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ISSN: 0976-5921
International Journal of Ayurvedic Medicine, 2013, 4(1), 48-56
Research Article
Abstract
Background: Pregnant females are susceptible to oral conditions like gingivitis and
pregnancy tumour, which affect both the mother and the developing foetus. Chlorhexidine,
conventionally used to treat these conditions, causes side effects on long term use. Ayurvedic
medications like G32 have been used for treating gingivitis.
Objective: To compare efficacy of G32 with Chlorhexidine in treating pregnancy
gingivitis after topical application.
Materials and Methods: This was a double blind, randomised controlled trial
conducted in a sample of 37 pregnant females, in second trimester, with gingivitis. They were
randomly divided into two groups and were allotted Chlorhexidine gel (n=18) or G32 gum-
paint (n=19) for local application for one month. Plaque index (Silness and Löe, 1964) and
Gingival index (Löe and Silness, 1963) were recorded at baseline and follow-up by a
calibrated examiner. Statistical analysis was performed using paired t-test for intragroup
comparison of mean plaque and gingival scores, and independent t-test for intergroup
comparison of mean percentage reduction in plaque and gingival scores.
Results: Both test and control groups showed a significant reduction in plaque and
gingivitis. The percentage reductions in plaque and gingivitis were similar among the two
groups.
Conclusion: G32 is effective in treating pregnancy gingivitis and can be economical
alternative to Chlorhexidine, with lesser side effects.
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Published online in http://ijam.co.in
ISSN: 0976-5921
Hathiwala S et.al., Efficacy of G32 in treating Pregnancy Gingivitis – a Randomized Controlled Trial
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Published online in http://ijam.co.in
ISSN: 0976-5921
International Journal of Ayurvedic Medicine, 2013, 4(1), 48-56
formulations have been tested and have Pipala ni Lakh (Ficus - 10 mg.
been proved to be effective in treating religiosa)
gingival diseases, with fewer deleterious Samudrafin (Os sapiae) - 10 mg.
effects. Many formulations like Salvadora Vajradanti (Barleria prioitis) - 10 mg.
persica (Miswak), Triphala, Propolis, Taj (Cinnamimum cassia) - 5 mg.
Azadirachta indica (Neem) have been Mari (Piper nigrum) - 5 mg.
widely used (15-18). Sajikhar (Sodium carbonate - 5 mg.
G32, used in this study, is one such impure)
ayurvedic preparation. It is available for Kulinjan (Alpinia chinensis) - 5 mg.
local application, in an easily crushable Pipar (Piper longum) - 5 mg.
tablet form and as gum paint. The main Kapur (Camphora - 5 mg.
ingredients in this ayurvedic preparation officinarum)
include Bakul, Chok, Katha, Laving, Kuth (Uncaria gambier) - 5 mg.
Fatakdi, etc. (Appendix A). It has anti-
inflammatory, antiseptic, antibacterial, Objectives:
astringent, anodyne, styptic and healing To evaluate the effectiveness of G32
actions. Various studies have shown it to gum-paint in reducing dental plaque
be effective in treating gingivitis (19-21) and gingivitis in pregnant females.
and pregnancy-induced gingivitis (22). To compare its effectiveness with
These studies have shown that it has Chlorhexidine gel.
minimal side effects and has good
compliance of the patients. However, no Materials and methods:
studies have been conducted till this date This was a parallel design,
that compare G32 with Chlorhexidine, the randomised controlled trial, conducted on
existing ‘gold standard’ for gingivitis (23). pregnant females with gingivitis, in their
So this study was conducted with an aim second trimester. The examinations were
to compare the effectiveness of ayurvedic performed in the Ante-natal
formulation, G32 with Chlorhexidine in Gynaecological clinics of Dr. T.M.A. Pai
treating pregnancy gingivitis. Hospital, Udupi (Karnataka, India). The
study was approved by the Kasturba
Constituents of G32 (19-22) Hospital Institutional Ethics Committee,
Bakul (Mimosops elangi) - 80 mg. Manipal (IEC 82/2011). An informed
Chok (Calcium Carbonate) - 75 mg. consent was taken from all the study
Katho (Acacia catechu) - 40 mg. participants before their inclusion.
Laving (Myrtus - 20 mg.
caryophyllus) Sample selection –
Chikani Sopari (Areca - 20 mg. The pregnant females, aged 20-35
catechu) years, who were in their second
Fatakadi (Alumen) - 20 mg. trimester and had signs of moderate to
Mayafal (Quercus infectoria) - 20 mg. severe gingivitis, with or without
Elaichi (Elettaria - 10 mg. plaque or debris, were included in the
cardamomum) study.
Sonageru (Silicate of - 10 mg. Those who had medical complications
Alumina and Iron Oxide) related to pregnancy, or any medical
Jiru (Carum carvi) - 10 mg.
disorders or chronic/acute infections
Majith (Rubia cordifolia) - 10 mg.
other than dental infection, requiring
Pashanbed (Saxifrua - 10 mg.
ligulata) any kind of intervention, or reported a
Vavding (Embelia ribes) - 10 mg. recent history of antibiotic
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Published online in http://ijam.co.in
ISSN: 0976-5921
Hathiwala S et.al., Efficacy of G32 in treating Pregnancy Gingivitis – a Randomized Controlled Trial
administration for any reason, were patients, using a mouth mirror and dental
excluded from the sample. probe. The Gingival scores ranged from 0-
The final sample comprised of 37 3 depending on the severity of
pregnant females who were randomly inflammation in gingival margin.
divided into two groups. 19 females in the Similarly, the Plaque scores ranged from
test group were given G32 Alarsin gum- 0-3 depending upon the thickness of
paint (ALARSIN, Mumbai), while 18 plaque at gingival area of the tooth. Only
others formed the control group and were one trained examiner did all the
given Chlorhexidine gel (Hexigel, ICPA, examinations to prevent the inter-examiner
Mumbai). Both the groups were instructed bias. Intra-examiner reliability was
to apply the medicament and massage it assessed by the kappa coefficient. The
over gums twice a day, along with their kappa values for Gingival and Plaque
existing oral hygiene practices. The effects scores were 0.81 and 0.78 respectively.
of the medicaments were assessed after Followed by this, the participants
one month of usage. were randomly allotted one of the two
medicaments in wrapped bottles, for one
Examination month usage. These bottles were
This trial was conducted from sequentially numbered by an investigator
March, 2011 to June, 2011. All the who was not a part of the clinical
pregnant females attending regular ante- examination. The subjects were instructed
natal check-ups in the Gynaecology Dept. to thoroughly massage the medicament
were examined for their oral health status over gums and surrounding areas, with the
by the principal investigator, while general help of finger-tip and were advised to keep
medical examination was performed by it for minimum five minutes, and then
other investigator. The females with rinse with fresh water, without swallowing
moderate to severe gingivitis (gingival it. This procedure was to be repeated twice
scores ≥ 1) were included in the study after daily for the first 15 days, in morning and
taking consent. at bed time.
The participants’ information
relating their demographics (age, Interim Review
education, income and address), months of After the first 15 days, a reminder
pregnancy, personal oral habits, oral call was made by the investigator to
hygiene practices were recorded by one of enquire about the compliance to the
the investigators, after interviewing them. instructions. The patients were asked if
Self-perceived oral health status was also they experienced any change in the
recorded on a 5-point Likert scale, ranging condition of their gums. They were
from ‘excellent’ to ‘poor’. instructed to continue using the
This was followed by clinical oral medicament once daily (in morning) for
examination which was performed by the the next 15 days.
principal investigator. The Gingival and
Plaque scores were assessed using the Löe Follow-up
and Silness Index (1963) (24) and Silness All the females were examined at
and Löe Index (1964) (25), respectively. the end of one month for all the parameters
These indices were calculated on selected evaluated at the baseline. The side effects,
maxillary and mandibular teeth for all the if any, were also recorded at this visit. The
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Published online in http://ijam.co.in
ISSN: 0976-5921
International Journal of Ayurvedic Medicine, 2013, 4(1), 48-56
females were instructed for better oral 80% (29 females) perceived their oral
hygiene methods and importance of oral health status as ‘fair’. None of them
health in pregnancy was reinforced. They perceived their oral status as ‘excellent’.
were also advised for a dental visit soon Three females were lost to follow-
after their delivery. up of 4 weeks. Two females prematurely
withdrew from the study, because of
Data analysis nausea; one each from the test and the
All the data were analysed using control groups. One female from the test
the SPSS version 16.0. The intragroup group failed to return for the post-test
changes in pre-test and post-test plaque examination. Hence, the final sample of 34
and gingival scores were evaluated using a females was analysed, with 17 patients in
Paired t-test. Post-test plaque and gingival each group.
scores between the test and control groups The mean age of the females in
were compared using Independent t-test. A Chlorhexidine and G32 groups was 28.3 (±
p-value ≤ 0.05 was considered to be 2.1) and 26.5 (± 3.6) years respectively,
statistically significant. with a range of 20-33 years. The mean
duration of pregnancy was 4.52 (± 0.8) and
Results 4.32 (± 0.9) months respectively, with a
A total of 400 pregnant females in range of 3-6 months. The mean baseline
their second trimester were examined, and plaque scores were 1.93 (± 0.5) and 1.64
69 females that fulfilled the inclusion (± 0.4) for Chlorhexidine and G32 groups
criteria were selected. From these, 37 respectively. Similarly, the mean baseline
females consented to participate in the gingival scores were 1.94 (± 0.5) and 1.76
study. The most common reason for not (± 0.3) respectively. There was no
participating in the study was statistically significant difference between
apprehension on part of the mothers about the test and control groups for mean age (p
the possible risk to their foetuses. The = 0.08), duration of pregnancy (p = 0.49),
females, who consented, were randomly and plaque (p = 0.06) and gingival (p =
divided into Chlorhexidine (n=18) and 0.22) scores. (Table 1)
G32 (n=19) groups.
Out of these 37 pregnant females
who were examined at the baseline, about
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Published online in http://ijam.co.in
ISSN: 0976-5921
Hathiwala S et.al., Efficacy of G32 in treating Pregnancy Gingivitis – a Randomized Controlled Trial
Table 2 – Comparison of pre- and post-test plaque scores in both the study groups
Mean
Pre-test plaque Post-test plaque Percentage
Treatment Difference P-value
(±SD) (±SD) reduction
(±SD)
Chlorhexidine 1.93±0.52 0.79±0.39 1.14±0.48 59% 0.001*
Table 3 – Comparison of pre- and post-test gingival scores in both the study groups
Pre-test Post-test Mean
Percentage
Treatment gingivitis gingivitis Difference P-value
reduction
(±SD) (±SD) (±SD)
Table 4 – Comparison of the percentage reduction of plaque and gingival scores between
Chlorhexidine and G32 groups –
Percentage reduction Percentage
Characteristics P-value
Chlorhexidine reduction G32
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Published online in http://ijam.co.in
ISSN: 0976-5921
International Journal of Ayurvedic Medicine, 2013, 4(1), 48-56
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Published online in http://ijam.co.in
ISSN: 0976-5921
Hathiwala S et.al., Efficacy of G32 in treating Pregnancy Gingivitis – a Randomized Controlled Trial
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Published online in http://ijam.co.in
ISSN: 0976-5921
International Journal of Ayurvedic Medicine, 2013, 4(1), 48-56
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