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Hameed et al.| A controlled randomized single blinded clinical study on the effects of unani drugs in Varm-e-lissa (Gingivitis)
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A controlled randomized single blinded clinical study on the effects of unani
drugs in Varm-e-lissa (Gingivitis)
Fazeenah Hameed1*, Carukshi Arumbepola2, Priyani PP 3, Mohammed Zeinadeen4, Mohammed Aleemuddin
Quamri5
*1Dept
of Moalejat, Institute of Indigenous Medicine, University of Colombo, Rajagiriya, Sri Lanka.
of Community Medicine, Faculty of Medicine, University of Colombo, Sri Lanka.
3Senior Lecturer, Consultant Surgeon/Dentist, Dept. of Dental Medicine, Wickramarachi, Gampaha, University of Kelaniya, Sri Lanka.
4Dept of Moalejat, Institute of Indigenous Medicine, University of Colombo, Rajagiriya, Sri Lanka.
5Dept of Moalejat, National Institute of Unani Medicine, Kottigepalya, Bangalore-560091, India.
2Dept
ORIGINAL RESEARCH ARTICLE
ARTICLE INFORMATION
Article history
Received: 07 February 2015
Revised: 28 February 2015
Accepted: 05 March 2015
Early view: 15 April 2015
*Author for correspondence
E-mail: [email protected]
Tel: +94714481148
Q
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C
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ABSTRACT
Background: Varm-e-lissa is one of the most common chronic infections in the
gingival crevices is induced by accumulation of dental plaque. It is one of the
most frequently occurring oral diseases at any age, but most prevalent and
severe in adolescence affecting more than 90% of the population. To evaluate
the efficacy and safety of Unani drugs in gingivitis, a clinical study was
contemplated.
Materials and Methods: A controlled randomized single blinded clinical study
was conducted in 99 patients of mild to moderate gingivitis. Test group (n=49)
was served with Unani drugs and control group (n=50) with Tripala choorna for
28 days. The pre and post study effects were assessed by gingival and plaque
indices.
Results: Test group showed statistically significant reduction comparatively
earlier than the control group in swelling of gums, bleeding on brushing,
bacterial plaque, Gingival Index and Plaque Index.
Conclusion: This study revealed that the test drug has shown precedence over
the control drug by effectively reducing the subjective and objective parameters
without any adverse effects. Therefore, it is concluded that the “test drugs” can
be used in the management of mild to moderate gingivitis.
Key wards: Gingivitis; Varm-e-lissa; Unani drugs; Tripala choorna.
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INTRODUCTION
Varm-e-lissa is the term used for gingivitis in Unani
literature and defined as an inflammatory process of the
gums which is caused by poor oral hygiene and
derangement in humours (ghaire tabaee akhlat). This
condition is characterized by swollen, painful, reddish
and bleeding gums (Anonymous, 2004).
In modern
medical literature, gingivitis is a term used to describe
non-destructive periodontal disease. It is one of the most
common chronic infections in the gingival crevices
(Krasse et al., 2006) due to inflammatory process which
limited to the gingiva (Salgado et al., 2006). It is
induced by accumulation of dental plaque (Grau et al.,
2004), characterized by gingival erythema, oedema,
changes in contour, loss of soft-tissue adaptation to the
teeth, bleeding (Kumar et al., 2011) on brushing, tender
to touch and bad breath (Mayo Clinic, 2012). In the
absence of treatment, inflammation and degradation of
Int J Adv Pharmacy Med Bioallied Sci. 3, 1, 2015.
collagen increases the gingivitis may develop into
periodontitis (Krasse et al., 2006), which is a destructive
form of periodontal disease.
The purpose of the study was to compare and evaluate
the efficacy of Unani drugs in comparison to a control
formulation on clinical parameters of naturally developed
gingivitis and also to validate the effects of Unani drugs.
MATERIAL AND METHODS
This study was conducted at Dental Clinic, National
Ayurvedic Teaching Hospital, Kotta Road, Borella,
Colombo, Sri Lanka from October 2007- April 2008 after
the approval of the Institutional Research Committee,
Dept. of Community Medicine, University of Colombo. A
total of 120 mild to moderate cases of gingivitis were
screened, out of which only 99 patients randomly
allocated into test (n=49) and control (n=50) groups.
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Hameed et al.| A controlled randomized single blinded clinical study on the effects of unani drugs in Varm-e-lissa (Gingivitis)
Inclusion criterion were patients of both gender, aged 1555 years, with bleeding on probing / brushing, swollen
gums and or bacterial plaque in the gingival margin. All
subjects should have at least 24 natural teeth, among
which the 4 posterior teeth in the lower left quadrant
(experimental teeth) should have the disease
involvement (experimental teeth). All participants were
informed about the nature of the study and obtained the
informed consent form in compliance with the study
guidelines.
Subjects with severe dental or gum
infections and any other systemic illnesses were excluded
from the trial.
surfaces of each tooth were recorded to obtain the PI and
GI means.
Study design: Randomized single blind control.
Statistical analyses: The Friedman test, Kruskal-Wallis
test with Dunn’s Multiple Comparison test were used to
evaluate statistical difference of subjective parameters
except halitosis (Fisher’s Exact test) between test and
control groups on 0, 7, 14, 21 and 28; and the objective
parameters PI and GI were assessed by using Wilcoxon
matched pairs test on baseline and the at the end of the
trial and the mean values were compared. Results were
expressed as mean and standard deviation. A P- value of
0.05 or less was considered for statistical significance.
The test group was received decoction (Joshanda) of
Punica granatum (35g), Zizyphus jujuba (35g) and Rubia
cordifolia (25g) (Anonymous, 2004) for gargle three times
a day for 28 days with powder (Safoof) of Borax
(Anonymous, 2004), Quercus infectoria and Piper cubeba
to apply over the gums twice a day for 14 days, whereas,
the control group was received luke warm salt water
(Fischman, 1997) for gargle and ‘Tripala Choorna’
(Maurya et al., 1997) to apply over the gums for the same
duration similar to that of test group.
The study effect with reference to baseline therapy was
assessed based on periodontal conditions by using
Modified Gingival Index (MGI) by Lobene (1986) (Butler et
al., 2011 and Sharma et al., 2004) (0- absence of
inflammation, 1- mild inflammation of any portion the
gingival area, 2- mild inflammation of the entire gingival
area, 3- moderate inflammation of the gingival area, 4severe inflammation of the gingival area) and Plaque
index (PI) by Silness & Loe 1964 (Lindhe et al., 2003) (0no plaque, 1- a film of plaque adhering to the free
gingival margin, apparent on tip of probe, 2- visible
plaque , 3-abundant plaque) as objective parameters;
and subjective symptoms of gingivitis like swollen gums,
bad breath (halitosis), bleeding gums and bacterial
plaques in four different follow ups on 7th, 14th, 21st and
28th days.
PI and GI were recorded by the qualified and trained
examiner on the mesiobuccal, buccal, distobuccal,
mesiolingual, lingual and distolingual surfaces of the
experimental teeth. The gingival tissues were inspected
for the presence of bleeding after running the tip of a
WHO probe along the gingival margin. The values of six
RESULTS
99 subjects completed the clinical trial, which comprises
75 females and 24 males, with mean age of 35.8 years
ranges from 15-55 with mean duration of disease
2.40±3.15 months. The experimental drugs had good
acceptance and did not show adverse effects, such as
abscess, ulcerations or allergic reactions.
On day 0, the test and control groups did not show
statistically significant difference to each other with
respect to PI (P=0.1205) and GI (p=0.4785) means p>0.05.
These results indicated that both groups were well
balanced at baseline (Table 1). At the 28th day, PI mean
0.24 in test and 1.12 in control, GI mean 0.33 in test and
1.70 in control and the difference between them was
statistically significant (P<0.001) (Table 1).
Table 1. Efficacy of drug in test and control groups on
objective parameters.
Mean ± SEM and median rating with range in
brackets
Parameter
Test Group
0 day
Control Group
th
28 day
0 day
*, +
Plaque
1.41±0.15
0.24±0.08
1.42±0.11
2(0,3)
0(0,2)
2(0,3)
index
Gingival
2.08±0.10
0.33±0.11 *, +
2.00±0.09
2(0,3)
0(0,3)
2(1,3)
index
*p<0.001 with respect to test before treatment;
+p<0.001 with respect to control after treatment.
28th day
1.12±0.12
1(0,3)
1.70±0.13
2(0,3)
Mean plaque scores 1.41 to 0.24 (p<0.001) and gingival
scores 2.08 to 0.33 (p<0.001) in test group showed that
there was a commendable decline after 28th day of
treatment, whereas, in control group it was 1.42 to 1.12
(p>0.05) and 2.00 to 1.70 (p>0.05) respectively.
Table 2. Efficacy of drug in test group assessed using subjective parameters.
Parameters
Bleeding on
probing
Swollen gums
Bacterial plaque
Mean ± SEM and median rating with range in brackets
0th day
7th day
2.06±0.09
2(0,3)
1.08±0.09
1(0,2)
1.41±0.15
2(0,3)
1.26±0.11**
1(0,3)
0.61±0.09*
1(0,2)
1.28±0.15**
1(0,3)
P
value
0.01
sig
0.05
sig
0.01
sig
14th day
0.91±0.09**
1(0,2)
0.24±0.06*
0(0,1)
0.65±0.10**
1(0,2)
Subjective parameters such as bleeding on probing,
swollen gum and bacterial plaque showed significant
reduction p<0.01 in both groups, but the test drugs
Int J Adv Pharmacy Med Bioallied Sci. 3, 1, 2015.
P
value
0.01
sig
0.05
sig
0.01
sig
21st day
0.28±0.06 **
0(0,1)
0.02±0.02**
0(0,1)
0.51±0.09***
0(0,2)
P
value
0.01sig
0.01
sig
0.001
sig
28th day
P value
0.06±0.03
0(0,1)***
0.00±0.00
0(0,0)**
0.14±0.05
0(0,1)***
0.001
sig
0.01 sig
0.001
sig
showed precedence over control drugs by exhibiting
comparatively quicker response (Tables 2 & 3). The
effect on halitosis (Table 04) out of 54 patients 47
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Hameed et al.| A controlled randomized single blinded clinical study on the effects of unani drugs in Varm-e-lissa (Gingivitis)
(87.38%) were found significant change with complete
(12.62%) patients, there is no significant difference
absence of symptom and no change was observed in 7
(p=0.4483) in observed between the group.
Table 3. Efficacy of drug in control group using subjective parameters.
Mean ± SEM and median rating with range in brackets
Parameters
0th day
7th day
P
value
14th day
P
value
21st day
P
value
Bleeding on
probing
2.00±0.09
2(1,3)
1.98±0.09
2(1,3)
Ns
1.2±0.09**
1(0,3)
0.01
0.92±0.09**
1(0,2)
0.01
0.07±0.08
1(0,2)
1.42±0.15
2(0,3)
0.56±0.08
1(0,2)
1.34±0.15
1(0,3)
Swollen gums
Bacterial plaque
Ns
Ns
0.08±0.04*
0(0,1)
0.78±0.07
1(0,2)
Table 4. Effect on halitosis.
Group
No of Patients
(+)ve history of
halitosis
Response
Percentage
of cure
Test
29
24
82.76
Control
25
23
92
Total
54
47
87.38
DISCUSSION
The present study showed that about 9% of the total
sample had good oral hygiene, about 76.76% patients
from village and 23% from town.
Gingivitis is not a significant threat to the health, but it
may develop into periodontitis with permanent
destruction of periodontal tissues, which can contribute
to illness and cause local and systemic complications. The
most common complications are progression to
periodontal diseases and tooth loss (Jeyaraj & Chithresan,
2010). Periodontitis and poor oral health in general to an
increased risk of heart attack (Mayo Clinic, 2012), strokes
(Grau et al., 2004). Women with periodontitis may be
more likely to give birth to premature babies or babies
with low birth weight than are women with healthy gums
(Mayo Clinic, 2012). In recent years, increasing evidence
has supported the concept that the relationship between
systemic and oral health is bidirectional (Schulze &
Busse, 2008; Williams & Offenbacher, 2000).
In this study, the prevalence of disease was found among
the females, this finding is in accordance with the studies
by Somu et al (2012), Emslie (1966) and Waerhaug (1960)
found slightly higher figures for females than in males
after the age of twenty, whereas it is highly contrary to
the study done by Fruta M et al (2011) have shown that
gingivitis is more prevalent in males than in females
(Fruta et al., 2011).
High prevalent age groups of this study was 15-30 years,
it was mentioned that as the age increases the overall
prevalence of gingivitis decreased; this is due to
progressive accumulation of the brushing knowledge by
the children as they develop (Bhayya et al., 2010).
The effect of the study may be due to the properties
posses by the drugs like Punica granatum has astringent,
anti inflammatory, strengthen the gum (Ghani, 2010) and
Int J Adv Pharmacy Med Bioallied Sci. 3, 1, 2015.
0.05
ns
0.06±0.03*
0(0,1)
0.66±0.08
1(0,2)
0.05
ns
28th day
0.44±0.07
**
0(0,2)
0.00±0.00**
0(0,0)
0.58±0.08**
1(0,2)
P
value
0.01
0.01
0.01
antibacterial effect (Salgado et al., 2006). The
antibacterial agents present in pomegranate the
hydrolysable tannins form complexes of high molecular
weight with protein soluble, increase bacterial lysis and
moreover,
interfere
with
bacterial
adherence
mechanisms to tooth surfaces (Salgado et al., 2006).
Another study showed that the tannins in the ethanolic
extract of the fruit of Punica granatum gel possessed
antimicrobial and antibacterial activity in oral infections
such as caries, periodontal diseases and stomatitis
(Vasconcelos et al., 2006). In the present study, the
Punica granatum Linn had prevented plaque formation
during the trial, as suggested by Pereira et al (2001) and
Kakiuchi et al (1986).
Zizyphus jujuba is a blood purifier (Ghani, 2010),
anodyne, astringent and cooling (Chatterjee and
Pakrashi, 2010). A study has shown that the essential oil
of Z. jujuba seeds has the property of anti inflammation
(Al Reza et al., 2010). Rubia cordifolia is an astringent,
anti-inflammation, blood purifier and analgesic (Ghani,
2010). A study has shown that the methanolic extract of
Rubia cordifolia shows significant analgesic and antiinflammatory activities (Patel et al., 2010). Borax (alum)
is an astringent which helps to arrest bleeding gums. In a
study by Putt MS et al (1996) assessed the efficacy of
alum containing mouth rinse for properties of reduction
of plaque (Amith et al., 2007) (22%) and gingivitis (13%)
(Putt et al., 1996). At both 2nd and 4th week
examinations, the alum group had lower plaque thickness
scores than the placebo group, but neither reduction
attained statistical significance. In the present study also
the reduction of plaque and gingival bleeding scores from
baseline to 28 days were significant.
Quercus infectoria has the properties of astringent,
strengthen the teeth and gums, anti-inflammatory and
reduce bad breath (Ghani, 2010). Methanolic extract of
Quercus infectoria showed minor anti-bacterial, but
substantial anti-inflammatory and anti-ulcerogenic
activities (Khouzami et al., 2009); and another study
showed the extracts of methanol and acetone of Q.
infectoria galls exhibited similar antibacterial activity
against oral pathogens (Basri et al., 2012); further the
extracts is used as traditional medicine in dental powder
and in the treatment of toothache & gingivitis (Vermani
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Hameed et al.| A controlled randomized single blinded clinical study on the effects of unani drugs in Varm-e-lissa (Gingivitis)
et al., 2009). The methanolic extract of Piper cubeba has
a potential antiulcer effect (Parvez et al., 2010).
Tripala is a traditional Ayurvedic herbal formulation
consisting of the dried fruits of three medicinal plants
Emblica officinalis, Terminalia belerica and Terminalia
chebula (Thomas et al., 2011). It has antibacterial,
antiseptic and anti-inflammatory properties (Maurya et
al., 1997). Alcoholic extract of Tripala has shown
antibacterial, wound healing and antioxidant activities
(Kumar et al., 2008), and the methanolic extract of
Tripala is incorporated collagen sponge even in fully
infected dermal wounds. Salt water has the property to
arrest bleeding (Kumar et al., 2010).
CONCLUSION
This study revealed that the test drug has shown
precedence over the control drug by effectively reducing
the subjective and objective parameters without any
adverse effects. Thus, further multicentre randomized
standard controlled clinical trials on large sample for
longer duration of time are recommended.
ACKNOWLEDGEMENT
Authors are highly thankful to the sponsors of WHO health
system research project, Dept. of Community Medicine,
University of Colombo; and the management of National
Ayurvedic Teaching Hospital, Borella for their support in
conducting this clinical trial.
CONFLICT OF INTEREST
None declared.
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