Method Of Using Homeopathic Kit Containing Gel, Rinse And Spray For Management Of Post-Oral Surgical Recovery And Maintenance Of Oral Health

Abstract

Methods of maintaining general oral care as well as reducing inflammation, pain and bruising after oral surgery with a homeopathic recovery kit are disclosed.

Claims

1. A homeopathic formulation for oral care comprising Hepar sulphuris calcareum, Calendula officinalis, Chamomilla, Aconitum napellus, Echinacea angustifolia, Echinacea purpurea, Ruta graveolens, Arnica montana, Mercurius vivus, Hypericum, Gelsemium, and Ignatia amara and optionally further comprising inactive ingredients.

2. The formulation of claim 1, wherein the oral care comprises general oral maintenance, reduction of flora in the mouth, reduction of pain in the oral cavity, reduction of inflammation in the oral cavity, reduction of edema in the oral cavity, the reduction of bruising in the oral cavity, the treatment of trismus, recovery after dental surgeries, pre-treatment prior to surgery pertaining to the oral cavity, the amelioration of anxiety associated with dental care or preventative measures for maladies of the oral cavity such as cavities, tooth decay, bone loss or periodontal pocket formation.

3. The homeopathic formulation of claim 1, wherein the homeopathic formulation is a spray or drops.

4. The homeopathic formulation of claim 3, wherein the spray or drops is part of a kit.

5. The homeopathic formulation of claim 4, wherein the kit comprises the spray or drops and further comprises a homeopathic gel formulation comprising Hepar sulphuris calcareum, Calendula officinalis, Chamomilla, Aconitum napellus, Echinacea angustifolia, Echinacea purpurea, Ruta graveolens, Arnica montana, Mercurius vivus, Hypericum, Gelsemium, and Ignatia amara and optionally further comprising inactive ingredients.

6. The homeopathic formulation of claim 5, wherein the kit further comprises a homeopathic rinse formulation comprising Calendula officinalis, Echinacea purpurea, Plantago major, and Azadirachta indica and optionally further comprising inactive ingredients.

7. A method of maintaining oral health comprising the homeopathic formulation of claim 1, wherein the maintaining of oral health comprises general oral maintenance, reduction of flora in the mouth, reduction of pain in the oral cavity, reduction of inflammation in the oral cavity, reduction of edema in the oral cavity, the reduction of bruising in the oral cavity, the treatment of trismus, recovery after dental surgeries, pre-treatment prior to surgery pertaining to the oral cavity, the amelioration of anxiety associated with dental care or preventative measures for maladies of the oral cavity such as cavities, tooth decay, bone loss or periodontal pocket formation.

8. A method of maintaining oral health comprising the homeopathic formulation of claim 6, wherein the maintaining of oral health comprises general oral maintenance, reduction of flora in the mouth, reduction of pain in the oral cavity, reduction of inflammation in the oral cavity, reduction of edema in the oral cavity, the reduction of bruising in the oral cavity, the treatment of trismus, recovery after dental surgeries, pre-treatment prior to surgery pertaining to the oral cavity, the amelioration of anxiety associated with dental care or preventative measures for maladies of the oral cavity such as cavities, tooth decay, bone loss or periodontal pocket formation.

9. A method of ameliorating or treating pain, inflammation and/or trismus comprising the homeopathic formulation of claim 6, wherein the pain, inflammation and/or trismus is a result of dental or oral surgery.

10. A method of shortening the duration and severity of maximum pain, inflammation and/or trismus comprising the homeopathic formulation of claim 6, wherein the pain, inflammation and/or trismus is a result of dental or oral surgery.

11. A method of promoting healing at a dental site comprising the homeopathic formulation of claim 6, wherein the healing is a result of dental or oral surgery.

12. A method of reducing the dosage of narcotics needed to relieve post-operative pain comprising the formulation of claim 6, wherein the narcotics are administered post-operatively to a surgical procedure of the oral or dental cavity.

13. The method according to claim 8, wherein the dental surgery is selected from the group consisting of: wisdom teeth removal, dental implants placement, advanced bone reconstruction, the use of BMP (bone morphogenetic proteins), dental extractions, bone grafting, soft tissue grafting, facial trauma, facial reconstruction, orthognathic surgery, periapical surgery and any other oral surgical procedure.

14. The method according to claim 8, wherein the formulations of the kit are applied topically and have a systemic effect.

15. The method according to claim 8, wherein one or more additional therapeutic agents are administered before, during and/or after a surgical procedure and the additional therapeutic agents are agents known to reduce pain, inflammation, bruising, edema and/or promote healing.

16. A method according to anyone of claims 7-12, comprising the homeopathic kit according to the following table: TABLE-US-00018 KIT SPRAY or DROPS GEL RINSE Hepar sulphuris calcareum Hepar sulphuris calcareum 8X, Calendula officinalis 1X 8X, Calendula officinalis 3X, Echinacea purpurea 1X Calendula officinalis 3X, Chamomilla 5X, Plantago major 1X Chamomilla 5X, Aconitum napellus 3X, Azadirachta indica/Neem 1X Aconitum napellus 3X, Echinacea angustifolia 3X, Inactive ingredients: Xylitol, Echinacea angustifolia 3X, Echinacea purpurea 3X Allantoin, Peppermint oil, Glycerin, Echinacea purpurea 3X Ruta graveolens 12X, Citric acid, potassium sorbate, Ruta graveolens 12X, Arnica montana, 3X, 6X, 18X, Purified Water, Polysorbate 20 Arnica montana 3X, 6X, 18X, Mercurius vivus 10X, Mercurius vivus 10X, Hypericum 10X, Hypericum 10X, Gelsemium 30X, Gelsemium 30X, Ignatia amara 30X Ignatia amara 30X Inactive ingredients: allantoin, Inactive ingredients: citric hydroxyethylcellulose, peppermint acid, glycerin, potassium oil, purified water, sodium benzoate, sorbate, purified water xylitol

17. A homeopathic kit comprising a spray or drops, a gel and a rinse according to the following table: TABLE-US-00019 KIT SPRAY or DROPS GEL RINSE Hepar sulphuris calcareum Hepar sulphuris calcareum 8X, Calendula officinalis 1X 8X, Calendula officinalis 3X, Echinacea purpurea 1X Calendula officinalis 3X, Chamomilla 5X, Plantago major 1X Chamomilla 5X, Aconitum napellus 3X, Azadirachta indica/Neem 1X Aconitum napellus 3X, Echinacea angustifolia 3X, Inactive ingredients: Xylitol, Echinacea angustifolia 3X, Echinacea purpurea 3X Allantoin, Peppermint oil, Glycerin, Echinacea purpurea 3X Ruta graveolens 12X, Citric acid, potassium sorbate, Ruta graveolens 12X, Arnica montana, 3X, 6X, 18X, Purified Water, Polysorbate 20 Arnica montana 3X, 6X, 18X, Mercurius vivus 10X, Mercurius vivus 10X, Hypericum 10X, Hypericum 10X, Gelsemium 30X, Gelsemium 30X, Ignatia amara 30X Ignatia amara 30X Inactive ingredients: allantoin, Inactive ingredients: citric hydroxyethylcellulose, peppermint acid, glycerin, potassium oil, purified water, sodium benzoate, sorbate, purified water xylitol

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0036] FIG. 1 is a graphical representation of the average number of NORCO® pills required post surgically as a result of the treatment of Example 1.

DETAILED DESCRIPTION OF THE INVENTION

[0037] The present invention will now be described more fully hereinafter with reference to the accompanying figures, in which preferred embodiments of the invention are illustrated. This invention may, however, be embodied in different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

[0038] Homeopathic mother tinctures are made following monographs published by Homeopathic Pharmacopeia of the United States (H.P.U.S.). While plants are the base ingredients for most homeopathic tinctures, some are made from mineral, animal or other non-tangible substances. A homeopathic mother tincture, comprising base ingredients such as for example fresh plants and/or herbs, is generally prepared by extracting the ingredients in a suitable solvent. Suitable solvents include alcohol, water, water-alcohol mixtures, glycerine or isotonic sodium chloride solutions. Other parts of the extraction process may include the steps of comminution, maceration and squeezing according to accepted homeopathic pharmacopoeia.

[0039] As used herein, the term “tincture” refer to extracts of a part, combinations of parts and/or the entirety of an ingredient. The “tincture” can be prepared by exposing a part; parts and/or the entirety of the ingredient in a solvent, e.g. alcohol and/or water. The “tincture” of an ingredient preferably is a mother tincture of the ingredient prepared according to the procedures in the Homeopathic Pharmacopeia of the United States (HPUS) which is incorporated herein by reference in its entirety.

[0040] Original tinctures prepared according to HPUS can be called a mother tincture and are typically a 1×potency (1×10−1 dilution) according to the decimal scale. The mother tincture can be further diluted and/or succussed (further dilution with a solvent and then vigorously shaken). The dilution and succussion potencies are denoted as “X” or “D” for the decimal scale. There are other applicable scales that some practitioners use such as the centesimal and quintamillesimal scales. According to the decimal scale, each successive dilution will dilute the substance ten times its volume. For example, a 1×dilution has an ingredient to solvent ratio of 1:10, a 2×dilution has an ingredient to solvent ratio of 1:100, a 3×dilution has an ingredient to solvent ratio of 1:1000, a 4×dilution has an ingredient to solvent ratio of 1:10000, a 5×dilution has an ingredient to solvent ratio of 1:100000, a 6×dilution has an ingredient to solvent ratio of 1:1000000, a 7×dilution has an ingredient to solvent ratio of 1:10.sup.7, a 8×dilution has an ingredient to solvent ratio of 1:10.sup.8, a 9×dilution has an ingredient to solvent ratio of 1:10.sup.9, a 10×dilution has an ingredient to solvent ratio of 1:10.sup.10, a 11×dilution has an ingredient to solvent ratio of 1:10.sup.11, a 12×dilution has an ingredient to solvent ratio of 1:10.sup.12, a 13×dilution has an ingredient to solvent ratio of 1:10.sup.13, a 14×dilution has an ingredient to solvent ratio of 1:10.sup.14, a 15×dilution has an ingredient to solvent ratio of 1:10.sup.15, a 16×dilution has an ingredient to solvent ratio of 1:10.sup.16, a 17×dilution has an ingredient to solvent ratio of 1:10.sup.17, a 18×dilution has an ingredient to solvent ratio of 1:10.sup.18, a 19×dilution has an ingredient to solvent ratio of 1:10.sup.19, a 20×dilution has an ingredient to solvent ratio of 1:10.sup.20, a 21×dilution has an ingredient to solvent ratio of 1:10.sup.21, a 22×dilution has an ingredient to solvent ratio of 1:10.sup.22, a 23×dilution has an ingredient to solvent ratio of 1:10.sup.23, a 24×dilution has an ingredient to solvent ratio of 1:10.sup.24, a 25×dilution has an ingredient to solvent ratio of 1:10.sup.25, a 26×dilution has an ingredient to solvent ratio of 1:10.sup.26, a 27×dilution has an ingredient to solvent ratio of 1:10.sup.27, a 28×dilution has an ingredient to solvent ratio of 1:10.sup.28, a 29×dilution has an ingredient to solvent ratio of 1:10.sup.29, a 30×dilution has an ingredient to solvent ratio of 1:10.sup.30, a 31×dilution has an ingredient to solvent ratio of 1:10.sup.31, a 32×dilution has an ingredient to solvent ratio of 1:10.sup.32, a 33×dilution has an ingredient to solvent ratio of 1:10.sup.33, a 34×dilution has an ingredient to solvent ratio of 1:10.sup.34, a 35×dilution has an ingredient to solvent ratio of 1:10.sup.35, and so on. The table below shows additional details for some of the potency levels.

[0041] Examples of Decimal Homeopathic Dilutions

TABLE-US-00001 Decimal Potency Dilution Concentration 1X or 1D 1:10 10.sup.−1 2X or 2D 1:100 10.sup.−2 3X or 3D 1:1000 10.sup.−3 4X or 4D 1:10000 10.sup.−4 5X or 5D 1:100000 10.sup.−5 6X or 6D 1:1000000 10.sup.−6 7X or 7D 1:10000000 10.sup.−7 8X or 8D 1:100000000 10.sup.−8 10X or 10D 1:10000000000 .sup. 10.sup.−10 12X or 12D 1:10.sup.12 .sup. 10.sup.−12 18X or 18D 1:10.sup.18 .sup. 10.sup.−18 30X or 30D 1:10.sup.30 .sup. 10.sup.−30

[0042] The homeopathic ingredients can be present in any amount that is safe and effective. The ingredients can be present in from dilutions from 1× to 40×. More preferably, the ingredients can be present in dilutions of 1×, 2×, 3×, 4×, 5×, 6×, 7×, 8×, 9×, 10×, 11×, 12×, 13×, 14×, 15×, 16×, 17×, 18×, 19×, 20×, 21×, 22×, 23×, 24×, 25×, 26×, 27×, 28×, 29×, 30×, 31×, 32×, 33×, 34×, 35×, 36×, 37×, 38×, 39×, or 40×.

[0043] Drops

[0044] In one embodiment, the present invention is a drop(s) comprising homeopathic ingredients. In one embodiment, the homeopathic drops comprise the following ingredients: Hepar sulphuris calcareum (also known as Calcium sulphide of Hahnemann, and sulphur of lime), Calendula officinalis (also known as Calendule, Calendula or C. officinalis), Chamomilla (also known as Matricaria recutita or chamomile), Aconitum napellus (also known as monkshood, aconite, wolfsbane, fuzi, monk's blood or acon), Echinacea angustifolia (also known as or Echinacea or E. angustifolia), Echinacea purpurea (sometimes referred to as Brauneria purpurea (L.) Britton, Helichroa purpurea (L.) Raf. and/or Eastern purple coneflower), Ruta graveolens (also known as or rue or R. graveolens), Arnica montana (also known as or arnica or A. montana), Mercurius vivus (also known as Quicksilver), Hypericum (also known as St. John's wort), Gelsemium, Ignatia amara (also known as ignatia, ignatia amara, samara, Strychnos ignatii or s. ignatii) and optionally inactive ingredients. The drops/spray gets absorbed systemically through sublingual mucosa. It acts systemically to decrease pain, swelling/edema including oral cavity. The use of the drops shorten the time to, duration of and duration of maximum pain, inflammation and/or trismus after a dental surgery. Additionally, when used in combination with VEGA™ rise and gel, use of the drops after dental surgery reduce the needed dosage of narcotics when used in combination.

[0045] In another embodiment the homeopathic drops and/or spray comprise the following ingredients in the following amounts: Hepar sulphuris calcareum having a dilution of 8×, Calendula officinalis having a dilution of 3×, Chamomilla having a dilution of 5×, Aconitum napellus having a dilution of 3×, Echinacea angustifolia having a dilution of 3×, Echinacea purpurea having a dilution of 3×, Ruta graveolens having a dilution of 12×, Arnica montana having a dilution of 3×, 6×, 18×, Mercurius vivus having a dilution of 10×, Hypericum having a dilution of 10×, Gelsemium having a dilution of 30×, and Ignatia amara having a dilution of 30×.

[0046] Gel

[0047] In one embodiment, the present invention is a gel comprising homeopathic ingredients. In one embodiment, the homeopathic gel comprises the following ingredients: Hepar sulphuris calcareum, Calendula officinalis, Chamomilla, Aconitum napellus, Echinacea angustifolia, Echinacea purpurea, Ruta graveolens, Arnica montana, Mercurius vivus, Hypericum, Gelsemium, Ignatia amara and optionally inactive ingredients. The gel can be used locally and have local effects. The gel can be applied topically. The gel can be applied directly on the oral mucosa. Moreover, the gel can get absorbed systemically as well and have systemic effects. The gel placed on the oral mucosa provides an alternative to injection into.

[0048] In another embodiment the homeopathic gel comprises the following ingredients in the following amounts: Hepar sulphuris calcareum having a dilution of 8×, Calendula officinalis having a dilution of 3×, Chamomilla having a dilution of 5×, Aconitum napellus having a dilution of 3×, Echinacea angustifolia having a dilution of 3×, Echinacea purpurea having a dilution of 3×, Ruta graveolens having a dilution of 12×, Arnica montana having a dilution of 3×, 6×, 18×, Mercurius vivus having a dilution of 10×, Hypericum having a dilution of 10×, Gelsemium having a dilution of 30×, and Ignatia amara having a dilution of 30×.

[0049] The gel has unique formula that allows direct delivery and absorption of active ingredients through oral mucosa. In the studies performed, it has shown to significantly reduce edema, pain and swelling associated with surgeries, provide immediate relief for Aphthous ulcers and cold sores.

[0050] Rinse

[0051] In one embodiment, the present invention is a rinse comprising homeopathic ingredients. In one embodiment, the homeopathic rinse comprises the following ingredients Calendula officinalis, Echinacea purpurea, Plantago major, Azadirachta indica (also known as Neem) and optionally inactive ingredients.

[0052] In one embodiment, the homeopathic rinse comprises the following ingredients in the following amounts: Calendula officinalis having a dilution of 1×, Echinacea purpurea having a dilution of 1×, Plantago major having a dilution of 1×, Azadirachta indica (also known as Neem) having a dilution of 1×, and optionally inactive ingredients.

[0053] The rinse was tested according to ASTM International Method E2315, Assessment of Antimicrobial Activity using a Time-Kill Procedure and the results can be found in the table below.

TABLE-US-00002 SPRAY Percent Log.sub.10 Reduction Reduction Test Compared Compared Average Average Micro- Test Contact to Control at to Control at Percent Log.sub.10 organism Substance Time Replicate CFU/ml Time Zero Time Zero Reduction Reduction S. mutans VEGA ™ Time Initial 3.95E+06 N/A N/A ATCC Dental Zero Numbers 25175 Rinse Control 45 Min 1 1.60E+04 99.59% 2.39 99.65% 2.46 2 1.10E+04 99.72% 2.56 3 1.45E+04 99.63% 2.44

[0054] In one embodiment, the present invention is a spray comprising homeopathic ingredients. In one embodiment, the homeopathic spray comprises the following ingredients: Hepar sulphuris calcareum (also known as Calcium sulphide of Hahnemann, and sulphur of lime), Calendula officinalis (also known as Calendule, Calendula or C. officinalis), Chamomilla (also known as Matricaria recutita or chamomile), Aconitum napellus (also known as monkshood, aconite, wolfsbane, fuzi, monk's blood or acon), Echinacea angustifolia (also known as or Echinacea or E. angustifolia), Echinacea purpurea (sometimes referred to as Brauneria purpurea (L.) Britton, Helichroa purpurea (L.) Raf. and/or Eastern purple coneflower), Ruta graveolens (also known as or rue or R. graveolens), Arnica montana (also known as or arnica or A. montana), Mercurius vivus (also known as Quicksilver), Hypericum (also known as St. John's wort), Gelsemium , Ignatia amara (also known as ignatia, ignatia amara, samara, Strychnos ignatii or s. ignatii) and optionally inactive ingredients. The use of the spray shortens the time to, the intensity of and the duration of maximum pain, inflammation and/or trismus after a dental surgery. Additionally, when used in combination with VEGA rinse and gel, the spray reduces the necessary dosage of narcotics when both are used in combination.

[0055] In another embodiment the homeopathic spray comprises the following ingredients in the following amounts: Hepar sulphuris calcareum having a dilution of 8×, Calendula officinalis having a dilution of 3×, Chamomilla having a dilution of 5×, Aconitum napellus having a dilution of 3×, Echinacea angustifolia having a dilution of 3×, Echinacea purpurea having a dilution of 3×, Ruta graveolens having a dilution of 12×, Arnica montana having a dilution of 3×, 6×, 18×, Mercurius vivus having a dilution of 10×, Hypericum having a dilution of 10×, Gelsemium having a dilution of 30×, and Ignatia amara having a dilution of 30×.

[0056] In some instances, the formulation of the spray is identical to that of the drops except to the extent of the packaging. Therefore, the terms “spray” and “drop or drops” have the same meaning and can be used interchangeably unless otherwise indicated.

[0057] In other embodiments the invention is in a form of a solution, an oral tablet, pill, pillule, gel cap, syrup, elixir, suspension, emulsion, capsules, powders, globules, lozenges, aerosol, paste, film or pellets. Preferably, the inventive formulation is applied topically, which includes as non-limiting examples sublingually, as a rinse, as a gel, and/or any manner prescribed by a practitioner. The inventive formulation can be administered at a dosage amount, application time and regimen as prescribed by a practitioner.

[0058] In some embodiments, the present invention is a kit comprising a spray/drops/pallets, a gel and a rinse. In some embodiments, the present invention is a kit comprising a spray and a gel. In some embodiments, the present invention is a kit comprising a spray and a rinse. In some embodiments, the present invention is a kit comprising a gel and a rinse. In other embodiments, the present invention is a kit comprising drops, a gel and a rinse. In some embodiments, the present invention is a kit comprising drops and a gel. In some embodiments, the present invention is a kit comprising drops and a rinse.

[0059] All of the spray, drops, gel and rinse can be packaged separately or together. Preferably, all of the spray (or drops), gel and rinse are individually packaged. More preferably, all of the spray (or drops), gel and rinse are individually contained and then packaged together as a kit.

[0060] The formulations can be applied prior to any surgical procedures, preferably any dental procedures. The formulations can, for example, be applied 5 days before surgery and every day up to surgery. The formulations can, for example, be applied 4 days before surgery and every day up to surgery. The formulations can, for example, be applied 3 days before surgery and every day up to surgery. The formulations can, for example, be applied 2 days before surgery and every day up to surgery. The formulations can, for example, be applied 1 day before surgery and every day up to surgery. The formulations can, for example, be applied prior to and the day of surgery.

[0061] The formulations can, for example, be applied the day after surgery and for 5 days post-surgery. The formulations can, for example, be applied the day after surgery and for 4 days post-surgery. The formulations can, for example, be applied the day after surgery and for 3 days post-surgery. The formulations can, for example, be applied the day after surgery and for 2 days post-surgery. The formulations can, for example, be applied post-operatively on the same day as surgery. More preferably, the formulations, can for example, be applied prior to, the day of and the day or days after surgery.

[0062] The formulations can, for example, be applied every day consecutively or can be applied as needed. The formulations can be used 1× a day. The formulations can be used 2× a day. The formulations can be used 3× a day. The formulations can be used 4× a day. The formulations can be used 5× a day. The dosage amounts and dosage routine of the each of the spray, gel and rinse can be the same or different.

[0063] In one embodiment, the kit comprising a spray, a gel and a rinse can have the following ingredients in the dilutions listed in the table below.

TABLE-US-00003 KIT DROPS/SPRAY GEL RINSE Hepar sulphuris calcareum Hepar sulphuris calcareum Calendula officinalis 1X 8X, 8X, Echinacea purpurea 1X Calendula officinalis 3X, Calendula officinalis 3X, Plantago major 1X Chamomilla 5X, Chamomilla 5X, Azadirachta indica/Neem Aconitum napellus 3X, Aconitum napellus 3X, 1X Echinacea angustifolia 3X, Echinacea angustifolia 3X, Inactive ingredients: Xylitol, Echinacea purpurea 3X Echinacea purpurea 3X Allantoin, Peppermint oil, Ruta graveolens 12X, Ruta graveolens 12X, Glycerin, Citric acid, Arnica montana 3X, 6X, Arnica montana, 3X, 6X, potassium sorbate, Purified 18X, 18X, Water, Polysorbate 20 Mercurius vivus 10X, Mercurius vivus 10X, Hypericum 10X, Hypericum 10X, Gelsemium 30X, Gelsemium 30X, Ignatia amara 30X Ignatia amara 30X Inactive ingredients: citric Inactive ingredients: acid, glycerin, potassium allantoin, sorbate, purified water hydroxyethylcellulose, peppermint oil, purified water, sodium benzoate, xylitol

[0064] Preferred inactive ingredients are citric acid, glycerin, potassium sorbate, and purified water. Other preferred inactive ingredients are allantoin, hydroxyethylcellulose, peppermint oil, purified water, sodium benzoate, and xylitol. Still other preferred inactive ingredients are Xylitol, Allantoin, Peppermint oil, Glycerin, Citric acid, Potassium sorbate, Purified Water, Polysorbate 20 and Poloxamer 407.

[0065] Other inactive ingredients may be any ingredient that forms a desirable consistency for the homeopathic ingredients. Inactive ingredients, such as excipients that are common to the health and/or cosmetic industries, as well as minerals, such as sea minerals can be used. Sea minerals, which can be included in the homeopathic formulation of the present invention include one or more of the following elements: Antimony, Barium, Beryllium, Bismuth, Boron, Bromine, Cadmium, Calcium, Carbonate, Cerium, Cesium, Chloride, Chromium, Cobalt, Copper, Dysprosium, Erbium, Europium, Gadolinium, Gallium, Germanium, Gold, Hafnium, Holmium, Indium, Iodine, Iridium, Iron, Lanthanum, Lead, Lithium, Lutetium, Magnesium, Manganese, Molybdenum, Neodymium, Nickel, Niobium, Osmium, Palladium, Phosphorus, Platinum, Potassium, Praseodymium, Rhenium, Rhodium, Rubidium, Ruthenium, Samarium, Scandium, Selenium, Silicon, Silver, Sodium, Strontium, Sulfate/Sulfur, Tantalum, Tellurium, Terbium, Thallium, Thorium, Thulium, Tin, Titanium, Tungsten, Vanadium, Ytterbium, Yttrium, Zinc, Zirconium, plus other naturally occurring trace minerals.

[0066] Preservatives such as potassium sorbate or silver can also be included in the homeopathic formulations.

[0067] The compositions herein taught might also be combined with surfactants and or items such as Dimethyl sulfoxide (DMSO) that may assist, such as, in the penetration of the skin. Optional ingredients are those that when combined with the inventive products, result in the same cutaneous reduction of swelling, bruising, pain. Other examples of some excipients used in accordance with the invention are viscosity modifying agents, buffers, antioxidants, emulsifying agents, absorbents, antiacne agents, antiperspirants, anticaking agents, antifoaming agents, antimicrobial agents, anti-infective agents, antioxidants, antidandruff agents, astringents, binders, buffers, biological additives, buffering agents, bulking agents, chelating agents, chemical additives, coupling agents, conditioners, colorants, cosmetic astringents, cosmetic biocides, denaturants, drug astringents, detergents, dispersants, external analgesics, film formers, foaming agents, fragrance components, flavoring agents humectants, keratolytics, opacifying agents, pH adjusters, preservatives, propellants, proteins, retinoids, reducing agents, sequestrants, skin bleaching agents, skin-conditioning agents (humectants, miscellaneous, and occulsive), skin soothing agents, skin healing agents, softeners, solubilizing agents, lubricants, penetrants, plastisizers, solvents and co-solvents, sunscreening additives, sweeteners, salts, essential oils, and vitamins. In some embodiments, homeopathic formulations may include inactive ingredients ranging from about 0.01 wt % to about 95 wt % relative to the total weight of the formulation.

[0068] In another embodiment, the invention demonstrates antimicrobial properties.

[0069] The inventive formulations herein might also be administered simultaneously or during or instead of, treatment with prescription medications such as NORCO® (also known as VICODIN®, and wherein any reference to NORCO® throughout shall mean Hydrocodeine 5 mg/Acetominophen 325 mg), DECADRON® 8 mg IV at the time of the surgery, MOTRIN® 600 mg, and/or additional analgesics, steroids or the like considered appropriate by a skilled practitioner.

[0070] Preparation

[0071] The ingredients used to formulate the compositions of the present invention were obtained from plants, minerals or animal substances and are readily available at homeopathic pharmacies. The homeopathic ingredients can also be obtained from other sources such as online sources (http://www.hahnemannlabs.com/ or http://www.swansonvitamins.com/). Each homeopathic remedy is attenuated using the decimal scale to the final potency ie: 3×, 5×, 9× etc. as described in the HPUS.

[0072] A spray formulation is made by combing homeopathic ingredients with the optional and/or inactive ingredients. For example, Hepar sulphuris calcareum, Calendula officinalis, Chamomilla, Aconitum napellus, Echinacea angustifolia, Echinacea purpurea, Ruta graveolens, Arnica montana, Mercurius vivus, Hypericum, Gelsemium and Ignatia amara are combined and mixed vigorously. Inactive ingredients, citric acid, glycerin, potassium sorbate and purified water, are then added and blended in the mixture.

[0073] An oral drops formulation is made by combing homeopathic ingredients with the optional and/or inactive ingredients. For example, Hepar sulphuris calcareum, Calendula officinalis, Chamomilla, Aconitum napellus, Echinacea angustifolia, Echinacea purpurea, Ruta graveolens, Arnica montana, Mercurius vivus, Hypericum, Gelsemium and Ignatia amara are combined and mixed vigorously. Inactive ingredients, citric acid, glycerin, potassium sorbate and purified water, are then added and blended in the mixture.

[0074] A gel formulation is made by preparing a homeopathic attenuation called the Mother Concentrate or Mother Tincture. A gel is further prepared by mixing purified water with hydroxyethyl cellulose to which the mother concentrate is added along with a sweetener, a skin conditioning, a flavoring agent and preservative. For example, a Mother concentrate is made with Hepar sulphuris calcareum, Calendula officinalis, Chamomilla, Aconitum napellus, Echinacea angustifolia, Echinacea purpurea, Ruta graveolens, Arnica montana, Mercurius vivus, Hypericum, Gelsemium and Ignatia amara. This Mother concentrate is then added to a mixture of purified water and hydroxyethyl cellulose. Finally, allantoin, hydroxyethylcellulose, peppermint oil, purified water, sodium benzoate and xylitol are then combined with the Mother concentrate, purified water and hydroxyethyl cellulose.

[0075] A dental rinse formulation is made by combing a Mother tincture with inactive ingredients and optional ingredients. For example, a Mother tincture will be a combination of Calendula officinalis, Echinacea purpurea, Plantago major and Azadirachta indica (also known as Neem). Mother tinctures are then measured and combined in a large glass beaker. In another vessel, purified water, glycerin, allantoin and xylitol are mixed together until dissolved, the mother mixture is then added with more mixing, flavoring such as menthol or peppermint oil are dissolved in a solubilizing agent such as Poloxamer 407 or Polysorbate 20 and then added to the mixture and mixed until well combined and clear. Preservatives, for example citric acid and/or potassium sorbate, are then added and the PH adjusted.

[0076] Each of the spray, drops, gel and rinse formulations can be used together or separately.

[0077] The present invention is directed to oral and/or dental care. Oral and/or dental care includes for example general oral maintenance, reduction of flora in the mouth, reduction of pain, reduction of inflammation, the reduction of bruising, trismus, recovery after dental surgeries, the amelioration of anxiety associated with dental care or preventative measures for maladies of the oral cavity. Maladies of the oral cavity include for example cavities, tooth decay, bone loss and periodontal pocket formation.

[0078] The present invention is directed to a method of decreasing or reducing post-operative inflammation, edema, bruising, pain and related symptoms such as trismus after bodily insult and preferably after oral surgery. The active ingredient in the gel and drops (spray) have anti-anxiety property and are unique in a sense that we have anti-anxiety and pain/swelling/bruising properties all in one drug. Ignathia which is the part of gel and drops is called “homeopathic prozac”. The rinse has antimicrobial properties and has additive “antibiotic” properties.

[0079] The invention is now described with reference to the following Examples. These Examples are provided for the purpose of illustration only and the invention should in no way be construed as being limited to these Examples, but rather should be construed to encompass any and all variations that become evident as a result of the teaching provided herein.

EXAMPLES

Example 1

[0080] The purpose of this case report was to evaluate the anti-inflammatory and analgesic effects of VEGA™ drops, gel and rinse (Vega Recovery Kit) (VEGA™ Products in table below) after the surgical removal of four complete bony third molars. All patients were given VEGA™ products. Methods: A group of 9 patients requiring removal of asymptomatic impacted third molars with ClassII/III position C impaction were selected. All of the patients satisfied the following selection criteria: ASA I; Full bony impacted (ClassII/III position C) 4 third molars. All surgical procedures were performed by the same surgeon; no NSAI DS or steroids for at least a month prior to the study. To assess postoperative pain, visual analogue scales and consumption of post-op analgesics were used. The facial swelling and trismus were evaluated by measuring facial reference distances and maximum opening. Results: Patients found to be mostly recovered on the fourth day post-op. The peak swelling was on the second post-operative day followed by a decrease almost back to the baseline on the fourth post-op day. Most of the patients required NORCO® for post-operative pain control for the first 2-3 days after the surgery. On the fourth post-operative day the swelling was reduced three-fold compared to the second post-operative day and was only 1% increase from the pre-operative baseline. Recovery for most HRQL measures, including pain occurred on post-operative day four. In contrast White R.P. et al published a study in which they looked at 630 patients undergoing third molar removal and reported the recovery for most HRQL measures occurred within five days after surgery. However, recovery from pain was delayed. By post-operative day seven, 15% of patients continued to report post-operative pain as severe, 5% reported post-operative pain as average. (3)

[0081] Conclusion: VEGA™ products can provide alternative ways to control post-third molar recovery.

TABLE-US-00004 VEGA ™ PRODUCTS SPRAY/DROPS GEL RINSE Hepar sulphuris calcareum Hepar sulphuris calcareum Calendula officinalis 1X 8X, 8X, Echinacea purpurea 1X Calendula officinalis 3X, Calendula officinalis 3X, Plantago major 1X Chamomilla 5X, Chamomilla 5X, Azadirachta indica/Neem Aconitum napellus 3X, Aconitum napellus 3X, 1X Echinacea angustifolia 3X, Echinacea angustifolia 3X, Inactive ingredients: Xylitol, Echinacea purpurea 3X Echinacea purpurea 3X Allantoin, Peppermint oil, Ruta graveolens 12X, Ruta graveolens 12X, Glycerin, Citric acid, Arnica montana 3X, 6X, Arnica montana, 3X, 6X, potassium sorbate, Purified 18X, 18X, Water, Polysorbate 20 Mercurius vivus 10X, Mercurius vivus 10X, Hypericum 10X, Hypericum 10X, Gelsemium 30X, Gelsemium 30X, Ignatia amara 30X Ignatia amara 30X Inactive ingredients: citric Inactive ingredients: acid, glycerin, potassium allantoin, sorbate, purified water hydroxyethylcellulose, peppermint oil, purified water, sodium benzoate, xylitol

[0082] This case report was performed to look into the use of homeopathic-based remedies applied both locally and systemically to reduce postoperative swelling and pain after third molar surgery. VEGA™ products (spray/drops, gel and rinse) have fourteen active homeopathic ingredients including arnica in three different concentrations.

[0083] Dosage Instructions

[0084] Pre-Surgery Medication Instructions

[0085] Please follow these instructions beginning 3 days before your surgery and continuing for 7 days after your surgery:

[0086] 1. Apply 15 VEGA™ Drops (Spray) under your tongue 4 times daily. Do not swallow for about 1 minute.

[0087] 2. Apply VEGA™ Gel using a Q-tip applicator to the areas of all 4 wisdom teeth over the gum 3 times daily. Allow several minutes for the VEGA™ Gel to absorb. Do not rinse or eat for 20 minutes.

[0088] 3. Swish with VEGA™ Rinse (10-15 cc) three times daily for 2-3 minutes and then spit out the VEGA™ Rinse.

[0089] Day of Surgery Medication Instructions:

[0090] Take 4 Amoxicillin (500 mg/tablet) or Clindamycin (150 mg/tablet) tablets 1 hour before your surgery. You may take the pills with a glass of water.

[0091] Post-Surgery Instructions:

[0092] 1. Continuing taking the VEGA™ Products (drops, gel, and rinse) as before surgery (see above).

[0093] 2. Take Amoxicillin (500 mg/tablet) or Clindamycin (150 mg/tablet) tablets as prescribed three times a day until gone.

[0094] 3. You may take NORCO® 5/325, 1-2 tablet every 4-6 hours. No MOTRIN® or other NSAIDs allowed. You do not have to take pain medications if no pain is experienced.

[0095] Patients

[0096] Total of nine patients, two males and 7 females participated. The age of the participants ranged between 17-21.

[0097] All patients received:

[0098] 1. 2 gm of Amoxicillin 1 hr pre-op, and subsequent 5 days course of 500 mg tid

[0099] 2. NORCO® 5/325 mg (15 tabs).

[0100] Materials and Methods (I-IV)

[0101] Facial swelling, trismus and pain were objectively measured on a post-op days 2, 4, and 7 by an independent examiner.

[0102] I. The facial swelling was measured by a tape measuring method. Four measurements were made between 6 reference points: tragus, lateral canthus of eye, pogonion, ala, gonion and the corner of the mouth. The post-op sum of the measurements was considered as the baseline for that side.

[0103] II. Mouth opening, taken as the maximum distance between upper and lower central incisors was measured by the ruler to the nearest mm. Pre-op value was recorded. Post-op Trismus was measured the same way on days 2, 4 and 7.

[0104] III. Post-operative pain was recorded by having the patient report the number of analgesic tablets required. Post-operative pain was rated daily for 7 days using a 100-point visual analog scale (VAS) anchored by the verbal descriptors “no pain”(0) and “very severe pain” (10).

[0105] IV. After surgery, each patient was given the HRQOL (also shown herein as Health-Related Quality of Life or HRQL) instrument or a diary as described by Shugars et al (16). HRQOL data were collected from the patients on daily bases for 7 days after the procedure.(3,12-16).

[0106] Post-operative pain was rated daily for 7 days using a 100-point visual analog scale (VAS). Indications for the severity of pain begin at 0 which is considered no pain and end at 100 which is considered the worst pain. Pain levels between about 10 to about 30 are indicative of a range of mild pain, pain levels between about 40 to about 60 are indicative of a range of moderate pain, and pain levels between about 70 to 100 are indicative of a range of severe pain.

[0107] In this study we looked at the use of alternative methods to decrease swelling and pain after removal of impacted third molars. Based on our data, on the post-op day 3 the patients required less than 1 NORCO® (Hydrocodone5/Actominophen325) pain pill. On the post-operative day 4 the swelling was three times less compared to the second day post-op and was only 1% increase from the pre-op baseline. Recovery for most HRQL measures, including pain, has occurred on the post-op day 4. By comparison, White R. P. et al. published a study (which is incorporated herein in its entirety) in which they looked at 630 patients undergoing third molar removal. However, the reference suggests that over-the-counter and prescribed medications were taken by the patients and not homeopathics. Similarly to our case report, the patients selected fell in the same age range. They reported that in their study the recovery for most HRQL measures occurred within 5 days after surgery. However, recovery from pain was delayed. By post-surgery day 7, 15% of patients still reported their pain as severe; 5% reported average pain as severe.(3)

TABLE-US-00005 Daily pain measurements DAY DAY DAY DAY DAY DAY DAY 1 2 3 4 5 6 7 Severity 73.375 51.23 49.25 38.38 29.63 20 10 (Patient) Severity 57.63 37 14 (Clinician) Intensity 58.88  40.13 36.13 29.13 21.63 13.25 8.5 (Patient) Intensity 46.63 26.25 9.75 (Clinician)

TABLE-US-00006 Pain Management Days Post Op DAY DAY DAY DAY DAY DAY DAY 1 2 3 4 5 6 7 avg # 3.5 2.3 0.8 0.6 0.5 0.4 0.25 NORCO ® pills

TABLE-US-00007 Trismus/Mouth Opening Days Post Op Pre-Op DAY 2 DAY 4 Day 7 mm 49 22.56 29.89 39.78 % trismus 46% 61% 81.20%

TABLE-US-00008 Swelling Days Post Op Pre-Op DAY 2 DAY 4 Day 7 MM 913.75 944.88 922.75 915.63 % 103 101 100.2 3% 1% 0.2

Example 2

[0108] Post-Surgical Management after Various Periodontal Surgical Procedures.

[0109] Background: a series of twenty case reports evaluated the effects of VEGA™ Oral Gel and Rinse as adjunctive therapy for post-surgical management after pocket reduction osseous surgery, connective tissue grafting, extraction and site preservation bone graft.

[0110] Methods: Twenty patients, not on medication, went through pocket reduction osseous surgery, connective tissue grafting, extraction and/or site preservation bone graft. VEGA™ Gel and Rinse were applied on only one side in the split mouth designs after pocket reduction osseous surgery. On the other side of the mouth, either PERIDEX® rinse (chlorhexidine gluconate 0.12%) or an AO PERIOSCIENCE® Rinse was applied.

[0111] Results: on day three less swelling was observed on the VEGA™ treated side than on the side treated with either the PERIDEX® rinse (chlorhexidine gluconate 0.12%) or the AO PERIOSCIENCE® Rinse.

[0112] Conclusion: patients unanimously reported having less problems with the VEGA™ treated side than on the side treated with either the PERIDEX® rinse (chlorhexidine gluconate 0.12%) or the AO PERIOSCIENCE® Rinse.

[0113] Comments: Many enjoyed the taste of the Stellalife™ products and wished to purchase it. This was reported by almost every patient and was unprompted.

Comparative Example 1

[0114] A study is conducted to determine the reduction of periodontal pocket depth in patients with moderate periodontal disease who underwent deep scaling and root planning. The pockets are measured before treatment. A split mouth study design is used. A study is conducted to determine the reduction of periodontal pocket depth after 1 month of VEGA™ gel and rinse product application to the gums and compared to the control side. Patients are instructed to apply the VEGA™ rinse and gel twice a day with a Qtip applicator to the gums and base of teeth on one side of the mouth for one month. Chlorhexidine is applied once daily to the other side of the mouth. After 1 month, the side of the mouth to which VEGA™ rinse/gel are applied shows a reduction in periodontal pocket depth of 1-2 mm more then on the control side.

Comparative Example 2 [ARNICA AND NORCO®]

[0115] The purpose of this case report is to evaluate the anti-inflammatory and analgesic effects of arnica after the surgical removal of four complete bony third molars. Methods: A group of 9 patients requiring removal of asymptomatic impacted third molars with ClassII/III position C impaction is selected. All of the patients satisfy the following selection criteria: ASA I; Full bony impacted (ClassII/III position C) 4 third molars. All patients are given arnica. The arnica regimen is to take 4 pallets under the tongue 4×/day. Patients are instructed to begin arnica regimen 3 days pre-op and continue regimen through the seventh day post-op. All surgical procedures are performed by the same surgeon; no NSAIDS or steroids are taken for at least a month prior to the study. To assess postoperative pain, visual analogue scales and consumption of post-op analgesics are used. The facial swelling and trismus are evaluated by measuring facial reference distances and maximum opening. Results: Patients are found to be mostly recovered on the sixth-seventh day post-op. The peak swelling is on the fourth post-operative day, following by decrease almost back to the baseline on the sixth to seventh post-op day. Most of the patients require NORCO® for post-operative pain control for the first 7 days after the surgery.

TABLE-US-00009 NORCO ® pain management Days Post Op DAY DAY DAY DAY DAY DAY DAY 1 2 3 4 5 6 7 avg # 4 4 3 2 1 1 1 NORCO ® pills

[0116] Conclusion: arnica does not control post-third molar recovery as compared to Vega™ products.

[0117] This case report is performed to look into the use of homeopathic-based remedies applied both locally and systemically to reduce postoperative swelling and pain after third molar surgery.

[0118] Patients, Materials and Methods: Same as in Example 1

Comparative Example 3 [TRAUMEEL® AND NORCO®]

[0119] The purpose of this case report is to evaluate the anti-inflammatory and analgesic effects of TRAUMEEL® after the surgical removal of four complete bony third molars. Methods: A group of 9 patients requiring removal of asymptomatic impacted third molars with ClassII/III position C impaction is selected. All of the patients satisfy the following selection criteria: ASA I; Full bony impacted (ClassII/III position C) 4 third molars. All patients are given TRAUMEEL®. The TRAUMEEL® regimen is to take 3 pallets under the tongue 4×/day. Patients are instructed to begin TRAUMEEL® regimen 3 days pre-op and continue regimen through the seventh day post-op. All surgical procedures are performed by the same surgeon; no NSAIDS or steroids are taken for at least a month prior to the study. To assess postoperative pain, visual analogue scales and consumption of post-op analgesics are used. The facial swelling and trismus are evaluated by measuring facial reference distances and maximum opening. Results: Patients are found to be mostly recovered on the sixth-seventh day post-op. The peak swelling is on the fourth post-operative day, following by decrease almost back to the baseline on the 7th post-op day. Most of the patients require NORCO® for post-operative pain control all 7 days after the surgery.

TABLE-US-00010 NORCO ® pain management Days Post Op DAY DAY DAY DAY DAY DAY DAY 1 2 3 4 5 6 7 avg # 4 4 3 3 1-2 1 1 NORCO ® pills

[0120] Conclusion: when combined with prescription narotic analgesics, TRAUMEEL® does not control post-third molar recovery as compared to VEGA™ products.

[0121] This case report is performed to look into the use of homeopathic-based remedies applied both locally and systemically to reduce postoperative swelling and pain after third molar surgery.

[0122] Patients, Materials and Methods: Same as in Example 1

Comparative Example 4 [ARNICA AND NORCO® AND MOTRIN®]

[0123] The purpose of this case report is to evaluate the anti-inflammatory and analgesic effects of Arnica and Motrin combination as compared to VEGA Recovery Kit after the surgical removal of four complete bony third molars. Methods: A group of 9 patients requiring removal of asymptomatic impacted third molars with ClassII/III position C impaction is selected. All of the patients satisfy the following selection criteria: ASA I; Full bony impacted (ClassII/III position C) 4 third molars. All surgical procedures are performed by the same surgeon; no NSAIDS or steroids are taken for at least a month prior to the study. All patients are given arnica. The arnica regimen is to take 4 pallets under the tongue 4×/day. Patients are instructed to begin arnica regimen 3 days pre-op and continue regimen through the seventh day post-op. To assess postoperative pain, visual analogue scales and consumption of post-op analgesics are used. The facial swelling and trismus are evaluated by measuring facial reference distances and maximum opening. Results: Patients are found to be mostly recovered on the sixth day post-op. The peak swelling is on the fourth post-operative day, following by decrease almost back to the baseline on the 7th post-op day. Most of the patients require NORCO® for post-operative pain control all 7 days after the surgery.

TABLE-US-00011 NORCO ® pain management Days Post Op DAY DAY DAY DAY DAY DAY DAY 1 2 3 4 5 6 7 avg # 4 4 3 2 1 0.5 0.5 NORCO ® pills

[0124] Conclusion: Arnica and MOTRIN® as a combination do not control post-third molar recovery as compared to VEGA™ products.

[0125] This case report is performed to look into the use of homeopathic-based remedies applied both locally and systemically to reduce postoperative swelling and pain after third molar surgery.

[0126] Materials and Methods: Same as in Example 1

[0127] Patients

[0128] Total of nine patients, two males and 7 females participate. The age of the participants ranges between 17-21.

[0129] All patients additionally receive:

[0130] 1. 2 gm of Amoxicillin 1 hr pre-op, and subsequent 5 days course of 500 mg tid

[0131] 2. NORCO® 5/325 mg (15 tabs).

[0132] 3. MOTRIN® 600 mg

Comparative Example 5 [TRAUMEEL® AND NORCO® AND MOTRIN®]

[0133] The purpose of this case report is to evaluate the anti-inflammatory and analgesic effects of TRAUMEEL® and Motrin combination as compared to VEGA Recovery Kit after the surgical removal of four complete bony third molars. Methods: A group of 9 patients requiring removal of asymptomatic impacted third molars with ClassII/III position C impaction is selected. All of the patients satisfy the following selection criteria: ASA I; Full bony impacted (ClassII/III position C) 4 third molars. All surgical procedures are performed by the same surgeon; no NSAIDS or steroids are taken for at least a month prior to the study. All patients are given TRAUMEEL®. The TRAUMEEL® regimen is to take 3 pallets under the tongue 4×/day. Patients are instructed to begin TRAUMEEL® regimen 3 days pre-op and continue regimen through the seventh day post-op. To assess postoperative pain, visual analogue scales and consumption of post-op analgesics are used. The facial swelling and trismus are evaluated by measuring facial reference distances and maximum opening. Results: Patients are found to be mostly recovered on the sixth day post-op. The peak swelling is on the fourth post-operative day, following by decrease almost back to the baseline on the 6th post-op day. Most of the patients require NORCO® for post-operative pain control all 7 days after the surgery.

TABLE-US-00012 NORCO ® pain management Days Post Op DAY DAY DAY DAY DAY DAY DAY 1 2 3 4 5 6 7 avg # 4 4 3 2 1 0.5 0.5 NORCO ® pills

[0134] Conclusion: TRAUMEEL® and MOTRIN® as a combination does not control post-third molar recovery as compared to VEGA™ products.

[0135] This case report is performed to look into the use of homeopathic-based remedies applied both locally and systemically to reduce postoperative swelling and pain after third molar surgery.

[0136] Materials and Methods: Same as in Example 1

[0137] Patients

[0138] Total of nine patients, two males and 7 females participate. The age of the participants ranges between 17-21.

[0139] All patients additionally receive:

[0140] 1. 2 gm of Amoxicillin 1 hr pre-op, and subsequent 5 days course of 500 mg tid

[0141] 2. NORCO® 5/325 mg (15 tabs).

[0142] 3. MOTRIN® 600 mg

Comparative Example 6 [ARNICA AND NORCO® AND DECADRON®]

[0143] The purpose of this case report is to evaluate the anti-inflammatory and analgesic effects of arnica after the surgical removal of four complete bony third molars. Methods: A group of 9 patients requiring removal of asymptomatic impacted third molars with ClassII/III position C impaction is selected. All of the patients satisfy the following selection criteria: ASA I; Full bony impacted (ClassII/III position C) 4 third molars. All surgical procedures are performed by the same surgeon; no NSAIDS or steroids are taken for at least a month prior to the study. All patients are given arnica. The arnica regimen is to take 4 pallets under the tongue 4×/day. Patients are instructed to begin arnica regimen 3 days pre-op and continue regimen through the seventh day post-op. To assess postoperative pain, visual analogue scales and consumption of post-op analgesics are used. The facial swelling and trismus are evaluated by measuring facial reference distances and maximum opening. Results: Patients are found to be mostly recovered on the sixth day post-op. The peak swelling is on the fourth post-operative day, following by decrease almost back to the baseline on the seventh post-op day.

TABLE-US-00013 NORCO ® pain management Days Post Op DAY DAY DAY DAY DAY DAY DAY 1 2 3 4 5 6 7 avg # 4 4 3 2 1 1 0.5-1 NORCO ® pills

[0144] Conclusion: Arnica and DECADRON® as a combination do not control post-third molar recovery as compared to VEGA™ products.

[0145] This case report is performed to look into the use of homeopathic-based remedies applied both locally and systemically to reduce postoperative swelling and pain after third molar surgery.

[0146] Materials and Methods: Same as in Example 1

[0147] Patients

[0148] Total of nine patients, two males and 7 females participate. The age of the participants ranges between 17-21.

[0149] All patients additionally receive:

[0150] 1. 2 gm of Amoxicillin 1 hr pre-op, and subsequent 5 days course of 500 mg tid

[0151] 2. NORCO® 5/325 mg (15 tabs).

[0152] 3. DECADRON® 8 mg IV—administered once during the surgery.

Comparative Example 7 [TRAUMEEL® AND NORCO® AND DECADRON®]

[0153] The purpose of this case report is to evaluate the anti-inflammatory and analgesic effects of TRAUMEEL® after the surgical removal of four complete bony third molars. Methods: A group of 9 patients requiring removal of asymptomatic impacted third molars with ClassII/III position C impaction is selected. All of the patients satisfy the following selection criteria: ASA I; Full bony impacted (ClassII/III position C) 4 third molars. All surgical procedures are performed by the same surgeon; no NSAIDS or steroids are taken for at least a month prior to the study. All patients are given TRAUMEEL®. The TRAUMEEL® regimen is to take 3 pallets under the tongue 4×/day. Patients are instructed to begin TRAUMEEL® regimen 3 days pre-op and continue regimen through the seventh day post-op. To assess postoperative pain, visual analogue scales and consumption of post-op analgesics are used. The facial swelling and trismus are evaluated by measuring facial reference distances and maximum opening. Results: Patients are found to be mostly recovered on the sixth day post-op. The peak swelling is on the fourth post-operative day, following by decrease almost back to the baseline on the sixth post-op day.

TABLE-US-00014 NORCO ® pain management Days Post Op DAY DAY DAY DAY DAY DAY DAY 1 2 3 4 5 6 7 avg # 4 4 3 2 1 1 0.5-1 NORCO ® pills

[0154] Conclusion: TRAUMEEL® and DECADRON® as a combination do not control post-third molar recovery as compared to VEGA™ products.

[0155] This case report is performed to look into the use of homeopathic-based remedies applied both locally and systemically to reduce postoperative swelling and pain after third molar surgery.

[0156] Materials and Methods: Same as in Example 1

[0157] Patients

[0158] Total of nine patients, two males and 7 females participate. The age of the participants ranges between 17-21.

[0159] All patients additionally receive:

[0160] 1. 2 gm of Amoxicillin 1 hr pre-op, and subsequent 5 days course of 500 mg tid

[0161] 2. NORCO® 5/325 mg (15 tabs).

[0162] 3. DECADRON® 8 mg IV—administered once during the surgery.

Comparative Example 8 [Arnica and NORCO® and DECADRON® AND MOTRIN®]

[0163] The purpose of this case report is to evaluate the anti-inflammatory and analgesic effects of arnica after the surgical removal of four complete bony third molars. Methods: A group of 9 patients requiring removal of asymptomatic impacted third molars with ClassII/III position C impaction is selected. All of the patients satisfy the following selection criteria: ASA I; Full bony impacted (ClassII/III position C) 4 third molars. All surgical procedures are performed by the same surgeon; no NSAIDS or steroids are taken for at least a month prior to the study. All patients are given arnica. The arnica regimen is to take 4 pallets under the tongue 4×/day. Patients are instructed to begin arnica regimen 3 days pre-op and continue regimen through the seventh day post-op. To assess postoperative pain, visual analogue scales and consumption of post-op analgesics are used. The facial swelling and trismus are evaluated by measuring facial reference distances and maximum opening. Results: Patients are found to be mostly recovered on the fifth-sixth day post-op. The peak swelling is on the third post-operative day, following by decrease almost back to the baseline on the 6th post-op day. Most of the patients require NORCO® for post-operative pain control all 7 days after the surgery.

[0164] NORCO® Pain Management

TABLE-US-00015 Days Post Op DAY DAY DAY DAY DAY DAY DAY 1 2 3 4 5 6 7 avg # 4 4 3 2 1 0.5 0.25 NORCO ® pills

[0165] Conclusion: Arnica, DECADRON®, NORCO® AND MOTRIN® as a combination do not control post-third molar recovery as compared to VEGA™ products Materials and methods: same as in Example 1

[0166] Patients

[0167] Total of nine patients, two males and 7 females participate. The age of the participants ranges between 17-21.

[0168] All patients additionally receive:

[0169] 1. 2 gm of Amoxicillin 1 hr pre-op, and subsequent 5 days course of 500 mg tid

[0170] 2. NORCO® 5/325 mg (15 tabs).

[0171] 3. MOTRIN® 600 mg

[0172] 4. DECADRON® 8 mg IV—administered once during the surgery.

Comparative Example 9 [TRAUMEEL® and NORCO® DECADRON® AND MOTRIN®O]

[0173] The purpose of this case report is to evaluate the anti-inflammatory and analgesic effects of TRAUMEEL® after the surgical removal of four complete bony third molars. Methods: A group of 9 patients requiring removal of asymptomatic impacted third molars with ClassII/III position C impaction is selected. All of the patients satisfy the following selection criteria: ASA I; Full bony impacted (ClassII/III position C) 4 third molars. All surgical procedures are performed by the same surgeon; no NSAIDS or steroids are taken for at least a month prior to the study. All patients are given TRAUMEEL®. The TRAUMEEL® regimen is to take 3 pallets under the tongue 4×/day. Patients are instructed to begin TRAUMEEL® regimen 3 days pre-op and continue regimen through the seventh day post-op. To assess postoperative pain, visual analogue scales and consumption of post-op analgesics are used. The facial swelling and trismus are evaluated by measuring facial reference distances and maximum opening. Results: Patients are found to be mostly recovered on the sixth day post-op. The peak swelling is on the third post-operative day, following by decrease almost back to the baseline on the 7th post-op day. Most of the patients require NORCO® for post-operative pain control all 7 days after the surgery.

TABLE-US-00016 NORCO ® pain management Days Post Op DAY DAY DAY DAY DAY DAY DAY 1 2 3 4 5 6 7 avg # 4 4 3 2 1 0.5 0.25 NORCO ® pills

[0174] Conclusion: DECADRON®, NORCO® AND MOTRIN® as a combination with TRAUMEEL® do not control post-third molar recovery as compared to VEGA™ products.

[0175] Materials and methods: same as in Example 1

[0176] Patients

[0177] Total of nine patients, two males and 7 females participate. The age of the participants ranges between 17-21.

[0178] All patients additionally receive:

[0179] 1. 2 gm of Amoxicillin 1 hr pre-op, and subsequent 5 days course of 500 mg tid

[0180] 2. NORCO® 5/325 mg (15 tabs).

[0181] 3. MOTRIN® 600 mg

[0182] 4. DECADRON® 8 mg IV—administered once during the surgery.

[0183] Comparison Table

[0184] The table below, as well as the graphical representation of similarly representative data shown in FIG. 1, shows representative data from Example 1 and Comparative Examples 2-9 above. It was surprisingly found that the number of NORCO® pills needed by the patients who were treated with VEGA™ products were reduced as compared to those patients who were treated with other homeopathics, steroids, and/or NSAIDS. As can be seen from the table, the number of NORCO® pills required is markedly reduced by day 3 and that the recovery from surgery is accelerated. Moreover, the time to peak swelling is accelerated as well.

TABLE-US-00017 Number of NORCO ® pills taken days 1-7 post-op Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Day of post- post- post- post- post- post- post- peak Day of full Treatment op op op op op op op swelling recovery V(Drops/Gel/ 3.5 2.3 0.8 0.6 0.5 0.4 0.25 Peak— Recovery— Rinse)/N 1 D-2 D 3.sup.rd-4th A/N 4 4 3 2 1 1 0.5-1 Peak— Recovery— 4 D 6.sup.th-7th T/N 4 4 3 2 1 1 0.5-1 Peak— Recovery— 4 D 6.sup.th-7th A/N/M 4 4 3 2 1 0.5 0.5 Peak— Recovery— 4 D 6.sup.th-7th T/N/M 4 4 3 2 1 0.5 0.5 Peak— Recovery— 4 D 6th A/N/D 4 4 3 2 1 1 0.5-1 Peak— Recovery— 4 D 6.sup.th-7th T/N/D 4 4 3 2 1 1 0.5-1 Peak— Recovery— 4 D 6.sup.th-7th A/N/M/D 4 4 3 2 1 0.5 0.5 Peak— Recovery— 3 D 5.sup.th-6th T/N/M/D 4 4 3 2 1 0.5 0.5 Peak— Recovery— 3 D 5.sup.th-6th V = VEGATM (from Example 1), A = arnica, T = TRAUMEEL ®, D = DECADRON ®, N = NORCO ® (Hydrocodone 5/Tylenol 325 mg), M = MOTRIN ® (600 mg).

[0185] Comparison Graph

[0186] The number of NORCO® pills taken by patients in Examples 1, Comparative Example 2 and Comparative Example 3 are compared in the graph below.

[0187] It can be seen that when patients are receiving VEGA™ as in Example 1, the number of NORCO® pills required is sharply less as compared to Comparative Example 2 wherein patients are administered arnica and Comparative Example 3 wherein patients are administered TRAUMEEL®. Moreover, the time required to reach peak swelling post-operatively is sharply reduced with the patients receiving VEGA™ products. This can be seen in the graph below.

[0188] It was surprising that there was a marked decrease in the number of days required for a full recovery post-operatively between the patients who received VEGA™ products and those that did not. The following graph compares the number of days required for a full recovery between patients receiving VEGA™ products and patients receiving other combinations of analgesics, steroids, homeopathics and/or NSAIDS.

[0189] The oral mucosa is the mucous membrane lining the inside of the mouth and consists of stratified squamous epithelium termed oral epithelium and an underlying connective tissue termed lamina propria. IgA found therein has a role in protecting against microbes and is an immunological regulator (htto://en.wikipedia.org/wiki/immunoglobulin A).

[0190] Oral mucosa heals differently than non-mucosal epidermis (Chen et al. Positional differences in the wound transcriptome of skin and oral mucosa. Chen et al. BMC Genomics 2010, 11:471). Oral mucosal tissues contains much less inflammatory potential than skin since they contain less cytokines involved in the inflammatory process. IL-1b and TNF-α, for example are reduced in oral mucosal tissue. As used herein “mucosal layer” means any mucous membranes (or mucosae, mucosas, or mucosa) or mucosal tissue.

[0191] The term “about” or “approximately” means within an acceptable error range for the particular value as determined by one of ordinary skill in the art, which will depend in part on how the value is measured or determined, i.e., the limitations of the measurement system. For example, “about” with respect to the compositions can mean plus or minus a range of up to 20%, preferably up to 10%, more preferably up to 5%. Alternatively, particularly with respect to biological systems or processes, the term can mean within an order of magnitude, preferably within 5-fold, and more preferably within 2-fold, of a value. Where particular values are described in the application and claims, unless otherwise stated the term “about” means within an acceptable error range for the particular value. For example, when referring to a period of time, e.g., hours, the present values (±20%) are more applicable. Thus, 6 hours can be, e.g., 4.8 hours, 5.5 hours, 6.5 hours, 7.2 hours, as well as the usual 6 hours. Another example includes a period of time measured in days such that “about” a week can refer to 6 days or 7 days or 8 days or any time in between such as 6 days 12 hours.

[0192] All references noted in this application, both patent literature and/or non-patent literature are incorporated herein by reference in their entirety. References that are not specifically singled out as being incorporated herein by reference in their entirety are nonetheless incorporated herein by reference in their entirety.

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