Hygiene Tribune Middle East & Africa Edition

hygiene tribune Dental Tribune Middle East & Africa Edition | March-April 20154B < Page 2B was as good as that of positive controls and concluded that the addition of sodium hexamet- aphosphate does not interfere with the normal activity of stan- nous fluoride.54 A series of in vitro studies evalu- ating the anticaries potential of the SFSH formulation have been reported in one publica- tion by Pfarrer and colleagues.55 In a study of fluoride uptake into demineralized enamel, it exhibited uptake comparable to a clinically proven stannous fluoride and silica dentifrice.55 In a second lesion progression pH- cycling experiment the stannous fluoride/sodium hexametaphos- phate dentifrice provided almost complete protection against le- sion initiation and progression; it was comparable to conventional clinically proven dentifrices.55 These studies indicate that this SFSH dentifrice is as effective as clinically proven fluoride denti- frices both in its mode of action and in its clinical effects. Anticalculus Effects Dental calculus results from the mineralization of bacterial plaque formed on the surfaces of teeth. Agents that inhibit crystal growth, particularly condensed phosphates, have been found to be very useful in the preven- tion of calculus development. In this class of phosphates, sodium hexametaphosphate has been shown to be particularly effec- tive. In vitro studies by White et al. have shown significant reductions in hydroxyapatite crystal growth and mineraliza- tion of plaque in the presence of sodium hexametaphosphate either in aqueous solution or in a dentifrice.56 The effects were significantly greater than for a conventional anti-tartar denti- frice containing pyrophosphate. This finding has been supported by four 6-month clinical trials in which sodium hexametaphos- phate produced significant re- ductions in calculus formation – when combined with sodium fluoride or stannous fluoride – as compared to a regular sodium fluoride dentifrice or a triclosan/ copolymer dentifrice.57-60 A total of 866 subjects participated in the four 6-month clinical trials. Efficacy was assessed using a standard clinical method (Volpe- Manhold Index) that measures supragingival calculus coverage on the lingual surfaces of the 6 anterior teeth. In the 2 studies evaluating SFSH formulations, calculus reductions of 55% and 56% were seen versus the re- spective controls at 6 months.59,60 Whitening Effects There is an increasing demand for tooth whitening products and also for oral care products that sustain whitening effects. Peroxide is a successful bleach- ing agent when delivered via whitening strips or in tray-based systems, but it is not particularly effective in dentifrices because of the brief contact time with the tooth surface.61 Pyrophos- phates, on the other hand, help maintain whitening and control staining because they have a strong affinity for the minerals in teeth. Sodium hexametaphos- phate has been shown to have important effects on the chemi- cal mechanisms of chromogen adsorption and desorption.62-63 It appears that the polymer chains interact with pellicle films to lift stain material out of the pellicle and to prevent the adsorption of new chromogens. Gerlach et al. reported a 29% reduction in composite stain relative to a negative control following 6 weeks use of a sodium fluoride dentifrice containing 7% sodi- um hexametaphosphate.64 Clini- cal studies providing evidence for the efficacy of sodium hex- ametaphosphate in the control of extrinsic staining have been reviewed by Baig et al.65 A number of recent clinical trials have assessed the extrinsic stain removal efficacy of the SFSH dentifrice. In their 6-month study of anti-calculus effects, Schiff et al.59 also assessed ex- trinsic stain, using the Lobene Stain Index on the facial surfac- es of the 12 anterior teeth; at nei- ther 3 nor 6 months did subjects in the SFSH group show signs of developing any such stain. Four recent clinical trials, which were summarized in two publica- tions, have used similar meth- odologies to compare the ex- trinsic stain removal efficacy of the SFSH dentifrice with that of a positive control whitening denti- frice.66,67 All 4 were randomized, double-blind studies in which efficacy was measured using a modified Lobene Stain Index. Two studies assessed whitening at baseline and 2 weeks;67 the other 2 studies measured stain at baseline, 3 and 6 weeks.66 In all cases, there was highly significant stain removal in the experimental groups and also in the positive control groups. There were no significant differ- ences in the effects of the SFSH and positive control dentifrices. In reviewing these data, it ap- pears that combining sodium hexametaphosphate with stan- nous fluoride in the SFSH for- mulation removes and inhibits extrinsic stain formation and that the SFSH dentifrice is as ef- fective as positive control whit- ening dentifrices. Practice-Based Evaluation The efficacy and safety of den- tifrice with stannous fluoride or a combination of stannous fluoride and sodium hexam- etaphosphate is supported by an extensive body of evidence. However, its success ultimately depends on its acceptability to users when used at home by consumers as part of their own personal oral hygiene routine. In order to assess the accept- ability of the SFSH dentifrice, a practice-based assessment was undertaken involving den- tal professionals and their pa- tients.68 Dentists and hygienists across the USA participated in the study, and samples of the SFSH formulation were offered to participating professionals to provide a supply to a small group of their patients for 3-4 months use, until their next visit. Patients’ oral health was assessed at the beginning and end of the trial by the dental pro- fessional using a questionnaire (not clinical indices). Conditions assessed included gingivitis, gingival bleeding, inflamma- tion, calculus, extrinsic staining and sensitivity. Professionals submitted a survey report and patients completed a question- naire at the end of the study. In total, 1267 completed sur- veys were returned by dentists and dental hygienists. Approxi- mately 75% of the evaluations were based on 3-4 months use and the remainder of subjects had used the product for up to 6 months. Responses analyzed were those in which dentists or hygienists provided both pre- and post-trial oral health as- sessments and gave answers to questions. Sixty-eight percent of all these responses reported im- provement in their patients’ oral health, including improvements in gingival bleeding and inflam- mation and reduction in cal- culus formation. Reductions in sensitivity were reported by 61% of professionals and in staining by 57%. Eighty percent report- ed they would recommend the SFSH dentifrice; this rose to 91% among those professionals who observed improvements. A total of 1078 questionnaires were returned by patients. Of these, 88% reported positive as- sessments of the SFSH dentifrice (Excellent/Very Good/Good) and two-thirds of all patients stated that they intended to con- tinue to use the product; this percentage rose to 77% when patients reported noticeable im- provements in their oral health. Intermsofratingspecificeffects, roughly 9 out of 10 patients rated the product positively for “keep- ing mouth healthy”, “clean- ing teeth thoroughly”, being a “comprehensive toothpaste”, “making gums healthier” and “freshening breath” (Figure 6). Eighty-three percent rated it positively for reducing surface stains and 77% for reducing gin- gival bleeding. It is important to differentiate practice-based evaluations from randomized, controlled clinical studies. For example, clinical trials typically involve calibrated examiners who use standard- ized indices to assess the status of a specific disease or condi- tion. Often the examiner and subject are blind to treatment. In this practice-based assessment, practicing professionals and their patients assessed oral con- ditions using a questionnaire. Calibration was not done across offices and the product identity was known. This type of evalua- tionissimilartotheassessments practicing professionals do on a routine basis. They recommend a home care product, and then use their experience and clini- cal judgment to determine the effect it has on the patient’s oral health. This large, practice based assessment with the SFSH dentifrice complements find- ings of the controlled clinical trials. The major outcome is that it provides evidence of excellent professional acceptance and an equal level of acceptance among patients, expressed as an inten- tion to continue using the SFSH dentifrice. Conclusions Extensive laboratory and clini- cal research add to the body of research supporting the value of stannous fluoride as a multi- benefit dentifrice ingredient. Stannous fluoride reduces bac- terial growth, bacterial activity, and inflammatory markers as well as protects against plaque, gingivitis and gingival bleed- ing, hypersensitivity and caries. Research also suggests the ef- fectiveness of sodium hexam- etaphosphate in the control of calculus and extrinsic staining. Seventeen published clinical and laboratory papers demon- strate the efficacy of these den- tifrice ingredients when they are combined in a dentifrice formu- lation, which is therefore able to deliver a wide combination of health and cosmetic benefits.21, 24, 30-32, 35, 36, 45- 47, 53-55, 59, 60, 66, 67 Re- sults from a large practice-based assessment involving over 1,200 dental professionals and over 1,000 patients further support the product is widely acceptable and beneficial for improving oral health.68 The authors thank Jane Mitchell (MWS Ltd., Staffordshire, UK) for assistance developing the manuscript. References 1. Genco RJ. The three-way street. Sci Am. 2006;Spec Iss:18- 22. 2. U.S. Department of Health and Human Services. Oral Health U.S. 2002. Available at: http://drc.hhs.gov/report/pdfs/ section3-diseases.pdf Accessed Dec 5, 2007. 3. Surveillance for dental cares, tooth retention, edentulism, and enamel fluorosis – United States, 1998-1994 and 1999-2002. Avail- able at: http://www.cdc.gov/ mmwr/preview/mmwrhtml/ ss5403a1.htm. Accessed Dec 11, 2007. 4. Addy M. Dentin hypersensitiv- ity: new perspectives on an old problem.IntDentJ.2002;52:367- 375. 5. Baig A, He T. A novel denti- frice technology for advanced oral health protection: A re- view of technical and clinical data. Comp Contin Educ Dent. 2005;26:4-11. 6. White DJ. A “return” to stan- nous fluoride dentifrices. J Clin Dent. 1995;6(spec no):29-36. 7. Tinanoff N. Review of the anti- microbial action of stannous flu- oride. J Clin Dent. 1990;2:22-27. 8. Tinanoff N. Progress regard- ing the use of stannous fluoride in clinical dentistry. J Clin Dent. 1995;6(spec no):37-40. 9. Beiswanger BB, Doyle PM, Jackson RD, et al. The clinical effect of dentifrices containing stabilized stannous fluoride on plaque formation and gingivi- tis—a six-month study with ad libitum brushing. J Clin Dent. 1995;6(spec no):46-53. 10. Williams C, McBride S, Bold- en TE, et al. Clinical efficacy of an optimized stannous fluoride dentifrice, part 3: a 6- month plaque/gingivitis clinical study, southeast USA. Compend Con- tin Educ Dent. 1997;18(spec iss):16-20. 11. Gerlach RW, Hyde JD, Poore CL, et al. Breath effects of three marketed dentifrices: a com- parative study evaluating single and cumulative use. J Clin Dent. 1998;9:83-88. 12. Miller S, Truong T, Heu R, et al. Recent advances in stannous fluoride technology: antibacte- rial efficacy and mechanism of action towards hypersensitiv- ity. Int Dent J. 1994;44 (1 suppl 1):83-98. Editorial note: The full list of references is avail- able from the publisher. Volume 83 Issue II Spring 2009 The Journal of Dental Hygiene 5 control (n=45) (Figure 5).46 At 8 weeks, the SFSH showed improve- ments of 71% and 44% versus the negative control for tactile and ther- mal measurements, respectively. These studies support that the SFSH dentifrice shares the anti- sensitivity characteristics of previ- ous stannous fluoride formulations. Anti-caries Effects The anticaries effects of stannous fluoride have been recognized for over 50 years and in the 1960s, the stannous fluoride-containing denti- frice, Crest® with Fluoristan™ , re- ceived a Seal of Acceptance by the ADA’s Council on Dental Thera- peutics. Fluoride, in various forms, is well-recognized for its ability to foster remineralization of partially demineralized tooth enamel using the calcium and phosphate present in saliva. In addition to these remin- eralization effects, stannous fluo- ride has been shown to react with enamel to form a tin fluorophos- phate complex which coats and pro- tects the surface of the enamel.48,49 The antibacterial activity of stan- physical chemistry and its bacterio- logical effects. Before the introduction of this SFSH dentifrice, a large number of clinical trials had been carried out that demonstrated the efficacy of stannous fluoride in the control of dental caries.52 More recently, Stookey et al. carried out a large- scale clinical trial with 955 subjects comparing the anticaries efficacy of a dual-phase early prototype SFSH dentifrice with a positive control standard sodium fluoride dentifrice, and also a high-dose (2800 ppm F) and a low-dose (500 ppm F) sodium fluoride formulation.53 Visual-tac- tile examination was supplemented with a radiographic examination at baseline, after 12 months and at the end of the trial at 24 months. Both examiners found that there was sig- nificantly less caries in the SFSH (17% and 25%) and high dose (2800 ppm) sodium fluoride groups (13% and 23%) than in the posi- tive control group treated with 1100 ppm fluoride. In an in situ study of mineralization-demineralization, Wefel et al. reported that a dual- phase stannous fluoride/sodium hexametaphosphate dentifrice pro- duced anticaries activity which was as good as that of positive controls and concluded that the addition of sodium hexametaphosphate does not interfere with the normal activ- ity of stannous fluoride.54 A series of in vitro studies evalu- ating the anticaries potential of the SFSH formulation have been report- ed in one publication by Pfarrer and colleagues.55 In a study of fluoride uptake into demineralized enamel, it exhibited uptake comparable to a clinically proven stannous fluoride and silica dentifrice.55 In a second lesion progression pH-cycling ex- SFSH dentifrice is as effective as clinically proven fluoride dentifric- es both in its mode of action and in its clinical effects. Anticalculus Effects Dental calculus results from the mineralization of bacterial plaque formed on the surfaces of teeth. Agents that inhibit crystal growth, particularly condensed phosphates, have been found to be very useful in the prevention of calculus devel- opment. In this class of phosphates, sodium hexametaphosphate has been shown to be particularly effec- tive. In vitro studies by White et al. have shown significant reductions in hydroxyapatite crystal growth and mineralization of plaque in the presence of sodium hexametaphos- phate either in aqueous solution or in a dentifrice.56 The effects were significantly greater than for a con- ventional anti-tartar dentifrice con- taining pyrophosphate. This finding has been supported by four 6-month clinical trials in which sodium hex- ametaphosphate produced signifi- cant reductions in calculus forma- tion – when combined with sodium fluoride or stannous fluoride – as compared to a regular sodium fluo- ride dentifrice or a triclosan/copo- lymer dentifrice.57-60 A total of 866 subjects participated in the four 6-month clinical trials. Efficacy was assessed using a standard clini- cal method (Volpe-Manhold Index) that measures supragingival calcu- lus coverage on the lingual surfaces of the 6 anterior teeth. In the 2 stud- ies evaluating SFSH formulations, calculus reductions of 55% and 56% were seen versus the respec- tive controls at 6 months.59,60 AdjustedMeanSchiffAirIndexScore Figure 5 – Thermal sensitivity scores for the SFSH dentifrice and negative control (lower scores indicate less sensitivity) 46 3 – 2.5 – 2 – 1.5 – 1 – 1.5 – 0 – Week 4 Week 8 n SFSH n Negative Control Figure 5 – Thermal sensitivity scores for the SFSH dentifrice and negative control (lower scores in- dicate less sensitivity) 46 Figure 6 – Results from patient surveys; Percent of patients rating SFSH product “Excellent/Very Good/Good”. Volume 83 Issue II Spring 2009 The Journal of Dental Hygiene 7 ments practicing professionals do on a routine basis. They recommend a home care product, and then use their experience and clinical judg- ment to determine the effect it has on the patient’s oral health. This large, practice based assessment with the SFSH dentifrice complements find- ings of the controlled clinical trials. The major outcome is that it provides evidence of excellent professional acceptance and an equal level of ac- ceptance among patients, expressed as an intention to continue using the SFSH dentifrice. Conclusions Extensive laboratory and clinical research add to the body of research supporting the value of stannous fluoride as a multi-benefit denti- frice ingredient. Stannous fluoride reduces bacterial growth, bacterial activity, and inflammatory markers as well as protects against plaque, gingivitis and gingival bleeding, hy- persensitivity and caries. Research also suggests the effectiveness of sodium hexametaphosphate in the control of calculus and extrinsic staining. Seventeen published clini- cal and laboratory papers demon- strate the efficacy of these dentifrice ingredients when they are combined in a dentifrice formulation, which is therefore able to deliver a wide com- bination of health and cosmetic ben- efits.21, 24, 30-32, 35, 36, 45- 47, 53-55, 59, 60, 66, 67 Results from a large practice-based assessment involving over 1,200 dental professionals and over 1,000 patients further support the product is widely acceptable and beneficial for improving oral health.68 The authors thank Jane Mitchell (MWS Ltd., Staffordshire, UK) for assistance developing the manu- script. Cynthia Sensabaugh, RDH, BS is the Manager of Clinical Research & Education for DENTSPLY Pro- fessional. Previously, she was the Manager of Professional Relations at Procter & Gamble. Mary Elizabeth Sagel, MA, BS, manages oral care scientific com- munications at Procter & Gamble in Mason, OH, USA. This includes managing clinical and technical publications and content for dental- care.com. Prior to this position, she was a Principal Researcher in Oral Care Research & Development. Figure 6 – Results from patient surveys; Percent of patients rating SFSH product “Excellent/Very Good/Good”. 1. Genco RJ. The three-way street. Sci Am. 2006;Spec Iss:18-22. 2. U.S. Department of Health and Human Services. Oral Health U.S. 2002. Available at: http://drc.hhs.gov/report/ pdfs/section3-diseases.pdf Accessed Dec 5, 2007. 3. Surveillance for dental cares, tooth retention, edentulism, and enamel fluorosis – United States, 1998-1994 and 1999-2002. Available at: http://www.cdc.gov/mmwr/pre- view/mmwrhtml/ss5403a1.htm. Accessed Dec 11, 2007. 4. Addy M. Dentin hypersensitivity: new perspectives on an old problem. Int Dent J. 2002;52:367-375. 5. Baig A, He T. A novel dentifrice technology for advanced oral health protection: A review of technical and clinical data. Comp Contin Educ Dent. 2005;26:4-11. 6. White DJ. A “return” to stannous fluoride dentifrices. J Clin Dent. 1995;6(spec no):29-36. 7. Tinanoff N. Review of the antimicrobial action of stannous fluoride. J Clin Dent. 1990;2:22-27. 8. Tinanoff N. Progress regarding the use of stannous fluo- ride in clinical dentistry. J Clin Dent. 1995;6(spec no):37- 40. 9. Beiswanger BB, Doyle PM, Jackson RD, et al. The clini- cal effect of dentifrices containing stabilized stannous fluoride on plaque formation and gingivitis—a six-month study with ad libitum brushing. J Clin Dent. 1995;6(spec no):46-53. 10. Williams C, McBride S, Bolden TE, et al. Clinical effica- cy of an optimized stannous fluoride dentifrice, part 3: a References Cynthia Sensabaugh, RDH, BS is the Manager of Clinical Research & Education for DENTSPLY Pro- fessional. Previously, she was the Manager of Professional Rela- tions at Procter & Gamble. Mary Elizabeth Sagel, MA, BS, manages oral care scientific communications at Procter & Gamble in Mason, OH, USA. This includes managing clinical and technical publications and con- tent for dentalcare.com. Prior to this position, she was a Princi- pal Researcher in Oral Care Re- search & Development. About the Authors

Hygiene Tribune Middle East & Africa Edition

Pages Overview