U.S. patent number 3,723,613 [Application Number 05/109,054] was granted by the patent office on 1973-03-27 for dental plaque disclosing agent.
Invention is credited to Philip L. Block, John P. Derdivanis.
United States Patent |
3,723,613 |
Block , et al. |
March 27, 1973 |
DENTAL PLAQUE DISCLOSING AGENT
Abstract
Disclosing agent for use in control of dental plaque. The agents
are compositions comprises of FDC Red No. 3 and FDC Blue No. 1; FDC
Red No. 3 and FDC Green No. 3 and FDC Red No. 3 and Hercules Green
Shade 3.
Inventors: |
Block; Philip L. (Moraga,
CA), Derdivanis; John P. (Oakland, CA) |
Family
ID: |
22325556 |
Appl.
No.: |
05/109,054 |
Filed: |
January 22, 1971 |
Current U.S.
Class: |
424/9.71; 424/48;
424/45; 424/49 |
Current CPC
Class: |
A61Q
11/00 (20130101); A61K 8/498 (20130101); A61K
8/466 (20130101); G01N 33/52 (20130101); G01N
31/22 (20130101); A61K 2800/43 (20130101) |
Current International
Class: |
G01N
33/52 (20060101); G01N 31/22 (20060101); G01n
031/00 (); G01n 033/16 () |
Field of
Search: |
;424/7,9,3 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Rose; Shep K.
Claims
What is claimed is:
1. In a process for the differential disclosure of dental plaque,
the improvement comprising applying to the oral cavity a
composition comprising for each part by weight of FDC Red No. 3,
from about 0.1 to 4 parts by weight of a dye selected from the
group consisting of FDC Blue No. 1, FDC Green No. 3 and Hercules
Green Shade 3, said composition adapted to differentially stain
areas of old, thick accumulations of dental plaque deep blue or
purple and thin, recent deposits of dental plaque red, whereby
effectively practiced plaque removal on a given tooth shows, and
can be photographed, as either no stain pickup or thin deposits
staining red, while certain areas on said tooth if consistently
missed, will be considerably thicker and therefore stained blue,
and on some teeth, an intermediate definite purple zone can be
distinguished between the red and blue areas, said intermediate
definite purple area tending to look more like blue plaque than red
plaque, but the thickness of this purple plaque being less than
that of blue plaque, while tooth surfaces not covered with plaque
do not show the dye at all.
2. A process in accordance with claim 1 wherein said dye is FDC
Green No. 3.
3. A process in accordance with claim 1 and further characterized
by a minor amount of surfactant being included in said
composition.
4. A process in accordance with claim 1 wherein said composition is
aqueous.
5. A process in accordance with claim 1 wherein said composition is
in tablet form.
6. A process in accordance with claim 1 wherein said composition is
in aerosol spray form.
7. In a process for the differential disclosure of dental plaque,
the improvement comprising applying to the oral cavity a
composition comprising for each part by weight of FDC Red No. 3,
from about 1-2 parts by weight of a dye selected from the group
consisting of FDC Blue No. 1, FDC Green No. 3 and Hercules Green
Shade 3, said composition adapted to differentially stain areas of
old, thick accumulations of dental plaque deep blue or purple and
thin, recent deposits of dental plaque red, whereby effectively
practiced plaque removal on a given tooth shows, and can be
photographed, as either no stain pickup or thin deposits staining
red, while certain areas on said tooth if consistently missed, will
be considerably thicker and therefore stained blue, and on some
teeth, an intermediate definite purple zone can be distinguished
between the red and blue areas, said intermediate definite purple
area tending to look more like blue plaque than red plaque, but the
thickness of this purple plaque being less than that of blue
plaque, close examination of said photographs revealing plaque
colonies growing on a tooth surface displaying a central raised
blue mass surrounded by a red and/or purple peripheral zone which
was lower than the central mass, the red zone of adjacent plaque
colonies tending to fuse forming red fields peppered with blue
raised areas, while tooth surfaces not covered with plaque do not
show the dye at all, said composition by color alone enabling the
estimation of the third dimension of plaque, its age, and
thickness.
8. A process in accordance with claim 7 wherein said composition is
aqueous.
9. A process in accordance with claim 7 wherein said composition is
in tablet form.
10. A process in accordance with claim 7 wherein said composition
is in aerosol spray form.
Description
This invention relates to novel disclosing agents for use in the
improvement of oral hygiene practices. More specifically the
invention pertains to combinations of dyes; FDC Red No. 3 and FDC
Blue No. 1; FDC Red No. 3 and FDC Green No. 3; FDC Red No. 3 and
Hercules Green Shade 3 for employment as disclosing agents in the
control of dental plaque.
Dental plaque is a well-organized structure which forms on tooth
surfaces and restorations. It consists mainly of bacteria
surrounded by a matrix derived primarily from saliva and the
bacteria themselves. Plaque differs from other soft tooth deposits
such as materia alba and food debris in that it has a definite
architecture and cannot be flushed away by rinsing with water.
It is well established that dental plaque plays a major role in the
etiology of periodontal diseases and caries. Although the exact
manner in which plaque contributes to these disease states is not
known at present, it is appreciated that effective and thorough
removal of these deposits is absolutely essential for oral health.
Accordingly it is desirable that an effective plaque control
program be established as part of the treatment plan for every
dental patient. For this program to be effective the patient must
be motivated to carry out thorough daily plaque control techniques.
Motivation can be achieved, however, only by establishing goals
that are meaningful and attainable by the patient. Experience has
shown that most patients would not be sufficiently motivated to
practice good oral hygiene if they were simply told that plaque is
a bacterial colony growing on their teeth; that plaque produces
gingival disease and carries and must be removed daily. However,
the entire concept of what plaque is and what it does to tissue can
be made vital and important to the patient by "visualization"
whereby every patient is shown his plaque in situ and under the
phase contrast microscope. The patient may also observe the
diseased gingival areas and their juxtaposition to the places of
plaque accumulation. These visual demonstrations serve two main
purposes. First, it shows the patient that he does indeed have
these dangerous bacterial deposits called plaques on his teeth.
Secondly, by microscopic visualization, he sees that those innocent
looking masses are composed of millions of living bacteria of
differing shapes; some even having the ability to move about.
Experience has shown that the technique of visualization of plaque
generates in patients a true interest in plaque, and an abvious and
apparent concern for its prompt removal.
Since plaque is translucent or tooth-colored, it is necessary that
it be appropriately stained in color for it to be made visible.
Disclosing dyes have been in use for over 50 years. Many substances
have been used, e.g. iodine, basic fuchsin neutral red, etc. Some
dyes previously tried by the prior art could not be used because
they were suspected carcinogens, others appeared in the urine, and
taste was a drawback to many materials.
Since its development in 1963, a disclosing tablet containing FDC
No. 3 as the staining agent has been widely employed as a
disclosing agent to stain plaque. One of the reasons the dye was so
widely accepted was because it met the criteria established at that
time for an effective disclosing medium; namely, that it should
have a pleasing shade of red. However, with regular use of the FDC
Red No. 3 tablet, it became abundantly clear that the "pleasing
shade of red" adversely affected the utility of the wafer. The
plaque interproximally and at the gingival margin, especially in
the posterior areas, could not easily be seen because of poor
contrast between the gingiva and the stained plaque. Accordingly,
the use of a red disclosing dye reveals that red is the wrong color
since plaque that has been stained red is extremely difficult to
see due to poor contrast with the oral tissues, especially in the
back areas of the mouth and between the teeth. It should be noted
that it is these precise areas which are the most prevelant sites
of caries and periodontal disease.
A disclosing agent having all the desirable properties of the
current red media, but possessing, however, a color which would be
in sharp contrast to the gingival tissues would vastly improve the
effectiveness of such a product. The continuing search for an
improved disclosing dye preparation has led to the development of
the blue dye medium of the invention which provides a two-tone dye
test for dental plaque.
The novel dyes of the invention not only stain plaque a color which
contrasts well with the tissues and teeth, thus making plaque
visible even in the hard to see places, but they possess the
property of selective differential staining and thereby permit a
distinction to be made between areas of old thick accumulations and
thin recent deposits. It has been well documented in dental
literature that it is thick plaque deposits which are generally
associated with periodontal disease and exhibit the anaerobic flora
seen in periodontal pockets. In other words, thick old plaques are
probably more pathogenic than the new deposits.
The novel dyes of the invention are unique in that by color alone
the third dimension of plaque, its age and thickness, can be
readily estimated. Thick plaques stain blue and thin plaques stain
red. Since old and new plaques have their own characteristic
microbial morphology, the bacterial types can be also judged by
color differentiation using the dyes of the invention. Utilizing
the novel two-tone dye test for dental plaque the patient can, for
the first time, judge for himself whether he has been practicing
effective plaque removal by noting whether any plaque deposits
which may be stained are either red or blue. If he consistently
misses certain areas they will be considerably thicker and
therefore stained blue. If he has been doing a thorough and
effective job of plaque control, he will either show no stain
pickup or if he has thin deposits they will stain red.
The dentist can also use this dye test to obtain virtually a
quantitative evaluation of the effectiveness of the patients plaque
control.
Additionally, the dyes are a useful tool in dental research. For
the first time the extremely important third dimension of plaque,
its thickness can be noted by color differential and this
information recorded in a photograph. Studies that have been
conducted heretofore to evaluate the effectiveness of antiplaque
agents and oral hygiene aids using the prior art erythrosine have
failed to convey the information about plaque thickness.
In the following study patients were selected at random and their
teeth were stained with a representative dye of the invention (FDC
Red No. 3 and FDC Green No. 3). Kodachromes were taken of these
stained areas from which plaque was to be removed for microscopic
examination. At all times plaque samples were taken from teeth that
showed red and blue plaque on the same tooth. This was done to
eliminate any variation in plaque bacterial morphology that could
exist between one tooth and another. Each plaque colony was
disected with the tip of a fine curette. The samples were placed on
a slide, suspended in Ringers Solution, and examined and
photographed through a phase contrast microscope at 400 X and 1000
X. According to the invention it is now possible to distinguish
between old thick plaque and new thin plaque based on the
distinctive color each takes with the novel dye of the
invention.
Generally, blue plaque shows the following clinical and microscopic
features:
1. Considerably greater thickness than red plaque.
2. High degree of architectural organization. Cocci, rods and/or
filaments arranged in parallel rows forming fan-shaped patterns.
These rays were perpendicular to the tooth but this pattern was
broken at the time of sample removal.
3. Filaments intertwined forming a mesh work.
4. Motility -- present in some blue plaques.
5. Spiral organisms and vibrios. Red plaques are distinguished by
the following:
1. Extreme thinness -- to the extent that sometimes it was hard to
obtain sufficient material for examination.
2. Low density of organisms.
3. No evidence of any orderly architecture.
4. No motility.
5. No filaments, spiral organisms or vibrios. On some teeth treated
with the dye it was also possible to distinguish an intermediate
zone between the red and blue areas that had a definite purple
color. This intermediate area tended to look more like blue plaque
than red plaque but the thickness of this plaque was less than that
of blue plaque.
Close examination of the Kodachromes revealed some interesting
facts. Plaque colonies growing on a tooth surface displayed a
central raised blue mass surrounded by a red and/or purple
peripheral zone which was lower than the central mass. The red
zones of adjacent colonies tended to fuse forming red fields
peppered with blue raised areas. Those tooth surfaces that were not
covered with plaque did not show the dye at all. It should be noted
that patients treated with the dye do not find the blue color
objectionable or the taste unpalatable. The blue color fades
quickly from teeth, restorations and tissues with simple water
rinses and brushing. In addition, stains are easily removed from
laundry or plumbing fixtures.
The dyes of the invention find particular value as research and
diagnostic tools. They can be used in evaluating antiplaque agents,
or plaque control techniques and devices by providing vital
information about the third dimension of plaque, its thickness.
Prior art disclosing dyes have not been able to supply this
information, thus severely limiting the value of those studies
conducted to measure the effectiveness of plaque removal.
The relative ratio of one dye to the other in formulating the dye
compositions of the invention is not critical and the unobvious
two-tone properties may be achieved by employing for each part by
weight of FDC Red No. 3 from about 0.1 to about 4 parts by weight
of either FDC Green No. 3, FDC Blue No. 1 or Hercules Green Shade
3. A preferred ratio would involve one to two parts by weight of
the latter for each part by weight of FDC Red No. 3.
Where the dye is to be used in the form of a solution, the
concentration of the dye is not critical and may vary from about
600 to 1,200 mg. per 100 ml. of solution. If one desires to utilize
the dyes as tablets or wafers, the amount of dye included in each
tablet or wafer is not critical and may vary from about 20 mg. to
about 100 mg. per dosage unit.
A representative example of a combination of FDC Red No. 3 and FDC
Green No. 3 that may be used in the practice of the invention is as
follows:
FDC Red No. 3 200 mg. FDC Green No. 3 400 mg. Surfactant between
20) 0.1 ml. Tap water 60 ml.
The formulation is painted on the teeth and gingiva, retained a few
seconds and rinsed off with a small amount of water. Newly formed
plaque stains red whereas old plaque stains deep blue or
purple.
The manner by which the dye is made available to the mouth area is
not critical and will vary according to patient acceptance and
convenience. For example, in addition to painting on the teeth the
novel dye can be formulated as a chewable tablet, wafer, powder,
lozenges, aerosol, liquid concentrate, etc.
Examples directed to the preparation of such formulations are as
follows:
Chewable Tablets or Wafers Grams
.905 Flavoring oils, spray dried in gum acacia .025 Calcium
stearate .010 FDC Red No. 3 .020 FDC Green No. 3 .040 1.000
Lactose, spray dried .855 Flavoring oils, spray dried in gelatin
.020 Magnesium stearate .020 FDC Red No. 3 FDC Green No. 3 .040
Saccharin .001 Citric acid .050 1.000
Fluid Preparation (May be painted on full strength, or diluted with
water for use as a rinse)
% by weight Ethanol, USP 15.00 Polysorbate 80 0.20 Flavoring oils
0.50 Glycerin 5.00 FDC Red No. 3 .25 FDC Blue No. 1 .50 Water, q.s.
ad 100.00
Aerosol Sprays
% by weight Glycerin 15.0 Ethanol, absolute 43.4 Saccharin 0.1
Flavor 0.2 Propellant 12 16.0 Propellant 114 25.0 FDC Red No. 3 0.1
FDC Green No. 3 0.2 100.0
Ethanol, USP 20.00 Glycerin 5 00 Flavoring oils 0.35 FDC Red No. 3
0.25 FDC Green No. 3 0.50 Water 68.90 Propellant 12 100.00
Lozenges
Grams Corn syrup solids, spray dried .880 Flavoring oils, spray
dried with modified starch 0.050 Calcium stearate .010 FDC Red No.
3 .020 Hercules Green Shade 3 .040 1.000
* * * * *