AU2019201530B2 - Concurrent treatment of oral and systemic maladies using direct current electricity - Google Patents

Abstract

A method and apparatus for the concurrent treatment of multiple oral diseases and defects while promoting general oral hygiene utilizing direct current electricity. Electrodes are used to deliver a direct current to the gingival tissues of a mouth in order to achieve a number of therapeutic, prophylactic, and regenerative benefits. These benefits include killing oral microbes, increasing oral vasodilation, reducing oral biofilm, improving oral blood circulation, reversing oral bone resorption, promoting oral osteogenesis, treating gum recession, and fostering gingival regeneration. Other benefits include the treatment of gingivitis, periodontitis, and oral malodor, and other systemic diseases correlated with oral pathogens. 3/7 see4 520 5104 Fig.5 Dual Unit 618 820 Second Part of Dual Unit 3SPort Switch (610) 3'W F 3PortSvwitch (610) IO0pA (812) F"AAA" 622 0- ON (614) Of (814) -0 524 ss 14 200pJA(SWO 24 m emMm 2( + Fig. 6 Fig. 6

Description

3/7

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Dual Unit 618 820 Second Part of Dual Unit 3SPort Switch (610) 3'W F 3PortSvwitch (610) IO0pA (812) F"AAA"

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CONCURRENT TREATMENT OF ORAL AND SYSTEMIC MALADIES USING DIRECT CURRENT ELECTRICITY

Cross-Reference to Related Applications This application claims the benefit of co

pending U.S. Serial No. 13/839,513 filed March 15, 2013,

which is a continuation-in-part of U.S. Serial No.

12/205,062 filed September 5, 2008, now U.S. Patent No.

8,660,669, issued February 25, 2014 which is incorporated

herein by reference and which is a continuation-in-part

of now abandoned U.S. Serial No. 11/850,661 filed on

September 5, 2007.

Background This invention relates to a method of

concurrently promoting general oral hygiene, treating

periodontal diseases such as gingivitis and

periodontitis, killing oral microbes including cavity

causing bacteria, reducing oral biofilms, increasing

blood flow in oral tissues, increasing salivation,

promoting gingival tissue regeneration, fostering

osteogenesis in the boney structures of the teeth, mouth

and related areas, treating systemic diseases associated

with oral bacteria, and treating other periodontal and oral maladies through the non-invasive application of weak direct current electricity to the surfaces in the oral cavity, and it also relates to an apparatus suitable for providing direct current electricity for these therapeutic, prophylactic, and regenerative effects.

Periodontal disease has been identified as a risk

factor for various systemic diseases by both dentists

and physicians. Included in these diseases are

cardiovascular disease, adverse pregnancy outcomes, and

diabetes with newfound evidence supporting its

association with pancreatic diseases and arthritis.

While many of the studies establish correlation between

the presence of periodontal disease and these systemic

conditions, causation, with most of these conditions, is

still a subject of ongoing research. A few of the

biological mechanisms which have been proposed as to how

oral bacteria stemming from periodontal disease can cause

systemic disease are as followed:

1. Direct effect of oral infections: Oral

microbes and their byproducts can gain systemic access

via the circulatory system through traveling through

compromised tissue and inflamed periodontium in the oral

cavity. In gaining systemic access, oral microbes have

the potential to directly influence subclinical

mediators of various systemic diseases.

2. Inflammation: People with periodontal disease

have elevated levels of systemic inflammatory markers

due to the burden of increased levels of oral bacteria.

Treatment for periodontal disease has been reported to

decrease systemic inflammation levels.

3. Cross-reactivity: The progression of systemic

diseases can be accelerated by the immune response to

bacterial heat-shock proteins creating antibodies that cross-react with innate heat shock proteins expressed on cells of the damaged tissues.

Cardiovascular Disease Studies investigating the potential association

between periodontal disease and cardiovascular diseases,

including atherosclerosis, coronary heart disease, and

stroke have found a significant positive correlation

between poor oral health and the prevalence of

cardiovascular disease. While both diseases share

several common risk factors, recent studies suggest that

periodontitis may precede and therefore contribute to

atherosclerotic complications. In fact, meta-analyses

show that subjects suffering from periodontitis

experience an increased risk for developing

cardiovascular diseases.

While it has not been definitively shown if these

bacteria initiate atherosclerosis or rather invade an

already compromised artery, antibodies to periodontal

bacteria, including Fuseobacterium nucleatum and

Streptococcus oralis, have been found in blood serum and

are associated with an increased risk of coronary heart

disease. A mouse study found that intravenous inoculation

with Porphyromonas gingivalis accelerated

atherosclerotic development. Further, following oral

inoculation, P. gingivalis DNA was found in the aortic

tissue of those infected mice that showed observable

signs of accelerated early atherosclerosis. Another

study has named F. nucleatum as a synergistic agent with

P. gingivalis. F. nucleatum enhances the ability of P.

gingivalis to invade host cells due to a coaggregating

effect between the two organisms. This is significant as

bacteria within the atheroma may lead to the development

of atherosclerotic plaque. The evidence thus far supports the idea that periodontitis leads to systemic exposure to oral bacteria which serves as a potential source of systemic inflammatory mediators, cytokines produced in the infected periodontal tissues, capable of initiating or worsening atherosclerosis and coronary heart disease when they enter into the blood stream. Clinical studies on periodontal disease have also revealed a positive association with coronary disease and emphasis is now being placed on understanding the exact relation between periodontal disease and atherosclerosis.

Pre-term Birth

Fusobaceterium nucleatum, one of the most prevalent

species of bacteria found in amniotic fluid and placental

infections that cause preterm birth, is also often named

the sole infectious agent in preterm labor with intact

fetal membranes. F. nucleatum is also highly associated

with various types of periodontal disease. During

periodontal infection, when the oral mucosa is injured

and inflamed and the quantities of periodontal pathogens

increase dramatically, transient levels of bacteria can

appear in the blood leading to selective colonization of

undesired sites. One study demonstrated that pregnant

mice injected hematogenously with F. nucleaturn isolated

from either amniotic fluid infection or an oral source

resulted in fetal death.

Recently, a human stillbirth case was analyzed and

it was found that the F. nucleatum did indeed originate

from the mother's oral cavity, a fact that had not yet

been proven. It is likely that the F. nucleatum

translocated from the mother's mouth via the blood stream

where it was then able to cross the endothelium to

proliferate and colonize within the fetal membranes,

amniotic fluid and fetus whereupon its presence lead to fetal demise. In a mouse model, hematogenous injection of F. nucleatum into pregnant mice resulted in specific bacterial colonization in the placenta causing localized inflammation. F. nucleatum was completely cleared from the maternal circulation after 24 hours of injection.

However, once colonized in the immune privileged

placenta, the bacteria proliferated quickly and caused

fetal death within 3 days. Chronic periodontal disease

could mediate infection through the translocation of

periodontal bacteria/inflammatory markers to the

fetoplacental unit.

Diabetes Diabetes mellitus is an endocrine disease that

stems from genetic, environmental and behavioral risk

factors. For the past several decades, diabetes has been

considered a modifying factor for periodontal disease

with recent years suggesting a bidirectional

relationship between the two. Further, presence of

periodontal disease has been implicated as a risk for

diabetic complications, namely poor glycemic control.

Recent longitudinal and systemic studies have seen

periodontal disease correlated to higher risks of death

from ischemic heart disease, diabetic nephropathy, end

stage renal disease and increased insulin resistance

compared to patients with mild or no periodontal disease.

In type II diabetes, insulin resistance is linked to the

actions of pro-inflammatory cytokines. It is believed

that periodontal disease leads to a significantly higher

amount of these serum markers of inflammation, thus

conferring insulin resistance. A human study examining

the bacterial content of adults with and without type II

diabetes found diabetic patients had significantly more

severe periodontitis and higher levels of many oral bacteria, including Streptococcus oralis. Pyogenic Liver Abscess F. nucleatum has recently been implicated in pyogenic liver abscess (PLA). Normally caused by biliary tract pathology, diverticular disease and bowel malignancy, atrophic gastritis and cryptogenic liver disease, PLA caused by F. nucleatum is very rare with Escherichia coli, Klebsiella and Enterobacter being the most commonly isolated microorganisms in the drained abscesses. F. nucleatum was found in the liver abscess with no other infectious source being found, except for a dental extraction. It is hypothesized that due to the coaggregation properties of F. nucleatum, it is able to transport and breach the mucosa of the colon and lead to bacteremia which results in hepatic abscess. Osteomyelitis Osteomyelitis is a bone infection caused by bacteria, fungi or other germs. Commonly, bacteria spreads to the bone from infected skin, muscles or tendons and often time occur under a skin sore. The infection can also start in another part of the body and spread hematogenously. Occasionally Fusobacterium species have been isolated from bone/joint infections in the head and neck area and were associated with chronic periodontitis. A recent study has reported a case of osteomyelitis caused by F. nucleatum in conjunction with muscle abscess. The patient had no known predisposing factors and had no other infection sources except a history of periodontal disease. It is believed that due to the patient's poor oral hygiene, F. nucleatum bacteremia may have developed and lead to a hematogenous osteomyelitis of the lower leg.

Arthritis Numerous clinical studies have suggested a

potential association between rheumatoid arthritis (RA)

and periodontal disease as several oral bacteria species,

such as P. gingivalis and Prevotella intermedia, have

been isolated from the synovial fluid of patients.

Periodontal disease is thought to allow bacteria to

penetrate through the permeable pocket epithelial in the

oral cavity to reach the underlying gingival connection

tissue. From there, it may be transported out into the

bloodstream with the ability to colonize elsewhere within

the body. The oral bacteria found in the synovial fluid

of patients suffering from RA has been attributed to

synovial inflammation favorably trapping oral bacteria

DNA, which suggests periodontal disease may have a

perpetuating effect on joint diseases. Therefore,

periodontitis may in fact be a factor leading to the

autoimmune inflammatory responses characteristic of RA.

Patients suffering from RA may also be at a higher risk

of developing periodontal disease thus suggesting a

bidirectional relationship between the two conditions.

One particular study examined the presence of bacterial

DNA in the synovial fluids of native and failed

prosthetic joints of patients suffering from arthritis.

Out of the 5 patients where bacterial DNA was found, F.

nucleatum was detected in 4 of these 5 patients. This

suggests that this bacterium can translocate from the

oral cavity to the synovial fluid, as F. nucleatum was

also found in the patient's plaque sample.

Oral Biofilm Periodontitis, gingivitis, and caries are

infectious diseases of the oral cavity in which oral

biofilm plays a causative role. Biofilm formation is also involved in the pathogenesis of dental implant failures such as peri-implantitis, denture stomatitis, and oral yeast infections such as candidiasis. Oral biofilms begin with dental pellicle formation on the teeth. This pellicle is composed of salivary proteins that coat the exposed surfaces of the teeth, primarily the supra-gingival ones, to which the planktonic bacteria begin to adhere. The aerobic bacteria, including gram positive cocci, such as S. oralis, are the early colonizers that begin forming the initial biofilm colony, primarily through cellular division of the adherent bacteria.

Once the initial colony has been

established, other co-aggregating bacteria species, such as F. nucleatum, P. gingivalis, and other gram

negative, anaerobic bacteria attach to the

previously formed colonies. As these colonies

mature, they grow to cover the sub-gingival surfaces

of the teeth and begin to induce inflammation in the

periodontium. Summary of the Invention One aspect of the present invention is to provide a method including the steps of providing a mouthpiece having a first electrode and a second electrode where the first and second electrodes having opposite polarities and are coupled to a power source. The method also includes positioning the mouthpiece such that the first electrode is in electrical contact with at least a portion of the patient's lingual gingival tissue and the second electrode is in electrical contact with at least a portion of the patient's buccal gingival tissue. The method also includes delivering current from the power source to said gingival tissue according to a predetermined treatment protocol.

According to another aspect of the present

invention the delivering step may further include

regulating the current delivered to the gingival tissue.

According to another aspect of the present

invention the delivering step may further include

administering the predetermined treatment protocol to a

patient in a dental office.

According to another aspect of the present

invention the delivering step may further include

administering a predetermined treatment protocol to a

patient in a dental office prior to a dental procedure.

According to another aspect of the invention

the dental procedure may be cleaning or prophylaxis.

According to another aspect of the invention

the dental procedure may be scaling.

According to another aspect of the invention

the dental procedure may be root planing.

According to another aspect of the invention

the current delivered to the gingival tissue is from 50

pA up to and including 500 pA.

According to another aspect of the present

invention the delivering step may further include

delivering current to the gingival tissue for a duration

of at least 10 minutes up to and including 30 minutes.

According to another aspect of the present

invention the delivering step may further include

administering the predetermined treatment protocol to a

patient in a dental office before or after a dental

procedure.

According to another aspect of the invention,

the mouthpiece may further include a third electrode and

a fourth electrode, the third and fourth electrodes

having opposite polarities and being coupled to a power

source. The positioning step may further include

positioning the mouthpiece such that the first electrode

is in electrical contact with at least a portion of the

patient's mandibular lingual gingival tissue, the second

electrode is in electrical contact with at least a

portion of the patient's mandibular buccal gingival

tissue, the third electrode is in electrical contact with

at least a portion of the patient's maxillary lingual

gingival tissue, and the fourth electrode is in

electrical contact with at least a portion of the

patient's maxillary buccal gingival tissue.

According to another aspect of the invention

the method may include reducing the amount of oral

biofilm in said patient.

According to another aspect of the invention

the method may include reducing oral bacterial to

prevent, treat and/or mitigate systemic disease.

According to another aspect of the invention

the method may include reducing F. nucleatum to prevent,

treat and/or mitigate cardiovascular disease.

According to another aspect of the invention

the method may include reducing F. nucleatum to prevent

still birth.

According to another aspect of the invention

the method may include reducing S. oralis to prevent,

treat and/or mitigate diabetes.

According to another aspect of the invention

the method may include reducing F. nucleatum to prevent,

treat and/or mitigate pyogenic liver abscess.

According to another aspect of the invention

the method may include reducing F. nucleatum to prevent,

treat and/or mitigate osteomyelitis.

According to another aspect of the invention

the method may include reducing F. nucleatum to prevent,

treat and/or mitigate arthritis.

Another aspect of the present invention is a

method including the step of providing a first mold,

threading one or more wires through the first mold,

injecting a nonconductive material into the first mold,

curing the nonconductive material, removing the

partially molded mouthpiece from the first mold, trimming

the excess wire from the partially molded mouthpiece,

providing a second mold, placing the partially molded

mouthpiece within the second mold, injecting a conductive

material into the second mold, curing the conductive

material, and removing a finished mouthpiece from the

second mold.

Brief Description of the Drawings Figure 1 demonstrates the overall structure

of the first embodiment of our invention, including a

microcontrolled power source, user input, user feedback

and oral electrodes.

Figure 2 shows a top-down view of another

embodiment that includes a mouthpiece with two continuous

electrodes and associated conductors.

Figure 3 shows a perspective view of the same

embodiment of Figure 2, with two electrodes embedded in

a mouthpiece.

Figure 4 offers a top-down view of another

embodiment similar to Figure 2 that includes a

mouthpiece, but with a plurality of discrete electrodes.

Figure 5 provides a perspective view of an additional embodiment similar to Figure 4 with a plurality of electrodes that are electrically connected by embedded conductors. Figure 6 shows an additional embodiment of with an analog power supply using a dual unit, three port switch. Figure 7 is an exploded view of a first mold for molding a mouthpiece according to the present invention. Figure 8 is a cross sectional view of a first mold for molding a mouthpiece according to the present invention. Figure 9 is an exploded view of a first mold for molding a mouthpiece according to the present invention with a partially molded mouthpiece. Figure 10 is an exploded view of a second mold for molding a mouthpiece according to the present invention with a partially molded mouthpiece. Figure 11 is perspective view of a second mold for molding a mouthpiece according to the present invention with a partially molded mouthpiece. Figure 12A is a cross section of the mold of Figure 11 with a partially molded mouthpiece in its unfilled state. Figure 12B is a cross section of the mold of Figure 11 with a partially molded mouthpiece in its filled state. Figure 13 is a perspective view of a mouthpiece molded according to an embodiment of the present invention. Detailed Description Although the disclosure hereof is detailed and exact to enable those skilled in the art to practice the invention, the physical embodiments herein disclosed merely exemplify the invention which may be embodied in other specific structures. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.

It is known in the art that oral bacteria

cannot survive when exposed to low-microampere direct

current electricity. This method of killing oral bacteria

and treating bacteria-caused conditions such as

gingivitis has been demonstrated in Nachman, U.S. Pat.

No. 4,244,373 of Jan. 13, 1981 and in Detsch, U.S. Patent

4,509,519 of Apr. 9, 1985. Killing oral bacteria has the

added benefit of preventing tooth decay and dental

caries, or cavities. Generally, tooth decay is attributed

to aerobic acid-producing bacteria whose acid causes

uncompensated demineralization of the teeth. However,

Nachman does not instruct optimal approaches to reducing

oral bacteria including aerobic and anaerobic bacteria

on a species-by-species level and instead teaches a

generic, untargeted treatment.

While researching the effect of direct

current electricity on the mouth, the applicants

discovered that by increasing the current level to the

approximate range of 50 to 250 microamperes, a direct

current electrical treatment was able to deliver new and

unexpected therapeutic, prophylactic, and regenerative

benefits previously unknown in the art.

Specifically, by utilizing a direct current

in the aforementioned range, not only did such a

treatment kill bacteria, but it was also found to kill

or disable viruses and fungus as well. Studies from the

podiatric field have shown that higher current levels than those used in existing oral electrical treatments are necessary to effectively treat fungal infections

("Low-Voltage Direct Current as a Fungicidal Agent for

Treating Onychomycosis", Kalinowski, et al., Journal of

the American Podiatric Medical Association Vol. 94 No.6:

565-572,2004). By applying this knowledge of increased

current levels from research outside the art, the

applicants were able to add fungicidal and viricidal

benefits to a method already known to be bactericidal.

The applicants' studies have shown that these

microbicidal properties begin to take effect within

approximately 5 and 15 minutes of treatment, reducing

both supra- and sub-gingival microbes.

In addition, the applicants' clinical

research unexpectedly demonstrated that a direct current in the approximate range of 50 to 250 microamperes was able to regenerate gingival tissues, providing a non surgical treatment alternative for those with recessed gums. While the osteogenic properties of electricity have been known in the art, the connection between nonosseous tissue regeneration and electricity were not well known in the art prior to these experiments. The unique current range associated with the method and apparatus of this invention is one of a few effective methods in the dental field to accomplish effective gingival tissue regeneration in a non-surgical manner. In further research, the applicants conducted preclinical testing that examined the effects of direct current stimulation on three different oral bacteria (F. nucleatum, S. oralis, P. gingivalis) in both saline and saliva solutions. This testing varied the current levels, inoculum size of bacteria, solution medium, and treatment time to develop a optimal treatment to reduce these three bacteria species associated with both periodontal and systemic diseases.

The results of this testing yielded

unexpected results and showed that each different

bacterium had a different dose response to DC

stimulation. Through this testing, the applicants

identified treatment parameters that were able to kill

up to 100% of S. oralis, 99.1% of F. nucleatum, and 52.3%

of P. gingivalis in a single treatment lasting thirty

minutes or less. This research yielded specifications

for DC-based treatments of targeted pathogens that was

previously unknown in the art. The optimal treatment

parameters discovered in this research and described in

this method can provide an innovative way to reduce these

three species of bacteria, in both supra- and sub

gingival environments, and thus prevent and/or treat

their associated complications including periodontal

disease, biofilm formation, as well as the systemic

diseases correlated to these oral pathogens.

In addition, scanning electron microscopy

(SEM) was conducted on F. nucleatum colonies before and

after at 30 minute treatment, according to the method of

this invention, to better understand the mechanism by

which the method according to this invention is able to

reduce bacterial levels. The SEM imagery suggested that

the method according to this invention interferes with

bacterial cellular division and can weaken the outer

envelope (cell membrane) resulting in fragile cellular

structures that can easily break. It is contemplated that

this is phenomenon is an example of electroporation,

where the permeability of cellular membranes may be

affected by electrical stimulation either temporarily or

permanently. It is further contemplated that the electroporation caused by the method according to this invention could play a role in developing new therapies in molecular biology which would take advantage of this cellular permeability and introduce new material into the cells of oral pathogens or oral tissues through mechanisms including, but not limited to genetic material

(transfection) such as DNA, RNA, sRNA, siRNA, plasmids,

etc. These effects would prove a new tool in targeted

gene therapies for oral applications.

Specifically, the method according to the

present invention has been shown to reduce viable colony

forming units (CFU) in various oral bacteria.

Table 1 below shows the efficacy of treatment

according to the present invention at current levels of

50 pA or 500 pA for 5, 10, 20 and 30 minute durations

for bacterial cultures ranging from 104 to 107 colony

forming units (CFU) of Streptococcus oralis in a saline

solution.

In Vitro Efficacy of Device Against Streptococcus oralis in Saline

CFU pA 0 Min 5 Min 10 Min 20 Min 30 Min 50pA 1120 1080 600 320 280 10e4 500pA 1120 1200 800 240 0 50pA 10000 9600 8400 9200 7600 10e5 500pA 11600 10400 11200 10800 8400 50pA 80000 63200 52800 32400 24800 10e6 500pA 80800 70000 15200 14000 15600 50pA 1280000 1080000 1040000 800000 440000 10e7 500pA 1080000 520000 160000 120000 320000

Table 1

Table 2 below shows the efficacy of treatment

to the present invention at current levels of 50 pA or

500 pA for 5, 10, 20 and 30 minute durations for bacterial

cultures ranging from 104 to 107 CFU of Streptococcus

oralis in a saliva solution.

In Vitro Efficacy of Device Against Streptococcus oralis in Saliva

CFU pA 0 Min 5 Min 10 Min 20 Min 30 Min 50pA 160 160 80 80 40 10e4 500pA 200 80 80 80 80 50pA 5600 5600 6800 5600 4000 10e5 500pA 8400 6800 7200 6400 2800 50pA 25600 25200 15200 17200 18400 10e6 500pA 23600 16800 15600 17600 15200 50pA 316000 284000 300000 276000 220000 10e7 500pA 324000 328000 300000 292000 252000

Table 2

Table 3 below shows the efficacy of treatment

to the present invention at current levels of 50 pA or

500 pA for 5, 10, 20 and 30 minute durations for bacterial

cultures ranging for 104 and 106 CFU of Fusobacterium

nucleatum in a saline solution.

In Vitro Efficacy of Device Against Fusobacterium nucleatum in Saline

CFU pA 0 Min 5 Min 10 Min 20 Min 30 Min 50pA 480 280 280 120 40 10e4 500pA 560 440 400 200 120 50pA 94000 91600 85600 70400 84400 10e6 500pA 46400 45600 27200 2000 400

Table 3

Table 4 below shows the efficacy of treatment

according to the present invention at current levels of

50 pA or 500 pA for 5, 10, 20 and 30 minute durations

for bacterial cultures ranging from 104 to 106 CFU of

Fusobacterium nucleatum in saliva.

In Vitro Efficacy of Device Against Fusobacterium nucleatum in Saliva

CFU pA 0 Min 5 Min 10 Min 20 Min 30 Min 50pA 1480 1480 1560 680 880 10e4 500pA 2360 2360 1720 1240 1080 50pA 19600 19600 15200 14400 14000 10e5 500pA 18000 17200 14400 11200 10800 50pA 348000 112000 120000 72000 68000 10e6 500pA 156000 128000 124000 32000 28000

Table 4

Table 5 below shows the efficacy of treatment

to the present invention at current levels of 50 pA or

500 pA for 5, 10, 20 and 30 minute durations for bacterial

cultures ranging for 10' CFU of Porphyromonas gingivalis

in a saline solution.

In Vitro Efficacy of Device Against Porphyromonas gingivalis in Saline

CFU pA 0 Min 5 Min 10 Min 20 Min 30 Min 50pA 3440 2040 2720 1640 1640 10e4 500pA 2440 2120 2200 1880 1840

Table 5

Thus, this method and corresponding apparatus

are able to achieve multiple prophylactic, therapeutic,

and regenerative effects whose combination was not

previously known or available in the art. Namely, these

effects are: promotion of oral osteogenesis, destruction or disabling of oral microbes, gingival tissue regeneration, reduction and prevention of the formation of oral biofilms, caries prevention, increased oral vasodilation and oral blood flow, treatment of common oral conditions such as gingivitis and periodontitis, treatment of systemic diseases and conditions correlated with oral pathogens, and generally improved oral hygiene.

These effects are accomplished by the

delivery of direct current to the gingiva through a

plurality of electrodes in direct contact with the

lingual and buccal gingival surfaces. The electrodes may

be fashioned out of any electrically-conductive

material, including but not limited to metals such as

silver, stainless steel, copper, gold, platinum,

palladium, aluminum, an alloy thereof, electrically

conductive nanotubes, carbonized rubber, electrically

conductive silicone, or electrically-conductive

polymers. The electrodes may be composed of the same or

of differing materials. These electrodes fit snuggly

against the lingual and buccal sides of the gingiva and

make direct contact with each side of the gingiva to pass

direct current electricity across the teeth and

neighboring gingival tissues.

The electrodes on each side (lingual or

buccal) of the gingiva are of the same polarity.

Electrodes on opposite sides of the gingiva are of the

opposite polarity. This allows the current to flow across

the teeth and gums to the electrodes positioned on the

transverse gingiva to complete the electrical circuit.

Put another way, all electrodes on the lingual side of

the gingiva will be completely anodic or completely

cathodic. All electrodes on the buccal surfaces of the

gingiva, transverse the lingual surfaces of the gingiva, would have the opposite polarity. The polarization of these electrodes may be reversed during treatment or in between treatments.

The mandibular and maxillary gingiva each

have a set of a plurality of polarized electrodes as

previously described. This allows for treatment of both

the maxillary and mandibular periodontium either

simultaneously or in isolation. The maxillary and

mandibular sets of electrodes may be powered by two

different adjustable power supplies or by the same

adjustable power supply.

Electrical conductors then connect these

electrodes to an adjustable power supply. All of the

anodic electrodes will connect to the positive pole of

the power supply and all of the cathodic electrodes will

connect to the negative pole of the power supply. The

adjustable power supply is capable of delivering a

stable, direct current in the approximate range of 1 to

500 microamperes. The preferred current setting for most

treatments is in the approximate range of 50 to 250

microamperes.

In order to increase conductivity in the

tissues adjacent to the electrodes, an ionic or colloidal

liquid or gel may be used as a conductive medium to

decrease electrical resistance in the mouth. This medium

would be placed along any desired areas of desired

electrical contact, such as the teeth, gums, or

surrounding oral tissues. Examples of such a medium would

include, but not be limited to, colloidal silver gel,

liquid colloidal silver, colloidal copper gel, liquid

colloidal copper, colloidal gold gel, liquid colloidal

gold, saline gel, liquid saline or any combination

thereof.

Colloidal silver, in whole or in combination,

has great promise not only in increasing electrical

current flow, but also in offering additional

bactericidal benefits. Colloidal silver, in

concentrations as little as five parts per million, is

known to be bactericidal by inhibiting a bacterium's

production of adenosine triphosphate.

This conductive medium may also contain

dietary supplements including, but not limited to, oil

of oregano. Oil of oregano is believed to have many

health benefits and may also be microbicidal. Such

microbicidal properties would be effective in treating

common oral infections and diseases as well as aiding in

preventative oral care.

This conductive medium may also contain teeth

whitening agents. This would allow for the addition of

teeth whitening to the list of benefits offered by an

embodiment of this invention. A whitening agent that is

catalyzed by direct current electricity could be included

and may even offer reduced teeth whitening treatment

times when compared with nonelectrically-catalyzed

whitening agents.

Artificial or natural flavorings may also be

added to this conductive medium to offer a more appealing

taste to the user, similar to the method of flavoring

dental fluoride treatments. This flavoring would mask

any unpleasant tastes from the ingredients of the

conductive medium or as well as any taste of the

mouthpiece or electrodes themselves.

Figure 1 shows one embodiment of a treatment

apparatus according to this invention. A user input

device 120 is connected to a microcontrolled direct

current power supply 110. This input device 120 may include, but not be limited to potentiometer dials, push buttons, switches, toggles, etc. User input device 120 allows the patient to control various aspects of the treatment including but not limited to power on or off, output current levels, treatment program selection, treatment duration, treatment reminders, polarity, etc. Input device 120 may also be used to run pre-programmed treatment regimens as described by this method targeted at specific pathogens, including but not limited to, S. oralis, P. gingivalis, and F. nucleatum. Microcontrolled power supply 110 reads the state of input device 120 and adjusts the output current to compensate for the continually varying resistance across cathodic electrodes 140 and anodic electrodes 150. An optional user feedback device 130 is show in Figure 1 connected to microcontrolled power supply 110. Feedback device 130 may contain various methods and devices capable of relaying treatment information to the user. Feedback device 130 could include, but not be limited to an LCD display, LCD matrix display, color LCD displays, indicator LEDs, LED bar graphs, LED segment displays, OLED displays, audio speakers, vibrating devices, or any combination thereof. Feedback device 130 offers the user information including, but is not limited to, output current level, treatment time elapsed, treatment time remaining, date, time of day, battery power level, treatment reminder indicators or sound alarms, recharging indicators, etc. Feedback device 130 also provides information regarding any state change from input device 120. This allows the user to receive information on how his/her input is affecting the treatment. Feedback device 130 is not required for the operation of this embodiment of the treatment apparatus and may be omitted. Microcontrolled power supply 110 contains a microcontroller 112 and a direct current power source 116. Microcontroller 112 is electrically connected to input device 120 and is capable of reading the device's state(s). Microcontroller 112, upon reading these state(s), is able to dynamically adjust the output of power source 116. This allows the user to control the level of current generated by the power source 116. Microcontroller 112 is also connected to an optional user feedback device 130. Microcontroller 112 is able to output information related to the treatment duration, current timer status, current levels, and other information to feedback device 130. Microcontroller 112 also has timing capabilities, represented by timer 114, that allow for limiting treatment time based on some predetermined treatment duration. Timer 114 is also used to output the elapsed treatment time to feedback device 130, if present. The user is able to input desired treatment parameters such as treatment duration, treatment current levels, etc. to microcontroller 112 by way of input device 120. The programmable nature of microcontroller 112 allows for advanced functionality not present in other oral electrical treatment devices. For example, the software on microcontroller 112 could be programmed to run a predetermined treatment regimen. This treatment regimen could include but not be limited to such factors as: treatment duration, targeted pathogen, treatment current levels, treatment time-of-day, treatment reminders, etc. This treatment regimen could also be programmed by a dental professional by way of input device 120 so that a patient's treatment may be simplified and guaranteed to follow set parameters.

Cathodic electrodes 140 are connected to the

positive pole of power source 116 and anodic electrodes

150 are connected to the negative pole of power source

116. These electrodes are placed in direct contact with

the gingiva, mounted transversely from one another. This

allows a current flow from cathodic electrodes 140 to

the gingival tissues, surrounding teeth, boney

structures, and connected mouth tissues to anodic

electrodes 150 mounted on the transverse gingiva and then

back to power supply 110, forming a complete circuit.

Power source 116 may be any known device

capable of delivering an adjustable direct electrical

current. This includes, but is not limited to disposable

batteries, rechargeable batteries, AC-DC power

converter, etc. Microcontroller 112 is able to regulate

the current output of power source 116 by a known method

of electrical current control. Power supply 116 is

capable of delivering a direct current of between 1 and

500 microamperes, with an approximate range of 50 to 250

microamperes used for most treatments. Microcontroller

112 is also able to reverse the polarity of the cathodic

electrodes 140 and anodic electrodes 150 by controlling

the output of power source 116. This allows for dynamic

changing of electrode polarity during treatment.

Microcontroller 112 is also programmable to allow for

pulsed application of direct current across the gingiva.

Figure 2 shows a top-down view of another

embodiment of the treatment apparatus. In this

embodiment, a mouthpiece unit 200, known in the art, has

two electrodes attached to or embedded in it, and is worn

in the mouth. A single lingual gingiva electrode 210 fits

snugly against the lingual gingival tissue of the mouth.

A single buccal gingiva electrode 220 is attached to or embedded in mouthpiece 200 so that it is transverse from the lingual gingiva electrode 210 and fits snugly against the buccal gingival tissues of the mouth. Two electrical conductors 230 connect electrodes 210 and 220 to an adjustable current power supply, of whose embodiment may be similar to that of 110 or that of Figure 3. Electrical conductors 230 are insulated so that a short circuit does not occur inside or outside of the mouth. Electrical conductors 230 are shown as attached to the anterior of mouthpiece 200, but may be electrically connected to electrodes 210 and 220 at any point along mouthpiece 200, so long as electrical conductors 230 are not attached to the same electrode. Electrical conductors 230 may also be partially or wholly composed of an electrically conductive polymer. Figure 3 shows a perspective view of the same type of embodiment shown in Figure 2. A mouthpiece 300 has a lingual gingiva electrode 310 and an buccal gingiva electrode 320 attached to or embedded it. Electrodes 310 and 320 span the lingual and buccal gingival surfaces of the mouth, respectively. A set of embedded electrical conductors 340 are connected to electrodes 310 and 320 on one end and on the other end to a set of conductors to the power supply 330. Conductors 340 are embedded in the mouthpiece material and are electrically insulated. Conductors 330 then connect to the positive and negative poles of a direct current power source, similar to that of 110 or Figure 6. Figure 4 presents another embodiment similar in nature to that of Figures 2 and 3. In this embodiment, electrode sets are attached to or embedded in a mouthpiece unit 400. A set of lingual gingiva electrodes

410 are affixed to or embedded in mouthpiece 400. Electrode set 410 comprises a plurality of discrete lingual gingiva electrodes 4102, which are electrically connected by embedded electrical conductors 4104. Conductors 4104 are insulated and are embedded in or attached to mouthpiece 400. Likewise, a set of buccal gingiva electrodes 420 are affixed to or embedded in mouthpiece 400 transverse of electrode set 410. Electrode set 420 comprises a plurality of discrete lingual gingiva electrodes 4202, which are electrically connected by embedded electrical conductors 4204. Conductors 4204 are insulated and are embedded in or attached to mouthpiece 400. This embodiment allows for multiple, discrete points of electrical contact within the mouth. In Figure 4, conductors to the power supply 430 are shown as attached to the posterior electrodes in mouthpiece 400. However, conductors 430 may be electrically connected to any point of electrode sets 410 and 420, so long as conductors 430 are not connected to the same electrode set. Conductors 430 then connect to the positive and negative poles of a direct current power source, similar to that of 110 or Figure 6. Figure 5 offers a perspective view of an embodiment similar to Figure 4. A lingual gingiva electrode set 510 and a buccal gingiva electrode set 520 are attached to or embedded in a mouthpiece 500. Electrode set 510 comprises a plurality of lingual gingiva electrodes 5102 that are electrically connected by embedded electrical conductors 5104. Conductors 5104 are electrically insulated and are embedded in or attached to mouthpiece 500. Similarly, electrode set 520 comprises a plurality of buccal gingiva electrodes 5202 that are electrically connected by embedded electrical conductors 5204. Conductors 5204 are electrically insulated and are embedded in or attached to mouthpiece

500. Electrode set 520 is mounted transverse of electrode

set 510 to allow direct current to flow across the tissue

of the teeth and gums. Electrode sets 510 and 520 are

connected to conductors to the power supply 530 by way

of embedded electrical conductors 540. Conductors 540

are electrically-insulated and are embedded in

mouthpiece 500. Conductors 530 then connect to the

positive and negative poles of a direct current power

source, similar to that of 110 or Figure 6.

Figure 6 presents another embodiment of an

adjustable direct current power source used to supply

direct current to a plurality of oral electrodes. This

particular circuit design is capable of delivering a

steady current regardless of moderate fluctuations in

the resistance between the electrodes. The circuit uses

a 9-volt power supply 640, which could be a disposable

battery, a rechargeable battery, an AC-to-DC converter,

or any other suitable 9-volt power source. A dual unit,

three-port switch 610 is used to select the current level

in the circuit. The three options of the switch circuit

are power off 614, 100pA 612, or 200pA 616. Switch option

614 simply does not complete a circuit, preventing

current from flowing. Switch option 612 comprises a 332kQ

resistor 618 in series with a 2 volt LED 620. These two

components are in parallel with a 48.7kQ resistor 622 to

provide a 100 microamp current. The Switch option 616

comprises a 665kQ resistor 624 in series with a 2 volt

LED 626. These two components are in parallel with a

97.6kQ resistor 628 to provide a 200 microamp current.

Cathodic upper mouth electrodes 630 and cathodic lower

mouth electrodes 632 are in parallel with each other and are electrically connected to the output of switch 610. Electrical current then travels from power supply 640 to these electrodes, through the gingival tissues of the mouth to anodic upper mouth electrodes 636 and anodic lower mouth electrodes 634 and finally back to power supply 640. This circuit design will allow moderate and reasonable fluctuations in the resistance across the electrodes and prevent over driving the circuit should the resistance in the mouth vary. In another embodiment of this invention or in combination with those previously described, an ionic or colloidal medium in the form of a liquid or a gel may be used to decrease electrical resistance in the mouth and to facilitate a more even current distribution across oral electrodes. Any combination of one or more ionic or colloidal compounds may be used. Examples of such a medium would include, but not be limited to, colloidal silver gel, liquid colloidal silver, colloidal copper gel, liquid colloidal copper, colloidal gold gel, liquid colloidal gold, saline gel, liquid saline or any combination thereof. Artificial or natural flavorings may be added to this medium to offer a more appealing taste to the user. The medium may also contain dietary supplements including, but not limited to, oil of oregano. This medium may also contain teeth-whitening chemical agents. A whitening agent that is catalyzed by the direct current would be most effective in this ionic or colloidal medium. In yet another embodiment, microcontrolled power supply 110 would be miniaturized and be physically attached to or embedded in a mouthpiece similar to 200, 300, 400, or 500. This would allow for an all-in-one unit that would fit inside the user's mouth. In this embodiment, power source 116 would have to be of small physical size. One of many possible options is a watch type battery or other small, portable power source. This circuitry would then be encased in a waterproof manner in the material of the mouthpiece itself. Input device 120 and feedback device 130 would be waterproofed and protected from any kind of electrical shorting, as well. Thus the reader will see that at least one embodiment addresses a desired need in the oral hygiene and dental fields to concurrently treat common oral diseases and conditions in a more effective, less invasive, and less expensive manner. These embodiments promote general oral hygiene, reduce oral biofilm, treat periodontal diseases such as gingivitis and periodontitis, kill oral microbes including bacteria and thus preventing cavities and tooth decay, increase vasodilation and blood flow in oral tissues, promote gingival tissue regeneration, foster osteogenesis in the boney structures of the teeth, mouth, and related areas, treat systemic diseases related to oral pathogens, and treat other periodontal and oral maladies through the non-invasive application of weak direct current electricity to the surfaces in the oral cavity. While our above descriptions contain many specificities, these should not be construed as limitations on the invention, but rather as an exemplification of several preferred embodiments thereof. Many other variations are possible. For example, electrodes may be attached directly to the gingiva without the use of a mouthpiece, perhaps using an electrically-conductive paste. Or electrodes may be placed in contact with tissues neighboring the gingiva, such as the teeth or tissues of the cheek, instead of directly on the gingiva to accomplish the same result.

Another example would be replacing LEDs 626 and 620 from

Figure 6 with standard diodes to achieve the same

resultant circuit. Overall, the circuitry from Figures 1

and 6 could be altered in many ways to deliver the same

electrical current to the oral electrodes.

In some cases dental procedures can break up

oral bacterial colonies found in biofilms and introduce

bacteria into the bloodstream causing bacteremia and

other infections. It is further contemplated that it may

be desirable to utilize a mouthpiece according to the

present invention immediately prior to performing a

dental procedure. The mouthpiece according to this

invention may be used by the patient either at home or

in the dental office. In this manner, the living bacteria

in the patient's mouth, both supra- and sub-gingival,

can be reduced prior to the procedure and the risk of

bacteremia and other infections will be reduced. For

example, and not by way of limitation, a mouthpiece

according to the present invention may be utilized prior

to a dental prophylaxis or a scaling and root planning

procedure in a dental office to reduce the risks of

introducing bacteria into the patient's blood stream.

Such a pre-procedural treatment would be used for

approximately 10 to 20 minute with a current level

ranging from 50pA to 500pA and would be timed to conclude

immediately before the procedure.

A mouthpiece according to the present

invention may also be utilized following a clinical

procedure as prevention for infections, for scenarios

including but not limited to post-extraction or post

implantation infection prevention. Such a post

procedural treatment would last for approximately 10 to

20 minutes with a current ranging from 50pA to 500pA.

This procedure may then be repeated at home by the

patient one or more times a week until the risk of

infection has passed.

Prevention of Systemic Disease It is contemplated that a mouthpiece

according to the present invention may be used to prevent

or treat systemic diseases as will be outlined in more

detail below. The method according to the present

invention has been shown to be effective in reducing the

amount of oral bacteria, specifically F. nucleatum, P.

gingivalis, and S. oralis.

1. Cardiovascular disease It is contemplated that use of a mouthpiece

according to the present invention may be used to reduce

microbial burdens caused by the translocation of oral

bacteria, including but not limited to S. oralis, P.

gingivalis, and F. nucleatum, from the gingival tissues

to the rest of the body and also decrease the amount of

inflammatory mediators produced by oral bacteria.

Further, by reducing F. nucleatum, it is contemplated

that the ability of P. gingivalis to invade host cells

will be lessened and thus diminishing the development of

bacteremia that has been linked with the

initiation/worsening of atherosclerosis and coronary

heart disease.

It is contemplated that a mouthpiece

according to the present invention may be used according

to a predetermined treatment regimen to prevent, treat

and/or mitigate cardiovascular disease. In the

predetermined treatment regimen, the patient will wear a

mouthpiece according to the present invention for a

predetermined amount of time at a predetermined current level and at predetermined time intervals. It is further contemplated that the specific treatment regimen may be determined based on the bacterial levels present in a patient. According to one embodiment of the invention, the treatment regimen would consist of a patient wearing a mouthpiece according to the present invention for 20 minutes once per day at a current level of 500pA. For acute cardiovascular conditions, this treatment may continue on a daily basis until the conditions is resolved. For chronic cardiovascular disease, this treatment may be repeated a few times a week on a continuing basis. 2. Still Birth It is further contemplated that a treatment with a mouthpiece according to the present invention according to a predetermined treatment protocol would reduce the oral population of F. nucleatum associated with periodontal disease and thus prevent, treat and/or mitigate still birth. In turn, this reduction would lessen the likelihood of F. nucleatum translocating from the oral cavity into the bloodstream, where it could then migrate into the placenta and colonize. It is contemplated that a mouthpiece according to the present invention may be used according to a predetermined treatment regimen to prevent still birth. In the predetermined treatment regimen, the patient will wear a mouthpiece according to the present invention for a predetermined amount of time at a predetermined current level and at predetermined time intervals. It is further contemplated that the specific treatment regimen may be determined based on the bacterial levels present in a patient. According to one embodiment of the invention, the treatment regimen would consist of a patient wearing a mouthpiece according to the present invention for 20 minutes once per day at a current level of 500pA for the duration of the pregnancy. The treatment parameters outlined above have been demonstrated to be highly efficient at reducing levels of S. oralis and F. nucleatum at inoculation sizes of 107 colony-forming units (CFU). 3. Diabetes It is contemplated that a mouthpiece according to the present invention according to a predetermined treatment protocol may be used to prevent, treat and/or mitigate diabetes by causing a reduction of S. oralis in the oral cavity and consequently reduce the amount of serum markers of inflammation produced by bacterial infections. In the predetermined treatment regimen, the patient will wear a mouthpiece according to the present invention for a predetermined amount of time at a predetermined current level and at predetermined time intervals. It is further contemplated that the specific treatment regimen may be determined based on the bacterial levels present in a patient. According to one embodiment of the invention, the treatment regimen would consist of a patient wearing a mouthpiece according to the present invention for 20 minutes once per day at a current level of 500pA to effectively reduce oral levels of S. oralis that in turn will lower the amount of systemic inflammatory markers. This treatment may be repeated multiple times a week on an ongoing basis to help reduce inflammatory markers. 4. Pyogenic Liver Abscess It is contemplated that a mouthpiece according to the present invention according to a predetermined treatment protocol may be used to prevent, treat and/or mitigate pyogenic liver abscess by causing a reduction of F. nucleatum. Specifically, it is contemplated that treatment with a mouthpiece according to the present invention would reduce bacterial levels and may stop F. nucleatum and other oral bacteria species from traveling to the liver and reduce overall bacteremia. In the predetermined treatment regimen, the patient will wear a mouthpiece according to the present invention for a predetermined amount of time at a predetermined current level and at predetermined time intervals. It is further contemplated that the specific treatment regimen may be determined based on the bacterial levels present in a patient. According to one embodiment of the invention, the treatment regimen would consist of a patient wearing a mouthpiece according to the present invention for 20 minutes once per day at a current level of 500pA to effectively reduce oral levels of F. nucleatum which may prevent any bacteria from being transported from the oral cavity systemically. This treatment may be repeated multiple times per week until the abscess is reduced. 5. Osteomyelitis It is contemplated that a mouthpiece according to the present invention according to a predetermined treatment protocol may be used to prevent, treat and/or mitigate osteomyelitis by causing a reduction of F. nucleatum. In the predetermined treatment regimen, the patient will wear a mouthpiece according to the present invention for a predetermined amount of time at a predetermined current level and at predetermined time intervals. It is further contemplated that the specific treatment regimen may be determined based on the bacterial levels present in a patient. According to one embodiment of the invention, the treatment regimen would consist of a patient wearing a mouthpiece according to the present invention for 20 minutes per treatment at a current level of 500pA to effectively reduce oral levels of F. nucleatum bacteria and prevent any bacteria from being transported from the oral cavity systemically. This treatment may be used in conjunction with or separate from standard antibiotic-based treatments for osteomyelitis. When used in conjunction with antibiotics, treatment will normally continue for approximately 29 to 42 days. When used separately from antibiotics, this treatment may be used once a day for a few months for acute conditions, or a few times a week on a continuing basis for chronic conditions. 6. Arthritis It is contemplated that a mouthpiece according to the present invention according to a predetermined treatment protocol may be used to prevent, treat and/or mitigate arthritis by causing a reduction of F. nucleatum. In the predetermined treatment regimen, the patient will wear a mouthpiece according to the present invention for a predetermined amount of time at a predetermined current level and at predetermined time intervals. It is further contemplated that the specific treatment regimen may be determined based on the bacterial levels present in a patient. According to one embodiment of the invention, the treatment regimen would consist of a patient wearing a mouthpiece according to the present invention for 20 minutes once per day at a current level of 500pA to effectively reduce oral levels of F. nucleatum bacteria and prevent any bacteria from being transported from the oral cavity and translocating to the synovial fluid and reducing the associated inflammation. This treatment may be repeated multiple times per week on a continual basis for this type of chronic condition. Reducing Biofilm and Preventing Biofilm Formation It is contemplated that a mouthpiece according to the present invention according to a predetermined treatment protocol may be used to prevent, treat and/or mitigate oral biofilm by causing a reduction of F. nucleatum, P. gingivalis, and/or S. oralis, all of which are involved in oral biofilm formation. In the predetermined treatment regimen, the patient will wear a mouthpiece according to the present invention for a predetermined amount of time at a predetermined current level and at predetermined time intervals. It is further contemplated that the specific treatment regimen may be determined based on the bacterial levels of specific bacterial species present in a patient. According to one embodiment of the invention, the treatment regimen would consist of a patient wearing a mouthpiece according to the present invention for 20 minutes once per day at a current level of 500pA to effectively reduce oral levels of F. nucleatum bacteria to prevent further biofilm formation caused by F. nucleatum and to reduce the viability of existing biofilm colonies of F. nucleatum. According to another embodiment of this invention, the treatment regimen would consist of a patient wearing a mouthpiece according to the present invention for 20 minutes once per day at a current level of 50pA to effectively reduce oral levels of P. gingivalis bacteria to prevent further biofilm formation caused by P. gingivalis and to reduce the viability of existing biofilm colonies of P. gingivalis. Furthermore, according to another embodiment of this invention, the treatment regimen would consist of a patient wearing a mouthpiece according to the present invention for 20 minutes once per day at a current level of 500pA to effectively reduce oral levels of S. oralis bacteria to prevent further biofilm formation caused by S. oralis and to reduce the viability of existing biofilm colonies of S. oralis. These treatments for biofilm reduction and prevention may be repeated on a daily basis for a three to six weeks for acute biofilm-based issues or may be repeated once or more per week on a continuing basis for chronic biofilm issues. Method of Manufacture A mouthpiece according to the present invention may be formed using any method and means known in the art. In one embodiment of such a method, a first mold 700 is provided. The first mold 700 preferably includes a top portion 710 and a bottom portion 720. Each portion of the first mold 700 includes a sealing means for sealing the first mold 700. In the illustrated embodiment the sealing means take the form of a cap 730A,730B. Each cap 730A,730B preferably has a first channel 740 and a second channel 750 therethrough. The first mold 700 preferably includes one or more fill ports 760 and one or more vents 770. The pieces of the first mold 700 are preferably cleaned. A plurality of wires 780A,780B,780C,780D are then prepared and treaded through the first mold 700. In the preferred embodiment, the four wires 780A,780B,780C,780D are threaded through the first mold 700 as shown in Figure 8. Preferably a first and a second wire 780A,780B are threaded through the top cap 730A and through the first mold 700 and a third and a fourth wire 780C,780D are threaded through the bottom cap 730 B and through the first mold 700. Preferably the first wire 780A extends through the first channel 740 in the top cap 730A and the second wire 780 B extends through the second channel 750 in the top cap 730A. Similarly, preferably, the third wire 780C extends through the first channel 740 in the bottom cap 730B and the fourth wire 780D extends through the second channel 750 in the bottom cap 730B. The first mold 700 is then closed. A non-conductive material is then injected through one or more fill ports 760 in the first mold 700. The first mold 700 cavity is filled when material is coming out of all vents 770 in the first mold 700. The non-conductive material may be a thermoplastic, a thermoplastic elastomer, a thermoset polymer, a room temperature vulcanizing elastomer, or other polymer. When the non-conductive material is cured, the first mold 700 is preferably opened and the partially formed mouthpiece 790 is removed from the first mold 700. The plurality of wires 780A,780B, 780C,780D are now encapsulated by the non-conductive material. Preferably a wire 780A,780B,780C,780D is located in each of the four exposed channels 800 of the mouthpiece 790. Preferably the first wire 780A is located in the inner upper channel 800A, the second wire 780B is located in the outer upper channel 800B, the third wire 780C is located in the inner lower channel 800C (not shown), and the fourth wire 780D is located in the outer lower channel 800D (not shown). The excess wire is then preferably trimmed from the mouthpiece 790 and the remaining wire 780A,780B,780C,780D is preferably inserted fully into its associated channel 800A,800B,800C,800D. A second mold 810 is preferably provided. The second mold preferably includes a top portion 810A and a bottom portion 810B. In the illustrated embodiment, each of the top and bottom portions of the second mold 810 preferably includes a mold base 820A,820B, a center piece 830A,830B, a first insert 840A,840B, and a second insert 850A,850B. The pieces of the second mold 850 are preferably designed to allow the channels 800A,800B,800C,800D of the mouthpiece 790 to be filled with an electrically-conductive material. The second mold 810 preferably includes one or more fill ports 760 for filling the mold cavities. As there are four channels 800A,800B,800C,800D to be filled, the preferred embodiment includes four fill ports 760. Further, the second mold 810 preferably includes one or more vents 770. In the illustrated embodiment each cavity includes its own vent 770. Preferably the pieces of the second mold 810 are cleaned and prepared. The second mold 810 is then assembled with the mouth piece 790 as shown in Figures 10-12B. Preferably, the bottom portion 810B of the second mold 810 is assembled first, with the mouthpiece 790. The top portion 810A of the second mold 810 is then assembled. A conductive material is then inserted into each of the fill ports 760. The cavities are filled when material is coming out of all vents 770 in the second mold 810. The conductive material is preferably a thermosetting elastomer, but may also be a thermoplastic, a thermoplastic elastomer, or other polymer. After the conductive material is cured, the second mold 810 is opened and the finished mouthpiece 760 is removed. Preferably, the top half 810A of the second mold 810 is removed first. The first 840A and second inserts 850A are preferably removed first. The center piece 830A can then be removed. The bottom half

810B of the second mold may then be removed, again first

removing the first 840B and second inserts 850B and then

the center piece 830B.

The foregoing is considered as illustrative

only of the principles of the invention. Furthermore,

since numerous modifications and changes will readily

occur to those skilled in the art, it is not desired to

limit the invention to the exact construction and

operation shown and described. While the preferred

embodiment has been described, the details may be changed

without departing from the invention, which is defined

by the claims.

Claims (19)

1. We Claim: 1. A method comprising:

   providing a mouthpiece, said mouthpiece

   having a first electrode and a second electrode, the

   first and second electrodes having opposite polarities,

   the first and second electrodes are coupled to a power

   source;

   positioning the mouthpiece such that the

   first electrode is in electrical contact with at least

   a portion of the patient's lingual gingival tissue and

   the second electrode is in electrical contact with at

   least a portion of the patient's buccal gingival tissue;

   delivering current from said power source to

   said gingival tissue according to a predetermined

   treatment protocol.
2. 2. The method of claim 1 wherein said

   delivering step further comprises a regulating the

   current delivered to said gingival tissue.
3. 3. The method of claim 2 further wherein said

   delivering step further comprises administering at least

   a portion of the predetermined treatment protocol to a

   patient in a dental office.
4. 4. The method of claim 3 wherein said

   delivering step further comprises administering at least

   a portion of the predetermined treatment protocol to a

   patient in a dental office prior to a dental procedure.
5. 5. The method of claim 4 wherein said dental

   procedure is cleaning or prophylaxis.
6. 6. The method of claim 4 wherein said dental

   procedure is scaling.
7. 7. The method of claim 4 wherein said

   procedure is root planing.
8. 8. The method of claim 2 wherein the current

   delivered to said gingival tissue is from 50 pA up to

   and including 500 pA.
9. 9. The method of claim 2 wherein the

   delivering step further comprises delivering current to

   the gingival tissue for a duration of at least 10 minutes

   up to and including 30 minutes.
10. 10. The method of claim 3 wherein said

    delivering step further comprises administering at least

    a portion of the predetermined treatment protocol to a

    patient in a dental office before or after a dental

    procedure.
11. 11. The method of claim 1

    wherein said mouthpiece further comprises a

    third electrode and a fourth electrode, the third and

    fourth electrodes having opposite polarities, the third

    and fourth electrodes being coupled to a power source;

    and

    wherein the positioning step further

    comprises positioning the mouthpiece such that the first

    electrode is in electrical contact with at least a

    portion of the patient's mandibular lingual gingival

    tissue, the second electrode is in electrical contact

    with at least a portion of the patient's mandibular

    buccal gingival tissue, the third electrode is in

    electrical contact with at least a portion of the

    patient's maxillary lingual gingival tissue, and the

    fourth electrode is in electrical contact with at least

    a portion of the patient's maxillary buccal gingival

    tissue.
12. 12. The method of claim 2 further comprising reducing the amount of oral biofilm in said patient.
13. 13. The method according to claim 1 further comprising reducing oral bacterial to prevent, treat and/or mitigate systemic disease.
14. 14. The method according to claim 13 further comprising reducing F. nucleatum to prevent, treat and/or mitigate cardiovascular disease.
15. 15. The method according to claim 13 further comprising reducing F. nucleatum to prevent still birth.
16. 16. The method according to claim 13 further comprising reducing S. oralis to prevent, treat and/or mitigate diabetes.
17. 17. The method according to claim 13 further comprising reducing F. nucleatum to prevent, treat and/or mitigate pyogenic liver abscess.
18. 18. The method according to claim 13 further comprising reducing F. nucleatum to prevent, treat and/or mitigate osteomyelitis.
19. 19. The method according to claim 13 further comprising reducing F. nucleatum to prevent, treat and/or mitigate arthritis.

    Fig. 2 1/7

    Fig. 1

    Fig. 4 2/7

    Fig. 3