Research Details
Pharmadens OsteoTherapy™
Mineral Support Formula
ProMineral Balance For Implantology, Oral Surgery, And Periodontal Surgery

Periodontal Formulas
Physician Information
by Clark Hansen, N.M.D.

Periodontal Disease

Orthodontics and Oral surgery creates unique demand for specialized mineral support to prevent osseous complications. Bone remodeling induced by orthodontics and oral surgery can, if left untreated, weaken the integrity of the bones of the maxilla or mandible and possibly increase the incidence of osteoporosis later in life

Bone accumulation and structure during growth, as well as bone loss or deposition in adults, are greatly affected by mechanical stress. The procedures involved in orthodontia and oral surgery create a biomechanical stress that leads to remodeling of the bone. The initial step involves activation of osteoclasts that breakdown the discrete segment of bone under biomechanical stress. The second step involves resorption of the bone. During the third step, new bone is formed by osteoblasts in the resorption cavity to occur This activation, resorption, formation sequence of remodeling takes about four months.2 Implant dentists report similar time frames for remodeling and osseointegration to occur with implants

In order to achieve optimal results in the shortest period of time during this remodeling phase it is critical to ensure the supply of the essential components of remineralization. This is particularly important during adolescence, when Growth Hormone (GH) enhances mineral retention and deposition in bone, 3 creating a bone reservoir against later bone loss. Adult patients also require supplemental mineral support due to the lower initial bone density and inferior capacity for remineralization that increases with age.

In the United States, at least 25 million people suffer from osteoporosis. In women bone mass begins to decline at approximately age 35, then accelerates rapidly for 8-10 years around the time of menopause. By the time of diagnosis, 50 to 75% of the original bone material has already been lost. Supporting the remineralization process simultaneous to orthodontic and oral surgical procedures will ensure more successful results and help to prevent the promotion of bone loss or bone reservoir depletion.

Conventional Therapy
Conventional orthodontic and oral surgical procedures have not addressed bone remineralization. This has lead to several significant adverse results including demineralization; mucogingival and marginal attachment bone loss, as well as devitalization of teeth. 1 No conventional therapy has been routinely employed to prevent bone demineralization associated with orthodontics or oral surgery.

Functional Therapy
Pharmaden LLC, the leader of functional medicine in dentistry, has developed a unique proprietary formulation that significantly enhances bone remineralization. OsteoTherapy is an all-natural nutritional supplement designed to assist the body to efficiently restore optimal density to the alveolar bone involved in the procedures of orthodontia and oral surgery.[/vc_column_text][vc_empty_space][vc_column_text]


Mineral Support Formula

Ingredients Per 4 Capsules

Calcium Citrate 1000 mg
Magnesium Aspartate 1000 mg
Boron (Krebs Cycle Chelate) 500 mcg
Vitamin D (Cholecalciferol) 200 I.U.
Vitamin K (Phytonadione) 500 mcg
Vitamin B6 (Pyridoxine HCl) 2.5 mg
Vitamin B12 (Cyanocobalamin) 100 mcg
Folate (Folic Acid) 100 mcg
Silica 100 mg
Betaine HCl 200 mg
Digezyme™ 100 mg
Vitis vinifera (Grape) seed extract* 25 mg
Bioperine™ 10 mg

See More:

Minerals and Vitamin Cofactors
Inorganic salts, comprise more than 70% of the matrix of bone. The major component of the extracellular organic matrix is collagen, which comprises more than 90% by weight. The intricate arrangement of collagen fibers and mineral crystals gives bone its incredible tensile strength.

Calcium is the major mineral in bones. However, too much calcium inhibits magnesium, which is essential to the production of the hormone calcitonin. The optimal supplemental ratio of Calcium to Magnesium is 1:1.5,6 Magnesium is also essential for the conversion of the active form of vitamin D, which is required for calcium absorption and its deposit into bone. Taking too much calcium actually blocks magnesium and therefore blocks the production of vitamin D in its active form, which prevents calcium from getting into the bone. Calcium should not be taken in excessive amounts relative to Magnesium.

Vitamin B6, Vitamin B12, and Folic acid are essential co-factors in the conversion of the amino acid methionine into cysteine. If they are deficient, homocysteine increases. As homocysteine increases in the body it interferes with collagen cross-linking, leading to a defective bone matrix, unable to hold calcium in its normal arrangement in the bone. These nutrients are in this way essential to the building of healthy teeth and bones and in the prevention of osteoporosis.

Vitamin K is a hormone-like vitamin necessary for the production of the active form of osteocalcin which is the major non-collagen protein in the bone. Without sufficient vitamin K and its production of active osteocalcin, calcium will not be retained within the bone matrix. Vitamin K is found in deep green leafy vegetables and is one of the most commonly deficient vitamins missing from our diet.

The trace mineral Boron also appears to be an essential factor in the prevention and treatment of bone loss. Studies indicate that boron directly effects the action of parathormone resulting in significant alterations in calcium, magnesium, cholecalciferol and phosphorus metabolism. Boron is required to activate certain hormones including estrogen and vitamin D. Fruits and vegetables are the main sources of boron. Diets that are deficient in these foods may also be deficient in boron.

Silicon is required for optimal bone hydroxyprolase activity and plays an essential role in the crosslinking mechanisms involved in collagen, elastin and mucopolysaccharide formation.

Betaine HCl is another essential ingredient necessary for the conversion of methionine to cysteine. Deficiencies lead to homocysteinemia and its associated negative effects on the collagen matrix of the bone.

Digezyme™ is a plant enzyme derived from Aspergillus niger which contains significant quantities of phytase. Phytase has been shown to significantly improve bioavailability of dietary minerals including calcium, magnesium, phosphorous and zinc. Phytates present in dietary fiber are known to bind with essential minerals such as calcium and magnesium and inhibit their absorption from the gut. Phytase found in Digezyme™ enzymatically breaks down the phytates and prevents them from binding minerals. Plant Cofactors

Certain bioflavonoids found in fruits have been shown to be very important in the prevention of bone loss. Proanthocyanidin bioflavonoids, especially those extracted from Vitis vinifera (grape) seeds, have been shown to stabilize the collagen structures that knit bone together. The inclusion of these essential flavonoids is necessary to protect the integrity of collagen, including that found in the bone matrix.

Bioperine is a pure piperine extract obtained from an Indian spice, black pepper fruit (US Patent # 5,536,506), has been shown in human clinical trials to significantly enhance the bioavailability of various supplemented nutrients through increased absorption. 24 The Bioperine R absorption studies, conducted on healthy volunteers in the U.S., showed dramatic increases in the blood levels of all nutrients tested compared to the control group receiving the nutrients alone. Nutrients tested included fat-soluble vitamins (beta-carotene), water-soluble vitamins (vitamin B6), minerals (selenomethionine), and coenzymes (Coenzyme Q10). Absorption rates were shown to increase 30 to 60 percent.

Calcium Citrate: Calcium is the major mineral in bones. Calcium Citrate is 400% better absorbed than Calcium Carbonate, even in individuals with low stomach acid.

Magnesium Aspartate: Magnesium is the determining factor of bone strength. 80-85% American women consume less than the RDA. Necessary for the formation of new calcium crystals and the active form of Vitamin D. Magnesium Aspartate is the most useable form.

Boron: Necessary for the production of natural estrogen and testosterone. Significantly reduces loss of calcium and magnesium.

Vitamin K: Required for the attraction of calcium to bones. Individuals with weak bones have been found to have 35% less Vitamin K than age matched controls. Overuse of antibiotics kills healthful intestinal flora that produce Vitamin K. Supplementation reduces calcium loss by as much as 18-50%.

Folic Acid: Decreases homocysteine levels which can cause bone loss. Alcohol and Birth Control Pills cause a deficiency. Pregnancy creates a higher demand.

Silica: Found in high concentrations at calcification sites in growing bones.

Betaine HCl: Source of hydrochloric acid that is essential for the absorption and assimilation of minerals.

Digezyme™: Plant enzyme that digests phytates, found in grains, that commonly bind to minerals and significantly reduce their availability for absorption.

Vitis vinifera (Grape) Seed Extract: Standardized extract of Proanthocyanidin bioflavonoids necessary for the proper formation of the bone/collagen matrix of the jaw.

Product Safety
Calcium supplements are generally well tolerated at dosages less than 2,000 milligrams. Higher dosages may increase the risk of kidney stones and soft-tissue deposition.

Magnesium is generally well tolerated, however, supplementation of magnesium chloride, magnesium hydroxide, or magnesium citrate are sometimes associated with loose stools.

Oral supplementation of boron is extremely safe when administered in the recommended dosage range of 1 to 3 mg per day. Extremely high doses greater than 500 mg per day can cause nausea, vomiting and diarrhea.

Vitamin D toxicity is known to occur at doses greater than 1,000 I.U. per day, including increased blood calcium levels, deposition of calcium into internal organs, and kidney stones.

There are no known side effects or toxicity with the administration of Vitamin K1.

Vitamin B6 is one of only two B-complex vitamins (the other is niacin) that is associated with any toxicity at high doses. Doses greater than 2,000 milligrams per day can produce symptoms of nerve toxicity including paresthesia. Chronic intake of more than 500 milligrams daily can be toxic if taken daily for several months.

Folic acid supplementation should always include vitamin B12 because folic acid can mask an underlying Vitamin B12 deficiency. Although Folic acid can reverse the macrocytic anemia, it does not prevent or reverse the neurological symptoms associated with a deficiency of Vitamin B12. Otherwise both of these two vitamins are devoid of toxicity. Silicon is generally recognized as nontoxic.

Betaine HCl is generally well tolerated in the recommended range of 100 to 500 mg per dose. Higher doses can cause acid irritation to the gastric mucosa. Patients with gastric ulcers should be able to tolerate this dose but may require gastric mucosa support such as Pepteal™ etc.

Vitis vinifera seed extract has been shown to be devoid of any toxic, carcinogenic, or teratogenic effects. It does not impair fertility and has been shown to be safe for use during pregnancy and breast-feeding with no peri-natal or post-natal toxicity. Due to its bitter nature, occasional nausea or stomach upset has been reported. Temporary skin irritation has occurred in patients with a specific hypersensitivity to grapes. Chronic toxicity studies have shown it to be safe even at extremely high doses (132mg/lb body weight/day for twelve months in dogs). LD50>4000 mg/kg in rats and mice.

Bioperine has been shown to be devoid of any toxic effects. The recommended amount of 5 mg of piperine per dose, is seven times less than the daily amount of piperine typically consumed by the average U.S. citizen from black pepper.

Take two capsules twice daily or as directed by your dentist.


  1. Kocsis A and Kocsis G: Adverse effects of orthodontic treatment. Fogorv Sz 1997 Nov;90(11):327-332.
  2. Frost HM: Tetracycline-based histological analysis of bone remodeling. Calcified Tissue Research 1969;3:211.
  3. Greig F et al.: Increase in bone density and plasma osteocalcin during growth hormone therapy in growth hormone deficient children. J Pediatr Endocrinol Metab 1997 Jan;10(1):11-17.
  4. Nelson PA and Artun J: Alveolar bone loss of maxillary anterior teeth in adult orthodontic patients. Am J Orthod Dentofacial Orthop 1997 Mar;111(3):328-334.
  5. Abraham GE and Grewall HA: Total dietary program emphasizing magnesium instead of calcium. J Repro Med 1990;35(5):503-507.
  6. Abraham GE: The calcium controversy. J Appl Nutr 1982;34:69.
  7. Fatemi S, Ryzen E, et al: Effects of experimental human magnesium depletionh on parathyroid hormone secretion and 1,25-dihydroxyvitamin D metabolism. J Clin Endocrinol Metab 1991;73(5):1067-1072.
  8. Makgoba NW and Datta HK: The critical role of magnesium ions in osteoclast-matrix interaction: Implication for divalent cations in the study of osteoclaststic adhesion molecules and bone resorption. Euro J Clin Invest 1992;22:692-6.
  9. Orowoll ES, Oviatt SK, et al: The rate of mineral loss in normal men and the effects of calcium and cholecalciferol supplementation. Ann Int med 1990;112(10):29-34.
  10. Mason JB, et al.: The effects of vitamins B12, B6, and folate on blood homocysteine levels. Ann N Y Acad Sci. 1992 Sep 30; 669: 197-203.
  11. Lubec B, et al.: Evidence for McKusick’s hypothesis of deficient collagen cross-linking in patients with homocystinuria. Biochim Biophys Acta 1996 Apr 12; 1315(3): 159-162.
  12. Brattstrom LE et al: Folic acid responsive postmenopausal homocysteinemia. Metabolism 1985 Nov;34(11):1073-1077.
  13. Hart JP et al: Electrochemical detection of depressed circulating levels of vitamin K1 in osteoporosis. J Clin Endocrin Met 1985;60:1268-9.
  14. Price PA: Vitamin K nutrition and postmenopausal osteoporosis. J Clin Invest 1993;91(4):1268.
  15. Nielson, FH: Studies on the relationship between boron and magnesium which possibly effect the formation and maintenance of bones. Magnesium Trace Elem 1990;9:61-69.
  16. Nielson NH and Curtiss DH, et al: Effects of dietary boron on mineral, estrogen, and testosterone metabolism in postmenopausal women. FASEB 1987;1:397-7.
  17. Carlisle EM. The nutritional essentiality of silicon. Nutr Rev 1982 Jul; 40(7): 193-198.
  18. Carlisle EM. Silicon: a requirement in bone formation independent of vitamin D1. Calcif Tissue Int. 1981; 33(1): 27-34.
  19. Wilcken DE, Dudman NP, Tyrrell PA: Homocystinuria due to cystathionine beta-synthase deficiency–the effects of betaine treatment in pyridoxine-responsive patients. Metabolism 1985 Dec;34(12):1115-1121.
  20. Franken DG, et al.: Treatment of mild hyperhomocysteinemia in vascular disease patients. Arterioscler Thromb 1994 Mar;14(3):465-470.
  21. Sanderg, A and Andersson H: Effect of phytase on the digestion of phytate in the stomach of humans. J Nutr 1988;118:469-473.
  22. Pfister a, et al: Sites de fixation des oligomeres procyanidoliques dans la paroi des capillaires sanguins du poumon decobaye. Acta Therapeutica 1982; 8:223-237.
  23. Masquelier J, Dumon MC, Dumas J: Stabilization du collagne par les oligomeres procyandoliques. Acta Therapeutica 1981;7:101-105.
  24. Badmaev V & Majeed M: Comparison of nutrient bioavailability when ingested alone and in combination with Bioperine. Research Report, Sabinsa Corporation, 1996.
  25. Masquelier J: Procyanidolic oligomers. J. Parfums Cosmet Arom, 95: 89-97, 1990.
  26. Cohen M and Bendich A: Safety of pyridoxine-A review of human and animal studies. Toxicol Letters 1986; 34:129-139.

Pharmaden FREE Report