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 CA 2842174, which is in turn a divisional of CA
2800233,
which is in turn a divisional of CA 2526826 having a filing date of
= 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 THB INVENTION
=
.
.
=
[02] According to. the American Dental AssoCiation, a major ammo of bad breath
in
= =
healthy people is microbial deposits oh the tongue, where a=bacterial coating
harbors
organisms and debris that c ontribute t o b ad breath. T he t ongno is a haven
for the
growth of microorgahisms since the papillary nature of the tongue surface
creates p.
unique ecological site that provides an extremely large surface area, favoring
the =
= accumulation of oral bacteria. Anaerobic flora and bacteria residing on
the toque
= play an .important role in the development of chronic bad breath commonly
called
halitosis. In general, the bacteria produce volatile sulfur compounds (VSC).
If there is
enough b uildup o fthe ulftir oompounds, the result o an b e I ead b adh reath
o ral
malodor. =
[03] While bladed tongue scrapers have b.eea used in tho .past, these scrapers
are
inadequate in respect to their effectiveness on the soft tissue surface of the
tongue.
=
Broad flat scraping blades are limited in their ability to reach between the
papillae
= where the bacteria and microdebris have collected. 'M oreover,
notwithstanding the
benefits .to be gained by any ability ta clean the tongue,=sOme users avoid
the use of
such blades because Of lack o'f 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
[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.
[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.
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[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.
[11a] Another aspect of the invention relates to 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 means for engaging a
surface of a tongue of a
user, the means for engaging disposed on a second side of the head opposite
the tooth cleaning
elements, the means for engaging configured and adapted for cleansing soft
tissue and having
a different configuration than the bristles; the means for engaging comprising
a soft tissue
.. cleanser comprising conical nubs formed of an elastomeric material, the
conical nubs disposed
on the head in longitudinal rows and transverse rows, wherein adjacent
transverse rows of
conical nubs are in a staggered relationship, the conical nubs having a base
portion, a tip
portion and a substantially circular cross-section, the conical nubs having a
height that is
greater than a width of the conical nubs at the base portion, and wherein the
base portion of
each conical nub is spaced apart from the base portions of adjacent conical
nubs; and a basin
formed in the second side of the head, the soft tissue cleanser disposed
within the basin; and
one or more peg members extending from a lower base surface of the basin, 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.
[11131 Another aspect of the invention relates to an oral care implement
comprising: a
head and a handle, the head having a longitudinal axis; a plurality of tooth
cleaning elements
disposed on a first side of the head and comprising a plurality of filament
bristles and arcuate
elastomeric walls; 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 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 a basin formed
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in the second side of the head, the soft tissue cleanser disposed within the
basin; and a peg
member extending from a lower base surface of the basin and aligned with the
longitudinal
axis of the head, the soft tissue cleanser comprising a complementary aperture
that receives
the peg member.
[11c] Another aspect of the invention relates to an oral care implement
comprising: a
body comprising a handle and a head, the head having a first face, a second
face, and at least
one port extending through the head from the first face to the second face; a
plurality of tufts
of bristles extending from the first face of the head; a soft tissue cleanser
positioned on the
second face of the head, the soft tissue cleanser comprising a pad formed of
an elastomeric
material and a plurality of tissue engaging elements extending from the pad;
and an
elastomeric tooth cleaning element extending from the first face of the head,
the elastomeric
tooth cleaning element integrally formed with the pad and extending through
the port in the
head.
[11d] Another aspect of the invention relates to an oral care
implement comprising: a
body comprising a handle and a head, the head having a first face, a second
face, and a
plurality of ports extending through the head from the first face to the
second face; a plurality
of tufts of bristles extending from the first face of the head; and a
monolithic mass of
elastomeric material coupled to the head, the monolithic mass of elastomeric
material
comprising: a pad having a bottom surface in contact with the second face of
the head and an
exposed top surface; a plurality of protrusions extending from the exposed top
surface of the
pad; and a plurality of elastomeric walls protruding from the first face of
the head, each of the
plurality of elastomeric walls integrally formed with the pad and extending
from the bottom
surface of the pad through one of the plurality of ports.
[11e1 Another aspect of the invention relates to an oral care
implement comprising: a
body comprising a handle and a head, the head extending from a proximal end to
a distal end
along a longitudinal axis, the head having a first face, a second face
opposite the first face,
and a plurality of ports extending through the head from the first face to the
second face, the
first face of the head having a peripheral portion and a central portion that
is inboard of the
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peripheral portion; a plurality of tufts of bristles extending from the first
face of the head; a
monolithic mass of elastomeric material injection molded onto the body, the
monolithic mass
of elastomeric material comprising: a soft tissue cleanser comprising a pad
and a plurality of
tissue engaging elements, the pad having a bottom surface positioned on the
second face of
the head and a top surface opposite the bottom surface, the plurality of
tissue engaging
elements extending from the top surface of the pad; and a plurality of
elastomeric tooth
cleaning elements extending from the first face of the head, the plurality of
elastomeric tooth
cleaning elements integrally formed with the pad, each of the plurality of
elastomeric tooth
cleaning elements extending through one of the plurality of ports; wherein
each of the
plurality of elastomeric tooth cleaning elements forms an elastomeric wall
having a first major
surface and a second major surface opposite the first major surface; wherein
each of the
plurality of tufts of bristles extends a greater distance from the first face
of the head than each
of the elastomeric tooth cleaning elements; wherein at least one of the tissue
engaging
elements is aligned with the longitudinal axis of the head; and wherein a
subset of the
plurality of tufts of bristles is located on the peripheral portion of the
first face of the head and
at least a portion of each of the elastomeric tooth cleaning elements is
located on the central
portion of the first face of the head, the subset of the plurality of tufts of
bristles comprising a
distal tooth cleaning element located adjacent the distal end of the head, a
proximal tooth
cleaning element located adjacent the proximal end of the head, and peripheral
tooth cleaning
elements located between the distal and proximal ends of the head.
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. 1;
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[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
nomially 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 3 03 o f e lastomeric tissue
cleanser 3 00
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 traverse 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 ram, 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 w ithin r Bilge from about 0.5 min to 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 ram; more
preferably
the spacing ranges between 0.7 mm to 2.5 mm, and most preferably between 1 mm
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 per square inch of surface area. T he 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 c
onstruction,
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 microflora 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 ft he head. N evertheless, other orientations are p ossible.
Also, b ase
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 foim 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 preferred construction (FIGS. 1 -6), tissue cleansers 300 may 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.
[35] 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 foim 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 a long longitudinal a xis 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 foimed 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.
[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
139J 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 (sec 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
[40] 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 f t hc tissue engaging elements controlled more odor 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 foi
ming units/ml
two hours after use on the tonguA
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EXAMPLE 3
[41] 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 +-I- +] 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 MTT 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
supernatatant
was siphoned out and 3 iriL 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 1 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 HalirneterTM 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. Then, 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 baying 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 follnulation 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
