brief description of trial...

Shining white teeth contribute a lot to personality and increase our face value. Everyone is impressed with a sparkling smile and wishes to have one. Oral Care is critical, not just for a radiant smile, but also because unhealthy gums and teeth can lead to other serious health problems.

The hardest part of the body, our teeth are exposed to a variety of food items which often stick to the teeth and become the breeding ground for bacteria. If not taken care, these bacteria cause Plaque, Tartar and Cavities which not only is a very painful condition, but also can lead to decay of the teeth. An ignored oral hygiene often leads to infection of the surrounding gums (Gingivitis) which causes swelling, redness, pain and bleeding of the gums. Gum disease is the most common reason for dental extraction in adults, besides causing bad breath (Halitosis) which can be a source of public embarrassment. All this can be prevented by maintaining oral hygiene habits including regular use of a toothpaste.

Bakson, known for its quality Homoeopathic medicines and cosmetic products has an effective dentifrice, BAKSODENT, a medicated toothpaste empowered with extracts of sources of Homoeopathic medicines along with other active ingredients to maintain oral hygiene.

BAKSODENT is a specially formulated toothpaste that reduces swelling of gums and stops gum bleeding. Its antibacterial action fights germs and bacteria responsible for Dental caries, thereby preventing toothache, fights bad breath and checks plaque formation.

As an Anti- inflammatory for toothache, swollen gums and caries. As an Antiseptic, Anti-inflammatory, Anti-haemorrhagic in dental conditions.

For bleeding gums. As an Antiseptic for Dental caries, Gingivitis.

As an abrasive to remove tartar or plaque. As a dental caries prophylaxis, to prevent formation of plaque, tartar in teeth.

SOME FACTS ABOUT ORAL CARE

WHY BAKSODENT?

ACTION OF ACTIVE INGREDIENTS OF BAKSODENTPlantago:

Calendula:

Hamamelis:

Eucalyptus :

Calcium Carbonate:

Sodium fluoride:

The fluoride content is not more than 1000PPM (as recommended).helps to keep breath ultra-fresh for up to 12 hours.

sources of

Saunf Flavour

CLINICAL STUDY REPORT Title:

Protocol / study number:

Protocol version number with date:

The IND name/number of the investigational drug:

BRIEF DESCRIPTION OF TRIAL DESIGN

Start of accrual of patients: End of study:

Site Location:

INTRODUCTION

Data generation on efficacy of Dr. Bakshi's BAKSODENT from Bakson containing extracts of Plantago, Calendula, Hamamelis & Eucalyptus ( Homoeopathic medicines) and saunf flavor as compared to Control Saunf Flavored Fluoride toothpaste without extracts of Plantago, Calendula, Hamamelis & Eucalyptus on reducing supragingival dental plaque formation and Gingivitis thus improving dental health status.

BAK/IV/09 Version I, 15th June, 2009.

Dr. Bakshi's BAKSODENT Bakson Drugs and Pharmaceuticals Pvt. Ltd., Shillu Kala, Parwanoo-173220

Therapeutic, Randomized, Controlled, Parallel group, Stratified, Triple blind efficacy study. This is an interventional type of study to generate additional data regarding efficacy of Dr. Bakshi's BAKSODENT as compared to Control Saunf Flavoured fluoride toothpaste in reducing Gingivitis and supragingival plaque formation, thus maintaining good oral hygiene.

January 2010 May 2010

SMILE INDIA, Lajpat Nagar, New Delhi.

Toothpaste is a paste dentifrice used to clean and improve the aesthetic appearance and health of teeth. Toothpaste use can promote good oral hygiene: it can aid in the removal of Dental plaque and food from the teeth, elimination and/or masking of halitosis and it can deliver active ingredients such as fluoride to prevent tooth and gum disease. Most people in developed countries consider toothpaste a necessity and use it every day. Bakson Drugs & Pharmaceuticals Pvt. Ltd., a renowned manufacturer of Homoeopathic medicines has introduced BAKSODENT Toothpaste for maintaining good oral hygiene.

Sponsor:

CONSULTANT: Dr. Sushant Umre B.D.S. INVESTIGATORS: Dr. Mayank Hans B.D.S.; M.D.S. (Assitant Professor, Periodontology, Kalka Dental College, Meerut) Dr. Sunil Motwani B.D.S (Director, Smile India, New Delhi.)

(Chief Executive, Smile India, New Delhi )CONSULTANTS & INVESTIGATORS WHO PARTICIPATED IN THE STUDY

INSTITUTIONAL REVIEW BOARD APPROVAL

STATEMENT OF COMPLIANCE

STUDY OBJECTIVE

SUBJECT ELIGIBILITY

TREATMENT PROCEDURES

BLINDING/RANDOMIZATION TECHNIQUES

The study on Dr. Bakshi's BAKSODENT was conducted from January 2010 to June 2010. After the approval of protocol by Institutional Review Board, Smile India, New Delhi the first subject was enrolled on 9th January, 2010.

This is to state that the study on Dr. Bakshi's BAKSODENT was conducted in compliance with the protocol and ICH Guidelines for Good Clinical Practice. The data presented here is accurate and reflects the data in the workbooks.

Post-marketing studies to delineate additional information on efficacy of BAKSODENT Toothpaste in maintaining oral hygiene including making a note of optimal use and any possible side effects or safety factors whatsoever.Primary objective: To evaluate evidence based study on safety and efficacy of Dr. Bakshi's BAKSODENT as compared to Control saunf flavoured fluoride toothpaste in reducing supragingival plaque and Gingivitis thus maintaining good oral hygiene. Secondary objective: To assess the awareness levels about regular use of toothpaste and importance of oral hygiene.

Subjects having a minimum of 16 natural uncrowned teeth (excluding 3rd molars) presenting with mild to moderate Gingivitis and/or supragingival plaque formation.

Ages Eligible for Study: 18 Years to 65 YearsGenders Eligible for Study: Both

Brush with supplied toothpaste twice daily regularly, as demonstrated by the physician (ROLL ON brushing technique).

Blinding procedures: It was a randomised triple blind study. Stratification done to ensure homogeneity amongst treatment and control groups. Subjects stratified into categories depending on their Gingival Index (Mild and moderate Gingivitis) irrespective of Plaque Index. There was no inclusion in ‘Plaque only’ category.Blinding carried out by allocating codes to Investigational Product and Control comparator. Both toothpastes were packed in similar tubes and labeled as per GMP guidelines carrying an allocation code. Toothpaste tubes were dispensed by investigator.

Allocation code concealment to ensure blinding was done. Subjects were randomly assigned to investigational medicinal product group and control group.

Unblinding procedures: Unblinding was done after closure of study and data analysis. Concomitant treatment: No other treatment was allowed.

STUDY ASSESSMENT PLAN Subjects were assessed through following indices at the beginning of study, at 2 and 4 weeks after proper oral examination by Periodontist as per protocol guidelines.

Loe & Silness index for Gingivitis and Plaque (Index Teeth)Ainamo and Bay index for Gingival bleeding (whole mouth)

A disclosing agent Alpha plaque was used to detect plaque and digital photographs were taken at baseline visit and after 2 & 4 weeks.

FLOW CHART OF THE STUDY

Reassessment at 2 weeks and at the end of 4 weeks duration with photographs of teeth after applying disclosing agent namely Alpha Plaque Primary Endpoint* -

Blinding and Randomisation

Category IIModerate Gingivitis

Gingival score 1.1- 2.0

Category I

Mild GingivitisGingival score 0.1-1.0

Cases to be taken up from dental clinic subject to eligibility criteria and screening through Loe and Silness Gingivitis Scale

Case Record and Assessment*

Informed consent for inclusion in study

Stratification of subjects

Category IIIPlaque Score 0.1-1.0

Prescription of to be used for brushing teeth twice daily.

Medicinal Toothpaste Prestoothpaste to be used for brushing teeth twice daily.

cription of Control Saunf Flavoured Fluoride

Final Report* Assessment & Reassessment on the basis of SILNE SS AND LOE SCALE for GINGIVAL INDEX, AINAMO & BAY

for GINGIVAL BLEEDING INDEX, SILNESS-LOE INDEX for PLAQUE

CASES ENROLLED

STATISTICAL METHODS USED

EFFICACY EVALUATION

PERCENTAGE FALL IN GINGIVAL INDEX OVER 4 WEEKS

After screening 106 cases, a total of 59 cases were enrolled after complete examination and case taking. During follow up 5 cases were dropped out. A total of 54 cases completed the study and 52 cases were statistically analysed giving equal number of cases to the both the codes for Investigational as well as Control Toothpaste.

The analysis was carried out using Statistical Package for Social Sciences 17.00 version for windows (SPSS 17.0). Statistical techniques included quantitative and qualitative analysis: unpaired t tests were used to compare the means of the groups for the significance of the differences of the Plaque, Gingival and GBI variables. The chi square tests were used to compare the groups for categorical variables. Repeated measures of analysis at different points of time were also done. P<.05 was considered as statistical significant.

Demographic Characteristics

In Group 1, mean age was 25.69 years. There were 18 female (69.2%) and 8 male (30.7%). In Group 2 mean age was 25.62. There were 20 female (76.9%) and 6 male (23.1%).The patient characteristics were comparable in both the groups as shown in (Table 1).

Group 1 Group 2 P value n 26 26

Age 25.69 ± 1.036 25.62 ± 0.975 P>.05 Sex(F/M) 18/8 20/6 P>.05

Table 1

5.37

7.79

4.25

-3.5

9.39

4.54

-4

-2

0

2

4

6

8

10

12

Per

cen

tag

e F

all

0-1 1-2 0-2

Time Period Group1 Baksodent

Group2 Control Toothpaste

Group 1 showed a fall of 5.37% whereas Group 2 showed a 7.79% fall in 2 weeks. The study shows progressive fall in Group 1 (9.39%) as compared to Group 2 (4.54%) in Gingival Index value at the end of 4 weeks duration. Although there is no significant difference when compared between the groups but over a time there is significant fall in Group1 only. INTERPRETATION: Bakson’s BAKSODENT is two times more effective than a normalnon medicated toothpaste. A 9.39% fall was observed in Gingival Index over a period of 4 weeks of regular use of BAKSODENT which is two times more effective than the control toothpaste (without extracts of Plantago, Calendula, Hamamelis & Eucalyptus). The control toothpaste showed worsening of GBI in second follow up of case thus supporting the fact that presence of Plantago, Calendula, Hamamelis & Eucalyptus in BAKSODENT had a significant role to play in treating Gingivitis due to their antiseptic and antihaemorrhagic properties.

PERCENTAGE FALL IN GINGIVAL BLEEDING INDEX OVER 4 WEEKS

20.7123.72

16.59

10.85

33.87 31.99

0

5

10

15

20

25

30

35

40

Per

cen

tage

Fall

0-1 1-2 0-2

Time Period Group1 BaksodentGroup2 Control Toothpaste

% FALL IN GINGIVAL INDEX 1st Two Weeks 2-4 Weeks 0-4 Weeks

Group 1 5.37 4.25 9.39 Group 2 7.79 (-) 3.5 4.54

Table 2

% FALL IN G G INDEXINGIVAL BLEEDIN 1st Two Weeks 2-4 Weeks 0-4 Weeks

Group 1 20.71 16.59 33.87Group 2 23.72 10.85 31.99

Table 3

Group 1 showed a fall of 20.71% whereas Group 2 showed a 23.72% fall in 2 weeks. The study shows progressive fall in GBI value at the end of 4 weeks duration respectively.INTERPRETATION: It is observed that there is comparatively higher percentage fall in Gingival Bleeding Index in users of BAKSODENT Toothpaste. Also the fall in GBI in first two and next two weeks is maintained in BAKSODENT users whereas in users of Control Toothpaste the fall in GBI is significant in first two weeks only but the percentage fall in next two weeks is reduced to half. This shows that BAKSODENT has a good maintainenance effect over continued use.

The study shows progressive fall in Plaque Index value at the end of 4 weeks duration.

0

0.5

1

1.5

2

Group 1 Baksodent 1.64 1.48 1.42

Group 2

ControlToothpaste

1.72 1.45 1.42

Baseline First Visit Second Visit

Pla

que

Inde

xTECHNIQUE OF ASSESSING

PLAQUE INDEX

Plaque Index is assessed withstraight probe along the margin

of gingival surface of tooth.

TECHNIQUE OF ASSESSINGGINGIVAL BLEEDING INDEX

Gingival Bleeding Index is assessed withangulated probe parallel to the long axis

of tooth, 1 mm into gingival sulcus.

PERCENTAGE FALL IN PLAQUE INDEX OVER 4 WEEKS

% FALL IN PLAQUE INDEX

4.059.7515.69 2.07

1st Two Weeks 2-4 Weeks Group 1 Baksodent Group 2 Control Toothpaste

Table 4

BEFOREst th1 Visit: 19 Feb. 2010

Plaque Index: 2.38

Anterior View

Left Lateral View

SUBJECT CODE : BT/032

AFTERnd th2 Visit: 5 Mar. 2010

Plaque Index: 1.79

ASSESSMENT OF PLAQUE ON APPLYINGDISCLOSING AGENT TO BAKSODENT USERS

INTERPRETATION: The results show BAKSODENT to have an edge over the Control toothpaste in reducing plaque by showing sustained effect over two assessment periods of every fortnight. BAKSODENT showed effective control in reduction of Plaque Index which was 13.4 % over a period of 4 weeks. In Control Toothpaste the initial plaque score reduction was quite high but second visit scoring showed very low levels of reduction in plaque thus suggesting almost nil maintenance effect in Plaque reduction. After using disclosing agent Alpha Plaque it was observed that more of BAKSODENT users (70% OF ENROLLED CASES) showed localised and overall decrease in plaque deposition as compared to Control toothpaste users who in some cases either showed no change and in some cases even worse than before.

Right Lateral View

BEFOREst th1 Visit: 12 Mar. 2010

Plaque Index: 1.71

AFTERrd th3 Visit: 8 Apr. 2010

Plaque Index: 1.42


BEFOREst th1 Visit: 19 Mar. 2010

Plaque Index: 1.25

Lingual Surfaceof lower jaw

rd th3 Visit: 14 Apr. 2010Plaque Index: 0.71

st th1 Visit: 19 Mar. 2010Plaque Index: 1.25

Lingual Surfaceof upper jaw


AFTERnd nd2 Visit: 2 Apr. 2010

Plaque Index: 1.00

BEFOREst th1 Visit: 14 Apr. 2010

Plaque Index: 2.08

AFTERrd th3 Visit: 17 May 2010

Plaque Index: 1.67

Anterior View

Left Lateral View

Right Lateral View



Plaque Index: 1.0

LeftLateral View


AFTERrd st3 Visit: 31 May 2010

Plaque Index: 0.96

BEFOREst rd1 Visit: 23 Apr. 2010

Plaque Index: 1.96


Plaque Index: 1.67

RightLateral View

LeftLateral View



Plaque Index: 1.92


Plaque Index: 1.54

RightLateral View

LeftLateral View


Left Lateral View

BEFOREst th1 Visit: 6 Feb. 2010Plaque Index: 2.04

AFTERrd th3 Visit: 12 March 2010

Plaque Index: 1.17



BEFOREst rd1 Visit: 3 May 2010Plaque Index: 1.625

RightLateral View

AFTERnd th2 Visit: 17 May 2010

Plaque Index: 1.33

LeftLateral View

BEFOREst nd1 Visit: 2 Apr. 2010

Plaque Index: 1.33

AFTERnd th2 Visit: 14 Apr. 2010

Plaque Index: 1.29


RightLateral View

CONCLUSION

FACTS ABOUT COMMONLY AVAILABLE MEDICATED TOOTHPASTE

Periodontal diseases (Gum problems) are of very common occurrence. While many different diseases affect the tooth-supporting structures, plaque-induced inflammatory lesions make up the vast majority of Periodontal diseases and have traditionally been divided into two categories namely Gingivitis and PeriodontitisAmongst the 106 cases screened for Gingivitis and Dental plaque approx. 97% cases had evidence of Periodontal disease. Approx. 10% cases had advanced Periodontitis presenting with loose teeth, recession of gums, increased spacing between teeth etc. Awareness of oral hygiene maintenance although prevalent in education, is still lacking in practice with over 60 % cases brushing only once daily and that too with improper technique. Brushing twice daily appropriately is considered to be imperative to break the cycle of dental plaque formation.

Over the last two decades many toothpastes have been formulated to contain antimicrobial compounds with the aim of preventing or reducing plaque, calculus, gingival inflammation and Dental caries. One of these compounds is Triclosan and the other is Chlorhexidine.Triclosan is known to be a toxin and an environmental hazard but its use in very low doses in dentrifrices, although controversial, has survived till date. Same studies have shown that low doses of Triclosan act as an endocrine disruptor in animals. The hypothesis proposed is that Triclosan blocks the metabolism of thyroid hormone, because it chemically mimics thyroid hormone and binds to the hormone receptor sites, blocking them, so that normal hormones cannot be used. The negative effects of Triclosan on the environment and its questionable benefits in toothpastes has led to the Swedish Govt. to recommend not using Triclosan in toothpaste. Canadian Medical Association has banned Triclosan use in household products under concerns of creating bacterial resistance and producing dangerous side products (chloroform). Reports have suggested that triclosan can combine with chlorine in tap water to form chloroform gas, which the United States Environmental Protection Agency classifies as a probable human carcinogen. Triclosan safety is currently under review by the FDA.Some trials have concluded that dentifrice products containing Triclosan do not possess sufficient antimicrobial activity to suppress plaque and Gingivitis development in the absence of normal oral hygiene. Use of Chlorhexidine has also been marred by controversies where studies demonstatrated inefficacy of chlorhexidine as chlorhexidine gluconate has not been proven to reduce subgingival calculus and in some studies actually increased deposits. Chlorhexidine's role in preventing tooth decay (dental caries) is controversial. Continued use of products containing chlorhexidine for long periods can cause stains on teeth, especially on silicate and resin restorations; prolonged use can also alter taste sensation.

In the light of all these factors the challenge of developing a safe and effective dentifrice which can stand the test of time led to incorporation of extracts of sources of Homoeopathic medicines in a dentifrice formula in the form of BAKSODENT and the results of this study justify its use in combating Gingivitis and Dental plaque.Most of the studies conducted on dentifrices have shown 13 to 59 percent reductions in Plaque and 20-70 % reduction in Gingivitis over a period of 7 months whereas BAKSODENT has shown 13 % reduction in Plaque and 9.39 % in Gingivitis in short period of 4 weeks which will show better effects after sustained use over longer periods.

Percentage subjects who would recommend BAKSODENT to others - 91.3%Average score for BAKSODENT - 7.57/10Percentage of subjects who experienced better freshness of mouth as compared topreviously used toothpaste - 78.26%Percentage of subjects who experienced better taste as compared to previously used toothpaste - 73.91%Percentage of subjects who experienced better FOAMING as compared to previously used toothpaste - 47.82%

Brush teeth with BAKSODENT toothpaste twice a day for that perfect smile.

40 & 100 grams

SUBJECTIVE EVALUATION OF BAKSODENT

RECOMMENDED USE

PRESENTATION

brief description of trial...

Documents