JADA Continuing Education
The rationale for the daily use of an antimicrobial mouthrinse
Michael L. Barnett, DDS
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ABSTRACT
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Background. This article reviews the rationale for incorporating effective antimicrobial mouthrinses into a daily oral hygiene regimen along with mechanical plaque control methods.
Types of Studies Reviewed. The author reviewed studies demonstrating the essential etiologic role of a pathogenic dental plaque biofilm in the development of gingivitis, as well as studies indicating that most people fail to maintain a level of mechanical plaque control sufficient to prevent disease. In addition, he did a brief review of studies of oral microbial ecology that identified the oral mucosal tissues as a reservoir of bacteria that colonize tooth surfaces, and he summarized six-month clinical studies of marketed antimicrobial mouthrinse ingredients and products.
Conclusions. There is a twofold rationale for daily use of antimicrobial mouthrinses: first, given the inadequacy of mechanical plaque control by the majority of people, as a component added to oral hygiene regimens for the control and prevention of periodontal diseases; second, as a method of delivering antimicrobial agents to mucosal sites throughout the mouth that harbor pathogenic bacteria capable of recolonizing supragingival and subgingival tooth surfaces, thereby providing a complementary mechanism of plaque control. The efficacy of several mouthrinse ingredients and products is supported by published six-month clinical trials.
Clinical Implications. The daily use of an effective antiplaque/antigingivitis antimicrobial mouthrinse is well-supported by a scientific rationale and can be a valuable component of oral hygiene regimens.
Key Words: Plaque control; antimicrobial mouthrinse; gingivitis; periodontitis; oral bacterial reservoirs
The concept of mouthrinsing as an oral hygiene measure dates back thousands of years, with the first reference to it as a formal practice being attributed to Chinese medicine in the year 2700 B.C.1 A variety of ingredients and combinations have been used for this purpose by various cultures in the past, including mixtures of betel leaves, camphor, and cardamom or other herbs2(p78); a mixture of salt, alum and vinegar3; and anise, dill and myrrh in white wine.2(p78)
However, it is only relatively recently that the use of therapeutic antimicrobial mouthrinses has been based on a well-documented scientific and clinical rationale. This began in the 1960s with the clear demonstration of the relationship between plaque accumulation and the development of gingivitis.4 It is interesting to note that a few years later, a prominent periodontist wrote that "for the immediate future, plaque control must rest with mechanical means" because of a lack of long-term studies to confirm the effectiveness and safety of antimicrobial mouthrinses.5 The conduct of such long-term studies was facilitated by the development of guidelines by the American Dental Association (ADA) Council on Dental Therapeutics (now the Council on Scientific Affairs)6,7 for the design of clinical trials to evaluate antimicrobial antiplaque/antigingivitis products. These guidelines, developed for the ADA’s Seal of Acceptance Program, also have been adopted by a U.S. Food and Drug Administration (FDA) advisory panel charged with evaluating antiplaque/antigingivitis ingredients contained in over-the-counter products.8,9
In this article, I will consider the rationale for incorporating effective antimicrobial mouthrinses into a daily oral hygiene regimen aimed at controlling the plaque biofilm. I will address two aspects of the rationale:
- – the essential role of adequate plaque control in the prevention and control of periodontal diseases;
- – recent findings in oral microbial ecology suggesting that antimicrobial activity at mucosal sites throughout the mouth can have a significant impact on the supragingival and subgingival colonization of teeth by oral bacteria.
Even though we know that not all cases of gingivitis will progress to periodontitis, we do not yet have the means by which to identify the people in whom such progression will occur.
In addition, the article includes a summary of the clinical effectiveness of ingredients and products investigated in published clinical trials of at least six months’ duration conducted in accordance with the ADA guidelines.
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THE ESSENTIAL ROLE OF PLAQUE CONTROL IN PREVENTING AND CONTROLLING PERIODONTAL DISEASES
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The variety of mechanical implements, potions and dental procedures used through the centuries attests to the importance attributed to oral cleanliness and the recognition that deposits of food debris and bacteria can in some way have a detrimental effect on oral health. Nevertheless, the mechanisms by which the deposits can result in disease were not really appreciated until the late 19th century, when Dr. W.D. Miller proposed a key role for acid-producing oral bacteria in the etiology of dental caries. From this, the concept of preventive dentistry developed.2(p271)
A comparable role for a pathogenic oral flora in the etiology of gingivitis was demonstrated somewhat later in a now-classic study by Löe and colleagues.4 In this simple experiment, the researchers instructed 12 subjects with essentially healthy gingivae and low levels of plaque to cease all oral hygiene procedures and then monitored their condition for up to 21 days. During this period, the subjects received periodic plaque and gingivitis assessments, and plaque samples were obtained for microbiological analysis. After cessation of oral hygiene, all the subjects experienced a marked and rapid increase in the quantity and complexity of the plaque bacterial flora that was followed by the development of gingivitis. Once gingivitis developed, the subjects were given detailed instruction in mechanical oral hygiene methods that they then employed twice daily. The reinstitution of oral hygiene resulted in a rapid decrease in plaque scores and the subsequent resolution of gingival inflammation within a week’s time. This study clearly demonstrated the temporal relationship between the accumulation of plaque and the development of gingivitis, thereby emphasizing the importance of plaque control in a preventive regimen for periodontal diseases as well as for dental caries.
Other investigators have confirmed the correlation between plaque levels and gingivitis severity.10–12 More recent studies have enhanced our understanding of the effect of a biofilm in enhancing bacterial pathogenicity and resistance to antimicrobial agents (see the article by Thomas and Nakaishi13 in this supplement).
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GINGIVITIS AND PERIODONTITIS
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It is generally understood that periodontitis is preceded by gingivitis, though signs of gingivitis may not always be apparent during bursts of disease activity leading to further attachment loss.14 For example, the significance of gingivitis as a precursor to periodontitis was demonstrated in two studies on specific subject populations, a group of Norwegian men followed for 26 years (chronic periodontitis)15 and a group of adolescents followed for six years (early-onset periodontitis).16 In both studies, sites with more severe gingivitis were shown to have a higher risk of developing periodontal attachment loss. On the other hand, it is clear that not all cases of gingivitis will proceed to periodontitis.14 From a clinical practice point of view, it is important to note that even though we know that not all cases of gingivitis will progress to periodontitis, we do not yet have the means by which to identify the people in whom such progression will occur. As a result, the maintenance of good oral hygiene becomes important not only in preventing or reducing gingivitis per se and controlling the associated plaque bacteria, both of which are significant oral health objectives, but also as a measure to prevent the subsequent development of periodontitis in susceptible people. Indeed, the effectiveness of rigorous levels of plaque control in helping manage the onset or progression of periodontal diseases has been demonstrated in several clinical trials of up to 46 months’ duration,17–19 as well as in a patient cohort monitored for 30 years.20
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REAL-WORLD LIMITATIONS OF MECHANICAL PLAQUE CONTROL METHODS
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While it theoretically is possible to maintain a level of oral hygiene sufficient to control gingivitis using mechanical methods alone, data indicate that the vast majority of people are unable to accomplish this on an ongoing basis. For example, in a survey conducted in the United Kingdom, an average of one-third of the teeth in 72 percent of all the dentate adults examined were found to have visible plaque.21 Especially interesting was the finding that a subset of participants who cleaned their teeth immediately before the examination still had visible plaque on close to one-third of their teeth, providing an indication of the challenge presented by thorough plaque removal. This has been further documented by a study of the effectiveness of a powered toothbrush that revealed plaque reductions of only 20 and 31 percent after one and three minutes of brushing, respectively.22 In addition, surveys conducted in developed countries reveal the percentage of people who claim to use dental floss or some other interdental cleaning device daily to be between 11 and 51 percent,23–27 providing additional evidence for a lack of adequate plaque control.
The difficulty in accomplishing effective plaque removal by most people is reflected in epidemiologic studies of gingivitis. The largest study in the United States, the Third National Health and Nutrition Examination Survey,28 has identified gingivitis by assessing bleeding at mesiobuccal and midbuccal sites on all fully erupted teeth in a randomly selected maxillary and mandibular quadrant. The investigators found a gingivitis prevalence of 50.3 percent in all people between the ages of 30 and 90 years, with a mean of 13.5 percent of teeth involved. The authors noted that because the study assessed 28 tooth sites per subject at most, it might have significantly underestimated the prevalence of any clinical parameter, including gingivitis. In addition, it is important to note that the study design also has the potential of underestimating gingivitis prevalence. Mandibular lingual surfaces—sites often difficult to brush—were not assessed and, moreover, signs of less severe gingivitis that can occur in the absence of bleeding (for example, changes in tissue color and consistency) but that are included in traditional gingival indexes29 were not recorded.
In another study of adults 25 to 73 years of age, the researchers found no subject to be entirely plaque-free, with 35.7 percent of subjects having visible plaque on more than 90 percent of tooth surfaces.30 In addition, they found bleeding on gentle probing in more than 98 percent of subjects, with an average of 38.5 percent of surfaces affected. A Swedish study evaluating a random sample of 600 adults in six age groups from 20 to 70 years in 1973, 1983 and 1993 found that levels of plaque accumulation and gingivitis actually increased in 20-year-old subjects between 1983 and 1993.27
Thus, the role of the plaque biofilm in the etiology of gingivitis and the findings of studies indicating that the majority of people fail to maintain an adequate level of plaque control provide a clear rationale for incorporating effective antimicrobial measures, such as use of an antimicrobial mouthrinse, into daily oral hygiene regimens. From the perspectives of both individual health and general public health, the daily use of antimicrobial measures shown to have significant antiplaque/antigingivitis activity would be a meaningful, cost-effective addition to mechanical oral hygiene methods.28,30–32
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ORAL MUCOSAL SITES AS SOURCES OF BACTERIA COLONIZING TOOTH SURFACES
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When assessing the effectiveness of mechanical oral hygiene procedures, dentists generally measure percentage plaque reductions per se, focusing on the tooth surface without considering the dynamic aspects of plaque formation. Yet we know, for example, that within a short time after a thorough dental prophylaxis, bacteria begin to recolonize the tooth surface and initiate the process of plaque re-formation. We also know that after thorough root débridement in periodontal pockets, the subgingival root surfaces eventually will be repopulated with a potentially pathogenic flora. Where do the repopulating bacteria come from, and is there anything that can be done to diminish the overall intraoral bacterial burden?
The supragingival and subgingival tooth surfaces are, in fact, part of a larger ecological system that includes oral mucosal surfaces and saliva. In the adult, the oral mucosal tissues are estimated to compose approximately 80 percent of the total surface area, with the teeth providing the other 20 percent.33 These surfaces are a source of bacteria; in fact, the oral mucosal surfaces in infants have been shown to be colonized by bacteria,34 including gram-negative periodontopathogens,35,36 well before the time of tooth eruption. Bacteria are shed constantly from mucosal and tooth surfaces into saliva and carried to other areas of the mouth, which they can colonize in turn. As unstimulated saliva often contains from 5 x 107 to 1.0 x 108 bacteria per milliliter, the oral surfaces constantly are bathed in suspended microorganisms.37 Studies comparing the bacterial composition of supragingival and subgingival plaque with that of saliva and various mucosal surfaces have indicated that the oral mucosae—in particular the dorsum and lateral borders of the tongue and, to a lesser degree, the buccal mucosae—serve as reservoirs for bacteria and can be the source of pathogens that recolonize teeth after a dental prophylaxis or periodontal therapy.33,38–44 To illustrate this, in a study in which conventional periodontal therapy was shown to significantly decrease the subgingival prevalence of three putative pathogens, there was not a concomitant reduction in the prevalence of these organisms on oral mucous membranes.40 It also should be noted that supragingival plaque has been shown to harbor periodontal pathogens and thus can serve as a reservoir of these species for the spread to, or reinfection of, adjacent subgingival sites.45
The finding that the oral mucosae serve as reservoirs of pathogenic bacteria that can be transferred to the tooth surface provides a further rationale for supplementing mechanical plaque control methods with effective antimicrobial mouthrinses; such products would deliver antimicrobial agents to mucosal sites throughout the mouth that are unaffected by mechanical plaque control methods. Studies have demonstrated the effectiveness of rinsing with an antimicrobial mouthrinse in significantly reducing both salivary46–48 and mucosal49,50 levels of bacteria. The addition of an antimicrobial mouthrinse to daily oral hygiene regimens would help reduce the total oral bacterial burden and thereby could complement a direct action on bacteria contained within the plaque biofilm itself.
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PUBLISHED SIX-MONTH ANTIPLAQUE/ANTIGINGIVITIS MOUTHRINSE CLINICAL TRIALS
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Numerous clinical trials have demonstrated the effectiveness of certain antimicrobial mouthrinses in reducing plaque and gingivitis. The table
lists the active ingredients and marketed mouthrinse products supported by published six-month clinical trials51–60 conducted in accordance with the ADA guidelines.6,7
Chlorhexidine is the active ingredient in a prescription product marketed pursuant to FDA approval via the New Drug Application route; the fixed combination of essential oils and cetylpyridinium chloride are in over-the-counter products and have received a Category I (safe and effective) recommendation by an FDA advisory panel.8 (Additional discussion of studies conducted to demonstrate product effectiveness has been published elsewhere.32) The effectiveness of these antiplaque/antigingivitis agents has been confirmed in a meta-analysis of published and unpublished six-month clinical trials.61 Both Peridex (Zila Pharmaceuticals, Phoenix) and Listerine Antiseptic (Pfizer, Morris Plains, N.J.) have received the ADA Seal of Acceptance for the control of supragingival plaque and gingivitis.62,63
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SUMMARY
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The daily use of an effective antiplaque/antigingivitis antimicrobial mouthrinse is well-supported by a scientific rationale and can be a valuable component of oral hygiene regimens. Advances in our knowledge of oral microbial ecology have enhanced our understanding of the role that antimicrobial mouthrinses can play in controlling the plaque biofilm and related periodontal diseases. Several ingredients and products have been found to be effective against plaque and gingivitis, two of which—chlorhexidine (Peridex) and a fixed combination of essential oils (Listerine Antiseptic)—have received the ADA Seal of Acceptance for this indication.
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FOOTNOTES
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Dr. Barnett is a clinical professor, Department of Periodontics/Endodontics, School of Dental Medicine, University at Buffalo, The State University of New York. Address reprint requests to Dr. Barnett at 112 Hidden Ridge Common, Williamsville, N.Y. 14221-5785, e-mail "mlbgums{at}aol.com".
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ABSTRACT
THE ESSENTIAL ROLE OF...
