“EFFECT OF BIOMINF, NOVAMINR, ARGIN AND NANOHYDROXY PARTICLES CONTAINING DENTIFRICES ON DENTINE HYPERSENSITIVITY AND GINGIVITIS AMONG 35- 44 YEARS AGED POPULATION OF DISTRICT – A RANDOMIZED CONTROLLED TRIAL (RCT).”

Main Dissertation Submitted

For the degree of

MASTER OF DENTAL SURGERY

BRANCH VII

PUBLIC HEALTH DENTISTRY

TAMILNADU Dr.M.G.R. MEDICAL UNIVERSITY

CHENNAI-600 032

2017 - 2020

DECLARATION BY THE CANDIDIATE

I hereby declare that this dissertation titled “Effect of BiominF, NovaminR, Argin

And Nanohydroxy particles containing dentifrices on dentine hypersensitivity and gingivitis among 35- 44 years aged population of – A

Randomized Controlled Trial (RCT)” is a bonafide and genuine research work carried out by me under the guidance of DR.UMESH.K., M.D.S., Head of the

Department, Department of Public Health Dentistry, Best Dental Science College,

Madurai - 625104.

DR.SHRIMATHI.S

THE Dr. M.G.R MEDICAL UNIVERSITY TAMILNADU CERTIFICATE BY THE GUIDE

This is to certify that the main dissertation entitled “EFFECT OF BIOMINF,

NOVAMINR, ARGIN AND NANOHYDROXY PARTICLES CONTAINING

DENTIFRICES ON DENTINE HYPERSENSITIVITY AND GINGIVITIS

AMONG 35- 44 YEARS AGED POPULATION OF MADURAI DISTRICT – A

RANDOMIZED CONTROLLED TRIAL (RCT)” is a bonafide research work done by Dr.SHRIMATHI.S under my guidance, in partial fulfillment of the requirements for the degree of MDS in PUBLIC HEALTH DENTISTRY (branch

VII) degree examination.

Signature of the Guide Date: Dr.UMESH.K., M.D.S, Place: Professor and Head of the Department

Department of Public Health Dentistry THE TAMIL NADU Dr. M.G.R MEDICAL UNIVERSITY TAMIL NADU ENDORSEMENT BY HEAD OF THE DEPARTMENT AND HEAD / PRINCIPAL OF THE INSTITUITION

This is to certify that the main dissertation entitled “EFFECT OF BIOMINF,

NOVAMINR, ARGINE AND NANOHYDROXY PARTICLES CONTAINING

DENTIFRICES ON DENTINE HYPERSENSITIVITY AND GINGIVITIS

AMONG 35- 44 YEARS AGED POPULATION OF MADURAI DISTRICT – A

RANDOMIZED CONTROLLED TRIAL (RCT)” is a bonafide research work

done by Dr. S. SHRIMATHI under my guidance, in partial fulfillment of the

requirements for the degree of MDS in PUBLIC HEALTH DENTISTRY(branch

VII) degree examination.

Seal and Signature of the Principal Seal and Signature of the HOD DR. K.S. PREMKUMAR., M.D.S, Dr.UMESH.K., M.D.S, Principal, Professor and Head of the Department Best Dental Science College. Department of Public Health Dentistry DATE: DATE: PLACE: MADURAI PLACE: MADURAI

COPYRIGHT

DECLARATION BY THE CANDIDATE

I hereby declare that The Tamil Nadu Dr. M.G.R Medical University, Tamil Nadu shall have the rights to preserve, use and disseminate this research in print or electronic format for academic / research purpose.

DATE: SIGNATURE OF THE CANDIDATE

PLACE: (Dr. S. SHRIMATHI)

© THE TAMIL NADU DR. M.G.R MEDICAL UNIVERSITY, TAMIL NADU ACKNOWLEDGEMENT

“Research is to see what anyone else has seen and to think what nobody else has thought”

To Begin with I wish to thank the Lord Almighty for his Showers of Blessings on me for the

Completion of this Project.

Without the support, patience and guidance of the following people, this study could not been completed. It is to them that I owe my deepest gratitude.

I would like to express my special thanks of gratitude to our College Chairman

Prof.K.R.Arumugam.,M.Pharm and our Vice Chairman Mr.Babu Thandapani.,M.Pharm. for permitting me to do this project.

I offer my sincere thanks to my Principal Dr.K.S.PREMKUMAR., M.D.S., for his constant motivation and tremendous support all through my post graduation.

I would like to extend my deepest gratitude to Dr. Umesh.K.,M.D.S Professor and Head for his aspiring guidance and constant encouragement throughout this project.

I would like to express my sincere thanks of Gratitude to Dr.Muthu Karupaaiah., M.D.S.,Reader for his illuminating views and suggestions.

I would like to extend my sincere thanks of gratitude to Dr.Sangeeta.,M.D.S Reader, for her valuable constructive criticism and for her motivational support.

I would express my sincere thanks of gratitude to Dr.R.Palanivelpandian., M.D.S. Senior Lecturer for his Valuable suggestion and timely help. I gratefully thank my seniors Dr.Premkumar, Dr.Dheepthasri, Dr.Vidhya and my juniors

Dr.Ravishankar, Dr.Sasidharan, Dr.Selvamani, Dr.Keerthana, Dr.Ramalakshmi, Dr.Vinoth for guiding me every day, in every way possible in all my endeavors. They have inspired me in so many ways and helped me to make impossible things possible.

Its with immense pleasure, I acknowledge the contributions of my batch mates Dr.S.Lavanya Rahavi and Dr.M.Abinaya for always being there for me.

Last but not the least I would like to thank my family, without whom I am incomplete. I thank my father Mr.V.Sathya Narayanan, my mother Mrs.S.Siva Kumari who have kept me as their eyes and my husband Dr.U.Manikandan for all his help, encouragement and their love and support. U R K U N D

Urkund Analysis Result

Analysed Document: Shrimathi Thesis.pdf (D60972785) Submitted: 12/13/2019 1:03:00 PM Submitted By: [email protected] Significance: 2 %

CERTIFICATE

This is to certify that this dissertation work titled “EFFECT OF

BIOMINF, NOVAMINR, ARGIN AND NANOHYDROXY PARTICLES

CONTAINING DENTIFRICES ON DENTINE HYPERSENSITIVITY AND

GINGIVITIS AMONG 35- 44 YEARS AGED POPULATION OF MADURAI

DISTRICT – A RANDOMIZED CONTROLLED TRIAL (RCT)” of the candidate

Dr.SHRIMATHI.S with registration number 241723153 for the award of MASTER OF

DENTAL SURGERY in the branch of PUBLIC HEALTH DENTISTRY. I personally verified the urkund.com website for the purpose of plagiarism check. I found that the uploaded thesis files contain from introduction to conclusion pages and result shows

TWO percentage of plagiarism in the dissertation.

Guide & Supervisor Sign With Seal

DECLARATION

EFFECT OF BIOMINF, NOVAMINR, ARGIN AND NANOHYDROXY PARTICLES CONTAINING DENTIFRICES ON DENTINE TITLE OF THE DISSERTATION HYPERSENSITIVITY AND GINGIVITIS AMONG 35- 44 YEARS AGED POPULATION OF MADURAI DISTRICT – A RANDOMIZED CONTROLLED TRIAL (RCT). KADACHANENTHAL, Y., PLACE OF STUDY ARUMBANUR, KODIKULAM, MADURAI – 625104.

DURATION OF THE COURSE 3 YEARS

NAME OF THE GUIDE Dr. UMESH.K.,M.D.S.,

HEAD OF THE DEPARTMENT Dr. UMESH.K.,M.D.S.,

I hereby declare that no part of the dissertation will be utilized for gaining financial assistance/any promotion without obtaining prior permission of the Principal, Best Dental Science College, Madurai – 625104. In addition, I declare that no part of this work will be published either in print or in electronic media without the guide who has been actively involved in dissertation. The author has the right to reserve for publish of work solely with the prior permission of the Principal, Best Dental Science College, Madurai – 625104.

HOD

Dr. UMESH.K.,M,D.S., GUIDE Signature of the Department of Dr. UMESH.K.,M.D.S., candidate Public Health Dentistry

TRIPARTITE AGREEMENT

This agreement herein after the “Agreement” is entered into on this day Nov 2020, between the

Best Dental Science College represented by its Principal having address at Best Dental Science

College, Madurai – 625104, (hereafter referred to as, ‘the College’)

And

Dr. UMESH.K aged 38 years working as Head of the Department in the Department of Public

Health Dentistry at the College, having residence address at No 4 staff quarters, Ultra’s Best

Dental Science College, Madurai-625104 (herein after referred to as the ‘Chief Investigator’)

And

Dr.S.SHRIMATHI aged 25 years currently studying as Post Graduate student in Department of Public Health Dentistry, Best Dental College, Madurai- 625104 (herein after referred to as the

‘PG/Research student and co-investigator’)

Whereas the PG/Research student as part of her curriculum undertakes to research on “EFFECT

OF BIOMINF, NOVAMINR, ARGIN AND NANOHYDROXY PARTICLES

CONTAINING DENTIFRICES ON DENTINE HYPERSENSITIVITY AND GINGIVITIS

AMONG 35- 44 YEARS AGED POPULATION OF MADURAI DISTRICT – A

RANDOMIZED CONTROLLED TRIAL (RCT).” for which purpose PG/Research student shall act as Principal Investigator and the college shall provide the requisite infrastructure based on availability and also provide facility to the PG/Research student as to the extent possible as a

Co-investigator. Whereas the parties, by this agreement have mutually agreed to the various issues including in particular the copyright and confidentiality issues that arise in this regard.

Now this agreement witnessed as follows

1. The parties agree that all the Research material and ownership therein shall become the

vested right of the college, including in particular all the copyright in the literature

including the study, research and all other related papers.

2. To the extent that the college has legal right to do so, shall grant to license or assign the

copyright so vested with it for medical and/or commercial usage of interested

persons/entities subject to a reasonable terms/conditions including royalty as deemed by

the College.

3. The royalty so received by the college shall be shared equally by all the parties.

4. The PG Student and Principal Investigator shall under no circumstances deal with the

copyright, Confidential information and know – howgenerated during the course of

research / study in any manner whatsoever, while shall sole vest with the college.

5. All expenses pertaining to the research shall be decided upon by the Principal

Investigator/Co-investigator or borne solely by the PG/Research Student, (co-

investigator).

6. The college shall provide all infrastructure and access facilities within and in other

institutes to the extent possible. This includes patient interactions, introductory letters,

recommendation letters and such other acts required in this regard.

7. The Chief Investigator shall suitably guide the Student Research right from selection of

the Research Topic and Area till its completion. However the selection and conduct of

research, topic and area of research by the student researcher under guidance from the Principal Investigator shall be subject to the prior approval, recommendations and

comments of the Ethical Committee of the College constituted for this purpose.

8. It is agreed that as regards other aspect not covered under this agreement, but which

pertain to the research undertaken by the PG student, under guidance from the Chief

Investigator, the decision of the college shall be binding and final.

9. If any dispute arises as to the matters related or connected to this agreement herein, it

shall be referred to arbitration in accordance with the provisions of the Arbitration and

Conciliation Act1996.

In witness of the parties herein above mentioned have on this day, month and year herein

above mentioned set their hands to this agreement in the presence of the following two

witnesses.

College represented by its Principal:

Student Guide:

PG Student:

Witnesses:

1.

2.

ABSTRACT

INTRODUCTION Oral health is the mirror of general health, oral disease are the most common among

chronic diseases and are important public health problems because of their prevalence

and their impact on individuals as well as society. The most common oral problems were

dental caries, dental hypersensitivity, gingivitis, periodontitis, etc. Among which the

dentin hypersensitivity, affects between 4% to 57% of the adult population. Though there

are several causative factors for dentin hypersensitivity, gingival recession is closely

associated with it. It is reported that teeth with gingival recession actually showed a higher

level of dentinal hypersensitivity when compared to the teeth without gingival recession.

AIM To compare the effect of dentifrices containing BioMinF, NovaMinR, Argin and

Nanohydroxy apatite particles on dentinal hypersensitivity and gingivitis.

MATERIALS AND METHODS The present research is a randomized, parallel arm, double blind clinical trial designed to compare the effect of NovaMinR, Nano hydroxy apatite particles, Argin and

BioMinF containing desensitizing dentifrices on dentinal hypersensitivity and gingivitis.

A total of 100 subjects (48 Males and 52 Females) belonging to the age group of 35-44 years were participated in the study. 25 subjects from each village, participated in the study.

The study was conducted during the period of April 2019 to July 2019. The intervention was carried out for all the selected villages and were coded as Group A,B,C and D respectively. The intervention using allocated dentifrices was given. The data on dentinal hypersensitivity using Visual Analogue Scale and Electric Pulp tester and gingival Status

ABSTRACT

using Loe and Silness index was collected at baseline, 1st, 2nd, 3rd and 4th week was collected and subjected to statistical analysis.

RESULTS

There was a statistically significant reduction in the dentinal hypersensitivity recorded using Visual Analogue Scale, Electric Pulp Tester and gingival score recorded using Loe and Silness gingival index among the NovaMinR, Nanohydroxy apatite particles, Argin and BioMinF dentifrice group with p<0.05.

CONCLUSION

All the four dentifrices in the present study demonstrated a significant reduction in dentinal hypersensitivity and gingivitis relatively in a shorter period of time while

Nanohydroxy apatite dentifrices showed the greatest reduction.

ABBREVIATIONS

SI.NO. ABBREVIATIONS DESCRIPTION

1 VAS Visual Analogue Scale

2 DH Dentinal Hypersensitivity

3 n-HA Nanohydroxy apatite

4 MTDI Mirror, tactile dental inspection

5 GD Gumma Desensitizer

6 SP Seal & Protect

7 OG Oxa-Gel

8 F Fluoride

9 LIL Low Intensity Laser

10 EPT Electric Pulp Tester

11 CaF Calcium Fluoride

12 NaF Sodium Fluoride

13 DEJ Dentino Enamel Junction

14 BAG Bio Active Glass

15 pH Potential of Hydrogen

16 SD Standard Deviation

17 SPSS Statistical Package for Social Sciences

18 ANOVA Analysis of Variance

19 GI Gingival Index

20 ADA American Dental Association

21 WHO World Health Organization

LIST OF TABLES

SI.NO. Title Page no

1 Demographic characteristics of the study participants 46 based on gender

2 Demographic characteristics of the study participants 47 based on age in different groups

3 Demographic characteristics of the study participants 48 based on age

4 Intragroup comparison of Dentinal Sensitivity 49 Recorded by Visual Analogue Scale

5 Intergroup comparison of Dentinal Sensitivity 50 Recorded by Visual Analogue Scale

6 Intragroup comparison of Dentinal Sensitivity 51 Recorded by Visual Analogue Scale

7 Intragroup comparison of Dentinal Sensitivity 53 Recorded by Electric Pulp Tester

8 Intergroup comparison of Dentinal Sensitivity Recorded 53 by Electric Pulp Tester

9 Intergroup comparison of Dentinal Sensitivity Recorded 54 by Electric Pulp Tester 10 Intragroup comparison of Gingival Status by 55 Friedman test

11 Intergroup comparison of Gingivitis 56

12 Intragroup comparison of Gingival Score 57

LIST OF GRAPHS

oSI.NO. Title Page no

1 Demographic characteristics of the study participants 46 based on gender

2 Demographic characteristics of the study participants 47 based on age in different groups

3 Intragroup comparison of Dentinal Sensitivity 49 Recorded by Visual Analogue Scale

4 Intragroup comparison of Gingival Status among 55 study subjects

LIST OF FIGURES

S.NO FIGURES PAGE NUMBER

1 Study design 26

2 Map showing Madurai District blocks 27

3 Visual Analogue Scale 34

4 Schematic representation of methodology 40

5 Armamentarium Used 41

7 Clinical Examination 42-43

6 Study participants filling the proforma 44

7 Study participants brushing using the dentifrice 44

LIST OF CONTENTS

SI.NO. TITLE PAGE NO

1 INTRODUCTION 1

2 AIM AND OBJECTIVES 5

3 REVIEW OF LITERATURE 6

4 MATERIALS AND METHODS 26

5 PHOTOGRAPHS 41

6 RESULTS 45

7 DISCUSSION 59

8 SUMMARY AND CONCLUSION 66

9 RECOMMENDATIONS 67

10 BIBLIOGRAPHY 68

11 ANNEXURES 74

INTRODUCTION

INTRODUCTION

“Oral health is the mirror of overall health”. On one hand there is the development of modern lifestyle and attraction toward the junk foods, while on the other there is lack of awareness towards oral health which lead to the development of various oral problems. The most common oral problems are dental caries, dental hypersensitivity, gingivitis, periodontitis, etc. The dentine hypersensitivity, affects between 4% to 57% of the adult population.1 This condition is prevalent among the age group of 20-50 years and females are more prone to have dentinal hypersensitivity that would probably be related to their dental hygiene and dietary habits.2

Dentine hypersensitivity is due to the exposure of the dentinal tubules.3 The etiology of dentine hypersensitivity is multi-factorial, it is generally accepted that open dentinal tubules are a major factor which causes dentinal hypersensitivity.3 Three main mechanisms of dentine sensitivity are proposed. Direct Innervation (DI) Theory,

Odontoblast Receptor (OR) Theory and Fluid Movement/Hydrodynamic Theory. The most accepted is the Hydrodynamic Theory which was proposed by Brannstorm.4 It is believed that dentinal hypersensitivity is the result of movement of the fluid inside the dentinal tubules, which is further due to the thermal and physical changes, or as the result of formation of osmotic stimuli near the exposed dentine.5 The movement of fluid stimulates a baroreceptor and leads to neural discharge. The process is called the hydrodynamic theory of pain.6 The movement of fluid can be in the direction of inside of the pulp or the outside of dentine. Cooling, drying, evaporation, and hypertonic chemical stimuli cause the dentinal fluid to flow away from the dentin-pulp complex and lead to an increase in pain.5

1

INTRODUCTION

The heat stimuli causes the fluid to flow toward the pulp. About 75% of patients with

Dentinal hypersensitivity feel pain as a response to cold stimuli. The tubules of sensitive dentine are wider than those in non sensitive dentine. The increase size of dentinal tubules finally results in increase in the pressure of dentinal fluid which finally results in the dentinal hyper sensitivity.2

Several factors have been reported as the causes for dentine hypersensitivity, amongst which gingival recession is closely associated with it. It is reported that teeth with gingival recession actually showed a higher level of dentinal hypersensitivity when compared to the teeth without gingival recession, the reason being attributed to the various methods of oral hygiene measures.7

Other factors such as attrition from occlusal wear, abfractions, parafunctional habits, abrasive tooth brushing or erosion from acidic diet also result in dentin hypersensitivity.2 The pain attributed to dentinal hypersensitivity varies from episodic nature in some individual to far more severe in other.1

The primary prevention of dentinal exposure or hard tissue damage by prophylactic measures like avoidance of an acidic diet is the best way to treat this.

The mechanical blockage of the dentinal tubules forms the vital therapeutic approach in the treatment of dentinal hypersensitivity, among the two varied therapeutic approaches.5

Physical means like protein precipitation, plugging of dentine tubules, sealing or laser applications are the various mechanisms that are identified to modify the dentine surface or tubules apart from chemical and mechanical means. Among these methods occlusion of the tubule openings using advanced toothpaste containing arginine/calcium

2

INTRODUCTION

carbonate, bioactive glass have appeared to provide optimal pain relief compared to the various toothpastes in the market.1

The Latest research on Pro-Argin Technology suggests that at physiological pH, arginine and calcium carbonate interact and bind to the negatively charged dentine surface to form a calcium rich layer on the dentine surface and in the dentine tubules to plug and seal them.9 On the other hand, Pro-Argin Technology triggers occlusion of the dentine tubules that remains intact even after exposure to acids, preventing transmission of pain- producing stimuli.1 Toothpaste with argin is a well known desensitization dentifrice but the effect on gingivitis is questionable.10

The search for alternate anti sensitivity toothpaste with antigingival effect lead to the origin of toothpaste with Nano hydroxy particles and tooth paste with Bioactive glasses

NovaMinR and Bioactive glasses BioMinF technology.

Dentifrice with BioMinF, has appreciable effect on gingival health of an adult population with moderate gingivitis. The key ingredient of the tooth paste is 5% flurocalcium phosphosilicate a fluoride containing bioactive glass (BioMinF) particles.

These particles reacts by chemically binding to the tooth surface where it releases calcium, phosphate and fluoride ions finally forms fluorapatite crystals which seals the dentinal tubules.11

Tooth paste incorporated with bioactive glass has a significant impact on gingivitis.

Allan et al in his previous study, stated much of the antibacterial effect at an alkaline pH of saliva. The alkalinity of saliva was due to the action of ions released by bioactive glass,

3

INTRODUCTION

and the release of large quantities of calcium from the bioactive glass might also play a role in the observed behavior towards the sensitivity.12

The key ingredients of tooth paste with NovaMin Technology is calcium sodium phosphosilicate (Bioactive glass) and titanium dioxide. The bioactive particles binds to the exposed dentinal tubules and leads to the formation of biological mineral which in turn reduces the dentin hypersensitivity.11

The nanohydroxy toothpaste where the nano crystals mimics the natural hydroxyapatite crystals releases the calcium and phosphate ions which recrystallize to form biomimetic apatite layers with greater resistant effect towards acid attack.

Thus by considering the advantages of bioactive glass on dentinal hypersensitivity and gingivitis. Thus the present study is aimed to compare and evaluate the effect of dentifrice containing bioactive glass particulate, BioMinF, NovaMinR, Argin and Nano hydroxy particles on dentinal hypersensitivity and gingivitis.

4

AIM AND OBJECTIVES

AIM To compare the effect of dentifrices containing BioMinF, NovaMinR, Argin and

Nanohydroxy apatite particles on dentinal hypersensitivity and gingivitis.

OBJECTIVES ➢ To assess the effect of dentifrices containing BioMinF, NovaMinR, Argin and

Nanohydroxy apatite particles on dentinal hypersensitivity using Visual Analogue

Scale and Electric Pulp Tester.

➢ To assess the effect of dentifrices containing BioMinF, NovaMinR, Argin and

Nanohydroxy apatite particles on gingivitis using Loe and Silness Gingival index.

➢ To compare the effect of dentifrices containing BioMinF, NovaMinR, Argin and

Nanohydroxy apatite particles on dentinal hypersensitivity.

➢ To compare the effect of dentifrices containing BioMinF, NovaMinR, Argin and

Nanohydroxy apatite particles on gingivitis.

5

REVIEW OF LITERATURE

REVIEW OF LITERATURE Gautami.S.Penmetsa et al in 2016, conducted a double blind trial. The dentine hypersensitivity was considered as the most prevalent condition and make them visit dental clinic often. Novamin and proargin were the recent trends proposed to have a better reduction of sensitivity. The study was aimed to compare the efficacy of commercially available desensitizing dentifrice containing Novamin and Pro-Argin in reduction of hypersensitivity. A total of 50 patients who had sensitivity of at least one tooth due to gingival recession were selected. The randomization was done employing a simple random method. Examination of sensitivity was done using tactile, air-blast and cold water stimulation. The intervention was provided after the collection of baseline data and patients were instructed to massage gently with the dentifrice for 5 mins and then brush the teeth twice daily in the regular technique with a soft bristled toothbrush for 2 min. Examination of patients were done at 2nd, 4th and 6th of intervention. The data were analysed using repeated measure analysis of variance, unpaired t test, post hoc analysis. Results showed product A (VANTEIJ) was better than product B (COLGATE SENSITIVE PRORELIEF) in the reduction of sensitivity, only the cold water stimulation test showed a statistical difference. The study concluded that Desensitizing toothpaste containing Novamin showed better reduction of sensitivity compared to dentifrice with Proargin technology.1

Davari AR et al in 2013, conducted a non-systematic review on dentin hypersensitivity; The PUBMED was used to find relevant English-language literature published during the period of 1999 to 2010. The study was aimed to increase the knowledge of dental trainees, dentists and specialists in the field of dentistry regarding the dentin hypersensitivity. This review has highlighted the newest trend on the etiology,

6

REVIEW OF LITERATURE

methods of diagnosis and management strategies of the condition. The recommendations on the future research on Dentinal hypersensitivity with respect to methodology of the current study was given. Dentinal hypersensitivity can be detected after elimination of various etiological factors of the pain. The treatment of dental hypersensitivity should include at-home therapy as well as complementary therapies. The follow-up visits were recommended after the periodic treatments.2

Martin Brannstrom and Arne Astrom in 1964, conducted a research to identify the various etiological factor for sensitivity. The various factors that causes the displacement of the contents in the dentinal tubules and may give rise to a mechanical stimulation of the pain fibers at the pulpo-dentinal border. This was tested by bringing the contents of the exposed outer apertures of the dentinal tubules into contact with an absorbent material. The displacement of the tubular contents produced by capillary forces would be comparable to that resulted from a jet of air. The study concluded that the odontoblasts do not play an important role in the mechanism of pain elicitation from the dentin surface.4

D. G. Gillam et al in 1999, attempted to determine the prevalence of dentine hypersensitivity in hospitals and general practice. The study reflected that hypersensitivity was prevalent among referral patients than in general practice. The study was conducted with the aim to determine perception and prevalence of hypersensitivity among general practice. The questionnaires were used to collect the data from 277 patients. Dentinal hypersensitivity was prevalent (52%) among the third and fourth decades, higher in the third and significantly higher in females when complained to males. Cold was appraised to be the most common cause of hypersensitivity. The results stipulated that self-reporting of

7

REVIEW OF LITERATURE

dentinal hypersensitivity was lower than reported in a dental hospital population. The hypersensitivity is not comprehended as a major dental problem among general dental practice patients.6

Yoshikazu Fukumoto et al in 2014, aimed to determine the association of gingival recession and other factors with the dentinal hypersensitivity. 104 Japanese subjects with or without gingival recession and intact canine or 1st premolar in all the quadrants were randomly selected. Gingival recession was measured at the buccal surface of the teeth.

Hypersensitivity was recorded on the ordinal scale after cold stimulation; ranging from no discomfort to severe pain during and after stimulation. Association of hypersensitivity with periodontal parameters and daily lifestyle was also done. Analysis of 446 teeth from 104 subjects showed that dentinal hypersensitivity was significantly higher in teeth with gingival recession than the normal teeth. Increase in hypersensitivity with the increase in recession was observed, showing 18, 49, 52, 60, and 79 % of sensitivity with 0, 1, 2, 3, and

4–8 mm recession, respectively. There was no significant difference in hypersensitivity with respect to smoking, probing depth and bleeding on probing. Multiple logistic regression analysis showed that gingival recession and plaque deposition were significant contributors of hypersensitivity. Multilevel model analysis revealed that V-shaped cervical notch and tooth brushing frequency were also associated with hypersensitivity. The study concluded that the progression of gingival recession, plaque-free teeth, V-shaped cervical notch and brushing frequency could be significant predictors of hypersensitivity.7

David H. Pashley in 1986, stated that hydrodynamic theory of dentin sensitivity where the movement of tubular fluid causes dentine sensitivity. The theory suggested that anything that can decrease dentinal fluid movement or permeability should reduce the

8

REVIEW OF LITERATURE

dentine sensitivity. There were ample variety of physicochemical mechanisms such as growth of intratubular crystals, adsorption of plasma proteins to the inner surfaces of dentinal tubules or formation of a smear layer on the exposed dentin surface that can result in the reduction in the sensitivity of exposed dentin. But these procedures can result in partial tubule occlusion. Currently there are several therapeutic approaches for tubular occlusion which includes application of unfilled resins, the topical application of oxalate salts, crystals of calcium oxalate which occlude the tubules resulting at instant desensitization.8

Cummins in 2010, provided a brief overview of the diagnosis, epidemiology, etiology and clinical management of dentine hypersensitivity to discuss various approaches to relieve sensitivity, with special accent on occlusion of dentine tubule and the clinical mark for efficacy of desensitizing toothpastes and to abridge the science behind a new dentifrice technology, such as arginine and calcium carbonate, and the clinical evidence which proves the instant and lasting relief of hypersensitivity. Clinical studies reflected that a new toothpaste, containing arginine and calcium carbonate (Pro-Argin technology) with 1450 ppm fluoride, provides instant and lasting relief of dentine hypersensitivity.

Three 8-week studies proved that this new toothpaste offers superior efficacy in reduction of sensitivity. This relief was maintained even after twice-daily brushing. Mechanism of action of this technology is that it physically seals dentine tubules with a plug of arginine, calcium carbonate and phosphate which is resistant to pulpal pressures, acid challenge and reduces dentin fluid flow and thereby relieves sensitivity.9

Amit Jena, Govind Shashirekha in 2015, evaluated the effectiveness of three different dentifrices that contains 5% NovaMin, 8% arginine, and 15% hydroxyapatite

9

REVIEW OF LITERATURE

nanoparticles (n-HA) respectively in the treatment of dentine hypersensitivity. A study was conducted for a period of 4 weeks on 45 patients with cervical abrasions of two or more teeth anterior to molars. Patients were divided into Group I: 5% NovaMin, Group II: 8% arginine and Group III: 15% n-HA. Sensitivity was assessed at baseline, immediately after application and 1-week and 4 weeks. Tactile stimuli response was assessed using a visual analog scale and cold air blast using Schiff cold air sensitivity scale. The data was analyzed using two-way analysis of variance and post-hoc. The current study resulted that Group III and Group II showed statistically significant reduction in hypersensitivity when analyzed

Visual analog scale analysis when compared with Group I. There was no statistically significant difference between Group II and Group III immediately after application on

Schiff cold air sensitivity scale. This settled that Toothpaste containing 15% n-HA was most effective in reduction of hypersensitivity after a single application up to a period of 4 weeks followed by 8% arginine and 5% NovaMin toothpastes.11

Eshita Dasharathbhai Patel, Sharmila Verma, Raghu T. N. in 2012, aimed to compare the anti-gingivitis and anti-plaque effects of a dentifrice containing bioactive glass with a positive control triclosan and fluoride and negative control dentifrice with fluoride in a period of 6 weeks. The study was conducted among 150 subjects aged 19-33 years.

The data Plaque, Gingival, Calculus Index and saliva samples for Porphyromonas

Gingivalis count were recorded at baseline and after six weeks. Supragingival prophylaxis was done for all the subjects and intervention was given for six weeks. Polymerase Chain

Reaction was carried out for quantification of P. gingivalis. A change in plaque, gingival and calculus index was observed in all the three groups. Paste B dentifrice containing bioactive glass showed greater effect on gingivitis compared to Paste A dentifrice with

10

REVIEW OF LITERATURE

fluoride and C dentifrice containing triclosan at 6 weeks from baseline. Reduction of P. gingivalis was statistically significant in Paste B, C and A with p<0.001 at 6 weeks compared to baseline. The study concluded that a dentifrice containing triclosan and fluoride significantly improves oral health by a reduction of plaque, gingivitis and calculus along with reduction in P. gingivalis in the period of 6 weeks.12

Allan et al in 2001, described that particulate Bioglass is a bioactive material used in the repair of periodontal defects. This material undergoes a surface reaction in an aqueous environment which resulted in osseointegration. The study was aimed to determine antibacterial effect on oral bacteria. Streptococcus sanguis, Streptococcus mutans and Actinomyces viscous were put off in nutrient broth (NB), artificial saliva (AS) or Dulbecco's modified eagle medium with 10% foetal calf serum (DMEM+10%FCS), with or without particulate Bioglass. All bacteria showed a reduction after exposure to

Bioglass in all the media after 1 hour which increased after 3 hours. Porphyromonas gingivalis, Fusobacterium nucleatum, Prevotella intermedia and Actinobacillus actinomycetemcomitans were suspended in either BM broth or 40% horse serum (HS). A considerable reduction was observed with all bacteria tested, in both media when compared to inert glass controls. It was found that the increased reduction of S. sanguis was observed following exposure to NB pre-incubated with Bioglass. A solution of Nutrient broth and

NaOH exerted an antibacterial effect when pre-incubated with Bioglass. The shows that particulate Bioglass exerts an antibacterial effect on certain oral bacteria which might be due to the alkaline nature of its surface reactions.13

Iain Allan et al in 2002, described 45S5 BioglassA is a bioactive implant material, which is used for the repair of periodontal defects. This material exert an antibacterial effect

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which was beneficial. Though Biofilms of Streptococcus sanguis, and mixed species biofilms from a salivary inoculum grown on particulate BioglassA and inert glass particulate in a constant depth film fermenter. At duration of 3, 24 and 48 hours the biofilms of S. sanguis grown on BioglassA was grown significantly low compared to that of inert glass. The study concludes that particulate BioglassA had the potential in the reduction of bacterial establishment of its surface in vivo which was relevant to post-surgical periodontal wound healing.14

Martin Addy et al in 2005, stated that patients with dentine hypersensitivity suffering from painful symptoms, on exposure of dentine to allow stimuli which trigger a neural response in the pulp via a hydrodynamic mechanism. The processes of development of sensitivity needed to localise lesions which include either loss of enamel or gingival recession. At the same time as tooth brushing with or without toothpaste appears to cause minimal wear to enamel, circumstantial evidence associates tooth brushing with gingival recession and exposure of dentine. Other tooth wear processes remarkably attrition and acid erosion root loss of enamel and can expose dentine leading to sensitivity. The study concluded that available evidence supports the link of tooth brushing, with or without toothpaste and an acidic diet on tooth wear and dentine hypersensitivity.15

Tai BJ et al in 2006, aimed to evaluate the antigingival and anti-plaque effects of a dentifrice with bioactive glass (NovaMinR) compared with a placebo control dentifrice for a period of 6 weeks. The current study was a randomized, double-blinded, controlled trial. 100 subjects participated in the study and were matched for plaque, gingival bleeding index, age and gender. The ethical approval was obtained from Ethical Committee of the

Wuhan University. The supragingival prophylaxis was done to all subjects to remove all

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plaque, calculus and extrinsic stain after which the baseline examination was done and intervention given. The Plaque and Gingival Bleeding index were collected at baseline and

6 weeks and analysed using a repeated-measures ANOVA. The current study resulted that the Plaque and Gingival bleeding Index were significantly reduced over the 6 weeks period in the test group. A 58.8% reduction in gingival bleeding and 16.4% reduction in plaque growth was observed. There was no difference of the Plaque and Gingival Bleeding index over 6 weeks in the control group. The study concluded that a dentifrice containing

NovaMinR significantly improves oral health by a reduction in gingival bleeding and supragingival plaque compared with a negative dentifrice over the 6 weeks.16

Nancy J Thompson in 2006, conducted a small pilot study to examine the validity of visual dental hygiene screenings among local communities. A 126 kindergarten through second grade children were screened by 2 dental hygienists under inspection of a dentist.

Two dental hygienists used tongue blade and a goose-neck lamp (VDHS) to noted teeth as decayed or not. The dentist examined the decayed tooth using a mirror, explorer on a portable dental chair with a goose-neck lamp; this examination is known as a mirror, tactile dental inspection (MTDI) which was the "gold standard." Data were analyzed to test the significance of differences and to investigate for discrepancies between the VDHS and

MTDI. Sensitivity and specificity for the VDHS for all teeth were 61% and 96% respectively. The analysis showed, the sensitivity of the VDHS is greater when, lesions are large and single surface lesions are located anteriorly in primary teeth.17

Ana Cecilia Correa Aranha et al in 2009, aimed to compare various treatments for dentine hypersensitivity in a period of 6-month. 101 teeth exhibited a non carious cervical lesions were selected for the study. The method used for the quantification of

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sensitivity was the cold air syringe method, recorded by the visual analogue scale (VAS) at baseline, immediately after topical treatment, 1 week, 1, 3 and 6 months. Teeth were randomly assigned to five groups (n = 20) as G1: Gluma Desensitizer (GD); G2:

Seal&Protect (SP); G3: Oxa-gel (OG); G4: Fluoride (F); G5: Low intensity laser-LILT

(660 nm/3.8 J/cm²/15 mW). The statistical analysis was done using non-parametric

Kruskal-Wallis test. This demonstrated statistical differences immediately after the treatment (p = 0.0165). for intragroup comparison was done using Friedman test. It was detected that GD and SP presented immediate effect after application. Reduction in the pain level throughout 6 months was also observed. In contrast, Low intensity laser showed a gradual reduction of hypersensitivity. Oxa-gel and Fluoride exhibited effects as of the first and third month respectively. The current study concluded that, after 6 months clinical evaluation, all therapies showed lower VAS sensitivity values when compared with baseline.19

Isabel.C.C.M. Porto et al in 2009, reviewed about the etiology, characteristics and treatment of dentinal hypersensitivity to enable in the therapeutic management. The author described the associated factors that predisposes the causes of dentinal hypersensitivity that have to be controlled or eliminated through education of patient in regard to the ill effects of excessive intake of acidic food and proper guidance have to be given for tooth brushing technique and analysis of occlusion. The effective treatment was possible only after appropriate diagnosis and elimination of any other probable causes of the pain. Recently a extensive variety of treatment were available for treatment of dentinal sensitivity, quick and permanent relief. These treatment aids an effective desensitizing agent to completely resolve which were difficult to treatment.20

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Sanjay Miglani et al in 2010, describes Dentinal hypersensitivity as a common clinical condition habitually associated with exposed dentinal surfaces. It can affect patients of any age group and frequently affects the canines and premolars of both the arches. This reviews the patho-physiology, mechanism and clinical management of the hypersensitivity. Treatment of hypersensitivity should start with an accurate diagnosis.

Differential diagnosis of dentinal hypersensitivity should be made after exclusion of all other probable etiological factors. By eliminating the etiological factors, the recurrence of the condition can be prevented. “At home” desensitizing agents include toothpastes, mouthwashes or chewing gums which act by either occluding the dentinal tubules or blocking the neural transmission. The recent treatment options like bioglass, Portland cement, lasers and casein phosphopeptide provided an effective outome.22

Giovanna Orsini et al in 2010, aimed to evaluate the desensitizing efficacy of a recent dentifrice based on zinc– carbonate hydroxyapatite (CHA) nanocrystals. A double- blind, randomized controlled trial was designed to compare with potassium nitrate/fluoride dentifrice. The participant’s hypersensitivity was evaluated at baseline and at 4th and 8th week using air blast (primary outcome), tactile, cold water and subjective tests (secondary outcomes). The final sample consisted of 70 subjects among which 36 received the new dentifrice and 34 the control dentifrice. Both dentifrices were highly effective; the percentage of reduction of hypersensitivity from baseline to 8 weeks was higher than 28% for all tests group. The experimental subjects had a significant improvement in the airblast test score (mean reduction of 46.0%) and the subjective test score (47.5%) when compared to the control. There was no significant difference between groups for the tactile and cold water tests at any time point. The present study concluded that the novel dentifrice

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containing zinc–CHA nanocrystals significantly reduced dentinal hypersensitivity after 4 and 8 weeks.23

Eilis Lynch et al in 2012, described Dentine hypersensitivity as a commonly occurring dental condition and bioactive glasses were used in formulations of dentifrice for treating dentinal hypersensitivity by forms a surface layer of hydroxycarbonate apatite on the tooth, thereby occludes exposed dentinal tubules. Fluoride-containing bioactive glass form fluorapatite, which is more stable towards acid attack and provide a more justifiable option for treating hypersensitivity. Melt-derived multi-component bioactive glass with increasing CaF2/SrF2 content (0 to 32.7 mol%) were prepared. Apatite formation, occlusion of dentinal tubules in dentine discs and ion release in Tris buffer were done in vitro up to 7 days using X-ray diffraction, infrared spectroscopy, scanning electron microscopy and inductively coupled plasma emission spectroscopy. The fluoride- containing bioactive glasses resulted in apatite from in 6 hours. The glasses resulted in the successful occlusion of dentinal tubules by formation of apatite crystals and released ions such as fluoride, strontium and potassium. Fluoride significantly increases apatite formation of the bioactive glasses, permitting the treatment of hypersensitivity by occlusion of dentinal tubules. The glasses also release active ions, such as strontium and fluoride for prevention of caries, zinc for bactericidal properties and potassium used as a desensitising agent in dentifrices.24

Suryaprakash Ananthakrishna et al in 2012, conducted a study aimed to compare in the effect of NovaMin and 10% strontium chloride containing dentifrices on dentinal hypersensitivity in a 6-week clinical study. Bioactive glass is a calcium sodium phosphosilicate material (24.5% CaO, 24.5% Na2 O, 6.0% P2 O5, and 45% SiO2) that was

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formerly industrialized as an implant material to regenerate bone and lately revised for use in oral care products (NovaMin®, NovaMin Technology Inc.). NovaMin reacts hastily with saliva to release sodium, which increases the salivary pH, calcium and phosphate, creating the perfect conditions for remineralization. The property of NovaMin to occlude dentinal tubules and remineralize dentin paved the way to be used in the treatment of dentinal hypersensitivity. Forty subjects were examined for dentinal hypersensitivity using air blast and cold water method and subjective perception of pain (0–10 scale) at baseline and at 2, 4, and 6 weeks. The subjects were then randomly alienated into two different test dentifrice groups. Though both the groups showed a decrease in dentinal hypersensitivity over 6 weeks, there was a statistically greater difference in hypersensitivity at 2, 4, and 6 weeks in the DenShiel group (NovaMin containing dentifrice) when compared with the

Senolin (strontium chloride containing dentifrice) group.25

Jorg Eberhard et al in 2013, described gingivitis as a low-level oral infection persuaded by bacterial deposits. A probable link between the severe periodontitis and cardiovascular disease had been shown. The study was conducted among 37 non-smoking young volunteers with no inflammatory disease, cardiovascular risk factors. This single- subject interventional study with an intra-individual control. The oral inflammation was induced by the interruption of oral hygiene for 21 days intentionally, tracked by a resolving phase of 21 days after reinitiation of oral hygiene measures. The concentrations of hs CRP,

IL-6, and MCP-1, adhesion capacity and oxLDL uptake of isolated blood monocytes outcome measures at baseline, day 21 and 42. The partial termination of oral hygiene practice resulted in the significant increase of gingival bleeding. This inflammation was associated with a increase in hsCRP and MCP in peripheral blood samples at 21st day,

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which decreased by 42 days. There was increased adherence of monocytes to endothelial cells and increased in formation of foam cell after oxLDL uptake (P=0.050) at day 21. The present study concluded that bacterial-induced gingival low-level inflammation persuaded a systemic rise in inflammatory markers. The study suggested that appropriate dental prophylaxis play a role in limiting systemic markers of inflammation in subjects with gingivitis.26

Deyu Hu et al in 2012, conducted a eight week, single-center, two-cell, double- blind, and randomized clinical study aimed to evaluate the effect of Pro Argin Mouthwash

Technology containing 0.8% arginine, PVM/MA copolymer, pyrophosphates and 0.05% sodium fluoride in an alcohol-free base (‘‘Arginine’’) on dentin hypersensitivity. The subjects who satisfied the criteria with two hypersensitive teeth with a tactile hypersensitivity score of 10 and 50g of force and an air blast score of 2 or 3 participated in this study. The study participants (n=90) were randomized into two groups. Subjects brushed fluoride tooth paste and tooth brush and then rinsed with 20mL of assigned mouth wash for twice daily. Subjects abstained from eating or drinking for a duration of 30 minutes after rinsing. Dentine hypersensitivity, hard and soft tissues examination were conducted at baseline and 2, 4 and 8 weeks of use. The study concluded that the Argine

Mouthwash delivers a significant reduction in dentin hypersensitivity.27

Neuhaus KW et al in 2013, conducted a single-site, randomized, controlled, double-blind, parallel arm study. The study was aimed to evaluate the effectiveness of dentifrice containing 15% calcium sodium phosphosilicate (CSPS; NovaMin) with and without fluoride in reduction of dentine hypersensitivity after a single application and 28 days following dental scaling and root planing. A total of 151 subjects were participated in

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this study. Before the intervention scaling and root planing procedure was done for all the subjects. The subjects were randomly allocated into three different groups as Test-A (15%

NovaMin and NaF), Test-B (15% NovaMin) and a control. Dentine hypersensitivity was assessed by tactile stimulus (Yeaple Probe) and by air blast (Schiff scale) at baseline and

28 days. The present study concluded that, the single application of both fluoridated and non-fluoridated dentifrice containing 15% CSPS (NovaMin) provided a significant reduction of dentine hypersensitivity till 28 days.28

Vijaya Puthiriraj Pillai, Prasanna Neelakantan in 2013, described dentin hypersensitivity as a condition characterized by short, sharp pain in response to external stimuli. Several treatment aids and clinical methods are presented to manage the hypersensitivity. Desensitizing dentifrices seem to be the most common method of management of dentin hypersensitivity. The components of commercial desensitizing pastes include potassium salts, strontium salts, stannous salts and fluorides. The recent technology are the bioglass (NovaMin) and arginine (ProArgin) technology which have shown moral results in clinical trials. The review converses the desensitizing toothpastes used for treatment of dentine hypersensitivity.29

Asad Mahmood et al in 2014, conducted a research with the purpose to determine the abrasivity of a 45S5 bioactive glass dentifrice on enamel as the role of the particle size and shape of the glass. 45S5 glass was produced minced and sieved to give several particle sized < 38, 38-63 and 63-110 microns. Two different grinding routes were used: percussion milling and ball milling. The glass powders were formulated into toothpastes and their tooth brush abrasivity measured. Enamel loss increased with increasing particle size. The percussion milled powder exhibited particles that had sharp edges and the pastes were

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significantly more abrasive than the pastes made with round ball milled powders. The present study showed that there was preferential wear of the enamel at the dentin-enamel junction (DEJ), particularly with the coarse particle sized pastes.30

Amit kumar et al in 2015, described Calcium Sodium Phosphosilicate (NovaMin) have been used in regeneration of bone and tissue for more than 15 years is effective adjunct to conventional surgery in treatment of intrabony defects. It has been incorporated in dentifrices as an ingredient for remineralization for treatment of dentinal hypersensitivity. Novel studies with NovaMin dentifrices and the particulates mixed with water have been shown to possess a strong anti-microbial action against periodontal pathogens that is beneficial to the periodontal maintenance therapy. The dentifrice comprising Bioactive glass expressively improves gingival health as measured by reducing gingival bleeding and supragingival plaque. Hence the present review attempeted to discuss the various benefits of NovaMin in periodontal therapy.31

Arun et al in 2015, reviewed that Pulp vitality testing, a facet of oral diagnosis, is crucial in monitoring the health of the dental pulp. Pain response to hot, cold or an electric pulp tester specifies the vitality of a tooth’s pulpal sensory supply. Though the traditional tests shows a high sensitivity, the response does not give any idea about the state of the pulp. They frequently yield response which is false-negative and false-positive. The novel pulp testing deliberates the vascular supply is additionally important to determine the health of the pulp than the sensory supply. The pulp testing has been considered as an

‘overvalued’ and ‘underused’ diagnostic aid. The study gave a comprehensive view of various tests based on sensitivity as well as vitality.32

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Ram Sabarish Chandrasekar et al in 2015, analyzed the antibacterial property of a Perioglass against Streptococcus salivarius (early colonizer) which was a common oral commensal . Invitro study was conducted with Perioglas (in various concentrations) to assess for its antibacterial property against the ATCC 13419 strain of S. salivarius. The anti-microbial activity was analyzed by considering the reduction of colony-forming units in culture plates and smear following a 24 hours incubation at 37°C. The bioactive glass

(BAG) showed an antibacterial effect against the S. salivarius while suspending the media and smear. The antibacterial activity of Bioactive glass increased in with its concentration.

Perioglas established a substantial antibacterial effect against S. salivarius at 50 mg/mL concentration.33

Furqan A. Shah et al in 2015, investigated the role of serum proteins their influence on ion release and the ability in the formation of in vitro fluoride-containing bioactive glasses in the dissolution medium. Five bioactive glass compositions in the SiO2–

P2O5–CaO–Na2O–CaF2 system and Bioglasss 45S5 were assessed for their apatite forming ability in the culture media which is serum-free and serum-containing up to seven days. The present study concluded that Fluoride ions in low concentrations were highly beneficial for apatite formation of Bioactive glass, while increased fluoride content resulted in formation of fluorite and calcite. The presence of serum proteins delayed the precipitation of apatite for fluoride-containing glasses, while Bioglasss 45S5, in spite of a considerably higher concentration of phosphate, formed an amorphous calcium phosphate.34

Rithesh Kulal et al in 2016, evaluated and compared the effects of three different desensitizing agents (15% nano hydroxyapatite crystals; 5% novamin and 8% proargin) on

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dentinal sensitivity and tubule occlusion in-vitro. Scanning Electron Microscope (SEM) was used in the evaluation of the effect of these commercially available desensitizing toothpastes. The study was conducted with the contextual idea of Dentinal Hypersensitivity

(DH) as frequently encountered clinical condition which affects 8-57% of the adult population. A total of 40 dentin specimens in shape of disc were dissected from extracted premolars. The Dentin discs of 1mm were attained with the help of diamond discs. Ten specimens were randomly allocated to the groups A (control group), B (Nano- hydroxyapatite), C (Novamin) and D (Proargin) for evaluation. Each treatment group dentine disc was treated with the respective slurry for a period of two minutes for seven days. Each disc was subjected to a pre- and post-treatment SEM analysis for the evaluation of the changes occurring in the dentinal tubules. The current study showed that there was no occlusion of the dentinal tubules in Group A (control group) and Group B which has nanohydroxyapatite showed 98.1% tubule occlusion. Group C which is Novamin and D i.e

Proargin showed tubule occlusion of 83.1% and 69.1% respectively. The statistical analysis showed a significant difference between Group B and D (p< 0.005). The present study concluded that all the three desensitizing agents were effective in the occlusion of dentine tubule and the nano-hydroxyapatite toothpaste showed a greater effect on dentinal hypersensitivity when compared to the other desensitizing agents.35

Paul Ikhodaro Idon et al in 2017, stated that Dentine hypersensitivity remains an enigma though, it was known to usually present with sharp, short pain caused by one or more external stimuli and it is often incompetently understood. There were abound controversies concerning the appropriate terminology for the condition, variations in the prevalence, and which is the most important to the patients suffering from the condition

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and treatment that provides an immediate relief which has long lasting effect. Existing interventions using desensitizing agents provide the relief which is temporary. The interest of dental practitioners and researchers towards the dentine hypersensitivity which remained a common complaint among patients worldwide. The paper was aimed to review the published literature and provide a current opinion on the prevalence, aetiology, mechanism, clinical features, treatment as well as the concept of oral health related quality of life among patients with dentine hypersensitivity. A manual and PubMed literature search was conducted with the help of the keywords, dentine hypersensitivity, tooth sensitivity, cervical dentine hypersensitivity, root dentine hypersensitivity and also with the combination of prevalence, epidemiology, diagnosis, mechanism, aetiology, clinical features, treatment, oral health or quality of life. The inclusion of a measure of oral health related quality of life is indorsed as one of the outcome measures for novel treatment modalities.36

Shuya Shi et al in 2017, conducted a study with the aim of comparing the long- term in vitro effectiveness of a newer desensitizing agent containing bioactive glass and two other commercial products used for dentin hypersensitivity. Fifty occlusal dentin disks were obtained from extracted sound human third molars and then treated with 0.5M ethylene diamine tetra acetic acid for 2 min then randomly divided into five groups (n=10).

Specimens were brushed for 2 minutes twice daily using Actimins Paste in Group 1,

Group2 which has Lesening Super Desensitizing Toothpaste, Group3 using Colgate

Sensitive Pro-Relief Desensitising Polishing Paste and Group4 using distilled water at 9:00 am and at 5:00 pm. Specimens of Group5 had no brushings. All specimens were immersed consecutively for 5 min into coffee (pH=5.4) at 10:00 am and cola which is undiluted

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(pH=2.5) at 6:00 pm. Dentin permeability was calculated weekly over one month using electrochemical impedance spectroscopy (EIS). Data were subjected to statistical analysis using repeated measures ANOVA and post hoc tests. The study results showed that the three desensitizing agents significantly reduced dentin permeability over one month. Post hoc tests of the EIS values reflected that brushing with Actimins showed no significant difference from Colgate Sensitive (P=0.32). The current study concluded that the three desensitizing agents were effective in the occlusion of dentinal tubules and Actimins and

Colgate Sensitive were the most effective. Actimins was initially active and a faster- working desensitizing agent.37

Guntakala Vikram Reddy et al in 2018, aimed to compare the efficacy of four commercially available toothpastes in the treatment of dentinal hypersensitivity. A single-centered clinical trial was conducted among 160 subjects and were divided equally into four groups, group 1 (Biomin); group 2 (NovaMin); group 3 (herbal formulation) and group 4 (5% potassium nitrate). The patient’s dentinal hypersensitivity scores for tactile, evaporative stimuli were recorded on a visual analog scale at baseline, 2nd and at 4th week.

The current study concluded the Biomin group showed a comparable clinical response at the end of 4th week when compared with others. The current study concluded that Biomin group showed significantly results when compared with NovaMin, herbal and potassium nitrate toothpastes in the treatment of dentinal hypersensitivity symptoms.38

Imran Farooq et al in 2019, aimed to compare the remineralization potential of a innovative dentifrice consisting of a fluoride-containing bioactive glass (BiominF) with that of a dentifrice containing bioactive glass (BG) as well as sodium monofluorophosphate

(Novamin). Fifteen enamel blocks were randomized into three groups: 1 is the Control

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(n=3), group 2 is the Novamin (n = 6), and group 3 is the BiominF (n = 6) dentifrice group.

Toothpaste slurries were prepared by mixing of 1gram toothpaste with 5 mL artificial saliva. The specimens were exposed to 6% citric acid of weight (pH, 2.2) for 5 minutes to mimic demineralization, and specimens in groups 2 and 3 were stored in the toothpaste slurries for 5 minutes and 24 hours. The changes in the mean enamel volume were evaluated by micro–computed tomography, and the mean surface loss or gain was investigated using a profilometer. The data were subjected to statistical analysis using

Wilcoxon rank sum test and one-way analysis of variance with post-hoc. BiominF performed better when compared to Novamin in terms of remineralization after 5 minutes and 24 hours, as observed by micro-CT. The current study concludes that the dentifrice comprised of a fluoride-containing Bioactive glass showed promising potential to encourage remineralization of demineralized human enamel.39

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MATERIALS AND METHODS

MATERIALS AND METHODS

STUDY DESIGN:

The present study is a randomized, parallel arm, controlled trial designed to compare the effect of four different dentifrices containing NovaMinR, Nanohydroxy apatite particles, Argin and BioMinF on dentinal hypersensitivity and gingivitis among 35-

44 years aged population.

R GROUP A NovaMinR TOOTH PASTE A N

GROUP B LIST D NANOHYDROXY PARTICLES TOOTH

OF VILLAGESOF PASTE O

M GROUP C 4 4 VILLAGES ARGIN TOOTH PASTE

RANDOMSAMPLING I Z GROUP D A BioMinF TOOTH PASTE

T I Figure 1: Study Design- Parallel arm, Randomized controlled trial with 4 groups . O

N

26

MATERIALS AND METHODS

STUDY AREA

Madurai is one of the ancient city, located in the south of the state of Tamil Nadu in . It is also known as the Athens of the East. It is the administrative headquarters of Madurai District. It is 25th populated city and is the 31st largest city in India. Madurai is the 9th largest city by population in Tamil Nadu. The history of Madurai is intertwined with the history of the and the third Tamil Sangam, a chief assembly of

Tamil scholars, is believed to have been conducted in the city. According to 2011 census based on per-expansion limits, the area covered under the Madurai Municipal

Corporation had a population of 3,038,252 with a sex-ratio of 999 females for every 1,000 males, much above the national average of 929. A total of 100,324 were under the age of six, constituting 51,485 males and 48,839 females. The average literacy of the city was

81.95%, compared to the national average of 72.99%. The urban agglomeration of

Madurai had a population of 18,46,801, rural population constitutes of 11,91,451 and is the third largest in Tamil Nadu and the 31st in India.40

Figure 2: MAP SHOWING MADURAI DISTRICT BLOCKS6 27

MATERIALS AND METHODS

ETHICAL CLEARANCE AND INFORMED CONSENT:

The synopsis of the proposed research was prepared and submitted to the

Institutional Review Board of Best Dental Science College, Madurai. After the review and scrutiny by the board members of the institutions, approval was granted to conduct the research (ANNEXURE I). Informed consent was obtained from the subjects before the commencement of study (Annexure II). Participation in this study was purely on voluntary basis and they were allowed to opt out from the study at any time they wish to do so. It was emphasized that strict confidentiality would be maintained at all times and that no names or personal details will be used in the write up of the study.

SAMPLE SIZE CALCULATION:

2 2 n = 4 Σ {z (1- a /2)+ z(1- b )}

d2

• Where z (1- a /2) is the Alpha error at 5 % significance level

• z(1- b ) is the beta error or power of the study whose value for power of 80%

d = Difference in means

S.D

• The estimated sample size was 22 in each group.

• An additional 10% was added to compensate for the sample loss, if any and the

final sample size was 25 in each group.

• 100 people of 35 - 44 years (4 groups). 11

28

MATERIALS AND METHODS

EXAMINER CALIBRATION

Training exercises were first carried out in the Department of Public Health

Dentistry, Best Dental Science College and Hospital on the out-patients under the guidance of a trained person. About ten subjects were examined to assess the consistency of intra and inter examiner reproducibility. Intra examiner reliability was determined using

Cohen’s Kappa coefficients. A value of 90% was attained for Gingival index. The inter examiner reliability of Gingival index was assessed using Cronbach’s α. The results showed a good consistency with α value of 82%.

SOURCE OF DATA:

The source of the data was primary in nature. The list of the total villages (665 villages) of Madurai district were collected.13 From the above list 4 villages were selected through lottery method.

SELECTION PROCESS:

STUDY POPULATION:

The study sample comprised of 35- 44 years old people from 4 villages of Madurai district.

INCLUSION CRITERIA:

• The subjects to be at least 35 - 44 years of age.

• With good general health (free of systemic disease).

• With a minimum of 20 firm teeth.

• No visible signs of untreated caries.

29

MATERIALS AND METHODS

• Patients with periodontal disease (Free of pain).

• Patients with dental hypersensitivity.

EXCLUSION CRITERIA:

• Patients on long-term antibiotic or anti-inflammatory therapy.

• Patients with unacceptable restorations.

• Patient already under desensitizing toothpaste and mouth rinse.

• Pregnant or lactating women.

• Patients with removable dentures (partial).

• Patients who were not willing for the cessation of the adverse habits.

• Patients with deleterious oral habits.

• Patients with history of chronic regurgitation of acids.

• Patients with painful symptomatic tooth/teeth.

• Patients who were allergic to the ingredients of the tooth paste.

• Patients undergoing orthodontic treatment.

SAMPLING PROCEDURE:

The list of the total villages (665 villages) of Madurai district were collected.13

From above list, 4 villages were selected through lottery method. In the selected villages a door to door survey was conducted to select the subjects aged 35-44 years based on the inclusion and exclusion criteria. 25 subjects from each village were selected for the study.

The study was conducted during the period of April 2019 to July 2019. The villages selected for the study were Kadachanenthal, Y.Othakadai, Arumbanur, Kodikulam and were coded as Group A, B, C and D respectively.

30

MATERIALS AND METHODS

BLINDING

It is a double blinded study. Both the study subjects and the Principal examiner were blinded. The codes “A”, “B”, “C” and “D” to the dentifrice was assigned by the person who was not involved in the study. The Principal investigator was blinded to the interventions and was not aware of the dentifrice assigned to the group. The tooth paste were masked using colored cellophane tape.

PREPARATION OF SPECIAL PROFORMA

A special proforma was prepared to collect the required data. The proforma was prepared in English language (Annexure III). The proforma was divided into three different sections.

i. The first section contained provision to record patient’s demographic details which

includes Name, Age, Gender, Address and Phone Number

ii. The second section contained provision to record dentinal sensitivity through

Visual Analogue Scale and Electric pulp tester.

iii. Provision to record the Gingival Index (GI) developed by Loe and Silness in

1963 to describe the clinical severity of gingival inflammation.

STUDY DESIGN:

Double blinded Parallel arm Randomized Controlled Trial.

31

MATERIALS AND METHODS

RANDOMIZATION:

The trade name of the dentifrices was masked by the colored cellophane tape and

encoded as A, B, C, D. These tooth pastes were randomly assigned to selected

villages by the person who was not directly involved in the study. A particular

village received a common intervention. The village receiving tooth paste coded

A,B,C,D were considered as group A,B,C,D respectively.

• Group A - Dentifrice containing bioactive glass non fluoridated (NovaMinR).

• Group B- Dentifrice containing nanohydroxy apatite particles.

• Group C - Non- aqueous toothpaste (proArgin).

• Group D- Dentifrice containing bioactive glass fluoridated (BioMinF).

DATA COLLECTION:

Data was collected using predefined data capture form. Privacy and Confidentiality were maintained.

The socio demographic profile was recorded by the principal examiner.

According to ADA specification, Type III Clinical examination was carried out under natural daylight.17 The subjects were made seated comfortably on an ordinary chair and examined using natural light. The examinations were carried without cleaning or drying of the teeth by using number 2 plane dental mouth mirror, dental tweezer and a

WHO probe. Radiographs were not taken. The data on Dentinal hypersensitivity using

Visual Analogue Scale,41 and Electric pulp tester43 and Gingival status using Loe and

Silness Gingival index43 procedures were carried out by a single calibrated examiner and the readings were recorded by a trained assistant.

32

MATERIALS AND METHODS

The baseline data was recorded on dentinal hypersensitivity using Visual Analogue

Scale (using ice stick)19 and Electric Pulp Tester on tooth/teeth the patient experienced sensitivity.41 Gingival status was recorded using Loe and Sillness Gingival Index 1963.42

After collection of baseline data, all the study groups were subjected to respective allocated dentifrices for 4 weeks. The patients were instructed to use pea sized tooth paste on the tooth brush and brush following the regular oral brushing technique and frequency. They were also instructed to report any untoward experience to the principal examiner through phone call/message.

Four consecutive data of dentinal hypersensitivity and gingival status were recorded on every 7th day of intervention. Minimum of 20 minutes was required for examination of each patient.

Visual Analogue Scale:

Dentin hypersensitivity was assessed by the principal examiner through ice stick method. The subject’s response was considered as a baseline measurement, according to the visual analogue scale of pain (VAS). Each patient was asked to rate the perception of discomfort after the application of ice stick perpendicular to the tooth surface for the duration of 3 seconds. Neighboring teeth were isolated during testing using the operator’s fingers and cotton rolls. The VAS scale consists of a horizontal line, 100 mm long, with by the descriptor “no pain” on the left hand side and at the other end by “unbearable pain.”

The patients were asked to rate their pain according to the scale in order to mark the severity of their hypersensitivity. The distance of this point in millimeters from the left end of the scale was recorded and used as the VAS score.

33

MATERIALS AND METHODS

The VAS score was classified as

1. 0 - no pain,

2. 1-3 - mild,

3.4-6 – moderate,

4. 7-10 - severe pain.

Patients with a VAS score ≥ 40 mm participated in the study.41

Figure 3: Visual Analogue Scale

0 1 2 3 4 5 6 7 8 9 10

Electric Pulp Tester:

Electric Pulp Tester was placed at occlusal third42 of buccal surface for the evaluation of pulp vitality and the EPT value. The tooth paste was used as an electrolyte medium. The current was increased from 0 to 10. The point at which the patient elicited the response was noted at each intervention. The Electric Pulp Testing score was recorded only the tooth or teeth in which the patient had sensitivity. This procedure was repeated in the contralateral normal tooth.43

34

MATERIALS AND METHODS

Loe and Silness Gingival Index:44

Gingival Index (GI) was developed by Loe H and Silness J in 1963 to describe

the clinical severity of gingival inflammation as well as its location.

Scoring criteria for Gingival Index

Appearance Bleeding Inflammation Score

Normal No Bleeding None 0

Slight change in color and little change in No Bleeding Mild 1 texture

Moderate glazing, redness, edema and Bleeding on Pressure Moderate 2 hypertrophy

Marked redness, and hypertrophy, ulceration Spontaneous bleeding Severe 3

Surfaces Examined on each tooth

A typical examination of all surfaces of all teeth usually starts with the right upper

second molar, is continued over the midline to the upper left second molar. On the teeth of

the right side the sequence will be: distal surface, buccal surface, mesial surface and on

those of the left side: mesial surface, buccal surface and distal surface. When these three

surfaces of all teeth have been assessed, the palatal surfaces of all maxillary teeth are

assessed beginning with the upper left second molar.

Examination of the lower jaw starts with the lower left second molar and is carried

through to the lower right second molar. On the teeth of the left side the sequence will be:

35

MATERIALS AND METHODS

distal surface, buccal surface, mesial surface and on those of the right side: mesial surface, buccal surface and distal surface. Finally, all lingual surfaces are scored beginning with the lower left second molar.

Each gingival unit (buccal, lingual, mesial and distal) of the individual tooth is given a score from 0-3 called the gingival index for the area.

The scores from the four areas of the tooth are added and divided by four to give the GI for the tooth.

Finally, by adding the scores for the teeth and dividing by six the Gingival Index for the patient is obtained. The Index for the patient is thus an average score for the area examined.

Before examination for Gingival Index, the gingiva were dried by cotton rolls.

Subjects with mild inflammation usually score from 0.1-1.0, those with moderate inflammation from 1.1-2.0, and an average score between 2.1-3.0 signifies severe inflammation.44

STUDY DURATION:

6 months from the month of March to August. The intervention given for 4 weeks.

36

MATERIALS AND METHODS

ARMAMENTARIUM:

The following instruments were used for the study:

1. Diagnostic instruments

a. Mouth mirror.

b. WHO probe.

c. Electric pulp tester.

d. Ice Sticks

2. Tweezers

3. Cotton holder

4. Sterilized cotton rolls

5. Kidney trays

6. Torch

7. Disposable gloves

8. Disposable mouth masks

9. Korsolex solution

10. Lifeboy hand wash

11. Study Proforma

12. Dentifrices

37

MATERIALS AND METHODS

CROSS INFECTION CONTROL:

An asepsis protocol was developed and strict procedures were followed for infection control. A new set of autoclaved instruments were used for each subject.

Sufficient number of instruments was carried to the examination site to avoid interruption during the study. Cold sterilization method was followed using Korsolex chemical solution

(Glutaraldehyde – 7.0 grams, 6-dihydroxy 2, 5-Dioxahexane – 8.2 grams and Polymethylol urea derivatives – 17.6 grams). One part of Korsolex was diluted to nine parts of clean tap water to get 10% solution, into which, pre-rinsed instruments were immersed for a minimum of 30 minutes before reused, if needed. Used instruments were placed in the disinfectant solution, then washed and drained well before re sterilization. After end of each day examination, all the instruments were autoclaved. New gloves were used for examination of each subjects. The collected wastes during examination were segregated and disposed based on biomedical waste management guidelines.

EMERGENCY CARE AND REFERRAL:

After the examination a brief summary of the findings were explained to the institutional authorities. If a life threatening condition, or a condition that requires immediate attention, is detected during the examination appropriate measures has been taken to refer the case to our institution for treatment.

38

MATERIALS AND METHODS

STATISTICAL METHODS:

The data were entered in Excel sheet. Appropriate statistical analysis was carried out using SPSS Version 23 (Statistical Package For Social Sciences)

Inter Group Comparison – Repeated Measures ANOVA and Post Hoc Test

Friedman`s Test

Intra Group Comparison – Wilcoxon’s Sign Rank Test

ANOVA & Post Hoc Test is the parametric test was used to assess the difference in the scores of the Electric Pulp Tester before and after intervention among the 4 groups.

Friedman was the non - parametric version of ANOVA used to compare the difference in dentinal sensitivity using Visual Analogue Scale and Gingival index. Wilcoxon’s sign rank tests were used to assess the difference between the scores before and after intervention in the same group. Statistical significance was fixed at p≤0.05 and p value of 0.001 or less represents a highly significant relation.

39

Figure 4: METHODOLOGY: Study protocol

Ethical Clearance

4 villages in Madurai District

Age group of 35-44 years

Exclusion criteria Inclusion criteria Final sample size n=100

Randomization

Group A Group B Group C Group D BioMinF NovaMinR ProArgin Nanohydroxy

Data collected by single inspector Data recorded by trained assistant

Baseline Data (Gingival Index, VAS Score, Electric Pulp Tester Score )

Intervention at 1st Week

Data collection at the end of 1st week of Intervention

Intervention at 2nd Week

Data collection at the end of 2nd week of Intervention

Intervention at 3rd Week

Data collection at the end of 3rd week of Intervention

th Intervention at 4 Week

Final Data collection at the end of 4th week of Intervention

40 Statistical Analysis PHOTOGRAPHS

ARMAMENTARIUM USED

Figure 4: Instruments for clinical examination

Figure 5 :Materials used in the research –cotton bin, disposable masks, sterile gloves, chemical disinfectants, Diagnostic instruments, dentifrices,

Electric pulp tester.

41

PHOTOGRAPHS

Figure 6 : Clinical Examination

Figure 7 : Clinical Examination

42

PHOTOGRAPHS

Figure 8 : Clinical Examination

Figure 9 : Clinical Examination

43

PHOTOGRAPHS

Figure 10 : Study participants filling the proforma

Figure 11 : Study Participant brushing using the dentifrice

44

RESULTS

RESULTS

A randomized, parallel arm, double blind clinical trial was designed to compare the desensitization efficacy of NovaMinR, Nano hydroxy apatite particles, Argin and

BioMinF tooth paste and its effect on gingival health.

The study was conducted among 35 to 44 years old subjects in four different villages of Madurai. A total of 100 subjects were selected from the four villages which consisted of 48 Males and 52 Females.

By Blocked randomization, study subjects (25 subjects) of each village were allocated into one of the four groups NovaMinR (A), Nano hydroxy apatite particles (B),

Argin (C) and BioMinF (D) tooth paste. The study was conducted during the period of

April 2019 to July 2019.

Among the total (100 subjects) subjects there was an attrition of 1% seen at the end of the study.

The information collected regarding all the selected cases were recorded in a Master

Chart. Data analysis was done with the help of computer using Statistical Package for

Social Sciences (SPSS Inc., Chicago, IL, version 23.0 for Windows). The frequencies and percentages were calculated for qualitative variables. Means and standard deviations were calculated for quantitative variables. A 'p' value less than 0.05 denotes significant relationship in the present study.

45

RESULTS

DEMOGRAPHIC CHARACTERISTICS

TABLE 1: DEMOGRAPHIC CHARACTERISTICS OF THE STUDY

PARTICIPANTS BASED ON GENDER

GENDER FREQUENCY PERCENT

FEMALE 52 52

MALE 48 48

GRAPH 1: DEMOGRAPHIC CHARACTERISTICS OF THE STUDY

PARTICIPANTS BASED ON GENDER

Chart Title

52

51

50

49

48

47

46 FEMALE MALE

Table 1 shows the demographic characteristics based on gender.

A total of 100 participants were included in the study with respect to the sample size which includes 52 female and 48 male.

46

RESULTS

TABLE 2: DEMOGRAPHIC CHARACTERISTICS OF THE STUDY

PARTICIPANTS BASED ON AGE IN DIFFERENT GROUP

Group N Mean age Standard Deviation p Value

(Years)

A 25 39.440 3.176

B 25 39.520 2.709

C 25 39.560 2.662 0.892 D 25 38.960 3.088

A-NovaMinR, B- Nano hydroxy apatite particles, C- Argin and D- BioMinF

GRAPH 2: DEMOGRAPHIC CHARACTERISTICS OF THE STUDY

PARTICIPANTS BASED ON AGE IN DIFFERENT GROUP

39.7 39.56 39.6 39.52 39.5 39.44 39.4 39.3 39.2 39.1 39 38.96 38.9 38.8 38.7 38.6 1

GROUP A GROUP B GROUP C GROUP D

Table 2 shows the mean age of the participants in each study group. The mean age of the study subjects in the Group A (NovaMinR) was 39.44 years, followed by 39.52,

47

RESULTS

39.56 and 38.96 years in Group B (Nano hydroxy apatite particles), Group C (Argin) and

Group D (BioMinF) respectively. There was no statistical significance found between the mean age of different groups (p=0.892).

TABLE 3: DEMOGRAPHIC CHARACTERISTICS OF THE STUDY

PARTICIPANTS BASED ON AGE

Age (Years) Frequency Percentage

35 8 8.0

36 10 10.0

37 14 14.0

38 10 10.0

39 10 10.0

40 8 8.0

41 13 13.0

42 8 8.0

43 6 6.0

44 13 13.0

Table 3 shows, the study participants age ranged from 35 to 44 years. Among the total subjects (100), the majority (14%) of the subjects belonged to the age group of 37 years followed by 13% in 41 years and 44 years age group, 10 % subjects each in 36, 38 and 39 years age group, 8% of the subjects each in 35, 40 and 42 years age group and the least (6%) were belonged to 43 years age group respectively.

48

RESULTS

Table 4: Intragroup comparison of Dentinal Sensitivity Recorded by Visual Analogue Scale Baseline 1st Week 2nd Week 3rd Week 4th Week p Value

Mean±SD Mean±SD Mean±SD Mean±SD Mean±SD

GROUP A 2.760±.435 1.240±.435 0.920±.276 .480±.509 .080±.276 0.002

GROUP B 2.680±.556 1.200±.408 .600±.500 .200±.408 .080±.278 0.001

GROUP C 2.600±.577 1.600±.500 1.080±.276 .720±.458 .160±.374 0.036

GROUP D 2.760±.522 1.320±.476 .760±.435 .240±.435 .120±.331 0.008

A-NovaMinR, B- Nano hydroxy apatite particles, C- Argin and D- BioMinF

Graph 3: Intragroup comparison of Dentinal Sensitivity Recorded by Visual Analogue Scale

3

2.5

2

1.5

1

0.5

0 1 2 3 4 5

GROUP A GROUP B GROUP C GROUP D

Table 4 shows the response to Dentinal Sensitivity using Visual Analogue Scale

among subjects in the group. There was gradual reduction in the Mean value of the response

rate among the subjects in Group A and Group B which was highly significant with a p

value of 0.002 and 0.001 respectively. Group C and Group D subjects showed a gradual

49

RESULTS

reduction in the Mean value of the response rate which was statistically significant with a p value of 0.036 and 0.008 respectively.

Table 5: Intergroup comparison of Dentinal Sensitivity Recorded by Visual Analogue Scale

Group Intervention Mean Std. Deviation p Value

A BASELINE 2.7000 .52223 0.758 B C D A 1st WEEK 1.3400 .47610 0.013 B C D A 2nd WEEK .8400 .41972 0.004 B C D A 3rd WEEK .4100 .49431 0.005 B C D A 4th WEEK .1100 .31447 0.774 B C D A-NovaMinR, B- Nano hydroxy apatite particles, C- Argin and D- BioMinF

Table 5 shows intergroup comparison of subjective response of dentinal sensitivity at baseline,1st, 2nd, 3rd and 4th week. The intergroup comparison showed that there was no significant difference found at baseline and 4th week with the p value of 0.758 and 0.774 respectively. The Mean±SD of Dentinal Sensitivity score recorded though Visual

Analogue Scale in Baseline was 2.700±0.52223, 1st week was 1.340±.476, 2nd week was

0.840±.419, 3rd week was 0.4100±.4943 and 4th week was 0.1100±.3144, and a significant difference found in the subjects response to dentinal sensitivity in 2nd week, 3rd week and

1st week with a p value of 0.004, 0.005, 0.013 respectively.

50

RESULTS

Table 6: Intragroup comparison of Dentinal Sensitivity Recorded by Visual

Analogue Scale

Group Mean Rank p Value

Group A 1 & 2 13.00 0.007 1 & 3 13.00 0.004 1 & 4 13.00 0.005 1 & 5 13.00 0.008 2 & 3 4.5 0.000 2 & 4 9 0.001 2 & 5 12 0.000 3 & 4 6 0.001 3 & 5 11 0.000 4 & 5 5.50 0.002 Group B 1 & 2 12.5 0.001 1 & 3 13 0.007 1 & 4 13 0.000 1 & 5 13 0.006 2 & 3 8 0.011 2 & 4 10.50 0.036 2 & 5 12 0.000 3 & 4 5.50 0.002 3 & 5 7 0.003 4 & 5 2 0.083 Group C 1 & 2 11.50 0.000 1 & 3 12.50 0.001 1 & 4 13 0.001 1 & 5 13 0.007 2 & 3 7 0.031 2 & 4 10 0.000 2 & 5 11.50 0.002 3 & 4 5 0.003 3 & 5 11 0.001 4 & 5 7.50 0.000 Group D 1 & 2 13 0.001 1 & 3 13 0.007 1 & 4 13 0.000 1 & 5 13 0.001 2 & 3 7 0.005 2 & 4 10.50 0.000 2 & 5 12 0.001 3 & 4 7 0.003 3 & 5 8.50 0.000 4 & 5 2 0.002 1-Baseline data, 2- 1st week, 3- 2nd week, 4-3rd week, 5-4th week of intervention.

A-NovaMinR, B- Nano hydroxy apatite particles, C- Argin and D- BioMinF

51

RESULTS

The Table 6 shows that, there was a significant difference in the subjective response between the Baseline and 1st, 2nd, 3rd and 4th week of intervention with a p value of 0.007, 0.004, 0.005 and 0.008 respectively. 1st week and 2nd week (p=0.000), 1st week and 3rd week (p=0.001), 1st week and 4th week (p= 0.000), 2nd week and 3rd week (p=0.001),

2nd week and 4th week (p=0.000), 3rd week and 4th week (p=0.002) of intervention in

NovaminR (Group A) showed a significant reduction.

A significant reduction was observed in the subjects response to dentinal sensitivity in Nano hydroxyparticles group (Group B) between the Baseline and 1st, 2nd week, 3rd week and 4th week with the p value of 0.001, 0.007, 0.000 and 0.006 respectively. Similarly a significant reduction was seen between 1st week and 2nd week followed by 1st week with

3rd week and 4th week of intervention consequently with the p values of 0.000, 0.036, 0.000.

2nd week and 3rd week (p=0.002) and 2nd week and 4th week (p=0.003) of intervention.

There was a significant difference between the Baseline and 1st,2nd, 3rd and 4th week,

1st week and 2nd, 3rd and 4th week with a p value < 0.05. A significant difference exist between 2nd week and 3rd week (p=0.003), 2nd week and 4th week (p=0.001), 3rd week and

4th week (p=0.000) of intervention in Argin (Group C).

A significant statistical reduction of Dentinal Sensitivity was observed in BioMinF

(Group D) among the Baseline and 1st week, 2nd week, 3rd week and 4th week of intervention with p-value of 0.001, 0.007, 0.000 and 0.001 respectively, 1st week and 2nd week (p=0.005), 1st week and 3rd week (p=0.000), 1st week and 4th week (p= 0.001), 2nd week and 3rd week (p=0.003), 2nd week and 4th week (p=0.000) and 3rd and 4th week

(p=0.002) of intervention.

52

RESULTS

Table 7: Intergroup comparison of Dentinal Sensitivity Recorded by EPT

Time Group Mean Std. 95% Confidence Interval for p Value Interval Deviation Mean Lower Bound Upper Bound BASELINE A 2.5600 .65064 2.2914 2.8286 .622 B 2.3600 .63770 2.0968 2.6232 C 2.5600 .91652 2.1817 2.9383 D 2.6400 .86023 2.2849 2.9951 1st WEEK A 3.8400 .89815 3.4693 4.2107 .017 B 4.6000 .70711 4.3081 4.8919 C 3.5200 .82260 3.1804 3.8596 D 4.1200 .92736 3.7372 4.5028 2nd WEEK A 5.6800 1.06927 5.2386 6.1214 .000 B 7.1200 .60000 6.8723 7.3677 C 4.7600 .83066 4.4171 5.1029 D 5.8400 .85049 5.4889 6.1911 3rd WEEK A 7.2000 .57735 6.9617 7.4383 0.009 B 7.2400 .59722 6.9935 7.4865 C 6.4400 .86987 6.0809 6.7991 D 7.3600 .56862 7.1253 7.5947 4th WEEK A 7.3200 .69041 7.0350 7.6050 .002 B 7.3600 .56862 7.1253 7.5947 C 6.8000 .70711 6.5081 7.0919 D 7.4400 .58310 7.1993 7.6807 A-NovaMinR, B- Nano hydroxy apatite particles, C- Argin and D- BioMinF

Graph 4: Intergroup comparison of Dentinal Sensitivity Recorded by EPT

8

7

6

5

4

3

2

1

0 1 2 3 4 5

GROUP A GROUP B GROUP C GROUP D

53

RESULTS

Table 7 shows, the intergroup comparison of Dentinal Sensitivity through Electric

Pulp Tester. The baseline data was not significant between the groups. There was a significant difference in the intervention among the groups with a p value of 0.001.

Table 8: Intergroup comparison of Dentinal Sensitivity Recorded by Electric

Pulp Tester

Group Group Mean Difference Std. Error p Value

A B -.4160* .14621 .027

C .5040* .14621 .005

D -.1600 .14621 .694

B C .9200* .14621 .000

D .2560 .14621 .303

C D -.6640* .14621 .000

A-NovaMinR, B- Nano hydroxy apatite particles, C- Argin and D- BioMinF

Table 8 depicts the intergroup comparison of Dentinal Sensitivity using Electric

Pulp Tester determined by PostHoc.

There was a significant reduction in dentinal sensitivity seen between Group A and

B,C, Group B and C and Group C and D considering all the four weeks of intervention with a p value of < 0.05 respectively. But there was no significant difference found among the Group A and D as well as in Group B and D.

54

RESULTS

Table 9: Intragroup comparison of Gingival Status

Baseline 1st Week 2nd Week 3rd Week 4th Week p Value

Mean±SD Mean±SD Mean±SD Mean±SD Mean±SD

GROUP A 2.040±.5385 2.000±.577 1.840±.687 1.840±.687 1.840±.687 .001

GROUP B 2.160±.472 1.800±.645 1.320±.556 1.240±.522 1.040±.200 .000

GROUP C 2.240±.435 2.023±.577 1.960±.640 1.920±.435 1.920±.435 .032

GROUP D 2.120±.439 1.920±.571 1.920±.678 1.720±.678 1.680±.556 .014

A-NovaMinR, B- Nano hydroxy apatite particles, C- Argin and D- BioMinF

Graph 4: Intragroup comparison of Gingival Status among the study subjects

2.5

2

1.5

1

0.5

0 1 2 3 4 5

GROUP A GROUP B GROUP C GROUP D

Table 9 shows the intra group comparison of Gingival Status among study subjects.

There was a gradual decrease in the Mean value among the subjects in Group B and Group

D from the Baseline to 4th week of intervention with a p value of 0.000 and 0.014

respectively which was highly significant. A gradual reduction in the Mean value from

baseline to 2nd week of intervention was seen and remained constant in the latter

55

RESULTS

interventions in Group A and C subjects, with a p value of 0.001 and 0.032 which was statistically significant.

Table 10: Intergroup comparison of Gingivitis

Group Time Interval N Mean Std. Deviation p Value

A BASELINE 100 2.1400 .4718 0.550 B C D A 1ST WEEK 100 1.9300 .5904 0.574 B C D A 2ND WEEK 100 1.7500 .6871 0.002 B C D A 3RD WEEK 100 1.6900 .6771 0.004 B C D A 4TH WEEK 100 1.6300 .6614 0.017 B C D A-NovaMinR, B- Nano hydroxy apatite particles, C- Argin and D- BioMinF

Table 10 shows the intergroup comparison of gingival status among the study subjects in the groups. There was no significant difference found in baseline and 1st week of intervention between the groups. A significant difference was noticed between the

Groups in the 2nd, 3rd and 4th week of intervention with the p value <0.05 which was statistically significant.

56

RESULTS

Table 11: Intragroup comparison of Gingival Score

Group Mean Std. Deviation p Value

Group A 1 & 2 2.040 .538 0.317 1 & 3 0.025 1 & 4 0.025 1 & 5 0.025 2 & 3 2.000 .577 0.046 2 & 4 0.046 2 & 5 0.046 3 & 4 1.840 .687 1.000 3 & 5 1.000 4 & 5 1.840 .687 1.000 5 1.840 .687 Group B 1 & 2 2.160 .472 0.003 1 & 3 0.001 1 & 4 0.001 1 & 5 0.004 2 & 3 1.800 .645 0.001 2 & 4 0.000 2 & 5 0.000 3 & 4 1.320 .556 .157 3 & 5 0.008 4 & 5 1.240 0.522 0.025 5 1.040 0.200 Group C 1 & 2 2.240 .435 0.014 1 & 3 0.005 1 & 4 0.035 1 & 5 .035 2 & 3 2.000 .577 .157 2 & 4 .705 2 & 5 .705 3 & 4 1.920 .640 .655 3 & 5 .655 4 & 5 1.960 0.675 1.000 5 1.960 0.675 Group D 1 & 2 1.960 .675 .822 1 & 3 .816 1 & 4 0.237 1 & 5 0.124 2 & 3 1.920 .571 1.000 2 & 4 .132 2 & 5 0.058 3 & 4 1.920 .702 .132 3 & 5 0.034 4 & 5 1.840 .687 .763 5 1.680 0.556 1-Baseline data, 2- 1st week, 3- 2nd week, 4-3rd week, 5-4th week of intervention.

A-NovaMinR, B- Nano hydroxy apatite particles, C- Argin and D- BioMinF

57

RESULTS

Table 11 shows the intragroup comparison of Gingival Status among the subjects.

There was no significant difference found between the Baseline and 1st week, followed by

2nd and 3rd, 2nd and 4th and 3rd and 4th week of intervention with a p value of >0.05 which was not statistically significant in Group A (NovaminR).

Subjects in Group B (Nano hydroxy apatite particles) shows a significant difference between all the interventions with a p value < 0.05 which was highly statistically significant.

Subjects in Group C (Argin) shows a statistical difference with p value of <0.05 in Baseline with 1st,2nd and 3rd week of intervention only

There was a significant difference between 1st and 4th (p= 0.058), 2nd and 4th week

(p=0.034) of intervention in Group D (BioMinF) study subjects.

58

DISCUSSION

DISCUSSION

A journey of a thousand miles begins with a single step. Oral health is an integral aspect to general well-being and relates to the quality of life. Dental diseases are the most prevalent chronic diseases worldwide, and a costly burden to health care services. The treatment of dental diseases were expensive, accounts between 5% and 10% of total health care expenditures in industrialized countries. In most developing low-income countries, the prevalence rate of dental caries is high and more than 90% of caries is untreated. An estimated 5 billion people worldwide suffer from dental caries (tooth decay). Nutrition affects the teeth and growth of the jaw during development.45 The dental plaque is considered to be the one of the primary etiological factors for dental diseases. The formation of plaque on the tooth surface is characterized by the progression from a limited number of pioneer microbial species to the complex flora of mature dental plaque. This progression involves initial adherence of bacteria to the salivary pellicle and subsequent accumulation by growth and inter-bacterial adherence. Ultimately, the tooth surface gets coated with a dense, complex microcommunity that ends up in the destruction of hard enamel tissue.18 Micro organisms play a significant role in the causation of the dental problems.

Periodontal disease is pathological inflammatory condition of the gum and the supporting bone structure. Periodontal disease are complex process with strong cause and effect relationship between the accumulation of supra gingival plaque and development of gingivitis.12 The rate of progression of periodontal disease is dependent on the virulence and the host.45 Periodontal disease is mostly commonly seen in middle aged population.45

59

DISCUSSION

Most commonly Dentine hypersensitivity (DH) is associated with periodontal diseases.

Improper oral hygiene practices leads to various complication such as abrasion of teeth and gingival recession.27 Though there are several causative factors for dentine hypersensitivity, gingival recession is closely associated with it. It is reported that teeth with gingival recession actually showed a higher level of dentinal hypersensitivity when compared to the teeth without gingival recession.7 Other factors such as attrition from occlusal wear, abfractions, parafunctional habits, tooth abrasion and erosion of teeth from acidic diet also results in dentinal hypersensitivity.2

Over the last decade, efforts have been made in various areas like advances in tooth brush technology to improve the standards of safety, design, texture, type of filament, etc.

Improved material science in dentifrice formulation has both oral health and cosmetic benefits and improved periodontal procedures aimed towards the management of dentinal hypersensitivity.16

Studies have suggested the combined use of both mechanical and chemical therapy as the most efficient way in bringing down the gingival inflammation. Various chemico therapeutic agents have been incorporated into dentifrice formulation to prevent and reduce gingivitis and dental caries. Desensitizing tooth paste appear to be the most common method of management of dentinal hypersensitivity. Along with various therapeutic approaches numerous products have been formulated to treat dentinal hypersensitivity. In this regard the novel products are bioglass technology (NovaMinR and BioMinF), Argin and nano hydroxy apatite particles.37 The formulation derived from this combination, Pro-

Argin, had been described as a novel dentine occlusion technology based on the fact that

60

DISCUSSION

8% arginine and calcium carbonate are believed to seal exposed dentinal tubules with a plug that contains arginine, calcium carbonate and phosphate thereby providing relief for

Dentine hypersensitivity. This claim has been supported by the results of studies which demonstrated relief of Dentine hypersensitivity for variable periods following the use of

Pro-Argin mouthwash or paste.28

Recently, NovaMin, a product based on bioglass technology containing 15% of calcium sodium phosphosilicate (CSPS) has been introduced into the market. In an aqueous environment, such as saliva, the CSPS releases sodium ions, which leads to an increase in the local pH, resulting in the rapid formation and precipitation of calcium hydroxyapatite mineral layer on the dentine surface and provides the relief of the dentinal hypersensitivity.29

Improved material science with the aid of nanotechnology has found a role to play in the treatment of dentine hypersensitivity. With decreasing particle size, nano- hydroxyapatite has bioactive and biocompatible properties. The incipient lesions penetrated into the enamel and were significantly more porous than sound enamel, which allows a greater penetration of solution ion constituents and a larger surface area for a subsequent reaction of enamel mineral. These factors increased the potential of nano hydroxyapatite to directly fill up the defects and micropores on demineralized teeth. If nano hydroxyapatite penetrates the enamel pores, it will act as a template in the precipitation process and will continuously attract a large amount of Calcium and phosphate from the remineralization solution to the enamel surface to fill the vacant positions of the enamel calcium crystals. This in turn will promote crystal integrity and growth.22

61

DISCUSSION

The BioMinF toothpaste comprises of fluoro calcium phosphosilicate which is an improved form of bioactive glass and also have glycerine, Silica, PEG 400, Titanium dioxide, Carbomer and Potassium Acesuflame. BioMinF dentifrice forms acid resistant fluorapatite and releases fluoride over a period of 8-12 hours. This combined action of apatite formation and ion release makes BioMinF an unique dentifrice for remineralization.46

The present research is a randomized, parallel arm, double blind clinical trial designed to compare the effect of NovaMinR, Nano hydroxy apatite particles, Argin and

BioMinF containing desensitizing dentifrices on dentinal hypersensitivity and gingivitis.

This study is first of its kind to compare the effect of four different desensitization dentifrice on gingival health.

A total of 100 subjects (48 Males and 52 Females) belonging to the age group of

35-44 years were participated in the present study. This age group is considered to be the standard monitoring group for the periodontal health condition of the adults as per the

WHO index age criteria.2

In the present study results all the dentifrice showed a significant reduction of dentinal hypersensitivity for both VAS, EPT and gingival status using Loe and Silness

Gingival scores at baseline, 1st, 2nd, 3rd and 4th weeks after single application.

The intra group comparison of the desensitizing dentifrices showed a significant reduction of Dentinal hypersensitivity recorded through Visual Analogue Scale with p<0.05 respectively. The current result with respect to Nanohydroxy apatite particles was inline with the study conducted by Jena et al11 in 2015. A contradictory result was found in

62

DISCUSSION

the previous study between NovaMin and ProArgin dentifrices, where ProArgin showed higher reduction of dentinal hypersensitivity which may be due to the variation in the study setting and age group of the population in each group.11

The results of the present study with respect to desensitizing dentifrice were inline with the invitro study conducted by Rithesh et al, where the Nanohydroxy apatite particles

(Aclaim) showed 97.62%, followed by NovaminR and ProArgin with 81.9% and 65.42% of tubular occlusion respectively.36 Desensitizing dentifrices precipitate and also mediate the formation of biological minerals on the exposed dentinal surfaces forming physical barriers and occludes the dentinal tubules.

The results of the present study with respect to BioMinF dentifrice, was contradictory to the result of invitro study conducted by Imran Farooq et al40 in 2019 where

BioMinF showed a better performance when compared to NovaMinR. This variation may be due to the patient’s compliance with respect to Visual Analogue Scale and the assessment of tubule occlusion though SEM analysis.

The study conducted by Suryaprakash et al also supported the results of the present study. In the previous study effect of bioactive glass and strontium chloride was tested on dentinal hypersensitivity. The NovaMinR showed a better reduction when compared to strontium chloride.26

The inter group comparison of dentinal hypersensitivity among NovaMinR,

Nanohydroxy apatite, Argin and BioMinF showed a significant difference from the first to third week with a Mean±SD of 1.340±.476, .840±.419, .410±.494 at 1st week, 2nd week and

3rd week respectively. There is no significant difference was found between the groups at

63

DISCUSSION

the end of 4th week of intervention. The reason could be due to categorizing of sensitivity score recorded through the Visual Analogue Scale.

The current study is the first of its kind to compare the effect of four different desensitizing dentifrices on dentinal hypersensitivity recorded through the Electric Pulp

Tester. The intergroup comparison between the dentifrices of the present study reflects that there was a significant reduction of dentinal hypersensitivity seen throughout the intervention. The Nanohydroxy apatite dentifrice group showed a higher response followed by NovaMinR, BioMinF and ProArgin with the increase in dentinal hypersensitivity with a Mean±SD scores of 5.00±.69, 4.76±.40, 4.8±.315, 4.24±.209 respectively from baseline to 4th week of intervention.

In the current study the intra group comparison of the Gingival status among

NovaMinR, Nanohydroxy apatite, Argin and BioMinF reflects that there was a significant difference seen in the all the four weeks of intervention among the groups with the p <

0.05. This shows that there was a noticeable reduction in the gingival score which was recorded through the Loe and Silness Gingival index 1963 among all the four groups. The inter group comparison shows that there was a significant difference seen in the 2nd, 3rd and

4th week of intervention with the p value of 0.002, 0.004 and 0.017 respectively. The results of the current study with respect to gingival score among NovaMinR dentifrice group was in line with the study conducted by Bao Jun Tai et al17 and Eshita et al.12

The literature search showed a lack of comparative studies between desensitizing paste and gingival inflammation, an attempt was made to compare four different dentifrices

64

DISCUSSION

containing NovaMinR, Nanohydroxy apatite, Argin and BioMinF. This was the first study to compare dentinal hypersensitivity and gingival score of those desensitizing dentifrices.

In the present study there was a gradual reduction in gingival index score and dentinal hypersensitivity throughout the intervention was observed. There was a drastic reduction noticed in gingival inflammation score from baseline to end of the intervention.

This reduction could be due to proper oral hygiene maintenance among the study subjects and may be due to ionic release and local changes in the oral pH. Though the result of the current study shows the significant effect of desensitizing dentifrice on gingival health no proper mechanism could be established on gingival health. The reason for this could be the

Hawthorne effect which would have influenced the outcome.

65

SUMMARY AND CONCLUSION

SUMMARY AND CONCLUSION

The present research was a randomized, parallel arm, double blind controlled trial designed to compare the the effect of four different dentifrices containing NovaMinR,

Nanohydroxy apatite particles, Argin and BioMinF on dentinal hypersensitivity and gingivitis among 35-44 years aged people.

The results could be summarised as

1. There was a statistically significant reduction in the dentinal hypersensitivity recorded using Visual Analogue Scale among the NovaMinR, Nanohydroxy apatite particles, Argin and BioMinF dentifrice group.

2. There was a statistically significant reduction in the dentinal hypersensitivity recorded using Electric Pulp tester among the NovaMinR, Nanohydroxy apatite particles, Argin and

BioMinF dentifrice group.

3. Statistically significant difference was observed in the gingival score recorded using

Loe and Silness gingival index among the NovaMinR, Nanohydroxy apatite particles,

Argin and BioMinF dentifrice group.

Thus we can conclude that,

All the four dentifrices in the present study demonstrated a significant reduction in dentinal hypersensitivity and gingivitis relatively in a shorter period of time with

Nanohydroxy apatite dentifrices showing a greatest reduction.

66

RECOMMENDATIONS

RECOMMENDATIONS

This research aspired to explore the the effect of four different dentifrices containing NovaMinR, Nanohydroxy apatite particles, Argin and BioMinF on dentinal hypersensitivity and gingivitis among 35-44 years aged people. However further research might aid in strengthening this evidence established in the study.

To our knowledge this is the first study to compare the effect of four different dentifrices containing NovaMinR, Nanohydroxy apatite particles, Argin and BioMinF on dentinal hypersensitivity and gingivitis. So, further longitudinal clinical studies are required to determine the effectiveness of dentifrices and to determine any build up of microbial resistance and reductions seen in the gingival inflammations due to modification of plaque component either in quantity or species of microorganism or mearly a reduction in plaque level at a larger study population. There were no hostile events noted with the use of above dentifrices. The present study recommends that the desensitizing dentifrices can be used for symptomatic relief of hypersensitivity.

67

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ANNEXURES

ANNEXURE I

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ANNEXURES

ANNEXURE II

75

ANNEXURES

ANNEXURE II

76

ANNEXURES

ANNEXURE III

77

ANNEXURES

78

ANNEXURES

79