Therapeutic Mouthrinsing: An Effective Component to Oral Hygiene

Continuing Education Units: 1 hour

Pam Hughes, RDH, MS

Brushing and flossing remain the preferred method for plaque control. Unfortunately, many patients lack the motivation or ability to maintain low plaque levels, leading to periodontal disease, dental caries and other oral health conditions. Chemotherapeutic rinses provide a convenient, cost-effective way to enhance plaque control achieved with mechanical hygiene. This course reviews three common agents used in chemotherapeutic rinses and recommends factors to consider when advising patients to add a rinse to their oral hygiene routine.

Conflict of Interest Disclosure Statement

The author has done consulting work for P&G.

ADA CERP
The Procter & Gamble Company is an ADA CERP Recognized Provider. ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education. ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry. Concerns or complaints about a CE provider may be directed to the provider or to ADA CERP at: http://www.ada.org/prof/ed/ce/cerp/index.asp

Overview
Dental disease remains prevalent in the population. Clinical data show three antibacterial active systems - chlorhexidine (Rx), cetylpyridinium chloride and essential oils - reduce gingival inflammation and bleeding and help maintain good gingival health in conjunction with mechanical hygiene. Data also support

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Crest Oral-B at dentalcare.com Continuing Education Course, Revised February 21, 2012

incremental benefits of antibacterial rinses even when used in conjunction with an antibacterial dentifrice. This course reviews supporting evidence showing safety and efficacy of each agent and discusses ways to help ensure compliance to a regimen involving rinsing.

Learning Objectives
Upon completion of this course, the dental professional should be able to: List agents used in rinses to provide bacterial reduction and gingival health benefits. Understand the clinical data supporting the antiplaque and antigingivitis benefits of each agent. Identify plaque control rinses that will address specific patient needs.

Course Contents
Introduction Chlorhexidine Cetylpyridinium Chloride (CPC) Essential Oils Regimen Data Practical Implications Course Test References About the Authors

Introduction
Research suggests over half of our adult patients suffer from some form of periodontal disease.1 These findings are not surprising since other studies indicate most people spend less than a minute brushing their teeth,2 and data for flossing frequency is equally disappointing.3 Suboptimal plaque control is not only detrimental for our patients oral health, but prolonged oral inflammation may also affect their overall health status.4-6 Mechanical hygiene specifically brushing and flossing continues to be the first line of defense against plaque biofilm accumulation. However, a large proportion of patients continue to fall short of desired oral hygiene.1,2,3 Use of chemotherapeutic antiplaque/antigingivitis formulations in addition to mechanical hygiene can serve as an effective and successful adjunct to patients daily hygiene routine. Recently, there has been a dramatic increase in the number of rinses, including new flavors and formulations, offering patients more options to meet their unique needs and preferences. The expansion of rinses also increases the need for dental professionals to be familiar with their modes of administration, mechanisms of action, and clinical effectiveness to ensure successful outcomes.

Three common therapeutic agents have been clinically proven to produce significant gingival and plaque control benefits when formulated at specific therapeutic concentrations: chlorhexidine; cetylpyridinium chloride (CPC); and essential oils.7,8 The latter two active ingredients are the only two the US Food and Drug Administration (FDA) Dental Plaque Subcommittee of the Nonprescription Drugs Advisory Committee recommended to be classified as safe and effective for use in over-the-counter mouthrinses to treat plaque-induced gingivitis.8 This course reviews the clinical evidence behind each agent and discusses practical implications of incorporating rinses into patients daily routine.

Chlorhexidine
Chlorhexidine gluconate rinses are highly effective prescription treatments commonly marketed in formulations containing 0.12% chlorhexidine gluconate with 11.6% alcohol (Peridex, 3M ESPE Dental Products). An alcohol-free formula has been introduced in the United States that is reportedly as effective as formulas with alcohol (GUM, Sunstar

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Butler).9 Chlorhexidine is strongly adsorbed to oral surfaces. Approximately 30% is reported to be retained in the oral cavity post-rinsing, creating a reservoir for sustained antibacterial activity against a broad range of bacteria.10 Chlorhexidine rinses are indicated for use between dental visits as part of a professional program for the treatment of gingivitis and are generally considered the gold standard for therapeutic rinses. Their effect on periodontitis or acute necrotizing ulcerative gingivitis has not been determined.10 Numerous long-term clinical studies have evaluated the effects of chlorhexidine rinses with concentrations ranging from 0.12% to 0.2%.7,11-15 Excellent efficacy has been reported for gingivitis, gingival bleeding and plaque. Formulations with 0.12% chlorhexidine demonstrated gingivitis reductions from 17% to 40% and plaque reductions from 35% to 61%.7 Despite its clinical potency, extended use of chlorhexidine is generally avoided due to the potential development of extrinsic stain, taste alteration, and calculus formation.16 cosmetic products used for the temporary control of halitosis. Numerous 6-month clinical studies have shown statistically significant reductions in plaque and gingivitis for therapeutic CPC rinses relative to 11,21,22 Reductions ranged from negative controls. 15% to 24% for gingivitis, 27% to 67% for bleeding, and 16% to 28% for plaque. Other extended use research has shown parity benefits to a positive control rinse.23,24 CPCs safety has been well-documented.11,21-24 A small percent of patients may experience temporary taste alteration and/or transient staining as documented with any effective antimicrobial rinse.18 These side effects are usually observed more frequently from the use of prescription rinses (e.g., chlorhexidine) and occur less often in the over-the-counter formulations. With the 0.07% CPC rinse, (Crest Pro-Health Rinse) user acceptability was favorable along with a high patient compliance.25 This CPC therapeutic mouthrinse has further demonstrated excellent bioavailability success with bacterial cidal activity and antibacterial retention.26

Cetylpyridinium Chloride (CPC)

CPC is a well-known, broad-spectrum antimicrobial agent used in over-the-counter rinses to promote gingival health. It acts by penetrating the cell membrane, causing cell components to leak, which eventually leads to cell death.17 This action can be described to patients using the analogy of puncturing a water balloon. Recently, overthe-counter therapeutic CPC rinses have been introduced in alcohol-free formulations (Crest Pro-Health Rinse, Procter & Gamble).18 CPC is recognized to be effective against plaque and gingivitis when formulated at concentrations of 0.045% to 0.1% with at least 72% to 77% chemically available cetylpyridinium chloride.8 CPCs efficacy can be affected by other ingredients in the product formulation thus necessitating specific criteria to be established for its concentration and bioavailability.19 Studies have reported formulations with high bioavailable CPC are associated with greater biological activity, consequently indicating an increased probability for clinical efficacy.20 Rinses with lower CPC concentrations or with less chemically available CPC are long standing marketed products identified as

Essential Oils
The other active system recommended by the FDA Dental Plaque Subcommittee as safe and effective for an over-the-counter antiplaque/ antigingivitis rinse is essential oils (Listerine, Johnson & Johnson).8 The specific formulation that has been approved combines 0.092% eucalyptol, 0.042% menthol, 0.06% methyl salicylate, and 0.064% thymol in a hydroalcoholic vehicle containing 21.6% to 26.9% alcohol.27 Essential oils rinses work by disrupting the bacterial cell wall and inhibiting the cells enzymatic activity.

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The efficacy of essential oils for antiplaque and antigingivitis activity has been well documented in the literature.28-32 Long-term trials, including those involving flossing and rinsing have shown reductions in gingivitis from 12% to 30% and plaque reductions from 21% to 56% when compared to a placebo. The safety of rinses containing essential oils is also wellestablished.28-32 The burning associated with the alcohol in the formula may be difficult for some patients to tolerate33 which could affect compliance. Light extrinsic staining, a potential occurrence with use of antimicrobial rinses, has also been reported in clinical research.28

clinical trials.34,35 Both studies confirm significant incremental plaque inhibition is still achieved, whether adding a CPC rinse to a stannous fluoride dentifrice or adding an essential oils rinse to a triclosan dentifrice. Thus, even patients brushing with an antiplaque toothpaste can further enhance plaque control by using a therapeutic rinse. Research demonstrating statistically significant findings provides valuable information for clinicians in assisting their patients with daily oral health care regimens.34

Practical Implications
As dental professionals, we should advise patients to utilize additional plaque control measures not only to improve treatment outcomes but also to maintain optimal oral health. When adding a rinse to a patients home care routine is determined to be appropriate, it is most important to make sure the rinse meets the individual patients needs. Here are some considerations to help ensure compliance: Stress that rinsing is not a replacement for mechanical hygiene Remind patients therapeutic rinses are not intended to replace proper mechanical hygiene methods, but rather provide an additional means for improved plaque and gingivitis control. Brushing and flossing are the primary means to remove plaque while rinsing reduces plaque build-up and facilitates plaque removal. Advise patients to choose a product with a pleasant usage experience Rinses are available in various flavors so patients can choose one that best fits their personal preference. If patients enjoy using the product, they will be more likely to be compliant and realize the maximum level of benefits.

Regimen Data
Most long-term research evaluating the gingival health benefits of chemotherapeutic rinses has involved twice a day brushing with a standard fluoride dentifrice (i.e., not containing an antiplaque agent). However, during the last few years antibacterial dentifrice formulations (e.g., stannous fluoride, triclosan) have become more widespread. The value of adding an antibacterial rinse to a regimen involving an antibacterial dentifrice has been assessed in two recent

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Consider a product without alcohol Any patient taking medications where adverse reactions with alcohol may occur should select alcohol-free mouthrinses. Patients exhibiting and/or suffering from xerostomia should also be advised to select an alcoholfree mouthrinse.36,37 Alcohol-free rinses can prove beneficial for those patients immunocompromised, suffering from severe mucositis, and undergoing radiation therapy for head and neck cancers38 as well as recovering alcoholics and/or substance abusers. Conditions such as xerostomia and ulcerative gingivitis can be exacerbated by alcohol39 creating painful and unpleasant experiences thus preventing long-term compliance with adjunctive plaque removal. Follow Usage Instructions For example, some patients have been known to dilute alcohol-containing rinses to help

with tolerability. Dilution may lower the effectiveness of some formulations, so it should only be done if stated in the usage instructions. Advise patients to read the label and contact the manufacturer if questions remain.

Conclusion
As dental professionals, we are likely to encounter at least 1 of 2 patients who could benefit from better plaque control. In addition to educating them on proper brushing and flossing technique, recommending use of a chemotherapeutic rinse after mechanical hygiene provides a simple way to improve their gingival health. Chlorhexidine is a widely used prescription agent, and CPC and essentials oils rinses are widely available overthe counter in various flavors. Various flavors and alcohol-free formulations (chlorhexidine and CPC) can be recommended to help assist with a pleasant usage experience and compliance.

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Course Test Preview

To receive Continuing Education credit for this course, you must complete the online test. Please go to www.dentalcare.com and find this course in the Continuing Education section. 1. Research studies have indicated effectiveness from a chlorhexidine gluconate rinsing agent against bacterial plaque and gingivitis can be attributed to: a. High alcohol content b. Low pH c. Oxygenating properties d. Adsorption properties to oral surfaces Which of the following factors requires the MOST consideration when recommending mouthrinsing as an adjunctive plaque control method: a. Flavor of rinse b. Breath freshening c. Individual patient needs d. Affordability of rinse Mouthrinsing can effectively serve as a viable and practical adjunctive approach to mechanical home care regimens that can: a. Also replace mechanical hygiene b. Eliminate subgingival pathogens c. Be used alone to treat advanced periodontitis d. Improve gingival health The role of mouthrinsing has become increasingly important in reducing plaque and gingivitis thereby requiring the dental professional to become aware of the efficacy of the rinsing products, modes of administration, mechanisms of action, and clinical effectiveness. a. True b. False A chemotherapeutic oral rinse that can inhibit plaque and is generally viewed as the gold standard against a broad range of bacteria is: a. Essential oils b. Xylitol c. Povidone iodine d. Chlorhexidine According to the Food and Drug Administration (FDA) Dental Plaque Subcommittee, only two antimicrobial systems for over-the-counter rinses have been determined safe and effective for the treatment of plaque-induced gingivitis, including: a. High bioavailable Cetylpyridinium chloride (CPC) b. Chlorhexidine c. Essential oils d. A and C Alcohol-free mouthrinses are suitable and/or desirable for patients suffering from: a. Xerostomia b. Severe mucositis c. Radiation therapy from head and neck cancers d. All of the above.

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3.

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According to the FDA Dental Plaque Subcommittee, the acceptable concentration range for high bioavailable Cetylpyridinium chloride formulas to be considered safe and effective in over-the-counter antiplaque/antigingivitis rinses is: a. 0.1% - 0.2% b. 0.12% c. 0.045% - 0.1% d. 0.12% - 0.2% All of the following are effects from long-term use of chlorhexidine gluconate rinses except _____________. a. taste alteration b. increased calculus formation c. white pitting of teeth d. potential development of extrinsic stain New flavors and alcohol-free formulas of mouth rinses now offer assistance with bacterial reduction, gingival improvements and pleasant usage experiences. a. True b. False Overall, therapeutic rinses are not intended to replace proper mechanical hygiene methods, yet can and will provide assistance in improving gingival health when specifically designed recommendations are followed properly. a. True b. False The following mouthrinsing agents have been clinically proven to reduce gingivitis and plaque in long-term trials: a. Essential oils b. Cetylpyridinium chloride c. Chlorhexidine gluconate d. All of the above. Clinical studies have shown that incorporating a therapeutic rinse in an oral hygiene regimen with a therapeutic dentifrice _______________ plaque levels. a. further reduces b. greatly increases c. has no affect on d. None of the above. Factors to consider when recommending a mouthrinsing agent to assist with compliance include: a. Reminding patient to follow usage instructions b. Advising patients to choose one with a pleasant usage experiences c. Considering an alcohol-free product d. All of the above. The active ingredient available in an over-the-counter alcohol-free rinse formulation for the treatment of plaque-induced gingivitis is: a. Iodine b. Baking soda c. Essential oils d. Cetylpyridinium chloride (CPC) 8
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10.

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References
1. United States National Health and Nutrition Examination Survey 1988-1994 and 1999-2002. 2. Cancro LP, Fischman SL. The expected effect on oral health of dental plaque control through mechanical removal.Periodontol 2000. 1995 Jun;8:60-74. 3. ADA. Survey results reveal oral hygiene habits of men lag behind women. Last accessed January 5, 2008 4. Guynup S. Our Mouths, Ourselves. Sci Am 2006;Supplmental Issue: 3-5. PDF 5. Hughes P. Continuing Education: Women and aging: systemic disease affecting oral health globally. J Contemp Dental Pract 2007; 8(6). 6. Ross PE. Invaders and the bodys defenses. Sci Am 2006;Supplemental Issue:6-11. PDF 7. Paraskevas S. Randomized controlled clinical trials on agents used for chemical plaque control. Int J Dent Hyg. 2005 Nov;3(4):162-78. 8. Food and Drug Administration, Department of Health and Human Services. Oral health care drug products for over-the-counter human use antigingivitis/antiplaque drug products; establishment of a monograph; proposed rules. Federal Register. 2003;May, 29. PDF 9. Eldridge KR, Finnie SF, Stephens JA, et al. Efficacy of an alcohol-free chlorhexidine mouthrinse as an antimicrobial agent. J Prosthet Dent. 1998 Dec;80(6):685-90. 10. Peridex prescribing information. PDF 11. Stookey GK, Beiswanger B, Mau M, et al. A 6-month clinical study assessing the safety and efficacy of two cetylpyridinium chloride mouthrinses. Am J Dent. 2005 Jul;18 Spec No:24A-28A. 12. Quirynen M, Soers C, Desnyder M, et al. A 0.05% cetyl pyridinium chloride/0.05% chlorhexidine mouth rinse during maintenance phase after initial periodontal therapy. J Clin Periodontol. 2005 Apr;32(4):390-400. 13. Lorenz K, Bruhn G, Heumann C, Netuschil L, Brecx M, Hoffmann T. Effect of two new chlorhexidine mouthrinses on the development of dental plaque, gingivitis, and discolouration. A randomized, investigator-blind, placebo-controlled, 3-week experimental gingivitis study. J Clin Periodontol. 2006 Aug;33(8):561-7. 14. Hase JC, Attstrm R, Edwardsson S, Kelty E, Kisch J. 6-month use of 0.2% delmopinol hydrochloride in comparison with 0.2% chlorhexidine digluconate and placebo. (I). Effect on plaque formation and gingivitis. J Clin Periodontol. 1998 Sep;25(9):746-53. 15. Lang NP, Hase JC, Grassi M, et al. Plaque formation and gingivitis after supervised mouthrinsing with 0.2% delmopinol hydrochloride, 0.2% chlorhexidine digluconate and placebo for 6 months. Oral Dis. 1998 Jun;4(2):105-13. 16. Ciancio SG. Antiseptics and antibiotics as chemotherapeutic agents for periodontitis management. Compend Contin Educ Dent. 2000 Jan;21(1):59-62, 64, 66 passim; quiz 78. 17. Scheie AA. Models of action of currently known chemical antiplaque agents other than chlorhexidine. J Dent Res. 1989;68:1609-1616. 18. White DJ. An alcohol-free therapeutic mouthrinse with cetylpyridinium chloride (CPC)--the latest advance in preventive care: Crest Pro-Health Rinse. Am J Dent. 2005 Jul;18 Spec No:3A-8A. 19. Jenkins S, Addy M, Wade W, Newcombe RG. The magnitude and duration of the effects of some mouthrinse products on salivary bacterial counts. J Clin Periodontol. 1994 Jul;21(6):397-401. 20. Hunter-Rinderle SJ, Bacca LA, McCaughlin KT, et al. Evaluation of cetylpyridinium chloridecontaining mouthwashes using in vitro disk retention and ex vivo plaque glycolysis methods. J Clin Dent. 1997;8:107-113 21. Mankodi S, Bauroth K, Witt JJ, et al. A 6-month clinical trial to study the effects of a cetylpyridinium chloride mouthrinse on gingivitis and plaque. Am J Dent. 2005 Jul;18 Spec No:9A-14A. 22. Allen DR, Davies R, Bradshaw B, et al. Efficacy of a mouthrinse containing 0.05% cetylpyridinium chloride for the control of plaque and gingivitis: a 6-month clinical study in adults. Compend Contin Educ Dent. 1998;19(2 Suppl):20-6. 23. Witt JJ, Walters P, Bsoul S, Gibb R, Dunavent J, Putt M. Comparative clinical trial of two antigingivitis mouthrinses. Am J Dent. 2005 Jul;18 Spec No:15A-17A.

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24. Albert-Kiszely A, Pjetursson BE, Salvi GE, et al. Comparison of the effects of cetylpyridinium chloride with an essential oil mouth rinse on dental plaque and gingivitis - a six-month randomized controlled clinical trial. J Clin Periodontol. 2007 Aug;34(8):658-67. 25. Blenman TV. Practice implications with an alcohol-free, 0.07% cetylpyridinium chloride mouthrinse. [286] Am J Dent 2005;18:29A-34A. 26. Busscher HJ. Cetylpyridinium chloride rinse bioavailability assessed by plaque vitality kinetics. [287] J Dent Res (AADR/IADR) 2006;85, Abstract 691. 27. Fine DH. Mouthrinses as adjuncts for plaque and gingivitis management. A status report for the American Journal of Dentistry. Am J Dent. 1988 Dec;1(6):259-63. 28. Charles CH, Mostler KM, Bartels LL, Mankodi SM. Comparative antiplaque and antigingivitis effectiveness of a chlorhexidine and an essential oil mouthrinse: 6-month clinical trial. J Clin Periodontol. 2004 Oct;31(10):878-84. 29. Lang NP, Hase JC, Grassi M, et al. Plaque formation and gingivitis after supervised mouthrinsing with 0.2% delmopinol hydrochloride, 0.2% chlorhexidine digluconate and placebo for 6 months. Oral Dis. 1998 Jun;4(2):105-13. 30. Sharma N, Charles CH, Lynch MC, et al. Adjunctive benefit of an essential oil-containing mouthrinse in reducing plaque and gingivitis in patients who brush and floss regularly: a six-month study. J Am Dent Assoc. 2004 Apr;135(4):496-504. 31. Bauroth K, Charles CH, Mankodi SM, et al. The efficacy of an essential oil antiseptic mouthrinse vs. dental floss in controlling interproximal gingivitis: a comparative study. J Am Dent Assoc. 2003 Mar;134(3):359-65. 32. Sharma NC, Charles CH, Qaqish JG, et al. Comparative effectiveness of an essential oil mouthrinse and dental floss in controlling interproximal gingivitis and plaque. Am J Dent. 2002 Dec;15(6):351-5. 33. Charles CH, Sharma NC, Galustians HJ, et al. Comparative efficacy of an antiseptic mouthrinse and an antiplaque/antigingivitis dentifrice. A six-month clinical trial. J Am Dent Assoc. 2001 May;132(5):670-5. 34. Gerlach RW, Biesbrock AR, Bartizek RD, Terezhalmy GT. Incremental clinical plaque effects with CPC and essential oils rinses. J Dent Res 2007;86 (Spec Iss). Abstract 2501 35. White DJ, Kozak KM, Barker ML. Antiplaque efficacy of combined therapeutics. J Dent Res 2007;86(Spec Iss). Abstract 1072. 36. Daniel SJ, Harfst SA. Dental Hygiene Concepts, Cases, and Competencies. St. Louis: Mosby;2004:418. 37. ADA Division of Communications. For the dental patient. Do you have dry mouth? J Am Dent Assoc. 2002 Oct;133(10):1455. 38. Cacchillo D, Barker GJ, Barker BF. Late effects of head and neck radiation therapy and patient/ dentist compliance with recommended dental care. Spec Care Dentist. 1993 Jul-Aug;13(4):159-62. 39. Blanco-Carrion A, Rodriguez-Nunez I, Gandara-Rey JM, Lopez-Lopez J. A new mourthrinse formulation for painful lesions of the oral mucosa [in Spanish]. Rev Eur Odontol Estamatol. 1996;3:169-172.

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About the Author

Pam Hughes, RDH, MS Pam has lectured internationally and throughout the United States on such topics as oral risk assessment, advances in therapeutic oral care products, womens aging complexities with oral health impacts, and clinical challenges observed in patients with erosive decay and xerostomia. She is a past President of the California Dental Hygiene Educators Association and California Dental Hygienists Association. Pam has over 30 years of clinical practice in general and periodontal practice settings and holds a faculty position at the Ostrow School of Dentistry of University of Southern California in the Department of Periodontology, Diagnostic Sciences and Dental Hygiene. Email: [email protected]

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Crest Oral-B at dentalcare.com Continuing Education Course, Revised February 21, 2012