Drug – bio-affecting and body treating compositions – Dentifrices – Ferment containing
Reexamination Certificate
2002-12-30
2004-08-17
Henley, III, Raymond J. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
Ferment containing
C424S053000, C424S057000, C424S058000, C424S093450, C424S094600, C424S630000, C424S643000, C514S054000, C514S474000
Reexamination Certificate
active
06776979
ABSTRACT:
CROSS REFERENCES TO RELATED APPLICATIONS
None
STATEMENT REGARDING FEDERALLY-SPONSORED RESEARCH OR DEVELOPMENT
None
BACKGROUND OF THE INVENTION
This present invention relates to an improvement in office hygiene treatment and follow-up care, and more particularly to treatment and prevention of periodontal disease.
The gums of one's mouth and the bone under the gums and around the teeth hold one's teeth firmly in place. Periodontal disease is an infection of that gum. Its manifestations include an increase in gingival sulcus [pocket or furrow] depth, inflamed gingival tissues, bleeding gums, loss of bone structure, bad breath and increase of plaque, calculus and harmful bacteria in the periodontal sulcus. The sulcus is the depth of the space below the visible crest of gingiva of the lower teeth and above the visible crest of the gingiva of the upper teeth and the actual location of the gingival attachment to the tooth. Sulcus depths of 1 mm to 3 mm are considered normal, 4 mm and over are considered unhealthy and disease involved. Periodontal disease is commonly referred to as gum disease and is caused by the build-up and retention of dental plaque (i.e., a sticky mass of harmful germs [bacteria]) in the space between the gum and tooth. It is estimated that there are about 300 different types of bacteria in one's mouth. Of this amount, dental scientists have found that about a dozen of these nearly 300 bacteria can lead to and cause gum diseases. As it is presently understood, however, not all bacteria are harmful. In fact, many are helpful. As a result, not all bacteria should be eliminated, only the harmful bacteria which cause or contribute to periodontal disease.
It is also estimated that there are approximately 200 million people in the United States alone that are affected by some form of periodontal disease. In the 1960's the cause and treatment of periodontal disease was not well understood. It was then commonly believed that deep cleaning and some form of surgery, either curettage of the lining of the sulcus gum tissue, or surgical removal of the infected tissue was the treatment of professional choice. This was costly, painful and cumbersome for doctor and patient alike, and was not a permanent cure. The problem could recur and the same treatment would resume followed by the same temporary results. Further research later demonstrated that periodontal disease was more related to the build-up of plaque and bacteria in the gum space as well as poor periodontal and systemic immunity. This build-up caused the gum attachment to gradually pull away from the tooth leaving a pocket or furrow (sulcus) into which more plaque and bacteria could flourish. The greater the build-up, the greater the separation, the more severe the problem.
In the early 90's, based on these and other findings, more attention was given to the removal of this built-up plaque and bacteria, typically by the use of chemical agents or oral antibiotics or both. Lasers became a popular source for removing the tissue lining infected with plaque and bacteria. These procedures, though fine for removal of the plaque and bacteria, did nothing to prevent a recurrence. Whatever habits the patient had or whatever one's immunity, a recurrence was most probable. Nothing in the prior art treatment regimens provided for a simple, user-friendly preventive oral health regimen to attack the problems associated with periodontal disease at their incipient stages, or before, or after.
More and more attention is now being given to attacking the harmful bacteria, which are now well recognized as the main contributors to periodontal disease. Treatment protocols presently include antibiotic gels applied by syringe into the infected gum space, chemical rinses, time-released antibiotic chips inserted into the infected gum space, chemical flushes into the infected gum space, and stronger oral antibiotics.
These invasive chemical and antibiotic approaches are having some success in the treatment of periodontal disease, thereby decreasing the amount of periodontal procedures such as curettage and surgery. However, the overall satisfaction of both doctor and patient is still less than optimum and less than desired. Repeated use or over-use of antibiotics can compromise the immune system of the patient. Though these antibiotic approaches do help the periodontal tissues they also are inherent with problems and other undesirable side effects. They mask the real problem by treating the symptoms not the cause of the problem; they are expensive, they are not user-friendly, and they lack a comprehensive approach to the treatment of the whole mouth.
In July of 1998, the American Academy of Periodontology launched an effort to educate the public about new findings that support the proposition that infections in the mouth can wreak havoc elsewhere in the body. From these findings, many oral health-care professionals believe that persons with periodontal disease may be at greater risk of other and more serious health problems than those persons without the disease. Various other studies suggest, or an inference can be made to, a connection between periodontal disease and an increased risk for developing heart disease, suffering a stroke, developing uncontrolled diabetes, encountering pre-term births, and developing respiratory disease and other health problems.
Evidence continues to mount supporting these connections or links. While more research is required to definitively conclude that people with periodontal disease are at higher risk for developing heart disease, stroke, uncontrolled diabetes, pre-term births, and respiratory disease, periodontists do know that periodontal disease is a bacterial infection and can enter the blood stream, thereby providing the disease great access to all major organs. As such it is a cause for serious concern.
Several theories exist to explain the link between periodontal disease and heart disease. One theory is that oral bacteria can affect the heart when they enter the blood stream, attaching to fatty plaques in the coronary arteries (heart blood vessels) and contributing to clot formation. Coronary artery disease is characterized by a thickening of the walls of the coronary arteries due to the buildup of fatty proteins. Blood clots can obstruct normal blood flow, restricting the amount of nutrients and oxygen required for the heart to function properly. This may lead to heart attacks.
To develop an effective and efficient periodontal treatment program, the program must be based on a natural healing approach, which centers on the dental hygiene department of a dental office, rather than on a continued and repeated reliance and over-reliance, on antibiotics and chemicals. Many oral health-care professionals are aware of this and thus have attempted to create products or procedures to be used in the dental offices to combat this disease.
Many of the doctors and their patients are not satisfied with the current and past treatments and lack of long-term results. Because of cost and safety limitations, many current methods target treating only quadrants of the mouth, one at a time, per each office visit. If the entire mouth requires treatment, up to four office visits would generally be required. More office appointments result in greater expense, more time away from work, from home, and from family.
The cost of current treatments can range from approximately $200-$400 per treatment and these generally only target select quadrants of the mouth, one at a time. This can be rather expensive when more then one quadrant requires treatment, which generally is the case. The upshot from the costs involved and the time involved is that many patients in need of such treatment delay or, worse yet, decline treatment. When considering the estimates that nearly 200 million people in the United States [80% of all adults and teenagers] have some degree of gum disease, it is very important to create a treatment that most will feel they can afford to engage and, thereby, are
Frager Marvin B.
Gaynor R. Douglas
Taylor John R.
Henley III Raymond J.
Morkunas Frank G.
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