Drug – bio-affecting and body treating compositions – Dentifrices
Reexamination Certificate
2000-03-17
2002-04-02
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
C106S035000, C433S217100, C433S228100
Reexamination Certificate
active
06365132
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to methods for whitening, lightening, bleaching or removing stains from teeth using certain bioactive glass compositions.
BACKGROUND OF THE INVENTION
A tooth is comprised of an inner dentin layer and an outer hard enamel layer that is the protective layer of the tooth. The enamel layer of the tooth is naturally an opaque white or slightly off-white color. It is this enamel layer that can become stained or discolored. The enamel layer of the tooth is composed of hydroxyapatite mineral crystals that create a somewhat porous surface. It is believed that this porous nature of the enamel layer is what allows staining agents and discoloring substances to permeate the enamel and discolor the tooth. In addition, the tooth naturally acquires a film called pellicle, made up of salivary glycoproteins. The pellicle may also acquire stain. As the terms “tooth” or “teeth” are used herein, they are intended to mean a material which is apatite and the acquired pellicle.
Many substances that a person confronts or comes in contact with on a daily basis can “stain” or reduce the “whiteness” of one's teeth. In particular, the foods, tobacco products and fluids such as tea and coffee, that one consumes tend to stain one's teeth. These staining and discoloring substances can then permeate the enamel layer. This problem occurs gradually over many years, but imparts a noticeable discoloration of the enamel of one's teeth.
WO 96/10985 discloses particulate bioactive silica containing glasses that can reduce pulpal irritation of a tooth and/or strengthen the structure of a tooth and therefore have use in the treatment of hypersensitive teeth. It is suggested that such glasses can consist solely of silicon oxide or silicon hydroxide or can contain one or more additional elements selected from Ca, P, Na, K, Al, B, N, Mg, Ti, or F. It is also suggested that it is advisable to use bioactive glass compositions comprising calcium and phosphate which can help induce remineralisation of dentin or alternatively to use separate sources of calcium and phosphate together with a bioactive glass not containing them.
WO 97/27148 discloses particulate bioactive and biocompatible glasses which can remineralise teeth and are of particular use in the reduction of dentin hypersensitivity.
Various treatment modalities have been used to whiten teeth including in-office bleaching, night guard bleaching and whitening toothpastes. However, the available methods and compositions are not satisfactory for a variety of reasons. For example, shade reduction has been less than ideal.
SUMMARY OF THE INVENTION
It has now been discovered that the above-noted bioactive glasses can be used to whiten teeth. Accordingly the present invention provides a method of whitening teeth, which comprises contacting a tooth structure with a tooth-whitening amount of a particulate bioactive and biocompatible glass.
DETAILED DESCRIPTION OF THE INVENTION
These following words are intended to be given the same meaning here as would be accorded to them in their contemporary usage in the oral and dental care arts. More specific usage for the invention herein is described below.
The term “whitening” is used herein at all occurrences to include bleaching, lightening, or removing stain from the teeth.
The present invention provides a method for whitening, lightening or bleaching teeth. The method is also useful for removing stains from teeth. The method includes contacting teeth with an effective tooth-whitening amount of bioactive glass as disclosed in WO 96/10985 and WO 97/27148. Preferably, multiple applications are carried out. Each application may include between about 0.02 to 0.3 grams of bioactive glass. Suitably, the instant method of whitening teeth comprises contacting the teeth with said effective tooth-whitening amount of bioactive glass twice daily for two weeks or more. As the term “tooth-whitening amount” is used herein, it is intended to mean any amount that will result in a Vita shade guide lightening of one or more shades in a patient with a pre-treatment shade darker than A3.5 after 4 weeks of application twice daily for two minutes or more per application.
Accordingly the present invention provides a method for whitening teeth which comprises contacting teeth with an effective tooth-whitening amount of particulate bioactive and biocompatible glass comprising silicon oxide or hydroxide and optionally one or more elements selected from Na, K, Ca, Mg, B, Ti, Al, P, N or F.
Preferably the bioactive glass comprises at least Na, Ca and P, although it is possible to use simple sodium silica glasses together with external sources of calcium and phosphate. It will be understood by the skilled artisan that an external source of calcium and phosphate may be from saliva itself, or may be formulated into the oral hygiene composition.
A bioactive glass in accordance with the present invention is a glass composition that will form a layer of hydroxycarbonate apatite in vitro when placed in a simulated body fluid. Bioactive glasses in accordance with the present invention may be prepared by a variety of processes, e.g., melt-derived or sol gel and may have a variety of compositional elements and ranges. For example, the following composition by weight will provide an acceptable and preferred bioactive glass:
SiO
2
40-60
CaO
10-30
Na
2
O
10-35
P
2
O
5
2-8
CaF
2
0-25
B
2
O
3
0-10
K
2
O
0-8
MgO
0-5
Bioactive glasses with these properties provide a more efficacious material for interaction with the tooth structure. The addition of fluoride in the glass composition will enhance and strengthen the tooth structure. Other examples include sol gel glasses having, for example, about 40 to about 86% by weight SiO
2
, substantially no amount of sodium, about 6-36% by weight Ca and about 2-12% by weight P
2
O
5
. A biocompatible glass in accordance with the present invention is one that does not trigger an overwhelmingly adverse immune response.
In, some embodiments of the present invention, extremely small particles are used. For example, particles that are in the range of 2 mm to submicron are beneficial. Particle size in accordance with the present invention is determined by scanning electron microscopy or laser light scattering techniques (e.g., Coulter LS100). Surprisingly, the relatively small bioactive particulate glass does not generate a significant immune response. Moreover, it is generally not engulfed by macrophages and rendered inactive in this application.
The compositions of the present invention may be formulated as oral hygiene compositions such as dentifrices, toothpaste, gels, powders, mouthwashes, irrigating solutions, and presentations for sucking or chewing such as gums, pastilles, tablets, and lozenges.
Such oral hygiene compositions suitably comprise between 0.1 to 50% by weight, preferably 1 to 25% by weight, more preferably 5 to 10% by weight of the bioactive glass.
In addition to the active ingredients, the oral hygiene compositions suitable for this invention will contain the usual carriers, binders, surfactants, humectants, coloring agents, pigments, antiplaque agents, anti-bacterial agents, bioadhesive-type agents, abrasives, anticaries agents, flavorings, sweeteners, bulking agents, and the like.
In the case of a toothpaste formulation, an abrasive typically includes amorphous, gelled, precipitated, or fumed silica, plastics particles; alumina, calcium carbonate, and zinc orthophosphate, insoluble metaphosphates and calcium pyrophosphate. Silica is an especially preferred abrasive for use herein. The patent and scientific literature is replete with examples of such abrasives. U.S. Pat. No. 4,822,599 listing a series of dentifrice abrasives also references commercial sources and methods for their preparation. The bioactive glass particles may replace all, some, or none of the abrasive currently used in toothpastes.
Inorganic thickeners may be included in the dentifrices of the present invention and include fumed silicas such as Cabosil available from Cabot Co
Greenspan David C.
Hack Gary D.
Litkowski Leonard J.
Burns Doane , Swecker, Mathis LLP
Rose Shep K.
Univ. of MD., Baltimore
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