Australian Dental Journal 2010; 55: 6569

SCIENTIFIC ARTICLE

doi: 10.1111/j.1834-7819.2009.01180.x

Short-term clinical effects of commercially available gel

containing Acacia arabica: a randomized controlled clinical
trial
AR Pradeep,* D Happy,* G Garg*
*Department of Periodontics, Government Dental College and Research Institute, Fort, Bangalore, Karnataka, India.

ABSTRACT
Background: Certain plants used in folk medicine serve as a source of therapeutic agent by having antimicrobial and other
multi-potential effects. This prospective, randomized, placebo and positively controlled clinical trial was designed to
evaluate the short-term clinical effects of a commercially available gel containing Acacia arabica in the reduction of plaque
and gingival inflammation in subjects with gingivitis.
Methods: Ninety subjects diagnosed with chronic generalized gingivitis were selected and randomly divided into three
groups: Group I placebo gel, Group II gumtone gel and Group III 1% chlorhexidine gel. Clinical evaluation was
undertaken using the gingival index of Loe and Silness and the plaque index at baseline, 2 weeks, 4 weeks and 6 weeks.
A subjective evaluation was undertaken by questionnaire.
Results: Gumtone gel showed significant clinical improvement in gingival and plaque index scores as compared to a placebo
gel. This improvement was comparable to 1% chlorhexidine gel. Unlike chlorhexidine gel, gumtone gel was not associated
with any discolouration of teeth or unpleasant taste.
Conclusions: Gumtone gel may be a useful herbal formulation for chemical plaque control agent and improvement in
plaque and gingival status.
Keywords: Herbal, Acacia arabica, chlorhexidine, antiplaque effect, clinical trial.
Abbreviations and acronyms: ANCOVA = analysis of covariance; ANOVA = analysis of variance; CHX = chlorhexidine.
(Accepted for publication 27 May 2009.)

INTRODUCTION
Bacterial plaque is the primary aetiological agent in
periodontal diseases.1,2 Experimental gingivitis studies
have proved the role of plaque in the aetiology of
periodontal infections and demonstrated the direct
relationship between plaque levels and the development
of human gingivitis.1,2 The accumulation of bacterial
plaque associated with gingivitis and periodontitis
indicates the basis for reducing plaque to lower the
risk of periodontal destruction. Mechanical plaque
control, like scaling and root planing, is the first
recommended step in the management of gingivitis
and periodontitis and is an indispensable phase of
periodontal therapy,3 but there are factors, such as
accessibility or presence of plaque retentive areas, that
can limit the clinical and microbiological response.
Many chemical agents have been tested as adjuncts to
2010 Australian Dental Association

mechanical methods which can reduce plaque and its

associated gingivitis. Several antibacterial chemicals,
like chlorhexidine, have been used. However, sideeffects such as discolouration of teeth and unpleasant
taste can occur when these chemicals are prescribed for
an extended period.4,5 There is still a need for an
antiplaque agent that can be used on a daily basis with
minimal side-effects.
Certain plants used in folk medicine serve as a source
of therapeutic agent by having multi-potential effects in
addition to their antimicrobial activity. Herbal formulations can provide an option for safe and long-term
use.6 Gumtone gel (Charak Pharma Pvt. Ltd, India) is
one such polyherbal formulation with Acacia arabica as
its main ingredient.
Acacia arabica gum is a traditional oral hygiene
substance which has been used for centuries by many
communities in the Middle East and North Africa.7
65

AR Pradeep et al.
It consists mainly of arabica, a complex mixture of the
calcium, magnesium and potassium salts of arabic acid.
There are also other constituents such as tannins,
cyanogenic glycosides, oxidases, peroxidases and pectinases; all of which have been shown individually
to exhibit antimicrobial properties.8 Clark et al. has
reported the antibacterial and antiprotease activities of
Acacia arabica.9
Thus, the present study was carried out as a
prospective, randomized, placebo and positively controlled clinical trial designed to evaluate the short-term
clinical effects of a commercially available, prescription
gel containing Acacia arabica in the reduction of plaque
and gingival inflammation in subjects with gingivitis.
MATERIALS AND METHODS
After ethical approval was granted, 90 dentate subjects
(48 males, 42 females, mean age 30.34 years) who
reported to the Department of Periodontics, Government Dental College and Research Institute, Bangalore
were recruited for the study conducted in January to
March 2008.
Subjects diagnosed with chronic generalized gingivitis, aged 2540 years, having at least 20 natural teeth,
with no history of periodontal therapy or previous use
of antibiotics or anti-inflammatory medication within
the preceding six months were included in the study. All
patients fulfilled the clinical criteria of the gingival
index (Loe and Silness10) > 1, pocket probing depth
3 mm, clinical attachment loss = 0, with no evidence
of radiographic bone loss. Subjects with known allergies to the constituents of the formulation, haematological disorders or other systemic illness, undergoing
orthodontic treatment and with smoking habits were
excluded.
Each subject was randomly assigned to one of the
three groups (30 subjects in each group) after informed
consent was obtained: Group I placebo gel (Charak
Pharma Pvt. Ltd, India) (similar to gumtone gel
without the active ingredients); Group II gumtone
gel (Charak Pharma Pvt. Ltd, India); and Group III
1% chlorhexidine (CHX) gel (Hexidine gel, ICPA
Health Products Ltd, India). The gels were dispensed
to subjects by a dental assistant not involved in the
study. Subjects were instructed to apply a pea-sized
amount of gel gently by finger or soft brush to the
gums for about an hour after regular brushing and to
leave it for five minutes before rinsing. Subjects were
also asked to refrain from all other unassigned forms
of oral hygiene aids, including dental floss, chewing
gum or oral rinse during the study. No oral hygiene
instructions like brushing and flossing were given to
the patients to exclude the influence of improved oral
hygiene practices on the results. No prophylaxis was
undertaken prior to commencement of the study.
66

The same clinician, who was blinded to the groups

assigned to the subjects, conducted all the examinations and scorings. Subjects were assessed for gingivitis
using the gingival index (GI) (Loe and Silness)10 and
for plaque, using the plaque index (PI) (Tureskey et al.
modification of Quigley Hein Index)11,12 in the same
dental unit under identical conditions at baseline,
2 weeks, 4 weeks and 6 weeks. Intra-examiner calibration was performed on 20 patients before the
study and the intra-examiner agreement was 95.2%
(j = 0.905).
Apart from clinical evaluation, subjective evaluation
was also undertaken at each visit, using a questionnaire
relating to the taste and flavour of the gels or any
adverse effect experienced after use. Immediately after
the completion of six weeks, subjects received a
professional prophylaxis.
To check for compliance, the participants were asked
to return their assigned gel tubes, so that the investigator could verify the amount of gel that was used.
Statistical analysis
All three groups were compared with variation in
baseline PI and GI scores by one-way analysis of
variance (ANOVA). The three groups were compared
with respect to 2 week, 4 week and 6 week PI and GI
scores by taking baseline scores as covariates by
analysis of covariance (ANCOVA). The reductions
from baseline to 2 week, 4 week and 6 week followups in PI and GI scores were statistically tested by using
Wilcoxon matched-pairs rank-sum test and students
paired t-test, respectively.
RESULTS
Five subjects did not complete the study and were
excluded from the analyses. There was no significant
difference between Groups I, II and III with respect to
PI and GI scores at baseline. There was a gradual
decrease in the PI and GI scores by the 2 week, 4 week
and 6 week time interval, respectively, in all three
groups (Table 1).
A significant reduction in PI and GI scores was
observed for Groups II and III at all time intervals.
Group I showed a significant reduction in GI scores at
all time intervals and PI scores at 2, 4 and 6 weeks as
compared to baseline but not between 4 and 6 weeks.
(Tables 2 and 3).
There was a significant difference with respect to
reduction in PI and GI in Group I (placebo group) as
compared to Group II (gumtone gel group) and Group
III (CHX gel group). However, no significant difference
was found between Group II (gumtone gel group) and
Group III (CHX gel group) for both the parameters
(Tables 4 and 5).
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Antiplaque effect of Acacia arabica

Table 1. Plaque index and gingival index scores of all groups at different follow-ups
Group

Plaque scores at baseline and different follow-ups

I
II
III

Gingival index scores at baseline and different follow-ups

Baseline

2 weeks

4 weeks

6 weeks

Baseline

2 weeks

4 weeks

6 weeks

4.28 0.72
4.37 0.64
4.52 0.59

4.16 0.72
3.40 0.73*
3.53 0.75#

4.03 0.67
2.82 0.75*
2.92 0.75#

4.04 0.65
2.38 0.72*
2.47 0.72#

1.78 0.33
1.77 0.31
1.84 0.32

1.72 0.32
1.34 0.28*
1.35 0.29#

1.66 0.32
1.07 0.28*
1.12 0.30#

1.64 0.32
0.83 0.25*
0.85 0.24#

*p < 0.001 between Groups I and II at same time interval.

#
p < 0.001 between Groups I and III at same time interval.
Note: No significant difference between Groups II and III at any time interval.

Table 2. Intra-group comparison of reduction of plaque scores

Baseline 2 weeks

Baseline 4 weeks

Baseline 6 weeks

2 weeks 4 weeks

2 weeks 6 weeks

4 weeks 6 weeks

%
%
%
%
%
%
Mean SD reduction Mean SD reduction Mean SD reduction Mean SD reduction Mean SD reduction Mean SD reduction
Group I 0.12 0.19 2.86* 0.25 0.26 5.94* 0.24 0.44 5.57* 0.13 0.21 3.17* 0.12 0.38 2.79 0.02 0.25 0.40
Group II 0.97 0.36 22.21* 1.55 0.41 35.54* 1.99 0.50 45.52* 0.58 0.23 17.13* 1.02 0.38 29.97* 0.44 0.26 15.49*
Group III 0.99 0.37 21.92* 1.60 0.39 35.47* 2.05 0.46 45.29* 0.61 0.26 17.35* 1.06 0.36 29.92* 0.44 0.24 15.21*
*p < 0.05.

Table 3. Intra-group comparison of reduction of gingival index scores

Baseline 2 weeks

Baseline 4 weeks

Baseline 6 weeks

2 weeks 4 weeks

2 weeks 6 weeks

4 weeks 6 weeks

%
%
%
%
%
%
Mean SD reduction Mean SD reduction Mean SD reduction Mean SD reduction Mean SD reduction Mean SD reduction
Group I 0.06 0.06 3.57* 0.12 0.06 6.83* 0.15 0.07 8.14* 0.06 0.05 3.38* 0.08 0.05 4.73* 0.02 0.06 1.41*
Group II 0.43 0.12 24.45* 0.70 0.25 39.65* 0.94 0.26 53.08 0.27 0.16 20.12* 0.51 0.20 37.90* 0.24 0.10 22.26*
Group III 0.49 0.12 0.49* 0.72 0.26 0.72* 1.00 0.27 0.99* 0.24 0.23 0.24* 0.51 0.22 0.51* 0.27 0.19 0.27*
*p < 0.05.

Table 4. Inter-group comparison of reduction in plaque scores

F-value
P-value
P-value of
paired t-test

Groups III
Groups IIII
Groups IIIII

Baseline
2 weeks

Baseline
4 weeks

Baseline
6 weeks

2 weeks
4 weeks

2 weeks
6 weeks

4 weeks
6 weeks

73.4797
0.0000*
0.0001*
0.0001*
0.8075

135.5662
0.0000*
0.0001*
0.0001*
0.5942

143.0325
0.0000*
0.0001*
0.0001*
0.6404

39.8340
0.0000*
0.0001*
0.0001*
0.6239

60.8999
0.0000*
0.0001*
0.0001*
0.7023

32.6917
0.0000*
0.0001*
0.0001*
0.9107

*p < 0.05.

Table 5. Inter-group comparison of reduction in gingival index scores

F-value
P-value
P-value of Wilcoxon
matched paired
rank sum test

Groups III
Groups IIII
Groups IIIII

Baseline
2 weeks

Baseline
4 weeks

Baseline
6 weeks

2 weeks
4weeks

2 weeks
6 weeks

4 weeks
6 weeks

150.7875
0.0000*
0.0001*
0.0001*
0.0419*

78.6025
0.0000*
0.0001*
0.0001*
0.7058

140.2927
0.0000*
0.0001*
0.0001*
0.3451

14.3208
0.0000*
0.0001*
0.0001*
0.4210

60.1145
0.0000*
0.0001*
0.0001*
0.9824

31.8216
0.0000*
0.0001*
0.0001*
0.3268

*p < 0.05.

On subjective evaluation, all the subjects gave

positive responses regarding the taste and flavour of
the gumtone and placebo gels. Adverse reactions like
discolouration of teeth, alteration of taste or paraesthesia were not reported after use of the gumtone and
placebo gels. However, about 44% of subjects reported
an unpleasant taste and discolouration of teeth following the use of CHX gel.
2010 Australian Dental Association

DISCUSSION
The purpose of this investigation was to determine the
effectiveness of gumtone gel in reducing plaque scores
and gingival inflammation in gingivitis subjects. Both
the gumtone gel group and the CHX gel group showed
significant improvement over the placebo gel group.
Several studies have shown that CHX gel is significantly
67

AR Pradeep et al.
more active than placebo, or a control substance, in
controlling plaque in different patient groups1315 and
the improvement seen in the CHX gel group was in
accordance with all those previous studies. Considered
as a gold standard antiplaque agent, CHX is used as a
positive control in the present study.16 However, its
unpleasant taste and discolouration of teeth limits its
long-term use.5,7 The discolouration of teeth after the
use of CHX gel may have affected the blinding to a
certain extent.
In our study, the reduction in GI and PI scores by
gumtone gel was significantly higher than the placebo
gel group and similar to the CHX gel group. The
positive clinical effects of gumtone gel can be attributed
to its main ingredients, such as Acacia arabica, Barleria
prionitis, Mimusops elengi, Terminalia chebula and
Melia azadirachta. The reduction in plaque and gingivitis scores in Group I (placebo) can be attributed to the
Hawthorne effect (i.e., patients frequently appear to
improve merely from the effects of being placed in a
clinical trial).17
Similar to studies by Lindhe et al.18 and Triratana
et al.,19 prophylaxis and scaling were not carried out
prior to the experimental phase of the present clinical
study, unlike other studies by Gazi et al.20 and Brecx
et al. in which oral prophylaxis was carried out prior to
the experimental phase.4
Porphyromonas gingivalis and Prevotella intermedia
are strongly implicated in the pathogenesis of chronic
periodontitis21 and the proteolytic activity of P. gingivalis is recognized as a potential virulence factor.22
Therefore, the in vitro inhibitory action of acacia gum
against these organisms and their enzymes is of possible
clinical significance.9 This inhibitory effect on periodontal pathogens along with the inhibition of protease
production by them can be attributed to active constituents like arabica, cyanoglycosides, oxidases, peroxidase and pectinases present in Acacia.7,8 Tannins are
also found to be present in Acacia leading to its
astringent and haemostatic effects.23 All these properties may be responsible for the antimicrobial, antigingivitis and antiplaque effects of Acacia arabica. Gazi
concluded that Acacia gum has the potential to inhibit
early plaque formation although the long-term effect
may not be there.20
The anti-inflammatory activity of Barleria prionitis,
another ingredient of gumtone gel, is proved by Singh
et al. TAF, an active fraction from the plant Barleria
prionitis, exhibited significant anti-inflammatory activity against different inflammagens like carrageenan,
histamine and dextran along with the inhibition of
vascular permeability.24
Another constituent of formulation is Terminalia
chebula, the extract of which strongly inhibits growth,
sucrose induced adherence and glucan induced aggregation of Streptococcus mutans. It has been found that
68

10% mouthrinse of Terminalia chebula inhibits total

salivary bacterial count, especially S. mutans and
salivary glycolysis for up to three hours after rinsing.25
In a six-week clinical trial, 5% extract of Melia
azadirachta resulted in a significant reduction of plaque
and gingivitis scores compared to the placebo.26
Various components of Melia azadirachta are responsible for this activity. Tetraterpenoid mahmoddin
present in Melia azadirachta is responsible for its
antibacterial properties,27 while nimbidin and sodium
nimbidinate are responsible for its anti-inflammatory
activity.28 Other constituents which can add to its
activity include azadirachtins, nimbolides, flavoglycosides, coumarine derivatives etc.
All these herbal ingredients have been used for many
centuries without any reported side-effects. These active
constituents result in almost similar antiplaque and
antigingivitis efficacy of gumtone gel compared to CHX
which is a gold standard antiplaque agent. Apart from
this, gumtone gel can be used for an extended period of
time unlike CHX which causes tooth discolouration
and has an unpleasant taste.
The use of natural herbal preparations in health care
continues to be popular and gumtone gel may be a
useful addition. Its efficacy is comparable to CHX,
therefore it could be used for the improvement of
plaque and gingival status. Further long-term prospective studies are needed to confirm the results achieved in
this short-term study.
ACKNOWLEDGEMENTS
We would like to thank Mr RR Bellary (Business
Development Manager, Charak Pharma Pvt. Ltd.
India), for his kind cooperation and support throughout
the study. This study was partly funded by Charak
Pharma Pvt. Ltd. India.
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Address for correspondence:

AR Pradeep
Professor and Head
Department of Periodontics
Government Dental College and Research Institute
Fort, Bangalore-560002
Karnataka, India
Email: periodontics_gdc@yahoo.co.in

69

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