WO2018026892A1 - Intraoral appliance for multiple treatment applications - Google Patents

Abstract

An intraoral device, comprising arches shaped to be received over teeth sets in situ in a mouth. Radiation sources (preferably LEDs or lasers) are provided in sets, wherein the sets are deployed on the arches in predetermined locations such that the radiation sources in such deployed sets are disposed to irradiate preselected targets within the mouth. A power supply is configured to energize selected radiation source sets according to a predetermined energization/de-energization script, preferably for selected time periods according to a predetermined combination and sequence of set energization and de-energization. In some embodiments, radiation sources irradiate blue light (about 650 nm to about 670 nm wavelength) to remediate and deter infection, and/or infra-red light (about 810 nm to about 850 nm wavelength) to remediate inflammation and reduce pain.

Description

INTRAORAL APPLIANCE FOR

MULTIPLE TREATMENT APPLICATIONS

RELATED APPLICATIONS AND PRIORITY CLAIM

This application claims the benefit of, and priority to, commonly-invented U.S. Provisional Patent Application serial no. 62/369,843 filed August 2, 2016. The entire disclosure of 62/369,843 is further incorporated herein by reference.

FIELD OF THE DISCLOSURE

This disclosure is directed generally to intraoral appliances, and more specifically to an appliance that may be controlled to deliver different wavelengths of radiation (such as, for example, LED radiation or laser radiation) according to a customized program configured by the dental professional. The controlled exposure to such radiation is useful in treatment of oral conditions.

BACKGROUND OF THE DISCLOSED TECHNOLOGY

A variety of intraoral mouthpieces have been used in the past for many different purposes. Historically, light emitting diodes (LEDs) have been added to intraoral mouthpieces to achieve specific actions. Some, for example, are used to activate teeth whitening gels, while others claim to achieve certain bactericidal advantages. The irradiated wavelengths of the LEDs define specific actions of which the appliance is capable. Some prior art LED appliances work in specific wavelengths, or limited ranges, restricting their potential uses and applications. Most are in the blue and lower red regions or the visible light spectrum.

The peer-reviewed professional journals are replete with reported LED-enabled intraoral applications. It is estimated that there may be as many as 10,000 relevant scientific articles on PubMed, the National Center for Biotechnology Information (NCBI) database of scientific references. This body of work on PubMed covers a wide range of articles going back to the 1960s with the use of the very first intraoral lasers for biostimulation and biomodulation. More recent articles report both laser and LED energy being applied in low levels in intraoral applications, many with excellent reported medical results. The process is now referred to generally in the relevant art as Low Level Light Therapy ("LLLT"). There is currently a need in the LLLT art for an intraoral appliance that can irradiate LEDs at various wavelengths (both inside and outside the visible spectrum) at controlled levels to target and remediate specific oral conditions presented by the patient. The needed appliance will allow control of LLLT over multiple variables, such as type of radiation, its level, its time of exposure, its precise location of exposure, its pattern of exposure (including the sequence and combination of different areas of exposure and corresponding time periods of exposure for such areas), etc., all per the selection of the treating dental professional.

SUMMARY AND TECHNICAL ADVANTAGES

These and other needs in the LLLT art are addressed by an intraoral appliance as described in this disclosure, exemplary embodiments of which are also described further below. It will be appreciated that the scope of this disclosure is not limited to the specific embodiments described further below, which are examples of the types of intraoral appliance that fall within the inventive scope of the disclosure.

Our present intraoral appliance evolved out of substantial proprietary and confidential research and development of application of LLLT for intraoral healing, infection control, guided tissue regeneration, osteogenic proliferation and osseous regeneration. Our appliance provides a very accurate and controlled delivery of a wide range of LLLT treatment options. Our appliance is very versatile, giving the dental professional a high level of control associated with the variables of LLLT. The present appliance thus allows the dental professional to treat the patient with a highly controlled and targeted course of LLLT. This allows the dental professional to use our intraoral appliance to treat and remediate a wide range of conditions presented by various patients.

While this disclosure describes our intraoral appliance mainly with reference to embodiments that enable light-emitting diode (LED) radiation, embodiments are also described herein which enable laser radiation for alternative LLLT regimens. The scope of this disclosure is not limited to any particular radiation source (such as LEDs or lasers) for treatment. Further, although not specifically described with reference to illustrated embodiments herein, the scope of this disclosure includes intraoral appliances deploying hybrid sources of radiation for treatment (e.g. LEDs and lasers).

The technical advantages provided by our intraoral appliance thus include, without limitation, improved healing after oral surgery and periodontal surgery, improved regeneration of hard and soft tissues in gum disease therapy, improved remediation of intraoral infection, and improved and rapid movement of teeth redirected via orthodontics stimulation.

Our disclosed intraoral appliance is advantageously configured to deliver the proper amount of energy to the correct locations to render rapid healing and/or remediate bacterial growth. With the addition of multiple wavelengths with different diodes (visible and infrared wavelengths), healing can be promoted and bacterial growth can be inhibited at the same time or during different treatment sessions by adjusting the disclosed powered time controls.

The foregoing has rather broadly outlined some features and technical advantages of the disclosed intraoral appliance, in order that the following detailed description may be better understood. Additional features and advantages of the disclosed technology may be described. It should be appreciated by those skilled in the art that the conception and the specific embodiments disclosed may be readily utilized as a basis for modifying or designing other structures for carrying out the same inventive purposes of the disclosed technology, and that these equivalent constructions do not depart from the spirit and scope of the technology as described.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the embodiments described in this disclosure, and their advantages, reference is made to the following detailed description taken in conjunction with the accompanying drawings, in which:

FIGURE 1 illustrates a first exemplary embodiment 100 of the disclosed intraoral appliance, deploying LEDs 102 for LLLT;

FIGURE 2 is a plan view of the embodiment depicted on FIGURE 1 ;

FIGURE 3 is a section as shown on FIGURE 2;

FIGURE 4 illustrates a second exemplary embodiment 200 of the disclosed intraoral appliance in which LLLT may be directed to a specific oral region;

FIGURE 5 illustrates a third exemplary embodiment 300 of the disclosed intraoral appliance, similar to the embodiment of FIGURE 1 , except also providing rearward-radiating LEDs 302 for LLLT at the back of the mouth and throat;

FIGURE 6 illustrates a fourth exemplary embodiment of the disclosed intraoral appliance, similar to other illustrated embodiments, except using lasers as source of LLLT radiation;

FIGURE 7 is a section as shown on FIGURE 6; and FIGURE 8 illustrates an exemplary circuit diagram 800 for delivering power to the LEDs 102 on the intraoral appliance 100 depicted on FIGURE 1.

DETAILED DESCRIPTION

Exemplary embodiments of our disclosed intraoral appliance will now be described in detail with reference to the accompanying FIGURES 1 through 8. Where the same reference number or letter is used in FIGURES 1 through 8, the same part or feature of a disclosed embodiment is being identified on that Figure. In this way, reference numbers and letters on FIGURES 1 through 8 can be omitted for clarity on some views while still allowing the reader to understand the subject matter depicted on FIGURES 1 through 8.

FIGURE 1 illustrates a first exemplary embodiment 100 of the disclosed intraoral appliance, deploying LEDs 102 for LLLT. FIGURE 2 is a plan view of intraoral appliance 100 on FIGURE 1 , and FIGURE 3 is a section as shown on FIGURE 2. FIGURE 8 illustrates an exemplary circuit diagram 800 for delivering power to the LEDs 102 on FIGURE 1 in an "all on" or "all off power embodiment (i.e. LEDs 102 on FIGURE 1 not addressable with power individually or in groups thereof via circuit diagram 800).

Referring to FIGURES 1 and 2 together, it will be seen that the exemplary embodiment of intraoral appliance 100 provides 48 (forty-eight) LEDs 102 in total: 24 (twenty-four) LEDs 102 on each of the upper and lower arches lOl A and 101 B, each arch 101A, 101 B comprising 12 (twelve) LEDs 102 on each of the left and right sides, each side comprising 6 (six) LEDs 102 on each of the buccal and lingual faces. In the example of FIGURE 1 , LEDs 102 may be positioned to irradiate generally from the midline to about the second molars on both left and right sides of both the upper and lower jaws, from both lingual and buccal sides.

Referring now to FIGURE 8, and with comparison to FIGURES 1 and 2, circuit diagram 800 depicts delivering power to the forty-eight LEDs 102 on FIGURES 1 and 2 in an "all on" or "all off' power embodiment. Power supply 107 advantageously delivers 5 volts DC and is rated for 1 Amp delivered on a timer. In some embodiments, power supply 107 may be a GLO power supply, although this disclosure is not limited in this regard. Power supply 107 may be any suitable power supply, operating off batteries or via connection to a mains power source. With further reference to FIGURES 1 and 8, multi-pin plug/receptacle connector is provided in line between power supply 107 and LEDs 102. Power indicator LEDs 109 are further provided near the front of intraoral appliance 100, and act as an on/off indicator by illuminating with visible light when power is being delivered to LEDs 102. LEDs 102 on FIGURE 8 are in groups of 3 (three) in series. LEDs 102 may each be rated for 1.5 volts, each consuming approximately 8 mW in power, and each drawing about 10 mA current. As shown on circuit diagram 800, parallel circuitry delivers 5 volts to each group of three LEDs 102. All forty-eight LEDs 102 together draw about 480 mA total. LEDs 102 preferably have a view angle (or emergence angle) in a range of at least about 60 degrees to about 80 degrees, and in some embodiments, in a range from about 120 degrees to about 180 degrees.

In one embodiment of FIGURES 1 , 2, 3 and 8, LEDs 102 may irradiate infra-red radiation in a range of about 810 nm to about 850 nm wavelength. As noted above, power supply 107 advantageously delivers power on a timer. Purely by way of example, an 8-minute exposure of radiation of the foregoing configuration of LEDs 102 will deliver about 4.8 Joules/cm² to about 6 Joules/cm² of radiation within intraoral appliance 100. With placement of LEDs 102 at approximately one centimeter spacing and positioned at elevations "d" on FIGURE 3 to view/irradiate the cervical one third of the tooth, such an 8-minute exposure has been shown to deliver excellent healing results. Currently preferred embodiments further select "d" to be about 1 cm, although the scope of this disclosure is not limited to any particular value of'd".

Power supply 107 on FIGURE 1 and circuit diagram 800 on FIGURE 8 are further not limited to the "all LEDs 102 on" or "all LEDs 102 off' embodiment illustrated and described above. Other embodiments of power supply 107 and circuit diagram 800 may enable LEDs 102 to be individually addressed with power, or addressed with power in preselected groups thereof. Combining and/or sequencing hardware may then enable individual/grouped addressable LEDs 102 to follow preselected scripts of power supply and power cut, enabling corresponding patterns of radiation. As a result, the dental professional may program LLLT regimens customized to the needs of the patient. In particular, just by way of example, irradiated tissue cool-down periods maybe programmed into the script by de-energizing individual LEDs 102, or groups thereof, for predetermined periods. After cool-down, such LEDs 102 may be re-energized again to continue treatment. This may be important when working with infra-red radiation on sensitive oral tissue.

It will be appreciated that in such embodiments in which LEDs 102 are individually - or group-addressable, associated components of intraoral appliance 100 are adapted accordingly, including power supply 107 and circuit diagram 800.

With further reference to FIGURE 1 , breathing holes 108 are provided to assist patient breathing while intraoral appliance 100 is in use. Also, multi-pin plug/receptacle 106 is provided in line between power supply 107 and LEDs 102. Plug/receptacle 106 is located such that a pigtail 105 is provided extending from the front of intraoral appliance 100. Pigtail 105 is advantageously long enough so that connection of intraoral appliance 100 to power supply 107 via plug/receptacle 106 may be made outside the patient's mouth. Among other advantages, this feature deters oral secretions from interfering with the electrical connections in plug/receptacle 106 during use of intraoral appliance 100. This feature further assists cleaning of intraoral appliance 100 after use, again by deterring cleaning fluids from interfering with plug/receptacle 106.

FIGURE 4 illustrates a second exemplary embodiment 200 of the disclosed intraoral appliance in which LLLT may be directed to a specific oral region. It will be appreciated that intraoral appliance 200 on FIGURE 4 is similar in form, structure, components, features, circuitry and specification to the example of intraoral appliance 100 on FIGURE 1 , except that intraoral appliance 200 on FIGURE 4 provides 12 (twelve) LEDs 102, six on the buccal side of upper arch 201 A and six on the buccal side of lower arch 201 B. LEDs 102 on FIGURE 4 are focused on the front and outside of the jaws in order to provide localized LLLT in that specific oral region.

FIGURE 5 illustrates a third exemplary embodiment 300 of the disclosed intraoral appliance, similar to intraoral appliance 100 on FIGURE I , except also providing rearward- radiating LEDs 302 for LLLT at the back of the mouth and throat. In this way, intraoral appliance 300 may treat, for example, conditions such as strep throat or temporomandibular joint (TMJ) disorders. It will be appreciated that intraoral appliance 300 on FIGURE 5 is similar in form, structure, components, features, circuitry and specification to the example of intraoral appliance 100 on FIGURE 1. However, intraoral appliance 300 on FIGURE 5 also provides thickened portions 303 in the back regions of upper and lower arches 301 A, 30 IB. Although illustrated on FIGURE 5 on the lingual side, other embodiments may provide thickened portions 303 on the buccal side, or both sides. The scope of this disclosure is not limited in this regard. FIGURE 5 further depicts thickened portions 303 providing rearward- radiating LEDs 302. Although FIGURE 5 illustrates 2 (two) rearward-radiating LEDs 302 on each of 2 (two) thickened portions 303, the scope of this disclosure is again not limited in these regards.

It will be appreciated that the scope of this disclosure is not limited to the general or specific positioning of LEDs 102, 302 on the examples of intraoral appliances 100, 200, 300 as illustrated on FIGURES 1 , 4 and 5 respectively. The positioning of LEDs 102, 302 may be per user requirements to enable patient-specific LLLT. In the exemplary embodiments illustration on FIGURES 1 through 5, LEDs 102, 302 are embedded in a conventional clear plastic or silicone material from which intraoral appliances 100, 200, 300 are formed, so that the irradiated energy is delivered without excessive heat buildup in the patient's tissues. Embedment in the conventional clear plastic or silicone material also protects the patient's mouth from electrical shock. If greater energies are desired, a pulsing of alternate LEDs 102, 302 and/or arches 101 A/B. 201 A/B, 301A/B may be provided and controlled by the power pack 107 and associated timer. This pulsing option may be adjusted to very low energy levels for long durations, which has been demonstrated to help healing in cases of extreme oral tissue degeneration, such as, for example, with patients with AIDS or other auto immune diseases. Some research shows this type of low energy for long durations can boost natural immune defenses.

FIGURE 6 illustrates a fourth exemplary embodiment 400 of the disclosed intraoral appliance, similar to other exemplary embodiments illustrated on FIGURES 1 through 5 and described above, except that intraoral appliance 400 on FIGURE 6 deploys lasers as source of LLLT radiation. FIGURE 7 is a section as shown on FIGURE 6. Looking at FIGURE 6, and with comparison to FIGURE 1 for example, intraoral appliance 400 on FIGURE 6 is similar in many regards to intraoral appliance 100 on FIGURE 1 , except that LEDs 102 on FIGURE 1 have been substituted for lasers 410 on FIGURE 6. Similar to intraoral appliance 100 on FIGURE 1 , the example of intraoral appliance 400 on FIGURE 6 provides 48 (forty-eight) lasers 410 in total : 24 (twenty-four) lasers 410 on each of the upper and lower arches 401 A and 401 B, each arch 401 A, 40 I B comprising 12 (twelve) lasers 410 on each of the left and right sides, each side comprising 6 (six) lasers 410 on each of the buccal and lingual faces. Similar to FIGURE 1, lasers 410 on FIGURE 6 may be positioned to irradiate generally from the midline to about the second molars on both left and right sides of both the upper and lower jaws, from both lingual and buccal sides.

FIGURE 6 also illustrates breathing holes 408 to assist patient breathing while intraoral appliance 400 is in use. Visual on/off indicator 409 is also provided. Multi-line plug/receptacle 406 is further provided in line between laser power supply 407 and lasers 410. Plug/receptacle 406 is located such that a pigtail 405 is provided extending from the front of intraoral appliance 400. As with pigtail 105 on FIGURE 1 (refer discussion above), pigtail 405 on FIGURE 6 is advantageously long enough so that connection of intraoral appliance 400 to power supply 407 via plug/receptacle 406 may be made outside the patient's mouth.

FIGURE 7 depicts lasers 410 each being addressed by a separate laser supply line 41 1 (e.g. optical cable). Each laser supply line 41 1 may be supplied by power supply 407 individually and/or in a predefined group thereof. Lasers 410 may thus be individually addressable, or addressable in a predefined group thereof. As discussed analogously above referring to LEDs 102 on FIGURE 1 , lasers 410 on FIGURES 6 and 7 may thus be programmed by the dental professional to follow an illumination script customized to the needs of the patient. The scope of this disclosure is not limited in this regard.

Different power supplies 407 may also energize different lasers 410 having different wavelengths. Conversely, multiple lasers 410 may be supplied by one power supply 407. The scope of this disclosure is not limited in this regard. For example, in orthodontic applications, visible blue radiation (about 570 nm wavelength) will deter cavities from forming by killing bacteria, while infra-red radiation will minimize pain by reducing inflammation.

For additional reference, the illustrations in commonly-invented U.S. Provisional Patent Application Serial No. 62/369,843, incorporated herein by reference, include photographs depicting actual prototypes of embodiments of the disclosed intraoral appliance. See Figures 5, 6 and 7 of 62/369,843, which are self-explanatory in view of the exemplary embodiments depicted and described above with reference to FIGURES 1 through 8 in this disclosure.

As noted in the "Summary" section, the disclosed intraoral appliance functions as a combined healing and rapid orthodontic stimulator, and advantageously applies the correct levels of radiation energy at the correct wavelengths in a manner that is controlled and definite to the target tissues. By improving the published research with our own inventive research, we have configured our new intraoral appliance (and associated power pack) to deliver both visible and infrared wavelengths either separately or simultaneously. Tests using the appliance have shown startling and unexpected improvements in medical results. The following paragraphs describe examples of the improvements observed, and examples of construction embodiments that may be configured to achieve desired results.

Example 1. Using wavelengths in the infrared spectrum has been shown to help stimulate rapid redirection and movement of teeth in orthodontic applications. Our appliance has advanced orthodontic movement where desired results are now taking 1 -4 months, as compared to 2-3 years historically seen in conventional cases without infrared LLLT.

Example 2. These same infrared wavelengths can be used to stimulate proper and rapid healing after oral surgery, periodontal surgery, oral injuries, and oral stomatitis induced by cancer chemotherapy. By combining both blue LEDs (about 550 to about 570 nm wavelength) to induce bactericidal effects, with infrared LEDs (about 800 nm to about 1064 nm wavelength) to reduce inflammation and stimulate rapid healing, outstanding intraoral healing has been observed with decreased healing times and very infrequent infections.

The intraoral appliances described in this disclosure may be manufactured in a range of standard sizes to fit patients of various ages, having mouths of various dimensions. Additionally, intraoral appliances described herein may be made with extra-wide arches to accommodate patients with braces or other orthodontics.

As noted earlier in this disclosure, the scope of our intraoral appliance is not limited to the exemplary embodiments illustrated on FIGURES 1 through 8, and alterations may be made to the exemplary embodiments of FIGURES 1 through 8 to offer different advantageous results. For example, and without limitation, such alterations may include: (1 ) positioning of the LEDs or lasers within the buccal or lingual flange (higher/lower or laterally), (2) the number of LEDs or lasers (including LED and laser hybrids), (3) the LED or laser irradiated wavelengths and combinations thereof, and (4) the script programmed into the power pack (or other ancillary control hardware) so that each combination of radiation sources can enable different patterns of time exposure and/or sequence exposure. Further, our appliance can be manufactured (A) with both upper and lower arches together or separate, or (B) upper and lower segmental arches restricting light exposure to only the upper and lower right side (appliance can then be flipped over to be use on the left side) or limited to the anterior 6 teeth also in either upper and lower or only one anterior sectional arch (which can be used either on upper or lower anterior 6 teeth).

The radiation sources on the appliance can also be positioned to expose any wavelength (visible or infrared, for example) at the posterior regions on either upper or lower arches, buccal or lingual sides, in order to irradiate the posterior oral cavity, lingual, and oropharynx. With blue radiation sources positioned here, for example infections of the throat, soft palate and tonsils can be treated often without antibiotics. And with infrared radiation sources added, reduction of inflammation and association stimulation of healing of tissues can be accelerated by a factor of 4-6 times normal healing rates.

By limiting the radiation sources to buccal areas and turning the exposure side outwards, the lips can be treated with LLLT, which can be useful in stimulating healing with soft tissue procedures intraorally and extaorally for faster healing with fewer complications and less scarring.

Also, a differently constructed appliance, only using lingually positioned LEDs with irradiation directed toward the tongue and or palate, instead of toward the teeth and bone, can be used for promotion of rapid and uncomplicated healing after surgeries of the hard and soft palate or tongue.

Variations. Although the following material may duplicate disclosure above in places, we describe in the following paragraphs some alternative embodiments and variations of the exemplary embodiments illustrated on FIGURES 1 through 8. The following alternative embodiments and variations are not exhaustive. We consider these alternative embodiments and variations within the inventive scope of this disclosure.

1. Upper and lower arches with infrared radiation sources exposed towards teeth, gum tissue and bone.

2. Upper and lower arches with visible and infrared radiation sources exposed towards teeth, gum tissue and bone.

3. Sectional or partial coverage with infrared radiation sources exposed towards teeth, gum tissue and bone.

4. Sectional and partial coverage with visible and infrared radiation sources exposed towards teeth, gum tissue and bone.

5. Upper and lower arches with infrared radiation sources exposed towards lips and/or palate tissues and tongue.

6. Upper and lower arches with visible and infrared radiation sources exposed towards lips and/or palate tissues and tongue.

7. Sectional or partial coverage with infrared radiation sources exposed towards lips and/or palate tissues and tongue.

8. Sectional and partial coverage with visible and infrared radiation sources exposed towards lips and/or palate tissues and tongue.

9. Intraoral appliance with infrared and/or visible radiation sources exposed toward the posterior of the mouth and tongue, the throat and oropharynx.

10. As an alternative to LEDs, lasers at the radiation sites or fiber optics delivering laser radiation from within the power pack to the radiation sites on the appliance. The end terminus of each fiber optic strand in a bundle would have light emissions at each location described for the LEDs. Separate and different wavelengths of several lasers can be in one power pack and thereby produce the same range of visible and infrared emissions that the LEDs provide and at the same energy flow and positions.

Although the inventive material in this disclosure has been described in detail along with some of its technical advantages, it will be understood that various changes, substitutions and alternations may be made to the detailed embodiments without departing from the broader spirit and scope of such inventive material as set forth in the following claims.

Claims

CLAIMS We claim:

1. An intraoral device, comprising:

at least one of upper and lower arches, wherein each arch is shaped to be received over a corresponding one of upper and lower teeth sets in situ in a mouth;

at least one set of radiation sources, wherein a predetermined number of radiation sources are provided in each set thereof;

wherein radiation source sets are deployed on arches in predetermined locations such that the radiation sources in such deployed sets are disposed to irradiate preselected targets within the mouth; and

a power supply, wherein the power supply is configured to energize selected radiation source sets according to a predetermined energization/de-energization script, wherein further the script includes energization and de-energization of selected radiation source sets for selected time periods according to a predetermined combination and sequence of set energization and de-energization.

2. The intraoral device of claim 1 , in which at least one preselected target within the mouth is selected from the group consisting of:

(a) lingual sides of selected teeth;

(b) buccal sides of selected teeth;

(c) lingual sides of selected gum tissue regions;

(d) buccal sides of selected gum tissue regions;

(e) lingual sides of selected bone regions; and

(f) buccal sides of selected bone regions.

3. The intraoral device of claim 2, in which at least one preselected target within the group of claim 2 is selected to extend from the midline of the mouth to about the second molar tooth.

4. The intraoral device of claim 1 , in which at least one preselected target within the mouth is selected from the group consisting of:

(a) the tongue;

(b) the palate; (c) the lips;

(d) the throat;

(e) the oropharynx; and

(f) the tonsils.

5. The intraoral device of claim 1 , in which at least one radiation source is selected from the group consisting of:

(a) an LED; and

(b) a laser.

6. The intraoral device of claim 1 , in which at least one radiation source irradiates light in a wavelength range selected from the group consisting of:

(a) about 550 nm to about 570 nm;

(b) about 810 nm to about 850 nm; and

(c) about 800 nm to about 1064 nm.

7. The intraoral device of claim 1, in which the predetermined energization/de- energization script includes pulsing of selected radiation source sets.

8. The intraoral device of claim 1 , further comprising a power connector in line between the power supply and the intraoral device, wherein the power connector is located outside the mouth when the intraoral device is resident inside the mouth.

9. The intraoral device of claim 1 , further comprising an on/off indicator irradiating visible light when the power supply is energized and delivering power to the intraoral device.