Note: Descriptions are shown in the official language in which they were submitted.
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COMPOSITIONS FOR INHIBITING GINGIVITIS
BA~CKGR~OUND OF THE INVENTION
1. FIELD OlF THE I~~1VENTION
The present invention relates to compositions and a method for
inhibiting gingivitis. Specifically, the invention is directed to a dentifrice
1 o composition with particular amounts of specific essential oils and a
method for
treating gingivitis by brushing with the dentifrice composition.
2. DESCRIPTION OF RELATED ART
Volatile or essential oils are widely used in oral care products.
Essential oils are a~~omatic compounds that are derived from plant sources or
15 synthesized. Some essential oils show long-lasting germicidal effectiveness
against the most corrunon pathogens in the mouth. These pathogens are
frequently
associated with oral malodor, plaque and gingivitis. Thymol is a well-known
essential oil widely used as an antimicrobial in oral care products. Other
essential
oils include menthol, methyl salicylate, eucalyptol, anethol and eugenol.
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Essential oils have been included in formulations of toothpaste. U.S.
Patent No. 1,526,940 to Staegemann teaches a toothpaste with the germicide
ammonium ichthyol sulphonate with high amounts of thymol, menthol,
eucalyptol, methyl salicylate, and peppermint oil as flavorants and taste-
masking
ingredients.
U.S. Patent No. 3,164,524 to Fand et al. teaches an oral antiseptic
comprising 2, 2'-thiobis-(4,ti-dichlorophenol), boric acid, methyl salicylate,
thymol, menthol and e;ucalyptol.
U.S. Patent No. 5,(194,843 to Mazzanobile et al. teaches an anti-plaque,
anti-gingivitis toothpaste with a fluoride source and an andmicrobial agent
consisting essentially of about 0.15% to about 0.80% thymol, about 0.15% to
about 1.00% methyl ;>alicylate, about 0.25% to about 0.80% eucalyptol and from
about 0.15% to about 0.60% menthol. Mazzanobile et al. teach that the
toothpaste
15 will usually have a pH of from about 4 to about 8. The only example in
Mazzanobile et al. has a pH of about 6.3. Mazzanobile et al. also disclose
that
Euthymol toothpaste has been sold in the United Kingdom. According to
Mazzanobile et al. Euthymol toothpaste contains 0.12% thymol, 1.26% methyl
salicylate, 0.07% menthol and 0.012% eucalyptol. Euthymol toothpaste has a pH
2 0 of approximately 7.3-~7.5.
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European Patent Application 0497476 to Colgate-Palmolive Co.
teaches an antiplaque oral connposition, including a toothpaste, with
triclosan. The
antiplaque activity of the triclosan is increased by essential oils such as
eucalyptol,
thymol, methyl salicylate, andL menthol.
PCT Application ENO 96/03109 to Warner-Lambert Company teaches
an antiseptic, anticaries dentifrice having a pH of about 3.0 to about 5.5.
The
dentifrice contains thymol from about 0.01 % w/w to about 1.0 % w/w, menthol
from about 0.01 w/w to about 1.0% w/w, eucalyptol from about 0.41 % w/w to
about 1.0% w/w and methyl salicylate from about 0.01% w/w to about 1.0% w/w.
1 o Sloane, "Henley's; Twentieth Century Book of Formulas, Processes
and Trade Secrets" (Gardener D. Hiscox ed., 1965), pp. 252-253 teaches an
antiseptic tooth powder containing the antiseptic ingredients of Listerine.
The
formula contains 20~ grains each of thymol, menthol, eucalyptol and oil of
wintergreen (methyl salicylate).
i5 U.S. Patents Nos. 4,545,979 and 4,550,018 to Ambike et al. teach a
dental hygiene composition in an acidic pH range of from 3.0 to 5.0, pH
buffers,
fluoride, thymol, eu.calyptol, methyl salicylate, peppermint and spearmint oil
flavors, and 0.1 to 2.0 percent by weight of one or more highly pure alkali
metal
salts of dodecyl sulphate having less than 5% non-dodecyl alkyl sulphate
salts.
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Canadian Patent No. (334131 to Tisserand teaches a dentifrice preparation
that has an acidic pHf of about 3.8 to 5.8, optimally a pH of 4.0 to 5.5, and
most
preferably a pH of 4.0 to 4.8.; fluoride; and contains flavor oils such as
menthol,
methyl salicylate or thyme oil and other flavors such that the composition is
substantially free of hydrocarbon terpenes. According to Tisserand, when
essential oils that are not free of terpenes are employed in a fluoride
dentifrice that
has a pH in the ranges of about 3.8 to 5.8, the flavor develops a pronounced
rancid
and sour taste in a period of less than 3 months.
Warner-Lambert has marketed Euthymol~ Toothpaste that was formulated
1 o with thymol, eucalyptol, methyl salicylate and menthol at a pH above 7Ø
This
toothpaste was not formulated with fluoride. Warner-Lambert has also marketed
Listerine~ toothpaste; in the lJnited States and Canada that did not contain
thymol
or eucalyptol and was formulated at a pH above 6Ø This toothpaste did not
contain fluoride.
i 5 While the prion~ art discloses toothpaste and other dentifrice
compositions with antiseptic essential oils, there is a need for dentifrice
compositions providing antigingivitis efficacy. Additionally, there is a need
for a
dentifrice composition containing antigingivitis ingredients that remain
stable for
extended periods.
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SUMMARY OF THE INVENTION
The present invention is directed to a method of inhibiting gingivitis
comprising brushing 'the oral cavity with a dentifrice composition including
about
0.5 % w/w to about 0.7% v~r/w thymol, about 0.5% w/w to about 0.7% w/w
5 methyl salicylate, about 0.7 °/o w/w to about 1.0% w/w eucalyptol and
about 0.3%
to about 0.6% w/w menthol.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
A dentifrice composition used in conjunction with a toothbrush cleans
the accessible tooth surfaces. Dentifrice compositions of this invention
contain
essential oils having antiseptic properties. When the dentifrice also contains
one
or more fluoride-rele~~sing compound, the composition also has anticaries
activity.
Dentifrice compositions of tlus invention also contain, but are not limited
to, one
or more of the following dentifrice additives: acidifiers, abrasives,
surfactants,
binders and thickeners, humectants, sweeteners, desensitizing agents, flavors,
~ 5 colors, and preservatives. Th.e dentifrice composition of the invention is
acidified
to a pH of about 4~.0 to about S.0 by acidifiers including, but not limited
to,
phosphoric acid, acidic phosophate salts, benzoic acid, and food grade acids
(e.g.
citric acid, gluconic acid, etc;l. The preceding active ingredients and
additives are
combined in a hydrous or anhydrous vehicle to form a solid (i.e. toothpowder),
a
2 o semi-solid (i.e. paste or gel), ~or a liquid.
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- Essential oils are volatile aromatic oils that are synthetic or are derived
from plants by distilllation, e:Kpression or extraction. Essential oils
usually carry
the odor or flavor oi" the plant from which they are obtained. In the
dentifrice
compositions of this invention, antigingivitis activity is provided by
essential oils.
s Some of these essential oils ;also act as flavoring agents. The essential
oils of this
invention include, but are not limited to, thymol, menthol, methyl salicylate
(wintergreen oil) and eucalyptol. Thymol, also known by the chemical formula
5-methyl 2-(1-methylethyl) phenol, is obtained from the essential oil of
Thymus
vulgaris Labiatae and Monarch punctata Labiatae. Thymol is a white crystalline
powder with an aromatic odor and taste. Thymol is soluble in organic solvents
but
only slightly soluble in deionized water.
Menthol is isolated principally from the oil of Mentha arvensis. In its
commercial form, menthol its available as L-menthol crystals obtained from a
process involving cooling of the oil. Fractional distillation of peppermint
oil that
i5 usually contains from abouit 40% to about 65% menthol represents another
important source of menthol. Synthetic sources of L-menthol are also
available.
Eucalyptol is derived from the eucalyptus tree. Having a cam-
phoraceous odor anda cooling; taste, this essential oil is often combined with
other
essential oils such ~~s mend:~ol in confection formulations to impart
medicinal
2 o effect. Combinations of menthol and eucalyptol are widely used.
Particularly
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- preferred uses of the menthol-eucalyptol combination include, according to
the
present invention, dentifrices ouch as toothpastes or dental gels.
Methyl s~~licylate is the main ingredient in many essential oils,
constituting about 99'% of oil of wintergreen (Gaultheria procumbens) and
sweet
birch (Betula lenta). Methyl salicylate, which has a distinctive refreshing
aroma,
is used widely in mouthwashes, chewing gums and other oral and pharmaceutical
preparations.
The four essential oils used in the present invention are also used in the
well known mouthv~rash Listerine~. The amount of the oils in Listerine~
1 o mouthwash is 0.064°.% thymo~l, 0.092% eucalyptol, 0.060% methyl
salicylate and
0.042% menthol. Listerine~ mouthwash is known to help reduce the incidence of
gingivitis. The inventors were faced with the challenge of formulating a
toothpaste that delivE;rs the same amount of essential oils so as to provide
anti-
gingivitis activity.
The recommended amount of mouthwash used at one time is
approximately 20 milililiters. In contrast, the average amount of toothpaste
is only
approximately 2.0 grams. Based upon the difference in amounts of product used,
the inventors believed that a toothpaste with ten times the concentration of
essential oils in the mouthwash would be needed to deliver anti-gingivitis
activity.
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Suprisingly, a dentifrice with only eight times the concentration of
essential oils present in Listerine~ mouthwash is sufficient to provide anti-
gingivitis activity. Specifically, a dentifrice with about 0.46% to about
0.5623%
thymol, about 0.4644% to about 0.5676% methyl salicylate, about 0.306% to
about 0.374% mentlhol and about 0.6971% to about 0.8519% eucalyptol is
clinically effective in inhibiting gingivitis. More preferably a dentifrice
according
to the present invention conxnins about 0.5112% thymol, about 0.5160% methyl
salicylate, about 0.34% menthol and about 0.7745% eucalyptol and is clinically
effective in inhibiting; gingivitis.
~ o Fluoride-releasing compounds may be used in the dentifrice
compositions of the present invention. These compounds may be fully or
slightly
water soluble, release: fluoride ions or fluoride-containing ions in water and
do not
react with other components in the composition. It is well known that
dentifrice
compositions containing fluoride-releasing compounds help prevent dental
caries.
15 Typical fluoride-releasing compounds are inorganic fluoride salts such as
water-soluble alkaline earth metal, alkali metal, and heavy metal salts.
Sodium
monofluorophosphate, sodiwm fluoride, stannous fluoride and mixtures of these
compositions are preferred.
The amount of fluoride-releasing compound present in the dentifrice
2 o compositions of this invention must be nontoxic. The specific amount
depends
upon the type of fluoride-releasing compound employed, the solubility of the
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fluoride-releasing compound and the formulation of the dentifrice composition.
In
general, the fluoride-releasing; compound will be present in an amount by
weight
of up to about 1.2% w/w, preferably from about 0.1 % w/w to about 1.0% w/w,
and most preferably from about 0.175% w/w to about 0.8% w/w of the dentifrice
s composition so as to provide 800 - 1500 ppm F-.
The pH for the preferred embodiment according to the present
invention is from about 4.0 to about 5Ø A pH greater than about 5.0 has been
found to decrease the antiseptic activity of the dentifrice composition.
In addition to providing improved antiseptic activity, maintaining the
pH of the dentifrice compositions from about 4.0 to about 5.0 also provides
for a
stable product. The amount of methyl salicylate in the composition drops
dramatically over time at a pH greater than 5Ø
The pH o:f the claimed dentifrice is adjusted to below S.0 using suitable
food or pharmaceutical grade; acidifiers. These include, but are not limited
to, one
~ s or a combination of the following: phosphoric acid, benzoic acid, citric
acid, or
other tricarboxylic a~;,ids, and the like. Acidifiers in the present invention
include
a mixture of phosphoric acid from about 0.01 % w/w to about 3.0% w/w,
preferably in the range of from about 0.1% w/w to about 1.5% w/w, and most
preferably in the range of from about 0.2% w/w to about 0.75% w/w; monobasic
2 o sodium phosphate from about 0.01 % w/w to about 1 % w/w, preferably from
about
0.1% w/w to about 0.5% w/~w and most preferably from about 0.2% w/w to about
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- 0.4% w/w; dibasic sodium phosphate from about 0.001 % w/w to about 1.0% w/w,
preferably from about 0.01% w/w to about 0.5% w/w and most preferably from
about 0.01 % w/w to about 0.05% w/w; and benzoic acid in the range of from
about 0.01% w/w to about 1.0% w/w, preferably from about 0.05% w/w to about
5 0.5% w/w, and most ;preferably from about 0.08% w/w to about 0.35% w/w. The
exact amount of acidifier addled will depend on the final pH and buffer
capacity
desired.
The pH o f the products may be buffered with salts of the acids in
question. Common buffer systems include phosphoric acid and sodium phosphate
1 o salts, or citric acid a.nd sodium citrate. Suitable buffers for use in
this invention
include citric acid-sodium citrate, phosphoric acid-sodium phosphate, sodium
monobasic phosphate-sodiurn dibasic phosphate, acetic acid-sodium acetate,
gluconic acid-sodium; gluconate and benzoic acid and sodium benzoate in
amounts
up to about 1 % w/w, preferably from about 0.05% w/w to about 0.75% w/w of the
1 s composition and most preferably from about 0.1 % w/w to about 0.5% w/w of
the
composition.
The cornposition~s of the present invention may also contain
conventional dentifiice additives including, but not limited to, humectants,
binders, thickeners, surfactants, preservatives, sweeteners, flavors, colors,
2 o glycerin, and a buffer. These; additives are present in amounts that do
not interfere
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with the antiseptic, antigingivitis and anticaries properties of the
composition of
the present invention.
Surfactants or surface active agents are organic compounds that reduce
surface tension between liquids and aid in the dispersion of a composition
s throughout the oral cavity. The surfactant in the present invention may be
anionic,
nonionic, or amphotc:ric. Tlhe oral hygiene or dentifrice compositions of the
present invention may contain surfactants in amounts up to about 5.0% w/w; pre-
ferably from about 0..1 % w/v~r to about 3.0% w/w of the dentifrice
composition;
and most preferably from about 0.2% w/w to about 2.0% w/w of the dentifrice
1 o composition.
The :most preferred surfactants are anionic. These anionic
surfactants include, but are n.ot limited to, sodium lauryl sulfate, sodium
lauroyl
sarcosinate, sodium methyl c~ocoyl taurate, and disodium lauryl
sulfosuccinate. A
preferred surfactant is sodiunn lauryl sulfate. The compositions according to
the
15 present invention are substantially free from one or more highly pure
alkali metal
salts of dodecyl sulpr~ate having less than 5% non-dodecyl alkyl sulphate
salts.
Amphotenc surfactants have the capacity to behave as either an acid or
a base and include quaternuzed imidazole derivatives. Preferred amphoteric
surfactants include long chain (alkyl) amino-alkylene aklylated amine
derivatives,
2 o also known as MIRANOL~~, manufactured by Rhone-Poulanc, Cranberry, New
Jersey.
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- Natural and artificial sweeteners may be used in the dentifrice
compositions. The sweetener may be selected from a wide range of well known
materials including naturally occurring water-soluble sweeteners, artificial
water-soluble sweeteners and! modified water-soluble sweeteners derived from
naturally occurring water-soluble sweeteners. Artificial water-soluble
sweeteners
include, but are not limited t:o, soluble saccharin salts, e.g., sodium or
calcium
saccharin salts, cyclamate salts, the sodium, ammonium or calcium salt of
3,4-dihydro-6-methyl-1,2,3-oxathiazine-4-one-2,2-dioxide, the potassium salt
of
3,4-dihydro-6-methyl-1,2,3-o;cathiazine-4-one-2,2-dioxide (Acesulfame-K), the
1 o free acid form of saccharin ,and dipeptide based sweeteners, such as L-
aspartic
acid derived sweeteners. Dipeptide sweeteners include
L-aspartyl-L-phenylalanine methyl ester (Aspartame) and materials described in
U.S. Pat. No. 3,492,131, L-alpha-aspartyl-N-(2,2,4,4-tetramethyl-
3-thietanyl)-D-alanin,amide hydrate (Alitame), methyl esters of L-aspariyl-L-
1 s phenylglycerine arid L-aspartyl-L-2,5-dihydrophenylglycine,
L-aspartyl-2,5-dihydro-L-phe~nylalanine and L-aspartyl-L-
(1-cyclohexene)-alanine. Naturally occurring water-soluble sweeteners include,
but are not limited to, sugar alcohols, including sorbitol as 70% sorbitol
solution,
mannitol, xylitol, malritol, hydrogenated starch hydrolysates and mixtures
thereof.
2 o Water-soluble sweeteners derived from naturally occurnng
water-soluble sweeteners include, but are not limited to, chlorinated
derivatives of
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- sucrose, known, for example, under the product designation of Sucralose; and
protein-based sweeteners such as thaumaoccous danielli (Thaumatin I and II).
Sorbitol solution supplies sweetness and body to the composition and
gives a desirable month feel. Sorbitol solution also enhances flavor, prevents
harsh taste and provides a fresh and lively sensation in the mouth. It also
prevents
caking of the dentifrice.
In general, an effective amount of sweetener is utilized to provide the
level of sweetness desired in any particular embodiment of the dentifrice
composi-
tions according to the present invention. This amount will vary with the
sweetener
1 o selected and the final form of the composition. The amount of sweetener
normally
present is from about 0.0025% w/w to about 60% w/w of the 'dentifrice
composition. The exact ra~lge of amounts for each type of sweetener in a
dentifrice is readily determined by those skill in the art.
The flavors that may be used in the invention include natural and
1 s artificial flavors known in the dentifrice art. Suitable flavors include,
but are not
limited to, mints, such as peppermint, citrus flavors such as orange and
lemon,
artificial vanilla, cinnamon, various fruit flavors, and the like. Anethole
(or anise
camphor, p-propenyl anisole ) is a flavor constituent of anise and fennel oils
that
are used widely as flavoring .agent and antiseptic and was found useful in
masking
2 o the harsh taste of thymol.
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- The amount of flavor is normally a matter of preference subject to
the type of final dentifrice composition, the individual flavor employed and
the
strength of flavor desiired. The flavors are preferably utilized in amounts
that may
range from about 0.01 % w/w to about 6% w/w of the dentifrice composition. The
flavors used in the .compositions according to the present invention comprise
flavoring oils that are not sub;>tantially free of terpenes.
Coloring agents cure used in amounts effective to produce a dentifrice
of the desired color. These coloring agents may be incorporated in amounts up
to
about 3% by weight of the dentifrice composition. The coloring agents may also
1 o include natural food colors and dyes suitable for food, drug and cosmetic
applications. These coloring agents are known as FD & C dyes and lakes. The
coloring materials are preferably water-soluble. Illustrative nonlimiting
examples
include the indigoid dye known as FD & C Blue No.l, and D & C Yellow No. 10.
A full recitation of all FD & C colorants and their corresponding chemical
structures may be found in the Kirk-Othmer Encyclopedia of Chemical
Technology, 3rd Ediition, in volume 5 at pages 857-884. A preferred opacifier,
titanium dioxide, may be incorporated in amounts up to about 2.0% w/w,
preferably less than about 1.0% w/w of the composition and most preferably
less
than about 0.4% w/w.
2 o Suitable )humectants in this invention include sorbitol, as 70% sorbitol
solution, glycerin, propylene glycol, polyethylene glycol, mixtures thereof,
and the
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like. Humectants may be present in amounts from about 1.0% to about 75.0% by
weight of the dentifrice composition.
Suitable abrasive substances for use in this invention must be
compatible with the low pHf of the composition and include hydrated silica,
5 alumina or alkali metal meta-phosphates. Silica abrasives in the dentifrice
composition according to this invention may include among others, ZEODENT~
(113), manufactured by J. W. Huber Corp. and SYLOID~ or SYLODENT~,
manufactured by W.F:. Grace Co. These polishing agents may be used in amounts
up to about 75.0% cv/w of the composition, preferably in amounts from about
10 5.0% w/w to about 4~0% w/w of the composition and most preferably from
about
5.0% w/w to about 30.0% whw of the composition.
The dentiiiice composition includes an oral vehicle that can be a paste,
gel, powder or liquid. Depending upon the specific form of the dentifrice, the
composition may also include binders or gelling agents to provide a desired
1 s consistency. Gelling agents such as hydroxyethyl cellulose, carboxymethyl
cellulose, methyl cellulose, xanthan gum, gelling silicas and the like may be
used
singly or in combination. The preferred gelling system is a mixture of carboxy
methyl cellulose, xa~ithan gum and gelling silica. Gelling agents may be used
in
amounts from about 0.5% v~r/w to about 30% w/w, preferably from about 5.0%
2 o w/w to about 15.0% w/w of the dentifrice composition, and most preferably
from
about 7.0% w/w to about 20°,~o w/w of the composition.
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The dentifrice composition of this invention may also contain a
desensitizing agent such as strontium chloride, potassium nitrate or sodium
citrate-
citric acid, which may be used in an amount from about 0.5% w/w to about 10%
w/w.
Suitable preservatiives include benzoic acid, butylated hydroxyanisole
(BHA), butylated hydroxytoluene (BHT), ascorbic acid, methyl paraben, propyl
paraben, tocopherols and mixtures thereof. Preservatives when used are
generally
present in amounts ul> to about 1.0% w/w, and preferably from about 0.1 % w/w
to
about 1.0% w/w of the dental gel composition.
to The present invention is further illustrated by the following non-
limiting examples. All parts and percentages in the examples and throughout
the
specification and claiims are by weight of the final composition unless
otherwise
specified.
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Example 1 and Comp,~rative F:x_ ample 1
Dentifrice compositions were formulated with the ingredients listed in
Table 1.
Table 1.
FORMULA NUMBER 1 Comparative Example
1
PH 4:5 4.5
THYMOL 0.5112 0
METHYL SALICYLAT'E0.5160 0
MENTHOL 0.3400 0
EUCALYPTOL 0.7745 0
GLYCERIN 6.0000 6.0000
SORBITOL 40.0000 40.0000
SOLUTION (70%)
WATER 25.0820 27.8237
PEG 1450 3.0000 3.0000
XANTHAN GUM 0.2500 0.2500
Na CMC 1.2000 1.2000
FLAVOR 0.2250 0.2250
SODIUM FLUORIDE 0.2540 0.2540
Na SACCHARIN 1.2000 0.6000
NaHZP04 0.2900 0.2900
Na2HP04 0.0300 0.0300
BENZOIC ACID 0.1500 0.1500
Ti02 0.3500 0.3500
GELLING SILICA 11.000 11.000
ABRASIVE SILICA 7.0000 7.0000
SLS 1.5000 1.5000
COLOR 0.0022 0.0022
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- Example 2
A three week, randomi:aed, double blind study was performed studying the
antiplaque and antigingivitis efficacy of brushing with Example 1 versus
Comparative Example 1. Forty four subjects were screened for evidence of
gingivitis and plaque. Subjects were instructed to brush twice daily by
filling the
head of their toothbrush with the assigned toothpaste and brushing for one
minute.
The subjects were in;>tructed to not use any other toothpaste or mouthwash
during
the study.
The subjects were then screened for Modified Gingival Index, Plaque Index
i o and Bleeding Index. The Modified Gingival Index is described in Lobene,
R.R., et
ai., A Modified Gingival Index For The Use In Clinical Trials, Clin. Prev.
Dent.
8:3, 1986. The severity of gingivitis is scored using a 4 point scale O -
normal, 1
mild inflammation in any portion of the unit, 2 - mild inflammation in the
entire
unit, 3- moderate inflammation, 4 - severe inflammation.
15 The plaque index used was the Turesky modification of the Quigley-Hein
Plaque index as described in Turesky, S., et al., Reduced Plaque Formation By
The Chloromethyl Analogue of Vitamin C, J. Periodontol. 41:41, 1970. This
index scores the amount of tile toothsurface covered with plaque using a 0-5
point
scale.
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The bleeding index used was the Gingival Bleeding Index as described in
Saxton, et al., The Efi:ect Of A Dentifrice Containing Zinc Citrate And
Triclosan
On Developing Gingivitis, J. Perio. Res. 24:75, 1989. The level of bleeding is
recorded following probing the gingiva with a periodontal probe in a sweeping
fashion and using a 3 point scale 0 no bleeding, 1 - bleeding after 30
seconds, and
3 - bleeding immediately.
The subjects using Example 1 had a 39.6% reduction in Plaque Index, a
10.8% reduction in Gingival Index and a 65.4% reduction in Bleeding Index
compared to the subjects using Comparative Example 1.
1 o Example 3
A six month study testing Example 1 versus Comparative Example 1 was
performed. The procedures and indices used in Example 2 were also used in
Example 3. In addition to the indices measured in the three week study, the
subjects were also :measured for interproximal Modified Gingival Index and
15 interproximal Plaque Index. The subjects were measured at three and six
months.
The results are sumnnarized in Table 2.
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Table 2
Comparative
Example 1 Example 1
..-....------.-
% Reduction:
Adjusted Adjusted ' Comparative
.Mean .Mean
Example
l
Month 6 (N=154) (N-158)
Mean Modified Gingival 2.01 1.48 26.2%
Index
Mean Bleeding Index 0.115 0.037 67.7%
Mean Plaque Index 2.45 1.41 42.4%
Mean Int. Mod. Gingival 2.23 1.73 22.3%
Index
Mean Int. Plaque Index 2.58 1.58 38.9%
Month 3 (N-155) (N-161 )
Mean Modified Gingival 2.03 1.80 11.6%
Index
Mean Bleeding Index 0.112 0.064 48.8%
Mean Plaque Index 2.67 1.94 27.4%
Mean Int. Mod. Gingival 2.21 2.03 8.3%
Index
Mean Int. Plaque Index 2.83 2.16 23.9%
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21
Example 4
An additional example of a dentifrice according to the claimed invention
was formulated with the following ingredients.
ne.."o"t cxmx~
i. Purified Water 24.8485
2. Sorbitol Solution 40.0000
3. Sodium Monofluorophospha~te .7600
4. Sodium Saccharin 1.2000
S. Sodium Phosphate Monobas,ic Anhydrous .2500
6. Sodium Phosphate Dibasic Anhydrous .0300
7. Polyethylene Glycol 3.0000
8. Acid Benzoic .1500
9. FD and C Blue No. I .0020
10. D and C Yellow No. 10 .0002
11. Phosphoric Acid .4425
12. Silicon Dioxide 7.0000
13. Amorphous Silica i;Sylodent 750) 11.0000
2 0 14. Xanthan Gum .2500
15. Carboxyrnethylcell.ulose Sodium 1.2000
16. Glycerin 6.0000
17. Thymol .5112
18. Methyl Salicylate .5160
2 5 19. Menthol .3400
20. Eucalyptol .7745
21. Spearmint Oil Blend .1000
22. Mint Flavor .1250
23. Sodium Lauryl Sulfate 1.5000
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22
While the inve;ntion has been described in detail and with reference to
specific examples thereof, it v~rill be apparent to one skilled in the art
that various
changes and modifications can be made therein without departing from the
spirit
and scope thereof.
