Calcium Phosphate Technologies

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About NovaMin®

NovaMin®:  The NovaMin Technology was developed by Dr. Len Litkowski and Dr. Gary Hack at the Department of Restorative Dentistry at the University of Maryland and by Dr. David Greenspan at NovaMin Technology Inc.  There are currently 5 products on the market that include NovaMin:

Product: Sold By: Launched:
SootheRx®- Dentist Dispensed Take Home Tooth Sensitivity Therapy System OMNII Oral Pharmaceuticals (West Palm Beach., FL) October 2004
DenShield™- Same as above NovaMin Technology Inc. (through independent distributors) December 2004
NuCare® Root Conditioner with NovaMin®- In-chair product for treatment of sensitivity post periodontal surgery Sunstar-Butler Co. (Chicago, IL) November 2004

NuCare® Prophylaxis Paste with NovaMin®-

In-chair product used during prophylaxis  (tooth cleaning) procedures by your hygienist

Sunstar-Butler Co. (Chicago, IL) March 2005
Oravive®- Consumer toothpaste that whitens and desensitizes teeth (www.oravive.com)

Dr. Collins Restore Toothpaste

NovaMin Technology Inc. (mainly through internet sales) December 2002

NovaMin is made of synthetic mineral containing sodium, calcium, phosphorous and silica (sodium calciumphosphosilicate) which are all elements naturally found in the body.  When NovaMin particles come in contact with saliva or water, they rapidly release sodium, calcium and phosphorous ions into the saliva that are available for remineralization of the tooth surface.  Unlike the other calcium phosphate technologies, the ions that NovaMin release form hydroxycarbonate apatite (HCA) directly, without the intermediate amorphous calcium phosphate phase detailed above 10.  NovaMin particles also attach to the tooth surface and continue to release ions and remineralize the tooth surface after the initial application.  These particles have been shown, in in-vitro studies, to release ions and transform into HCA for up to two weeks 11.  Ultimately these particles will completely transform into HCA which is the mineral your teeth and bones are made of.  

NovaMin has been shown, in in-vitro and clinical studies, to be a significant tubule occluder and desensitizer.  In a number of in-vitro studies NovaMin has been shown to occlude by over 80%.  In a clinical on tooth hypersensitivity a NovaMin containing toothpaste (Oravive®) was shown to decrease sensitivity significantly greater that a strontium chloride toothpaste which is the favored tubule occlusion ingredient in Europe 12.  In another clinical study on tooth hypersensitivity a NovaMin containing toothpaste (SootheRx®) was shown to decrease sensitivity by 90% which was highly significant versus placebo 13.  In an open label study on a NovaMin product used to treat sensitivity post scaling and planning (NuCare® Root Conditioner), the product was shown to reduce sensitivity by up to 52 % 24 hours post procedure.  Nearly 80% of the patients reported significant relief from sensitivity at the 24-hour post treatment time point 14.  NovaMin has also been shown to have significant anti microbial properties and can kill up to 99.999% of oral pathogens associated with periodontal disease and caries 15.  In a gingivitis study, A NovaMin containing toothpaste (Oravive®) was shown to reduce gingivitis by up to 58% used twice per day for 6-weeks which is equivalent to chlorhexadine used 3 times a day for 6-months 16.

NovaMin Technology Inc. has 510(k) approvals from the FDA on the above products for the treatment of tooth hypersensitivity.

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About Recaldent®

Recaldent®:  The Recaldent technology was developed by Prof Eric Reynolds of the University of Melbourne and supported by the Australian Milk Council.  Recaldent was first used in Trident Chewing Gum, introduced in February 2002, and more recently in GC America’s MI Paste, introduced in mid 2004 in the US.

Recaldent (also referred two as CPP-ACP) is a complex of casein phosphopeptide (CCP), a protein found in milk, and amorphous calcium phosphate (ACP). This complex is said to adhere to plaque on the tooth surface and release calcium and phosphorous during a “normal acid challenge” in the mouth which can then be use for tooth remineralization 1,2 .  Most of the scientific research conducted on Recaldent relates to its anti-caries benefit.  Recaldent has been shown in several laboratory studies and in one clinical study to be effective in remineralizing carious lesions and to interfere with the adhesion of some bacteria to the tooth surface.  There are no clinical studies available that address the ability of Recaldent to reduce tooth hypersensitivity.  The GC America web site and literature do show a graph of “Inhibition of Dentin Permeability” which is a measurement of how effective a material is at occluding tubules.  It is generally believed that materials which occlude dentinal tubules will reduce clinical sensitivity 3,4.  In this graph the MI paste achieves a 100% reduction in flow immediately after application  but before rinsing and a 30% reduction in flow only 5 minutes after rinsing.  This data indicates that the CCP-ACP complex doesn’t strongly adhere to the dentin surface and is readily rinsing off.

To read more about Recaldent, Click here!

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About SensiStat®

SensiStat®:  The SensiStat Technology was developed by Dr. Israel Kleinberg at the Department of Oral Biology and Pathology at State University of New York at Stony Brook.  The technology was first incorporated into Ortek’s Proclude® desensitizing prophy paste that was launched in March of 2003 and later in Denclude®, a dentist dispensed sensitivity paste for take home use that was launched in November of 2004.

The SensiStat technology is made of arginine bicarbonate, an amino acid complex, and particles of calcium carbonate, a common abrasive in toothpaste.  The arginine complex is responsible for adhering the calcium carbonate particles to the dentin or enamel surface.  Although the calcium carbonate is said to create an “alkaline environment that react with tubule fluids to further enhance particle attachment” the research and literature on SensiStat characterize the calcium carbonate as “poor solubility” 8.  Calcium carbonate is, in fact, not very soluble and releases very low levels of calcium into the oral environment.  As a result, the SensiStat technology does not increase calcium levels in saliva as significantly as the other calcium phosphate technologies do to enhance remineralization.

The in vitro data on the Proclude in-office product indicates it is an effective tubule occluder and a clinical study on the Proclude prophy paste indicates that a 90% reduction in sensitivity was achieved for up to 28 days in a non-placebo controlled study 8,.  A non placebo controlled clinical study on sensitivity reduction for the Proclude in-office product resulted in significant reduction of tooth sensitivity 9.  Although the Ortek website claims that a clinical study of the Denclude take-home product resulted in a 60% reduction in sensitivity, no clinical data has been published that details this study. Ortek does have 510(k) approval from the FDA on both the Proclude and Denclude products for the treatment of tooth hypersensitivity.

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About ACP (Amorphous Calcium Phosphate)

 

Amorphous Calcium Phosphate (ACP):  The ACP technology was developed by Dr. Ming S. Tung at the American Dental Research Associations Paffenbarger Research Center.  The technology was first incorporated into a consumer toothpaste product called Enamelon that was launched in 1999 but failed in the market place as it competed directly with consumer giants like Procter and Gamble and Colgate Palmolive.  The technology was reintroduced in the Enamel Care toothpaste brand by Church & Dwight (the Arm & Hammer folks) in mid 2004. 

The ACP technology requires a two phase delivery system to keep the calcium and phosphorous components from reacting with each other before use (a dual compartment tube is used for Enamel Care toothpaste).  The current sources of calcium and phosphorous are two salts, calcium sulfate and dipotassium phosphate.  When the two salts are mixed, they rapidly form amorphous calcium phosphate (ACP) that can precipitate onto the tooth surface.  This precipitated ACP can then readily dissolve into the saliva and can be available for tooth remineralization 5Arm & Hammer claims the toothpaste is the only one with `liquid calcium' and that it “fills the tooth surface and restores luster”,  which are cosmetic claims and do not require approval from the FDA.  The “fights cavities” claim is associated with the fluoride in the toothpaste.            

The scientific research on ACP has addressed both the anti caries and desensitization potential of the technology.  Although there has been a significant amount of in vitro and some clinical studies conducted by the Paffenbarger Institute on a variety of two-phase ACP systems, there is limited clinical data available for the Enamel Care toothpaste product.  The current product claims are associated with increased gloss of the tooth surface.  A recent clinical study on the product claims a “23.4% increase in tooth gloss and a 13.7 % decrease in tooth roughness” 6. A recent study on dentin permeability indicated that “successive treatments of dentin with dual-phase calcium-containing toothpastes can progressively reduce dentin permeability by surface deposition of mineral” 7.  There are no clinical studies that support the use of Enamel Care toothpaste for reducing tooth hypersensitivity and there are no FDA approvals for tooth desensitization for the Enamel Care product at this time.

 

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More detailed information on the above technologies can be found at the following websites:

References:

  1. Reynolds, EC. “Remineralization of enamel subsurface lesions by casein phosphopeptide – stabilized calcium phosphate solutions”.  J Dent Res. 1997 Sep; 76(9):1587-95.
  2. Shen P, Cai F, Nowicki A, Vincent J, Reynolds, EC. “Remineralization of enamel subsurface lesions by sugar-free chewing gum containing casein phosphopeptide –amorphous calcium phosphate”. J Dent Res. 2001 Dec; 80 (12): 2066-70.
  3. Brännström M, Astrom A. The hydrodynamics of the dentine; its possible relationship to dentinal pain. Int Dent J. 1972 Jun;22(2):219-27.
  4. Orchardson R, Gillam DG. The efficacy of potassium salts as agents for treating dentin hypersensitivity. J Orofac Pain. 2000 Winter;14(1):9-19.
  5. C.A Munoz, J. Stephens, A. Wilson, HM Proskin, A. Ghassemi, L. Vorwerk, and T. Winston, Loma Linda University, Howard M. Proskin & Assoc., Church & Dwight, “Tooth surface restoration by a bicarbonate – dentifrice containing calcium and phosphate”.  Abstract  2115.
  6. A. Ghassemi, T. Winston, A. Charig, L.Litkowski, K. Quinlan, M. Flickinger, F. Saunders, and L.Vorwerk, Church & Dwight, Univ. of Maryland. “Intra-Oral evaluation of a two-phase containing bicarbonate toothpaste”.  Abstract 3597.
  7. A. Charig, A. Winston, and S. Gupta, Church & Dwight. “Dentin permeability reduction due to two-phase calcium-containing toothpaste”.  Abstract 0954.
  8. Ortek Website-www.ortekinc.com
  9. M.S. Wolff, and I. Kleinberg, “Duration of reduction of dentinal hypersensitivity after prophylaxis with a calcium/arginine bicarbonate carbonate prophy paste”.  Journal of Dent. Res. 2003; 82: Special Issue A, Abstract #0180 (AADR 2003).
  10. Litkowski LJ, Hack GD, Sheaffer HB, Greenspan DC, “Occlusion of Dentin Tubules by 45S5 Bioglass®” 1997, Bioceramics, Vol 10
  11. Jennings DT, McKenzie KM, Greenspan DC, Clark AE. “Quantitative Analysis of Tubule Occlusion Using NovaMin (Calcium Sodium Phosphosilicate)” Journal of Dental Research (#2416), Vol. 83 A March 2004
  12. Report on file at NovaMin Technology Inc. March 2004, currently being prepared for publication.
  13. Report on file at NovaMin Technology Inc. May 2004, currently being prepared for publication
  14. Report on file at NovaMin Technology Inc. February 2005, currently being prepared for publication
  15. D.C. Greenspan, A. Clark, and G.P. LaTorre, NovaMin Technology, Inc., University of Florida, “In-Vitro antimicrobial properties of a bioactive glass (NovaMin) containing dentifrice”.  Abstract 1586.
  16. Report on file at NovaMin Technology Inc. March 2005, currently being prepared for publication

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