U.S. patent application number 13/072490 was filed with the patent office on 2011-09-29 for oral ph and buffering capacity modifiers.
This patent application is currently assigned to CAO Group, Inc.. Invention is credited to Densen Cao, Steven D. Jensen.
Application Number | 20110236322 13/072490 |
Document ID | / |
Family ID | 44656751 |
Filed Date | 2011-09-29 |
United States Patent
Application |
20110236322 |
Kind Code |
A1 |
Jensen; Steven D. ; et
al. |
September 29, 2011 |
ORAL PH AND BUFFERING CAPACITY MODIFIERS
Abstract
Example embodiments of the present invention include various
compositions that include a pH modifier composition and/or a
buffering capacity modifier composition. In some examples, the pH
modifier compositions include a dose of pH modifier to raise the pH
in a patient's mouth from about 1 to about 2 pH levels. The
compositions are then incorporated into various confections for
oral ingestion or application that allow a patient to easily use
the composition with the pH and/or buffering capacity modifiers.
For example, compositions with the pH and/or buffering capacity
modifiers can be incorporated within chewing gum, tablets,
lozenges, breath strips, hard candy, oral sprays, and other
confections. Another embodiment of the invention includes a testing
device to test the pH and buffering capacity within a patient's
mouth.
Inventors: |
Jensen; Steven D.; (South
Jordan, UT) ; Cao; Densen; (Sandy, UT) |
Assignee: |
CAO Group, Inc.
West Jordan
UT
|
Family ID: |
44656751 |
Appl. No.: |
13/072490 |
Filed: |
March 25, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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61317602 |
Mar 25, 2010 |
|
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61353609 |
Jun 10, 2010 |
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Current U.S.
Class: |
424/48 ; 424/49;
600/309; 600/362; 600/582 |
Current CPC
Class: |
A23G 3/50 20130101; A61K
33/16 20130101; A23G 4/18 20130101; A61B 5/14539 20130101; A61K
8/676 20130101; A61Q 11/00 20130101; A61B 10/0051 20130101; A61K
31/375 20130101; A23G 3/36 20130101; A61B 5/14507 20130101; A61K
33/00 20130101; A23G 4/06 20130101; A61K 2800/52 20130101; A61K
31/375 20130101; A61K 2300/00 20130101; A61K 33/00 20130101; A61K
2300/00 20130101; A61K 33/16 20130101; A61K 2300/00 20130101 |
Class at
Publication: |
424/48 ; 424/49;
600/582; 600/309; 600/362 |
International
Class: |
A61K 8/02 20060101
A61K008/02; A61K 8/18 20060101 A61K008/18; A61K 9/68 20060101
A61K009/68; A61K 8/21 20060101 A61K008/21; A61K 33/16 20060101
A61K033/16; A61K 33/00 20060101 A61K033/00; A61K 31/341 20060101
A61K031/341; A61Q 11/00 20060101 A61Q011/00; A61B 5/00 20060101
A61B005/00 |
Claims
1. A dental treatment composition, comprising: a delivery device in
the form of a confection, the confection comprising: an oral pH
modifier composition; and an oral buffering capacity modifier
composition, wherein the buffering capacity compound is selected
from the group of compounds found in natural saliva.
2. The dental treatment composition recited in claim 1, wherein the
confection is in the form of chewing gum.
3. The dental treatment composition recited in claim 1, wherein the
confection is in the form of a hard candy.
4. The dental treatment composition recited in claim 1, wherein the
confection is in the form of a breath strip.
5. The dental treatment composition recited in claim 1, wherein the
confection is in the form of an oral spray.
6. The dental treatment composition recited in claim 5, wherein the
oral spray is a two-part composition having a first part comprising
calcium ascorbate and a second part comprising sodium
carbonate.
7. The dental treatment composition recited in claim 1, wherein the
oral buffering capacity modifier composition comprises a soluble
salt of calcium.
8. The dental treatment composition recited in claim 7, wherein the
soluble salt of calcium comprises calcium ascorbate.
9. The dental treatment composition recited in claim 8, further
comprising fluoride.
10. A dental treatment system for directly controlling the pH
environment within a patient's oral cavity, comprising: a testing
device, comprising: a testing strip; a pH testing pad attached to
the testing strip and configured to test the pH level of a
patient's saliva; and a buffering capacity testing pad attached to
the testing strip and configured to test the buffering capacity of
a patients saliva; and a delivery device, comprising: an oral pH
modifier composition; and an oral buffering capacity modifier
composition, wherein the testing device is used to determine the
dosage of the delivery device such that the patient can customize
the use of the delivery device to control the pH within the
patient's oral cavity.
11. The dental treatment system recited in claim 10, wherein the
delivery device is in the form of a confection.
12. The dental treatment system recited in claim 11, wherein the
buffering capacity modifier composition comprises calcium
ascorbate.
13. The dental treatment system recited in claim 12, wherein the
calcium ascorbate has a weight percentage within the range of about
1% to about 10% of the overall weight of the confection.
14. The dental treatment system recited in claim 10, wherein the
test strip comprises a first side and a second side, and wherein
the pH testing pad is attached to the first side and the buffering
capacity testing pad is attached to the second side.
15. The dental treatment system recited in claim 10, wherein the pH
testing pad comprises an absorbent material soaked in a plurality
of pH indicator compounds.
16. The dental treatment system recited in claim 10, wherein the
buffering capacity testing pad comprises an absorbent material
soaked in a known quantity of acid or base.
17. An oral saliva testing device, comprising: a test strip; and an
oral buffering capacity test pad attached to the test strip,
wherein the oral buffering capacity test pad measures a buffering
capacity of a patient's saliva when brought into contact with the
patient's saliva.
18. The oral saliva testing device recited in claim 17, further
comprising an oral pH test pad attached to the test strip.
19. The oral saliva testing device recited in claim 18, wherein the
pH testing pad comprises an absorbent material soaked in a
plurality of pH indicator compounds.
20. The oral saliva testing device recited in claim 19, wherein the
buffering capacity testing pad comprises an absorbent material
soaked in a known quantity of acid or base.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/317,602, filed Mar. 25, 2010, and U.S.
Provisional Application No. 61/353,609, filed on Jun. 10, 2010. The
content of each of the aforementioned applications is incorporated
herein by reference in its entirety.
TECHNICAL FIELD OF THE INVENTION
[0002] The present invention relates to the field of cavity
prevention by controlling the environmental factors found within
the oral cavity that may cause tooth decay.
BACKGROUND OF THE INVENTION
[0003] Most people will at one point or another experience tooth
decay that eventually leads to a cavity. To the average person,
cavities are small annoyances that a dental professional can easily
correct by removing the cavity and replacing the decay with some
type of dental filling. Some individuals, however, experience tooth
decay more than others. In particular, a portion of the population
deals with rampant cavities that are difficult to contain and
control.
[0004] Recent advances in dental science have helped dental
professionals to more fully understand the causes of tooth decay
and cavities. Many studies suggest that a person's diet may
drastically affect the chances of getting a cavity. In particular,
many experts argue that diets high in carbohydrates and other
sugars, and lower in meat and whole grains, cause an increased risk
of cavities. For example, studies have suggested that diets high in
carbohydrates may cause oral micro-flora to become imbalanced,
which may lead to increases risk of tooth decay, and ultimately an
increased risk of cavities.
[0005] Modern microorganism studies have confirmed that the main
bacterial culprits of tooth decay do indeed feed on carbohydrates,
and other sugars that make up the building blocks of carbohydrates.
Studies have also shown that of all the bacterial culprits
responsible for tooth decay, the bacterium known as Streptococcus
mutans is the bacterium with the most influence on causing tooth
decay.
[0006] Streptococcus mutans depends entirely upon human hosts for
its survival and progresses through a standard cycle of events with
its host. The cycle begins with inoculation of an infant soon after
birth by parental contact. Streptococcus mutans can be transmitted
through saliva and is highly contagious. In order for Streptococcus
mutans to become a permanent resident in the oral environment, the
bacterium must attach somewhere in the oral cavity. By attaching to
a site within the oral cavity, the Streptococcus mutans may
colonize and avoid being washed to the stomach by saliva.
Unfortunately, the human oral environment provides ample attachment
sites for Streptococcus mutans as there are various crevasses to
inhabit such as the gingival margin, spaces between teeth, etc.
[0007] After the Streptococcus mutans finds an attachment site, the
process of tooth decay begins. The process begins when
Streptococcus mutans consume sugar and excrete lactic acid as a
waste product. As is well known, tooth enamel is composed entirely
of mineral rods of calcium hydroxyapatite, which is susceptible to
dissolution in acidic environments. The residual food that remains
lodged in the oral cavity after eating provides the nutrient source
for Streptococcus mutans to digest, which therefore produces the
lactic acid that eventually dissolves holes in the enamel.
[0008] Once the lactic acid has produced holes in the teeth the
decay process intensifies because the holes create even more
protected space for food and the Streptococcus mutans to occupy.
The rate at which the Streptococcus mutans digests carbohydrates
and produce lactic acid can exponentially increase, causing tooth
decay to exponentially increase, which can lead to a cavity in a
fairly short amount of time.
[0009] Providing quality oral hygiene in the fight against cavities
requires a direct understanding and plan to deal with the lactic
acid produced from the Streptococcus mutans. The most common
prevention method today is brushing the teeth with a fluoride
dentifrice (tooth paste). First, the toothbrush allows a person to
remove the excess food after he or she eats, and thereby deprive
the Streptococcus mutans of an available nutrient source. Second,
the toothbrush stirs up or aggravates the bacteria and dislodges it
from attachment sites, thereby impeding colony progression and
growth.
[0010] As far as the toothpaste's function, the toothpaste's
primary function is to deliver a dose of fluoride to tooth enamel.
Fluoride may chemically change the calcium hydroxyapatite of tooth
enamel into a more acid resistant composition of calcium
fluoroapatite. The process of fluoroapatite synthesis takes
advantage of the electronegative reactivity of the fluoride ion
during the natural re-mineralization cycles between the tooth and
saliva, causing the tooth enamel to be more resistant to acid
environments.
[0011] Although brushing the teeth helps fight tooth decay,
toothbrushes and toothpaste are purely preventative measures and do
nothing to address the eradication of the Streptococcus mutans. The
eradication of the offending microorganisms was at one time thought
to be the ultimate end of restorative dentistry. Research
eventually produced the antibiotic "tetracycline" that was intended
to wipe out tooth decay from the human race once and for all. This
project ended in abysmal failure; instead, tetracycline treatment
resulted in tetracycline resistant Streptococcus mutans, with the
children of these patients being stricken with brown to green
mottled teeth. It is now generally understood that microorganisms
are very adaptable and usually evolve faster than antibiotics can
be produced.
[0012] The foregoing leaves the toothbrush and fluoride as the
essential means to combat tooth decay. The toothbrush and
toothpaste, however, have disadvantages that decrease their
effectiveness in the overall prevention of tooth decay. The biggest
disadvantage is patient compliance. For example, most people brush
twice a day and it is usually before breakfast and after dinner.
The most effective time to brush is after eating to immediately
remove any food left behind in the oral cavity. Moreover, the
average person brushes less than 60 seconds at a time. In order for
the fluoride in the toothpaste to have any positive effect, a
person must brush for at least 60 seconds or longer.
[0013] There are several reasons that most people to not brush
properly. For example, brushing teeth is not always convenient. To
brush after every meal a person would have to deal with the
annoyance of carrying a toothbrush and toothpaste during the day.
Additionally, the person would have to find a convenient place to
brush his or her teeth, which is another annoyance. Finally, after
brushing a patient has to deal with a wet toothbrush and where to
store it. In contemporary lifestyles the toothbrush and toothpaste
are consigned for home use because that is the time and location
when a person can most easily and conveniently brush their teeth
and store the toothbrush and toothpaste.
[0014] As indicated above, the time when most people brush their
teeth is the least effective time to brush teeth. In particular,
the largest variances in oral pH happen after each meal
corresponding with the cycle of sugar consumption by the
Streptococcus mutans into lactic acid. In the early 20th century
many studies were completed measuring the oral pH of patients as it
relates to time and events. The general conclusions from these
studies give us a better understanding of the oral environment. The
general conclusions are as follows: [0015] a. The average pH of
oral saliva varies between individuals, yet the average pH of an
individual stays fairly constant. The pH of some individuals within
a group may differ in range from as wide as 5 to 8, yet the pH of
each individual within the group would remain fairly repetitive.
This conclusion may explain why some people have such a large
problem with getting cavities, while others do not. [0016] b. The
largest drop in pH of saliva happens after eating, followed by a
slow rise in pH. The average pH drop of oral saliva after eating is
between about 0.5-1.0 in healthy patients. The change in pH spikes
at about 15-20 minutes after eating, followed by a gradual rise
back to normal levels in about 60 minutes.
[0017] Among other conclusions, these studies indicated that the pH
level of saliva was a major factor in tooth decay of an individual.
The more acidic the saliva, the greater risk of tooth decay.
[0018] In addition, studies have also shown that it is not the pH
levels of the saliva alone that cause cavities. An additional
factor that can affect the rate at which dental caries occur
concerns the buffering capacity of the salvia. Buffering capacity
relates to the ability of a buffer--e.g., a partially neutralized
acid--to resist changes in pH. Salts such as sodium citrate or
sodium lactate are common buffers used to partially neutralize an
acid. In patients that tend not to easily get cavities, their
saliva is usually shown to have an increased buffering
capacity.
[0019] In sum, clinical studies have shown that the greatest
correlating cause of tooth decay between patients is the pH and the
buffering capacity of their saliva. In order to adequately address
prevention of tooth decay, both the pH and buffering capacity of
saliva must be controlled. Some conventional products have been
developed to attempt to address the pH issue of saliva. For
example, conventional products that contain ingredients such as
sorbitol, xylitol and other sugar free sweeteners claim to be
helpful in restoring pH levels after a meal. These conventional
products, however, do not chemically modify the saliva, but rather
simply increase and stimulate natural saliva flows after a meal.
Although increasing the saliva flow is more beneficial than doing
nothing, the rate at which the pH level within the saliva is
normalized is slow, which may still allow tooth decay.
[0020] What is needed is a dental treatment which quickly and
efficiently adjusts pH levels within the oral cavity, increases the
buffering capacity of salvia, avoids side effects, and provides a
product suitable for simple patient compliance.
SUMMARY OF THE INVENTION
[0021] Example embodiments of the present invention include various
compositions that include a pH modifier composition and/or a
buffering capacity modifier composition. In some examples, the pH
modifier compositions include a dose of pH modifier to raise the pH
in a patient's mouth from about 1 to about 2 pH levels. The
compositions are then incorporated into various confections for
oral ingestion or application that allow a patient to easily use
the composition with the pH and/or buffering capacity modifiers.
For example, compositions with the pH and/or buffering capacity
modifiers can be incorporated within chewing gum, tablets,
lozenges, breath strips, hard candy, oral sprays, and other
confections. Another embodiment of the invention includes a testing
device to test the pH and buffering capacity within a patient's
mouth.
[0022] Additional features and advantages of the invention will be
set forth in the description which follows, and in part will be
obvious from the description, or may be learned by the practice of
the invention. The features and advantages of the invention may be
realized and obtained by means of the instruments and combinations
particularly pointed out in the appended claims. These and other
features of the present invention will become more fully apparent
from the following description and appended claims, or may be
learned by the practice of the invention as set forth
hereinafter.
DETAILED DESCRIPTION OF THE INVENTION
[0023] Example embodiments of the present invention include various
compositions that include a pH modifier composition and/or a
buffering capacity modifier composition. In some examples, the pH
modifier compositions include a dose of pH modifier to raise the pH
in a patient's mouth from about 1 to about 2 pH levels. The
compositions are then incorporated into various confections for
oral ingestion or application that allow a patient to easily use
the composition with the pH and/or buffering capacity modifiers.
For example, compositions with the pH and/or buffering capacity
modifiers can be incorporated within chewing gum, tablets,
lozenges, breath strips, hard candy, oral sprays, and other
confections. Another embodiment of the invention includes a testing
device to test the pH and buffering capacity within a patient's
mouth.
[0024] By using example embodiments of the present invention,
patients will have a convenient product to use to fight tooth decay
and cavities. For example, patients can use the composition right
after a meal during the time that the pH level in the mouth is most
acidic. Moreover, embodiments of the present invention allow
patients to fight tooth decay without having the annoyance of
carrying a tooth brush or tooth paste with them wherever they
go.
[0025] Furthermore, example embodiments of the present invention
provide patients with a more effective way to fight cavities than
regular gum or candy that simply promote saliva flow. In
particular, example embodiments of the present invention actually
chemically change the pH levels and/or buffering capacity of saliva
such that the pH levels in the oral cavity are returned to a pH
balanced or less acid state quickly and efficiently.
Notwithstanding the various improvements to the fight against tooth
decay, example embodiments of the present invention generally
provide devices and methods to increase the buffering capacity of
saliva and raise the pH within the oral cavity to a less acidic
state.
[0026] Example embodiments of the present invention can include a
buffering capacity modifier composition that includes any soluble
or insoluble compound found in saliva that increases the buffering
capacity of saliva. Example buffering capacity modifier
compositions that increase the buffering capacity of saliva are the
soluble and insoluble salts of calcium. Examples of salts that are
useful in buffering capacity modifier compositions are calcium
phosphate tribasic, calcium phosphate di-basic, calcium phosphate
monobasic, calcium lactate, calcium citrate, calcium ascorbate,
calcium carbonate, calcium hydrogen carbonate, calcium hydroxide,
protein bound calcium and any other useful saliva buffering
compounds.
[0027] The most preferred buffering capacity modifier compositions
are those salts that are water soluble at pH above about 6. The
solubility of the calcium salt in water allows the calcium ion to
become available for natural re-mineralization processes that occur
between the saliva and tooth on a readily basis. Some salts are
more soluble in water than others, as illustrated in the table
below. Salts with a high solubility in water such as calcium
lactate and calcium ascorbate are especially useful. Mono-calcium
phosphate is also effectively soluble in water.
TABLE-US-00001 Calcium Salt Solubility in water g/100 ml Calcium
lactate pentahydrate 9 grams Calcium ascorbate (citrate) 43.6 grams
Calcium stearate Insoluble Calcium carbonate 0.001 grams
Tri-calcium phosphate Insoluble Di-calcium phosphate 0.02 grams
Calcium hydroxide 0.173 grams Mono-calcium phosphate 22 grams
[0028] We analyzed the immediate release of calcium ion of various
salts by a calcium test kit by EM Quant and found that the most
readily available calcium ion source is calcium ascorbate and
calcium lactate. In particular, calcium ascorbate provided calcium
ions on contact with water, and is therefore a good candidate for
the buffering capacity modifier composition.
[0029] A combination of salts can be utilized to maximize the
effects of the buffering capacity with respect to re-mineralization
and pH. A preferred delivery device of the present invention
comprises both pH modifier compositions and buffering capacity
modifier compositions. Therefore, the delivery device can be
designed to increase both the pH and the buffering capacity of
saliva that neutralizes acids, raises the pH level above about 7,
and floods the saliva with acid buffering salts. The same buffering
salts also can act as a re-mineralization agent.
[0030] In addition, example embodiments of the present invention
include the use of these same pH modifier compositions incorporated
into a fluoride dentifrice in order to combine the synergistic
effects of both a higher pH environment coupled with the beneficial
qualities of the fluoride ion. For example, the fluoride ion may be
incorporated into any of the pH modifier compositions of the
present invention, especially in lower doses, such as below 100
ppm. The objective being to raise the pH of oral saliva along with
the steady release of fluoride ion over longer periods of time
versus the dose received through conventional tooth brushing. It is
also within the scope of this invention to incorporate an abrasive,
such as fine silica or diatomaceous earth into the confection that
would aid in the physical removal of oral debris while chewing.
[0031] As summarized above, the preferred pH modifier composition
of the present invention includes a pH modifier that raises the pH
of oral saliva of the average person in a range from about 1 to
about 2 to temporarily raise the pH of oral saliva firmly and
safely out of the acidic range following eating. The elevated pH
level counteracts acids produced by Streptococcus mutans and other
organisms acting on food particles in the mouth remaining after
eating.
[0032] Example pH modifier compositions can comprise those basic
compounds that are safe for human consumption, and at the same
time, can be used in the smallest quantities to deliver the biggest
change in pH. For example, the pH modifier compositions of example
embodiments of the present invention can raise the pH level of oral
saliva with a minimum quantity of pH modifier composition such that
the only parts of the body receiving a significant impact are
isolated within the oral cavity. Insignificant quantities of the pH
modifier composition swallowed during digestion would have a
negligible effect on the stomach, as such are neutralized quickly
by stomach acid.
[0033] Examples of the pH modifier compositions of the present
invention include, but are not limited to, alkali salts and oxides
such as the hydroxides, oxides and carbonates of magnesium, sodium,
potassium, and calcium. Also included are any soluble salts of
transition metals that can be made by various methods alkaline in
an aqueous environment such as iron hydroxide and zinc hydroxide.
Even further examples include amines and alkyl amines such as
ammonia, diethylamine, dimethyl amine, hydroxylamine, quinoline,
triethanol amine, triethylamine, ethylamine and methylamine and
others. Additional pH modifier compositions include the alkaline
salts having moderate to strong bases such as sodium carbonate,
sodium hydroxide, potassium hydroxide and potassium carbonate.
[0034] The pH modifier(s) compositions can be dosed depending on
the size, weight, solubility rate, and chosen basic compound into
the confection of choice. The final dosage is that concentration
necessary to provide an average change in oral pH by at least about
1 to about 2 pH. In other example embodiments, however, compounds
producing pH modification ranges higher than about 1 to about 2 pH
for those patients that have extremely acidic oral cavity
properties. In short, the objective of example pH modifier
compositions is to bring the oral pH following a meal to levels
slightly higher than normal, but other pH modification ranges are
also within the scope of this invention.
[0035] One example embodiment of the present invention includes a
delivery device in the form of chewing gum that contains a pH
modifier composition and/or a buffering capacity modifier
composition. Chewing gum offers an ideal substance that is chewed
but not swallowed providing a convenient way to deliver the pH
modifier, buffering capacity modifier and/or fluoride at a steady
rate. Other example confections can include, but are not limited
to, lozenges and hard candies that are sugar-free.
[0036] Notwithstanding the type of delivery device used, the effect
is to deliver pH modifiers and buffering capacity modifiers in a
manner that releases the pH modifier and buffering capacity
modifiers at a near constant rate. A chewing gum is ideal for this
delivery because it is not swallowed like a lozenge or a hard
candy, as these may be crushed with the teeth and broken down
prematurely into pieces and swallowed. The downside to chewing gum
is that the release rate of the pH modifier and/or buffering
capacity modifier is greatest at the beginning of chewing and
decreases in time. Conversely, the lozenge or hard candy, if not
crushed into pieces, can provide a more constant release rate of
the pH modifier and/or the buffering capacity modifier.
[0037] The delivery device confections can be made with
carbohydrate substitutes as the bulk material that makes the body
of the candy. These sugarless confections accelerate the natural
neutralization cycle of the oral cavity by stimulating saliva flow,
while delivering the pH modifier. As can be understood, any similar
item that can be chewed or dissolved within the mouth following a
meal would be effective as long as the item did not contain
cariogenic sugars and/or carbohydrates. When added as bulk
material, the functions of these non-cariogenic sweeteners like
xylitol, sorbitol, phenylalanine, sucralose, saccharin and others
are to make the delivery devices or confections sweet, and
therefore more palatable.
[0038] The delivery devices and compositions of the present
invention can raise the pH level and buffering capacity of oral
saliva rapidly since oral acid is neutralized into a salt by an
acid base reaction with a known basic compound. This actual change
in the pH level and buffering capacity of the oral saliva is unique
compared to conventional compositions that don't chemically change
the saliva, but rather depend on the dilution and rinsing effects
of saliva.
[0039] Many other confections containing pH modifiers are also
within the scope of this invention, as long as they meet the
general objective to combine a pH modifier composition and/or a
buffering capacity modifier composition with a traditional
confection that can be conveniently and inconspicuously
administered following a meal. Another example embodiment is a
breath strip. In particular, the breath strip can be a thin
water-soluble composition that is intended to dissolve in the
mouth. As the breath strip dissolves, the pH modifier and/or the
buffering capacity modifier can be released from the breath strip,
thus adjusting the pH levels and buffering capacity within the
mouth and saliva.
[0040] In another example embodiment, the delivery device can be in
the form of an oral spray or rinse. For example, the pH modifier
composition and/or the buffering capacity composition can be
dissolved into a liquid spray or rinse that a patient can spray or
rinse in their mouth. Because the spray or rinse will likely not
provide a long lasting release of the pH modifier and/or the
buffering capacity modifier, the dosage of the pH modifier and/or
buffering capacity modifier can be greatly increased to provide a
quick and efficient way to raise the pH level within the oral
cavity and saliva.
[0041] Various colors, scents, flavors and other ingredients can be
used with all the example embodiments to increase flavor, visual
athletics, and overall presentation of the various delivery devices
and compositions.
[0042] The following examples illustrate various example
embodiments of delivery devices used to deliver the pH modifier
composition and/or the buffering capacity modifier composition. The
following formulations are for example purposes only, and
illustrate only specific compositions and delivery devices
according to the broader principles described above.
Example 1
[0043] In one example embodiment of the invention, a chewing gum
including a pH modifier composition and a buffering capacity
modifier composition comprises the following components within the
percentage weight ranges in the following table.
TABLE-US-00002 Example 1 Component % Wt Range Gum Base 32-42%
Xylitol 35-45% Sorbitol 11-21% Sucralose 0.1-1% Flavoring 0.1-1%
Coloring 0.01-0.1% Calcium Ascorbate 1%-10% Sodium Carbonate
0.01%-0.05%
[0044] For example, and according to the general ranges of
percentage weight described above, one particular example
embodiment of a chewing gum containing pH and buffering capacity
modifier compositions comprises: a gum base (37.94%); xylitol
(40.00%); sorbitol (16.00%); sucralose (0.20%); peppermint oil
(0.40%); methyl salicylate (0.40%); glycerin (1.00%); brilliant
blue lake color (0.05%); calcium ascorbate (4.00%) and sodium
carbonate (0.01%). The resulting composition is blended in a sigma
blade mixer until homogenous, followed by forming the homogeneous
mixture into a shaped gum using a mold compression method. The
resulting compressed gum is ready to chew.
Example 2
[0045] In one example embodiment of the present invention, a hard
candy formulation comprises the following components within the
weight percentage ranges in the following table.
TABLE-US-00003 Example 2 Component % Wt Range Xylitol/Sorbitol
80-97% Calcium Ascorbate 1%-10% Sodium Carbonate 0.01%-0.05% Methyl
salicylate 0.1-1% Flavoring 0.1-1% Coloring 0.01-0.1%
[0046] For example, and according to the general ranges of
percentage weight described above with respect to Example 2, one
particular example embodiment of a hard candy containing a pH and
buffering capacity modifier compositions comprises: xylitol or
sorbitol (95.19%); calcium ascorbate (4.00%); sodium carbonate
(0.01%); peppermint oil (0.40%); and methyl salicylate (0.40%). The
sugars are melted and mixed until the composition reaches a hard
candy stage, followed by addition of the other ingredients. The
resulting mass is allowed to cool and is then cut into single
serving-sized pieces while still in a moldable state, after which
the sized pieces are allowed to further cool into hard candy.
Example 3
[0047] A third embodiment of the present invention comprises a
liquid rinse or oral spray. Since an aqueous solution of sodium
carbonate and soluble calcium salt will eventually react to produce
nearly insoluble calcium carbonate, it is preferred to deliver a
2-part composition in a dual chambered spray device, or
alternatively use a pH modifier that will not react with calcium
ion, for example, sodium hydroxide. An example of a 2-part liquid
spray composition is shown in the following table.
TABLE-US-00004 Part A Part B 5.0%-Calcium ascorbate 0.2%-Sodium
carbonate 0.5%-sucralose 0.5%-sucralose 1.0%-peppermint oil
1.0%-peppermint oil 93.5%-water 93.5%-water
[0048] In addition to the above examples of a delivery device that
delivers a pH modifier composition and/or a buffer capacity
modifier composition in a convenient manner to the oral cavity,
example embodiments of the present invention further include a
testing device to initially test the environment characteristics
within a particular patient's oral cavity. For example, the testing
device can be used to determine the strength or dosage of the pH
modifier and/or buffering capacity modifier in one or more of the
above delivery devices such that an individualized treatment plan
can be created for a particular individual. In at least one
embodiment, the testing device results and the dosage of the pH and
buffering capacity modifier compositions within the delivery
devices can be coordinated (e.g., by number or color) such that a
patient can easily know what dosage is required for the patient's
particular pH levels and buffering capacity.
[0049] On example of a testing device can include a testing strip
that measures both the pH and buffer capacity of saliva. For
example, the testing device can include a hand-held colorimetric
testing strip that can be easily covered in a patient's saliva by
having the patient place the testing strip into the patient's
mouth, or by placing the patient's saliva directly on the testing
strip. After the patient's saliva is in contact with the testing
strip, the testing strip has a corresponding color change that
correlates to that individual's pH and buffering salt concentration
in the patient's saliva. Thus, the testing strip can provide an
easy and convenient test for a patient to accurately know the pH
and buffering salt concentration within the patient's saliva.
[0050] In one example embodiment, the colorimetric testing strip
can contain both the pH-testing pad and the buffering salt testing
pad on the same strip, wherein the pH and buffering capacity can be
measured by a single analysis. For example, the pH testing pad can
be configured to measure the pH between 4.5-10, and the buffering
capacity testing pad can be configured to measure the available
calcium salt concentration between 0-1000 ppm.
[0051] In one example, the pH pad can be made of absorbent paper or
cotton that is soaked in an aqueous pH indicator comprising various
indicators such as bromocresol green, methyl red, azolitmin,
bromocresol purple, bromothymol blue, phenol red, neutral red,
napthophthalein, Alizarine yellow R, phenolphthalein, congo red,
thymol blue, methyl orange, leucomalachite green, methyl yellow,
and any like useful pH indicator. Similarly, the buffering capacity
test pad can be made of absorbent paper or cotton that is soaked in
a known quantity of acid or base with an aqueous alkalinity
indicator(s). Thus, when the patient's saliva reacts with the known
quantity of acid or base on the strip, the resulting colorimetric
pH achieved correlates to a ppm buffering salt concentration.
Alternatively, the calcium, phosphate, hydroxide, or carbonate ion
concentration can be measured directly by color sensitive
indicators that change colors with respect to the concentration of
the respective anion or cation.
[0052] Both the pH testing pad and the buffering capacity testing
pad can be fastened to a plastic or paper applicator test strip by
an adhesive or other similar means. For example, in one embodiment
the pH testing pad can be attached to a first side of the testing
strip, and the buffering capacity testing pad can be attached to a
second side of the testing strip. Alternatively, both the pH
testing pad and the buffering capacity testing pad can be attached
to the same side of the testing strip.
[0053] The completed colorimetric testing strip can then either be
inserted into the mouth, or saliva can be collected into a
container, in order to coat the testing pads with the patient's
saliva. The patient's saliva interacts with both the pH testing
strip and the buffering capacity testing strip to change colors as
described above. The patient can then compare the color on the
testing strip to a pre-determined colorimetric chart that
corresponds to the change in pH and buffering capacities. Upon
analyzing the results of the test, a patient can determine their
risk level with respect to tooth decay and determine a
corresponding treatment or dosage of pH modifier compositions and
buffering capacity modifier compositions described above. For
example, the test strip can determine the risk of cavities such
that the strength and the frequency for the need of the pH modifier
and/or buffering capacity modifier device or confection.
[0054] More particularly, the patients who score low in both pH and
buffering capacity are placed into a high risk category of
treatment wherein they receive devices or confections that
sufficiently modify the pH and buffering capacity with respect to
their low scores. The patients who have a moderate pH and buffering
capacity are placed into a medium risk category where they receive
devices and confections that modify their pH and buffering capacity
customized to the level of modification that is necessary for them.
The patients who have a high natural pH and buffering capacity may
not even require treatment because their respective pH and
buffering capacity are high enough that they do not drop below a pH
level of about 6.2 even after eating a meal.
[0055] For example, a patient who has measured their pH and
buffering capacity and has found that they are in the high risk
category of tooth decay may be prescribed to chew two or three
pieces of chewing gum for an increased concentration of pH and
buffering capacity after every meal, whereas someone in the medium
risk group may be required to chew only one piece of any desired
confection. Alternatively the strength of the confection can be
varied as to create a maximum strength and/or a regular strength
composition, so a specific gum can be prescribed depending upon to
which risk group the patient pertains.
[0056] The present invention may be embodied in other specific
forms without departing from its spirit or essential
characteristics. The described embodiments are to be considered in
all respects only as illustrative and not restrictive. The scope of
the invention is, therefore, indicated by the appended claims
rather than by the foregoing description. All changes which come
within the meaning and range of equivalency of the claims are to be
embraced within their scope.
* * * * *