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Gingival health benefits of essential-oil and cetylpyridinium chloride

mouthrinses: A 6-month randomized clinical study

Article  in  American journal of dentistry · June 2014

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Research Article
_______________________________________________________________________________________________________________________________________________________________

Gingival health benefits of essential-oil and cetylpyridinium chloride

mouthrinses: A 6-month randomized clinical study
SHEILA CAVALCA CORTELLI, DDS, PHD, JOSE ROBERTO CORTELLI, DDS, PHD, HONGYAN SHANG, MS,
RAFAEL COSTA, BSCE & CHRISTINE ANN CHARLES, RDH

ABSTRACT: Purpose: This randomized, single center, examiner-blind, controlled, parallel-group, 6-month clinical
study compared the antiplaque/antigingivitis potential of an essential oil (EO) versus a 0.07% cetylpyridinium chloride
(CPC)-containing mouthrinse. A 5% hydroalcohol solution was included as a control group. Methods: 354 healthy
volunteers (18-71 years of age) were enrolled in this clinical trial; 338 subjects completed the study. At baseline, 1-, 3-,
and 6-month visits, subjects received an oral examination, gingivitis (MGI), gingival bleeding (BI) and plaque
assessments (PI). Following randomization, subjects received a prophylaxis and began brushing twice daily with the
provided fluoride toothpaste and rinsing twice daily with 20 mL of the assigned mouthrinse for 30 seconds. Results: All
rinses were well tolerated by the subjects, with the exception of extrinsic tooth stain complaints in 13 subjects in the
CPC group between the 3- and 6-month exams. Statistically significant reductions in gingivitis, bleeding and plaque
were observed for both EO and CPC at all post-baseline time-points when compared to the negative control. At 6
months MGI and PI were reduced by 42.6% and 42.0% for EO and by 17.1% and 13.9% respectively, for CPC vs.
control. When compared to CPC, EO was statistically significantly superior at all post-baseline time-points. EO showed
increasing reductions in MGI of 10.5%, 20.3% and 30.7% as well as reductions in PI of 12.7%, 23.7% and 32.6% at 1,
3 and 6 months, respectively. When analyzing the number of healthy sites (MGI scores of 0 or 1), the beneficial effect
of the EO-containing mouthrinse is 45.8% greater than using a CPC-containing mouthrinse and 59.8% greater than
placebo. (Am J Dent 2014;27:119-126).

CLINICAL SIGNIFICANCE: The results of this study demonstrated the clinical superiority of a mouthrinse containing EO
versus 0.07% CPC in the long-term management of plaque and gingivitis, with 98% of subjects using EO rinse
achieving approximately one-third or more healthy gingival sites at 6 months.

: Christine A. Charles, Johnson & Johnson Consumer & Personal Healthcare Products Worldwide, Division of Johnson
& Johnson Consumer Companies, 185 Tabor Road, Morris Plains, NJ 07950, USA. E- : ccharles@its.jnj.com

Introduction This randomized, single center, examiner blind, controlled,

Plaque-induced gingivitis is clinically characterized by
inflammation, changes in color and consistency of the gingival
tissues, absence of clinical attachment loss and presence of
bleeding as a response to bacterial biofilm.1 Biofilm typically
adheres and grows on the hard tissue at the crevice level of the
teeth; however, it has also been reported that microorganisms
responsible for the onset of gingivitis and periodontitis harbor
in several areas of the soft tissues in the oral cavity.2,3
Early mechanical and therapeutic interventions, aiming at
removing the presence of etiological factors contributing to the
development of gingivitis allow restoration of the health of the
gingival tissues, thus preventing the progression to periodontitis.
In recent decades, despite great improvements in oral health
in several countries, the high prevalence of oral conditions,
such as periodontal disease, still remains a global health issue.4
Several reports have shown that patients have less than optimal
oral care compliance in performing traditional mechanical
home care even after receiving detailed oral hygiene instruc-
tions.5-7 Addition of antimicrobial and antiplaque agents may
supplement the oral hygiene practices as well as provide an oral
health benefit.
Both essential oil (EO)8,9 and cetylpyridinium chloride
(CPC)10,11 mouthrinses are indicated to help prevent and reduce
plaque and gingivitis. Previous comparative long term studies
have shown no difference12 or superiority of EO13 compared to
CPC mouthrinses.
parallel-group, 6-month clinical study compared the antiplaque/
antigingivitis potential of a new mouthrinse treatment in Brazil
containing 0.07% CPC to an existing essential oil-containing
mouthrinse.
Materials and Methods
The study protocol was reviewed and approved by the
University of Taubate, Taubate, São Paulo, Brazil Institutional
Review Board on February 10, 2012 (protocol #244/10) and
was conducted at the Nucleus of Periodontal Research in
accordance with the International Conference on Harmoni-
zation Good Clinical Practice (ICH GCP) and Declaration of
Helsinki. In addition, the study was designed in accordance
with the ADA Acceptance Program Guidelines for Chemo-
therapeutic Products for Control of Gingivitis, Council on
Scientific Affairs.14,15
The study was a randomized, single center, examiner blind,
controlled, parallel-group, 6-month clinical study (Fig. 1). It
was determined that 330 qualified subjects had to complete the
study (110 per treatment group) to provide 90% power to detect
a between-treatment difference of 0.13 with respect to Plaque
Index (PI) and 0.08 with respect to Modified Gingival Index
(MGI). These calculations were based on two-sided tests at the
0.05 level of significance, and standard deviations of 0.295 for
PI and 0.180 for MGI (based on previous studies). Based on
this sample size calculation, 354 systemically healthy volun-
teers meeting the general study inclusion/exclusion criteria and
 American Journal of Dentistry, Vol. 27, No. 3, June, 2014
120 Cortelli et al

presenting with a mean gingival index  1.75 according to the

Modified Gingival Index16 and a mean Plaque Index  1.95
according to the Turesky modification of the Quigley-Hein
Plaque Index on six tooth surfaces17 were enrolled in this
clinical trial. All enrolled subjects read and signed an informed
consent form prior to any study related activities.
After confirming study eligibility at screening, subjects
were scheduled for the baseline visit. For both visits, subjects
were asked to refrain from their usual oral hygiene practices for
at least 8 hours but no more than 18 hours and, from eating for
at least 2 hours prior to the examination. Baseline procedures
included collection of demographic information, review of
medical history, oral examination and determination of Modi-
fied Gingival Index, Bleeding Index18,19 (BI) and Plaque Index,
and confirmation of other study eligibility criteria.
Eligible subjects then received a dental prophylaxis, were
randomized and assigned to one of the three treatment groups:
EO - eucalyptol 0.092%, menthol 0.042%, methyl salicylate
0.060% and thymol 0.064% (Cool Mint Listerinea antiseptic
mouthrinse); CPC - 0.07% cetylpyridinium chloride (Oral B
Pro-Saudeb mouthrinse); or C - 5% hydroalcohol negative
control mouthrinse.a The study products were dispensed in
overwrapped bottles that were individually labeled by a
randomized number.
All subjects were instructed to rinse vigorously twice daily
(morning and night) with 20 mL of the assigned product for 30
seconds for 6 consecutive months using the provided pre-
marked plastic dosage cups. The first treatment rinse was
conducted at baseline under supervision of study personnel; all
other rinsing procedures were unsupervised. Subjects received
a diary card to document the daily product use, brushing and
rinsing times and were also provided standard fluoride tooth-
paste and a soft-bristled toothbrush and instructed to brush
twice daily in their usual manner followed by rinsing proce- Fig. 1. Study design from screening to completion of the trial.
dures. During the course of the study, subjects were allowed to
continue using an interdental cleaning device, if it was part of searcher was the examiner in several clinical trials with similar
their usual home care, and to follow their usual dietary habits. outcomes and study population sizes. Before each examination
In the 6-month study period, no other oral hygiene procedures visit within the same study and also between studies, calibra-
were permitted, including teeth cleaning; however, emergency tion and repeatability values were systematically checked.
dental treatment was allowed, if needed. Statistical analysis - The primary efficacy variables were the
Participants attended monthly follow-up visits and at each mean MGI and the mean PI at 6 months.
visit, subjects’ medical history was reviewed, medication up- The secondary efficacy variables were the mean MGI and
dates were obtained, adverse events assessed and product use the mean PI at 1 and 3 months and the mean BI at 1, 3 and 6
compliance was evaluated by reviewing the diary card and months. Following the Intent-to-Treat principle, analyses were
weighing the bottles of the assigned test product. Additional based on the full analysis set, defined as all randomized
test material was dispensed as necessary. At the 1-, 3- and 6- subjects who used the assigned study product and had data for
month visits, subjects also received an oral examination as well either mean MGI or mean PI at both the baseline and at least
as MGI, BI and PI assessments performed by a single calibrated one post-baseline visit.
examiner who was blinded to the study treatments. Prior to Summary statistics were provided by treatment group at
these visits, subjects were instructed not to use their test mate- baseline and post-baseline. No imputation of missing data was
rials for at least 8 hours, but no more than 18 hours, and asked performed.
to refrain from eating for at least 2 hours prior to their clinical Statistical comparisons for primary and secondary variables
examinations. were based on a one-way ANCOVA model with treatment as a
The examiner was considered calibrated if Kappa values factor and the corresponding baseline value as a covariate,
were > 0.80 and < 0.95. Intra-examiner error was recalculated 1 using 0.05 significance level tests, two-sided.
week prior to the evaluation in the third and sixth months, and Two separate types of post-hoc analyses were also
throughout the study Kappa values remained between > 0.84 performed. One type was a bar chart of the percentage of sub-
and < 0.95. In 2008 the examiner of the present study under- jects achieving healthy gingival status (MGI = 0, 1) and percent
went a 1-week training, with an experienced plaque and gin- achieving virtually plaque free tooth surfaces (PI scores of 0 or
givitis examiner as the gold standard. Since that time this re- 1) on a site-wise basis.20,21 For each site, the percentage of sub-
American Journal of Dentistry, Vol. 27, No. 3, June, 2014
Gingival health benefits of mouthrinses 121

Table 1. Study demographics and baseline characteristics.

_______________________________________________________________________________________________________________________________________________________________________________________________________________

Parameters Negative control (N=118) EO (N=118) CPC (N=118) Total

_______________________________________________________________________________________________________________________________________________________________________________________________________________

Age years (SD) 34.1 (12.7) 35.2 (13.3) 32.7 (12.5) 34.0 (12.8)
Gender
Male (%) 41 (34.7) 52 (44.1) 39 (33.1) 132 (37.3)
Female (%) 77(65.3) 66 (55.9) 79 (66.9) 222 (62.7)
Race (%)
White 91 (77.1) 91 (77.1) 98 (83.1) 280 (79.1)
Black or African American 11 (9.3) 15 (12.7) 14 (11.9) 40 (11.3)
Asian 2 (1.7) 0 0 2 (<1)
Other 14(11.9) 12 (10.2) 6 (5.1) 32 (9.0)
Ethnicity (%)
Not Hispanic or Latino 5 (4.2) 4 (3.4) 3 (2.5) 12 (3.4)
Not reported 113 (95.8) 114 (96.6) 115 (97.5) 342 (96.6)
Smoking status
Smoker: Yes (%) 8 (6.8) 10 (8.5) 5 (4.2) 23 (6.5)
Smoker: No (%) 110 (93.2) 108 (91.5) 113 (95.8) 331 (93.5)
Smokeless tobacco use: Yes (%) 1 (<1.0) 0 0 1 (<1.0)
Smokeless tobacco use: No (%) 117 (99.2) 118 118 353 (99.7)
Baseline mean MGI (SD) 2.241 (0.14) 2.240 (0.12) 2.238(0.14) 2.240 (0.14)
Baseline mean PI (SD) 2.801 (0.30) 2.796 (0.28) 2.754 (0.29) 2.784 (0.29)
Baseline mean BI (SD) 0.557 (0.17) 0.559 (0.16) 0.572 (0.15) 0.563 (0.16)
_______________________________________________________________________________________________________________________________________________________________________________________________________________

N= number of subjects; SD= standard deviation; EO = Essential Oil; CPC= cetylpyridinium chloride; MGI= Modified Gingival Index; PI= Plaque Index; BI=
Gingival Bleeding Index.

jects achieving healthy (of 108 sites total) or plaque-free (of
168 sites total) status is shown for each treatment.
A second post-hoc analysis characterizes response to treat-
ment for all possible definitions of “response”, i.e., a responder
analysis. In this analysis for each subject, percent healthy sites
(percentage of sites with MGI= 0, 1) at a given time point was
calculated. The responder analysis is a graph of the percentage
of subjects meeting each potential level of clinical response
(percent of healthy sites, in this case) for all possible definitions
of clinical response. It is generated by plotting the percentage of
subjects meeting the threshold for response for each choice of
response cutoff. In this way, the percentage of subjects
responding to treatment can be compared across treatments for
any threshold of interest, e.g. 20% healthy sites, 30% healthy
sites, 50% healthy sites, etc.
Qualified subjects were assigned study product sequential-
ly, in ascending numerical order, according to a block random-
ization with a fixed block size of six. The randomization
scheme was generated by a validated SAS-based randomization
application developed by the sponsor.
The safety analysis was based on all randomized subjects
who used study products and the number and percentage of
subjects experiencing adverse events during the clinical study
was presented by MedDRA System Organ Class, preferred
term, and treatment. Oral tissue tolerance was assessed by
summarizing all adverse events considered related to treatment.
Results
Study population - A total of 354 subjects fulfilled the study
criteria and were randomized into the three treatment groups;
338 completed all study visits (EO/n=113; CPC/n=108; C/n
=117), with a total of 353 ITT subjects. Subjects’ ages ranged
from 18 to 71 years old with an overall mean of 34 years. There
were 132 males (37.3%) and 222 females (62.7%) and the
majority of this population was white (79.1%) and non-
smoking (93.5%) (Table 1, Fig. 1). There were no significant
differences among the groups for demographics or baseline
efficacy variables.
Plaque - EO demonstrated statistically significant reductions
compared to CPC in plaque re-accumulation and the reductions
increased over time with 12.7%, 23.7% and 32.6% at 1, 3 and 6
months, respectively. Compared to the negative control, EO
statistically significantly reduced plaque by 16.9%, 28.8% and
42.0% at 1, 3 and 6 months, respectively (Table 2).
Gingivitis - All reductions of EO in gingivitis vs. negative
control and vs. CPC at post-baseline time points were
statistically significant (Table 2). EO demonstrated a 15.5%,
26.3% and 42.6% reduction vs. control at 1, 3 and 6 months,
respectively. Compared to CPC, EO showed a 10.5%, 20.3%
and 30.7% reduction at 1, 3 and 6 months, respectively. EO
also statistically significantly reduced gingival bleeding at 1, 3
and 6 months by 32.6%, 53.0%, and 74.5% when compared to
control and by 26.2%, 46.0%, and 67.0% when compared to
CPC (P< 0.001).
Safety summary - There were 25 subjects with at least one
adverse event, seven from the negative control group, six from
the EO group and 12 subjects from the CPC group. There were
four subjects with at least one treatment related adverse event,
one in the negative control group (glossodynia) and three
subjects from the CPC group (aphthous stomatitis n=1, dys-
geusia n= 2). Other non-related adverse events were cate-
gorized into infections, respiratory and gastrointestinal dis-
orders. There were no serious adverse events reported. Thirteen
subjects complained of extrinsic tooth staining between the 3-
and 6-month study visits and all were part of the 0.07% CPC
treatment group. Otherwise all products were well tolerated in
this study.
Post-hoc analyses – Post-hoc analyses were performed to fur-
ther understand the performance of the mouthwashes in
relation to attaining healthy gingival tissue. The MGI scale
was dichotomized into “healthy” (MGI score of 0 or 1) and
 American Journal of Dentistry, Vol. 27, No. 3, June, 2014
122 Cortelli et al

Table 2. Summary of results. Clinical efficacy. months, respectively (P< 0.001). CPC was superior to negative
____________________________________________________________________________________________________

Negative
control with 8.3 and 7.9 mean percent healthy sites at 1 and 3
Time Clinical control NC) EO CPC months and 14.0 at 6 months. The negative control group
points variables (N=118) (N=117) (N=118) exhibited 2.4 to 2.7 mean percent healthy sites throughout the
____________________________________________________________________________________________________
course of the study. An increasingly healthier gingival
Baseline PI
Mean ± SD 2.801 ± 0.296 2.794 ± 0.285 2.754 ± 0.287 condition, as represented by mean percent healthy sites per
MGI
subject was demonstrated for EO and to a significantly lesser
Mean ± SD 2.241 ± 0.142 2.238 ± 0.119 2.238 ± 0.145 extent for CPC. EO increased the number of healthy gingival
BI sites by 45.8% versus CPC and 59.8% versus negative control
Mean ± SD 0.557 ± 0.174 0.559 ± 0.165 0.572 ± 0.153 after 6 months.
1 month PI Figure 5 provides the proportion of responders over 6
LS mean ± SE 2.741 ± 0.014 2.277 ± 0.014 2.607 ± 0.014 months for every possible threshold of response. Such cumula-
% Reduction vs NC 16.9%* 4.9%*
% Reduction vs. CPC 12.7%* tive distribution displays show a continuous plot of the
MGI
percentage of subjects meeting the threshold for all possible
LS mean ± SE 2.232 ± 0.008 1.885± 0.008 2.107± 0.008 choices of threshold. The X-axis is the threshold and the Y-axis
% Reduction vs NC 15.5%* 5.6%* is the percentage of subjects meeting the threshold, by treat-
% Reduction vs. CPC 10.5%* ment. This display type allows the reader to observe the
BI proportion of subjects responding (meeting a threshold) for all
LS mean ± SE 0.557 ± 0.006 0.375 ± 0.006 0.509 ± 0.006
% Reduction vs NC 32.6%* 8.6%* possible choices of cutoff for example 20%, 30% or 50%
% Reduction vs. CPC 26.2%* healthy sites. The EO group provides the greatest percentage of
3 months PI subjects for all choices of cutoff compared to both CPC and
LS mean ± SE 2.736 ± 0.018 1.948 ± 0.018 2.553 ± 0.018 control at all post-baseline time points. For example in the EO
% Reduction vs NC 28.8%* 6.7%* group, at 1 month, 3% of the subjects achieved about 40%
% Reduction vs. CPC 23.7%*
healthy sites, by 3 months about 52% of subjects achieved 40%
MGI
LS mean ± SE 2.239 ± 0.011 1.650 ± 0.011 2.071 ± 0.011 healthy sites and by 6 months about 95% of subjects achieved
% Reduction vs NC 26.3%* 7.5%* 40% healthy sites. An increasing pattern of improvement is
% Reduction vs. CPC 20.3%* shown over the 6 months.
BI Figure 6 shows the cumulative curve of responders with
LS mean ± SE 0.562 ± 0.008 0.265 ± 0.008 0.490 ± 0.008 percent “problem or more involved sites” (MGI values  3).
% Reduction vs NC 53%* 12.8%
% Reduction vs. CPC 46%* These results confirm the effectiveness of EO mouthrinse, sug-
6 months PI gesting that EO is also effective in the more inflamed sites,
LS mean ± SE 2.891 ± 0.019 1.678 ± 0.019 2.489 ± 0.019 whereas CPC only shows marginal improvement in these prob-
% Reduction vs NC 42.0%* 13.9%* lem sites. In this Figure, for the EO group at 1 month, 78% of
% Reduction vs. CPC 32.6%* subjects had 10% problem sites, at 3 months < 8% subjects had
MGI 10% problem sites and at 6 months < 2% of subjects had 10%
LS mean ± SE 2.415 ± 0.015 1.388 ± 0.015 2.001 ± 0.015
% Reduction vs NC 42.6%* 17.1%* problem sites whereas in the control group, over 95% of subjects
% Reduction vs. CPC 30.7%* experienced at least 10% problem sites throughout the study.
BI
LS mean ± SE 0.631 ± 0.009 0.161 ± 0.009 0.487 ± 0.009 Discussion
% Reduction vs NC 74.5%* 22.8%*
% Reduction vs. CPC 67%* Gingivitis is one of the most common infectious diseases
____________________________________________________________________________________________________ affecting humans. Although gingivitis will progress to perio-
*P< 0.001 vs. control. N= number of subjects; NC = negative control; SD= dontitis only in susceptible subjects, as a chronic disease it has
standard deviation; EO = Essential oil; CPC= Cetylpyridinium chloride; MGI= received more scientific attention in recent years. The regular
Modified Gingival Index; PI= Plaque Index; BI= Gingival Bleeding Index.
use of specific mouthwashes containing antimicrobial agents
“unhealthy” (MGI score of  2) scores across the entire 108 has been shown to be a useful adjunctive procedure in daily
scorable sites in the mouth. Figure 2 provides the percentage of plaque control.22
subjects with healthy gingiva (MGI score 0, 1) at each of the Long term (6-month) studies of EO rinses have shown a
108 sites over the entire mouth at 6 months. EO resulted in a reduction in gingivitis of up to 36.3%23 and for mouthrinses
greater percentage of subjects with healthy gingival sites containing up to 0.1% CPC24-26 reductions of up to 38.1%26
compared to either CPC or control. have been shown compared to a negative control.
The plaque index (PI) scores of 0 or 1 were assigned to Previous studies have directly compared the effects of
“virtually plaque free” sites in Figure 3. A similar pattern was mouthrinses containing EO to those of 0.05% CPC in 6-month
shown as with the healthy gingival sites (Figure 2) with EO studies demonstrating a 19.5% to 32.4% greater reduction in
exhibiting a greater percentage of subjects with plaque free gingival inflammation in favor of EO. Studies directly
tooth surface sites at 6 months. comparing EO to 0.07% CPC in mouthrinses in a short term,27
Figure 4 provides the mean percent healthy sites per subject and long-term12indicated that there were no statistical
at each examination interval. EO demonstrated a statistically differences in the treatment of gingivitis when comparing the
significantly higher mean percent of healthy sites/subject vs. two mouthrinses. Neither of these studies had a negative control
negative control (24.3%, 36.9% and 59.8% reduction) and vs. group. In contrast, Santos et al13 demonstrated a 12.6% greater
CPC (16.1%, 29.1% and 45.8% reduction) at 1, 3 and 6 reduction in gingival inflammation, while the present study
American Journal of Dentistry, Vol. 27, No. 3, June, 2014
Fig. 2. Distribution (%) of subjects healthy at each site. Whole mouth.
Fig. 3. Distribution (%) of subjects virtually plaque free at each site. Whole mouth.
Fig. 4. Mean percent of healthy sites per subject.
Gingival health benefits of mouthrinses 123
resulted in a 30.7% greater reduction in favor of EO when
compared to 0.07% CPC.
As expected, the results of the present study showed the
beneficial effects of using two marketed mouthwashes on
gingival inflammation for a 6-month time period when com-
pared to a negative control group sustaining the recommenda-
tion of antimicrobial mouthrinses as part of ideal home oral
care. The present results visibly indicated the superior bene-
ficial effects of the EO compared to CPC for the management
of dental plaque and gingivitis, confirming an earlier study,13
 American Journal of Dentistry, Vol. 27, No. 3, June, 2014
124 Cortelli et al

Fig. 5. Cumulative Curve of Subjects with Percent of Sites with MGI= 0 or 1.

Fig. 6. Cumulative Curve of Subjects with Percent of Sites more inflamed (MGI  3).

and in contrast to another.12 chemotherapeutic mouthrinse. After 6 months, the EO-

Inflammation has a critical role in the well-being of the oral
cavity and lowering gingival inflammation leads to an overall
healthier mouth. In the Parameters of Care by the American
Academy of Periodontology,1 establishing gingival health is
considered to be the therapeutic goal of treatment. Therefore,
reduction of gingival inflammation and reaching an acceptable
level of plaque control are fundamental for a healthy mouth. A
progression towards a healthier mouth is observed when using a
containing mouthrinse showed 30.7% greater whole mouth mean
reduction in gingival inflammation compared to the 0.07% CPC-
containing mouthrinse. From the post-hoc analyses it is evident
that at 6 months there were 62.2 mean percent healthy sites per
subject for EO and 16.4% for CPC and 2.4% for control. The
percentage of subjects achieving one-third healthy sites at 6
months in the EO group was 98% compared to less than 5% of
subjects in the CPC group (Fig. 5). This is important when consi-
American Journal of Dentistry, Vol. 27, No. 3, June, 2014
dering treatment recommendations for patient’s home oral
hygiene care.
Results for plaque also indicated a higher beneficial effect
for EO when compared to CPC (Table 2, Fig. 3) and this im-
provement increased over the course of 6 months. In the nega-
tive control group, plaque index remained fairly consistent (2.7-
2.9) throughout the study.
In the past, the majority of patients were not capable of
effectively removing biofilm from interdental spaces,28 and
poor oral hygiene was associated with “development of gingivi-
tis.” It was therefore suggested that “therapeutic chemical agents”
should be used daily to reduce plaque accumulation, while still
maintaining the bacteria flora associated with oral health.29
According to Silverman & Wilder,30 the addition of an antimi-
crobial mouthrinse should be part of the daily home care of
patients along with daily brushing and flossing to reduce oral
plaque and gingivitis.30 The same recommendation was reported
by Lemos & Villoria.31 These authors summarized the rationale
for using a mouthrinse for oral care being two-fold; the first
being that for most people mechanical home care is not sufficient
to remove plaque and therefore could benefit from an adjunct
mouthrinse, and the second, to provide effective antimicrobials in
different sites of the oral cavity, to ultimately reduce gingivitis.
Reduction of inflammation and therefore reaching the status
of a healthier mouth should be interpreted according to the
suggestions by Drisko,32 in a review article, reporting the data
from Watt & Marinho33 suggesting that periodontal health
should be seen “within the context of general health promo-
tion,” giving therefore a more global and comprehensive look
at oral health, not just confined to the oral cavity.
A healthier mouth, within the context of general health
promotion, could be effectively achieved in a gingivitis popula-
tion by the regular daily use of an EO mouthrinse in combina-
tion with mechanical oral care. This is further illustrated when
the data was examined regarding the number of healthy (score
0 and 1) vs. unhealthy sites (scores > 2) from the present study
and comparing the baseline data with each observation time (1,
3 and 6 months). There was a statistically significant difference
between the mean percent of healthy sites per subject in the EO
group vs. the CPC group in favor of EO with 98% subjects
achieving more than more than one third healthy sites (and about
10% of subjects achieving at least 80% healthy sites) (Fig. 5).
Gingival inflammation and plaque accumulation are
quantified with indices used in clinical dentistry to assess the
overall health of the oral cavity. It is evident that in a gingivitis
population, periodontal health can be reached by adding the
daily use of an antimicrobial mouthrinse. Using a mouthrinse
consistently and continuously as a daily habit in conjunction
with mechanical oral hygiene lessens the degree of inflamma-
tion and increases the number of healthy gingival sites in the
oral cavity. When analyzing the number of healthy sites, the
beneficial effect of the EO-containing mouthrinse was 59.8%
greater than placebo (mechanical hygiene and placebo rinse)
and 45.8% greater than using a CPC-containing mouthrinse.
In conclusion, the reduction of plaque accumulation and
gingival inflammation was statistically significantly superior
for the EO group compared to the CPC group. At 6 months, the
percentage of subjects having at least one-third of sites healthy
was 98% of subjects in the EO group compared to less than
Gingival health benefits of mouthrinses 125
10% of the subjects in the CPC or control groups. Both mar-
keted antimicrobial mouthrinses showed a beneficial result in
gingival health over 6 months compared to the negative control.
Regular daily adjunctive use of a chemotherapeutic mouth-
rinse is more efficacious than brushing alone in achieving
healthy gingival tissue and should be considered part of a daily
oral hygiene regimen for better oral health.
a. Johnson & Johnson do Brasil, São Jose dos Campos, São Paulo, Brazil.
b. Procter & Gamble do Brasil, Queimados, Rio de Janeiro, RJ, Brazil.
Acknowledgements: The technical assistance of Ms. Carla Beneduce, RDH, MS,
CCRP in the preparation of this manuscript is greatly appreciated.
Disclosure statement: Ms. Shang, Mr. Costa and Ms. Charles are employed by
Johnson & Johnson Consumer and Personal Products Worldwide Division of
Johnson & Johnson Consumer Companies, Inc. Dr. S.C. Cortelli and Dr. J.R.
Cortelli declared no conflict of interest. This study was sponsored by Johnson &
Johnson Consumer and Personal Products Worldwide Division of Johnson &
Johnson Consumer Companies, Inc.
Dr. S.C. Cortelli and Dr. J.R. Cortelli are Associate Professors, University of
Taubaté, NUPER – Nucleus of Periodontal Research, Taubaté, São Paulo,
Brazil. Ms. Shang is Principal Scientist, Worldwide Emerging Markets
Innovation Center, Johnson & Johnson (China), Shanghai, China. Mr. Costa
is Senior Associate Clinical, Research and Development, Johnson & Johnson
Consumer & Personal Healthcare Products Worldwide, Division of Johnson
& Johnson Consumer Companies, Skillman, New Jersey, USA. Ms. Charles
is Director Clinical Research, Research and Development, Johnson &
Johnson Consumer & Personal Healthcare Products Worldwide, Division of
Johnson & Johnson Consumer Companies, Morris Plains, New Jersey, USA.
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