|
Comparison of the effect
of Salvizan Gel with Teriadent in patients with
minor aphthous ulcers
Fatemeh Babadi (1)
Reza Mirzaee Poodeh (2)
(1) Assistant Professor, Department of Oral
and Maxillofacial Medicine, Faculty of Dentistry
, Ahvaz Jundishapur University of Medical Sciences,
Ahvaz, Iran
(2) Student of General Dentistry, Faculty of
Dentistry, Student Research Committee Ahvaz
Jundishapur University of Medical Sciences,
Ahvaz, Iran
Correspondence:
Reza Mirzaee Poodeh
Faculty of Dentistry,
Student Research Committee
Ahvaz Jundishapur University of Medical Sciences,
Ahvaz, Iran
Email: rmirzaei22@gmail.com
|
Abstract
Background and objective:
Recurrent Aphthous Stomatitis (RAS) is
the most common inflammatory ulcer of
the mouth that has involved humans throughout
history. Relieving the pain and shrinking
the ulcer size is of great importance
for the patient. Finding an appropriate
drug is of particular importance in relieving
these sores.
Materials and
Methods: In this clinical trial study,
the study population was 30 patients referred
to the Department of Oral Disease of Faculty
of Dentistry of Ahvaz Jundishapur University
of Medical Sciences with the diagnosis
of minor oral aphthous in the academic
year 2015-2016. The participants were
divided randomly into two groups of 15
persons. Each group was given one of the
two drugs: salvizan gel or teriadent ointment.The
mount of pain was evaluated by VAS scale
and ulcer size was measured in millimeters.
The results were analyzed by using Mann-Whitney
and Friedman tests. (P < 0/05 was considered
significant).
Results:
No significant difference was seen between
the two groups in the amount of pain and
the ulcer size before use of drugs; however,
there was a significant difference between
the two groups in terms of the amount
of pain and the ulcer size after use of
drug on the second and sixth days (P <
0.05). ); so, salvizan gel with a lower
average rating has significantly better
performance in reducing the ulcer size.
Conclusion:
The results indicate the both medicines,
have a significant effect on reducing
the pain and the oral aphthous ulcer size;
so, salvizan gel and teriadent ointment
are markedly effective respectively in
the control of pain and in reducing the
ulcer size.
Key words:
Oral Aphthous; Pain, Salviza Gel; Teriadent;
Ulcer size
|
Recurrent Aphthous Stomatitis (RAS) is the
most common inflammatory ulcers of the mouth
(1) that has involved humans throughout human
history (1). The Greek word “Aphtha”
was used by Hippocrates for the first time for
the definition of these oral ulcers (2).
RAS is a disease with unknown cause, but factors
such as local trauma, systemic, genetic, immunological,
and nutritional problems as well as allergy
and microbial factors are suggested as its predisposing
factors (3).
Sometimes the patient feels prodromal symptoms
such as itching or burning feeling 2-48 hours
before the advent of the ulcer in the place
that turns gradually Erythematosus and eventually
turns into a small white papule that gets bigger
during 48- 72 hours (3). The prevalence of RAS
in a society is over 25% and its three-month
recurrence reaches to 50% (4). The first occurrence
of the disease is commonly in the second decade
of life (3) but the faster incidence of the
disease may be seen by slight trauma, menstruation,
upper respiratory tract infection, or associated
with certain foods (3). The percentage of incidence
of RAS in children may be higher (approximately
39%) and influenced by the incidence of RAS
in the parents (5). In this case in children
with parents affected by the RAS, its incidence
chance is 90% and in children whose parents
have not been affected by RAS so far, this level
is reduced to 20% (6).
The most important issue in the diagnosis and
management of aphthous in dental science is
that diagnosis of it is totally based on description
and clinical symptoms and there is no laboratory
test to prove any diagnosis (7).
The correct treatment of RAS depends on repeat
(s), size, and the number of sores (8). The
best treatment for aphthous, is a therapy where
the wound is controlled over a long time and
ththere are few risky side effects (9). In patients
with a history of repeated courses of RAS the
topical treatments reduce the risk of the disease
(8). The use of topical antiseptics, topical
antibiotics and topical corticosteroids are
some therapies that are prescribed for patients
with aphthous stomatitis (10).
Among the corticosteroids used for the aphthous
patients in Iran is triamcinolone acetonide
with a brand of teriadent. Due to the loss of
defensive mucous barrier of oral mucosa in aphthous
disease, this drug is well absorbed and also
due to the antiinflamatory features of the corticosteroids,
it causes earlier regeneration of tissue (11).
But since corticosteroids have systemic effects
such as hypothalamic-pituitary-adrenal axis
suppression, Cushing’s syndrome, epithelial
atrophy, hyperpigmentation, candidiasis, and
acne, it is better that a drug with less complications
is used (12, 13).
In the twenty-first century which is named
as century of back to nature and the use of
herbs in treatment, we see the increasing expansion
of the research in the field of medicinal herbs
and we see the supply of new herbal medicines
in the broader dimensions (14). One of the medicinal
plants that is said to have many healing properties,
is a plant known as Salvia officinalis (Common
sage).
The leaves of the Salvia officinalis are very
famous because of their antioxidant effect.
This plant has a variety of properties such
as antimicrobial, antifungal, antiviral, astringent
effects and it reduces secretion of sweat and
saliva and it is effective in the treatment
of RAS (15). The extract of this plant HAS its
antimicrobial effects more on gram negative
bacteria and IT also HAS anti-fungal effects
on Candida albicans. These effects are attributed
to the active substance of -thujone that the
leaves of the Salvia officinalis contain. Active
substances of -thujone because of their antifungal
and antimicrobial effects, remove the resulting
inflammation of pathogens; on the other hand,
ursolic acid contained in the herb has a powerful
anti-inflammatory and antiphlogistic effect
(16).
Salvizan gel in addition to -thujone has tannins,
phenolic acid, ursolic acid and so on, and reduce
the inflammation through these substances and
their effect on the lymph tissues (16).A pharmaceutical
company called the Gol daru in Isfahan has prepared
a therapeutic product from the herb Salvia officinalis
for the treatment of aphthous, which is distributed
under the commercial brand name of salvizan
gel and is marketed as there is 28% of the hydro-alcoholic
extract of Salvia officinalis per 15 g of gel
(16) and according to the manufacturer’s
claims, it has been prepared and marketed in
order to treat canker sores.
With regard to this point the policy of the
Ministry of Health, Treatment, and Medical Education
focuses on finding and using effective herbal
drugs in the treatment of disease. (17), given
the side effects of corticosteroids and to verify
the claims of the manufacturer, this study was
designed and conducted scientifically and practically
to evaluate the hydro-alcoholic extract of a
Salvia officinalis (Sage) compared with teriadent
ointment in the treatment of canker sores.
In this clinical trial study, 30 patients,
diagnosed as having minor oral aphthous,were
referred to the department of oral diseases
of Faculty of Dentistry of Ahvaz Jundishapur
University of Medical Sciences, and were investigated
in the academic year 2015-2016. This study was
conducted in a pilot form, and a final sample
size of 30 people was determined using random
sampling and on the basis of the results of
the initial pilot study.
In this study the inclusion criteria were:
1) patients referred to the Department of the
oral diseases of the dental school; 2) patients
who had a willingness to collaborate on this
research; 3) People who were perfectly healthy
and without systemic problems; 4) people with
a maximum 24- hour history of minor RAS since
the incidence of ulcers. Exclusion criteria
were: 1) any sensitivity to NSAID drugs; 2)
asthma patients; 3) a history of heart disease;
4) pregnant women; 5) people with gastrointestinal
tract diseases such as peptic ulcers; 6) people
with liver and kidney diseases; 7) patients with
any periodontal surgery in the last six months;
8) the presence of systemic diseases such as diabetes.
Participants were randomly divided into two groups
of 15 people. Age, sex and features of minor RAS
and ulcer size and amount of pain were recorded
before treatment and matched at each group.
After a full explanation of the terms and methods,
the basic situation of pain in patients was
measured with the use of the scale VAS (Visual
Analogue Scale). This scale is used to measure
the amount of pain, and patients were asked
to rate their pain to a number between zero
to 10. The number zero represents the absence
of pain and the number 10 represents the greatest
amount of pain. Furthermore, the initial size
of the ulcer was calculated and recorded using
a disposable paper ruler by mm square (mm2)
at baseline.
In the control group, 0.1% teriadent ointment
(Raha , Isfahan, Iran) was used and in the case
group, salvizan gel (Goldaru,Isfahan,Iran) containing
an amount of 28% of the hydroalcoholic extract
of Salvia officinalis per 15 g of gel, was used.
Before beginning the design, tubes of both drugs
were covered completely by a third party, so
that type of medication was not identified for
the patient and the investigator. Then, the
tubes were marked with “a” and “b”
marks, and were randomly given to patients.
For every drug use in each group, people were
trained to impregnate a small piece of health
cotton of about 3 to 5 cm in size, in the drug
and hold it in the sore’s location for
30 seconds. People were asked to repeat this
operation three times daily and refuse eating
and drinking or washing the mouth at least 30
minutes after doing this for the better impact
of the medication. Patients also were prohibited
to use any oral anti-inflammation and pain medication
during treatment. Patients were asked to refer
in the second and sixth days after receiving
the drug and to be examined again and the amount
of pain was recorded based on VAS and ulcer
size was measured with a disposable paper ruler.
The collected data were given to a statistics
expert to analyze statistics.
Statistical methods of analysis of the results
to compare the three groups, the Friedman- Whitney
test was used. The results of this research
were analyzed using SPSS version 22. A significance
level of P 0.05 for was considered for all statistical
tests.
After
providing
data
to
the
statistical
consultant,
they
were
evaluated
and
the
following
results
were
achieved;
the
number
of
patients
participating
in
the
study
was
30
people;
of
these
15
persons
were
men
(50%)
and
15
were
females
(50%).
The
overall
average
age
of
the
patients
participating
in
the
study
was
30.62±
0.515
for
men
it
was
559.0
±
2.31
and
for
women
it
was
57.29
±
913.0.
The
average
amount
of
pain
in
patients
receiving
teriadentointment
and
salvizan
gel
along
with
details
is
shown
in
Table
1
and
the
average
size
of
the
ulcer
in
Table
2.
In
this
study,
it
was
shown
that
there
are
significant
differences
between
the
amount
of
pain
in
the
patients
before
using
teriadent
ointment
and
salvizan
gel
with
the
amount
of
pain
after
use
of
medications
(P
0.05).
Also,
no
significant
differences
were
seen
between
the
amounts
of
pain
before
the
use
of
drugs
between
the
two
groups
however,
there
were
significant
differences
between
the
amount
of
pain
after
use
of
drugs
in
the
two
groups
on
the
second
and
the
sixth
days
(P
<
0.05).
As
it
was
shown,
salvizan
gel
with
a
lower
rank
average
has
significantly
better
performance
in
the
control
of
pain.
In
this
study,
it
was
shown
that
there
were
significant
differences
between
the
size
of
the
ulcer
in
patients
before
using
teriadent
ointment
and
salvizan
gel
with
the
size
of
the
ulcer
after
the
use
of
medications
(P
<
0.05).
Also,
this
study
showed
that
there
was
not
a
significant
difference
between
the
size
of
the
ulcer
prior
to
the
use
of
drugs
in
the
two
groups
but
there
was
no
significant
difference
between
the
two
groups
in
the
size
of
the
ulcer
after
the
use
of
drugs
on
the
second
day
and
the
sixth
day
.
As
it
was
shown
that
teriadent
ointment
with
a
lower
rank
average
has
significantly
better
performance
in
reducing
the
size
of
the
ulcer.
Table
1:
The
amount
of
pain
in
patients
with
oral
aphthous
by
day
and
the
type
of
gel
Table
2:
The
extent
of
oral
aphthous
by
the
following
time
and
the
gel
type
RAS
is
a
recurrent
inflammatory
disease
of
the
oral
mucosa
that
can
be
seen
as
single
or
multiple
or
painful
sores
in
patients
without
systemic
disease.
These
sores
are
one
of
the
most
common
oral
diseases
that
are
seen
in
20%
of
the
world’s
population
(18,
19).
Diagnosis
of
RAS
disease
is
based
on
history
and
clinical
profile
and
there
is
no
specific
test
for
RAS
(63).
Several
factors
are
discussed
in
the
etiology
of
RAS.
Heredity,
blood
factors
and
immunitye
are
the
three
main
factors
in
the
incidence
of
aphthous
ulcers
(64).
In
addition
to
these
various
factors,
such
as
local
trauma,
cigarette
smoking,
viruses,
stress,
medication
and
allergy
are
very
involved
in
the
creation
of
the
RAS
(20-24).
This
study
showed
that
there
is
a
significant
difference
between
the
amount
of
pain
and
the
size
of
the
ulcer
in
the
patients
before
the
use
of
teriadent
ointment
and
gel
salvizan
with
the
amount
of
pain
after
the
use
of
the
medications.
In
this
study,
it
was
shown
that
there
is
no
significant
difference
between
the
groups
in
the
amount
of
pain
and
the
size
of
the
ulcer
in
the
patients
before
the
use
of
the
medications
(P0.05);
however,
there
is
no
significant
difference
between
the
two
groups
in
the
amount
of
pain
and
ulcer
size
after
the
use
of
medicines
on
the
second
day
and
the
sixth
day
(P
<
0.05).
It
was
shown
that
salvizan
gel
with
a
lower
rank
average
has
significantly
better
performance
in
reducing
the
size
of
the
ulcer.
Farokh
Rad
et
al.
(25)
have
compared
the
medical
effect
of
topical
intraoral
triamcinolone
ointments
and
herbal
solution
of
myrtus
in
the
treatment
of
minor
oral
aphthous
ulcers.
Contrary
to
the
results
obtained
in
the
present
study,
they
found
that
there
is
no
significant
difference
between
topical
intraoral
triamcinolone
ointment
and
herbal
solution
of
myrtus
in
the
response
rate
to
treatment.
However,
in
this
study
it
became
clear
that
there
was
a
significant
difference
between
the
teriadent
ointment
and
salvizan
gel
in
the
response
rate
to
treatment,
as
salvizan
gel
has
significantly
better
performance
in
reducing
the
pain
of
RAS
and
teriadent
ointment
has
significantly
better
performance
in
reducing
the
size
of
the
ulcer.
Perhaps
the
differences
in
the
results
achieved
are
in
the
higher
number
of
patients
under
investigation
(100
patients)
compared
with
the
present
study
(30
patients).
MM
Fani
et
al.
(26)
have
compared
the
effect
of
phenytoin
syrup
and
triamcinolone
acetonide
ointment
on
aphthous
ulcers.
They
found
that
the
rate
of
the
effectiveness
of
triamcinolone
acetonide
ointment
in
the
treatment
of
aphthous
ulcers
is
more
than
phenytoin
syrup.
However,
in
this
study
it
became
clear
that
salvizan
gel
has
significantly
better
performance
in
reducing
pain
induced
by
aphthous,
and
teriadent
ointment
has
significantly
better
performance
in
reducing
the
size
of
the
ulcer.
Perhaps
the
differences
in
the
results
achieved
is
in
the
higher
number
of
patients
under
investigation
(60
patient)
compared
with
the
present
study
(30
patients)
as
well
as
differences
in
the
used
drugs.
They
also
investigated
patients
with
Behcet’s
syndrome
to
evaluate
the
impact
of
drugs
on
aphthous
ulcers,
but
in
this
study,
the
subjects
were
completely
healthy
and
lack
any
systemic
disease
and
syndrome.
Jahanshahi
et
al.
(27)
conducted
an
introductory
study
of
the
effectiveness
of
triamcinolone
in
treatment
of
the
minor
oral
aphthous
ulcer.
Similar
to
the
present
study,
they
found
that
triamcinolone
has
significant
effect
in
relieving
pain
and
reducing
the
sizes
of
the
ulcers
and
it
can
be
used
in
accelerating
the
improvement
of
aphtous
ulcers.
A
difference
between
their
study
compared
to
the
present
study
is
less
people
under
investigation
(23
patients)
and
the
methods
in
their
study
so
that
they
have
compared
the
effect
of
triamcinolone
with
placebo.
But
in
the
present
study,
the
therapeutic
effect
of
teriadent
ointment
was
compared
to
the
salvizan
gel.
So
it
can
be
said
that
the
results
obtained
from
this
study
was
more
comprehensive
and
more
accurate
than
their
study.
Abbasi
et
al.
(28)
compared
the
effect
of
triamcinolone
acetonide
0.1%
and
diclofenac
1%
in
patients
with
minor
oral
aphthous.
This
study
showed
teriadent
ointment
and
salvizan
gel
significantly
are
effective
in
reducing
pain
and
the
size
of
the
ulcers.
They
also
found
that
the
amount
of
pain
and
the
size
of
the
ulcers
has
a
significant
decrease
in
triamcinolone
gel
and
diclofenac
gel.
contrary
to
the
results
obtained
in
the
present
study
that
showed
the
salvizan
gel
with
a
lower
rank
average,
had
significantly
better
performance
in
controlling
the
pain
and
teriadent
ointment
with
a
lower
rank
average,
had
significantly
better
performance
in
reducing
the
size
of
the
ulcer.
In
their
study,
they
did
not
find
significant
differences
between
the
two
groups
in
the
reduction
of
pain
and
the
size
of
the
sore.
Perhaps
because
of
the
differences
in
the
results
achieved
is
in
the
lower
number
of
patients
undergoing
their
study
(25
patients)
compared
with
the
present
study
(30
patients)
as
well
as
differences
in
the
used
drugs.
Both
teriadent
ointment
and
salvizan
gel
have
a
significant
effect
on
reducing
the
amount
of
pain
and
the
size
of
the
oral
aphthous,
so
salvizan
gel
has
significantly
better
performance
in
the
control
of
pain,
and
teriadent
ointment
has
significantly
better
performance
in
reducing
the
size
of
the
ulcer.
Acknowledgement
This
work
was
Financially
Supported
by
Grand:
(
U-
36
263
)
from
Vice-chancellor
for
Research
Affairis
of
Ahvaz
Jundishapur
University
of
Medical
Science.This
Paper
Is
Issued
From
Thesis
Of
(Reza
Mirzaei)
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