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Hygiene Tribune Middle East & Africa Edition

hygiene tribuneDental Tribune Middle East & Africa Edition | March-April 2015 1B > Page 2B Stannous Fluoride Dentifrice with Sodium Hexametaphosphate: Review of Laboratory, Clinical and Practice-Based Data By Cynthia Sensabaugh, RDH, BS;MaryElizabethSagel,BS,MA A bstract Dentifrice was originally used to promote oral hy- giene by cleaningteeth. How- ever, with advances in product formulation, it has become a valuable vehicle for the deliv- ery of agents offering health and cosmetic benefits. Stannous fluoride, introduced in 1955 in dentifrice, is one of the longest established of such agents. The well-known anti-caries efficacy of stannous fluoride is based on its impact on the tooth surfaces and on its antibacterial activity. More recently, the demand for tooth whitening products has increased and sodium hexam- etaphosphate has been shown to be helpful in whitening surface stains and in controlling cal- culus. A dentifrice formulation which combines the benefits of stannous fluoride with those of sodium hexametaphosphate is now available. A review of the evidence shows that in addition to effective anti-caries action, this formulation is effective in fighting plaque, gingivitis, and gingival bleeding while inhibit- ing calculus and extrinsic stain. A practice-based evaluation in- cluding data from over 1,200 dental professionals and 1,000 patients demonstrates the prod- uct’s benefits and excellent acceptability. Collectively, the research shows this stannous fluoride/sodium hexametaphos- phate dentifrice provides mul- tiple benefits to meet the oral health and cosmetic needs of patients. Key Words: stannous fluoride, dentifrice, gingivitis, caries, sen- sitivity, calculus Introduction Patients today represent one of the most heterogeneous groups in history in terms of age, health status, oral hygiene habits and other factors. While certain oral health condi- tions are more prevalent among specific patient groups, such as periodontal disease among dia- betic patients,1 many oral health conditions affect the broad pop- ulation. According to U.S. sur- veys, virtually all adult patients have had dental caries, more than half experience gingivitis, and roughly one in three suffer from dental sensitivity.2-4 Fortu- nately, home care products are available to help prevent and treat many common oral health conditions in conjunction with routine professional care. Dentifrice is one important ex- ample. Many years ago, the ben- efits of dentifrice were limited to cleaning and the prevention of tooth decay. It was common for professionals to tell patients to “use any dentifrice with fluoride and the ADA Seal.” However, formulators today can design dentifrices to provide numerous other benefits, both for health and cosmetic purposes. In2005,astannousfluoridesodi- um hexametaphosphate (SFSH) formula* was introduced offer- ing protection against a broad range of health and cosmetic conditions commonly experi- enced by patients.5 The present report reviews the laboratory, clinical and practice-based as- sessments evaluating the effica- cy of this dentifrice formulation. Stabilized stannous fluoride/ sodium hexametaphosphate formulation The SFSH formula combines the therapeutic benefits of 0.454% stabilized stannous fluoride with the calculus and stain-control characteristics of sodium hex- ametaphosphate in a low-water formulation dentifrice. Stannous fluoride, which unlike sodium fluoride can be used in combi- nation with calcium-based abra- sives, has been incorporated in dentifrices since the 1950s to provide protection against car- ies, pathogenic bacteria, gingi- vitis, hypersensitivity, and the development of plaque. There is considerable evidence for its efficacy as a therapeutic agent with a wide spectrum of ben- eficial properties.6-12 However, its clinical usage was limited because of astringent taste and in some patients its use resulted in extrinsic staining of the teeth. Stannous fluoride was also somewhat unstable in aqueous solution. The latter problem was resolved with the introduction of stabilized stannous fluoride in the 1990s which rendered more available stannous fluoride and resulted in a renewed interest in the wide range of benefits offered by stannous fluoride in dentifrices.6 Sodium hexametaphosphate was first introduced in a denti- frice in 2000.13 It is a chemical whitening agent in the same class as pyrophosphate, which has long been used to inhibit cal- culus, but the molecule is about 10 times longer than that of py- rophosphate. Sodium hexamet- aphosphate therefore provides better coverage and retention on the tooth surface, thus in- creasing its ability to inhibit both calculus and stain formation on the enamel surface.14 Stability of the dentifrice can be an issue with the inclusion of polyphos- phates if ingredients are not properly balanced. Like other polyphosphates, sodium hexam- etaphosphate does not usually show good long-term stability in aqueous dentifrices. However the novel single-phase SFSH for- mula, which uses a low-water system in a silica-based formu- lation, significantly reduces the hydrolysis of sodium hexamet- aphosphate and helps to main- tain effective levels of whitening activity.5 The resulting dentifrice has im- proved esthetic qualities over the original stannous fluoride formulation, and delivers a broad range of therapeutic and cosmetic benefits (Figure 1). The remainder of this paper provides a summary review of research on stannous fluoride, sodium hexametaphosphate and, especially, the unique SFSH formulation. Antibacterial and Anti-inflam- matory Action Most of the oral health benefits of stannous fluoride result from its antibacterial efficacy, particu- larly against bacteria associated with dental caries, periodontal disease, and oral malodor. Labo- ratory and clinical studies have shown that stannous fluoride, unlike other fluorides, inhibits bacterial growth by a variety of mechanisms, including interfer- ence with metabolic pathways, thus reducing bacterial acid for- mation, and inhibition of bacte- 2 The Journal of Dental Hygiene Volume 83 Issue II Spring 2009 lem was resolved with the introduc- tion of stabilized stannous fluoride in the 1990s which rendered more available stannous fluoride and re- sulted in a renewed interest in the wide range of benefits offered by stannous fluoride in dentifrices.6 Sodium hexametaphosphate was first introduced in a dentifrice in 2000.13 It is a chemical whitening agent in the same class as pyrophos- phate, which has long been used to inhibit calculus, but the molecule is about 10 times longer than that of pyrophosphate. Sodium hexameta- phosphate therefore provides better coverage and retention on the tooth surface, thus increasing its ability to inhibit both calculus and stain formation on the enamel surface.14 Stability of the dentifrice can be an issue with the inclusion of poly- phosphates if ingredients are not properly balanced. Like other poly- phosphates, sodium hexametaphos- phate does not usually show good long-term stability in aqueous den- tifrices. However the novel single- phase SFSH formula, which uses a proved esthetic qualities over the original stannous fluoride formula- tion, and delivers a broad range of therapeutic and cosmetic benefits (Figure 1). The remainder of this pa- per provides a summary review of re- search on stannous fluoride, sodium hexametaphosphate and, especially, the unique SFSH formulation. Antibacterial and Anti- inflammatory Action Most of the oral health benefits of stannous fluoride result from its antibacterial efficacy, particularly against bacteria associated with den- tal caries, periodontal disease, and oral malodor. Laboratory and clini- cal studies have shown that stannous fluoride, unlike other fluorides, in- hibitsbacterialgrowthbyavarietyof mechanisms, including interference with metabolic pathways, thus re- ducing bacterial acid formation, and inhibition of bacterial cohesion and adhesion.15-17 The Plaque Glycolysis and Regrowth Model (PGRM) is an ed with the use of stannous fluoride dentifrice versus a standard sodium fluoride control dentifrice.18,19 Us- ing the same methodology, Liang et al. found that a stannous fluoride dentifrice, as compared to a control placebo, greatly reduced the amount of plaque acid and also inhibited plaque regrowth.20 Comparable results have been obtained in studies of the antibac- terial action of this SFSH formula. Ramji et al. carried out a series of in vitro and in vivo studies of this new formulation.21 In a Live/Dead as- say21 they found that the new SFSH dentifrice had killed over 90% of the salivary bacteria 16 hours after a single exposure, thus showing strong and lasting antibacterial ac- tivity (Figure 2). In a second study, using PGRM, the SFSH dentifrice produced sta- tistically significant reductions in plaque acid production and plaque regrowth at 15 and 45 minutes after brushing versus a standard sodium fluoride control dentifrice.21 Other research demonstrated the pres- ence of soluble tin, which serves as a marker for the active stannous fluoride, at levels above the mini- mum concentration required for the inhibition of salivary bacterial activity.21 Another related value of stan- nous fluoride is its effect on in- flammatory markers, independent of its action on bacteria. In vivo, antibacterial activity also helps re- duce inflammation since the inflam- matory response should diminish with reduced levels of pathogenic bacteria. A study was conducted with 16 healthy subjects to measure inhibition of several host and bac- terial pro-inflammatory enzymes by stannous fluoride.22 Following a one-week period of using a standard sodium fluoride paste and manu- Figure 1. Benefits of stannous fluoride and sodium hexametaphosphate Stannous fluoride • Antibacterial activity against species associated with plaque, gingivitis, cavities and malodor • Reduces plaque • Reduces gingival inflammation and bleeding • Protects against hypersensitivity • Remineralizes enamel and protects against demineralization Sodium hexametaphosphate • Inhibits calculus formation • Protects against new stain formation • Removes extrinsic stain Figure 1. Benefits of stannous fluoride and sodium hexametaphos- phate Figure 2. Bactericidal activity assessment 16 hours after exposure. Left; water control. Right; stannous fluoride/sodium hexametaphosphate dentifrice. Green-stained cells are live microbial cells; red-stained cells are dead cells (from Ramji et al21 ).

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