8550 Higuera Street Culver City, CA 90232

Amorphous Calcium Phosphate

Patented New Technology for

Rebuilding Enamel
Endnotes
1 Tung, M.S., Eichmiller, F.C. Amorphous Calcium Phosphate for tooth mineralization. Compend Contin Educ Dent, Vol 25, No 9 Suppl 1, Sep 2004, pp 9-13. Journal Code 9600713, Journal Subset MEDJSD, ISSN 1548-8578. Corporate Author: American Dental Association Foundation. 2 M. Markovic, B.O. Fowler And M.S. Tung. Preparation and Comprehensive Characterization of a Calcium Hydroxyapatite Reference Material. Journal of Research of the National Institute of Standards and Technology, Volume 109, Number 6, November-December 2004. 3 Tung, M.S., Eichmiller, F.C. Amorphous Calcium Phosphate for tooth mineralization. Compend Contin Educ Dent, Vol 25, No 9 Suppl 1, Sep 2004, pp 9-13. Journal Code 9600713, Journal Subset MEDJSD, ISSN 1548-8578. Corporate Author: American Dental Association Foundation. 4 Grant LP, Thompson A, Tanzer JM. Caries inhibition in rats by a remineralizing toothpaste. Journal of Clinical Dentistry. 1999;10(1 spec no):30-33. 5 Flaitz C, Hicks J. Whitening Agent Effects on Enamel Caries Formation and Progression. IADR Unpublished Abstract #73739.
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7 Giniger, MacDonald, Ziemba, Felix. The Clinical Performance of Professionally Dispensed Bleaching Gel with Added Amorphous Calcium Phosphate. Jada Vol. 136, March 2005. 8 Giniger M, Spaid M, Felix M, MacDonald J, Ziemba S. Tooth Surface Enhancement by a 16% Carbamide Peroxide Take-Home Bleaching Gel Containing ACP. Journal of Dental Research. 84(Spec Issue A): 1793,2005. 9 Tung, M.S., Eichmiller, F.C. Amorphous Calcium Phosphate for tooth mineralization. Compend Contin Educ Dent, Vol 25, No 9 Suppl 1, Sep 2004, pp 9-13. Journal Code 9600713, Journal Subset MEDJSD, ISSN 1548-8578. Corporate Author: American Dental Association Foundation. 10 Giniger M, Spaid M, Felix H, MacDonald J. A 180-Day Clinical Investigation of the Tooth Whitening Efficacy of a Bleaching Gel with Added Amorphous Calcium Phosphate. Journal of Clinical Dentistry, Volume XVI, No. 1, 2005. 11 Tung, M.S., Eichmiller, F.C. Amorphous Calcium Phosphate for tooth mineralization. Compend Contin Educ Dent, Vol 25, No 9 Suppl 1, Sep 2004, pp 9-13. Journal Code 9600713, Journal Subset MEDJSD, ISSN 1548-8578. Corporate Author: American Dental Association Foundation.

12 Tung, M.S., Eichmiller, F.C. Amorphous Calcium Phosphate for tooth mineralization. Compend Contin Educ Dent, Vol 25, No 9 Suppl 1, Sep 2004, pp 9-13. Journal Code 9600713, Journal Subset MEDJSD, ISSN 1548-8578. Corporate Author: American Dental Association Foundation. 13 Schemehorn BR, Orban JC, Wood GD, et al. Remineralization by fluoride enhanced with calcium and phosphate ingredients. J Clin Dent. 1999;10(1 spec no):13-16. 14 Litkowski, Quinlan, Ross, Church & Dwight. Intraoral Evaluation of Mineralization of Cosmetic Defects by a Toothpaste Containing Calcium, Fluoride, and Sodium Bicarbonate. Compendium Vol. 25, No. 9 (Suppl 1) September 2004. 15 Flaitz C, Hicks J. Whitening Agent Effects on Enamel Caries Formation and Progression. IADR Unpublished Abstract #73739. 16 Giniger, MacDonald, Ziemba, Felix. The Clinical Performance of Professionally Dispensed Bleaching Gel with Added Amorphous Calcium Phosphate. Jada Vol. 136, March 2005. 17 Giniger M, Spaid M, Felix H, MacDonald J. A 180-Day Clinical Investigation of the Tooth Whitening Efficacy of a Bleaching Gel with Added Amorphous Calcium Phosphate. Journal of Clinical Dentistry, Volume XVI, No. 1, 2005.

6 M. Cherng, S. Takagi And L.C. Chow. Reduction in Dentin Permeability Using a Calcium Phosphate Slurry. Journal of Dental Research 83 (Special Issue A); IADR CD-ROM Abstract No. 0119, 2004.

What is ACP?
Chemical Makeup ACP is an abbreviation for Amorphous Calcium Phosphate. ACP is created when dissolved calcium ions and phosphate ions react to form a non-crystalline insoluble salt. Due to the reactive nature of the chemicals involved, the calcium and phosphate must be stored separately until they are applied to the tooth surface. Patented Technology Discus Dental, Inc. has licensed patented technology from the ADA Foundation allowing Discus Dental to incorporate ACP technology in professionally dispensed whitening gels.

ACP Benefits
Rebuilds Enamel The deposition of hydroxyapatite onto teeth rebuilds enamel and restores luster through a process called remineralization. Preliminary research by Flaitz & Hicks at the University of Texas, Huston, showed that,The addition of calcium phosphate to whitening agents reduces the susceptibility of enamel to in vitro lesion initiation and progression.5 Effective Desensitizer ACP mimics the natural desensitizing process by eliminating the source of sensitivity by plugging dentinal tubules with calcium phosphate, the tooth mineral. This is similar to the process of sclerosis, where salivary mineral precipitates slowly over time in these tubules and reduces sensitivity. ACP simply speeds this process considerably with the same mineral at much higher concentrations. ACP has been clinically shown to dramatically reduce dentinal hypersensitivity by occluding dentinal tubules.6 Discus Dental whitening gels, such as Nite White ACP, are the only professional take-home whiteners to combine patented ACP technology with the proven effectiveness of Potassium Nitrate to establish a new standard for patient comfort in professional takehome whitening.7 Improved Appearance Restores Enamel Luster ACP has been clinically shown to improve the smoothness and luster of teeth8 by filling superficial tooth defects and improving the overall smoothness and luster of patients smiles.9 Lasting Results In clinical studies, patients who used a take-home dental tooth whitener containing ACP experienced less fadeback six months after treatment compared to patients who used an identical take-home whitener without ACP.10

How ACP Works Tooth demineralization from acid results in dulling, loss of tooth luster, and a higher susceptibility to caries. The oral environment can naturally rebuild enamel, through a process called remineralization, to some extent on its own, but the extent of remineralization is controlled by pH and the amount and availability of calcium and phosphate ions present in the mouth. Remineralization can easily be reversed in an under-saturated environment. The rebuilding of enamel is a slow kinetic reaction which can be rapidly sped up by the addition of ACP-forming components into the oral environment. Amorphous Calcium Phosphate (ACP) is the reacted complex of calcium and phosphate ions that precipitate and can grow on tooth surfaces in the oral environment. These initial ACP complexes are thermodynamically unstable under

the conditions normally prevalent in the oral environment; pH, temperature, etc. Over time, these unstable compounds will undergo further reactions as well as phase transformation into other more stable forms of calcium phosphate. The precise path of the complex transformation is not fully understood, but the final form has been shown to be hydroxyapatite, a large constituent of the normal, mineralized structure of healthy teeth. In practice, introducing ACP onto a tooth surface will lead to rapid deposition of a new coating of hydroxyapatite over the original tooth surface.1,2 At normal oral pH and temperature, the addition of ACP-components to the salivary system can cause the hydrolysis of ACP into apatite within a few minutes, which is roughly 20,000 times faster than normal, physiologic formation of apatite.3 Besides adding to the external resistance of the teeth by building a barrier of acid resistant hydroxyapatite, ACP also biases the remineralizationdemineralization equilibrium by releasing essential ions that favor remineralization by increasing the degree of saturation with respect to hydroxyapatite. Furthermore, calcium and phosphates can bind with other ions such as F, and other proteins in saliva, to form complexes that can be stored in plaque and saliva, ready to release calcium, fluoride, and phosphate ions in . response to acid challenges4

ACP clusters are applied to teeth during a take-home whitening treatment.

ACP quickly binds to the tooth surface.

ACP is a revolutionary chemistry that goes beyond traditional restorative materials by using the bodys own building blocks to desensitize the dentition through remineralization.

Alan Boghosian, D.D.S., Assistant Professor of Clinical Surgery, Department of Surgery, Division of Dental Surgery, Northwestern University Feinberg School of Medicine

ACP crystallizes into a new coating of hydroxyapatite.

Hydroxyapatite rebuilds enamel and fills surface defects.

Competing Technologies
Two other chemical compounds, CPP-ACP and CSP, claim to provide the same benefits as the ADAs ACP technology that is licensed to Discus Dental, Church & Dwight and Bosworth. The following claims are verbatim from each manufacturer.
Product Company Ingredient Verbatim Claims

Product

Company

Ingredient

Verbatim Claims

Nite White ACP, Day White ACP

Discus Dental

ACP (licensed from the ADA Foundation) ACP (licensed from the ADA Foundation)

Rebuilds enamel, reduces sensitivity, improves appearance and provides longer-lasting whitening Go beyond cleaning to replenish your surface enamel with our new Liquid Calcium technology which whitens and helps prevent future stains for a long lasting white How does Liquid Calcium technology work? Whitens teeth Fills in stain collecting crevices in surface enamel Helps prevent stains Strengthens teeth and fights cavities the liquid calcium fills in the stain collecting crevices to help prevent stains. The result is whiter, brighter teeth.

Prospec MI Paste

GC America

Mentadent Church & Dwight Replenishing White

Recaldent : CPP-ACP (casein phosphopeptideamorphous calcium phosphate)

RECALDENT (CPP-ACP) is a special milk-derived protein that can help replace lost minerals in teeth, make them stronger and helps protect them from decay and erosion. Adheres easily to soft tissue, pellicle, plaque and even hydroxyapatite. Reacts similar to the mineral/statherin relation in saliva supplying bio-available calcium and phosphate required for remineralization to take place. Supplies calcium and phosphate needed for patients with poor saliva flow.

NuCare Root Conditioner

Butler

NovaMin: CSP (calcium sodium phosphosilicate)

NuCare Root Conditioner with NovaMin provides biomimetic* tubule occlusion to desensitize tooth root dentin. NuCare Root Conditioner with NovaMin has been shown, in vitro, to kill 99.999% of bacteria associated with oral disease.

Enamel Care with Liquid Calcium

Church & Dwight/ Arm & Hammer

ACP (licensed from the ADA Foundation)

Restore and Protect Your Bright, White, Radiant Smile! ARM & HAMMER Enamel Care is the first and ONLY toothpaste with LIQUID CALCIUM to RESTORE Enamel Luster! ARM & HAMMER Enamel Care combines the power of ARM & HAMMER Baking Soda to gently clean, PLUS LIQUID CALCIUM Technology to fill these crevices and restore luster. ARM & HAMMER Enamel Care! Smoother, Glossier Teeth for a Bright, White, Radiant Smile!

NuCare Prophy Paste Oravive Toothpaste

Butler

NovaMin: CSP (calcium sodium phosphosilicate) NovaMin: CSP (calcium sodium phosphosilicate) NovaMin: CSP (Calcium Sodium Phosphosilicate)

Reduces Sensitivity Powered by Novamin technology to build hydroxycarbonate apatite layer. NovaMin nourishes the teeth with essential calcium and phosphorus ions needed for the natural self-repair process of the teeth. Oravive is clinically proven to reduce sensitivity and promote healthier gums. NovaMin is the only material available that can induce the formation of new hydroxyapatite (crystalline calcium phosphate) which is identical to the tooth mineral that is naturally replenished by saliva. The rapid release of mineral-building ions quickly occludes dentin tubules for fast relief from sensitivity. Sustained-release, mineral-building ions provide continual relief from sensitivity.

NovaMin Technologies

SootheRx Aegis Pit & Fissure Sealant Bosworth ACP (licensed from the ADA Foundation) Aegis products containing Amorphous Calcium Phosphate (ACP) will not only treat your patients, but may protect and preserve their natural teeth with the help of ACP!

OMNII

Trident White

Cadbury Schwepps

Recaldent: CPP-ACP (casein phosphopeptide amorphous calcium phosphate)

Trident White offers Recaldent (casein phosphopeptideamorphous calcium phosphate), a remineralizing ingredient that strengthens teeth by delivering calcium and phosphate to the tooths surface. Studies published in the Journal of Dental Research, Caries Research and the Journal of Clinical Dentistry describes the benefits of using Recaldent and its application in sugar-free chewing gum. Recaldent is: Our own patented ingredient Unique and highly effective way to strengthen teeth

ACP ACP is unique among the calcium phosphate technologies because it forms faster intraorally.11 This allows ACP to deliver the most calcium and phosphate ions in the shortest period of time. Once formed, ACP converts rapidly to apatite, the tooth mineral. ACP is also the only calcium phosphate technology whose compound is not crystalline (i.e. ACP is not stable), making it more reactive and soluble. Discus Dentals patented dual-barrel syringe stores the calcium and phosphate in ACP separately until use, therefore ACP forms on tooth enamel and within the dentinal tubules rather than in the body of the gel it is delivered in. This allows ACP to transform into tooth mineral the fastest under oral conditions.12

Unlike ACP, a pre-mixed calcium phosphate compound must first dissolve and then precipitate to rebuild enamel and desensitize. This is not an efficient way to deliver calcium phosphate unless the protocol includes long treatment times. Recaldent Casein Phosphopeptide (CPP) stabilizes ACP and keeps it from dissolving and transforming into crystalline apatite under normal oral conditions (neutral 7.0 pH). The CPP-ACP dissolves under acidic, low pH conditions (less than 5.5), however the formation of crystalline apatite will be slower in low pH conditions. Stabilizing also means there is less ACP available at normal pH.

Milk proteins such as casein are known allergens, and therefore cant be prescribed to every patient (see product label). NovaMin The Calcium Sodium Phosphosilicate (CSP) in Novamin is delivered in the form of a solid bioactive glass that must first dissolve before the CSP can be active. ACP on the other hand is already dissolved and is in an active, noncrystalline form.

*Biomimetic - mimicking a biological substance or process.

Clinical Support
The following clinical studies contain further information regarding the benefits of Calcium and Phosphate:

ACPs Role in Tooth Whitening

ACP is patented technology exclusively

Discus Dental Products Containing ACP

Nite White ACP
Effective and Comfortable For patients with dentinal sensitivity, Nite White ACP is a powerful, maximum sensitivity relief carbamide peroxide formula that combines patented ACP technology with the proven effectiveness of potassium nitrate to rebuild enamel, substantially reduce transient sensitivity, improve appearance, and reduce fadeback.

Nite White Turbo ACP

6 Shades in 3 Nights* This breakthrough patent-pending formula is clinically proven to achieve an average of 6 shades of whitening after just 3 nights use.

Day White ACP

Whiten in 30 Minutes Twice Per Day For patients who do not have the time or desire to whiten overnight, Day White effectively whitens teeth in only 30 minutes twice per day. Day White combines the whitening power of hydrogen peroxide with patented ACP technology and potassium nitrate to rebuild enamel, substantially reduce transient sensitivity, improve appearance, and reduce fadeback. Tray Case, Tray Fabrication Materials and Instructions (all kits except touchup and mini) 7.5% or 9.5% Hydrogen Peroxide gel Mint Flavor

1. Schemehorn BR, Orban JC, Wood GD, et al. Remineralization by fluoride enhanced with calcium and phosphate ingredients. J Clin Dent. 1999;10 (1 spec no):13-16. 2. Zhang L, Li Z, Dong Y, Chin. Expiramental study of phosphopeptide in promoting tooth remineralization J Dent Res. 2000 May;3(1):27-30. 3. Grant LP, Thompson A, Tanzer JM. Caries inhibition in rats by a remineralizing toothpaste. J Clin Dent. 1999;10(1 spec no):30-33. 4. Kashket, Shelby. Historical Review of Remineralization Research. The Journal of Clinical Dentistry Vol. X, No. 2. P.56-64 5. Litkowski, Quinlan, Ross, Church & Dwight. Intraoral Evaluation of Mineralization of Cosmetic Defects by a Toothpaste Containing Calcium, Fluoride, and Sodium Bicarbonate. Compendium Vol. 25, No. 9 (Suppl 1) September 2004. 6. Giniger, MacDonald, Ziemba, Felix. The Clinical Performance of Professionally Dispensed Bleaching Gel with Added Amorphous Calcium Phosphate. Jada Vol. 136, March 2005. 7. Tung, M.S., Eichmiller, F.C. Amorphous Calcium Phosphate for tooth mineralization. Compend Contin Educ Dent, Vol 25, No 9 Suppl 1, Sep 2004, pp 9-13. Journal Code 9600713, Journal Subset MEDJSD, ISSN 1548-8578. Corporate Author: American Dental Association Foundation. 8. Munoz, Stephens, Proskin, Ghassemi. Clinical Efficacy of a Fluoride Dentrifice Containing Calcium, Phosphate, and Sodium Bicarbonate on Surface-Enamel Smoothness and Gloss. Compendium Vol. 25, No. 9 (Suppl 1) September 2004. 9. Forward GC. Non-fluoride anticaries agents. Adv Dent Res. 1994;8:208-214. 10. Geiger S, Matalon S, Blasbalg J, et al. The clinical effect of amorphous calcium phosphate (ACP) on root surface hypersensitivity. Oper Dent. 2003;28:496-500. 11. Charig, Winston, Flickinger, Church & Dwight. Enamel Mineralization by Calcium-containing Bicarbonate Toothpastes: Assessment by Various Techniques. Compendium Vol. 25, No. 9 (Suppl 1) September 2004. 12. Litkowski, Quinlan, Ross, Church & Dwight. Intraoral Evaluation of Mineralization of Cosmetic Defects by a Toothpaste Containing Calcium, Fluoride, and Sodium Bicarbonate. Compendium Vol. 25, No. 9 (Suppl 1) September 2004. 13. Skrtic D, Antonucci JM, Eanes ED. Amorphous calcium phosphate-based bioactive polymeric composites for mineralized tissue regeneration. J Res Natl Inst Stand Technol. 2003;108:167-182. 14. Eanes ED. Amorphous calcium phosphate: thermodynamic and kinetic considerations. In: Amjad Z, ed. Calcium Phosphates in Biological and industrial Systems. Boston, Mass: Kluwer Academic Publishers; 1997:21-39. 15. Chow LC, Vogel GL. Enhancing remineralization. Oper Dent. 2001; 26(suppl 6):27-38. 16. Calcium phosphates in demineralization/remineralization processes. Legeros RZ J Clinical Dent X:65-73 (1999). 17. Zero, Dominick. Applications of Clinical Models in Remineralization Research. Journal of Clinical Dentistry Vol. X, No 2, pp 74-84

licensed to Discus Dental, Inc. in the field of whitening by the ADA Foundation. Rebuilds Enamel The deposition of hydroxyapatite onto teeth rebuilds enamel and restores luster through a process called remineralization. Preliminary research shows that remineralization can both strengthen teeth13,14 and reduce the susceptibility of enamel to in vitro lesion initiation and progression.15 Prevents Sensitivity Clinical tests comparing Nite White ACP with a Nite White formula containing no ACP showed that patients who used Nite White with ACP reported 30% less sensitivity, with twice as many patients experiencing zero sensitivity.16 Nite White ACP is the first whitener to combine ACP with the proven effectiveness of potassium nitrate to create a new standard for patient comfort in takehome whitening. Improves Appearance Tooth whitener with ACP also adds to the improved cosmetic appearance of teeth by restoring enamel luster to create a smoother, glossier appearance. Studies also show the patients who used a tooth whitener with ACP experienced less fadeback to their original tooth color after six months.17

Nite White Turbo combines the whitening power of hydrogen peroxide with patented ACP technology and potassium nitrate to rebuild enamel, substantially reduce transient sensitivity, Tray Case, Tray Fabrication Materials improve appearance and reduce and Instructions (all kits except Touch- fadeback. up and Mini) An activation matrix helps regulate 10%, 16% or 22% Carbamide the release of oxygen for optimal Peroxide equivalent gel, or 6% results Hydrogen Peroxide (3 Night Formula) ACP & potassium nitrate reduce Mint or Cherry Flavor sensitivity
*Data on file.

ACP represents the most innovative advancement in whitening technologies. Enhanced results, desensitization and the potential for remineralization make this the only choice for clinicians and patients alike!
Kristy Menage Bernie, RDH, BS Educational Designs