for the use only of registered medical practitioners or a
hospital or a laboratory
A DOUBLE BLIND TRIAL OF
G32
IN CONTROL OF GINGIVAL INFLAMMATION AND BLEEDING IN
100 ADULT CASES OF GINGIVITIS AND PERIODONTITIS
by
Dr. YADAV NIRANJAN SINGH
M.D.S. Asst. Prof. of Oral
Medicine & Radiology, Dental Dept.,
Dr. MRS. QUDWAE WAHEEDA SHAHIN
B.D.S. Dental Surgeon,
Paper presented at
1st International & 34th National
Dental Conference
INTRODUCTION:
We undertook a double-blind clinical trial 'totally in 100
cases of Gingivitis and Periodontitis both conditions
associated with bleeding gums, to assess the effect of G32, an Ayurvedic drug,
used as topical application and massage in control of Gingival Inflammation and
bleeding.
G32:
G32 is available in
easily crushable tablet form; it is to be powdered and applied to the gums etc.
|
Bakula (Mimisops elangi) |
.. 80 mg. |
|
Chok (Calcium carbonate) |
.. 75 mg. |
|
Katho (Acacia catechu) |
.. 40 mg. |
|
Laving (Myrtus Caryophyllus) |
.. 20 mg. |
|
Chikani Sopari
(Areca catechu) |
.. 20 mg. |
|
Fatakadi (Afumen) |
.. 20 mg. |
|
Mayaphal (Quercus infectoria) |
.. 20 mg. |
|
Elaichi (Elettaria
cardamomum) |
.. 10 mg. |
|
Sonageru (Silicate of Alumina & |
|
|
Iron
oxide) |
10 mg. |
|
Jiru (Carum Carui) |
.. 10 mg. |
|
Majith (Rubia Cordifolia) |
.. 10 mg. |
|
Pashanbhed (Sexifruga
ligulata) |
.. 10 mg. |
|
Vavding (Embelia ribes) |
.. 10 mg. |
|
Pipal lukh (Ficus religiosa) |
.. 10 mg. |
|
Samudrafin (Os Sapiae) |
.. 10 mg. |
|
Vajradanti (Barleria prionitis) |
.. 10 mg. |
|
Taj (Cinnamomum
cassia) |
.. 5 mg. |
|
Mari (Piper nigram) |
.. 5 mg. |
|
Sajikhar (Sodium carbondate
impura) |
.. 5 mg. |
|
Kulinjan (Alpinia chinensis) |
.. 5 mg. |
|
Piper (Piper longum) |
.. 5 mg. |
|
Kapur (Camphora officinarum) |
.. 5 mg. |
|
Kuth (Uncaria gambier) |
.. 5 mg. |
|
Gundar (Acacia arabica) |
.. 20 mg. |
Astringent,
anti-inflammatory, anodyne, styptic, deodorant, aromatic, cooling and healing
properties
MATERIALS AND METHODS
100 adults patients suffering from Gingival bleeding in chronic
gingivitis and periodontitis were taken at random for
this study which lasted for a 7 days
G32 was specially
supplied for this clinical trial in powder form in packets, each packet
equivalent to two commercially available G32 tablets. Similar packets of
placebo were also supplied. One set of packets was marked as XXX and the other
set was marked as YYY. The identity of XXX and YYY packets was revealed only
after the clinical trial was over. There were 59 cases in XXX Group and 41
cases in YYY Group. The placebo used was a fine Ayurvedic powder having no
properties of G32.
The trial period was
of seven days. Each patient was examined by the first author before the
commencement of the clinical trial and on III, V and VII days, and all the
clinical data and G. I. Index were recorded at each visit. No other drug or
cleaning agent was allowed during the seven day period of G32 trial.
No
surgical procedures were done before or during the period of the trial.
The Gingival Index of
Loe & Silness was used
to asses Gingival bleeding. There was no index used to
judge Periodontitis which was diagnosed only
clinically.
Each patient was
given 14 of XXX or WY packets to last for seven days. The patient was advised
to apply and massage the gingiva and the surrounding
parts with the powder of one packet at a time, once in the morning and once in
the night, preferably at bed time. After about 10 minutes, the patient was
asked to rinse and gargle the mouth with lukewarm
water. This was done for seven days. The packets were distributed by the second
author only and the assessee (First author) did not
even know whether the patient received XXX or YYY powders till the end of the
trial.
AGE GROUPS & SEX:
There were 47 males and 53 females in the study. The largest
age group was of 21-25 years (31 %), and the next one was of 26-30 years. (26%).
|
(Table I). TABLE Age
Group |
L- Age Males |
Groups
& Females |
Sex Total |
% |
|
16-20 years |
4 |
18 |
22 |
22% |
|
21-25 years |
13 |
18 |
31 |
31% |
|
26-30 years |
16 |
10 |
26 |
26% |
|
31-35 years |
13 |
7 |
20 |
20% |
|
40 years |
1 |
- |
1 |
1 % |
|
Total |
47 |
53 |
100 |
100% |
CHEWING AND OTHER HABITS
79% of patients had
one or more habits, and 21 % had no habits. Betel chewing habit was present in
61%, smoking was present in 19% (all males), and tobacco chewing was present in
23% of patients
|
Habit |
No. of cases |
% |
|
Smoking: (all
males) |
19 |
19% |
|
Betel chewing: |
61 |
61% |
|
Tobacco chewing: |
23 |
23% |
|
No habits: |
21 |
21% |
DIAGNOSIS & ASSOCIATED SYMPTOMS:
There were
60 patients with Chronic Gingivitis and 40 patients with periodontitis.
All the 100 patients had Bleeding Gums, and 53 patients had associated Pain.
Gingival enlargement type was papillary, marginally papillary or generalised.
TABLE III
|
Symptom/Diagnosis |
No. of cases |
% |
|
Chronic
Gingivitis |
60
. |
60% |
|
Periodontitis |
40 |
40% |
|
Bleeding
Gums |
100 |
100% |
|
Pain |
53 |
53% |
RESULTS:
Among the total of 100 cases, 17 cases showed Very Good
response and all these cases belonged to XXX (G32) Group (100%). 16 patients
showed Good response and all these belonged to XXX (G32) Group (100%). 25
Patients showed Moderate response, out of which 21, patients (84.0%)
belonged to XXX (G32) Group and 4 patients (16%) belonged to YYY (Placebo)
Group. 26 patients showed Poor response, out of which 5 patients (19.2%)
belonged to XXX (G32) Group and 21 patients (80.8%) belonged to YYY (Placebo)
Group.l6 patients showed no response and all these case belonged to YYY
(Placebo) group. (100%) (Table IV).
TABLE IV. -Results after therapy, XXX (G32)
& YYY (Placebo) Groups.
|
Gingival Index |
No. of cases |
XXX Group |
% |
YYY Group |
% |
|
Very
Good |
|
|
|
|
|
|
(0.7to1+) |
17 |
17 |
100.0% |
0 |
|
|
Good |
|
|
|
|
|
|
(0.5
to 0.6) |
16 |
16 |
100.0% |
0 |
|
|
Moderate |
|
|
|
|
|
|
(0.3
to 0.4) |
25 |
21 |
84.0% |
4 |
16.0% |
|
Poor |
|
|
|
|
|
|
(0.1
to 0.2) |
26 |
5 |
19.2% |
21 |
80.8% |
|
Nil
(0) |
16 |
0 |
- |
16 |
100.0% |
|
Total |
100 |
59 |
59.0% |
41 |
41.0% |
Among 59
patients of XXX Group (G32). 91.5% showed satisfactory Response (Very + Good +
Moderate), while 8.5% showed Poor response.
Among 41 patients of the YYY Group
(Placebo), 9.8% showed satisfactory response while 90.2% showed Poor or No
response. (Table V).
TABLE
V – OVERALL RESULTS
|
Group |
Satisfactory |
% |
Poor |
% |
Total |
% |
|
|
(V.
Good Good Moderate) |
|
(Poor-Nill) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
XXX |
|
|
|
|
|
|
|
Group |
54 |
91.5% |
5 |
8.5% |
59 |
100% |
|
YYY |
|
|
|
|
|
|
|
Group |
4 |
9.8% |
37 |
90.2% |
41 |
100% |
|
|
Total
58 |
58% |
42 |
42.0% |
100 |
100% |
CRITERIA FOR ASSESSMENT OF RESULTS: The results were assessed as
follows:
Very
Good : Bleeding from gums stopped G. I. Index reduced by 0.7 to 1.0+
Good: Bleeding from gums stopped. G. I. Index reduced by 0.5 to 0.6.
Moderate : Bleeding from gums stopped G. I Index reduced by 0.3 to 0.4.
Poor : Bleeding from gums present. G. I Index reduced by 0.1 to 0.2.
Nil
: Bleeding from gums not stopped and there
was practically no reduction in G. I. Index.
STATISTICAL STUDY:
Out of the total of 100 patients, Good results (Very Good
+ Good) were seen in 33 patients, and the rest of 67 patients showed Moderate
or Poor or Nil results. Using Chi2 test it is observed that there is
highly significant improvement in XXX Group (G32) with reference to Gingival
Bleeding and inflammation, when compared to YYY Group (Placebo). The beneficial
effects of G32 in control of bleeding and inflammation in case of Chronic
Gingivitis-is found to be statistically significant at P < 0.001. (Table
VI).
TABLE VI. --Chi2 Test. P<0.001
|
Group |
Very Good + Good cases |
Moderate + Poor + Nil cases. |
Total |
|
XXX
Group (G32) |
33 |
26 |
59 |
|
YYY
Group |
0 |
41 |
41 |
|
(Placebo) |
|
|
|
|
Total |
33 |
67 |
100 |
STUDENTS PAIRED ‘t’
TEST:
Using
Student's Paired 't' test for the mean decrease
difference of G. I. Index due to treatment with XXX Powder and YYY Powder, it
is found that decrease in G. .I. Index due to XXX Treatment (G32) is highly
significant at P/0.001.
TABLE VII. -Mean Difference in G.L
Index before and after and Student's 't' test' (Placebo Group)
|
XXX (G32) |
before treatment |
III day |
V day |
VII day |
Difference I VI |
|
Mean |
1.95 |
1.74 |
1.60 |
1.38 |
0.57 |
|
S.D.± |
0.3923 |
0.3836 |
0.4241 |
0.3877 |
0.2499 |
|
YYY |
|
|
|
|
|
|
(Placebo) |
|
|
|
|
|
|
Mean |
1.92 |
1.90 |
1.82 |
1.80 |
0.12 |
|
S.D.± |
0.3807 |
0.3665 |
0.3681 |
0.3681 |
0.0894 |
Student's Paired ‘t' Test : P
< 0.001..
DISCUSSION:
No scaling or surgical procedures were done before,
during or after the trial. Surgical intervention as part of secondary
prevention requires the removal of pockets etc.
SUMMARY:
60
Adult Indian cases of chronic gingivitis as assessed by Gingival Index of Loe & Silness and 40 cases of
Periodontitis as assessed only clinically (a total of
100 cases), associated with bleeding gums, were taken up for a double-blind
study. 59 patients received packets of powder marked XXX and 41 patients
received packets of powder marked YYY. The identity as to G32 or the placebo
was revealed only after the treatment was over. The patients were advised to
use the powder as topical application and massage for the gums two times a day.
The trial period was 7 days: Each patient was examined before starting the treatment
and then on the III, V and VII days.
It
was observed that the response to treatment was satisfactory in 91.5% with XXX
powder (G32), while with YYY powder (placebo) the satisfactory response was
only 9.8%. G. I. Index was noted in all the 100 cases before treatment and III,
V and VII days. The difference in G. I. Index before and after treatment was
noted in both the group.
The data of XXX treatment and YYY
treatment were put to statistical study. The results showed that they are
highly significant at P<0.001. It is observed that in this trial of 7 days
period on 100 cases of gingival bleeding and inflammation, G32 exerts
beneficial effects in reducing gingival inflammation and bleeding.
REFERENCES:
1.Ajgaonkar S.B.: (1978): Clinical Trial with G32,
local application in Gingivitis and Periodontitis-
Medicine and Surgery, XVIII 8 pp. 26-28 Aug. 78.
2. Bhasker P.K. Santhanakrishnan,
S. & Jayakumar
T. (1978): Histopathological Evaluation of G32 in
Periodontal disease-33rd Indian Dental Conf.:
3. Krishnarjun Rao,
C. & Ramaswamy, M. (1978) Effect of G32 massage
in Gingival Inflammation-Cur. Med. Pract. Vol. 32,
No.6: pp. 281.85, June 78.
4. Loe M. and Silness, J.:
Periodontal disease in Pregnancy, Acta Odontol Scand. 21 : 533 1963.
5. Radhakrishnan, A.N. (1978); G32 (Alarsin) as Gum Massage in 700 cases of Bleeding Gums and
loss of stippling. (A group study with cooperation of the local-family
Physicians) - 33rd Indian Dental Conf. Madras, 28-31 Dec. 78. (Under publication in Journal).
6. Rajasekhar, A. (1978) :
Therapeutic usefulness of G32 in various Periodontal Conditions-A Clinical
Study- 32nd Indian Dental Conf. Guntur 28-30 Jan. 78;
Antiseptic: Vol. 76: No. 6: June 79 pp. 336.
7. Shah, Kirti P. (1977): G32 in Acute and
Chronic Gingivitis associated with painful teeth: Cur. Med.' Pract. Vol. 21, No.2, P. 65-68, Feb, 77.
8. Srivastava Y.C. (1978): Clinical Trial of
G32 in the treatment of Leukoplakia- 33rd Indian
Dent. Conf. 28-31 Dec. 78.
9. WHO: "Epidemology, Etiology and Prevention of Periodontal Diseases": Report of a WHO scientific Group: Technical Report Series No. 621, 1978