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Earn 4 CE credits This course was written for dentists, dental hygienists, and assistants.

Reflections on Dentifrice Ingredients, Benefits and Recommendations A Peer-Reviewed Publication Written by Fiona M. Collins, BDS, MBA, MA

This course has been made possible through an unrestricted educational grant from Colgate-Palmolive, Co. The cost of this CE course is $59.00 for 4 CE credits. Cancellation/Refund Policy: Any participant who is not 100% satisfied with this course can request a full refund by contacting PennWell in writing. Educational Objectives dentifrice use. Recommendations should be based on an The overall goal of this article is to provide dental profession- individual patient’s specific needs and desires as well as the als with information on the active and inactive ingredients in scientific support for a dentifrice. Both the Food and Drug dentifrices and their benefits. Administration (FDA) and the American Dental Associa- Upon completion of this course, the clinician will be able tion (ADA) have played roles in controlling (FDA) and ac- to do the following: cepting (ADA) dentifrices. 1. List active ingredients in dentifrices and their therapeutic benefits. Dentifrice Ingredients 2. List inactive ingredients in dentifrices and their functions. Dentifrices contain both active and inactive ingredients. Ac- 3. Know the roles of the FDA and ADA with respect to tive ingredients are those that offer a therapeutic benefit, while over-the-counter dentifrices. inactive ingredients are non-therapeutic and also contribute 4. Understand the considerations involved and importance of to the physicochemical properties of the dentifrice – its feel, recommending OTC dentifrices for individual patients. consistency, sweetness, flavor, pH, texture, abrasiveness and appearance. Abstract The first major active ingredient introduced into modern- Active Ingredients day, over-the-counter dentifrices was fluoride. Since then, Active ingredients help prevent caries, sensitivity, plaque/ dentifrices have been developed with ingredients offering gingivitis, calculus formation and halitosis (Table 1). The first anti-plaque/anti-gingivitis, anti-halitosis, whitening or de- active ingredient included was fluoride. sensitizing benefits, or a multiplicity of benefits. Given the range of dentifrices currently available, and their differences, Table 1. Active ingredients and function a recommendation is important; this should be based on the Anti-caries fluoride individual patient’s specific needs and desires and the scien- Sodium monofluorophosphate tific support for a dentifrice. Stannous fluoride Introduction Amine fluoride Toothpastes existed as early as 5,000 B.C., and a toothpaste Xylitol made from iris flowers was created in the fourth century Anti-plaque/ A.D.1,2 Early modern toothpastes and tooth powders in Eu- anti-gingivitis Triclosan/copolymer rope and America often contained highly abrasive materials Stannous fluoride such as ground shells, , charcoal and chalk.3 Develop- citrate ments continued until the present day. One of the first mod- Anti-calculus Tetrapotassium pyrophosphate ern toothpastes contained hydrogen peroxide and baking Tetrasodium pyrophosphate soda – ingredients still used in dentifrices today. The collaps- Sodium hexametaphosphate ible toothpaste tube, invented by Dr. Washington Sheffield, revolutionized the use of toothpastes and was a primary factor Zinc compounds in their increased popularity. Fluoride, the first major active Triclosan/copolymer ingredient, was initially introduced in 1914, and in 1955 Anti-halitosis Essential oils fluoride toothpaste demonstrating anti-caries efficacy was Chlorine dioxide introduced (Crest with fluoride). Triclosan/copolymer Current over-the-counter (OTC) dentifrices variously Stannous fluoride/sodium offer preventive, esthetic and treatment benefits. Preven- hexametaphosphate tive benefits against caries, plaque/gingivitis, tartar, and Desensitizers citrate halitosis are available, and treatment benefits are offered Potassium nitrate for dentinal hypersensitivity. Esthetic benefits, which are not considered therapeutic, include both cleaning and whitening. While some dentifrices offer only cleaning Stannous fluoride benefits together with fluoride for anti-caries benefits, in Strontium chloride recent years dentifrices with multiple benefits aimed at of- fering solutions to as many potential problems as possible Anti-caries Dentifrices have been introduced. The vast range of available products Fluoride raises the issue of confusion in the eyes of consumers. This In the United States, , sodium monofluoro- increases the need to understand dentifrice ingredients and phosphate and stannous fluoride are all used as anti-caries benefits, to be able to give patients recommendations on actives. In Europe, amine fluoride is also used and dominates

2 www.ineedce.com the market in some countries, marketed under the brand fluoride concentration was reduced by more than 50% using name Elmex. By supplying topical fluoride on a regular basis, the pea-sized dose. They concluded that reduced amounts fluoride dentifrices help prevent demineralization and help should be limited to preschool children, as they are more at promote remineralization. If acid attacks occur and result risk for toothpaste ingestion and fluorosis.12 in the loss of ions from the hydroxyapatite crystals, fluoride The American Dental Association Council for Scientific can be taken up to form fluorapatite crystals. In addition, Affairs found from an evidence-based analysis that for indi- loss of fluoride ions from the tooth structure is inhibited. viduals with a low risk for caries, use of a regular OTC fluo- The concentration of fluoride in OTC dentifrices in the ride dentifrice may provide sufficient anti-caries protection. United States is typically 1,000–1,100 ppm fluoride, which Regular fluoride dentifrice and in-office topical fluorides are equates to 0.23% sodium fluoride, 0.76% sodium mono- recommended for medium and high risk patients.13 fluorophosphate or 0.4% stannous fluoride. The maximum allowable fluoride in OTC dentifrices in the United States is Xylitol 1,450 ppm. In contrast, in Europe the typical level of fluo- Xylitol offers anti-caries benefits in dentifrices as well as ride in dentifrices is 1,500 ppm. In either case, the therapeu- chewing gums and other vehicles. Xylitol occurs naturally tic level of fluoride in the dentifrice is higher than the level and is found in woods, cereal crops, fruits and vegetables. found in OTC fluoride mouthrinses, which typically ranges Acidogenic bacteria are unable to ferment xylitol, reducing from 250–900 ppm. Sodium fluoride and sodium monofluo- their ability to produce the acids necessary for tooth demin- rophosphate dentifrices in particular have been extensively eralization. It is also believed that the bacteria cannot thrive researched in clinical trials. The use of fluoride dentifrices (a starvation effect) and that over time xylitol-resistant bac- (as well as community-based water fluoridation programs) teria that are less cariogenic may dominate. In clinical trials, has resulted in substantial declines in caries rates since their xylitol dentifrices have been found to reduce caries. A three- introduction, in both urban and isolated communities (for year double-blind study, by Sintes et al., in Costa Rica in example, a remote island off the west coast of Scotland).4,5 children 8–10 years of age using a sodium fluoride dentifrice The profound effect of the use of fluoride-containing containing 10% xylitol found an additional 12.3% reduction dentifrices on caries reductions in the developed world has in DFS after three years of twice-daily use compared to a been well recognized.6 Marinho et al. conducted a meta- control dentifrice containing the same level of sodium fluo- analysis of 70 clinical trials on fluoride dentifrices found in ride but no xylitol.14 A similar three-month trial in Costa the Cochrane Database. Only studies that were controlled, Rica using sodium monofluorophosphate as the fluoride blinded, randomized (or “quasi-randomized”) and con- active with 10% xylitol also found DFS reductions of more ducted in children under 17 years of age were included. than 10% compared to a non-xylitol control dentifrice.15 Their conclusion was a pooled 24% reduction in D(M)FS, with a range of 21% to 28%. No differences were found in Anti-microbial (Anti-plaque/Anti-gingivitis) comparing the use of the dentifrices in fluoridated versus Dentifrices non-fluoridated communities. As has been found in studies Anti-microbial dentifrices offer anti-gingivitis benefits and of topical in-office fluoride agents, the response varied with may also offer an additional anti-caries benefit depending on the level of caries in the population being studied.7 Fluoride the agent used. The primary anti-microbial used in OTC dentifrices have also been found to be effective in reducing dentifrices in the United States is a triclosan/copolymer for- root caries; Jensen and Kahout found a 67% reduction in root mulation also containing fluoride (Colgate Total). Stannous surface DFS in a one-year trial using a 1,100 ppm sodium fluoride and zinc citrate are also used in dentifrices. fluoride dentifrice.8 Daily use of a fluoride dentifrice has also been found to be effective in school-based programs, Triclosan/copolymer including in disadvantaged communities.9,10 This formulation contains 0.3% triclosan, a broad-spectrum Some children’s dentifrices are formulated to provide anti-bacterial agent, together with a copolymer (polyvinyl lower levels of fluoride, for example 250 ppm. The rationale methylether/maleic acid) that increases the substantiv- for this is to reduce the possibility of fluorosis due to inges- ity of the triclosan, with the result it is present and active tion of toothpaste. In a Swiss study, Steiner et al. found a intraorally. Triclosan is bactericidal and targets the cell cy- slightly reduced anti-caries benefit using a reduced fluoride toplasm. This results in gaps in the bacterial cell membrane level dentifrice but concluded that in preschool children and bacterial cell death. Plaque reductions and gingivitis the benefit of reduced risk of fluorosis outweighed this.11 A reductions have been found in a number of studies, with an small study by DenBesten and Ko assessed fluoride levels in average plaque reduction of 48% and an average gingivitis whole saliva in 10 children after use of either a pea-sized or reduction of 26% found in a review of clinical trials using the regular amount (full brush) of a fluoride dentifrice (normal triclosan/copolymer formulation.16,17,18,19 One study found ppm fluoride). They found that the return to baseline levels significantly reduced bleeding upon probing scores, with was more rapid and the initial post-brushing whole saliva reduced gingivitis, and improved probing attachment levels www.ineedce.com 3 following non-surgical periodontal therapy compared to been found in clinical trials to reduce supragingival plaque the control group using a placebo dentifrice.20 Triclosan/ and gingivitis over three- and six-month periods. Williams copolymer dentifrice has also demonstrated improvements et al. found a 25.3% reduction in plaque and an 18.8% re- in healing and anti-inflammatory effects.21 In vitro, it has duction in gingivitis after twice-daily use for six months in been shown to affect inflammatory pathways, specifically adults, with greater reductions in more severely affected through reduced cytokine production, and to inhibit bone areas.28 resorption.22 This has potential implications for patients with periodontal disease as reductions in these would Anti-calculus (Tartar Control) Dentifrices reduce the destructive inflammatory response. A fluoride Dentifrices containing anti-calculus agents reduce the for- dentifrice containing 0.3% triclosan/0.23% copolymer was mation of calculus but do not reduce the levels of preexist- found in one study to offer additional caries reductions over ing calculus. Calculus forms through calcification of dental and above the effect of fluoride, while a second study found plaque and oral epithelial cells by minerals from the saliva it to be equivalent.23,24 and gingival crevicular fluid, and also contains bacteria.29 Anti-calculus agents, marketed as anti-tartar ingredients, Figure 1. Triclosan/copolymer dentifrice include tetrapotassium and tetrasodium pyrophosphates, sodium hexametaphosphate, and zinc. Pyrophosphates work by stabilizing the level in saliva and interfere with the growth of the crystals that help form calculus. They have also been found to offer anti-microbial benefits.30 Zinc compounds used as anti-tartar agents include zinc Stannous fluoride citrate trihydrate and work by inhibiting crystal growth Stannous fluoride dentifrice, containing 0.4% stannous fluo- and controlling bacterial growth.31 Triclosan/copolymer ride, also functions as an anti-microbial and is bactericidal. dentifrice has also been found in several studies to reduce One small study using digital plaque imaging found statis- supragingival calculus formation. One study found a 26% at tically significant plaque reductions with use of a stannous three months and 36% at six months.32 These function due fluoride dentifrice containing 0.454% stannous fluoride, to the zinc compounds or triclosan/copolymer, and do not compared to use of a sodium fluoride dentifrice.25 contain pyrophosphates.

Figure 2. Stannous fluoride dentifrices Figure 3. Anti-calculus dentifrices

Anti-halitosis Dentifrices Chlorine dioxide, essential oils and zinc chloride have all been used to reduce halitosis by inhibiting the production of volatile compounds. Essential oil dentifrice was found in one study to reduce halitosis.33 Triclosan/copolymer/ Tin retention in saliva was found in another study follow- fluoride dentifrice has also been found to control and reduce ing in vivo use of stannous fluoride dentifrice.26 Binney et the bacteria associated with volatile sulfur compounds, as al. found no differences in plaque regrowth assessed in vivo well as anaerobic periodontal bacteria, thereby reducing between a triclosan/copolymer dentifrice and stannous fluo- these compounds and halitosis.34,35,36 Stannous fluoride den- ride dentifrice. It should be noted that the subjects involved tifrice with sodium hexametaphosphate has also been found in the study only rinsed with the dentifrice slurries without to reduce volatile sulfur compound production.37 any brushing.27 Desensitizing Dentifrices Zinc citrate Desensitizing dentifrices may contain potassium nitrate, A dentifrice containing 2% zinc citrate together with sodium potassium citrate, potassium chloride, stannous fluoride or monofluorophosphate (MFP) for anti-caries benefits has strontium chloride as the active ingredient. Sensitivity occurs

4 www.ineedce.com when fluid flows in open dentinal tubules towards the surface Figure 5. Desensitizing dentifrices of the tooth as a result of hydrodynamic forces (Brännström’s theory), in response to stimuli. This fluid flow is believed to result in the pain associated with hypersensitivity.38 There are two mechanisms by which desensitizing dentifrices can work. The first is by preventing the transmission of neural signals, thereby preventing pain, and the second is by block- ing the dentinal tubules.

Figure 4. Mechanisms of action of potassium nitrate and stannous fluoride Stimulus Stannous Fluoride

Fluid flow due to stimulus Blocks dentinal Potassium nitrate is the most common OTC desensitizer tubules and is contained in several dentifrices (Sensodyne Pronamel; Colgate Sensitive; Butler Sensitive; Crest Sensitivity).

Inactive Ingredients Inactive ingredients in dentifrices include binders, abrasives, surfactants, buffering agents, humectants, preservatives, sweeteners, flavorings and dyes (Table 2).

Table 2. Inactive ingredients and function Binders Provide body Prevent separation Humectants Retain moisture Prevent dehydration Potassium Nitrate Blocks nerve Give sweetness synapses Surfactants/detergents Cause foaming Reduce surface tension Potassium nitrate prevents the transmission of neural Loosen and suspend plaque signals by increasing the level of extracellular potassium Buffering agents Control the pH (derived from the potassium nitrate contained in the den- tifrice), thereby blocking synapses, and has been found in Sweeteners Sweeten the dentifrice numerous studies over many years to provide effective relief Flavorings Provide flavor from sensitivity.39 Potassium chloride works in a similar Dyes Improve appearance manner.40 Potassium nitrate dentifrice has also been shown Titanium dioxide Give opacity to be effective in reducing sensitivity associated with tooth- Preservatives Preserve the dentifrice whitening treatments.41 The FDA monograph considers Water Form a paste with the ingredients only 5% potassium nitrate as the percentage required in a desensitizing dentifrice. Stannous fluoride blocks the Binders are used to provide a dentifrice with body (bulk) dentinal tubules,42 and has been shown in several studies and also help to prevent separation of the ingredients. Synthetic to be an effective desensitizer.43,44 It is contained in several cellulose (carboxymethylcellulose), carageenan from seaweed, dentifrices, including Crest Pro-Health and Gel-Kam gel. colloids from sources, carbomers and xanthan gum A clinical trial assessing stannous fluoride dentifrice (Crest have all been added as binders/thickening agents. Humectants Pro-Health) found a 44% reduction in the mean sensitivity help the dentifrice retain moisture and prevent it from dehy- score compared with use of a sodium fluoride dentifrice.45 drating; these include , which is commonly used, as well Stannous fluoride and potassium nitrate are accepted under as polyethylene glycol, sorbitol and propylene. While not their the ADA Seal of Acceptance program as desensitizers. A primary function, humectants also contribute to the sweetness potential drawback of stannous fluoride is its propensity to of the dentifrice. Surfactants/detergents reduce surface ten- stain teeth; this can be mitigated with cleaning agents.46 sion, induce foaming, and help to loosen and suspend plaque www.ineedce.com 5 and debris in an emulsion for easier removal during brushing sulting in a whiter appearance.51 Sodium hexametaphosphate, and interdental cleaning. Common detergents/surfactants an anti-calculus agent, has also been found to help inhibit include sodium lauryl sulfate and sodium laurylsarcoside. The stains.52 Low levels of hydrogen peroxide have also been in- buffering agents control the pH of the toothpaste, ensuring that corporated into some whitening dentifrices, with the intent it is neither too acidic nor too alkaline. Sweeteners and flavoring of generating oxygen bubbles that gently help lift debris and agents used in dentifrices do not contain sucrose; sweeteners stain from the tooth surface. However, the hydrogen peroxide used include sodium saccharin and sodium cyclamate.47 Re- has a very short contact time in this situation. cently, xylitol has increasingly been used as a sweetening agent in toothpastes. FD&C dyes (# 1 and #5) are also included in Figure 6. Whitening dentifrices dentifrices to improve their appearance and acceptability. The inclusion of titanium dioxide provides for opacity in a denti- frice. Finally, water is included to form the paste.

Abrasives Abrasive ingredients used in dentifrices include finely ground , various silicas, silicon dioxide, carbonate, dicalcium phosphate dihydrate, aluminum oxide and argonite. The abrasiveness of a dentifrice is usually measured us- ing the Radioactive Dentin Abrasivity (RDA) test, which uses radioactive dentin and a standard brushing protocol in an in vitro test. The FDA considers an RDA under 250 to be safe and effective. In general, the risk of abrasion is associ- ated more with incorrect brushing technique and/or use of a hard bristled brush than with dentifrice RDA. However, in patients with erosion of the dentition, the lowest RDA den- tifrice that still provides cleaning ability should be utilized to avoid increasing the risk of abrasion. Teeth can accumulate stains over time, depending on several factors, including diet, Role of the Food and Drug Administration smoking and oral hygiene. Aging also results in changes to the The Food and Drug Administration (FDA) regulates fluoride appearance of the color of the tooth. Surface roughness and dentifrices as OTC drugs through the Anti-Caries Mono- loss of enamel surface structure alter light refraction, reflec- graph. The FDA does not require approval of OTC fluoride tion properties and light penetration, resulting in a darker dentifrices as new drugs unless they contain ingredients and appearance.48 Abrasives provide cleaning ability, with the concentrations that do not fall under the monograph. New intensity of cleaning depending on the type of abrasive used Drug Applications for dentifrices are rare, and the require- and amount contained in the dentifrice, thereby helping to ments imposed by the FDA are stringent. The manufacturer remove plaque and debris from the tooth surface and also must prove long-term microbiological safety and clinical tri- remove extrinsic stains. Without any abrasives, a dentifrice als must show efficacy and no toxicity associated with use of is unable to do this.49 Typically, the RDA level determines the product. Requirements include two clinical trials meeting the cleaning ability, with the exception of baking soda, which FDA requirements; laboratory and biological testing. The has an RDA level of 30–40 yet still offers cleaning ability only recent new drug application and approval for a dentifrice equivalent to more typical RDA levels, believed to be due to was for one containing the then-new active ingredient triclo- the sodium bicarbonate lifting stains as well as the abrasive san/copolymer (Colgate Total). action of the dentifrice.50 In addition to cleaning ability, abrasives with fine, rounded Toothpaste Labeling particles also help polish the enamel and thereby increase its Toothpaste labels contain a list of the active and inactive ingre- luster and white appearance. This is the main mechanism for dients, as well as directions and warnings. The dentifrice may whitening dentifrices (Colgate Visible White; Crest Whiten- or may not carry the ADA Seal. If recommending a dentifrice ing Expressions; Crest Vivid White; Colgate Total Advanced to a patient, it is important to read the labeling to check if there Whitening; Aquafresh Extreme Clean). A further option is a is any ingredient contraindicated for the patient (for instance, dentifrice containing amorphous calcium phosphate (ACP) allergies to certain dyes) as well as the warnings section of the and baking soda (ARM & HAMMER® Age Defying); the label. Stannous fluoride dentifrices are required by the FDA incorporation of ACP helps fill in surface defects, thereby to carry a warning that staining may occur. Additionally, den- smoothing the tooth surface, enhancing tooth luster and re- tifrices indicated as desensitizers carry the warning that the

6 www.ineedce.com Figure 7. Labeling for sensitivity toothpaste

product should not be used for more than four weeks unless For products carrying the seal, a new application must be recommended by a dentist or physician. made if the formulation changes, or every five years, which- The FDA does not test dentifrices, although it can carry ever is sooner. The ADA Seal program does not support out audits to check that manufacturers are complying with plaque reduction as a claim since this is not the therapeutic the monograph and good manufacturing practices. benefit. Instead, the program supports an anti-plaque/anti- gingivitis claim if the manufacturer’s submitted documenta- The ADA Seal tion supports such a claim and the manufacturer requests it. Manufacturers can choose whether or not to apply for an One of the ADA’s requirements is that manufacturers place ADA Seal, which requires documentation, ADA-mandated a statement regarding use of a pea-sized amount by young standardized testing and considerable resources. Until children to help prevent fluorosis. The actual statement is as recently, the ADA Seal was available for both professional follows: “Do not swallow. Use only a pea-sized amount for and consumer products. The professional seal program children under six. To prevent swallowing, children under six was discontinued and phased out by the end of 2007.53 To years of age should be supervised in the use of toothpaste.” qualify for an ADA Seal, the manufacturer must submit the list of ingredients, indications and claims; clinical trials; Figure 9. ADA Seal of Acceptance laboratory tests in accordance with the ADA Seal program requirements that document efficacy and safety and support marketing claims, as well as submit good manufacturing practices (GMP) and facilities documentation.54,55 The man- ufacturer must provide copies of all product packaging and labeling for review and approval by the ADA, and comply with the ADA’s standards for accuracy and truthfulness. Patient-Specific Dentifrice Recommendations The ADA Seal for fluoride dentifrices is for anti-caries Dentifrice recommendations should be patient specific. Consid- efficacy and safety – if a manufacturer wishes to have other erations include any complaint or request the patient may have indications considered, data must be submitted that backs as well as any potential contraindications or relative contrain- up the indication and associated claims. The logo is always dications.. If a patient is allergic or sensitive to an ingredient, the same, while the wording alongside the logo differs and all dentifrices containing that ingredient should be avoided. For depends on what the ADA acceptance was for. Therefore, it example, sensitivity to SLS or pyrophosphate would, respec- is important to read the wording in the box by the seal. The tively, indicate use of an SLS-free or low-SLS dentifrice or of a standard statement is as follows: “The ADA’s Council on pyrophosphate-free dentifrice (for example, zinc compound or Scientific Affairs Acceptance of (Product Name) is based on triclosan/copolymer dentifrice). If a patient is experiencing hy- its finding that the product is effective in helping prevent or persensitivity, a desensitizing dentifrice containing potassium reduce tooth decay when used as directed.” nitrate or stannous fluoride can be recommended. However,

Figure 8. Stannous fluoride dentifrice labeling

www.ineedce.com 7 if a desensitizing dentifrice is not required it may mask other 10 Jackson RJ, Newman HN, Smart GJ, et al. The effects of a problems such as early cavities or erosion – hence the four-week supervised toothbrushing programme on the caries increment of primary school children, initially aged 5-6 years. Caries Res. labeling requirement. If a patient requests a whitening denti- 2005 Mar-Apr; 39(2):108-15. frice, recommending one may help patient compliance with 11 Steiner M, Helfenstein U, Menghini G. Effect of 1,000 ppm oral hygiene and considerations should include determining relative to 250 ppm fluoride toothpaste: a meta-analysis. Am J what other needs the patient has – for instance, anti-plaque/ Dent. 2004 Apr; 17(2):85-8. 12 DenBesten P, Ko HS. Fluoride levels in whole saliva of preschool anti-gingivitis and/or anti-tartar benefits. Is the patient’s desire children after brushing with 0.25 g (pea-sized) as compared to for a whitening toothpaste due to surface staining or changes in 1.0 g (full-brush) of a fluoride dentifrice.Pediatr Dent. 1996 Jul- the enamel surface that alter light properties – suggesting use Aug; 18(4):277-80. of a dentifrice with fine polishing capability or use of an ACP 13 American Dental Association Council on Scientific Affairs. dentifrice (to either remove or fill in microscopic defects in the Professionally applied topical fluoride: evidence-based clinical recommendations. J Am Dent Assoc. 2006; 137(8):1151-9. enamel). If the patient suffers from erosion, a low RDA denti- 14 Sintes JL, Escalante C, Stewart B, et al. Enhanced anticaries frice should be selected.56 For multi-benefit dentifrices, which efficacy of a 0.243% sodium fluoride/10% xylitol/silica benefits would most help a specific patient? Does the patient dentifrice: 3-year clinical results. Am J Dent. 1995 Oct; 8(5):231- acquire calculus readily or require a desensitizer or experience 5. 15 Sintes JL, Elías-Boneta A, Stewart B, et al. Anticaries efficacy halitosis? Would the patient benefit from anti-microbials, of a sodium monofluorophosphate dentifrice containing xylitol and if so is the patient’s periodontal status such that anti- in a dicalcium phosphate dihydrate base: a 30-month caries inflammatory activity would be desirable? Patients anticipate clinical study in Costa Rica. Am J Dent. 2002 Aug; 15(4):215- receiving recommendations. These can be explicit or implicit. 9. 16 Mankodi S, Walker C, Conforti N, et al. Clinical effect of a If you provide patients with samples of toothpastes, this is an triclosan containing dentifrice on plaque and gingivitis: a six- implicit recommendation even if you have not discussed or month study. Clin Prev Dent. 1992; 14(6):4-10. actively recommended a dentifrice. In all situations, dentifrice 17 Bolden TE, Zambon JJ, Sowinski J, et al. The clinical effect of selection should consider the available supporting science. a dentifrice containing triclosan and a copolymer in a sodium fluoride/silica base on plaque formation and gingivitis: a six- month study. J Clin Dent. 1992; 3(4):125-131. Summary 18 Deasy MJ, Singh SM, Rustogi KN, et al. Effect of a dentifrice The range of OTC dentifrices available today enables con- containing triclosan and a copolymer on plaque formation and sumers to use a dentifrice tailored to their individual needs gingivitis. Clin Prev Dent. 1991 Nov-Dec;13(6):12-9. 19 Davies RM, Ellwood RP, Davies GM. The effectiveness and desires. Dental professionals play an important role in of a toothpaste containing triclosan and polyvinyl-methyl helping patients select an appropriate dentifrice. Dentifrices ether maleic acid copolymer in improving plaque control offer therapeutic and cosmetic benefits, with the range of and gingival health: a systematic review. J Clin Periodontol. benefits varying with the ingredients in a specific dentifrice. 2004;31(12):1029-33. Considerations should include the support and documenta- 20 Furuichi Y, Rosling B, Volpe AR, Lindhe J. The effect of a triclosan/copolymer dentifrice on healing after non-surgical tion for the dentifrice, and the needs of the patient. treatment of recurrent periodontitis. J Clin Periodontol. 1999 Feb; 26(2):63-6. References 21 Kerdvongbundit V, Wikesjö UM. Effect of triclosan on healing 1 The history of teeth cleaning. Available at http://www.bbc. following non-surgical periodontal therapy in smokers. J Clin co.uk/dna/h2g2/A2818686. Accessed May 10, 2009. Periodontol. 2003 Dec; 30(12):1024-30. 2 http://www.cwanswers.com/8921/toothpaste. 22 Xu T, Deshmukh M, Barnes VM, et al. Effectiveness of 3 A brief history of your toothbrush, toothpaste and oral a triclosan/copolymer dentifrice on microbiological and hygiene. Available at http://www.associated content.com/ inflammatory parameters. Compend Contin Educ Dent. 2004 article/164851/a_brief_history_of_your_toothbrush.html. Jul; 25(7 Suppl 1):46-53. Accessed May 10, 2009. 23 Mann J, Vered Y, Babayof I, et al. The comparative anticaries 4 Hargreaves JA, Cleaton-Jones PE. Dental caries changes in the efficacy of a dentifrice containing 0.3% triclosan and 2.0% Scottish Isle of Lewis. Caries Res. 1990;24(2):137-41. copolymer in a 0.243% sodium fluoride/silica base and a 5 Franke W, Künzel W, Treide A, Blüthner K. Caries prevention by dentifrice containing 0.243% sodium fluoride/silica base: a means of aminofluoride after 7 years of collectively conducted two-year coronal caries clinical trial on adults in Israel. J Clin oral hygiene. Stomatol DDR. 1977 Jan; 27(1):13-6. Dent. 2001;12(3):71-6. 6 Renson CE. Changing patterns of dental caries: a survey of 20 24 Hawley GM, Hamilton FA, Worthington HV, et al. A 30-month countries. Ann Acad Med Singapore. 1986 Jul; 15(3):284-98. study investigating the effect of adding triclosan/copolymer to 7 Marinho VC, Higgins JP, Sheiham A, Logan S. Fluoride a fluoride dentifrice. Caries Res. 1995;29(3):163-7. toothpastes for preventing dental caries in children 25 White DJ. Effect of a stannous fluoride dentifrice on plaque and adolescents. Cochrane Database Syst Rev. 2003; formation and removal: a digital plaque imaging study. J Clin (1):CD002278. Dent. 2007; 18(1):21-4. 8 Jensen ME, Kohout F. The effect of a fluoridated dentifrice on 26 Ramji N, Baig A, He T, et al. Sustained antibacterial actions of a root and coronal caries in an older adult population. J Am Dent new stabilized stannous fluoride dentifrice containing sodium Assoc. 1988 Dec;117(7):829-32. hexametaphosphate. Compend Contin Educ Dent. 2005 Sep; 9 Hölttä P, Alaluusua S. Effect of supervised use of a fluoride 26(9 Suppl 1):19-28. toothpaste on caries incidence in pre-school children. Int J 27 Binney A, Addy M, Owens J, Faulkner J. A comparison of Paediatr Dent. 1992 Dec; 2(3):145-9. triclosan and stannous fluoride toothpastes for inhibition of

8 www.ineedce.com plaque regrowth. A crossover study designed to assess carry 48 Ten Bosch JJ, Coops CC. Tooth color and reflectance as related over. J Clin Periodontol. 1997 Mar; 24(3):166-70. to light scattering and enamel hardness. J Dent Res. 1995; 28 Williams C, McBride S, Mostler K, et al. Efficacy of a dentifrice 74:374-80. containing zinc citrate for the control of plaque and gingivitis: a 49 Dawson P L, Walsh J E, Morrison T et al. Dental stain prevention 6-month clinical study in adults. Compend Contin Educ Dent. by abrasive toothpastes: A new in vitro test and its correlation 1998; 19(2 Suppl):4-15. with clinical observations. J Cosmet Sci 1998 49: 275-283. 29 White DJ. Dental calculus: recent insights into occurrence, 50 Smith J, Ersen E, Coffman L, et al. Cyclic laboratory model formation, prevention, removal and oral health effects of to measure the chemical cleaning powder of seven grades of supragingival and subgingival deposits. Eur J Oral Sci. 1997; sodium bicarbonate. J Dent Res. 2003; 82:A #384. 105(5 Pt 2):508-522. 51 Muñoz CA, Stephens JA, Proskin HM, Ghassemi A. Clinical 30 Drake D, Grigsby B, Krotz-Dieleman D. Growth-inhibitory efficacy evaluation of a fluoride dentifrice containing calcium, effect of pyrophosphate on oral bacteria. Oral Microbiol phosphate, and sodium bicarbonate on surface-enamel Immunol. 1994 Feb; 9(1):25-8. smoothness and gloss. Comp Cont Ed Dent. 2004; 25(9)(Suppl 31 Sowinski J, Petrone DM, Battista G, et al. Clinical efficacy of 1):32-43. a dentifrice containing zinc citrate: A 12-week calculus clinical 52 Baig A, He T, Buisson J, et al. Extrinsic whitening effects of study in adults. Compend Contin Educ Dent. 1998; 19(Suppl sodium hexametaphosphate: a review including a dentifrice 2):16-19. with stabilized stannous fluoride. Compend Contin Educ 32 Lobene RR, Battista GW, Petrone DM, et al. Clinical efficacy Dent. 2005 Sep; 26(9 Suppl 1):47-53. of an anticalculus fluoride dentifrice containing triclosan and a 53 http://www.ada.org/ada/seal/faq.asp. Accessed June 9, 2009. copolymer: a 6-month study. Am J Dent. 1991 Apr; 4(2):83-5. 54 Ibid. 33 Olshan AM, Kohut BE, Vincent JW, et al. Clinical effectiveness 55 http://www.ada.org/ada/seal/toothpaste.asp. Accessed June of essential oil-containing dentifrices in controlling oral 9, 2009. malodor. Am J Dent. 2000 Sep; 13(Spec No):18C-22C. 56 Hooper S, West NX, Pickles MJ, et al. Investigation of erosion 34 Vazquez J, Pilch S, Williams MI, Cummins D. Clinical efficacy and abrasion on enamel and dentine: a model in situ using of a triclosan/copolymer/NaF dentifrice and a commercially toothpastes of different abrasivity. J Clin Periodontol. 2003; available breath-freshening dentifrice on hydrogen sulfide- 30(9):802-808. forming bacteria. Oral Dis. 2005; 11 Suppl 1:64-6. 35 Hu D, Zhang YP, Petrone M, Volpe AR, DeVizio W, Proskin Author Profile HM. Clinical effectiveness of a triclosan/copolymer/sodium- Fiona M. Collins, BDS, MBA, MA fluoride dentifrice in controlling oral malodor: a three-week Dr. Fiona M. Collins has authored clinical trial. Compend Contin Educ Dent. 2003 Sep; 24(9 and presented CE courses to dental Suppl):34-41. 36 Fine DH, Furgang D, Markowitz K, et al. The antimicrobial effect professionals and students in the of a triclosan/copolymer dentifrice on oral microorganisms in US and internationally. During her vivo. J Am Dent Assoc. 2006 Oct; 137(10):1406-13. career she has worked in the United 37 Farrell S, Barker ML, Gerlach RW. Overnight malodor States, Middle East, The Netherlands effect with a 0.454% stabilized stannous fluoride sodium and United Kingdom. In addition hexametaphosphate dentifrice. Compend Contin Educ Dent. 2007 Dec; 28(12):658-61. to clinical dentistry, she has held 38 Brännström M. Etiology of . Proc Finn positions in academia, marketing, Dent Soc. 1992;88(Suppl 1):7-13. professional relations, education and training, and general 39 Gillam DG. The efficacy of potassium as agents for treating management while at Groningen University, Straumann, dentin hypersensitivity. J Orofac Pain. 2000 Winter;14(1):9-19. Colgate Oral Pharmaceuticals and Timken. Dr. Collins 40 Salvato AR, Clark GE, Gingild J, Curro FA. Clinical effectiveness is a past member of the Academy of General Dentistry of a dentifrice containing potassium chloride as a desensitizing agent. Am J Dent. 1993;5(6):303-6. Foundation Strategy Board, and has been a member of the 41 Haywood VB, Cordero R, Wright K, et al. Brushing with a British Dental Association, Dutch Dental Association, potassium nitrate dentifrice to reduce bleaching sensitivity. J and the International Association for Dental Research. Dr. Clin Dent. 2005; 16:17-22. Collins earned her dental degree from Glasgow University 42 Ellingsen JE, Rolla G. Treatment of dentin with stannous and holds an MBA and MA from Boston University. She has fluoride – SEM and electron microprobe study. Scand J Dent Res. 1987; 95:281-286. been an active consultant in the dental industry for several 43 Blong MA, Volding B, Thrash WJ, et al. Effects of a gel containing years, and a national and international speaker. Dr. Collins 0.4 percent stannous fluoride on dentinal hypersensitivity. Dent is a member of the American Dental Association and the Hyg (Chic). 1985; 59:489-92. Organization for Asepsis and Safety Procedures. 44 Snyder RA, Beck FM, Horton JE. The efficacy of a 0.4% stannous fluoride gel on root surface hypersensitivity. J Dent Disclaimer Res. 1985; 62:237. 45 Schiff T, He T, Sagel L, Baker R. Efficacy and safety of a novel The author of this course has no commercial ties with the stabilized stannous fluoride and sodium hexametaphosphate sponsors or the providers of the unrestricted educational dentifrice for dental hypersensitivity. J Contemp Dent Pract. grant for this course. 2006; 7(2):1-8. 46 Wade W, Addy M, Hughes J, et al. Studies on stannous fluoride Reader Feedback toothpaste and gel (1). Antimicrobial properties and staining potential in vitro. J Clin Periodontol. 1997 Feb;24(2):81-5. We encourage your comments on this or any PennWell course. 47 http://www.ada.org/ada/seal/faq.asp. Accessed June 12, For your convenience, an online feedback form is available at 2009. www.ineedce.com. www.ineedce.com 9 Online Completion Use this page to review the questions and answers. Return to www.ineedce.com and sign in. If you have not previously purchased the program select it from the “Online Courses” listing and complete the online purchase. Once purchased the exam will be added to your Archives page where a Take Exam link will be provided. Click on the “Take Exam” link, complete all the program questions and submit your answers. An immediate grade report will be provided and upon receiving a passing grade your “Verification Form” will be provided immediately for viewing and/or printing. Verification Forms can be viewed and/or printed anytime in the future by returning to the site, sign in and return to your Archives Page. Questions 1. Ancient toothpastes were formulated 12. Triclosan ______. 22. The surfactant in a dentifrice containing ______. a. is bactericidal ______. a. ground shells b. attacks the bacterial cell cytoplasm a. causes foaming b. iris flowers c. results in gaps in the cell membrane and cell death b. reduces surface tension c. carbamide peroxide d. all of the above c. helps loosen and suspend plaque d. a and b 13. Average plaque and gingivitis reductions d. all of the above 2. The collapsible toothpaste tube was of 48% and 26% respectively have been 23. Abrasiveness in a dentifrice invented by ______. found in a review of triclosan/copolymer ______. a. Dr. Alberto Gomezzo dentifrice. a. Is measured in vitro by the Radioactive Dentin b. Dr. Washington Sheffield a. True Abrasivity (RDA) test c. Dr. Sheffield Washington b. False b. Is considered safe and effective by the FDA at an d. Dr. Brian Thompson 14. In vitro, triclosan/copolymer dentifrice RDA below 250 3. The first active ingredient introduced into has been found to ______. c. helps remove plaque, debris and stains from the dentifrices was ______. a. reduce cytokine production teeth a. sodium lauryl sulfate b. inhibit bone resorption d. all of the above b. fluoride c. affect inflammatory pathways c. zinc citrate 24. A whitening dentifrice can work by d. all of the above d. xylitol ______. 15. Using digital plaque imaging, statisti- a. polishing the surface of the enamel with fine, 4. An active ingredient in a dentifrice is one rounded abrasives that offers ______. cally significant plaque reductions have been found with use of a stannous fluoride b. removing microscopic surface defects a. an esthetic benefit c. filling in microscopic surface defects b. a therapeutic benefit dentifrice. d. all of the above c. a higher level of the same benefit offered by an a. True inactive ingredient b. False 25. While the ADA Seal for fluoride d. a benefit enhanced by physical activity 16. Tin retention in saliva has been dentifrices is for anti-caries efficacy and 5. An inactive ingredient in a dentifrice is found after using stannous fluoride safety, the manufacturer can have other one that ______. dentifrice. indications considered provided data a. is nontherapeutic a. True supporting the additional indication(s) b. functions in the same way as an active ingredient b. False and associated claims is submitted to the but at a lower level 17. Plaque and gingivitis reductions of up ADA. c. contributes to the physicochemical properties of the a. True to ______and ______, dentifrice b. False d. a and c respectively, were found in severely affected areas in a six-month clinical 26. The FDA labeling requirement for 6. The supply of topical fluoride from stannous fluoride dentifrices include a regular use of a dentifrice ______. study of zinc citrate dentifrice used statement concerning the possibility of a. helps prevent demineralization twice daily. b. helps promote remineralization a. 19.3%; 15.8% surface staining of the teeth. c. inhibits loss of fluoride ion from the tooth structure b. 22.3%; 18.8% a. True d. all of the above c. 25.3%; 18.8% b. False d. 28.3%; 23.8% 7. The use of fluoride dentifrices has resulted 27. Desensitizing dentifrices must carry a in substantial declines in the caries rate. 18. Anti-calculus agents used in dentifrices warning mandated by the FDA that the a. True include ______. product should not be used for more than b. False a. pyrophosphates ______unless recommended by a 8. The use of 250 ppm fluoride b. zinc dentist or physician. c. sodium hexametaphosphate dentifrice in children has been found a. two weeks d. all of the above to ______, compared to use of b. four weeks regular fluoride dentifrices. 19. Anti-calculus (tartar control) dentifrices c. six weeks a. reduce the risk for fluorosis work variously by ______. d. eight weeks b. slightly reduce the anti-caries benefit a. inhibiting, or interfering with, crystal growth of 28. If a patient suffers from erosion, a low c. improve a child’s attitude to brushing calculus RDA dentifrice should be selected. d. a and b b. inhibiting bacterial growth a. True c. stabilizing the level of calcium present in saliva 9. The use of xylitol as an active ingredient b. False d. all of the above in dentifrices has been found to reduce 29. An implicit recommendation occurs 20. If a patient is sensitive to pyrophos- caries. when a dental professional provides a a. True phates, an anti-calculus dentifrice that patient with a sample of, for instance, b. False does not contain these should be recom- a dentifrice in the absence of an active 10. The mechanism of action for xylitol in- mended and used, with options including one containing ______. recommendation, while an explicit volves the bacteria which ______. recommendation involves an active rec- a. are not able to ferment xylitol, reducing their ability a. triclosan/copolymer to produce acids b. charcoal ommendation. b. cannot thrive on xylitol c. zinc citrate trihydrate a. True c. may shift over time to xylitol-tolerant, less d. a or c b. False acidogenic bacteria dominating the flora 21. The mechanisms by which 30. A dentifrice recommendation should d. all of the above desensitizing dentifrices work are by consider ______. 11. Anti-microbials used in dentifrices in the ______. a. the individual patient’s needs and desires United States include ______. a. blocking nerve transmission of the response to b. the scientific support and documentation for the a. triclosan/copolymer stimuli dentifrice b. stannous fluoride b. blocking (occluding) the dentinal tubules c. any patient-specific contraindications, allergies or c. zinc citrate c. competitive stimulation sensitivities d. all of the above d. a and b d. all of the above 10 www.ineedce.com ANSWER SHEET Reflections on Dentifrice Ingredients, Benefits and Recommendations

Name: Title: Specialty:

Address: E-mail:

City: State: ZIP: Country:

Telephone: Home ( ) Office ( )

Requirements for successful completion of the course and to obtain dental continuing education credits: 1) Read the entire course. 2) Complete all information above. 3) Complete answer sheets in either pen or pencil. 4) Mark only one answer for each question. 5) A score of 70% on this test will earn you 4 CE credits. 6) Complete the Course Evaluation below. 7) Make check payable to PennWell Corp.

If not taking online, mail completed answer sheet to Educational Objectives Academy of Dental Therapeutics and Stomatology, 1. List active ingredients in dentifrices and their therapeutic benefits. A Division of PennWell Corp. P.O. Box 116, Chesterland, OH 44026 2. List inactive ingredients in dentifrices and their functions. or fax to: (440) 845-3447 3. Know the roles of the FDA and ADA with respect to over-the-counter dentifrices.

4. Understand the considerations involved and importance of recommending OTC dentifrices for individual patients. For immediate results, go to www.ineedce.com to take tests online. Answer sheets can be faxed with credit card payment to (440) 845-3447, (216) 398-7922, or (216) 255-6619. Course Evaluation Payment of $59.00 is enclosed. Please evaluate this course by responding to the following statements, using a scale of Excellent = 5 to Poor = 0. (Checks and credit cards are accepted.) If paying by credit card, please complete the 1. Were the individual course objectives met? Objective #1: Yes No Objective #3: Yes No following: MC Visa AmEx Discover Objective #2: Yes No Objective #4: Yes No Acct. Number: ______2. To what extent were the course objectives accomplished overall? 5 4 3 2 1 0 Exp. Date: ______Charges on your statement will show up as PennWell 3. Please rate your personal mastery of the course objectives. 5 4 3 2 1 0

4. How would you rate the objectives and educational methods? 5 4 3 2 1 0

5. How do you rate the author’s grasp of the topic? 5 4 3 2 1 0

6. Please rate the instructor’s effectiveness. 5 4 3 2 1 0

7. Was the overall administration of the course effective? 5 4 3 2 1 0

8. Do you feel that the references were adequate? Yes No

9. Would you participate in a similar program on a different topic? Yes No

10. If any of the continuing education questions were unclear or ambiguous, please list them. ______

11. Was there any subject matter you found confusing? Please describe. ______

12. What additional continuing dental education topics would you like to see? ______AGD Code 010/016

PLEASE PHOTOCOPY ANSWER SHEET FOR ADDITIONAL PARTICIPANTS.

AUTHOR DISCLAIMER INSTRUCTIONS COURSE CREDITS/COST RECORD KEEPING The author of this course has no commercial ties with the sponsors or the providers of the All questions should have only one answer. Grading of this examination is done All participants scoring at least 70% (answering 21 or more questions correctly) on the PennWell maintains records of your successful completion of any exam. Please contact our unrestricted educational grant for this course. manually. Participants will receive confirmation of passing by receipt of a verification examination will receive a verification form verifying 4 CE credits. The formal continuing offices for a copy of your continuing education credits report. This report, which will list form. Verification forms will be mailed within two weeks after taking an examination. education program of this sponsor is accepted by the AGD for Fellowship/Mastership all credits earned to date, will be generated and mailed to you within five business days SPONSOR/PROVIDER credit. Please contact PennWell for current term of acceptance. Participants are urged to of receipt. This course was made possible through an unrestricted educational grant. No EDUCATIONAL DISCLAIMER contact their state dental boards for continuing education requirements. PennWell is a manufacturer or third party has had any input into the development of course content. The opinions of efficacy or perceived value of any products or companies mentioned California Provider. The California Provider number is 4527. The cost for courses ranges CANCELLATION/REFUND POLICY All content has been derived from references listed, and or the opinions of clinicians. in this course and expressed herein are those of the author(s) of the course and do not from $49.00 to $110.00. Any participant who is not 100% satisfied with this course can request a full refund by Please direct all questions pertaining to PennWell or the administration of this course to necessarily reflect those of PennWell. contacting PennWell in writing. Machele Galloway, 1421 S. Sheridan Rd., Tulsa, OK 74112 or [email protected]. Many PennWell self-study courses have been approved by the Dental Assisting National Completing a single continuing education course does not provide enough information Board, Inc. (DANB) and can be used by dental assistants who are DANB Certified to meet © 2009 by the Academy of Dental Therapeutics and Stomatology, a division COURSE EVALUATION and PARTICIPANT FEEDBACK to give the participant the feeling that s/he is an expert in the field related to the course DANB’s annual continuing education requirements. To find out if this course or any other of PennWell We encourage participant feedback pertaining to all courses. Please be sure to complete the topic. It is a combination of many educational courses and clinical experience that PennWell course has been approved by DANB, please contact DANB’s Recertification survey included with the course. Please e-mail all questions to: [email protected]. allows the participant to develop skills and expertise. Department at 1-800-FOR-DANB, ext. 445. REFL0910RDH

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