Note: Descriptions are shown in the official language in which they were submitted.
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TOOTHBRUSH TISSUE, CLEANSER
[01] This is a divisional of Canadian Patent Application Serial No.
2,800,233 filed
December 21, 2012, which is a divisional of Canadian National Phase Patent
Application Serial No. 2,526,826, filed on June 18, 2004.
FIELD OF THE INVENTION
[01a] The present invention pertains taan oral care implement with a cleanser
for cleaning
=
soft tissue surfaces in the mouth.
BACKGROUND OF 'IRE INVENTION= =
=
[02] = According to the American Dental Association, a major iource of bad
breath in
healthy people is microbial deposits on the tongue, where ahacterial coaling
harbors =
'organisms and d ebris that contribute to b ad breath. The tongue is a h aven
for the
growth of microorganisms since the papillary nature of the tongue surface
creates u
unique ecological site that provides im extremely largo surface area, favoring
the
accumulation of oral bacteria. Anaerobic flora and bacteria residing on the
tongue
play an important role in the development of chronic bad breath commonly
called
halitosis. in general, the bacteria produce volatile sulfur coinpounds (VSC).
If there is
enough buildup o fthi ulfur compounds, the result canbe lead b ad.b math or
oral
malodor.
[03] While bladed tongue scrapers have been used in the _past; these scrapers
are
inadequate in respect to their effectiveness on the soft tissue surface of the
tongue.
Broad fiat scraping blado arc limited in their ability to reach between the
papillae
where the b acteria and microdebris have collected. =over, notwithstanding the
benefits .to be gained by any ability te clean the tonguer= some users avoid
the use of
such blades because Of lack Of comfort on the tongue surface.,
1 =
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[04] Hence, there is a need for an oral care implement with a
tongue cleanser that
provides effective removal of the tongue bacteria and other debris while
maintaining comfort
to the user.
BRIEF SUMMARY OF THE INVENTION
[04a] According to another aspect of the present invention, there is
provided an oral
care implement, comprising: a head and a handle; a plurality of tooth cleaning
elements
disposed on a first side of the head and comprising a plurality of filament
bristles; a soft tissue
cleanser having a plurality of conical nubs formed of an elastomeric material
and having a
different configuration than the bristles, the conical nubs disposed on a
second side of the
head opposite the tooth cleaning elements in longitudinal rows and transverse
rows, wherein
adjacent transverse rows of conical nubs are in a staggered relationship,
wherein each conical
nub is spaced apart from adjacent conical nubs, the conical nubs having a
cylindrical base
portion of substantially constant cross-sectional area and a tapered tip
portion, the conical
nubs having a height that is greater than a width of the conical nubs at the
base portion, and
the conical nubs having a substantially circular cross-section; and a basin
formed in the
second side of the head, the soft tissue cleanser injection molded into the
basin.
[04b] According to yet another aspect of the present invention, there is
provided an
oral care implement comprising: a head and a handle; a plurality of bristles
disposed on a first
side of the head; a basin formed into a second side of the head opposite the
first side, the basin
comprising a floor and a peripheral sidewall extending from the floor, the
peripheral sidewall
terminating at a surface of the second side of the head; an elastomeric soft
tissue cleanser
comprising a pad and a plurality of projections extending from the pad;
wherein the soft tissue
cleanser is disposed within and injection molded into the basin; and wherein
the pad
comprises a bottom surface that is in contact with the floor of the basin and
a top surface that
is substantially flush with the surface of the second side of the head, the
projections extending
outwardly from the top surface of the soft tissue cleanser so as to extend
beyond the surface of
the second side of the head.
[04c] According to a further aspect of the present invention, there is
provided an oral
care implement comprising: a head and a handle; a plurality of tooth cleaning
elements
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extending from a first face of the head; a receiving cavity formed into a
second face of the
head opposite the first face, the receiving cavity comprising a lower base
surface and a
sidewall extending from the lower base surface, the sidewall terminating at
the second face of
the head; and a soft tissue cleanser formed of an elastomeric material that is
injection molded
into the receiving cavity, the soft tissue cleanser comprising a base surface
that is substantially
flush with the second face of the head and a plurality of projections
extending from the base
surface beyond the second face of the head.
[04d] According to yet a further aspect of the present invention, there is
provided an oral
care implement comprising: a head and a handle; a plurality of tooth cleaning
elements extending
from a first face of the head; a receiving cavity formed into a second face of
the head opposite the
first face; and a soft tissue cleanser formed of an elastomeric material that
is injection molded into
the receiving cavity to bond the soft tissue cleanser to the head, the soft
tissue cleanser comprising
a plurality of projections extending beyond the second face of the head.
[04e] According to a further aspect, there is provided an oral care
implement
comprising: a head and a handle; a plurality of tooth cleaning elements
extending from a first
face of the head; a receiving cavity formed into a second face of the head
opposite the first
face; a soft tissue cleanser formed of an elastomeric material that is
injection molded into the
receiving cavity, the soft tissue cleanser comprising a plurality of
projections; and one or more
peg members extending from a lower base surface of the receiving cavity, the
soft tissue
cleanser comprising one or more complementary apertures that receive the one
or more peg
members and expose tops of the one or more peg members.
[0411 According to a further aspect, there is provided an oral care
implement
comprising: a handle; a head having a longitudinal axis; a plurality of tooth
cleaning elements
extending from a first face of the head; a receiving cavity formed into a
second face of the
head opposite the first face, the receiving cavity comprising a peripheral
sidewall extending
away from a lower base surface; a soft tissue cleanser formed of an
elastomeric material that
is injection molded into the receiving cavity to bond the soft tissue cleanser
to the head, the
soft tissue cleanser comprising a plurality of nubs that extend beyond the
second face of the
head; and at least one peg member aligned along the longitudinal axis and
extending from the
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lower base surface of the receiving cavity, the soft tissue cleanser
comprising at least one
complementary aperture that exposes a top of the at least one peg member.
[04g] According to a further aspect, there is provided an oral care
implement
comprising: a head and a handle, the head having a longitudinal axis; a
plurality of tooth
cleaning elements extending from a first face of the head; a soft tissue
cleanser on the head
opposite the first face, the soft tissue cleanser formed of an elastomeric
material that is
injection molded into a receiving cavity of the head to bond the soft tissue
cleanser to the
head, the soft tissue cleanser comprising a plurality of projections; and at
least one peg
member aligned along the longitudinal axis and extending from the head, the
soft tissue
cleanser comprising at least one complementary aperture that exposes a top of
the at least one
peg member.
[04h] According to a further aspect, there is provided an oral care
implement
comprising: a head having a longitudinal axis and a handle; a plurality of
tooth cleaning
elements extending from a first face of the head; a receiving cavity formed
into a second face
of the head opposite the first face; and a soft tissue cleanser formed of an
elastomeric material
that is injection molded into the receiving cavity to bond the soft tissue
cleanser to the head,
the soft tissue cleanser comprising a plurality of apertures extending
therethrough and a
plurality of projections extending beyond the second face of the head, the
plurality of
apertures aligned along the longitudinal axis.
[04i] According to a further aspect, there is provided an oral care
implement
comprising: a head having a longitudinal axis and a handle; a plurality of
tooth cleaning
elements extending from a first face of the head; a receiving cavity formed
into a second face
of the head opposite the first face; a soft tissue cleanser formed of an
elastomeric material that
is injection molded into the receiving cavity to bond the soft tissue cleanser
to the head, the
soft tissue cleanser comprising a base having a front surface and an opposing
rear surface and
a plurality of apertures extending through the front and rear surfaces of the
base, the plurality
of apertures aligned along the longitudinal axis; and a plurality of
protuberances extending
from a floor of the receiving cavity, each of the plurality of protuberances
extending into a
respective one of the plurality of apertures.
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[05] Some aspects of the invention pertain to an oral care implement with a
tissue
cleanser that provides improved cleaning and effective removal of bacteria and
microdebris
disposed on the oral tissue surfaces.
[06] In one aspect of the invention, the tissue cleanser includes a
plurality of nubs for
cleaning soft tissue surfaces in the mouth and particularly for cleaning
between the papillae of the
tongue. In a further preferred aspect of the invention, the tissue cleanser
includes a plurality of
conically shaped nubs.
[07] In another aspect of the invention, the tissue cleanser is constructed
from an
elastomeric material. In one preferred embodiment, the tissue cleanser is
formed as an
elastomeric pad mounted on the head of the oral care implement for improved
cleaning, ease of
manufacture, and user comfort.
[08] In another aspect of the invention, the oral care implement includes a
seat to
facilitate and ease molding of the tissue cleanser to the head. In one
preferred construction, the
head has one or more protuberances for anchoring the head during molding of
the tissue cleanser.
The head may also include a basin to further define the outline of the molded
tissue cleanser.
[09] In another aspect of the invention, an oral care implement includes a
tissue
cleanser having means for reducing oral volatile sulfur compounds by 35% from
a baseline
measured two hours after use.
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[10] In another aspect of the invention, an oral care implement is provided
with tooth
cleaning elements and a tissue cleanser for a thorough cleaning of the teeth,
gums,
tongue and oral surfaces of the cheeks and lips. In a preferred construction,
the tooth
cleaning elements and tissue cleanser are supported on opposite sides of a
supporting
head.
[11] In one other aspect of the invention, an oral care implement which
includes tooth
cleaning elements and a tissue cleanser forms at least one of the tooth
cleaning
elements as a unitary member with the tissue cleanser.
BRIEF DESCRIPTION OF THE DRAWINGS
[12] A more complete understanding of the present invention and the advantages
thereof
may be acquired by referring to the following description in consideration of
the
accompanying drawings, in which like reference numbers indicate like features,
and
wherein:
[13] Figure 1 is an exploded assembly perspective view of an oral care
implement
according to one or more aspects of an illustrative embodiment;
[14] Figure 2 is an enlarged perspective view of a head of an oral care
implement of FIG.
I;
[15] Figure 3 is a plan view of the oral care implement of FIG. 1 illustrating
a tongue
cleaning feature;
[16] Figure 4 is a partial section view of a head of the oral care implement
of FIG. 1 taken
along line 4-4 of FIG. 3;
[17] Figure 5 is a plan view of the oral care implement of FIG. 1 illustrating
at least one
tooth cleaning configuration;
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[18] Figure 6 is a perspective of the view of the oral care implement
illustrating example
tooth cleaning elements; and
[19] Figure 7 is a section view of an alternative construction of the head of
an oral care
implement.
DETAILED DESCRIPTION OF THE INVENTION
[20] In the following description, the invention is discussed in terms of a
toothbrush, but
could be in the form of other oral care implements including simply a tissue
cleansing
implement. Further, it is to be understood that other embodiments may be
utilized
and structural and functional modifications may be made without departing from
the
scope of the present invention.
[21] Figures 1-7 illustrate an oral care implement, such as a toothbrush 100,
having a
handle 103 and a head 105 which may be used for cleaning the teeth and soft
tissue in
the mouth, such as the tongue, interior surfaces of the cheeks, lips or the
gums.
Handle 103 is provided for the user to readily grip and manipulate the
toothbrush, and
may be formed of many different shapes and constructions. While the head is
normally widened relative to the neck of the handle, it could in some
constructions
simply be a continuous extension or narrowing of the handle. In the preferred
construction, head 105 has a first face 106 that supports tooth cleaning
elements 107
(FIGS. 5 and 6) and a second face 108 that supports a tissue cleanser 300
(FIGS. 2
and 3). The first and second faces 106, 108 are preferably on opposite sides
of head
105. Nevertheless, tissue cleanser 300 may be mounted elsewhere, such as the
proximal end 104 of handle 103. The tissue cleanser 300 or portions of it may
also be
located on the peripheral sidewall surface 101 of head 105 or extend farther
towards
the proximate end 104 of handle 103 than illustrated.
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[22] The elastomeric material of tissue cleanser 300 may be any biocompatible
resilient
material suitable for uses in an oral hygiene apparatus. To provide optimum
comfort
as well as cleaning benefits, the elastomeric material preferably has a
hardness
property in the range of A8 to A25 Shore hardness. As an example, one
preferred
elastomeric material is styrene-ethylene/butylene-styrene block copolymer
(SEBS)
manufactured by GLS Corporation.
Nevertheless, SEBS material from other
manufacturers or other materials within and outside the noted hardness range
could be
used.
[23] Tissue cleanser 300 is preferably configured with a multiplicity of
tissue engaging
elements 303 (FIGS. 1-4), which in the preferred construction are formed as
nubs. As
used herein a "nub" is generally meant to include a column-like protrusion
(without
limitation to the cross-sectional shape of the protrusion) which is upstanding
from a
base surface. In a general sense, the nub, in the preferred construction, has
a height
that is greater than the width at the base of the nub (as measured in the
longest
direction). Nevertheless, nubs could include projections wherein the widths
and
heights are roughly the same or wherein the heights are somewhat smaller than
the
base widths. Moreover, in some circumstances (e.g., where the nub tapers to a
tip or
includes a base portion that narrows to a smaller projection), the base width
can be
substantially larger than the height.
[24] Such tissue engaging elements 303 are designed to significantly reduce a
major source
of bad breath in people and improve hygiene. Nubs 303 enable removal of
microflora
and other debris from the tongue and other soft tissue surfaces within the
mouth. The
tongue, in particular, is prone to develop bacterial coatings that are known
to harbor
organisms and debris that can contribute to bad breath. This microflora can be
found
in the recesses between the papillae on most of the tongue's upper surface as
well as
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along other soft tissue surfaces in the mouth. When engaged or otherwise
pulled
against a tongue surface, for example, nubs 303 o f elastomeric tissue
cleanser 300
provide for gentle engagement with the soft tissue while reaching downward
into the
recesses of adjacent papillae of the tongue. The elastomeric construction of
tissue
cleanser 300 also enables the base surface 301 to follow the natural contours
of the
oral tissue surfaces, such as the tongue, cheeks, lips, and gums of a user.
Moreover,
the soft nubs 303 are able to flex as needed to Inverse and clean the soft
tissue
surfaces in the mouth along which it is moved.
[25] As seen in Figure 2 and 4, in one preferred arrangement of tissue
cleanser 300, nubs
303 are preferably conically shaped. As used herein, "conically shaped" or
"conical"
is meant to include true cones, frusto-conically shaped elements, and other
shapes that
taper to a narrow end and thereby resemble a cone irrespective of whether they
are
uniform, continuous in their taper, or have rounded cross-sections. With
reference to
Figure 4, the base portion 305 of each conically shaped tissue engaging
element 303
is larger than the corresponding tip portion 307. In this conically shaped
configuration, the base portion 305 has a wider cross-sectional area to
provide
effective shear strength to withstand the lateral movement of the tissue
cleanser 300
along the surface of the tongue or other soft tissue surface. The smaller
width or
diameter of the tip portion 307 in conjunction with the length of the
conically shaped
nub 303 enable the nubs to sweep into the recesses of the tongue and other
surfaces to
clean the microbial deposits and other debris from the soft tissue surfaces.
In the
preferred construction, nubs 303 are able to flex and bend from their
respective
vertical axes as lateral pressure is applied during use. This flexing enhances
the
comfort and cleaning of the soft tissue surfaces. In a preferred construction,
the
thickness or width of the base of the nub in 0.64 mm, and preferably within
the range -
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from about _ 0.51 mm to about 2.00 mm. Tip 307 of the nubs is 0.127 mm and
preferably within a that range from about 0.10 mm to about 0.75 mm for optimal
penetration between the recesses of papillae of a user's tongue. The length or
height
of nubs 303, as measured from base surface 301 to tip 307, is preferably 0.91
mm and
preferably within range from about 0.5 mm t o about 2.5 mm, and most
preferably
range between 0.75 mm to 1.5 mm. Nevertheless, nubs of other sizes and shapes
outside the given ranges can be used.
[26] Alternatively, the tissue cleaning elements 303 may have other shapes. As
one
example, the tissue cleanser may have a grated form such as described in co-
pending
U.S. Patent Application Publication No. 2004/0255416.
[27] In a preferred construction, nubs 303 are disposed on the base surface
301 of tissue
cleanser 300 in a high density pattern. Each nub 303 is preferably spaced
apart from
adjacent nubs 303 between a range of about 0.5 mm to about 3 mm; more
preferably
the spacing ranges between 0.7 mm to 2.5 mm, and most preferably between 1 ram
to
2 mm. Nevertheless, other spacing ranges are possible. The surface density of
the
nubs 303 on base surface 301 ranges preferably from about 100 to about 600
nubs per
square inch. In a more preferred construction of the tissue cleanser, the
surface
density may range from 200 to 500 nubs per square inch, and most preferably
between 300 to 450 nubs per square inch. In one preferred example, tissue
cleanser
300 includes about 400 nubs p er s quare inch o f s urface area. The surface
density
features in conjunction with the height of the nubs 303 enables the tissue
cleanser to
provide enhanced cleaning of the soft tissue surfaces with improved comfort.
Nonetheless, other surface densities are possible.
[281 As seen in Figure 3, nubs 303 are preferably disposed in longitudinal
rows in a
direction generally parallel to the longitudinal axis a-a. Further, nubs 303
are
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disposed in transverse rows R1, R2 on an axis parallel to base surface 301 and
generally p erpendicular to the longitudinal axis a-a. In one p referred
construction,
adjacent nubs 303 are provided on the base surface 301 in a staggered
arrangement.
For example, adjacent transverse rows of nubs R1 and R2 have nubs 303 that are
not
directly behind each other. A first nub is said herein to be "directly behind"
second
nub when it is located within the lateral bounds of the second nub extending
in a
longitudinal direction. This configuration enables improved cleaning of the
soft tissue
surfaces by facilitating the removal of micro flora and other debris, and
especially
from the recesses of adjacent papillae of the tongue. Nonetheless, the nubs
could be
arranged randomly or in a myriad of different patterns.
[29] Tongue cleanser 300 is preferably formed by being molded to head 105,
although
other manufacturing processes could be used. With reference to Figures 1 and
4,
tissue cleanser 300 is preferably molded within a basin or a receiving cavity
111 in
face 108 of head 105. The receiving cavity 111 has a lower base surface 113
and a
peripheral sidewall 115 extending away from the lower base surface 113. In one
mounting arrangement, nubs 303 of the tissue cleanser 300 are exposed for use
with
the base surface of the tissue cleanser 300 being flush or recessed relative
to the
surface 114 o f t he head. N evertheless, other orientations are possible.
Also, base
surface 301 of the tissue cleanser could be embedded in head 105 or covered by
another layer with nubs 303 projecting through appropriate openings.
[30] As can be seen in Figures 1 and 4, face 108 also preferably includes one
or more peg
members 117a-c disposed within basin 111. Peg members 117 form anchor points
against the opposing mold to prevent the head from moving under the pressure
of the
injection molding. As a result, tissue cleanser 300 preferably includes one or
more
complementary apertures 311a-c which exposes the tops of peg members 117a-c.
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Although, the pegs are illustrated in alignment along the centerline of the
head (e.g.
longitudinal axis a-a), the pegs could have many different positions. Further,
the pegs
and basin are preferably both included with head 105, but either could be used
without the other.
[31] Alternatively, basin 111 and peg members 117a-c may be provided to
position and
hold a previously molded tissue cleanser, although these constructions are not
necessary to use such a previously molded tissue cleanser.
[32] Peg members 117a-c may take on a variety of shapes and lengths. With
continued
reference to the Figures 1 and 4, head 105 includes peg members 117a-c
extending
away from the lower base surface 113 of basin 111 to the height of the
peripheral
sidewall 115. The peg members 117a-c are shaped in the form of a cylinder, but
other shapes and lengths of the peg members 117a-c are possible. While the
molding
process would preferably bond the tissue cleanser to the head, the tissue
cleanser
could be performed and attached by adhesive or other known means.
[33] As shown in Figures 1-4, tissue cleanser 300 is preferably formed as a
pad composed
of a soft and pliable elastomeric material for comfortable cleaning and
effective
removal of bacteria and debris disposed on the surface of the tongue, other
soft tissue
in the mouth and even along the lips. The tissue cleanser 300 also provides
effective
massaging, stimulation and removal of bacteria, debris and epithelial cells
from the
surfaces of the tongue, cheeks, gums or lips.
[34] In the p referred c onstruction (FIGS. 1 -6), tissue cleansers 300 in ay
rub against the
inside surfaces of the cheeks or lips, and on the sides of the tongue while
the user
brushes his or her teeth, and thus provide a desired massaging, stimulation
and
cleaning of various soft tissue surfaces within the mouth. For example, during
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=
brushing of the facial tooth surfaces, tissue cleanser 300 is disposed on the
outer face
108 of head 105 to naturally rub against the oral surfaces of the cheek. As a
result,
enhanced cleaning is attained without additional cleaning steps. Further, some
users
may sense a stimulating tingle on the cheek surfaces that leads to a positive
user
reaction, and even enjoyment of the comfortable feel of the tissue cleanser
along the
soft tissues surfaces in the mouth. Tissue cleanser 300 may also be
additionally
rubbed on the cheeks, tongue, etc. as desired for further cleaning aside from
the
contact that may occur while brushing the teeth.
1351 Referring to Figures 5 and 6, the tooth cleaning elements 107 of head 105
may
include a variety of tooth cleaning elements which can be used for wiping,
cleaning
and massaging the user's teeth and gums. Any suitable form of tooth cleaning
elements may be used. The term "tooth cleaning elements" is used in a generic
sense
which refers to filament bristles or elastomeric fingers or walls that have
any desirable
shape. In the illustrated example of Figure 5, tooth cleaning elements 107
include
distal tooth cleaning elements 203a-b disposed at a distal tip 121 of head
105,
peripheral tooth cleaning elements 205a-1, longitudinal tooth cleaning
elements 207a-
c disposed along longitudinal axis a -a, arcuate tooth cleaning elements 209a-
d and
211a-b, and proximal cleaning elements 213a,b. Tooth cleaning elements 205,
207,
211 and 213 are preferably provided as tufts of bristles whereas tooth
cleaning
elements 209 are preferably formed as elastomeric walls. Nevertheless, other
forms
and types of tooth cleaning elements may be used.
[36] Figure 7 illustrates a sectional view of an alternative arrangement of a
head 400 of a
= toothbrush. Head 400 is similar in construction to head 105, except that
tooth
cleaning elements 209a-d are integrally formed with tissue cleanser 300. To
accomplish the alternative construction, head 400 has appropriately sized
ports or
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=
openings 401 to allow the elastomeric material to flow through the head during
an
injection molding process. In this construction, tooth cleaning elements 209a-
d and
tissue cleaner 300 are formed with the same elastomeric material. Thus, head
400
may include at least one elastomeric tooth cleaning element formed as a
unitary
member with tissue cleanser 300.
[37] As various changes could be made in the above methods, compositions and
structures
without departing from the scope of the invention, it is intended that all
matter
contained in this application, including all mechanisms and/or modes of
interaction
described above, shall be interpreted as illustrative only and not limiting in
any way
the scope of the appended claims.
[38] The following examples are set forth as representative of the improved
operation of
the present invention. These examples are not to be construed as limiting the
scope of
the invention.
EXAMPLE 1
[39] The performance nature of a toothbrush can be measured using known oral
malodor
assessment methods. A study was conducted to evaluate the performance of a
toothbrush provided with an elastomeric tissue cleanser having conically
shaped nubs,
such as the preferred c onstruction of toothbrush 100 discussed above. Human
test
subjects participated in the study. There was a washout or normalization
period prior
to testing of about 7 days in which the test subjects brushed twice a day with
a
fluoride dental cream (see Table 1). After the washout period, the test
subjects were
asked to refrain from any oral hygiene (brushing, rinsing, and flossing),
eating and
drinking prior to oral testing. A baseline volatile sulfur compound (VSC)
sample
was taken from each of the test subjects. In the study for overnight odor
control, the
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test subjects brushed their teeth for one minute with a fluoride dental cream
(see Table
1) using toothbrush 100 provided with the above noted tissue cleanser 300.
Subsequently, the subjects cleaned their tongue surface with the tissue
engaging
elements of the toothbrush for ten seconds. The test subjects slept overnight
and
returned for post treatment. VSC samples were taken at the ten-hour time point
from
the previous day cleaning. In the illustrative example, use of the toothbrush
reduced
oral VSC about 60% verses brushing the teeth alone as measured from a baseline
ten
hours after use. The VSC readings were obtained by gas chromatography.
EXAMPLE 2
[401 In another study of the above-noted toothbrush 100, there was a washout
or
normalization period prior to testing of about 7 days which the test subjects
brushed
twice a day with a fluoride dental cream (see Table 1). The test subjects were
asked
to refrain from any oral hygiene (brushing, rinsing, and flossing), eating and
drinking
before testing. After the washout period, the test subjects provided a
baseline tongue
bacteria sample by swabbing a side of the back o f the tongue with a sterile
cotton
swab. The test subjects brushed their teeth with a fluoride dental cream (see
Table 1)
for one minute with the toothbrush having the above-noted tissue cleanser.
Subsequently, the test subjects cleaned their tongue surface with a preferred
construction of the tissue engaging elements 300 of the toothbrush 100 for ten
seconds. Two hours after the cleaning of the tongue surface, a tongue bacteria
sample
was taken from a side of the back of the tongue with a cotton swab. In the
illustrative
example, use o ft he tissue engaging elements c ontrolled more o dor causing
tongue
bacteria than simply brushing the teeth alone. Use of the tissue cleanser 300
demonstrated a tongue bacteria log reduction of over 0.8 Log colony forming
units/ml
two hours after use on the tongue
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=
EXAMPLE 3
1411 In another study of the above-noted toothbrush, a MTT assay was used to
examine the
viability of the epithelial cells collected from the oral cavity prior to and
after the use
of the toothbrush with the noted tissue cleanser. The MTT Assay was based on
the
enzymatic reduction of the tetrazolium salt MTT [3-(4,5-dimethylthiazol-2-y1)-
2,5-
diphenyl-tetrazoliumbromide -H- +] in living, metabolically active cells. The
reaction
was carried out in situ in test tubes, and the reaction product, a purple-
colored
formazan soluble in dimethylsulfoxide, was measured colormetrically using a
multiwell plate reader. Advantageously, the MTT Assay offers a high degree of
precision, ease of use, and suitability for the purpose for large scale
chemosensitivity
testing.
[42] Following a 7-day washout period, the test subjects reported to a test
site without
prior eating, drinking, or performing oral hygiene. The test subjects provided
salivary
rinse samples by rinsing their oral cavity with 9 ml of sterile water for 10
seconds and
then discharging the water from the rinse into a tube containing 10x sterile
phosphate
buffered saline(PBS) solution. The samples were refrigerated for approximately
30
minutes before the MTT Assay was run. The test subjects brushed their teeth
under
supervision for one minute using a fluoride dental cream (see Table 1)
followed by 10
seconds of tongue cleaning with the tongue cleanser 300 of the preferred
construction.
Approximately 30 minutes after brushing and tongue cleaning, the test subjects
provided a rinse sample in the manner described previously.
[43] The pre-rinse samples and post-rinse samples were centrifuged for 15
minutes at
about 3000 RPM. The supernatant, e.g., clear liquid, was removed and the
pellet was
resuspended in 2.5 mL of PBS. The samples were vortexed for 5 seconds, then
2.5 ml =
of MIT Solution was added. The samples were subsequently incubated in a gently
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shaking waterbath set at 37 C for 2 hours. Following the 2 hour incubation
period,
the samples were centrifuged for 15 minutes at about 3000 RPM. The
supematatant
was siphoned out and 3 mL of detergent (0.04 N Acid Isopropanol) was added to
dissolve purple crystals. An increase or decrease in MTT conversion was
spectrophotometrically quantified. From each sample, 200 111 of each was added
to
96 well plates and the optical density was measured at 570 nm and compared to
a
negative buffer control. In the illustrative example, one minute of brushing
followed
by 10 seconds of use of the tissue cleanser reduced oral epithelial cells
about 72% as
determined by a MTT assay protocol.
EXAMPLE 4
[44] In another study, human test subjects provided baseline VSC samples via a
HalimeterTm (i.e., a sulfide meter). A HalimeterTm uses an electrochemical,
voltammetric sensor which generates a signal when it is exposed to VSC such
as,
sulfide and mercaptan gases and measures the concentration of hydrogen sulfide
gas
in p arts p er billion. The test subjects b rushed their teeth under
supervision for one
minute with the preferred construction of a toothbrush having the above noted
tissue
cleanser. The; the test subjects used the noted toothbrush to provide six
strokes on
the tongue surface. A subsequent VSC sample was taken from the test subjects
two
hours after the brushing stage. In this illustrative example, use of a
toothbrush with
the tissue cleanser reduced the measured VSC in the mouth odor over 35% from a
baseline measured two hours after use.
EXAMPLE 5
- [45] In one other study, after a washout period, human test subjects
rinsed their mouths
with sterile water to provide a baseline sample for viable epithelial cell
analysis with
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the MTT assay. The subjects brushed their teeth under supervision for one
minute
with the preferred construction of the toothbrush having the above-noted
tissue
cleanser. Then, the test subjects used the tissue cleanser to provide six
strokes on the
tongue surface. The test subjects provided a post rinse sample for analysis.
The
samples were tested and analyzed in the manner as discussed with respect to
Example
3. In this example, use of the toothbrush reduced oral epithelial cells by
about 92%
from a baseline as determined by MTT assay protocol.
[46] In the above noted examples, the subjects brushed their teeth using a
fluoride dental
cream with the formulation in Table 1.
% wt. Ingredient
48.76% Dicalcium Phosphate Dihydrate
22.0063% Water
22.00% Glycerin
4.138% S03 Sodium Lauryl Sulfate base ¨29%
1.000% Sodium CMC ¨ 7MF ¨ Food Grade
0.89% 105 Dental Cream Flavor
.76% Sodium Monofluorophosphate
.25% Tetrasodium Pyrophosphate
.20% Sodium Saccharin
Table 1
