Ranbaxy Laboratories Ltd. Role of Novel Probiotic Formulation in Oro-Dental Care With Special Emphasis on New Drug Launch by Ranbaxy Laboratories Ltd.

A project report

On

Role of Novel Probiotic Formulation in Oro-Dental care

with special emphasis on new drug launch by Ranbaxy

laboratories Ltd.

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Acknowledgement

The project on Novel Probiotic formulation has been a great

learning experience for me and will help me transform my career

from Healthcare to Management. First of all I would like to thank

the organization for considering me for this project. I would like to

specially thank Mr. Naresh katara (Director- Pharma Marketing)

for commissioning this project.

I would also like to thank Mr. Rajbir Sandhu (GM- Pharma

Marketing) and Mr. Kanwaljeet Chopra (Manager- Training) for

helping me land up in Ranbaxy laboratories Ltd. for Summer

Internship.

I owe my sincere thanks and regards to my Industry Guides Mr.

Sumit Ray (Senior Manager Marketing) and Mr. Prince Uppal

(Group Brand Manager) for their constant guidance and support

throughout the project.

I am also grateful to Mrs. Manju Varma (Secretary Pharma

Marketing) for her constant help on how to get my work done in

the organization.

I hereby thank all the Sales Managers, Mr. Pradeep Sachdeva (SM-

NCR), Mr. Amir Ali (SM- Mumbai) and Mr. Jheelani Basha (SM-

Hyderabad) for being helpful and cooperative during my

fieldwork.

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I owe my sincere thanks to the sales force (Pharma Division) of

NCR, Mumbai and Hyderabad for helping me with the list of

Dental Surgeons and my fieldwork.

Last but not the least I would like to thank my Faculty Guide Prof.

D. Satish for instilling the values, attitude and competence in us.

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Abstract

The project ““Role of Novel Probiotic Formulation in Oro-Dental care with special

emphasis on new drug launch by Ranbaxy laboratories Ltd.” was intended to find out the

prevalence of Halitosis and Periodontitis as well as Halitosis due to Periodontitis in the

current practice of Dental Surgeons. This project also intends to find out the gaps in the

current therapy for Halitosis and Periodontitis and to fill these gaps with various

indications as an outcome.

This report contains a description of common Oro-dental problems with special emphasis

on Halitosis and the product (Inersan) that is going to be launched soon, the sampling

criteria, survey methodology, the outcomes of the primary survey of 126 Dental Surgeons

based on a questionnaire consisting of 14 questions. The key issues arising after the

primary survey were the unproven clinical efficacy, the price range and type of

formulation of the novel Probiotic formulation.

The various indications which came to the forefront through the study were chronic

Gingivitis and Periodontitis, aggressive Periodontitis, xerostomia, recurrent oral ulcers,

pre-pubertal Gingivitis and malocclusion.

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TABLE OF CONTENTSACKNOWLEDGEMENT 1

ABSTRACT 2

MARKET OVERVIEW 4

1 INTRODUCTION 5

1.1 PROBIOTICS: “A NEW STEP IN DENTAL AND MEDICAL THERAPY” 71.1.1 Mechanism of action 71.1.2 Route of Administration 81.1.3 Proposed clinical uses 8

1.2 OBJECTIVES OF THE PROJECT 91.3 WORKFLOW OF THE PROJECT 10

2 SURVEY METHODOLOGY 11

2.1 CITIES COVERED 112.2 NUMBER OF DENTAL SURGEONS INTERVIEWED 112.3 METHODOLOGY 112.4 NUMBER OF FIELDWORK DAYS 112.5 FIELDWORK DISTRIBUTION 112.6 SAMPLING CRITERIA 11

2.6.1 Geography 122.6.2 On the basis of place of work 122.6.3 Demographically 132.6.4 On the basis of specialization 132.6.5 On the basis of type of patients 132.6.6 On the basis of organization’s database 13

3 PROJECT FINDINGS 14

4 LEARNINGS OF THE SURVEY 42

5 RECOMMENDATIONS AND DISCUSSION 44

6 SWOT ANALYSIS 48

7 BIBLIOGRAPHY 49

ANNEXURE 50

Glossary of Terms 54

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Market overview

Disease segment: Halitosis (Oral Malodor), Gingivitis and Periodontitis.

Product: Probiotic Lozenge (Containing Lactobacillus Brevis CD2 strain).

Target category: Dental Surgeons including General Practitioners (Dental Specialty)

and specialists like Periodontists, Prosthodontists, Oral surgeons, Endodontists,

Pedodontists, Orthodontists and Oral Radiologists.

Research methodology: Primary survey among 126 Dental Surgeons by interview

method.

Competitor products: The competitor products for the new formulation are:

Product Indication

Chlorhexidine mouthwash Gingivitis and Halitosis

Listerine mouthwash Halitosis

AM-PM mouthwash Halitosis

Zinc lozenges Halitosis

Local Anesthetics and

CorticosteroidsOral Ulcers

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1 Introduction

Oro-dental conditions have troubled mankind from times immemorial. More than 2000

years ago Hippocrates suggested a rinse using herbs and wine to be used to get rid of bad

breath1. There are various Oro-dental conditions that have troubled mankind for long but

the prevalence of Dental Caries, Gingivitis, Periodontitis, Staining of teeth, Oral Ulcers

and Halitosis has been fairly common. Dental caries and Periodontitis have been the two

major Oro-dental diseases responsible for tooth loss in human beings2.

Periodontal disease is very common. Initially it affects the gums (Gingiva), but if left

untreated it can spread to the periodontal ligament and the bony socket, leading to the

loss of teeth. When only the gums are involved the condition is called Gingivitis; once

the supporting structures are involved it is called Periodontitis.

The cause of both the conditions is toxins and enzymes which are produced by

pathogenic bacteria of the oral cavity. These toxins and enzymes cause inflammation of

the periodontal tissues and eventually cause their destruction. Gingivitis and Periodontitis

are silent diseases since most of the times their progress is slow and painless until the

person affected by them notices a sign such as bleeding from the gums.

Gingivitis2:

Inflammation of the gums is called “Gingivitis”. In this disease the gums become red,

swollen and they bleed easily. Gingivitis is a mild form of gum disease that can be

reversed with daily brushing, flossing and maintaining a good oral hygiene. It may

require professional help only in case it becomes severe. This form of gum disease does

not include any loss of bone or tooth supporting structures that hold the teeth in place.

Periodontitis2:

When Gingivitis is not treated, it can advance on to become Periodontitis which means

the inflammation of the tooth supporting structure. In this form of the disease gums pull

away from the teeth which results in the formation of “Periodontal Pockets”.

Bacterial toxins and the body’s immune system fighting the infection start to break down

the bone and connective tissue that hold the teeth in place. If not treated the bones, gums

and the connective tissue that supports the teeth are destroyed and the teeth may

eventually become loose and fall down or have to be removed.

Halitosis3:

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Bad breath or Halitosis is defined as an offensive or unpleasant odor emanating from the

mouth. It may cause a psychological or social handicap to those suffering from it. It is

estimated that about 50% the population is affected by Halitosis with different levels of

frequency. The origin of Halitosis is related to both systemic and oral conditions with 90

% of Halitosis known to be originating from the oral cavity.

Cause of Halitosis

Local cause:

Halitosis can be directly linked to the breakdown of food debris, epithelial cells and

salivary compounds in the oral cavity by pathogenic bacteria. This breakdown results in

the formation of volatile sulphur compounds such as Hydrogen Sulphide,

Methylmercaptan and Dimethyl Sulphide. These volatile sulphur compounds (VSCs)

provide odor to the breath.

Numerous bacterial species have been shown to produce VSCs. The microflora of the

oral cavity is predominantly gram-positive in nature but becomes more gram-negative in

situations such as reduced salivary flow, periodontal disease, Gingivitis and poor oral

hygiene. Gram-negative anaerobic bacteria produce higher levels of sulphides and are

therefore more likely to produce bad breath.

Periodontal disease is a major cause of bad breath due to an environment that is favorable

to trapping food and allowing anaerobic bacteria to thrive. In the healthy individual the

gingival tissues are well adapted to the surface of the tooth. However, due to periodontal

disease, there is pocket formation in which food gets entrapped and anaerobic bacteria

can thrive. With increased substrate availability pathogenic bacteria can produce more

VSCs to cause Halitosis and elicit more destruction to the periodontal tissues.

Systemic cause:

Normal physiological processes can cause Halitosis which is usually transitory in nature.

This non-pathological Halitosis may be due to empty stomach, low level of salivation

during sleep, smoking and some vegetables like onion or garlic or from some drinks like

coffee or tea. Some pathological conditions may cause Halitosis such as diabetes,

gastrointestinal disorders, hepatic and renal failure.

Management:

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There are various treatment options available in case of Halitosis, such as:

Maintaining a good oral hygiene by Brushing and Flossing the teeth after every major

meal (a person can do it himself at home) and using an Antibacterial Mouthwash.

Removal of the local factors such as Plaque, Calculus and Food stuck between the

teeth by Scaling (done by the dentist).

In case of a systemic disease, treatment of the underlying medical condition.

Avoiding medicines, food items and habits like smoking that are responsible for

Halitosis.

1.1 Probiotics: “A new step in Dental and Medical therapy”

The majority of the bacteria residing in the oral cavity are harmless and some of them are

beneficial. It is the beneficial bacteria that keep the pathogens from doing the damage. In

the oral cavity the beneficial bacteria compete with the pathogens for the food particles.

They also produce certain inhibitory substances by acting on these food particles and

create an unfavorable environment; so that the pathogens are not able to survive.

This ability of the harmless bacteria is now being exploited by administering various

formulations either systemically or locally containing the strains of such bacteria in order

to combat systemic diseases and diseases of the oral cavity especially Halitosis,

Gingivitis and Periodontitis. This project is based on the role of such novel Probiotic

formulation in Oro-Dental care.

Compound description (Inersan): Lactobacillus Brevis (CD2)3

The use of Lactobacillus Brevis (CD2) is proposed as a safe and effective treatment

modality for Halitosis. It contains two very unique Lactobacillus origin enzymes,

Arginine Deaminase and Sphingomyelinase.

1.1.1 Mechanism of action

Arginine Deaminase: Nitric oxide is a potent inflammatory mediator responsible for the

production of various kinds of enzymes that cause destructive changes in the periodontal

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tissues. Arginine Deaminase causes the depletion of the substrate required to produce

nitric oxide and thus control inflammation.

Sphingomyelinase: Platelet activating factor or PAF is present in the saliva of healthy

human subjects and is involved in pathological events within the oral cavity. The salivary

PAF levels have been found to be associated with varied extent and severity of

periodontal disease. The use of Sphingomyelinase to hydrolyze PAF can resolve the

inflammatory process and thus help in controlling Periodontitis.

1.1.2 Route of Administration

It will be a locally administered formulation (lozenge form).

1.1.3 Proposed clinical uses

Gingivitis.

Periodontitis.

Halitosis.

Mucositis related to autoimmune disease like Bechet’s disease.

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1.2 Objectives of the project

The main objective of this project is to find out the perception of the Dental

Surgeons regarding the Probiotic formulations and the potential role they can play in

the therapy of Halitosis and Periodontitis.

Whether such formulations can fit in the gaps which are currently persistent in the

therapy of Halitosis and Periodontitis?

What are the expectations of the Dental Surgeons from the Novel Probiotic

formulation and whether such a formulation can fit in as a Direct to Customer

product?

To find out whether there is a prevalence of Halitosis due to Periodontitis in the

current practice of the Dental Surgeons.

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1.3 Workflow of the project

Initial groundwork was done on the Probiotic formulation by reading material on the

internet, books, journals and the material available with the organization. (1 Week)

↓

A structured questionnaire was framed on the basis of the initial groundwork. (1 week)

↓

A pilot survey was carried out amongst the Dental Surgeons of NCR. (1 week)

↓

Re-framing of the initial questionnaire was done on the basis of analysis of the responses

obtained in the pilot survey. (1 week)

↓

Primary data was collected by interview method from respondents in NCR, Mumbai and

Hyderabad/Secunderabad. (4 weeks)

↓

Tabulation, Documentation and Consolidation of the primary data collected. (1 week)

↓

Analysis of the Primary Data and formulation of the final report (1 week)

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2 Survey methodology

2.1 Cities covered

National Capital Region (New Delhi, Ghaziabad and Faridabad)

Mumbai (Mumbai Central, Suburban Mumbai and New Mumbai)

Hyderabad (Hyderabad Central, Suburban Hyderabad and Secunderabad)

2.2 Number of Dental Surgeons interviewed

126.

2.3 Methodology

Primary data was collected with the help of a structured questionnaire by Interview

method. The questionnaire consisted of 14 questions in all. There were 5 open ended

questions while the rest of the questions had answers based on ordinal and nominal scale.

2.4 Number of fieldwork days

19 days.

2.5 Fieldwork distribution

Table 1: Fieldwork distribution

City No of days

NCR (New Delhi) 8

NCR (Faridabad) 1

NCR (Ghaziabad) 1

Mumbai 4

Hyderabad/Secunderabad 5

2.6 Sampling criteria

The sample size of 126 Dental Surgeons was chosen on the basis of following criteria:

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2.6.1 Geography

The respondents were selected from three regions of India namely North (NCR), West

(Mumbai) and South (Hyderabad/Secunderabad). The break up of these regions is as

follows:

National Capital Region (Northern region):

Dental Surgeons from South and South West Delhi from areas viz. Panchsheel

Enclave, GK I, GK II and Alaknanda.

Dental Surgeons from North Delhi viz. Karol Bagh, Patel Nagar, Old and New

Rajendra Nagar and Rohini.

Dental Surgeons from North East Delhi viz. Pitampura, Ashok Vihar, Paschim

Vihar, Panjabi Bagh, Shalimar Bagh and Vikaspuri.

Dental Surgeons from Ghaziabad and Faridabad.

Mumbai (Western region):

Dental Surgeons from Andheri (E) and (W).

Dental Surgeons from Ville Parle (E) and (W).

Dental Surgeons from Navi Mumbai and Vaashi.

Dental Surgeons from Borivalli (E) and (W) and Mumbai central.

Hyderabad/Secunderabad (South Region):

Dental Surgeons from Somajiguda and Panjagutta.

Dental Surgeons from Kukatpally.

Dental Surgeons from Ameerpet and ABIDS.

Dental Surgeons from Secunderabad.

2.6.2 On the basis of place of work

Respondents were selected on the basis of their place of work such as:

Private practice.

Charitable institutions.

Private hospitals.

Government hospitals.

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2.6.3 Demographically

The respondents were chosen from different age groups ranging from minimum 25 years

to maximum 60 years.

2.6.4 On the basis of specialization

There were General Dental Surgeons in the Sample size of 126 as well as specialists like

Prosthodontists, Endodontists, Orthodontists, Periodontists, Pedodontists, Oral

Radiologists and Oral Surgeons.

2.6.5 On the basis of type of patients

The respondents were selected on the basis of the type of patients they handled such as

Dental Surgeons dealing with patients of high socio-economic class like Movie stars,

Government officials, Executives working in MNCs.

On the other hand Dental Surgeons dealing with patients of low socio-economic class

were also included in the sample size.

2.6.6 On the basis of organization’s database

The respondents were also included from outside Ranbaxy’s database of Dental

Surgeons which was provided at the time of primary survey.

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3 Project findings

Out come on the basis of questionnaire:

1) What is the most common Oro-dental problem that you are encountering in your

daily practice? (1-most common; 5 least common)

a) Caries ( ).

b) Halitosis ( ).

c) Gingivitis ( ).

d) Periodontitis ( ).

e) Stains ( ).

Table 2: Common Oro-dental conditions:

% of

Respondents

Rank Oro-dental

condition

97 1 Dental Caries

68 2 Gingivitis

42 3 Halitosis

45 4 Periodontitis

64 5 Stains

Interpretation:

I. 97% (123/126) of the respondents ranked dental caries as the most frequent

problem they encountered in their practice establishing the fact that dental pain is

still the most frequent reason for which mankind seeks professional help!

II. 68% (86/126) of the respondents ranked Gingivitis as the 2nd most frequent problem

they encountered with most of the Dental Surgeons saying that tooth pain and gum

diseases are the only two problems which drives patient traffic to their set-up.

III. Halitosis was ranked 3rd by 42% (53/126) of the respondents with most of them

saying that those who are affected are not aware of it unless someone points it out

to them. Most of the respondents stressed upon the lack of awareness on the part of

patient regarding his/her oral health.

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IV. 45% (57/126) of the respondents ranked Periodontitis as the 4 th most frequent

problem while 64% (81/126) ranked staining of teeth as the least frequent.

Important comments:

a) “Most of the patients who come to us have Halitosis but not all of them are aware

of it until we tell them”- Dr. L. Virmani (MDS); Mata Gujri Charitable Hospital,

GK (New Delhi).

b) “There is a need to educate the patients regarding their oral health since most of

them come to us only when there is a problem. Gingivitis and Periodontitis are

silent diseases in most of the cases.”- Dr. Manu Modi; Prosthodontist, Ashok

Vihar (New Delhi).

Graph 1:

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2) What is the number of patients encountered with chief complaint of Halitosis in

your weekly practice?

a) <5 ( ).

b) 6-10 ( ).

c) 11-15 ( ).

d) 16-20 ( ).

e) >21 ( ).

Table 2: No of patients with Halitosis as chief complaint

Number of patients % of Respondents

< 5 22

6-10 52

11-15 22

16-20 04

>21 00

Graph 2:

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Interpretation:

I. 52% (65/126) of the Dental Surgeons see on an average 400 patients annually who

have Halitosis as the main problem while 22% (28/126) see on an average 675 such

patients annually. However 22% (27/126) say that they see only 200 patients

annually who are affected by Halitosis. A very small number {5% (6/126)} say that

they see up to 936 patients of Halitosis annually.

II. Option < 5 was chosen by those Dental Surgeons who were practicing in areas

where higher socio-economic class resided. The patients of these Dental Surgeons

were educated and had knowledge regarding their oral hygiene thus the low

prevalence of Halitosis in their practice.

III. Option 16-20 was chosen by those who were either working in charitable or

government run institutions where the patient traffic was primarily from the low

socio-economic class and the cost of dental treatment is low.

IV. According to the all the respondents the average no of Halitosis patients seen

annually are:

65 x 400 = 26000

28 x 675 = 18900

27 x 200 = 5400

06 x 935 = 5610

Summing up we get a total of 55910. This gives an average of 440 patients per

respondent annually. Thus it shows that there is a significant no of patient traffic due to

Halitosis which seeks professional care even though it stands at no 3 in the ranking of

most frequent Oro-dental conditions according to the survey!

V. An important point to note is that the cities covered in the study are Tier I cities

where majority of population residing is concerned about their oral health and is

educated. These numbers can be higher if the study is carried out in Tier II and Tier

III cities.

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3) What is the most common cause of Halitosis that you encounter in your practice?

(1-most common; 6 least common)

a) Gingivitis ( ).

b) Periodontitis ( ).

c) Food impaction ( ).

d) Lifestyle- smoking, dietary habits ( ).

e) Pericoronitis ( ).

f) Systemic diseases ( ).

g) Any other.

In case of Periodontitis patients what actually leads to Halitosis?

Table 4: Most common cause of Halitosis

Cause Rank % of Respondents

Gingivitis 1 51

Periodontitis 2 40

Lifestyle 3 28

Systemic disease 4 37

Pericoronitis 5 38

Food impaction 6 52

Some other causes attributed except the options

Xerostomia 16

Malocclusion 12

Dry socket 08

Mouth breathing 08

Tongue coating 07

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Interpretation:

I. 51% (64/126) of the Dental Surgeons attributed Gingivitis as the No 1 cause for

Halitosis in their practice while 40% (51/126) of the Dental Surgeons attributed

Periodontitis as the No 2 cause. This brings to the fore the correlation between

Gingivitis, Periodontitis and Halitosis with most of the Dental Surgeons

commenting that all the three are linked to each other as Gingivitis progresses on

to Periodontitis with Halitosis acting as a sign of disease progression!

II. Other important cause for Halitosis which came out from the responses is lifestyle

i.e. smoking, beetle nut chewing and dietary habits. 28% (35/126) of the

respondents ranked it as the no 3 cause for Halitosis.

III. 37% (47/126) of the Dental Surgeons attributed systemic diseases as the No 4

cause with most of them attributing Diabetes and Upper Respiratory Tract

Infections as the systemic diseases responsible for causing Halitosis.

Important comments:

a) “Patients who are suffering from chronic Gingivitis or Periodontitis are

invariably having Halitosis whether they know about it or not.”- Dr. Vikesh

Kapila (BDS); Paschim Vihar (New Delhi).

b) “Gum disease is the single most important local factor responsible for

Halitosis.”- Dr. Greesh Lillaney, Periodontist, Andheri (W) (Mumbai).

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Chemistry behind Halitosis:

The actual reason for Halitosis given by various respondents:

Graph 3:

Table 5: Chemistry behind Halitosis

Cause % of Respondents

Action of oral bacteria on food particles

stuck to oral structures

50

Pus formation in periodontal tissues 38

Action of bacterial Plaque on food

impacted in periodontal pockets

7

Bacterial action on food particles stuck to

oral structures produces odorous gases

5

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Interpretation:

I. 50% (63/126) of the Dental Surgeons said that action of oral bacteria on food

particles stuck to oral structures is what causes Halitosis while 38% (45/126) of

the Dental Surgeons said that pus formation in periodontal tissues is what actually

causes Halitosis.

II. Only 5% (7/126) of the Dental Surgeons said that bacterial action on food

particles stuck to oral structures produces odorous gases; which is the actual

theoretical as well as clinical cause for Halitosis. However, almost all the Dental

Surgeons directly or indirectly pointed out on the role of bacteria whether it being

Plaque or pus formation, stressing upon the fact that almost all of the respondents

were aware to some extent regarding the role played by pathogenic bacteria in

Halitosis!

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4) How does Halitosis affect the patients socially, in terms of life at work and at the

personal front?

Graph 4:

Interpretation:

I. 62% (78/126) of the Dental Surgeons opined that people working in MNCs in the

age group of 20-30 years seek professional help for the problem of Halitosis as

they are embarrassed when someone at their office points out that they have bad

breath. Most of them feel that it reduces their confidence level and they shy away

from talking in close proximity.

II. 38% (45/126) of the Dental Surgeons opined that newly married couples are also

frequent seekers of professional help for the problem of Halitosis as a partner

having bad breath is a strict “no-no” for them. In this segment either the male or

the female partner was the one who came to seek help for the affected partner.

III. 33% (42/126) of the Dental Surgeons opined that teenagers especially girls were

very concerned and embarrassed regarding bad breath from their mouth as they

were beauty conscious and considered fresh breath a part of their beauty.

IV. 13% (16/126) of the Dental Surgeons opined that old people were also frequent

seekers of professional help since it is very embarrassing when their

grandchildren point it out in front of guests or other family members.

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V. 7% (9/126) of the Dental Surgeons said that mothers were very concerned

regarding the bad breath of their child and considered it as a bad thing for their

children’s health.

Important comments:

a) “Bad breath is a social stigma for those who are affected by it and are concerned

about it.”- Dr. D.C. Gupta (BDS), Faridabad (NCR).

b) “Teenagers especially girls are very embarrassed if they have bad breath.”- Dr.

Sunali Khanna (Oral radiologist), Nair Hospital (Mumbai).

c) “People working as PR executives feel that bad breath reduces their confidence

level while they are talking in close proximity to someone and it is not a good

thing for their kind of job.”- Dr. Chanchal Siddhu (BDS), Faridabad (NCR).

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5) What are the most frequent pre-disposing factors that you would attribute to

patients of Periodontitis?

Table 6: Pre-disposing factor for Periodontitis

Pre-disposing factor % of Respondents

Poor oral hygiene 64

Diabetes 32

Improper brushing technique 15

Malocclusion 14

Smoking 12

Failure to brush at night 10

Interpretation:

I. 63% (80/126) of the Dental Surgeons attributed poor oral hygiene directly as the

pre-disposing factor for Periodontitis while 15% (19/126) and 10% (13/126)

attributed improper brushing technique and failure to brush at night respectively

as the pre-disposing factors. This simply emphasizes the importance of

maintaining good oral hygiene in order to prevent periodontal disease as improper

brushing and failure to brush at night all lead to accumulation of Plaque which is

the single most important indicator of oral hygiene.

II. 32% (40/126) of the Dental Surgeons attributed diabetes as the pre-disposing

factor for Periodontitis. This endocrine disease results in high sugar levels in the

blood, saliva and GCF. This results in formation of advanced glycation end-

products (AGEs) which stimulate the inflammatory response by increasing the

activity of collagenases.

III. 14% (18/126) and 12% (15/126) of the respondents said that malocclusion and

Smoking are the pre-disposing factors for Periodontitis.

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6) What therapy do you choose for patients with Periodontitis related Halitosis? (1-

most frequent; 5-least frequent)

a) Brushing and flossing ( ).

b) Mouthwashes and gum paint ( ).

c) Hydrogen peroxide ( ).

d) Scaling ( ).

e) Antibiotics ( ).

f) Any other.

Table 7: Choice of therapy

Therapy Rank % of Respondents

Oral prophylaxis 1 85

Scaling 2 48

Mouthwashes and Gum

Paints

3 44

Hydrogen peroxide 4 38

Antibiotics 5 66

Interpretation:

I. 85% (107/126) of the Dental Surgeons said that Oral prophylaxis (patient

education and brushing and flossing) is the No 1 therapy for the treatment of

Periodontitis related Halitosis since poor oral hygiene is most frequent in such

patients. So, there is a need to educate patients regarding the correct way of

brushing as well as maintaining a good oral hygiene.

II. 48% (61/126) of the Dental Surgeons administered scaling after Oral prophylaxis

as they opined that mechanical removal of Plaque and Calculus (which can not be

removed by brushing alone!) is the most important way of reversing the problem.

III. 44% (55/126) of the Dental Surgeons opted for mouthwashes and gum paint after

scaling. The respondents felt the need to prescribe an antibacterial mouthwash in

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cases of severe infection to support the mechanical therapy while on the other

hand some respondents felt the need to prescribe a mouthwash only to satisfy the

patient psychologically!

IV. 38% (48/126) of the Dental Surgeons used hydrogen peroxide in order to de-

bride the periodontal tissues after the mechanical therapy as they felt that

hydrogen peroxide removes all the granulation tissue as well as bacteria from the

crevices due to its action.

V. 66% (83/126) of the Dental Surgeons opted for antibiotics as the last resort for

treatment of Periodontitis since they didn’t think it as a wise option. According to

them gum diseases are mostly locally treated and there is no need to give

systemic antibiotics for a local disease.

Important comments:

a) “Since gum problems have local etiology there is no need to give

systemic antibiotics as they will have some systemic effects also in

addition to the effects on gums”- Dr. Sushil. K. Lal (Oral Surgeon),

Inderprastha Dental College, Ghaziabad (NCR).

b) “Brushing and scaling alone removes all of the local causes so there is no

need to prescribe antibiotics, mouthwashes have to be prescribed in order

to satisfy the patient other wise they only act as deodorants!”- Dr

Deshpande (BDS), GK (New Delhi).

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7) What is the normal duration of the therapy that you prescribe?

a) 2-3 days ( ).

b) 4-5days ( ).

c) 5-7 days ( ).

d) > 7 days ( ).

e) Till the patient gets relief ( ).

Graph 5:

Interpretation:

I. 51% (64/126) of the Dental Surgeons prescribed mouthwashes and gum paints

for more than a week in the therapy of Periodontitis while 43% (54/126)

prescribed them for a week only. Very few 6% (8/126) prescribed supportive

therapy only till the patient got relief since most of them laid stress on long term

relief rather than quick short relief from the problem.

II. Some of the Dental Surgeons also reasoned on prescription of a mouthwash for

more than a week to cover up any lapse on part of the patients with respect to

maintaining good oral hygiene.

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Important comments:

a) “Mouthwashes are only deodorants and are generally prescribed for the

psychological satisfaction of the patient!”- Dr. Nishant Jaiswal (BDS),

Mani Devi Basia Dharmarth Chikitsalaya, Pitampura (NCR).

b) “We prescribe mouthwashes for the entire duration of fixed orthodontic

therapy since it is very important for the patients to maintain oral hygiene

during the therapy.”- Dr. Shweta Bhatt (Orthodontist); Nair Dental

Hospital (Mumbai).

c) “Mouthwashes are prescribed for regular use since patients find it

satisfying and fresh after the use of a mouthwash!”- Dr. Venkateshwara

(BDS); Asian Dental Hospital, Panjagutta (Hyderabad).

d) “Mouthwashes have to be used regularly along with brushing and flossing

to maintain good oral hygiene”- Dr. Prerna Mathur (MDS), Indraprastha

Dental College, Ghaziabad (NCR).

Page 30 of 57

8) How would you rate the compliance of your patients in terms of the supportive

therapy you prescribe?

a) Very good ( ).

b) Satisfactory ( ).

c) Can’t say ( ).

d) Not at all satisfactory ( ).

e) Very poor ( ).

Graph 6:

Interpretation:

I. 51% (64/126) of the Dental Surgeons were satisfied with the patient compliance

while 33% (42/126) said that patient compliance was very good. 11% (14/126)

said that compliance was not satisfactory and only 5% (6/126) said that it was

very poor.

II. This indicated that the patients do stick to the therapy as prescribed by the Dental

Surgeons and are ready to use additives for periodontal therapy even for more

than a week.

Important comments:

a) “Patient compliance depends upon how well you motivate the patient

regarding his/her oral health. If he is motivated he will use it even for a

lifetime!”- Dr Radhika Muppa (MDS), Kukatpally (Hyderabad).

Page 31 of 57

9) What are your criteria for choosing a therapy for Halitosis related to Periodontitis

and what is the main expectation from the treatment modality that is chosen?

What according to you are the gaps in the current therapy?

Table 8: Duration of therapy

Therapy No of days % of Respondents

Mouthwash/Gum Paint 7 days 33

Mouthwash/Gum Paint 15-20 days 27

Mouthwash/Gum Paint 3 months 18

Mouthwash/Gum Paint 1 month 5

Antibiotics 7 days 40

Interpretation:

I. All the Dental Surgeons said that the criterion for choice of therapy for Halitosis

due to Periodontitis is primarily removal of etiology i.e. Plaque and Calculus.

II. All the Dental Surgeons stressed upon administration of Oral prophylaxis as the

first choice in the therapy followed by prescription of a mouthwash and/or gum

paint. 93% (118/126) of the Dental Surgeons prescribed mouthwashes after oral

prophylaxis while 7% (8/126) prescribed mouthwashes as well as gum paint.

III. 33% (41/126) of the Dental Surgeons prescribed additive for a week after oral

prophylaxis while 27% (34/126) prescribed it for 15-20 days.

IV. 18% (23/126) prescribed it for 3 months, 7% (9/126) for 2-3 months, 5% (7/126)

for a month and a very few Dental Surgeons prescribed it for more than 6 months or

even for regular use.

V. All the Dental Surgeons felt the need of prescribing antibiotics only after

periodontal surgery or in case there was pus discharge from the periodontal tissues.

21% (27/126) Dental Surgeons preferred prescribing Doxycycline in such cases

while 18% (23/126) preferred prescribing Metronidazole since these are the

antibiotics that have the highest concentration in saliva and GCF.

Page 32 of 57

Graph 7:

Interpretation:

I. 41% (52/126) of the Dental Surgeons could not say anything about the gaps in the

current therapy while 34% (43/126) felt that there are no gaps at all!

II. 14% (18/126) of the Dental Surgeons felt that there is a big scope for LDDS in

case of dental therapy and that such delivery methods are seldom used although

these are the best for dental therapy.

III. 7% (9/126) said that the currently available mouthwashes (Chlorhexidine or

povidone iodine based) cannot be prescribed for a long time as they produce

staining of teeth and metallic taste with prolonged use.

IV. 4% (5/126) felt the need to develop chemical means of removing Plaque.

Important comments:

a) “There is a need to promote LDDS for periodontal diseases since they are

the best for such diseases with local causes”- Dr. Vatsalya Shetty;

Associate Professor (Endodontics), Nair Dental Hospital (Mumbai).

b) “In western countries if the need for pharmacotherapy arises it is met

primarily by LDDS. However in India they are still in the nascent stages”-

Dr. K.S. Banga; HOD (Periodontics), Nair Dental Hospital (Mumbai).

c) “Mouthwashes without metallic taste and staining should be developed.”-

Dr. Mohit Chawla (BDS), Shalimar Bagh (New Delhi).

Page 33 of 57

10) A Probiotic formulation would help a Dentist restore the normal oral micro flora

in a patient?

c) Strongly agree ( ).

d) Slightly agree ( ).

e) Can’t say ( ).

f) Slightly disagree ( ).

g) Completely disagree ( ).

Graph 8:

Interpretation:

I. 42% (53/126) of the Dental Surgeons strongly agreed that Probiotic formulation

would help them in restoring the normal oral microflora in a patient while 37%

(46/126) slightly agreed as they had doubts about it. Their prime concern was the

efficacy of the new formulation as according to them as far as the drug is giving

results they are happy to prescribe it. Another striking feature was that those who

strongly agreed were mostly post-graduates stressing upon the importance of

Continuing Dental Education among the general practitioners.

II. Those who were not ware of the role of probiotics; when told about the mechanism

of action of the new formulation were taken by surprise as they had never thought

of restoring the oral microflora in case of periodontal disease! They primarily

concentrated on removal of etiology i.e. Plaque and Calculus.

Page 34 of 57

III. 18% (23/126) were not able to decide whether a Probiotic formulation would help

them. This was primarily due to the lack of thorough knowledge regarding the role

probiotics can play in dental therapy. Only 3% (4/126) disagreed that such a

formulation would actually help them. Their view primarily centered on the concept

of mechanical therapy being the best choice for periodontal diseases. Some of the

Dental Surgeons who were practicing since the last 15-20 years were not ready to

accept the concept of probiotics in dentistry.

Important comments:

a) “Probiotics are only a fad and won’t actually provide long term benefit.”-

Dr. Deshpande (BDS), GK (New Delhi).

b) “What probiotics would do is already being done by mechanical therapy. It

can be only given as a cover to antibiotics”- Dr. Koccher (MDS), HOD R.

K. Mission Hospital, Karol Bagh (New Delhi).

c) “This is a novel concept and whosoever thought about it has actually hit the

bulls eye!”- Dr. Kavita Laamba (MDS), Faridabad (NCR).

Page 35 of 57

11) Do you believe that introducing a formulation containing Probiotic strain

(Lactobacillus Brevis) would…?

a) Complete your prescription ( ).

b) Can’t say ( ).

c) Prescription would still be incomplete ( ).

What else do you think would be left out in the prescription?

Graph 9:

Interpretation:

I. 47% (60/126) of the Dental Surgeons believed that such a formulation would

complete their prescription while 46% (59/126) couldn’t decide and only 7%

(7/126) said that the prescription won’t be complete. All the Dental Surgeons who

did not agree could not comment on what would complete the prescription!

II. Those who agreed said that they had never thought of such a concept. According

to them the concept seems theoretically right; the only concern was the actual

clinical efficacy of the new formulation.

Important comments:

a) “Research and development keeps on adding new drugs to the prescription

but their efficacy is only known after the widespread use. So, this new

formulation should be clinically tested on a large no of patients before

being brought to the market.”- Dr. Madhavi Mehta (MDS), Ville Parle

(Mumbai).

Page 36 of 57

12) What would help you in prescribing such a Probiotic formulation?

a) Clinical data regarding beneficial effects in various dental conditions ( ).

b) Clinical data regarding the superior efficacy of such formulations over other

adjunctive therapy ( ).

c) A and b Both ( ).

d) A Continuing Dental Education (CDE) program covering all the details of the

new formulation.

e) Can’t say ( ).

Graph 10:

Interpretation:

I. 46% (57/126) of the Dental Surgeons wanted both clinical data regarding the

beneficial effects as well as the superior efficacy of the new formulation while

25% (32/126) only wanted clinical data regarding the superior efficacy of the new

formulation.

II. 19% (24/126) wanted clinical data regarding the beneficial effects while only

10% (13/126) wanted to attend a CDE program on the topic.

III. The reason behind less no of respondents wanting to attend a CDE program was

the lack of time as most of the respondents worked late in the evenings.

IV. Those who wanted the clinical data regarding the efficacy recommended the data

being presented to them should be at least 4-5 years clinical data and that it should

compare the currently used additives with the new formulation.

Page 37 of 57

13) What would be the type of formulation you would suggest in such a case? What

would be the dosage and pricing according to you that would be best suited for

the formulation suggested?

Graph 11:

Interpretation:

I. 50% (63/126) of the Dental Surgeons preferred locally delivered or applied form

of the drug out of which 18% (23/126) said lozenges would be beneficial, 15%

(19/126) said they would like a mouthwash or a gum paint and the remaining said

that any locally applied form would be welcome. They opined that gum diseases

mostly have local etiology so there is no need to use systemic therapy.

II. 30% (38/126) of the Dental Surgeons preferred systemic (tablet) form of the drug.

According to them the systemic form was convenient to use and prescribe also.

III. 18% (23/126) of the Dental Surgeons could not comment on what type of

formulation should be launched primarily because of the lack of knowledge of the

Probiotic formulation.

Page 38 of 57

IV. Only 4 Dental Surgeons out of 126 felt that the proposed formulation won’t be

beneficial at all in Oro-dental conditions and declined to comment on the

question.

I. Price range suggested by Dental Surgeons according to the formulation desired:

7% (9/126) suggested the price range for lozenges as Rs 2-3/lozenge or Rs

5-6/ day.

5% (6/126) suggested the price range for bottle of mouthwash as Rs 40-

70/50ml bottle. The mean price being Rs 55/50 ml bottle.

17% (22/126) suggested the price range for tablets as Rs 5 - 30/ tablet, of

which 11% (14/126) suggested the price range of Rs. 5 - 15/ tablet and

remaining 6% (8/126) suggested the price range of Rs. 15 - 30/ Tablet.

This upper limit of the price range was reasoned on the basis of high price

of some antibiotics such as Augmentin.

15% (19/126) suggested that the price for full therapy should not exceed

Rs 100 be it any form. The reason given by the respondents was the

psychological mark that figure of 100 has in most of the patient’s mind.

13% (16/126) suggested the price for full therapy should lie between Rs

150 - 200.

7% (9/126) suggested the price for full therapy should lie between Rs 100

-150.

8% (10/126) suggested the price for full therapy should lie between Rs 40

- 60 since periodontal diseases are more prevalent in low socio-economic

class and hence they should be able to afford it.

7% (9/126) suggested the price for full therapy should either be equal to

that of currently available mouthwashes and gum paints or not more than

twice their price.

Rest of the Dental Surgeons did not suggest any price range but suggested

that the price of the new formulation should be cheap since the prevalence

of periodontal diseases is highest in low income group people.

Page 39 of 57

14) If such a formulation is available to you what indications you would suggest for

its use?

Table 9: Indications

Oro-dental condition % of Respondents

Chronic Gingivitis 30

Chronic Periodontitis 27

Patients with poor compliance to oral

hygiene

18

Aggressive Periodontitis 17

After periodontal surgery 15

Xerostomia 14

Recurrent oral ulcers 13

Pre-pubertal Gingivitis 11

Malocclusion 10

Pregnancy 9

Mouth breathing 8

Drug induced Gingivitis 7

Smoking 7

Halitosis 6

ANUG 6

Patients wearing prosthetic appliances 5

Patients undergoing treatment of

fractures

3

Interpretation:

Page 40 of 57

I. The most important and the most recommended indication came out to be

Diabetes associated Periodontitis {33% (41/126)} as most of the respondents felt

that the new formulation could be very helpful in this disease. If the pathogenic

bacterial action can be suppressed it would help to reduce Halitosis in such

patients.

II. Chronic Gingivitis {30% (38/126)} and chronic Periodontitis {27% (34/126)}

were other important conditions which the respondents felt could be the important

indications as the mechanism of action of the new formulation is antagonistic to

what happens in these dental diseases.

III. Those patients who have poor compliance to oral hygiene were also indicated by

the respondents as one of the target indications {18% (23/126)}.

IV. Aggressive Periodontitis which is a rapidly progressing periodontal disease and is

caused by Actinobacillus actinomycetemcomitans is another important indication

suggested by 17% (21/126) of the respondents. The reason for this indication is

again the proposed mechanism of action of the new formulation since it

suppresses the action of bacteria which are associated with periodontal disease.

V. 15% (19/126) of the respondents felt that the new formulation could be given

after the periodontal surgery in order to replenish the commensal bacteria which

are also removed by the surgical and mechanical therapy.

VI. 14% (18/126) of the respondents felt that the new formulation could be very

effective in patients with reduced saliva flow as the bacteria don’t even get

flushed by the saliva and have ample time and suitable environment to act and

cause Halitosis and Periodontitis.

VII. 13% (16/126) of the respondents felt that recurrent oral ulcers can also be treated

with the new formulation as this condition also has a lot of pathogenic bacterial

activity.

VIII. Pre-pubertal Gingivitis in which there is generalized Gingivitis and Halitosis due

to hormonal changes was also suggested as one of the indications by 11%

(14/126) of the respondents.

Page 41 of 57

IX. 10% (12/126) of the respondents felt that such a formulation could be pretty

helpful in cases of malocclusion since in these cases orientation of teeth makes it

difficult for the patient to mechanically clean the tooth surfaces.

X. Pregnancy was suggested by 9% (11/126) of the respondents as one of the

potential indications as in pregnancy they have to take care while prescribing any

pharmacotherapy.

XI. Mouth breathing was suggested by 8% (10/126) of the respondents as another

important indication as patients who breathe through mouth generally have dry

mouth due to which the flushing action of saliva can’t remove pathogenic bacteria

and as a result these patients are more prone to Halitosis and periodontal diseases.

XII. 7% (9/126) of the respondents suggested drug induced Gingivitis as the potential

indication as some drugs taken for hypertension and epilepsy are known to cause

gingival enlargement and Gingivitis due to which it is very difficult for the patient

to keep good oral hygiene.

XIII. 7% (9/126) of the respondents suggested Smoking as the indication; according to

them heavy smokers are frequent with the problem of Halitosis.

XIV. Halitosis was suggested by 6% (8/126) of the respondents as one of the

indications.

XV. Acute Necrotizing Ulcerative Gingivitis or ANUG was suggested by 6% (8/126)

of the respondents since it is a condition which is caused by action of pathogenic

bacteria and needs other means to control along with the mechanical therapy.

XVI. Patients who wear prosthetic appliances like CDs (Complete Dentures), RPDs

(Removable Partial Dentures) and FPDs (Fixed Partial Dentures) are also

suggested as potential indications by 5% (6/126) of the respondents. These

patients can’t clean all the surfaces of the appliance they are wearing and hence

the areas become harbinger of bacterial growth and action.

XVII. 3% (4/126) of the respondents suggested patients who are undergoing treatment

of fracture of the jaws as an important indication since in these patients the jaws

are immobilized by putting wires and hence they are unable to keep good oral

hygiene.

Page 42 of 57

Important comments

a) “Hypoplastic enamel spots are a harbinger of growth for pathogenic bacteria, your

formulation can be helpful in this condition.”- Dr .L. Virmani (MDS); Mata Gujri

Charitable Hospital, GK (New Delhi).

b) “This formulation might be given as a preventive therapy post implant insertion in

order to maintain gingival health”- Dr Rohit Karnak (Periodontist), Nair Dental

Hospital (Mumbai).

c) “Patients with minimal Plaque and Calculus deposits but still having Gingivitis and

Periodontitis”- Dr Rohit Paul (MDS), Ghaziabad (NCR).

d) “Mentally challenged patients with poor motor reflexes who can’t brush properly”-

Dr. Ajay Gupta (BDS), Paschim Vihar (New Delhi).

e) “Old patients having denture irritation where the cause is not physical irritation”- Dr.

J. Sabharwal (Oral Surgeon), Vikas Puri (New Delhi).

f) “Patients with Grade III Calculus where removal of Calculus would loosen the teeth”-

Dr. Seema Mittal (BDS), Rohini (New Delhi).

Page 43 of 57

4 Learnings of the survey

1. Lack of Knowledge regarding Probiotics: The main issue which was brought to

light in the primary survey was the incomplete or no knowledge at all on part of

some Dental Surgeons regarding the new developments in the field of probiotics

(especially in relation to dentistry).

2. Novel formulation- Unproven clinical efficacy:

The clinical efficacy of the new formulation was another area on which questions

were raised since the traditional concept of pharmacotherapy has placed

Doxycycline and Metronidazole as the main drugs for periodontal pharmacotherapy

because of their ability to achieve highest concentration in saliva and GCF. The

respondents suggested that the efficacy of the new formulation should be

comparable to antibiotics.

Another issue brought to light was the duration of efficacy of the new formulation.

The question unanswered was what if the new formulation is discontinued? Will it

be able to maintain the commensal bacterial load once it has supplied it to the

desired site?

3. Price consideration: Cost of the new formulation was another area of concern.

Many Dental Surgeons recommended that the overall cost of therapy with the new

formulation shouldn’t be very high since most of the people who are affected by

Halitosis and Periodontitis belong to the low socio-economic class.

4. Local or Systemic?: Type of formulation also raised some doubts as the

respondents felt that for any formulation to be effective in gum diseases it has to

stay in contact with the gums for at least some time or it has to produce a significant

concentration in the saliva and GCF (in case it is systemic).

5. Lack of knowledge with regards to oral hygiene: Lack of awareness regarding oral

health was another issue which was felt to be addressed since most of the people

affected by Halitosis are not aware of it unless told by someone!

6. Palatability: The taste of the new formulation and its sugar content was also one of

the issues. In case of local therapy respondents suggested that the formulation

should be good to taste and should be sugar free!

Page 44 of 57

7. Convenience to use: Convenience to use the drug was also cited as one of the

issues as respondents said that in case of locally applied formulations; more

cumbersome the application procedure less is the patient compliance.

8. Easy availability: Availability of the formulation was another issue raised by the

respondents as according to them sometimes the formulations are effective but they

are not available in all drug stores!

9. Orthodontic issue: Another issue which was brought to the fore by orthodontists is

care that they have to take while prescribing anti-inflammatory drugs during

orthodontic treatment since tooth movement might get affected.

Page 45 of 57

5 Recommendations and Discussion

1. Importance of Continuing Education

There is a need to create awareness among the Dental Surgeons regarding the role

probiotics can play in Oro-dental conditions since there was a large no of

respondents which didn’t have a clue regarding the new developments in dentistry

especially on the Probiotic front.

Before the new formulation is introduced in the market there should be distribution

of booklets and other material regarding the role of probiotics in dental therapy.

The Dental Surgeons only concentrate on removal of etiology (Plaque and

Calculus) while treating patients with Halitosis and Periodontitis. There is a need to

brief them regarding the concept of restoring the oral microflora and the role it can

play in periodontal therapy while marketing the product.

2. Positioning and Segmentation

There should be careful positioning of the new product among the Dental Surgeons.

They should be segmented on the basis of type of patients they handle e.g. Dental

Surgeons handling patients of high socio-economic class and Dental Surgeons

handling patients of low socio-economic class.

Those who handle patients of high socio-economic class don’t consider price as a

criterion while prescribing drugs as long as the drug is efficacious and the patient

gets relief. While those who handle patients of low socio-economic class are price

conscious since their patients want value for money!

The Dental Surgeons can also be segmented on the basis of largest age group they

handle e.g. Dental Surgeons on the panel of MNCs as well as Dental Surgeons on

the panel of schools and colleges as according to the primary survey these two are

important areas where people are very concerned about bad breath.

3. Fulfilling the Gaps!

Non-Medicated mouthwashes are considered as mere deodorants by the Dental

Surgeons while medicated mouthwashes like Chlorhexidine can’t be prescribed for

Page 46 of 57

a long time due to the staining it produces. The new formulation can fill these gaps

and can be a good substitute for mouthwashes and gum paints if it can prove its

efficacy.

Patient acceptance is an issue thus a good flavor as well as refreshing zing has to be

added to the formulation so that it can give the same kind of effect as the patient is

used to in order to satisfy the patient psychologically.

Antibiotics are least preferred by the Dental Surgeons according to the survey since

they think it is unwise to prescribe a systemic drug in order to treat a local disease

having local etiology. The new formulation can be positioned as a drug which fills

this gap by providing the benefits of antibiotics without systemic effects!

4. Preferred type of formulation

A lozenge as a preferred type of formulation has been suggested by 18% of the

respondents. This number can be increased if the beneficial effects of lozenges are

described while marketing the product such as:

Convenience of carrying the product since a bottle of mouthwash requires a lot of

space.

Convenience to use the product as using a mouthwash is a cumbersome procedure

which requires time and can not also be used in front of everyone! While a lozenge

form can be used even while working in the office!

5. Pricing Strategy

Pricing of the new formulation should be according to the goal set by the organization

i.e. whether to skim the market or to penetrate it. The organization can look into the

development of a tube form of the same product which can be put into Dental Trays

and worn at night or during free time (similar to topical fluoride application “GC Tooth

Mousse by Recaldent” which is available for Rs 690 per 40 gm).Thus the new product

can be up market stretched (tube form) as well as down market stretched (lozenge

from).

Page 47 of 57

6. Directing the patient traffic

Since Gingivitis and Halitosis are already No 2 and No 3 Oro-dental conditions

according to the survey there is a need to educate the end users of the formulation in

order to drive more patient traffic to the Dental Surgeons.

Whether the organization wants to market it through Dental Surgeons or directly to

the end users there should be a campaign on “Oral Malodor and its implications on

oral health” among the target groups (according to the survey) like Working class,

Married couples, Teenagers and Mothers as most of the respondents stressed upon

the need to educate the patients regarding their oral health.

7. Clinical trials to prove efficacy

Clinical trials should be undertaken in order to see the efficacy of the new formulation

in diabetes related Halitosis and Periodontitis since it was the indication which was

suggested by 33% of the respondents.

8. Indications

The new formulation should be positioned as a drug for:

Chronic Gingivitis.

Chronic Periodontitis.

Halitosis.

Pre-pubertal Gingivitis.

Dry mouth or reduced salivary flow.

Patients of malocclusion.

Aggressive Periodontitis.

After periodontal surgery.

Recurrent oral ulcers.

Mouth breathing.

Smoking.

Patients wearing Removable Partial Dentures (RPDs) and Fixed Partial Dentures

(FPDs).

Patients undergoing treatment for fracture of jaws.

Page 48 of 57

Post-implant insertion.

Patients of chronic Gingivitis and Periodontitis with minimal Plaque and Calculus.

9. Supply chain integration

The new formulation should be available at most of the drug stores for the ease of

availability. So, it should also be promoted among the channel partner’s of Ranbaxy i.e.

Super stockists, Stockists and Retailers.

Page 49 of 57

6 SWOT Analysis

SWOT ANALYSIS

STRENGTHS OPPORTUNITIES

1. Good safety profile- Antibiotic

has side effects.

2. Early mover advantage-It is

the first drug of its kind.

3. Local therapy for systemic as

well as local diseases.

4. Backed by Scientific rationale.

5. Patient convenience- Easy to

carry and use.

1. Can capture the big

Mouthwash market.

2. Bridging the gap- Can bridge

the gap of therapy only having

local effects.

3. Patient traffic- The concern

for ‘Bad Breath’ already

exists; patient traffic can be

driven to the doctors by an

awareness campaign.

WEAKNESSES THREATS

1. New concept- not known by

many Dental Surgeons.

2. Unproven efficacy.

3. Price could be a drawback.

1. NDDS (perio-chip).

2. Established positioning of a

Mouthwash.

Page 50 of 57

7 Bibliography

1. Halitosis Update: A Review of Causes, Diagnoses, and Treatments.

www.cda.org/page/Library/cda_member/pubs/journal/jour0407/lee.pdf

2. Carranza’s Clinical Periodontology, Michael G. Newman, DDS, Henry H.

Takei, DDS, MS, Firmin A. Carranza, Dr. Odont , 9th Edition.

3. Data on file (Company’s confidential data, available on request).

4. “Anti-inflammatory effects of Lactobacillus Brevis on periodontal disease.”

Journal of Oral Diseases, volume XIII, issue IV, page 376-385, July 2007.

5. “Probiotics: contribution to oral health”. Journal of Oral Diseases, volume XIII,

issue V, page 443, September 2007.

6. “Guiding periodontal pocket decolonization: a proof concept”. Journal of Dental

Research, 86 (11), page 1078-1082, October 2007.

Page 51 of 57

Annexure

Questionnaire on Probiotics

Name of the Dental Surgeon:

1. What is the most common Oro-dental problem that you are encountering in

your daily practice? (1-most common; 5 least common)

a) Caries ( ).

b) Halitosis ( ).

c) Gingivitis ( ).

d) Periodontitis ( ).

e) Stains ( ).

2. What is the number of patients encountered with chief complaint of Halitosis

in your weekly practice?

a) <5 ( ).

b) 6-10 ( ).

c) 11-15 ( ).

d) 16-20 ( ).

e) >21 ( ).

3. What is the most common cause of Halitosis that you encounter in your

practice? (1-most common; 6 least common)

a) Gingivitis ( ).

b) Periodontitis ( ).

c) Food impaction ( ).

d) Lifestyle- smoking, dietary habits ( ).

e) Pericoronitis ( ).

f) Systemic diseases ( ).

g) Any other ……………………………………………………………………

Page 52 of 57

In case of Periodontitis patients what actually leads to

Halitosis? ...............................................................................................................................

................................................................................................................................................

.....

4. How does Halitosis affect the patients socially, in terms of life at work and at

the personal

front? ...................................................................................................................

..............................................................................................................................

...........

5. What are the most frequent pre-disposing factors that you would attribute to

patients of Periodontitis?

…………………………………………………………………………………

…………………………………………………………………………………

6. What therapy do you choose for patients with Periodontitis related Halitosis?

(1-most frequent; 5-least frequent)

a) Brushing and flossing ( ).

b) Mouthwashes and gum paint ( ).

c) Hydrogen peroxide ( ).

d) Scaling ( ).

e) Antibiotics ( ).

f) Any other ……………………………………………………………………

7. What is the normal duration of the therapy that you prescribe?

a) 2-3 days ( ).

b) 4-5days ( ).

c) 5-7 days ( ).

d) 7 days ( ).

e) Till the patient gets relief ( ).

Page 53 of 57

8. How would you rate the compliance of your patients in terms of the

supportive therapy you prescribe?

a) Very good ( ).

b) Satisfactory ( ).

c) Can’t say ( ).

d) Not at all satisfactory ( ).

e) Very poor ( ).

9. What are your criteria for choosing a therapy for Halitosis related to

Periodontitis and what is the main expectation from the treatment modality

that is chosen? What according to you are the gaps in the current therapy?

…………………………………………………………………………………

…………………………………………………………………………………

10. A Probiotic formulation would help a Dentist restore the normal oral micro

flora in a patient?

a) Strongly agree ( ).

b) Slightly agree ( ).

c) Can’t say ( ).

d) Slightly disagree ( ).

e) Completely disagree ( ).

11. Do you believe that introducing a formulation containing Probiotic strain

(Lactobacillus Brevis) would…?

a) Complete your prescription ( ).

b) Can’t say ( ).

c) Prescription would still be incomplete ( ).

What else do you think would be left out in the prescription?

………………………………………………………………………………..

…………………..............................................................................................................

................

Page 54 of 57

12. What would help you in prescribing such a Probiotic formulation?

a) Clinical data regarding beneficial effects in various dental conditions ( ).

b) Clinical data regarding the superior efficacy of such formulations over other

adjunctive therapy ( ).

c) A and b Both ( ).

d) A CDE program covering all the details of the new formulation.

e) Can’t say ( ).

13. What would be the type of formulation you would suggest in such a case?

What would be the dosage and pricing according to you that would be best

suited for the formulation suggested?

…………………………………………………………………………………

…………………………………………………………………………………

14. If such a formulation is available to you what indications you would suggest

for its use?

…………………………………………………………………………………

…………………………………………………………………………………

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Glossary of Terms

1. Calculus/Tartar: Hard calcified form of Plaque which attaches to the teeth.

2. Dry Socket: Painful condition after the extraction of the tooth.

3. Gingival Crevicular Fluid: A fluid which bathes the crevices between the gums

and the teeth and is composed of various compounds that are food for bacteria.

4. Lozenge: A drug in the form of candy which has to be either chewed or kept in

the mouth while it disintegrates.

5. Malocclusion: Crooked teeth.

6. Oral Prophylaxis: Instructing the patient on proper ways of maintaining good

oral hygiene and removal of Plaque and Calculus by mechanical ways.

7. Pericoronitis: inflammation of the gum flap covering the wisdom teeth.

8. Plaque: A thin bio-film which covers the tooth surface and other oral structures.

9. Probiotics: Are live microorganisms, which, when administered in adequate

amounts, confer a health benefit on the host.

10. Xerostomia: Reduced flow of saliva.

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