Note: Descriptions are shown in the official language in which they were submitted.
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LASER ASSISTED PERIODONTIUM AND OSSEUS REGENERATION PROTOCOL
by
Margaret V. Kalmeta
CROSS REFERENCES
This application claims priority to United States Continuation-In-Part Patent
Application
No. 13/864,226 filed April 16, 2013, which claims the benefit of priority
under 35 U.S.C. 120
from United States Patent Application No. 13/078,757 filed April 4, 2011, the
entire contents of
which are herein incorporated by reference.
FIELD OF THE INVENTION
The present invention relates generally to a method of treating gum diseases
using a soft
tissue diode laser which produces a beam of light having a wavelength in the
visible portion of
the electromagnetic spectrum (400nm ¨ 700nm). Optionally, the laser light
utilizes green
wavelength range (520¨ 570 nm) at a laser power of 0.5 to 1.2 watts to treat
gum disease.
BACKGROUND OF THE INVENTION
Laser Assisted Periodontium And Osseus Regeneration (LAPOR) is a protocol
which is
laser assisted with the use of a substrate such as but not limited the LAPOR
periodontal solution,
the LAPOR periodontal gel and the LAPOR substrate and thus causes an increase
in cell
attachment of epithelial cells, gingival fibroblasts, PDL fibroblasts and
adhesion of osteogenic
cells. This protocol has shown to increase the expression of transcription
factors related to the
differentiation of osteoblasts/ cementoblasts as well as chondroblasts.
Enhanced cell migration
and proliferation appears to lead to accelerated wound fill rates in vitro
using PDL fibroblasts,
gingival fibroblasts and osteoblast-like cells.
A substrate such as the LAPOR periodontal solution, the LAPOR periodontal gel
and the
LAPOR substrate, used in the LAPOR protocol, stimulates total protein
synthesis and the
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synthesis of specific extracellular matrix molecules. Studies that evaluate
the bone remodeling
regulation system indicate that enamel matrix proteins influence this by
modulating the OPG and
RANK! expression, thus indicating an indirect involvement in the bone
remodeling process.
The soft tissue diode laser used produces a beam of light having a wavelength
in the
visible portion of the electromagnetic spectrum (400nm ¨ 700nm). Optionally, a
beam of light
having a wavelength in the green wavelength range (520 ¨ 570 nm) at a laser
power of 0.5 to 1 .2
watts is used in the LAPOR protocol. It has been shown by the LAPOR protocol
to biostimulate
the healing and regenerative processes of the periodontium, including the
biostimulation of new
bone and its supporting elements. Previous studies have shown a positive
healing effect of low
power laser therapy (infrared range of a soft tissue diode laser) on tissue
repair. Low power
lasers, in the infrared range, have been shown to positively affect several
indices of tissue repair.
They biostimulate wound healing by acceleration of collagen synthesis,
acceleration of
inflammation, decrease of healing time, acquisition of strength. They
biostimulate regeneration
of tissue via elevated metabolic indices of ATP synthesis, elevated fibroblast
proliferation,
elevated collagen synthesis and increased indices of biomechanical aspects of
tissue healing. The
soft tissue diode laser used in the LAPOR protocol, biostimulates the healing
response of the
periodontium nonsurgically, and biostimulates the tissue regeneration of the
periodontium,
nonsurgically, and prevents long junctional epithelium from migrating
downwards into the
sulcus (a biomechanical aspect of tissue healing), thereby preserving the
tissue height. A soft
tissue diode laser used in the LAPOR protocol helps a substrate such as but
not limited to enamel
matrix proteins to stimulate total protein synthesis and the synthesis of
extracellular matrix
molecules, nonsurgically.
SUMMARY OF THE INVENTION
In an exemplary embodiment of the present invention, there is disclosed a
method of
treating gum disease using a soft tissue diode laser which generates a beam of
light having a
wavelength in the visible portion of the electromagnetic spectrum (400nm ¨
700nm). Optionally,
a beam of light having a wavelength in the green range (520 ¨ 570 urn) at a
laser power of 0.5 to
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1.2 watts is used to decontaminate the gum tissue and to biostimulate healing
and regenerate the
periodontium (including cementurn of the root surface), thus preventing long
junctional
epithelium from migrating downwards into the sulcus and thereby preserving the
tissue height.
The soft tissue diode laser also biostimulates the healing and regenerative
response induced by a
substrate, i.e. the LAPOR periodontal solution, the LAPOR periodontal gel and
the LAPOR
periodontal substrate, the method comprising: 1) placing the laser inside the
sulcus; 2)
penetrating the entire sulcus by moving the laser light intermittently
vertically and horizontally
throughout the sulcus; and 3) placing the substrate in the sulcus prior to a
blood clot forming
(which then increases cell attachment, adhesion, migration and proliferation).
In another embodiment of the present invention, there is disclosed a
root/bone/cartilage
conditioner comprised of EDTA 15%, calcium gluconate 20%, methylparaben,
propylparaben,
Ethanolamine as a buffering agent, carboxymethyleellulose, and green food
coloring and sterile
water.
In still another embodiment of the present invention, there is disclosed a
first substrate
comprised of: a combination of mono or disodium phosphate and sodium hydroxide
in solution
with a sodium content of 11mg/100g; 60% water; 9% Lysine; 9% Proline; 9% all
other essential
amino acids wherein the amino acids are chosen from the group consisting of
Isoleucine,
Leucine, Methionine, Phenylalanine, Threonine, Ttyptophan, Valine, Histadine,
Asparagine and
Selenocysteine; 2% of all other non-essential amino acids wherein the amino
acids are chosen
from the group consisting of Alanine, Arginine, Aspartate, Cysteine,
Glutamate, Glutamine,
Glycine, Serine, Tyrosine and Pyrrolsine; 6.9% free bases wherein the free
bases are chosen
from the group consisting of adenosine, uridine, guanosine, iridin and
cytidine; 2% phosphates
wherein the phosphates are chosen from the group consisting of ADP, ATP and
acetycholine;
and 1% benzoic acid at a pH of 7.45.
In still another embodiment of the present invention, there is disclosed a
second substrate
comprised of: tricalcium phosphate wherein the tricalcium phosphate is
precipitated with
calcium hydroxide/Claw oil; and hydroxyapatite crystals.
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The more important features of the invention have thus been outlined in order
that the
more detailed description that follows may be better understood and in order
that the present
contribution to the art may better be appreciated. Additional features of the
invention will be
described hereinafter and will form the subject matter of the claims that
follow.
Before explaining at least one embodiment of the invention in detail, it is to
be
understood that the invention is not limited in its application to the details
of construction and the
arrangements of the components set forth in the following description or
illustrated in the
drawings. The invention is capable of other embodiments and of being practiced
and carried out
in various ways. Also it is to be understood that the phraseology and
terminology employed
herein are for the purpose of description and should not be regarded as
limiting.
As such, those skilled in the art will appreciate that the conception, upon
which this
disclosure is based, may readily be utilized as a basis for the designing of
other structures,
methods and systems for carrying out the several purposes of the present
invention. It is
important, therefore, that the claims be regarded as including such equivalent
constructions
insofar as they do not depart from the spirit and scope of the present
invention.
The foregoing has outlined, rather broadly, the preferred feature of the
present invention
so that those skilled in the art may better understand the detailed
description of the invention that
follows. Additional features of the invention will be described hereinafter
that form the subject
of the claims of the invention. Those skilled in the art should appreciate
that they can readily use
the disclosed conception and specific embodiment as a basis for designing or
modifying other
structures for carrying out the same purposes of the present invention and
that such other
structures do not depart from the spirit and scope of the invention in its
broadest form.
BRIEF DESCRIPTION OF THE DRAWINGS
Other aspects, features, and advantages of the present invention will become
more fully
apparent from the following detailed description, the appended claim, and the
accompanying
drawings in which similar elements are given similar reference numerals.
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FIG. 1 shows an X-Ray view of a patient's teeth before treatment with a soft
tissue diode
laser before a substrate has been applied.
FIG. 2-7 show X-Ray views of the lower teeth of FIG. 1 after treatment with a
soft tissue
diode laser after treatment with a substrate.
FIG. 8 shows an X-Ray view of the upper teeth before treatment with a soft
tissue diode
laser after treatment with a substrate.
Fig. 9 shows an X-ray view of the upper teeth of Fig. 8 after treatment with a
soft tissue
diode laser after treatment with a substrate.
Fig. 10 shows a flow diagram of a method of using a soft tissue diode laser to
treat gum
disease in accordance with the principles of the invention.
Fig. 11 shows bone density measurements for tooth 15 of a patient at 12 loci
on the tooth
following treatment with a soft tissue diode laser and a substrate over time.
Fig. 12 shows bone density measurements for tooth 28 of a patient at 17 loci
on the tooth
following treatment with a soft tissue diode laser and a substrate over time.
Fig. 13 shows bone density measurements for tooth 2, tooth 3 and tooth 15 of a
patient at
3 loci per tooth following treatment with a soft tissue diode laser and a
substrate over time.
Fig. 14 shows X-rays of tooth 15 of a patient from which measurements shown in
Fig. 11
were collected. (a) shows tooth 15 before treatment. (b) shows tooth 15 at the
October 2011
measurement following three treatments.
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Fig. 15 shows X-rays of tooth 28 of a patient from which measurements shown in
Fig. 12
were collected. (a) shows tooth 28 before treatment. (b) shows tooth 28 at the
January 2011
measurement following four treatments.
Fig. 16 shows a panoramic X-ray of tooth 2, tooth 3 and tooth 15 of a patient
from which
measurements shown in Fig. 13 were collected. (a) shows the teeth before
treatment. (b) shows
the teeth at the July 2011 measurement.
DETAILED DESCRIPTION OF THE INVENTION
Definitions
As used herein, the term "gum disease" means periodontal disease which can
lead to
tooth loss and/or other health problems. Examples of periodontal disease
include gingivitis,
aggressive periodontitis, chronic periodontitis, periodontitis as a
manifestation of systemic
diseases, and necrotizing periodontal disease.
As used herein, the term "patient" means any individual suffering from a
disease of the
gums and in need of treatment for said gum disease.
As used herein, the term "locus" means an exact point of measurement within
the sulcus
or the immediate surrounding area.
As used herein, the term "substrate mixture" means the mixture of the first
substrate and
the second substrate disclosed herein for treatment of gum disease.
As used herein, the term "bone regeneration" means increasing the density of
calcium at
specific loci in or around the sulcus.
As used herein, the term "calcium density" means the measurement of calcium
mass
around a given loci.
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The LAPOR protocol can be used in the treatment of gum disease by combining
the most
effective methods of treatment with the use of a special laser. Approximately
66% of the United
States population has some form of gum disease. But many avoid seeking
treatment because of
the discomfort that often results from gum surgery. LAPOR provides a new
choice. The LAPOR
protocol is a treatment that is more effective as traditional periodontal
surgery, and it is much
more beneficial to the patient both in the short term and in the long run.
The LAPOR protocol takes only about an hour and only two short follow-up
visits.
Patients enjoy no downtime with recovery taking only 24 hours. This makes
immediate return to
work both possible and comfortable.
After having the LAPOR protocol performed, gum recession is minimal to none
when
compared to that which most often follows normal periodontal surgery. This,
combined with new
cementum formation on the roots, bone formation in previous defects,
periodontal ligament
formation tooth loss.
The special type of laser used in the LAPOR protocol is the diode, a
semiconductor
coherent light beam used on soft tissues. The laser light used has a
wavelength in the visible
portion of the electromagnetic spectrum, between 400nm ¨ 700nm wavelength.
Optionally, the
green range (520 ¨ 570 nrn) of the visible spectrum is utilized at a laser
power of 0.5 to 1.2 watts,
which disinfects the site, leaving the gum tissue bacteria free, and
biostimulates healing; in
conjunction with treatment with a substrate, the laser bio stimulates
regeneration of the
peiiodontium. Traditional periodontal therapy removes tissue height of a tooth
to reduce the
pocket depths. The LAPOR protocol is a regenerative procedure. The patient
does not lose tissue
volume. Tissue volume is increased and bone is regenerated.
The green wavelength is ideally suited for soft tissue procedures since it is
highly
absorbed by hemoglobin and melanin. This gives the diode laser the ability to,
in this case, target
the soft tissues.
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The use of the diode laser in conjunction with routine scaling and root
planning is more
effective than scaling and root planning alone. It enhances the speed and
extent of the patients
gingival healing and postoperative comfort. This is accomplished through laser
bacterial
reduction and biostimulation with a laser light having a wavelength in the
visible portion of the
electromagnetic spectrum, between 400mn 700nrn wavelength. Optionally, the
green range
(520 ¨ 570 nm) of the visible spectrum is utilized at a laser power of 0.5 to
1.2 watts.
Referring to FIG. 10, there is disclosed a method 10 of using a soft tissue
diode laser
which produces a beam of light, used intermittently, having a wavelength in
the visible portion
of the electromagnetic spectrum, between 400nm ¨ 700nm wavelength. Optionally,
the green
range (520 ¨ 570 nm) of the visible spectrum is utilized at a laser power of
0.5 to 1.2 watts to
treat gum disease. Starting at block 12, a perio probe determines the degree
of excessive pocket
depth and thus helps the dentist better identify diseased tissue and areas of
bacterial infection.
The dentist removes tartar from the root surface using an ultrasonic scaler
and hand instruments,
block 14. This action by the dentist helps stimulate a healing response in the
sulcus by opening
up the capillaries upon scaling. Going to block 18, the laser tip is placed
inside the sulcus and a
continuous light beam with intermittent stops for tissue temperature control
is allowed to
penetrate the entire sulcus by moving the tip vertically and horizontally
throughout the sulcus.
The laser tip is cut at a 45 degree angle during the first pass. The laser is
cut at the opposite 45
degree angle during the second pass. This allows for the laser beam to
penetrate the existing
periodontium to decontaminate the tissue, as the heat of the targeted laser
light kills the bacteria.
This also allows for biostimulation of the sulcular contents. At block 20, the
dentist scales the
sulcular area and root surfaces once again to induce a healing response
through renewed blood
flow. Going to block 22, a substrate, such as but not limited to enamel matrix
proteins, is then
placed in the sulcus of the tooth prior to the blood clot forming and at block
24, a blood clot is
carefully allowed to form by gently helping patient keep their mouth open for
5 minutes, to keep
the substrate intact.
The LAPOR protocol is much less invasive than traditional surgery and offers
advantages
and benefits over its counterpart. Recovery time is much faster because most,
if not all, damage
to healthy tissue is avoided through the use of more advanced technology.
Because the LAPOR
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protocol leaves healthy tissue intact, the height of the gums themselves
around the teeth is much
better preserved. The LAPOR protocol prevents long junctional epithelium from
migrating
downwards into the sulcus, thus preserving the tissue height and allowing for
the regeneration of
the periodontium.
Firstly, the root conditioner is applied to the sulcus. The root conditioner
comprises the
following at Table 1:
Table 1
Component
EDTA 20-25g.
Calcium gluconate 10-20 g.
Methylpara ben .1-.9 g.
Pro pylpa ra be n .01-.1 g.
Ethanolamine 2-8 mis.
Ca rboxymethylce II u lose 2-10 g.
Green food coloring 1-2 drops
Sterile water 100 mls.
The conditioner is optionally rinsed out prior to application of additional
substrates or
laser light. Alternatively, the conditioner is left in the sulcus, with the
laser light being applied
prior to application of any substrate. In an alternative embodiment, the
conditioner is left in with
only one substrate applied prior to application of the laser light.
Optionally, the conditioner is left
in the sulcus and substrate is added prior to any application of laser light.
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The placement of the substrate into the sulcus containing luminesced blood
enables the
lumineseed blood to coagulate upon the substrate. The substrate contains
building blocks for
protein synthesis as well as substances used as energy for protein synthesis.
The substrate also
contains hard components that are able to be used by the body as a "lattice"
for regeneration.
The substrate also contains a slow release pH increasing agent to increase the
pH for optimal
regeneration while not "startling" the body such that it will have a negative
reaction to the
substrate.
Optionally, the liquid substrate is comprised of the following, per 1L of
solution, at Table
2:
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Table 2
Essential %
Amino Acids
Isoleucine 1.125
Leucine 1.125
Methionine 1.125
Phenylalanine 1.125
Threonine 1.125
Tryptophan 1.125
Valine 1.125
Histidine 1.125
Lysine 9
Non
Essential %
Amino Acids
Alanine 0.25
Arginine 0.25
Aspartate 0.75
Glutamate 0.25
Glycine 0.25
Serine 0.25
Proline 9
Phosphates %
ADP 0.667
ATP 0.667
Acetylcholine 0.667
Free Bases %
Adenosine 1.725
Uridine 1.725
Guanosine 1.725
Cytidine 1.725
Benzoic Acid 1
Sodium
1.1
Chloride
Sterile water 60
Total: 100
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Optionally, the total sterile water component is adjusted 20% up or down,
depending on
the desired viscosity to be achieved.
In an alternative embodiment, the liquid substrate is comprised of the
following, at Table
3:
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Table 3
Essential
Grams
Amino Acids
Isoleucine 11.25
Leucine 11.25
Methionine 11.25
Phenylalanine 11.25
Threonine 11.25
Tryptophan 11.25
Valine 11.25
Histidine 11.25
Lysine 90
Non-
Essential Grams
Amino Acids
Alanine 2.5
Arginine 2.5
Aspartate 7.5
Glutamate 2.5
Glycine 2.5
Serine 2.5
Praline 90
Phosphates Grams
ADP 7-8
ATP 7-8
Acetylcholine 6-7
Free Bases Grams
Adenosine 13-14
Uridine 13-14
Guanosine 13-14
Cyhdine 13-14
Iridine 13-14
Benzoic Acid 20
Sodium
.1-.9
Chloride
Sterile water .9-1.2L
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Most preferred, the pH of the final solution for the liquid substrate should
be 7.45 with a
tendency to apply a basic pH.
An additional substrate may be applied, the additional substrate comprised of
the
following: a mixture of tricalcium phosphate and hydroxyapatite crystals. The
tricalcium
phosphate is precipitated with CaOH/devil's claw oil, in a preferred
embodiment. Optionally, the
additional substrate include 50% tricalcium phosphate/devil's claw oil
precipitated with 50%
porous hydroxyapatite crystals. The tricalcium phosphate crystals used are
granules in the
following sizes: 10-50 gm, 50-150 gm, 100-300 gm, 500-1000 inn, 1-3mm and 3-6
mm. The
tricalcium phosphate crystals may be dense or porous.
The additional substrate may be comprised of hydroxyapatite crystals of
granules
containing the following sizes: 10-50 gm, 50-150 gm, 100-300 gm, 500-1000 pun,
1-3mm and
3-6 mm. The hydroxyapatite crystals may be dense or porous.
In the following examples, the conditioner is applied and is rinsed out.
Optionally, the
conditioner is left in the sulcus, as the conditioner allowed the micropores
within the tooth
structures to remain open.
After the conditioner is applied, the sulcus is biostimulated with a laser
light. After this
occurs, the liquid substrate is applied. Optionally, the additional substrate
is applied.
Examples
I. Analysis of Tooth #15 at 12 Unique Loci
A patient's pocket depths at tooth 15 were measured at 12 separate loci. The
root of the
tooth was then scaled and planed to remove calculus build up on the root
surface. After scaling
and planning, bleeding occurs in the sulcus. The sulcus was allowed to air dry
and immediately
thereafter the conditioner is applied to the sulcus and left for 30 seconds
before being rinsed with
saline. The tooth was next scaled and planed again to renew blood flow. With
blood pooling in
the sulcus, the 450 laser tip was placed into the sulcus. The laser light used
has a wavelength in
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the visible portion of the electromagnetic spectrum, between 400nm ¨ 700nm
wavelength. The
laser was emitted continuously with only intermittent stops for tissue
temperature control. The
laser was allowed to penetrate the entire sulcus by moving the tip vertically
and horizontally
throughout the sulcus for 30 second. The laser tip was cut to 450 in the
opposite angle for the
second pass into the sulcus and 90' for the third pass to allow the laser bean
to penetrate the
existing periodontium to decontaminate and biostimulate the sulcular contents.
In the meantime, the first substrate and the second substrate were mixed in a
glass dish.
Some of the patient's blood that has been treated with the laser light in the
sulcus was also mixed
in the glass dish. This mixture is then placed immediately into the sulcus
upon mixture. Enough
of the mixture was placed into the sulcus to fill the sulcus while ensuring
the mixture stayed 3
mm below the top of the gingival margin and also remained immersed in blood.
The patient's
mouth was kept open for 5 minutes to ensure the newly formed blood clot
containing the
substrate mixture remained intact.
Treatment was repeated on tooth 15 on four subsequent occasions, at which time
the
pocket depths at each loci were measured prior to treatment. Measurements are
shown in Fig.
11. The data show an increase in calcium density at the specific loci.
IL Analysis of Tooth #12 at 17 Unipue Loci
A patient's pocket depths at tooth 28 were measured at 17 separate loci. The
treatment
disclosed herein was performed on five subsequent occasions, at which time the
pocket depths at
each loci were measured prior to treatment. Measurements are shown in Fig. 12.
The data show
an increase in calcium density across all loci.
III. Analysis of Tooth #2, #3 and #15 at 3 Unique Loci Per Tooth
A patient's pocket depths at tooth 2, tooth 3 and tooth 15 were measured at
three separate
loci per tooth. The treatment disclosed herein was performed 3 months after
the initial treatment,
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at which time the pocket depths at each loci were measured prior to treatment.
Measurements
are shown in Fig. 13. The data show a progression of bone generation.
While there have been shown and described and pointed out the fundamental
novel
features of the invention as applied to the preferred embodiments, it will be
understood that the
foregoing is considered as illustrative only of the principles of the
invention and not intended to
be exhaustive or to limit the invention to the precise forms disclosed.
Obvious modifications or variations are possible in light of the above
teachings. The
embodiments discussed were chosen and described to provide the best
illustration of the
principles of the invention and its practical application to enable one of
ordinary skill in the art to
utilize the invention in various embodiments and with various modifications as
are suited to the
particular use contemplated All such modifications and variations are within
the scope of the
invention as determined by the appended claims when interpreted in accordance
with the breadth
to which they are entitled.
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