1.

NAMES OF THE RESEARCHERS

DR. NISHTHA KUMAR

POST GRADUATE STUDENT
DEPARTMENT OF PERIODONTICS
GOVERNMENT DENTAL COLLEGE
AND RESEARCH INSTITUTE,
BANGALORE.

2.

GUIDED BY

DR. A.R.PRADEEP
PROFESSOR AND HEAD
DEPERTMENT OF PERIODONTICS
GOVERNMENT DENTAL COLLEGE
AND RESEARCH INSTITUTE,
BANGALORE.

3.

BRIEF RESUME OF THE INTENDED WORK:

3.1 NEED FOR THE STUDY: Gingivitis is a chronic inflammatory process limited to the gingiva, without either
attachment or alveolar bone loss. It is one of the most frequent oral diseases, affecting more
than 90% of the population, regardless of age, sex or race. The earliest clinical sign is
bleeding, which is a sequel of the vasodilator effect caused by an inflammatory
response.The prevention of gingivitis by daily and effective supragingival plaque control via
brushing the teeth and dental floss is necessary to arrest a possible progression to
periodontitis.
Certain plants used in folk medicine serve as a source of therapeutic agent by
having multi-potential effects in addition to their antimicrobial activity.1
Acacia arabica gum has been shown to exhibit antimicrobial properties.2
Gumtone gel may be a useful herbal formulation for chemical plaque control agent
and improvement in plaque and gingival status.3
Calendula extract toothpaste reduces gingival inflammation and plaque formation
and therefore recommended as an adjunctive procedure effective for improvement in
gingival inflammation.4
Calendula mouthwash is effective in reducing dental plaque and gingivitis
adjunctive to scaling.5
This study is designed with the aim of comparing clinical efficacy of Acacia arabica
and Calendula gel in the reduction of gingival inflammation.

COMPARISON OF CLINICAL EFFICACY OF ACACIA ARABICA AND CALENDULA

GEL IN REDUCTION OF GINGIVAL INFLAMMATION : A RANDOMIZED
CONTROLLED CLINICAL TRIAL

3.2 REVIEW OF LITERATURE: Herbal formulations can provide an option for safe and long term use. Gumtone gel
(Charak Pharma Pvt. Ltd, India) is one such polyherbal formulation with Acacia arabica as
its main ingredient.1
Acacia arabica gum is a traditional oral hygiene substance which has been used for
centuries by many communities in the Middle East and North Africa. It consists mainly of
arabica, a complex mixture of the calcium, magnesium and potassium salts of arabic acid.
There are also other constituents such as tannins, cyanogenic glycosides, oxidases,
peroxidases and pectinases; all of which have been shown individually to exhibit
antimicrobial properties.2
In a study, ninety subjects diagnosed with chronic generalized gingivitis were
selected and randomly divided into three groups: Group I placebo gel, Group II gumtone
gel and Group III 1% chlorhexidine gel. Clinical evaluation was undertaken using the
gingival index of Loe and Silness and the plaque index at baseline, 2 weeks, 4 weeks and 6
weeks.A subjective evaluation was undertaken by questionnaire. Gumtone gel showed

significant clinical improvement in gingival and plaque index scores as compared to a

placebo gel. This improvement was comparable to 1% chlorhexidine gel.Unlike
chlorhexidine gel, gumtone gel was not associated with any discolouration of teeth or
unpleasant taste.3
In a prospective, double-blind clinical study, a total of 40 volunteers with established
gingivitits (21 males an 19 females) were included. They were randomly assigned to two
treatment groups: Group 1(n=20)- treated with base dentifrice as control toothpaste; Group
2(n=20)- treated with Calendula flower extract toothpaste. Data was collected at baseline and
at increment of 2,3 and 4 weeks. The data included Plaque index(PI), Gingival index(GI)
And Bleeding on probing(BoP). Over a period of 4 weeks,all indices were significantly
decreased with a significant reduction in PI.4
In a study, two hundred and forty patients within the age group of 20-40 years were
enrolled with their informed consent. The subjects were randomly assigned into two groups test group (n = 120) and control group (n = 120). All the test group patients were advised to
dilute 2 ml of tincture of calendula with 6 ml of distilled water and rinse their mouths once in
the morning and once in the evening for six months. Similarly, the control group patients
were advised to use 8 ml distilled water (placebo) as control mouthwash and rinse mouth
twice daily for six months. In the absence of scaling (that is, between the first and second
visit), the test group showed a statistically significant reduction in the scores of PI, GI, SBI
(except OHI-S) (P < 0.05), whereas, the control group showed no reduction in scores when
the baseline scores were compared with the third month scores. Also, when scaling was
performed during the third month (second visit), there was statistically significant reduction
in the scores of all parameters, when the third month scores were compared with the sixth
month scores in both groups (P < 0.05), but the test group showed a significantly greater
reduction in the PI, GI, SBI, and OHI-S scores compared to those of the control group.5

3.3 OBJECTIVES OF THE STUDY: To evaluate the clinical efficacy of Acacia Arabica gel and Calendula gel in reducing
gingival inflammation
4.

MATERIALS AND METHODS: 4.1 SOURCES OF THE DATA

Those to be studied will be subjects referred to the outpatient section, Department
of Periodontics, Government Dental College and Research Institute, Bangalore.
It will be made clear to the potential subjects that participation will be voluntary and
written informed consent will be obtained from those who agree to participate.
4.2 METHODS OF COLLECTION OF DATA
INCLUSION CRITERIA: 1. Age group 25-40 years.
2. Subjects having atleast 20 natural teeth.
3. Subjects who have not received periodontal therapy within preceding six months.
3

4. Gingivitis with bleeding on probing (PPD 3 mm)

EXCLUSION CRITERIA: 1.
2.
3.
4.
5.

Subjects with known allergies to the constituents of the formulation..

Subjects undergoing orthodontic therapy.
Subjects having any haematological disorder.
Subjects with a smoking habit.
Subjects with known systemic disease or any other systemic inflammation/ infection
which can alter the course of periodontal disease.
6. Pregnant/ lactating women.
7. Subjects who are on any medication/ drugs which could influence periodontal status.
90 subjects (On the basis of power analysis with 90% confidence at p<0.05.) will be
selected randomly and categorized into 3 groups which are subdivided on the basis of the
ingredient of the gel
Group I: 30 subjects will receive placebo gel.
Group II: 30 subjects will receive Acacia arabica gel
Group III: 30 subjects will receive Calendula gel
Oral prophylaxis will be done and oral hygiene instructions will be given. Subjects will
be instructed to apply a pea-sized amount of gel gently by finger or soft brush to the
gums for about an hour after regular brushing and to leave it for five minutes before
rinsing.Subjects will be assessed for gingivitis using the gingival index (GI), for plaque,
using the plaque index (PI), and bleeding on probing in the same dental unit under
identical conditions at baseline, 2 weeks, 4 weeks and 6 weeks. The clinical
measurements will be carried out using a UNC-15 periodontal probe.

STATISTICAL ANALYSIS:
Power analysis was applied to calculate the appropriate sample size and the following
Statistical tests will be carried out:
1. Analysis of variance.
2. Paired t-test.
4.3 Will ethical clearance be obtained from your institution?
Will be obtained from institutional ethical committee and review board,
GDCRI, Bangalore.

5.

LIST OF REFERENCES:
1. Takahashi K, Fukazawa M, Motohira H, Ochiai K, Nishikawa H, Miyata T. A pilot
study on antiplaque effects of mastic chewing gum in the oral cavity. J Periodontol
2003;74:501-505
2. Kirtikar KR, Basu BD, Lalit Mohan Basu. Indian medicinal plants. 1984:2:919935.
3. AR Pradeep, D Happy, G Garg. Australian Dental Journal 2010;55:6569
4. Amoian B, Moghadamnia A, Mazandarani M et al. Research Journal of Medicinal
Plant 2010;4:132-140
5. Khainar MS, Pawar B, Marawar PP, Mani A. J Indian Soc Periodontol 2013;17:741-7

5.

LIST OF REFERENCES:

6.

SIGNATURES OF RESEARCHERS

7.

REMARKS OF THE GUIDE

8.

NAME AND DESIGNATION OF

8.1 GUIDE

DR A. R. PRADEEP
PROFESSOR AND HEAD,
DEPARTMENT OF PERIODONTICS,
GOVERNMENT DENTAL COLLEGE AND
RESEARCH INSTITUTE,
BANGALORE.

8.2 SIGNATURE

8.3 HEAD OF THE DEPARTMENT

DR A.R. PRADEEP

8.4 SIGNATURE