Dentistry – Method or material for testing – treating – restoring – or... – By lining or coating
Reexamination Certificate
2002-08-15
2004-02-03
Rose, Shep K. (Department: 1614)
Dentistry
Method or material for testing, treating, restoring, or...
By lining or coating
C424S049000, C424S125000
Reexamination Certificate
active
06685474
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention generally relates to compositions and methods useful for oral hygiene, and more particularly to such compositions and methods that are self-practicable by a human, or that can be practiced by a human on another human or other warm-blooded animal, for indicating the presence of and removing both plaque and calculus, as well as removing stains, adherent to tooth surfaces of the human or other warm-blooded animal.
2. Description of the Related Art
Practicing good oral hygiene is critical in the prevention of tooth decay and periodontal, or gum, disease. Periodontal disease is one of the most prevalent chronic diseases affecting humans and other mammals. Children as young as 5 years of age can have the disease. By the age of 35, three out of four people are affected, and by age 65, an estimated 98 percent of Americans have periodontal disease.
Before the onset of disease, healthy pink gingiva, or gum tissue, surrounds the teeth. Gum tissue, which is the soft tissue covering the neck of the tooth, serves to hold teeth in place and prevent infectious material from entering the jaw bone or tooth itself. The area between the tooth enamel and the gigiva is called the gingival crevice. Gums are constantly exposed to bacteria. Gingivitis typically develops when large masses of bacteria fill the gingival crevice, and is first manifested by bleeding gums. This inflammatory condition is reversible. Gum disease occurs when the gingival crevice between the tooth and gum is more than 3 mm deep.
As gingivitis progresses, the tissue surrounding the teeth is destroyed and the supporting collagen fibers degenerate, leaving abnormally deep (1 to 3 mm) crevices, or pockets adjacent to the teeth due to the loss of gum attachment thereto. As the pockets grow, and the amount of bacteria therewithin increases, the gums recede down the root of the teeth. Eventually, the bone supporting each affected tooth socket degenerates and results in tooth loss. These are the defining characteristics of periodontal disease. In fact, the latter is the principal reason that adults have teeth removed. Typically, this is a slow, painless, progressive disease and, hence, is insidious in nature.
More specifically, periodontal disease is caused by certain types of bacteria that form a clear (almost invisible), sticky, film of the bacteria, having an organized structure and referred to as dental plaque (hereinafter, “plaque”). Plaque is not food or food residue. Plaque forms at all ages and on both non-permanent (“baby”) and permanent (adult) teeth. It adheres to the surfaces of teeth, gum tissues, dental restorations, and even the tongue and is adherent to the point that it cannot be washed or rinsed off. Instead, plaque must be removed mechanically. Brushing and flossing are most commonly used. Picking and scraping may also be used. Such techniques are effective in removing the plaque that is, in fact, accessed thereby.
Studies have shown that plaque forms very soon after it is removed—from as soon as five minutes, to up to four hours after removal. It is fair to say that plaque must be continually removed and that its formation cannot be stopped. When all oral hygiene measures are suspended, gingivitis can result from the presence of plaque within about three weeks. As noted, gingivitis is reversible. With diligent flossing and toothbrushing, the inflammatory condition usually disappears. In the absence of such measures, periodontal disease is sure to follow. Plaque also causes tooth decay (cavities).
Despite normal diligence in removal of plaque, which may be regarded as thoroughly brushing teeth twice a day, and proper flossing between all teeth daily, some amount of plaque remains. Thus, the formation of calculus (also referred to as tartar), which stems from the presence of plaque, appears to be inevitable. In fact, research has shown that about 92% of Americans have a significant accumulation of calculus in their mouths. Calculus forms when the calcium carbonate and phosphate in saliva combine with plaque at the tooth surface and precipitates to form a hard and tough, unsightly scale deposit not unlike a limestone type substance. Once the deposit mineralizes, it can grow rather quickly. Typically, calculus is yellow or brown in color. It bonds cohesively with teeth and, unlike plaque, cannot be removed by normal brushing or flossing.
Calculus can exist both above the gum line as a hard deposit on the top portion of teeth (supragingival calculus), and below the upper gum surface (subgingival calculus). Supragingival and subgingival calculus deposits are equally hard and adherent. The surface of calculus tends to be rough and filled with microscopic holes. In fact, when examined under a microscope, it is apparent that calculus has a myriad of nooks and crannies, not unlike a coral reef.
The removal of calculus is an important aspect of good dental hygiene for a number of reasons. First, as noted above, it is unsightly due to its yellow or brown color. Also, it absorbs stains easily. Therefore, its removal is important from an aesthetic standpoint. Second, the microscopic holes found therein harbor food particles, bacteria, and viruses that cause swelling and bleeding of the gums. Third, the rough surface of calculus both attracts bacterial plaque to tooth surfaces, and enhances its adherence thereto, making thorough plaque removal more difficult. When this layer of plaque mineralizes, more calculus forms, and the result is a continuous cycle of accumulation. This cycle is particularly problematic in the case of subgingival calculus and is a significant contributor to more extreme conditions of gingivitis and periodontal disease. In the case of supragingival calculus, this cycle is also problematic, principally as a contributor to tooth decay.
As noted, hard calculus cannot be removed by normal brushing and flossing. Typically, it is mechanically removed by dentists and dental hygienists by scraping, picking, drilling and abrading with metal instruments having hard, sharp edges and tips. Often, the movement of the instruments is by manual manipulation, although, for example, an oscillating device, typically having a metal tip and operating at ultrasonic frequencies, may be used. Such removal of calculus is most often performed on a patient on a rather infrequent basis. Twice a year is usually recommended. Often, patients will avail themselves of such calculus removal only once a year, or less frequently.
One of the principal disadvantages of this approach to calculus removal is associated with the infrequency of the removal. The extended period of time between visits to the dentist is likely to allow significant accumulation of calculus and plaque, and, thus, the tooth decay and gingivitis that is often associated therewith. A resultant, additional disadvantage is the pain and discomfort associated with the calculus removal (especially when gingivitis is extant) and the repair of damage often caused by the accumulation of calculus and plaque (e.g., drilling to remove decayed tooth matter and filling the tooth to replace the same. Other resultant disadvantages include the considerable expense and inconvenience associated with the above.
If the individual patient could self-practice the above techniques, used by dentists and dental hygienists, for calculus removal, as part of a frequent and regular, personal oral hygiene regimen, some of the above disadvantages could be avoided. However, such use of the methods and instruments, typically used by the skilled dental practitioner on a patient, would be hazardous and likely to result in serious injury to teeth, gingiva, and other soft tissues in the mouth. Accordingly, various methods, devices and compositions, other than those associated with conventional tooth brushing and flossing, have been described as allegedly suitable for use by a patient to remove at least some calculus as part of personal oral hygiene, while avoiding the risk of such injury.
For example, U.S. Pat. No. 4,878,508 describes a
Rose Shep K.
Seed IP Law Group PLLC
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