respect to saliva. Suitable materials include the natural and synthetic rubbers, polymers of ethyl vinyl acetate, elastomeric silicone resins, etc.  
 BRIEF DESCRIPTION OF THE DRAWINGS Other objects, advantages and features of this invention will become more fully apparent from the following detailed description, appended claims and accompanying drawings in which:  
  FIG. 1 is a perspective view of the device of this invention which may sometimes be referred to as a chewbrush.  
  FIG. 2 is a cross-sectional view of the chewbrush of this invention shown positioned over two opposing teeth before being chewed into.  
  FIG. 3 is a detail cross-sectional view of the chewbrush of this invention as it appears over a typical tooth when chewed upon (in a fully closed position).  
 DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Refer now to FIG. 1, which is a perspective view of the tooth-cleaning device of this invention. The device is formed of a pair of integral channels 11 and 12. which are fabricated to conform to the maxillary and mandibular arches, respectively, and to the arcuate arrangement of the teeth and surrounding structures within the mouth of a person utilizing the device. Formed integral with the channels 11 and 12 is an arm 13 which is terminated in a handle 15. Each channel 11 and 12 has inner surfaces of two distinct parts, which are formed by a molding process to l) the contour of the teeth, and (2) to conform approximately to the adjacent structures of the Marginal Gingiva. Accordingly, when the device is positioned in the mouth and the user chews, the entire crown portions of the teeth will fit snugly against the walls of the channels and be cleansed and the unattached gingiva (Free Marginal Gingiva) will be compressed to allow for the cleansing of the gingival crevice and the massaging of the marginal gingiva.  
  FIG. 2 is a cross-sectional view of the upper and lower channels 1 l and 12 of the tooth-cleaning and gingival therapeutic device positioned over opposing teeth. In FIG. 2, the area of the clinical crown, the Free Marginal or unattached gingiva, the epitheliel attachment, the gingival crevice and the peridontal ligament have been labeled.  
  The gingiva surrounding the clinical crown attaches itself in the healthy mouth to the tooth at a depth ranging from 0.05 to 2 millimeters below the superior position of the marginal gingival thus creating what is known as the gingival crevice. It is through this crevice that bacteria gain entry into the epitheliel attachment and into the peridontal ligament 25, initiating its breakdown, together with assymptomatic and progressive bone destruction. This pathologic progressive asymptomatic destruction of supporting bone is what ultimately challenges the integrity of the tooth structure itself.  
  It therefore is important that the gingival crevice be cleaned and the marginal gingiva be massaged on a regular basis. Of particular importance is the configuration of the interior channels 11 and i2, which comprises two parts, the main channel portion 32 corresponding to the clinical crown of the tooth, and the ledge portions 33, adapted to fit over the free marginal gingiva adjacent to the gingival crevice. Thus, when the teeth are closed into the device upon chewing, the lower channel is pressed down upon the teeth as best illustrated in FIG. 3. The main channel portion 32 also includes a number of bristles 29 or similar projections, the bases of which may be slightly indented in the surface. The ledge portion 33 is free of bristles, except for a series of bristles 29 right at the gingival line 34.  
  FIG. 3 shows separate areas 32, 33 and 34 of the channel 12 with area 32 scrubbing the surface of the clinical crown, line 34 and bristles 29 cleansing the gingival crevice and area 33 compressing and massaging the free marginal gingival. Accordingly, it can be seen that by contouring the tooth-cleansing device to the precise shape of the teeth and gums of the user, and by including the ledge portions 33, substantially all areas of l the teeth, and (2) the areas between the teeth and the gums and the unattached gingiva are cleansed and stimulated. By chewing into the device, the projections or bristles of the two separate and distinct areas of each channel move back and forth across the tooth and gums to provide the cleaning and massaging action.  
  The gingival lines 34, as shown in FIG. 1, are typical and it is readily seen that these lines are undulating rather than straight. Brushes or protuberances positioned along or fairly close to the gingival line will tend to brush particles out of the gingival crevice when one chews in to the device due to the undulating nature of the gingival crevice and to the lateral movement of the jaws during chewing. The channels, although made of elastomeric material, are, nevertheless, of sufficient thickness to require the user to exert some force in order to chew against the same. As illustrated in FIGS. 2 and 3, the ledges 33 of the device have a concavity to fit about the free marginal gingiva and to compress the same without irritation.  
  The present invention has been illustrated in conjunction with a preferred embodiment. However, it should be understood that there may be other equivalent embodiments which fall within the spirit and scope of the invention as defined by the appended claims.  
 I claim:  
  1. A tooth-cleansing device for cleaning and massaging substantially the entire surface of the teeth comprsing:  
 a molded body of elastomeric material having arcuate lower channels of the curvature of the lower jaws ofthe user and a superposed upper channel of the curvature of the upper jaw of the user,  
 each of said channels having a central portion substantially conforming to the shapes of the clinical crown portions of the teeth of the user,  
 each of said channels containing undulating gingival interior ledge portions on each side of the central portion, corresponding to the free marginal gingiva of the teeth of the user, whereby when the user chews upon the device, the Free Marginal Gingiva is compressed and released substantially uniformly along the length thereof.  
  2. The tooth cleansing device as claimed in claim 1 wherein the central portions of said channels contain a multiplicity of spaced, cleansing projections extending from the surface thereof.  
  3. The tooth-cleansing device as claimed in claim 1, wherein the cleansing projections comprise clusters of bristles embedded in the elastomeric material of the channels.  
  4. The tooth-cleansing and gingival stimulating device as claimed in claim 1 wherein the lines connecting the gingival ledge portions of said device to the central portion of the channels comprise a series of bristles adapted to extend into the gingival crevices when the ledge portions compress the free marginal gingiva.  
  5. The tooth-cleansing device as claimed in claim 1 comprising, in addition, a handle extending from the connecting mass of elastomeric material in the region between the central parts of the arcuate channels.  
  6. A process of making a chew brush type of tooth cleansing device comprising taking an impression of patients dentition, forming a replica of said impression from elastomeric material comprising upper and lower channels adapted to closely conform to the contour of the teeth in the maxillary and mandibular arches,  
 said impression taken of the patients dentition including the clinical crown portions of all of the teeth and, in addition, portions of the free marginal gingiva beyond the gingival lines formed between the clinical crown portions of the teeth and the free edges of the gingiva, and providing ledges on the elastomeric replica adjacent at least a portion of the gingival lines whereby said ledges are adapted to substantially uniformly compress the free marginal gingiva of the patient when chewed upon.  
  7. The process as claimed in claim 6, comprising forming scrubbing projections on those portions of the elastomeric replica corresponding to the clinical crown portions of the teeth whereby to clean the teeth when the chew-brush is chewed upon.  
  8. The process claimed in claim 6 wherein the ledges are formed as smooth surfaces, except that a line of brushes is formed along said gingival lines.