Drug – bio-affecting and body treating compositions – Dentifrices – Oxygen or chlorine releasing compound containing
Reexamination Certificate
2002-09-13
2003-11-11
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
Oxygen or chlorine releasing compound containing
C424S049000, C424S058000
Reexamination Certificate
active
06645472
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to a storable, normally inactive, anhydrous oral dentifrice which promotes oral hygiene and which is activated by saliva and/or water, then applied onto the surface of teeth and adjacent gum tissues. The composition and method includes calcium or magnesium peroxide, sodium bicarbonate, ascorbic acid, methylsulfonymethane, and colostrum which are believed to function synergistically to cosmetically whiten, brighten, and bleach (to make whiter or lighter) teeth and therapeutically to cleanse the teeth and surrounding oral tissues and to kill the bacteria which contribute to the formation of dental plaque, caries, and mouth odor. Optionally green tea extract, sodium laurel sulfate, flavors, and sweeteners may be added.
2. Description of Related Art
The desire of people to have white teeth has been present in our society for decades. This desire is heightened by the presence of stains on teeth caused from the food we eat, smoking tobacco, medications, and poor oral hygiene, just to name a few. Many materials, compositions and processes have been developed over the years in attempts to solve this problem. These approaches are not without drawbacks, the most common being product instability, cost, product harshness to teeth and gums, specially trained personnel being required for product application, necessity of wearing specially crafted dental appliances often referred to as “splints”. Thus, it is clear that a need exists for a tooth whitener and cleanser that is stable until use, reasonably priced, safe, easy to use, requires no special apparatus or trained personnel to apply, is not harmful to teeth, gums, and other surrounding tissues, and combats tooth and gum diseases commonly caused by bacteria.
To a large degree, dental caries and periodontal disease are connected closely to the formation of dental plaque. The literature has long reported that a majority of the world's population suffers from periodontal disease. According to the Merck Manual, 14th ed. 1982, P. 2104, the most common types of periodontal disease are gingivitis and periodontitis. Gingivitis (early stage gum disease) is an inflammation of the gums, characterized by swelling, redness, change in normal contours, and bleeding. If gingivitis is allowed to progress, periodontitis (late, stage gum disease), characterized by loss of tooth-supporting bone, will follow. The greatest single source of periodontal disease is poor hygiene, indicated by the appearance of bacterial and calcified plaque.
Dental plaque consists of a thin layer of mucilaginous film which is subject to invasion by colonizing bacteria. These bacteria in the presence of dietary carbohydrates lead to the production of acids which demineralize tooth enamel and dentine, attack gum tissue causing gingivitis (inflammation of the tissue surrounding the teeth) and react with the calcium in the teeth. Alkaline compounds such as sodium bicarbonate (baking soda) have been suggested in the art to neutralize plaque acids in order to inhibit caries formation and reduce demineralization of tooth enamel.
It, has long been known that bacteria play a part in pathogenic dental caries. Over the years, an abundance of research has implicated anaerobic bacteria as the causative agents of periodontal disease. Armitage, G. C., Biological Basis of Periodontal Maintenance Therapy, 1980. Anaerobic bacteria thrive only in the absence of oxygen. By providing high levels of oxygen, peroxides are believed to be effective in killing these bacterial organisms. The dental profession has considered many bacterial compounds over the years for their efficacy in preventing and treating periodontal diseases, peroxide being among them.
The Ng et al. U.S. Pat. No. 4,839,156, noted that peroxy compounds have long been recognized as effective against plaque and gingivitis. Peroxide preparations inhibit colonization and multiplication of the bacteria often associated with dental plaque and periodontal disease and also function as bleaching agents to whiten stained or discolored teeth.
Peroxides are known to be effective in curative and preventative treatments related to caries, dental plaque, gingivitis, periodontitis, mouth odor, tooth stains and oral lesions of the mucous membranes. In addition to treating periodontal disease, many individuals prefer using a combination of sodium bicarbonate and hydrogen peroxide to clean their teeth citing stain removal, a clean feeling, reduced mouth odor, and healthy gums as additional benefits. Sodium bicarbonate is particularly convenient, palatable and non-toxic. A mixture of approximately 60% sodium bicarbonate paste with a 3% solution of hydrogen peroxide has been used to treat periodontal disease.
The Winston et al, U.S. Pat. No. 4,812,308 created a stable composition in the form of a tooth powder mixture of sodium bicarbonate and sodium percarbonate. When the tooth powder makes contact with water, it releases active hydrogen peroxide. The percarbonate formulations generally have high pH in solution which could cause irritation of the gums and oral tissues.
Other sodium bicarbonate-containing and peroxide-releasing dentifrices incorporate enzymes for generating hydrogen peroxide in situ. See Kessler et al., U.S. Pat. No. 4,476,108. These enzyme induced hydrogen peroxide formulations, however, are so slow that only low levels of peroxide are produced during brushing.
Most peroxy compounds tend to be unstable in storage and hence lose their capacity to release the active or nascent oxygen which attacks the bacteria colonized plaque. As indicated in the Rosenthal U.S. Pat No. 3,657,413, it is the nascent oxygen which is believed to cause the antiseptic and/or cleansing effect of peroxide.
Various peroxide-releasing dentifrice formulations have been utilized over the years as oxidizing agents. For instance, urea peroxide has been used in combination with sodium bicarbonate, however, it is unstable and as a result preparations such as these require separate compartments of a container, increasing the cost of packaging.
The Scheller U.S. Pat. No. 4,223,003, discloses a dentifrice in a paste or powder form of magnesium peroxide as an oxidizing agent for removing film from teeth.
The Smigel U.S. Pat. No. 4,405,559, discloses a dental paste which combines calcium peroxide and sodium perborate as oxidizing agents to remove stains and plaque from teeth.
The Clipper et al. U.S. Pat. No. 4,537,778 discloses hydrogen peroxide in oral an aqueous oral composition for use as a mouthwash, rinse, gel or toothpaste.
U.S. Pat. No. 4,971,782 to Rudy a toothpaste or gel comprising a peroxide, bicarbonate, peroxide stabilizer, and non-aqueous hydrophilic vehicle. The present invention is a powder, not a paste or gel and does not include the non-aqueous, hydrophilic vehicle.
Dentifrice whitening products formulated with peroxide compounds normally do not contain abrasive polishing agents as such materials activate the rapid decomposition of the peroxide compounds whereby the oxygen is prematurely released. A disadvantage to the use of whitening products formulated without abrasives is that in addition to slow bleaching action, the products are not as effective in stain removal. Thus, the polishing agent incorporated in a dentifrice acts to debride and physically scrub the external surface of the teeth. This scrubbing action removes filmy bacterial and plaque layers, stains, discoloration and polishes the teeth to give the enamel a more lustrous appearance, higher optical sheen, and thus a brighter appearance.
None of the above prior art taken either alone or in combination, describes, suggests or renders obvious the instant invention as claimed.
BRIEF SUMMARY OF THE INVENTION
A chemically stable anhydrous tooth and gum dentrice is provided which is formulated principally of calcium or magnesium peroxide, sodium bicarbonate, ascorbic acid, methylsufonymethane, and colostrum which act synergistically to release oxygen for use to whiten, brighten, polish, and reduce bacteria in the oral cavit
Malin Haley & DiMaggio, P.A.
Rose Shep K.
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