CA2211382A1 - Method for maintenance and preservation of dental health and oral dental health dietary supplement for use in said method - Google Patents

Abstract

The invention relates to a method for the maintenance and preservation of dental health consisting essentially of the step of orally administering to a living human being in need of such dietary supplementation a dietary supplement composition, in unit dosage form, consisting essentially of an effective amount of a plurality of vitamins and minerals for strengthening gingiva, an effective amount of a plurality of vitamins and minerals for strengthening of the immune system and decreasing sensitivity, pain, and soreness, and an effective amount of a plurality of vitamins and minerals for the strengthening of teeth and bone, as well as the oral dietary supplement composition itself, preferably as a readily-ingestible tablet or caplet.

Description

METHOD FOR MAINTENANCE AND PRESERVATION OF
DENTAL HEALTH AND ORAL DENTAL HEALTH DIETARY
SUPPLEMENT FOR USE IN SAID METHOD

An oral dietary supplement composition in unit dosage form specifically designed for maintaining and preserving dental health and a method for the maintenance and preservation of dental health by the oral administration 10thereof to a living human being in need of such dietary supplementation.
BACKGROUND OF THE INVENTION AND PRIOR ART
It is clear that, in the great milieu of vitamin and mineral supplement compositions presently available on the 15market either over the counter or by prescription, insufficient emphasis has been placed upon dietary supplements which are specifically designed for the attainment, maintenance, and preservation of dental health, including not only the fortification of the teeth and oral 20cavity so as to provide enhanced resistance to the usual diseases, avoidance of such ailments and actual recovery from and elimination of such ailments once they have commenced within the oral cavity. Although numerous vitamin, mineral, and other nutritional substances have 25been identified which have a desirable effect in promoting and maintaining total dental health, up until the present time there has been no complete oral dietary supplement which is fortified to fulfill all of the desirable objectives of a total dental health-care package including the establishment, maintenance, and preservation of dental health, much less an oral dietary supplement fortified for just such purpose and to provide the proper nutrition for fending off common ailments before they cc ~nce as well as eliminating or ameliorating them and their consequences once they have com~?nced, even though it is estimated that up to 98% of the U.S. population have some sort of dental deficiency or disease. The composition and method of the present invention are designed for just such multipurpose nutrition, namely, the establishment, maintenance, and preservation of dental health by means of a complete oral dietary supplement designed for just such purpose as well as for the prevention of numerous common dental diseases and the elimination or amelioration thereof, as well as their symptoms and consequences, even though they may have advanced to a certain stage but yet within the boundaries and possibilities of recovery through the medium of nutritional therapy.
To the best of our knowledge, no combination of all of the essential ingredients put together in the present oral dietary supplement for dental health have ever been employed together, much less in unit dosage form, for the establishment, treatment, and preservation of complete dental health, nor have any pharmaceutical composition or nutritional supplement consisting of the same heretofore been made available for such purpose.
OBJECTS OF THE INVENTION
It is an object of the present invention to provide a method for the maintenance and preservation of dental health consisting essentially of the step of orally admini-stering to a living human being in need of such dietary supplementation a dietary supplement composition in unit dosage form consisting essentially of an effective amount of a plurality of vitamins and minerals for strengthening gingiva, for strengthening of the immune system and decrea-sing sensitivity, pain, and soreness, and for the strength-ening of teeth and bone. A further object of the invention is the provision of an oral dietary supplement composition for maintaining and preserving dental health, in unit dosage form, for use in the said method. Additional objects of the invention will become apparent hereinafter and still other objects will be obvious to one skilled in the art to which this invention pertains.
SUMMARY OF THE INVENTION
What we believe to be our invention, then, inter alia, comprises the following, singly or in combination:
A method for the maintenance and preservation of dental health consisting essentially of the step of orally administering to a living human being in need of such dietary supplementation a dietary supplement composition, in unit dosage form, consisting essentially of an effective amount of a plurality of vitamins and minerals for streng-thening gingiva, an effective amount of a plurality of vitamins and minerals for strengthening of the immune system and decreasing sensitivity, pain, and soreness, and an effective amount of a plurality of vitamins and minerals for the strengthening of teeth and bone; such a method wherein the vitamins and minerals include an effective amount of each of Vitamin C, Vitamin A, and calcium; such a method wherein the vitamins and minerals for strength-ening gingiva include:
Vitamin C, Bioflavanoids, Rutin, Hesperidin, essential Amino Acids, Iron, and Folic Acid;
the vitamins and minerals for strengthening the immune system and decreasing sensitivity, pain, and soreness include:
Zinc, Vitamin E, Vitamin A, Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B6, Vitamin B12, Biotin, and Selenium; and the vitamins and minerals for strengthening tooth and bone include:
Calcium, Vitamin D, Phosphorous, Magnesium, Vitamin K, Manganese, Iodine, and Copper; such a method wherein the essential amino acids include all of the ten essential amino acids; such a method wherein the formulation range of the vitamins and minerals comprising the oral dietary supplement composition includes the following ingredients in the approximate amounts:
Ingredient Amount Vitamin A 5,000 to 7,000 IU
Vitamin B1 1.4 to 6 mg.
Vitamin B2 1.7 to 6.8 mg.
Vitamin B3 18 to 45 mg.
Vitamin B6 2 to 6 mg.
Vitamin B12 3 to 18 mg Folic Acid 400 to 600 mcg.
Biotin 30 to 60 mcg.
Vitamin C 60 to 480 mg.
Vitamin D 200 to 400 IU
Vitamin E 10 to 60 IU
Vitamin K 15 to 50 mcg.
Calcium 150 to 400 mg.
Bioflavanoids 50 to lO0 mg.
Hesperidin 15 to 35 mg.
Rutin 15 to 35 mg.
Phosphorous 20 to 45 mg.
Zinc 5 to 20 mg.
Iron 9 to 27 mg.
Selenium 50 to 150 mcg.
Magnesium 50 to 400 mg.
Manganese 2 to 4 mg.
Iodine (as alkali metal salt) 50 to 150 mcg.
Copper 1 to 3 mg.

Amino Acids (selected from the ten essential amino acids) 50 to 150 mg.
Pantothenic Acid 5 to 15 mg Chromium 15 to 35 mcg in an appropriate unit dosage form; such a method wherein the oral dietary supplement composition is in the form of a compressed tablet or caplet; such a method wherein the oral dietary supplement composition is in the form of a compressed tablet or caplet, having a total weight of 1500-1800 mg.; such a method wherein the oral dietary supplement composition is in the form of a compressed tablet, having a total weight of approximately 1670 mg. plus or minus ten percent;
such a method wherein the vitamins and minerals comprising the oral dietary supplement composition include the following ingredients in the approximate amounts (RDA% in parentheses; *no established USRDA):
Vitamin A 5000 I.U. All as Beta Carotene (100) Vitamin Bl (Thiamine) 4.5 mg. (300) Vitamin B2 (Riboflavin) 5.1 mg. (300) Vitamin B3 (Niacinamide) 30 mg. (150) Vitamin B6 3 mg. (150) Vitamin B12 9 mcg. (150) Folic acid 400 mcg. (100) Biotin 30 mcg. (10) Vitamin C 240 mg. (400) Vitamin D 200 I.U. (50) Vitamin E 45 I.U. (150) Vitamin K 25 mcg. (*) Calcium (Carbonate) 200 mg. (20) Bioflavanoids 75 mg. (*) Hesperidin 25 mg. (*) Rutin 25 mg. (*) Phosphorus 35 mg. (10) Zinc 15 mg. (100) Iron 18 mg. (100) Selenium 100 mcg. (*) Magnesium 100 mg. (25) Manganese 3 mg. (*) Iodine (Potassium iodide) 100 mcg. (66.6) Copper 1 mg. (50) Amino Acids (Ovalbumin) 100 mg. (*) Pantothenic Acid 10 mg. (100) Chromium 25 mcg. (*) in an appropriate unit dosage form; such a method wherein the oral dietary supplement composition is in the form of a compressed tablet or caplet; such a method wherein the oral dietary supplement composition is in the form of a compressed tablet or caplet having a total weight of 1500-1800 mg; such a method wherein the oral dietary supplement composition is in the form of a compressed tablet having a total weight of approximately 1670 mg. plus or minus ten percent.
Moreover, an oral dietary supplement composition for maintaining and preserving dental health, in unit dosage form, consisting essentially of an effective amount of a plurality of vitamins and minerals for strengthening gingiva, an effective amount of a plurality of vitamins and minerals for strengthening the immune system and decreasing sensitivity, pain, and soreness, and an effective amount of a plurality of vitamins and minerals for strengthening teeth and bones; such an oral dietary supplement composition wherein the vitamins and minerals include an effective amount of each of Vitamin C, Vitamin A, and calcium; such an oral dietary supplement composition wherein the vitamins and minerals for strengthening gingiva include:
Vitamin C, Bioflavanoids, Rutin, Hesperidin, essential Amino Acids, Iron, and Folic Acid;

the vitamins and minerals for strengthening the immune system and decreasing sensitivity, pain, and soreness include:
Zinc, Vitamin E, Vitamin A, Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B6, Vitamin B12, Biotin, and Selenium; and the vitamins and minerals for strengthening tooth and bone include:
Calcium, Vitamin D, Phosphorous, Magnesium, Vitamin K, Manganese, Iodine, and Copper; such a composition wherein the essential amino acids include all of the ten essential amino acids; such a composition wherein the formulation range of the vitamins and minerals comprising the oral dietary supple-ment composition includes the following ingredients in the approximate amounts:
Inqredient Amount Vitamin A 5,000 to 7,000 IU
Vitamin B1 1.4 to 6 mg.
Vitamin B2 1.7 to 6.8 mg.
Vitamin B3 18 to 45 mg.
Vitamin B6 2 to 6 mg.
Vitamin B12 3 to 18 mg Folic Acid 400 to 600 mcg.
Biotin 30 to 60 mcg.
Vitamin C 60 to 480 mg.
Vitamin D 200 to 400 IU
Vitamin E 10 to 60 IU
Vitamin K 15 to 50 mcg.
Calcium 150 to 400 mg.
Bioflavanoids 50 to 100 mg.
Hesperidin 15 to 35 mg.
Rutin 15 to 35 mg.
Phosphorous 20 to 45 mg.
Zinc 5 to 20 mg.

Iron 9 to 27 mg.
Selenium 50 to 150 mcg.
Magnesium 50 to 400 mg.
Manganese 2 to 4 mg.
Iodine (as alkali metal salt) 50 to 150 mcg.
Copper 1 to 3 mg.
Amino Acids (selected from the ten essential amino acids) 50 to 150 mg.
Pantothenic Acid 5 to 15 mg Chromium 15 to 35 mcg in an appropriate unit dosage form; such a composition wherein the oral dietary supplement composition is in the form of a compressed tablet or caplet; such a composition wherein the oral dietary supplement composition is in the form of a compressed tablet or caplet having a total weight of 1500-1800 mg.; such a composition wherein the oral dietary supplement composition is in the form of a compressed tablet having a total weight of approximately 1670 mg. plus or minus ten percent; such a composition wherein the vitamins and minerals comprising the oral dietary supplement composition include the following ingredients in the approximate amounts:

Vitamin A 5000 I.U. All as Beta Carotene Vitamin B1 (Thiamine) 4.5 mg.
Vitamin B2 (Riboflavin) 5.1 mg.
Vitamin B3 (Niacinamide) 30 mg.
Vitamin B6 3 mg.
Vitamin B12 9 mcg.
Folic acid 400 mcg.
Biotin 30 mcg.
Vitamin C 240 mg.
Vitamin D 200 I.U.

Vitamin E 45 I.U.
Vitamin K 25 mcg.
Calcium (Carbonate) 200 mg.
Bioflavanoids 75 mg.
Hesperidin 25 mg.
Rutin 25 mg.
Phosphorus 35 mg.
Zinc 15 mg.
Iron 18 mg.
Selenium 100 mcg.
Magnesium 100 mg.
Manganese 3 mg.
Iodine (Potassium iodide) 100 mcg.
Copper 1 mg.
Amino Acids (Ovalbumin) 100 mg.
Pantothenic Acid 10 mg.
Chromium 25 mcg.
in an appropriate unit dosage form; such a composition wherein the oral dietary supplement composition is in the form of a compressed tablet or caplet; such a composition wherein the oral dietary supplement composition is in the form of a compressed tablet or caplet having a total weight of 1500-1800 mg; and such a composition wherein the oral dietary supplement composition is in the form of a compressed tablet having a total weight of approximately 1670 mg. plus or minus ten percent.
GENERAL DESCRIPTION OF THE INVENTION
The oral dietary supplement composition of the inven-tion and the method for the maintenance and preservation of dental health utilizing the same involve, as previously stated, an effective amount of a plurality of vitamins and minerals for strengthening gingiva, for strengthening the immune system and decreasing sensitivity, pain, and soreness, and for the strengthening of teeth and bone, and the vitamins and minerals included in the compositions according to the present invention which are used according to the method of the present invention each have a definite and positive role to play in dental health, essentially as set forth in the following:
**Vitamin C - formation of collagen - important for growth and repair of tissue cells, blood vessels, bones and teeth - heals wounds and bleeding gums - accelerates healing after surgery - helps slow healers, receding gums, and gingival inflammation, may reduce the risk of mouth cancer - maintains connective tissue - fights infections.
Bioflavonoids, Rutin, and Hesperidin - increase capillary strength - work synergistically with Vitamin C -keep connective tissue healthy - increase resistance to infection - prevention and healing of bleeding gums.
**Calcium - healthy bones and teeth - 20% of bone calcium is resorbed and replaced each year - 99% of calcium is in bones and teeth - excess is eliminated daily in urine - many surveys show calcium intake for many people below RDA which accelerates bone loss with low calcium intake causing bone loss from jaw bone and speed up of periodontal disease - ADA booklet on alveolar (jaw) bone loss advises increase in calcium - research shows decrease in alveolar bone resorption for those given calcium and Vitamin D
supplements in double blind studies - not enough calcium leads to bone disease and brittle bones.
Vitamin D - helps to properly utilize Calcium and Phosphorus - necessary for strong bones and teeth - defi-ciencies can lead to osteoporosis, soft bones and teeth, tooth decay, and gum disease.
Phosphorus - helps calcium formation for bones and teeth, important for tooth formation, deficiencies can lead to bone disease and tooth and gum disorders.

Magnesium - helps bone development, helps Vitamin C, deficiencies can cause calcium resorption, tooth decay, and soft bones.
Zinc - regulates the inflammatory process, helps enzyme systems, aids wound healing - fights bad breath -deficiencies can lead to poor healing, susceptibility to infection, slow healing, and loss of taste.
Ovalbumin - contains the ten essential amino acids in soluble form - goes directly to the stomach and is easily digested - helps connective tissue repair in the periodon-tal pocket, nerve dendrites, and bone and muscle healing -the body cannot make this.
Vitamin K - recent studies show it aids calcium absorption in bone.
Vitamin E - helps supply oxygen to the oral tissues -prevents and dissolves blood clots - helps healing - good for wound healing.
**Vitamin A - strong bones, formation and maintenance of teeth, and health of gums - Beta Carotene studies show it may reduce the risk of oral cancer - helps the healing process - needed for the health of mucous membranes of the mouth - stimulates the body's defense system and guards against infection.
Selenium - synergistic with Vitamin E - important for tissue elasticity - increases resistance to infection -antioxidant.
B Complex - important for a healthy nervous system to minimize oral pain - this group includes B 1, 2, 3, 6, and 12.
Vitamin B1 (Thiamine) helps relieve dental postopera-tive pain - general pain relief.
Vitamin B2 (Riboflavin) - helps eliminate sore mouth, lips, and tongue - aids healthy skin and healing process in general - deficiencies can lead to cracks and sores at the corner of the mouth, sore tongue, and sore mouth.

Vitamin B3 (Niacinamide) helps the nervous system -improves circulation - deficiencies can cause canker sores, bad breath, and swollen tongue.
Vitamin B12 - helps the nervous system - helps form and regenerate red blood cells.
Manganese - helps bone development.
Folic acid - helps prevent canker sores and red tongue - analgesic for pain - helps in production of red blood cells.
Biotin - helps ease muscle pains, alleviate dermati-tis, and sore tongue.
Iodine - helps dispose of body wastes - aids tooth development.
Iron - helps in production of red blood cells -promotes resistance to disease - improves health of teeth, skin, and bones.
Copper - aids in bone formation and healing.
Pantothenic acid - produces coenzyme A which the body does not produce on its own - fights cellular toxicity.
Chromium - helps burn free sugar which promotes the healing of damaged tissue.
** - most important of its group, so the presence of an effective amount is essential.

* * * * *
Note: The collagen and mucosal epithelial barrier is dependent on Zinc, Folic acid, Vitamin C, and Iron, which increase the gingival tissue resistance to bacterial plaque.
Note: The "Lime Complex" trio of bioflavonoids potentiates the action of Vitamin C, especially in prevent-ing capillary permeability and gingival bleeding.
Using Beta Carotene instead of Vitamin A itself takes advantage of recent Beta Carotene studies which show a decrease in cancer using Beta Carotene, which would apply to oral cancer as well.
The compositions of the invention supply all of the essential Vitamins and Minerals needed for dental health.
In addition, the present formulations include items not usually found in multivitamin preparations, such as Ovalbumin, Bioflavonoids, Hesperidin, Rutin, Bone Meal (Calcium and Phosphorus), and three to four times the usual amounts of Vitamin C, Bl, and B2.
Some categories of dental diseases for which certain ingredients of the present dental dietary supplement are important are as follows:
1) Loose teeth and rece~;ng gums: C, D, Bioflavon-oids, Calcium, Magnesium, Manganese, A, Selenium, Phospho-rus, Copper, Hesperidin, Rutin, Ovalbumin.

2) Bleeding gums and flabby gums: C, K, E, A, B2, B3, B6, B12, Bioflavonoids, Zinc, Selenium, Biotin, Rutin, Iodine, Iron, Folic acid, Hesperidin, Ovalbumin.

3) Bad breath: Zinc, B2, B3, A, C, B6.

4) Sensitive teeth and sore gums: B6, B2, B1, B3, B12, Folic acid, Magnesium, Zinc, Biotin, Ovalbumin.

5) Denture and Bridgework wearers: Bioflavonoids, C, Calcium, Zinc, A, E, B2, Selenium, Ovalbumin.

6) Pyorrhea and gingivitis: Pantothenic acid.

7) Damaged gums: Chromium.
The above-identified active components, considered separately, have been known to provide certain physiologi-cal benefits and effects, as described above. However, it has not been known previously that the combination dietary supplements of the present invention can provide such outstanding maintenance and preservation of dental health when administered to a living human being in need of such dietary supplementation.
The form of the dietary supplement of the present invention for oral administration may be in solid or liquid form, such as tablets, capsules, granulates, chewable wafers or tablets, powder packets, syrups, elixirs, disper-sible drink mixes (with or without effervescence-producing ingredients), any other liquid form, e.g., emulsion or suspension, or the like, and is preferably in the form of tablets or caplets, most especially tablets.
As is usual in the art, compositions according to the present invention may contain optional preservatives, sweeteners, or flavorants, which may provide a more palatable dosage form and assist in long-term patient compliance, but in general such additional ingredients are optional. Such additional ingredients and further addita-ments to be included will be at the discretion of the formulator. In addition, physiologically-acceptable buffers or antacids or the like may be incorporated in the dietary supplements of the present invention at the option of the formulator.
In the formulations of the invention, the mineral and vitamin components may be admixed with at least one pharmaceutically-acceptable diluent (excipient) or carrier such as cane sugar, lactose, starch, talc, or synthetic or natural gum, a binder such as gelatin, a lubricant such as sodium stearate, and/or a disintegrant such as sodium bicarbonate, calcium carbonate, magnesium carbonate, or potassium carbonate. To effect a sustained release, a substance such as a hydrocolloid or other polymer may be incorporated into the composition. Additional substances such as lubricants or buffers may also be added, as is conventional in the art. The tablets, pills, or granules may be subjected to coatings if desired. Additionally, agents for the sweetening, flavoring, or for the imparting of fragrance may be utilized if desired.
In the compositions of the present invention, the proportions of the active agents, e.g. vitamins and minerals, in the composition may be varied widely, it being necessary only that the active ingredients of the present invention or a prodrug therefor (e.g., betacarotene) constitute or provide an effective amount such that a suitable effective dose will be obtained in a single administration consistent with the dosage form employed.
Obviously, several dosage forms may be administered in the course of a daily regimen and, of course, a plurality of individual active components will always be administered in the same unit dosage of the dietary supplement composition or formulation, such in fact being of the essence of the present invention.
As noted above, inactive components or excipients which are well known in the art, may optionally be provided as fillers to place the active ingredients, vitamins and minerals into tablet or caplet form. For example, the fillers may include binders, lubricants, and disintegrants, which can for example optionally include cellulose, gelatin, silica, and the like. Additionally, anticaking and flow-enhancing agents, for example anhydrous dicalcium phosphate and magnesium oxide may be employed if desired, as well as flavors and sweeteners, for example aspartame, natural orange flavor, or the like.
The active ingredients or components are either simply a~ix~ together or granulated and mixed together, either by dry or wet granulation, together with usual excipients, and tabletted or encapsulated according to conventional procedure.
DETAILED DESCRIPTION OF THE INVENTION
The following Examples are given by way of illustra-tion only, and are not to be construed as limiting.
Example 1 - Preferred Unit Dosage Form The ingredients and amounts for the formulation of a unit dosage form of the oral dietary supplement composition of the present invention for maintaining and preserving dental health consist essentially of the following ingredi-ents in the following amounts:
Vitamin A 5000 I.U. All as Beta Carotene (100) Vitamin B1 (Thiamine) 4.5 mg. (300) Vitamin B2 (Riboflavin) 5.1 mg. (300) Vitamin B3 (Niacinamide) 30 mg. (150) Vitamin B6 3 mg. (150) Vitamin B12 9 mcg. (150) Folic acid 400 mcg. (100) Biotin 30 mcg. (10) Vitamin C 240 mg. (400) Vitamin D 200 I.U. (50) Vitamin E 45 I.U. (150) Vitamin K 25 mcg. (*) Calcium (Carbonate) 200 mg. (20) Bioflavanoids 75 mg. (*) Hesperidin 25 mg. (*) Rutin 25 mg. (*) Phosphorus 35 mg. (10) Zinc 15 mg. (100) Iron 18 mg. (100) Selenium 100 mcg. (*) Magnesium 100 mg. (25) Manganese 3 mg. (*) Iodine (Potassium iodide) 100 mcg. (66.6) Copper 1 mg. (50) Amino Acids (Ovalbumin) 100 mg. (*) Pantothenic Acid 10 mg. (100) Chromium 25 mcg. (*) All formulated into a unit dosage form, preferably a caplet or a tablet, and most especially a tablet, having a total weight of approximately 1670 mg., plus or minus ten percent.
Note: * No U.S. RDA established I.U. = International Units **The ten essential amino acids are well known to be Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Arginine, and Histidine.
The above-identified active ingredients are blended with additional inactive ingredients or excipients in stainless steel containers using stainless steel mixers or otherwise in standard equipment and the ultimate blend of all ingredients is transferred to usual equipment for encapsulation or compression tableting. Preferred excipi-ents employed in minor amounts, up to a maximum of two (2) percent w/w of the total formulation, are as follows:
microcrystalline cellulose as binder, croscarmellose sodium as a disintegrant, magnesium stearate as lubricant, stearic acid as lubricant, and hydroxypropylmethylcellulose as a tablet coating, with an optional artificial coloring incorporated in the tablet coating, such artificial color as usual selected from a GRAS and/or FDA-approved artifi-cial coloring, when employed. After simple admixture, or after wet or dry granulation and admixture, tablets are produced on semiautomatic or high-speed automation compression machines and capsules are filled on semiauto-matic or high-speed automatic encapsulation equipment according to the usual procedure of the art and packages are checked in process for tablet or capsule count and product uniformity. Example 2 - Formulation Range The ingredients and amounts for the formulation of a unit dosage form of the oral dietary supplement composition of the present invention for maintaining and preserving dental health consist essentially of the following ingredi-ents in the following amounts, given by ranges:
Inqredient Amount Vitamin A 5,000 to 7,000 IU
Vitamin B1 1.4 to 6 mg.
Vitamin B2 1.7 to 6.8 mg.
Vitamin B3 18 to 45 mg.

Vitamin B6 2 to 6 mg.
Vitamin B12 3 to 18 mg Folic Acid 400 to 600 mcg.
Biotin 30 to 60 mcg.
Vitamin C 60 to 480 mg.
Vitamin D 200 to 400 IU
Vitamin E 10 to 60 IU
Vitamin K 15 to 50 mcg.
Calcium 150 to 400 mg.
Bioflavanoids 50 to 100 mg.
Hesperidin 15 to 35 mg.
Rutin 15 to 35 mg.
Phosphorous 20 to 45 mg.
Zinc 5 to 20 mg.
Iron 9 to 27 mg.
Selenium 50 to 150 mcg.
Magnesium 50 to 400 mg.
Manganese 2 to 4 mg.
Iodine (as alkali metal salt) 50 to 150 mcg.
Copper 1 to 3 mg.
Amino Acids (selected from the ten essential amino acids) 50 to 150 mg.
Pantothenic Acid 5 to 15 mg Chromium 15 to 35 mcg All formulated into a unit dosage form, preferably a caplet or tablet, not exceeding a total weight of 1800 mg., preferably about 1500 to 1800 mg. and most especially a tablet of about 1670 mg. plus or minus ten percent.
The above-identified active ingredients are blended with additional inactive ingredients or excipients in stainless steel containers using stainless steel mixers or otherwise in standard equipment and the ultimate blend of all ingredients is transferred to usual equipment for encapsulation or compression tableting. Preferred excipi-ents employed in minor amounts, up to a maximum of two (2) percent w/w of the total formulation, are as follows:
microcrystalline cellulose as binder, croscarmellose sodium as a disintegrant, magnesium stearate as lubricant, stearic acid as lubricant, and hydroxypropylmethylcellulose as a tablet coating, with an optional artificial coloring incorporated in the tablet coating, such artificial color as usual selected from a GRAS and/or FDA-approved artifi-cial coloring, when employed. After simple admixture, or after wet or dry granulation and admixture, tablets are produced on semiautomatic or high-speed automation compression machines and capsules are filled on semiauto-matic or high-speed automatic encapsulation equipment according to the usual procedure of the art and packages are checked in process for tablet or capsule count and product uniformity.
* * * * *
The exact time of administration or ingestion of the oral dental health dietary supplement of the present invention is immaterial, but is preferably at any time after a period of fasting, e.g., in the morning, at or before breakfasttime, and especially when a healthy breakfast is not eaten, since fasting from proper vitamins and minerals has been taking place during the night since the ingestion of foods from dinner many hours ago, and ingestion of the dietary supplement of the present invention in the morning brings the fast from the proper vitamins and minerals to an end essentially instantaneously by providing the superb combination of minerals and vitamins present in the dietary supplement of the inven-tion, which is especially designed to help maintain and preserve dental health.
* * * * *
It is therefore seen that the present invention provides a novel and effective dietary supplement composi-tion, in unit dosage form, for the maintenance of complete dental and oral health and for preventing periodontal disease and tooth loss, by providing effective amounts of components for strengthening the gingiva, for strengthening the immune system and decreasing sensitivity, pain, and soreness, and for strengthening teeth and bone, and a method for the maintenance and preservation of dental health by the oral administration of such an oral dental health dietary supplement composition to a living human being in need of such dietary supplementation. The composition and method of the invention have the unpredict-able and highly advantageous characteristics and effects of preventing periodontal disease and tooth loss by the building of resistance to gum diseases which cause flabby and inflamed gums and tooth loss, by helping the body to combat bleeding gums, swollen gums, loosening teeth, decay, bad breath, and the like, through the provision of effective amounts of minerals and vitamins for the streng-thening of gingiva, for the strengthening of the immune system and decrease of sensitivity, pain, and soreness, and for the strengthening of teeth and bone, all as more fully set forth in the foregoing, and whereby all of the objectives of the present invention are attained.
It is to be understood that the present invention is not to be limited to the exact details of operation, or to the exact compounds, compositions, methods, procedures, or embod;rents shown and described, as various modifications and equivalents will be apparent to one skilled in the art, wherefore the present invention is to be limited only by the full scope which can be legally accorded to the appended claims.

Claims

WE CLAIM:

A method for the maintenance and preservation of dental health consisting essentially of the step of orally administering to a living human being in need of such dietary supplementation a dietary supplement composition, in unit dosage form, consisting essentially of an effective amount of a plurality of vitamins and minerals for strengthening gingiva, an effective amount of a plurality of vitamins and minerals for strengthening of the immune system and decreasing sensitivity, pain, and soreness, and an effective amount of a plurality of vitamins and minerals for the strengthening of teeth and bone.

A method of Claim 1 wherein the vitamins and minerals include an effective amount of each of Vitamin C, Vitamin A, and calcium.

A method of Claim 1 wherein the vitamins and minerals for strengthening gingiva include:
Vitamin C, Bioflavanoids, Rutin, Hesperidin, essential Amino Acids, Iron, and Folic Acid;
the vitamins and minerals for strengthening the immune system and decreasing sensitivity, pain, and soreness include:
Zinc, Vitamin E, Vitamin A, Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B6, Vitamin B12, Biotin, and Selenium; and the vitamins and minerals for strengthening tooth and bone include:
Calcium, Vitamin D, Phosphorous, Magnesium, Vitamin K, Manganese, Iodine, and Copper.

The method of Claim 3 wherein the essential amino acids include all of the ten essential amino acids.

The method of Claim 3 wherein the formulation range of the vitamins and minerals comprising the oral dietary supplement composition includes the following ingredients in the approximate amounts:
Ingredient Amount Vitamin A 5,000 to 7,000 IU
Vitamin B1 1.4 to 6 mg.
Vitamin B2 1.7 to 6.8 mg.
Vitamin B3 18 to 45 mg.
Vitamin B6 2 to 6 mg.
Vitamin B12 3 to 18 mg Folic Acid 400 to 600 mcg.
Biotin 30 to 60 mcg.
Vitamin C 60 to 480 mg.
Vitamin D 200 to 400 IU
Vitamin E 10 to 60 IU
Vitamin K 15 to 50 mcg.
Calcium 150 to 400 mg.
Bioflavanoids 50 to 100 mg.
Hesperidin 15 to 35 mg.
Rutin 15 to 35 mg.
Phosphorous 20 to 45 mg.
Zinc 5 to 20 mg.
Iron 9 to 27 mg.
Selenium 50 to 150 mcg.
Magnesium 50 to 400 mg.
Manganese 2 to 4 mg.
Iodine (as alkali metal salt) 50 to 150 mcg.
Copper 1 to 3 mg.
Amino Acids (selected from the ten essential amino acids) 50 to 150 mg.
Pantothenic Acid 5 to 15 mg Chromium 15 to 35 mcg in an appropriate unit dosage form.

The method of Claim 5 wherein the oral dietary supplement composition is in the form of a compressed tablet or caplet.

The method of Claim 5 wherein the oral dietary supplement composition is in the form of a compressed tablet or caplet, having a total weight of 1500-1800 mg.

The method of Claim 5 wherein the oral dietary supplement composition is in the form of a compressed tablet having a total weight of approximately 1670 mg. plus or minus ten percent.

The method of Claim 5 wherein the vitamins and minerals comprising the oral dietary supplement composition include the following ingredients in the approximate amounts:
Vitamin A 5000 I.U. All as Beta Carotene Vitamin B1 (Thiamine) 4.5 mg.
Vitamin B2 (Riboflavin) 5.1 mg.
Vitamin B3 (Niacinamide) 30 mg.
Vitamin B6 3 mg.
Vitamin B12 9 mcg.
Folic acid 400 mcg.
Biotin 30 mcg.
Vitamin C 240 mg.
Vitamin D 200 I.U.
Vitamin E 45 I.U.
Vitamin K 25 mcg.
Calcium (Carbonate) 200 mg.
Bioflavanoids 75 mg.
Hesperidin 25 mg.
Rutin 25 mg.
Phosphorus 35 mg.
Zinc 15 mg.

Iron 18 mg.
Selenium 100 mcg.
Magnesium 100 mg.
Manganese 3 mg.
Iodine (Potassium iodide) 100 mcg.
Copper 1 mg.
Amino Acids (Ovalbumin) 100 mg.
Pantothenic Acid 10 mg.
Chromium 25 mcg.
in an appropriate unit dosage form.

The method of Claim 9 wherein the oral dietary supplement composition is in the form of a compressed tablet or caplet.

The method of Claim 9 wherein the oral dietary supplement composition is in the form of a compressed tablet or caplet having a total weight of 1500-1800 mg.

The method of Claim 9 wherein the oral dietary supplement composition is in the form of a compressed tablet having a total weight of approximately 1670 mg. plus or minus ten percent.

An oral dietary supplement composition for maintaining and preserving dental health, in unit dosage form, consisting essentially of an effective amount of a plurality of vitamins and minerals for strengthening gingiva, an effective amount of a plurality of vitamins and minerals for strengthening the immune system and decreasing sensitivity, pain, and soreness, and an effective amount of a plurality of vitamins and minerals for strengthening teeth and bones.

An oral dietary supplement composition of Claim 13 wherein the vitamins and minerals include an effective amount of each of Vitamin C, Vitamin A, and calcium.

An oral dietary supplement composition of Claim 13 wherein the vitamins and minerals for strengthening gingiva include:
Vitamin C, Bioflavanoids, Rutin, Hesperidin, essential Amino Acids, Iron, and Folic Acid;
the vitamins and minerals for strengthening the immune system and decreasing sensitivity, pain, and soreness include:
Zinc, Vitamin E, Vitamin A, Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B6, Vitamin B12, Biotin, and Selenium; and the vitamins and minerals for strengthening tooth and bone include:
Calcium, Vitamin D, Phosphorous, Magnesium, Vitamin K, Manganese, Iodine, and Copper.

The composition of Claim 15 wherein the essential amino acids include all of the ten essential amino acids.

The composition of Claim 15 wherein the formulation range of the vitamins and minerals comprising the oral dietary supplement composition includes the following ingredients in the approximate amounts:
Ingredient Amount Vitamin A 5,000 to 7,000 IU
Vitamin B1 1.4 to 6 mg.
Vitamin B2 1.7 to 6.8 mg.
Vitamin B3 18 to 45 mg.
Vitamin B6 2 to 6 mg.
Vitamin B12 3 to 18 mg Folic Acid 400 to 600 mcg.
Biotin 30 to 60 mcg.
Vitamin C 60 to 480 mg.
Vitamin D 200 to 400 IU
Vitamin E 10 to 60 IU
Vitamin K 15 to 50 mcg.
Calcium 150 to 400 mg.
Bioflavanoids 50 to 100 mg.
Hesperidin 15 to 35 mg.
Rutin 15 to 35 mg.
Phosphorous 20 to 45 mg.
Zinc 5 to 20 mg.
Iron 9 to 27 mg.
Selenium 50 to 150 mcg.
Magnesium 50 to 400 mg.
Manganese 2 to 4 mg.
Iodine (as alkali metal salt) 50 to 150 mcg.
Copper 1 to 3 mg.
Amino Acids (selected from the ten essential amino acids) 50 to 150 mg.
Pantothenic Acid 5 to 15 mg Chromium 15 to 35 mcg in an appropriate unit dosage form.

The composition of Claim 17 wherein the oral dietary supplement composition is in the form of a compressed tablet or caplet.

The composition of Claim 17 wherein the oral dietary supplement composition is in the form of a compressed tablet or caplet having a total weight of 1500-1800 mg.

The composition of Claim 17 wherein the oral dietary supplement composition is in the form of a compressed tablet having a total weight of approximately 1670 mg. plus or minus ten percent.

The composition of Claim 17 wherein the vitamins and minerals comprising the oral dietary supplement composition include the following ingredients in the approximate amounts:
Vitamin A 5000 I.U. All as Beta Carotene Vitamin B1 (Thiamine) 4.5 mg.
Vitamin B2 (Riboflavin) 5.1 mg.
Vitamin B3 (Niacinamide) 30 mg.
Vitamin B6 3 mg.
Vitamin B12 9 mcg.
Folic acid 400 mcg.
Biotin 30 mcg.
Vitamin C 240 mg.
Vitamin D 200 I.U.
Vitamin E 45 I.U.
Vitamin K 25 mcg.
Calcium (Carbonate) 200 mg.
Bioflavanoids 75 mg.
Hesperidin 25 mg.
Rutin 25 mg.
Phosphorus 35 mg.
Zinc 15 mg.
Iron 18 mg.
Selenium 100 mcg.
Magnesium 100 mg.
Manganese 3 mg.
Iodine (Potassium iodide) 100 mcg.
Copper 1 mg.
Amino Acids (Ovalbumin) 100 mg.
Pantothenic Acid 10 mg.
Chromium 25 mcg.
in an appropriate unit dosage form.

The composition of Claim 21 wherein the oral dietary supplement composition is in the form of a compressed tablet or caplet.

The composition of Claim 21 wherein the oral dietary supplement composition is in the form of a compressed tablet or caplet having a total weight of 1500-1800 mg.

The composition of Claim 21 wherein the oral dietary supplement composition is in the form of a compressed tablet having a total weight of approximately 1670 mg. plus or minus ten percent.