Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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DENTAL BALM AND METHOD OF PREVENTION OF DAMAGE TO TEETH
FIELD OF THE INVENTION
The present invention relates to a dental balm
composition and a method of using a dental balm to prevent
damage to teeth, particularly caused when teeth are permitted
to become dry, and to reduce sensitivity due to dehydration
of teeth after tooth whitening procedures. The invention
provides a composition designed to prevent dental decay in
athletes and others prone to dry mouth conditions, and dental
sensitivity immediately after tooth whitening procedures,
whether at home or a dental office.
BACKGROUND OF THE INVENTION
Many people suffer from dry mouth conditions from time to
time, but this can present a serious problem for individuals
who suffer from dry mouth as a chronic condition. Dry mouth
presents itself in a variety of circumstances and causes
dental problems when the surfaces of teeth become dry from
overexposure to air. It is well known that antibodies in
saliva are useful in the prevention of cavities or dental
caries; however, the beneficial effects of saliva are not
possible when, for whatever reason, teeth are permitted to
become dry.
Athletes, particularly those involved in aerobic sports,
are prone to dry mouth conditions. It is recognized that
aerobic athletes spend a great deal of time breathing through
their mouths causing tooth enamel surfaces to dry out, and
increasing the prevalence of dental caries in these
individuals, especially on their front teeth. Athletes
subject to this condition would include runners, swimmers,
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bicyclists, skiers and long-distance competitors of all
types.
Other persons who may be prone to dry mouth and teeth
include individuals who, for various reasons, breathe
principally through their mouths. Individuals with dental or
skeletal malocclusion with anterior open bite (i.e. the front
teeth do not meet, leaving space between upper and lower
teeth) sometimes experience problems with improperly closing
lips. Other individuals prone to dry mouth and teeth include
those with sinus and related breathing problems, as well as
other persons who suffer from excessive snoring. All of
these persons may develop damage to their tooth enamel due to
the inaction of saliva when their mouth and teeth become dry.
Others who may benefit from the composition and method
of the present invention are persons with xerostomia having
compromised or non-functioning salivary glands (such as
certain radiation therapy patients and people with Sjogren's
syndrome, diabetes and vitamin deficiencies) as well as
persons taking certain medications including some anti-
depressives, anti-hypertensives, diuretics and anti-
histamines.
In the mouth, teeth are naturally protected from decay
by saliva. When saliva is removed from the front teeth, as
when an athlete is involved in long-distance running or
swimming with the mouth open, or where a person is mouth
breathing throughout the night while sleeping, tooth enamel
is more susceptible to destruction by naturally occurring
acids in the mouth produced by Streptococcus Mutans. S.
Mutans is a bacteria that is always present in the mouth and
in the presence of carbohydrates produces acids that de-
mineralize tooth enamel and cause cavities. This is
especially true for cervical and root cavities when some of
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the tooth's root is exposed. Additionally, with decreased
saliva there is an increase in bacteria which causes an
increase in plaque formation. Traditional fluoride
treatments help to prevent cavities by re-mineralizing tooth
enamel when the fluoride is incorporated into the calcium
phosphate matrix of the enamel.
In general, traditional cavity preventing formulations,
particularly tooth pastes, whether used separately or in
combination, are known in the art.
Consumers are most familiar with oral hygiene products
delivered in the form of toothpastes but balm and ointment
treatments are also known. Dental compositions for the
treatment of hypersensitive teeth are known and may be
applied to teeth in balm form and may be applied via
fingertip. U.S. Patent No. 6,761,879 discloses the use of
titanium compounds to prevent dental caries and specifies
that these may be used in balm form. A further U.S. Patent
Application Publication 2002/0137728 discloses topical oral
care compositions using ascorbyl phosphate which may be
delivered to the oral cavity by means of a tooth balm.
The present invention overcomes the problems presented
by dry teeth by providing a decay preventative material in a
dental balm composition capable of both delivering the active
ingredient to the surface of teeth and maintaining it there
while simultaneously preventing the exposure of tooth
surfaces to the drying effect of exposure to air, or
dehydration due to whitening procedures. Enamel dehydration
causes sensitivity immediately after tooth whitening
procedures.
The dental balm composition of the present invention may
be readily applied to the subject's teeth, with a swab or
forefinger, prior to sleep, athletic activity or other
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activities which contribute to dry mouth conditions and
applied to the teeth immediately after tooth whitening
procedures.
The advantage of the present invention over the known
art is provided by the combination of an active decay
preventing material and a water insoluble protectant adhesive
dental balm base material which is capable of delivering and
maintaining the active ingredient in contact with the surface
of the teeth during periods of strenuous breathing or other
drying conditions.
A general objective of the invention is to promote
dental health in persons subject to strenuous activity and
breathing conditions.
Another broad objective of the invention encompasses a
dental balm composition and method for the prevention of
damage caused to dry tooth surfaces upon prolonged exposure
to air.
A more specific object of the invention is to provide a
fluoride tooth balm composition to prevent or reduce the
incidence of caries on front teeth in long-distance athletes
such as runners or swimmers and other people who breathe
primarily through their mouths.
A further object is to provide a dental balm for
reducing sensitivity in teeth undergoing whitening
procedures, due to dehydration of the enamel from the
procedure.
In the method of the present invention, damage caused by
prolonged exposure of dry teeth to air is minimized by
application of a dental balm comprised of a water insoluble
protectant adhesive material in combination with an active
decay preventative material, applying the balm to the surface
of the exposed teeth and maintaining the active ingredient in
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close proximity to the surface of teeth during periods of
strenuous activity, mouth breathing or sensitivity due to
whitening procedures.
SUMMARY OF THE INVENTION
These objects, as well as others which will be apparent,
are achieved generally by providing a dental balm composition
and method of use for the prevention of damage via
dehydration to teeth which are subject to prolonged exposure
to air, as by vigorous aerobic exercise, a variety of
breathing difficulties including excessive mouth breathing
and sensitivity from whitening procedures.
The dental balm composition is comprised of a water
insoluble protective adhesive base material and a decay
preventative agent in an amount effective for protecting
teeth during strenuous activities, exposure to air, and other
drying conditions. The protective adhesive base material is
effective for delivering the decay preventive agent to the
required dental site and maintaining it there for the
duration of the subject activity or exposure.
The water insoluble protective adhesive base material
is preferably petrolatum which is a semi-solid mixture of
hydrocarbons obtained from petroleum. Petrolatum is also
known as petroleum jelly and is commonly used as a lubricant
or medicinal ointment.
The water insoluble protective adhesive base material
may additionally contain a thickening agent to adjust the
consistency of the desired final balm composition. The
thickening agent may be flour, talc, arabic gum and other gum
additives, starch, silica, beeswax and other waxes or other
colloidal stabilizer.
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The dental balm composition of the present invention
contains an active decay preventive agent which is preferably
fluoride ion. The fluoride ions are generally obtained by
utilizing sodium fluoride or stannous fluoride compounds
approved for dental treatments. Particularly preferred are
fluoride treatments in aqueous solutions (such as rinses)
which may be readily mixed or emulsified in the water
insoluble protective adhesive base material.
The dental balm composition described above is used in
the method of the present invention to prevent damage, such
as tooth decay, experienced when teeth are permitted to
become dry. The dental balm of the present invention is
easily swabbed, via finger or applicator, onto the frontal
aspect (front surfaces) of the upper and lower teeth prior to
overexposure to air or drying conditions, or to sensitive
teeth after exposure to whitening procedures. The adhesive
quality of the balm base enables it to remain in close
proximity to the areas of the tooth surfaces most affected by
exposure and delivers the active decay preventive agent, such
as fluoride, where it is most useful. It is preferred that
the dental balm composition be applied to clean teeth and
removed after use by brushing with toothpaste.
Other objects, features and advantages of the present
invention will be apparent upon consideration of the
following detailed description of the invention and the
examples, which should be construed in an illustrative and
not limiting sense.
DETAILED DESCRIPTION OF THE INVENTION
In accordance with the present invention a dental balm
composition and method for protecting teeth is provided to
promote dental health in persons experiencing deleterious
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drying effects from prolonged air exposure or harsh whitening
procedures.
The dental balm composition is comprised of a water
insoluble protective adhesive base material and a decay
preventative agent in an amount effective for preventing
dental caries.
The water insoluble protective adhesive base material is
preferably petrolatum (petroleum jelly) which is a semi-solid
mixture of hydrocarbons obtained from petroleum. The dental
balm composition of the present invention requires a water
insoluble protectant adhesive. Commercially available white
petrolatum, USP is available for consumer use and is
particularly effective for use in the present application.
Petrolatum has a specific gravity of about 0.815 to 0.880 at
60 C.
Alternative protective adhesive base materials may
include any medically approved water insoluble ointment, gel
or balm formulations capable of carrying the active
ingredients, and applying and maintaining same to the
affected teeth in the prescribed manner. One such
alternative protective adhesive base material is wax.
The water insoluble protective adhesive base material
such as petrolatum may additionally contain a thickening
agent to adjust the consistency of the desired final balm
composition. The thickening agent may be selected from
flour, talc, starch, silica, wax (such as beeswax), gums such
as agar-agar, Arabic, locust bean, carrageen, guar, karaya,
and tragacath gums or other thickening agents. Some of these
may benefit from the use of chemical preservatives as
discussed below.
Stabilizers, such as the gums, may be used to prevent
degradation of the products, and as protective colloids,
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thickeners and emulsifying agents as is common in food and
pharmaceutical products, including toothpastes.
Thus the viscosity and adhesiveness of the subject
dental balm composition may be readily adjusted to ensure
effective consumer packaging, ease of removal of the balm
from its container, ease of application and effective
adhesiveness of the product after application to the
consumer's teeth and effective removal from the teeth when
the treatment is finished. It will be recognized that all
ingredients and additives utilized in the dental balm
composition of the present invention are selected in forms
approved for oral applications.
Some formulations may include chemical preservatives to
retard spoilage of the balm, especially when certain optional
compounds prone to spoilage (e.g. flour) are used therein.
Common chemical preservatives include benzoates, such as
sodium benzoate, nitrites, such as sodium nitrite, sulphites
such as sulphur dioxide, and sorbic acid. These and other
chemical preservatives are effective for killing or
inhibiting the bacteria which cause spoilage.
Dry, solid active agents are less preferred as additives
in the water insoluble protective adhesive base material
which will tend to cover such particles and hold them away
from the teeth. Inactive ingredients such as thickeners or
stabilizers may be dry so long as they can be efficiently
mixed in the balm composition. Liquid additives which can be
homogenously mixed or emulsified can disperse the active
ingredients uniformly in the base and in close contact with
the treated teeth.
The dental balm composition of the present invention
contains an active decay preventive agent which is preferably
fluoride ion obtained by utilizing sodium fluoride or
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stannous fluoride compounds. More preferably, the fluoride
ion may be contained in aqueous solution which may optionally
also include alcohol. It will be understood that the
fluoride concentration in the balm of the present invention
can be readily adjusted by manipulation of either the
fluoride concentration in the aqueous solution or in the
amount of such solution used in the insoluble base material.
The fluoride concentration should be sufficient to be
effective yet not so great as to be unsafe or separate out of
the dental balm composition.
Taste of the dental balm may be improved with small
amounts of flavorants or sweeteners. Low calorie additives
are preferred because sugar based sweeteners and flavors
would be counterproductive to the intended purposes of the
dental balm composition and method.
It is contemplated that the balm composition of the
present invention will be packaged in glass or plastic jars,
metal tins, tubes or plastic tubs with lids, in sizes and
amounts convenient for athletes and others. Small tubes
containing about 11.5 g or small plastic containers
containing about 7.5 g of the product would seem particularly
useful.
Topical application of fluoride has long been the
decay preventing treatment of choice. Two methods of topical
application of fluoride are by use of acidulated phosphate-
fluoride (APF) gels in trays, or liquid rinses. Sodium
fluoride gels and rinses, and stannous fluoride gels are also
available. See, for example, Dental Materials: Properties, &
Manipulation, Sixth Edition, R. G. Craig, et al., Published
by Mosby-Year Book, Inc., 1996 at p. 30.
A neutral gel-like topical sodium fluoride agent is
Nupro, from Ash USA/ Dentsply. Nupro is thixotropic and its
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sodium fluoride is thickened by polyacrylic acid and a gum.
Its pH is adjusted to between six and eight to minimize acid
etching of restorative materials. Another source of fluoride
for topical applications is Thera-FlurO-N brand of neutral
sodium fluoride gel-drops which provide 0.5% fluoride ion (F-
) from 1.1% (w/v) sodium fluoride (NaF) at neutral pH, and is
available by prescription from Colgate Oral Pharmaceuticals,
Inc. Its inactive ingredients include purified water,
sorbitol, propylene glycol, hydroxyethylcellulose, methyl
paraben and propyl paraben. These and other sources of
fluoride ion may be combined with the insoluble base material
of the present invention but are less preferred than fluoride
solutions such as the rinses discussed next.
The fluoride ion active agent used in the present dental
balm composition and method is preferably provided in a
solution. This offers the advantage of convenient
manipulation or adjustment of the fluoride ion concentration
for a variety of treatment effects, as necessary. Note that
although fluorosis is not generally a problem when fluoride
treatments are applied topically, nonetheless, users of the
subject dental balm composition should not swallow the
product.
The active fluoride agent may be conveniently
incorporated in the dental balm composition by utilizing a
commercially available consumer fluoride rinse product such
as ACTO brand fluoride rinse, from Johnson & Johnson. The
active ingredient in ACTO brand rinse is sodium fluoride at a
level of 0.05%, providing a fluoride ion concentration of
approximately 0.02% w/v in the rinse. ACTO brand rinses are
preferred for use in compositions of the present invention
because they are readily available and are offered in several
flavors as well as alcohol free versions. The inactive
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ingredients in the commercial rinse formulations include
water, preservatives, stabilizers, colorants, sweeteners and
the like. Additional fluoride rinses are available from
Colgate Oral Pharmaceuticals, Inc. Gel-Kam brand oral care
rinse is a 0.63% w/w stannous fluoride concentrate which,
when diluted according to directions provides 0.1% w/v
stannous fluoride and contains glycerin as an inactive
ingredient. Colgate PreviDent rinse provides 0.2% w/v
neutral sodium fluoride in a mint-flavored, neutral, aqueous
solution containing 6% alcohol.
Fluoride may be provided by sodium fluoride or stannous
fluoride in other forms where their respective compositions
are adjusted to achieve suitable concentrations of active
fluoride ion in the dental balm product.
For dental balm compositions of the present invention
which utilize a fluoride-containing liquid rinse as the
active ingredient, a preferred formulation will contain about
three parts by volume of the water insoluble adhesive base
material such as petrolatum per one part by volume aqueous
fluoride-containing rinse. For instance, suitable
formulations may combine 15 ml petrolatum with 5 ml of ACT
brand fluoride rinse. Five milliliters of such liquid rinse
appears to be about the practical limit unless mixing or
emulsifying agents are used. Up to about 7.5 ml can be
utilized when effective mixing or emulsifying agents are
used. Compositions containing less than about 2 ml of the
fluoride-containing rinse would tend to be less efficacious
or would begin to require increasing concentrations of
fluoride in the aqueous solution. Dental balm compositions
made in accordance with these formulations will typically
incorporate about one half part by volume of thickening agent
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to adjust the balm to a desired consistency. Artificial
sweetener may be used to taste.
It should be understood that both wet and dry
measurements are given in milliliters to denote relative
volumes of the respective ingredients. Approximations of
weights are given in grams where known or calculated.
As noted, prolonged exposure to vigorous breathing or
whitening procedures tends to dry tooth surfaces such that
saliva cannot readily perform its natural decay preventive
function. The subject dental balm is easily swabbed, via
finger or applicator, onto the front surfaces of teeth prior
or after such exposure. The adhesive quality of the balm
base enables it to remain in close proximity to the areas of
the tooth surfaces most affected and delivers the active
decay preventive agent, such as fluoride, where it is most
useful.
In the preferred method of the present invention, the
teeth will be cleaned by the consumer, as by brushing and
flossing, prior to application of the dental balm. Brushing
with toothpaste is particularly preferred. The adhesive
dental balm is then applied to protect the teeth prior to
athletic activity or other exposure of the teeth, or to
soothe sensitive teeth immediately after whitening
procedures, after which the dental balm composition is
readily removed, again preferably by brushing and flossing.
Example 1
A dental balm composition in accordance with the present
invention was prepared by combining in a glass bowl one
tablespoon (approximately 15 ml) of white petrolatum, USP
with 1 teaspoon (approximately 5 ml) of cinnamon flavored
ACTO brand fluoride rinse. The ingredients were mixed
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vigorously by hand, whereupon one half teaspoon
(approximately 2.5 ml) of talc (Caldesene Protective Powder
containing 81% talc and 15% zinc oxide) was added to the
composition. Mixing continued until all ingredients were
fully incorporated into a pink colored homogenous dental balm
composition. A similar formulation utilizing approximately 2
teaspoons fluoride rinse did not mix satisfactorily by hand
but would benefit from mechanical mixing or use of a mixing
aid or emulsifier.
Example 2
A second dental balm composition in accordance with the
present invention was prepared by combining in a glass bowl
one tablespoon (approximately 15 ml) of white petrolatum, USP
with 1 teaspoon (approximately 5 ml) of mint flavored ACT
brand fluoride rinse. The ingredients were mixed vigorously,
whereupon one half teaspoon (approximately 2.5 ml) of talc
(Caldesene Protective Powder) was added to the composition.
Mixing continued until all ingredients were fully
incorporated into a light green colored homogenous mixture.
Samples of the compositions provided in Examples 1 and 2
showed no discernible separation or spoilage of ingredients
four months after formulation.
Example 3
Two laboratory specimens of denture shaped typodont
artificial dental enamel were rinsed with tap water and
placed wet side by side on a lab bench. A portion of the
dental balm composition made in accordance with example 1
above was applied to one rinsed specimen and placed back on
the lab bench. A small fan directed room temperature air on
the treated and untreated specimens for a period of five
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minutes. At the end of the five minute period each specimen
was examined. The untreated specimen, which had only been
rinsed with water was dry to the touch after five minutes
exposure to the fan. The treated specimen having the dental
balm composition applied to the surface remained protected
from exposure to the fan air.
Example 4
The procedure of Example 3 was repeated by replacing the
tap water rinse with Salivart Synthetic Saliva from Gebauer
(75 g can with nitrogen propellant). The specimens were
sprayed, treated with the dental balm and exposed to fan air
for five minutes. The treated surfaces remained protected
after exposure to the fan air.
Example 5
Another dental balm composition was prepared by
combining in a glass bowl one tablespoon (approximately 15
ml) of white petrolatum, USP with 1 teaspoon (approximately 5
ml) of cinnamon flavored ACTO brand fluoride rinse. The
ingredients were mixed vigorously, whereupon one half
teaspoon (approximately 2.5 ml) of Gold Medal brand All
Purpose Flour was added to the composition, along with one
drop (approximately 0.65 ml) of Sweetleaf Stevia Clear brand
artificial sweetener. Mixing continued until all ingredients
were fully incorporated into a homogenous mixture. A subject
applying this formulation to his teeth found satisfactory
performance and taste. After two months, the formulation of
this example showed signs of spoilage and would have
benefitted from the addition of a preservative such as sodium
benzoate.
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Example 6
The method of the present invention was practiced by an
individual, who tested the dental balm composition of example
1 above. First, the subject brushed and flossed his teeth in
accordance with a preferred embodiment of the method.
Thereupon, the subject placed a portion of the dental balm
composition on his forefinger and applied it to the outer
surface of his upper teeth by swiping his coated forefinger
with the composition on the front surfaces of his upper teeth
from approximately behind his left canine across the front
upper arch to approximately behind the right canine. The
lower arch was left untreated. After an aerobic exercise
session of 15 minutes on a Schwinn AirDyne stationary
bicycle, the subject inspected his teeth. The lower
untreated teeth were relatively dry to the touch, whereas the
treated upper teeth retained the dental composition on their
surfaces. A second exercise session of a further 15 minutes
was undertaken for a total aerobic workout of 30 minutes
whereupon the teeth were examined again. The lower untreated
teeth were dry to the touch whereas the upper teeth retained
the dental balm treatment intact. Light brushing with
conventional toothpaste removed the dental balm from the
subject's teeth.
Example 7
A dental patient underwent a whitening treatment on his
front teeth utilizing Discus Dental Nite White whitening gel
in a custom tray for one hour. The active ingredient in the
whitening gel was 16% by volume carbamide peroxide. After
one hour of treatment, the whitened teeth experienced
sensitivity to air and temperature changes due to dehydration
of the enamel. The teeth were then treated for 10 minutes
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with a finger swab of the dental balm composition of Example
1. The teeth were then brushed with fluoride toothpaste
whereupon the aforementioned sensitivity was noticeably
lessened.
The invention now being fully described, it will be
apparent to one of ordinary skill in the art that many
changes and modifications can be made thereto without
departing from the spirit or scope of the invention as set
forth herein.
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