16S JADA, Vol. 137 http://jada.ada.

org November 2006

Background. This article reviews the rationale
for incorporating effective antimicrobial mouthrinses
into a daily oral hygiene regimen along with mechan-
ical 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 ingredi-
ents 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.
JADA 2006;137(11 supplement):16S-21S.
T
he concept of mouth-
rinsing as an oral
hygiene measure dates
back thousands of years,
with the first reference to
it as a formal practice being attrib-
uted to Chinese medicine in the
year 2700 B.C.
1
A variety of ingredi-
ents and combinations have been
used for this purpose by various cul-
tures in the past, including mix-
tures of betel leaves, camphor, and
cardamom or other herbs
2(p78)
; a mix-
ture of salt, alum and vinegar
3
; 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 scien-
tific 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 con-
firm 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
AB STRACT
A
R
T
I CL
E
2
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@aol.com.
J
A
D
A
C
O
N
T
I
N
U
I
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G E
D
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C
A
T
I
O
N

The rationale for the daily use

of an antimicrobial mouthrinse
Michael L. Barnett, DDS
Copyright 2006 American Dental Association. All rights reserved.
JADA, Vol. 137 http://jada.ada.org November 2006 17S
on Dental Therapeutics (now the Council on Sci-
entific Affairs)
6,7
for the design of clinical trials to
evaluate antimicrobial antiplaque/antigingivitis
products. These guidelines, developed for the
ADAs Seal of Acceptance Program, also have
been adopted by a U.S. Food and Drug Adminis-
tration (FDA) advisory panel charged with evalu-
ating antiplaque/antigingivitis ingredients con-
tained 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 con-
trolling the plaque biofilm. I will address two
aspects of the rationale:
dthe essential role of adequate plaque control
in the prevention and control of periodontal
diseases;
drecent findings in oral microbial ecology sug-
gesting 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.
In addition, the article includes a
summary of the clinical effective-
ness of ingredients and products
investigated in published clinical
trials of at least six months dura-
tion conducted in accordance with
the ADA guidelines.
THE ESSENTIAL ROLE
OF PLAQUE CONTROL
IN PREVENTING
AND CONTROLLING
PERIODONTAL DISEASES
The variety of mechanical imple-
ments, 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-pro-
ducing oral bacteria in the etiology of dental
caries. From this, the concept of preventive den-
tistry developed.
2(p271)
A comparable role for a pathogenic oral flora in
the etiology of gingivitis was demonstrated some-
what later in a now-classic study by Le and col-
leagues.
4
In this simple experiment, the re-
searchers 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 cessa-
tion 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 res-
olution of gingival inflammation within a weeks
time. This study clearly demonstrated the tem-
poral relationship between the accumulation of
plaque and the development of gingivitis, thereby
emphasizing the importance of
plaque control in a preventive reg-
imen for periodontal diseases as
well as for dental caries.
Other investigators have con-
firmed 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 Nakaishi
13
in this supplement).
GINGIVITIS AND
PERIODONTITIS
It is generally understood that periodontitis is
preceded by gingivitis, though signs of gingivitis
may not always be apparent during bursts of dis-
ease 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 adoles-
cents followed for six years (early-onset periodon-
titis).
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 gin-
givitis will proceed to periodontitis.
14
From a clin-
ical practice point of view, it is important to note
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.
Copyright 2006 American Dental Association. All rights reserved.
18S JADA, Vol. 137 http://jada.ada.org November 2006
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 sig-
nificant 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
REAL-WORLD LIMITATIONS OF
MECHANICAL PLAQUE CONTROL METHODS
While it theoretically is possible to maintain a
level of oral hygiene sufficient to control gin-
givitis 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 par-
ticipants 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 docu-
mented by a study of the effectiveness of a pow-
ered 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
pro-
viding additional evidence for a lack of adequate
plaque control.
The difficulty in accomplishing effective plaque
removal by most people is reflected in epidemio-
logic 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 sub-
ject at most, it might have significantly underesti-
mated 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 surfacessites often difficult
to brushwere 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 indexes
29
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 sub-
jects, 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 eti-
ology of gingivitis and the findings of studies indi-
cating 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
ORAL MUCOSAL SITES AS SOURCES OF
BACTERIA COLONIZING TOOTH SURFACES
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
Copyright 2006 American Dental Association. All rights reserved.
JADA, Vol. 137 http://jada.ada.org November 2006 19S
recolonize the tooth surface and initiate the
process of plaque re-formation. We also know that
after thorough root dbridement 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 sur-
faces 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 bac-
teria,
34
including gram-negative periodon-
topathogens,
35,36
well before the time of tooth
eruption. Bacteria are shed constantly from
mucosal and tooth surfaces into saliva and car-
ried to other areas of the mouth, which they can
colonize in turn. As unstimulated saliva often
contains from 5 10
7
to 1.0 10
8
bacteria per mil-
liliter, 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
mucosaein particular the dorsum and lateral
borders of the tongue and, to a lesser degree, the
buccal mucosaeserve as reservoirs for bacteria
and can be the source of pathogens that recolo-
nize teeth after a dental prophylaxis or peri-
odontal 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 sub-
gingival 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 antimi-
crobial 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
TABLE
MARKETED
PRODUCT
PLAQUE
REDUCTION
(%)*
GINGIVITIS
REDUCTION
(%)*
STUDY
0.12 Percent
Chlorhexidine
Fixed Combination
of Essential Oils

Cetylpyridinium
Chloride
0.05 percent
0.07 percent
Peridex (Zila
Pharmaceuticals, Phoenix)

Listerine Antiseptic, Cool

Mint Listerine, FreshBurst
Listerine, Natural Citrus
Listerine (Pfizer, Morris
Plains, N.J.)

Viadent (Colgate-Palmolive,
New York)
Crest Pro-Health Rinse
(Procter & Gamble,
Cincinnati)
21.6-60.9
13.8-56.3
28.2
15.8
18.2-42.5
14.0-35.9
24.0
15.4
Grossman and colleagues,
51
Overholser and colleagues,
55
Charles and colleagues
57
Lamster and colleagues,
52
Gordon and colleagues,
53
DePaola and colleagues,
54
Overholser and colleagues,
55
Charles and colleagues,
56
Charles and colleagues,
57
Sharma and colleagues
58
Allen and colleagues
59
Mankodi and colleagues
60
Summary of published six-month plaque/gingivitis mouthrinse
clinical trials.
ACTIVE INGREDIENT
* Compared with negative control at six months.
These products have received the American Dental Association Seal of Acceptance.
Thymol 0.064 percent, eucalyptol 0.092 percent, methyl salicylate 0.060 percent, menthol 0.042 percent.
Copyright 2006 American Dental Association. All rights reserved.
20S JADA, Vol. 137 http://jada.ada.org November 2006
salivary
46-48
and mucosal
49,50
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 comple-
ment a direct action on bacteria contained within
the plaque biofilm itself.
PUBLISHED SIX-MONTH
ANTIPLAQUE/ANTIGINGIVITIS
MOUTHRINSE CLINICAL TRIALS
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 clin-
ical trials
51-60
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 advi-
sory panel.
8
(Additional discussion of studies con-
ducted 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 Lis-
terine Antiseptic (Pfizer, Morris Plains, N.J.)
have received the ADA Seal of Acceptance for the
control of supragingival plaque and gingivitis.
62,63
SUMMARY
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 peri-
odontal diseases. Several ingredients and prod-
ucts have been found to be effective against
plaque and gingivitis, two of whichchlorhexi-
dine (Peridex) and a fixed combination of essential
oils (Listerine Antiseptic)have received the ADA
Seal of Acceptance for this indication. I
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