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.,Osmania Hospital.

 

Dr. MRS. QUDWAE WAHEEDA SHAHIN

B.D.S. Dental Surgeon, Hyderabad A.P.

 

Paper presented at

1st International & 34th National Dental Conference Bombay

 

 

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.: Madras 28-31 Dec. 78.

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