COMPARATIVE EVALUATION - IN OFFICE TREATMENT OF ROOT DENTIN

SENSITIVITY WITH IONTOPHORESIS: A RANDOMIZED CLINICAL TRIAL

Dissertation submitted to

THE TAMILNADU Dr. M.G.R. MEDICAL UNIVERSITY

In partial fulfillment for the degree of

MASTER OF DENTAL SURGERY

BRANCH – II

PERIODONTOLOGY

APRIL 2015

DECLARATION BY THE CANDITATE

Comparative evaluation - In office treatment of root

TITLE OF DISSERTATION dentin sensitivity with iontophoresis: A randomized

clinical trial

PLACE OF STUDY K.S.R. Institute of Dental Science and Research

DURATION OF COURSE 3 Years

NAME OF THE GUIDE Dr. N. Raghavendra Reddy

HEAD OF THE DEPARTMENT Dr. N. Raghavendra Reddy

I hereby declare that no part of the dissertation will be utilized for gaining financial assistance for research or other promotions without obtaining prior permission of the

Principal, K.S.R Institute of Dental Science and Research, Tiruchengode. In addition, I declare that no part of this work will be published either in print or electronic without the guide who has been actively involved in dissertation. The author has the right to reserve for publish of work solely with prior permission of the Principal, K.S.R Institute of

Dental Science and Research, Tiruchengode.

Head of the Department Signature of candidate

CERTFICATE BY THE GUIDE

This is to certify that dissertation titled “COMPARATIVE EVALUATION – IN

OFFICE TREATMENT OF ROOT DENTIN SENSITIVITY WITH

IONTOPHORESIS: A RANDOMIZED CLINICAL TRIAL” is a bonafide research work done by Dr. NAARAYANEN.M.B in partial fulfillment of the requirements for the degree of MASTER OF DENTAL SURGERY in the specialty of PERIODONTICS.

Date:

Place:

Signature of the Guide

Dr. N.RAGHAVENDRA REDDY., M.D.S

PROFESSOR & H.O.D.

K.S.R. INSTITUTE OF DENTAL SCIENCE AND RESEARCH

TIRUCHENGODE

ENDORSEMENT BY THE H.O.D, PRINCIPAL/ HEAD OF THE INSTITUTION

This is to certify that Dr. NAARAYANEN.M.B. , Post Graduate student (2012-2015) in the Department of Periodontics, K.S.R. Institute of Dental Science and Research, has done this dissertation titled “COMPARATIVE EVALUATION – IN OFFICE TREATMENT

OF ROOT DENTIN SENSITIVITY WITH IONTOPHORESIS: A RANDOMIZED

CLINICAL TRIAL” under our guidance and supervision in partial fulfillment of the regulations laid down by the Tamilnadu Dr.M.G.R. Medical University, Chennai for

M.D.S., (Branch – II) Periodontics degree examination.

Seal & signature of H.O.D. Seal & signature of Principal

Dr. N.RAGHAVENDRA REDDY., M.D.S. Dr. G.S.KUMAR., M.D.S.

PROFESSOR AND GUIDE PRINCIPAL

K.S.R. INSTITUTE OF DENTAL SCIENCE AND RESEARCH

TIRUCHENGODE

ACKNOWLEDGEMENT

First of all, I am grateful to the almighty god for giving me strength and confidence to complete this thesis.

I am deeply grateful to my respected guide Dr. N. Raghavendra reddy , Head of

Department of periodontics, for his invaluable guidance in completing this work and pointing out the shortcomings in timely manner. His ideas, motivation and encouragement made possible to complete this research work.

I take this opportunity to thank my respected faculty members Dr. Esther nalini,

Dr. Arun kumar Prasad, Dr. Renuka Devi and Dr. Thirumalai, Department of periodontics for their constant support and help in times of need.

I would like to express my sincere thanks to respected Dr. G.S.Kumar, Principal,

KSR Institute of Dental Sciences & Research for providing a well established infrastructure with access to most of the international journals which helped a lot in completing this work and giving permission to avail lab facilities during this study.

I like to thank Mr. Mavatmi Marchang, Lecturer, Department of Microbiology for his ideas and guidance during propolis preparation.

I like to thank my seniors Dr. Yuvaraja, Dr. Kokila and Dr. Tamilselvi for providing indispensable advice, information and support. I also thank my batch mates

Dr. Charles and Dr. Rahul for their help and sharing their thoughts. I express my thanks to

Dr. Ajesh, Dr. Karthika and Dr. Deepthi for their help during this study.

Last but not least I like to thank my parents who always support me both mentally and financially which made possible to complete this work. I like to dedicate this work to my wife and family members for their encouragement throughout my career.

CONTENTS

CONTENT PAGE NO

1. INTRODUCTION 1

2. AIMS AND OBJECTIVES 3

3. REVIEW OF LITERATURE 4

4. MATERIALS AND METHODS 28

5. STATISTICAL ANALYSIS 43

6. RESULTS 44

7. DISCUSSION 63

8. SUMMARY AND CONCLUSION 68

9. BIBLIOGRAPHY 70

10. ANNEXURE 78

LIST OF FIGURES

FIGURE CONTENT PAGE NO.

Figure 1 Sodium Fluoride Formulation 36

Figure 2 Acidulated Phosphate Fluoride 36

Figure 3 Propolis Gel Formulation 37 - 39

Figure 4 Armamentarium 40

Figure 5 Iontophoresis Unit 40

Figure 6 Desensitizing Agents Application With Iontophoresis 41

Figure 7 Evaluation of Clinical Parameters 42

LIST OF TABLES

TABLE CONTENT PAGE NO

Table 1 Properties of sodium fluoride 10

Table 2 Properties of acidulated phosphate fluoride 13

Table 3 Descriptive statistics for baseline before application of 47

desensitizing agents for all three groups

Table 4 Descriptive statistics for baseline after application of 48 desensitizing agents for all three groups

Table 5 Descriptive statistics for 14th day before application of 49

desensitizing agents for all three groups

Table 6 Descriptive statistics for 14th day after application of 50 desensitizing agents for all three groups

Table 7 Descriptive statistics for 28th day for all three groups 51

Table 8 Wilcoxon Signed Ranks Test to compare Air, Tactile and 52 Cold water test for NaF, APF and propolis groups at

baseline before and after application

Table 9 Wilcoxon Signed Ranks Test to compare Air, Tactile and 52 Cold water test for NaF, APF and propolis groups at

baseline before application and 14th day before application

Table 10 Wilcoxon Signed Ranks Test to compare Air, Tactile and 53 Cold water test for NaF, APF and propolis groups at 14th

day before and after application

Table 11 Wilcoxon Signed Ranks Test to compare Air, Tactile and 53 Cold water test for NaF, APF and propolis groups at

baseline before application and 28th day

Table 12 Mann-Whitney Test to compare Air, Tactile and Cold water 54 test in between two groups at baseline before and after

application, at 14th day before and after application and at

28th day

Table 13 Kruskal-Wallis Test to compare Air, Tactile and Cold water 55 test in between three groups at baseline before and after

application, at 14th day before and after application and at

28th day

LIST OF GRAPHS

GRAPH CONTENT PAGE NO

Graph 1 Age and Sex distribution of the samples 55

Graph 2 Mean scores for Air, Tactile and Cold water test for NaF, 56

APF and propolis groups

Graph 3 Comparison between NaF, APF and propolis groups in line

diagram for tactile test at baseline before and after 57

application, at 14th day before and after application and at

28th day

Graph 4 Comparison between NaF, APF and propolis groups in line 58 diagram for air test at baseline before and after application,

at 14th day before and after application and at 28th day

Graph 5 Comparison between NaF, APF and propolis groups in line 59 diagram for cold water test at baseline before and after

application, at 14th day before and after application and at

28th day

Graph 6 Comparison between NaF, APF and propolis groups in bar 60 diagram for tactile test at baseline before and after

application, at 14th day before and after application and at

28th day

Graph 7 Comparison between NaF, APF and propolis groups in bar 61 diagram for air test at baseline before and after application,

at 14th day before and after application and at 28th day

Graph 8 Comparison of mean scores for NaF, APF and propolis 62 groups in bar diagram for cold water test at baseline before

and after application, at 14th day before and after application

and at 28th day

LIST OF ABBREVIATIONS

1 Appl Application

2 Aft After

3 Bef Before

4 ºC Celsius

5 CaF2 Calcium Fluoride

6 CAS Chemical Abstracts Service

7 CDC Centre of Disease Control

8 CPP – ACP Casein Phosphopeptide – Amorphous Calcium phosphate

9 cm Centimeters

10 DC Direct Current

11 EDTA Ethylene diamine tetra acetic acid

12 EPA Environmental Protection Agency

13 Er:YAG Erbium-doped yttrium aluminium garnet

14 F Fluoride

15 FDA Food and Drug Administration

16 g Grams

17 GaAlAs Gallium Aluminum Arsenide

18 HCl Hydrochloric Acid

19 HEMA Hydroxy Ethyl Methacrylate

20 HeNe Helium Neon

21 Hz Hertz

22 HF Hydrofluoric Acid

23 H2O Water

24 K Potassium

25 mA Milli Ampere

26 mJ Mega Joules

27 min Minutes

28 mol Mole

29 Na Sodium

30 NaF Sodium Fluoride

31 NaOH Sodium Hydroxide

32 NaHF2 Sodium Bifluoride

33 NaPH3O4F Acidulated Phosphate Fluoride

34 Nd:YAG Neodymium-doped yttrium aluminium garnet

35 psi Pounds Per Inch

36 pH Potential of hydrogen

37 RDS Root Dentin Sensitivity

38 V Volts

Introduction

Introduction

INTRODUCTION

Biofilms and bacterial plaque deposits have to be removed periodically to control inflammatory diseases in the periodontium. This can be achieved through professional scaling with use of either hand instruments or ultrasonic driven instruments.1 Use of ultrasonics has been in practice since 1955 which is effective and quick way of plaque removal. However removal of plaque deposits results in dentinal hypersensitivity which occurs either due to exposure of root surface to oral cavity or removal of portion of cementum which can lead to exposure of dentinal tubules.2, 3

Dentinal hypersensitivity may be defined as pain arising from exposed dentin, typically in response to tactile, thermal, chemical, or osmotic stimuli that cannot be explained as arising from any other form of dental defect or pathology. Root dentin sensitivity is the term used to describe the sensitivity which occurs due to periodontal disease and its treatment.4 Non surgical periodontal treatment may temporarily increase root dentin sensitivity which reduces subsequently over period of time.5, 6

Though there are various theories to explain about the etiology of dentinal hypersensitivity, Brannstrom theory which explains about the rapid fluid movement inside the dentinal tubules is most accepted theory. Scanning electron microscopic examination of exposed dentin revealed, eight times more open dentinal tubules in sensitive dentin as compared to non-sensitive dentin.7

Dentinal hypersensitivity can be treated by means of different treatment strategies. It can be treated either by reducing the nerve excitability or by occluding the dentinal tubules or by combination of the two approaches. Desensitizing agents which are capable of forming a crystalline precipitate that occludes the dentinal tubules can be applied through either home based desensitizing agents or through in office procedure called iontophoresis.

1

Introduction

Iontophoresis is a method in which electrical current is passed over the desensitizing agents which are applied over the tooth surface and through which the ionic particles in the form of anions is moved in to the dentinal tubules to achieve the desensitizing effect by blocking it. 2 % Sodium fluoride and 1.23% APF are the common agents used in the fluoride iontophoresis. Fluoride is a negative anion which is moved inside the dentinal tubules to block it by passage of electrical current.8, 9

Recently propolis has gained its importance in the treatment of dentinal hypersensitivity. Propolis is a substance which is collected by honey bees from different plant sources. The composition and properties of propolis varies according to its geographical and botanical origin. Propolis has wide range of applications in dentistry. In vitro studies have shown that propolis can block the dentinal tubules and therefore considered as one of desensitizing agents.10, 11

In this present study root dentin sensitivity which occurs following ultrasonic scaling was treated with iontophoresis with either one of the following agents 2% sodium fluoride,

1.23 % acidulated phosphate fluoride and 10% propolis. Effectiveness of these agents in reducing the root dentin sensitivity immediately after its application is assessed by various parameters such as tactile, air and cold water stimuli test over a period of time. An attempt has also been made to compare these desensitizing agents.

2

Aims & Objectives

Aims and Objectives

AIM AND OBJECTIVES

The study is having the following aim and objectives

1. To evaluate and compare three different treatment strategies, 2% NaF, 1.23% APF

and 10% propolis with iontophoresis in reducing root dentin sensitivity after

mechanical therapy by air stimuli immediately after application, followed by 14 days

and at the end of 28 days.

2. To evaluate and compare three different treatment strategies, 2% NaF, 1.23% APF

and 10% propolis with iontophoresis in reducing root dentin sensitivity after

mechanical therapy by tactile stimuli immediately after application, followed by 14

days and at the end of 28 days.

3. To evaluate and compare three different treatment strategies, 2% NaF, 1.23% APF

and 10% propolis with iontophoresis in reducing root dentin sensitivity after

mechanical therapy by cold water stimuli immediately after application, followed by

14 days and at the end of 28 days.

3

Review of Literature

Review of Literature

REVIEW OF LITERATURE

DENTIN HYPERSENSITIVITY

Addy defines dentin hypersensitivity as a “Short, sharp pain arising from exposed dentin in response to stimuli typically thermal, evaporative, tactile, osmotic, or chemical and which cannot be ascribed to any other form of dental defect or pathology.” Exposure of dentin leading to opening of the dentinal tubules is the major cause for dentinal hypersensitivity to occur. This results in connection between pulp tissue of tooth and external environment thereby causing sensitivity.12

Dentinal exposure can occur either due to various causes including attrition, abrasion, erosion, faulty tooth brushing habits, cementum and enamel not meeting each other.

Exposure of dentin in periodontal therapy as a result of professionally performed mechanical debridement will cause undesired effect due to receding of gingival tissues, root surface roughness and iatrogenic denudation of root dentin due to removal of cementum.3, 13 The sensitivity which occurs as a result of periodontal treatment is distinct from that of other conditions. Recently the term root dentin sensitivity has been used by European federation to describe the sensitivity which occurs due to periodontal disease and treatment.14

STIMULI FOR DENTINAL HYPERSENSITIVITY

Dentin hypersensitivity which is transient can occur as a result of various stimuli which will reduce upon removal of stimulus. The various stimuli includes, the chemical stimuli which is by acids from foods, beverages, fruits, balsamic vinegars and wine, osmotic stimuli which occurs by fluid flow due to pressure or pH changes within tissue, mechanical stimulus from toothbrushes on tooth surface, denture clasps on tooth surface and oral hygiene devices, air stimulus which cause evaporation of air from tooth causing it to dry out,

4

Review of Literature dehydration of dentinal tubule fluids leading to evaporation of fluids and thermal stimuli which occurs due to hot/cold rapid temperature changes, temperature changes in food and beverages.

THEORIES OF DENTINAL HYPERSENSITIVITY

The cause for occurrence of dentinal hypersensitivity is still not understood. But various theories have been put forward for possible etiology of dentinal hypersensitivity.

Odontoblastic Transduction Theory

According to this theory any stimuli will excite the odontoblastic process which in turn will release neurotransmitters and stimulate the nerve endings. But this theory is unproven as there are no known neurotransmitters found to be released from the odontoblasts.

Neural Theory

This theory explains that any stimuli will alter the nerve endings inside the dentinal tubules which have communication with pulpal nerve fibers.

Hydrodynamic Theory

This is the most accepted theory proposed by Brannstrom and his coworkers which suggest that fluid filled dentinal tubules which are open to oral cavity and pulp tissue, respond to any stimuli including thermal, air, osmotic and physical by fluid movement inside the tubules, which stimulate the baroreceptors leading to neural discharge. 15

ROOT DENTIN SENSITIVITY

Root dentin sensitivity which occurs following periodontal treatment occurs both after non surgical and surgical periodontal therapy. The prevalence following nonsurgical

5

Review of Literature intervention was 62.5% to 90% in treatments after one day which subsequently decreased to approximately 52.6% to 55% after one week. 5

According to studies by Tammarow et al (2000) 5 it is shown that only a few teeth in a comparatively low number of patients developed severe RDS, but that initially sensitive teeth more frequently developed increased RDS following root instrumentation compared to initially non-sensitive teeth. The finding that fewer patients had sensitivity could be related to local factors in the oral cavity, as well as to the level of the subject pain perception. This sensitivity which occurs as a result of mechanical debridement was due to opening of dentinal tubules which ultimately treated with desensitizing agents to obliterate the dentinal tubules.

Navid Knight et al (1998)16 carried out an in vitro study with electron microscope to examine the effect of mechanical and chemical treatments in obliterating dentinal tubules.

46 experimental specimens with one test and one control surface are prepared on premolars extracted for orthodontic reasons. The specimens were treated with sharp & dull curets, sonic scaler with metal & plastic tips and ultrasonic scaler with metal & plastic tips. After debridement among the surfaces treated with mechanical procedures the surfaces treated with sharp curets show complete obliteration of dentinal tubules. The surfaces treated with ultrasonic scalers were abraded & irregular. Among the chemical treatments resin is found to completely obliterate the tubules which resisted the tubule occlusion even after treating with water for one minute.

DESENSITIZING AGENTS

Desensitizing agents are materials which can be applied over the tooth surface to reduce dentinal hypersensitivity. The desensitizing agent can act by two main methods one is by ceasing the nerve transmission from dentin to pulp by nerve depolarization and another

6

Review of Literature method is by occluding the dentinal tubules. The agents that act by latter method have gained importance.

IDEAL REQUIREMENTS

According to lutin, an ideal desensitizing agent should have to possess the following properties17

(1) Painless,

(2) Non irritant to pulp

(3) Easy handling,

(4) Permanently effective,

(5) Quick acting,

(6) Consistently effective and

(7) Not discolour.

IN OFFICE TREATMENT MODALITIES FOR DENTINAL HYPERSENSITIVITY

The various treatment modalities and agents by which dentinal hypersensitivity can be treated by in office treatment methods are as follows

Potassium Nitrate

Potassium nitrate acts by decreasing fluid flow through the tubules by occluding them and decreases the activation of sensory nerves, thus preventing the pain signals to be transmitted to the central nervous system. Potassium ions of this agent diffuse through the dentinal tubule and reach the pulp-sensory complex and form a region of greatly increased

7

Review of Literature concentration with K+ ions which subsequently depolarizes the pulpal sensory complex and reduces pain transmission.18

Calcium Hydroxide

Calcium hydroxide because of its high pH provokes the odontoblastic process protein coagulation and decrease the hydraulic conductance by precipitation of proteins in tubules and also by binding of calcium ions over the protein radicals. One of the negative features of calcium hydroxide is irritation of gingival tissues.19

Strontium Chloride

Strontium ions penetrate dentin deeply and replace calcium, resulting in recrystallization in the form of a strontium apatite complex.20, 21

Casein Phospho Peptide – Amorphous Calcium Phosphate

CPP-ACP acts as reservoir of calcium and phosphate ions which favours remineralization. It causes collagen fibers and apatite crystals to get deposited in tubules, leading to blockage of tubules.22

Formaldehyde or Glutaraldehyde

Formaldehyde and glutaraldehyde has the ability to precipitate salivary proteins in dentinal tubules. These agents are very strong tissue fixatives and should be used with extreme caution to ensure they do not come in contact with the vital gingival tissues. 23

Laser Therapy

Nd: YAG laser could cause melting and closure of exposed dentinal tubules without dentin surface cracking, resulting in a reduction of permeability and hydraulic conductance.

8

Review of Literature

Er: YAG laser with the parameters 3 Hz and 100 mJ effectively decreased the pain of dentinal hypersensitivity.

In low level laser therapy the most used in dentinal hypersensitivity treatments are the

GaAlAs and HeNe lasers. 24

Fluorides

Fluorides in high concentrations act by increasing resistance of dentin to acid decalcification as well as produce precipitations in exposed dentinal tubules. The probable desensitizing effects of fluoride are related to precipitated fluoride compounds mechanically blocking exposed dentinal tubules or fluoride within tubules blocking transmission of stimuli.21

Stannous Fluoride

The mode of action of stannous fluoride appears to be through the induction of high mineral content which creates a calcified barrier blocking the tubular openings on the dentine surface or it may precipitate on the dentine surface leading to occlusion of the exposed dentinal tubules. 25

SODIUM FLUORIDE

Sodium fluoride is an inorganic compound with the formula NaF which is available in the form of white powder or colourless crystals. Sodium fluoride is an ionic compound and on dissolving it gets separated into Na+ ions which are positive cations and F− ions which are negative anions. Sodium fluoride was first introduced by Bibby in 1941 and later Knutson in

1948 developed the present 2 % concentration with neutral pH 7.

9

Review of Literature

TABLE 1: PROPERTIES OF SODIUM FLUORIDE

PROPERTIES SODIUM FLUORIDE

FORMULA NaF

CAS NO. 7681-49-4

MOLAR MASS 41.98 g/mol

COLOUR White

APPEREANCE Crystalline solid

DENSITY 2.55 g/cm3

MELTING POINT 993 ºC

BOILING POINT 1,704 ºC

Soluble In Water,

SOLUBILITY Slightly Soluble In Ammonia

Insoluble In Alcohol

Preparation

Sodium Fluoride is prepared by neutralizing hydrofluoric acid or hexafluorosilicic acid, byproducts of the reaction of fluorapatite which is obtained from phosphate rock during the production of superphosphate fertilizer. Neutralizing agents include sodium hydroxide and sodium carbonate. Alcohols are sometimes used to precipitate the NaF:

HF + NaOH → NaF + H2O

From solutions containing HF, sodium fluoride precipitates as the bifluoride salt

NaHF2. Heating the bifluoride salts releases HF and also gives NaF.

HF + NaF ⇌ NaHF2

10

Review of Literature

Sodium Fluoride – Uses

Sodium Fluoride has wide range of uses. It can be used in

Tooth Pastes and Mouth Rinses

Sodium fluoride is an active ingredient in tooth pastes containing 1000 to 1500 parts per million. Sodium fluoride can also be used in mouth rinses.

Water Fluoridation

Treatment system uses one of three different sources of fluoride, with sodium fluoride as the source of choice, especially for small treatment plants, according to the centers for disease control and prevention. EPA limits the amount of fluoride added to drinking water to

4 mg/L, according to the CDC. 27

Industrial Uses

This can be used in pesticides, including fungicides and insecticides. The concentration of sodium fluoride in this type of product ranges from 15% to 95%.

In Dentinal Hypersensitivity

Sodium fluoride can be effectively used to treat the dentinal hypersensitivity. They can be used either alone or along with iontophoresis.

Pankaj Singal et al (2005) 28 has made a comparative study between two groups of

50 patients with total of 425 teeth. One group treated with 2 % sodium fluoride iontophoresis and another group treated with aqueous solution of hydroxy-ethyl-methacrylate and glutaraldehyde (HEMA-G). The patients were recorded on the pain scale for hypersensitivity in the following order tactile test followed by air blast test and finally cold water test with a

11

Review of Literature gap of 5 min for each test. The results showed no significant difference between two groups in all tests performed.

Adeyemi Oluniyi Olusile et al (2008) 29 have tested 116 teeth of 25 patients for hypersensitivity which responded positively to intra oral test. Tactile test is simply performed using dental probe by scratching the suspected site and scorings are recorded subjectively by patient using visual analog scale from 0 to 10. Four different treatment modalities copal varnish, duraphat, gluma comfort bond, 2% sodium fluoride iontophoresis for hypersensitivity are used in this study which is consecutively altered for every four teeth applied. Results showed significant difference at first 24 hrs for all the four treatment group but 7th day results showed significant difference for gluma bonding agent and iontophoresis group only.

ACIDULATED PHOSPHATE FLUORIDE

Acidulated phosphate fluoride is an inorganic fluoride preparation with the formula

NaPH3O4F introduced by Brudevold and his coworkers in 1960. FDA describes the acidulated phosphate fluoride as an aqueous solution derived from sodium fluoride which is acidulated with a mixture of sodium phosphate, monobasic and phosphoric acid to a level of

0.1 M phosphate ion and a pH of 3.0 to 4.5 and which yields an effective fluoride ion concentration of 0.02%.

Development of this agent is based on the knowledge that slightly demineralised enamel will acquire more fluoride than the unaffected enamel. Addition of phosphate was found to inhibit enamel dissolution but increase the fluoride uptake by the enamel.

12

Review of Literature

TABLE 2: PROPERTIES OF ACIDULATED PHOSPHATE FLUORIDE

PROPERTIES ACIDULATED PHOSPHATE FLUORIDE

FORMULA NaPH3O4F

CAS NO. 39456-59-2

MOLAR MASS 139 g/mol

COLOUR Colourless

APPEREANCE Aqueous solution

DENSITY 2.55 g/cm3

MELTING POINT 993 ºC

BOILING POINT 158 ºC

Preparation

APF is 1.23 % NaF which is buffered to a pH 3 to 4 in 0.1 M phosphoric acid. This is prepared by dissolving 2g of sodium fluoride in 100 ml 0.1 M phosphoric acid. To this 50 % hydro fluoric acid is added to adjust pH at 3 and fluoride ion concentration at 1.23 %. This will give acidulated phosphate fluoride solution. Gel form can be prepared by adding methyl cellulose or hydroxy ethyl cellulose to this prepared solution.26

Applications of acidulated phosphate fluoride in dentistry

For inhibition of erosion

1.23 % APF gel can significantly reduce the depth of erosion of root cementum/dentin caused by gastric reflux lasting for up to 30 min to 12 hours following its application. 31

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Review of Literature

As anti caries agent

Topical application of 1.23 % APF gels will prevent caries formation.30

In dentinal hypersensitivity

APF gel application has shown that it will block dentinal tubules. This blocking action could be increased by applying iontophoresis.

Cesar Augusto Galvao Arrais et al (2004)32 have done an in vitro study to understand the mechanism of blocking the dentinal tubules by three different desensitizing agents. The study involved 24 freshly extracted sound third molars which are sectioned mesio-distally to prepare a specimen. The specimens are randomly assigned in to one of the four different groups untreated control, potassium oxalate, 2-hydroxyethyl methacrylate & glutaraldehyde and acidulated phosphate fluoride and examined under scanning electron microscope. Results obtained with SEM of oxalate group showed precipitation of oxalate crystals of depth 15 µm within the tubules whose diameter is approximately the same diameter of the tubules. The crystals are formed inside the tubules as result of penetration of potassium oxalate and its reaction with calcium to form insoluble calcium oxalate. HEMA group showed obliterated dentinal tubules and a thin surface resinous in composition which gets infiltrated in to tubules as plugs. APF group showed mild removal of peritubular dentin with precipitates closing the dentinal tubules without getting attached to its walls. The precipitates are calcium fluoride formed as result of reaction of ionized calcium from acid etched dentin with active sodium fluoride released from the gel.

Jose C. Pereira et al (2005)33 conducted an in vitro study in which he measured the hydraulic conductance of dentin by using Pashley and Galloway method after use of desensitizing agents acidulated phosphate fluoride and potassium oxalate. The deionized

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Review of Literature water is filtered and measured at four different times. First it was measured in the presence of smear layer created by 320 – grit, second it was measured after removal of smear layer with EDTA, third after 4min passive application of desensitizing agents and finally after treating with acid challenge to check the treatment. The two hundred dentin discs are randomly divided according to four different desensitizing agents used following five different pre treatment making twenty groups with ten specimens in each group. Results showed that dentin discs treated with 6% Potassium oxalate monohydrate carboxy methyl cellulose showed least filtration similar to those obtained with presence of smear layer whereas fluoride gel showed only less reduction in filtration rate.

Ana Cecilia Correa Aranha et al (2009)34 has done a comparative study on five different treatment aspects for dentinal hypersensitivity they are hydroxy ethyl methacrylate and glutarldehyde, di & trimethacrylate resins, potassium oxalate, acidulated phosphate fluoride and diode laser. The subjects were assessed for air test with air syringe 45 to 60 psi which is kept 2mm away from root surface applied for 3 seconds and patient scored the response using visual analog scale. Clinical parameters were recorded immediately after application except laser group in which it was done after third application and then at 1 week,

1 month and 3 months. Results showed that hydroxy ethyl methacrylate & glutarldehyde and di & trimethacrylate resins showed immediate effect after application which lasted for 6 months whereas laser group showed effect after first week while the APF and potassium oxalate showed its effect after one month.

Aparna et al (2010)35 have done a randomized split mouth study comparing APF gel iontophoresis to dentin bonding agent. Thirty sites were randomly divided between two groups and the stimuli tests are performed in the order of tactile test first followed by air test and at last cold water test which are recorded by patient using voluntary report scale at baseline and after two weeks. Results showed both group are effective in reducing sensitivity

15

Review of Literature however iontophoresis group is statistically better when air test is performed and also only one site required reapplication in APF iontophoresis group compared to six sites in dentin bonding agent group.

PROPOLIS

The word propolis originates from the Greek word which means: pro = in front, polis = city. Propolis is a resinous substance which is collected by honey bees mainly from buds and also from leaves, branches and barks. Its principle role is to maintain antiseptic environment and keep the bee colony healthy. On average a bee colony gather 50g to 150g propolis per year. Propolis has strong antibacterial and fungicidal properties.

Propolis Composition

The composition of propolis varies according to geographical region based on change in botanical nature. The balsam part of poplar propolis originates from the collected glue, while the non-balsamic constituents are added by the bees. The main components of propolis are derived from plant sources while the remaining constituents are derived from bee and pollen.

The typical compounds found are

Resin and balsams (50 - 70%): Phenols, phenolic acids, esters, flavonones, dihydroflavanones, flavones, flavonols, chalkones, phenolic glycerides, acids, alcohols, esters, aldehydes, ketones, benzoic acid and esters

Essential oils and wax (30 - 50%): Mono-, and sesquiterpenes

Pollen (5 - 10%)

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Review of Literature

Other constituents : Amino acids, Polysaccharides, Amides, Lactones, Quinones, Minerals,

Vitamins A, B complex, E, Bioflavonoid (Vitamin P), Phenols and Aromatic compounds36

Harvesting Of Propolis

Bees have the habit of sealing the cracks in the hive which is used for harvesting propolis. Plastic nets or a grid with mesh diameter 2 to 4 mm is placed over the bee hive and bees will seal them. The nets filled with propolis is taken out and kept in the freezer. After freezing they are rolled out to collect it. Propolis generally needs to be stored in an air tight conditioner in dark place keeping away from excessive heat and direct heat. Extracts of propolis is stored in dark brown glass to prevent photo-oxidation.

Forms of propolis

Raw propolis

Raw propolis is a pure unprocessed form which is frozen to hard and broken down in to pieces or can be milled to fine powder.

Propolis Pills

Propolis can also be made in pill form by grinding deeply frozen pure whole propolis with a cold mill and mix it with lactose and press into pills.36

Ethanol Tinctures

Non toxic solvents can be used to dissolve propolis. Propolis showed be broken in to pieces or milled in to powder for better solubility. 70 % ethanol is found to be safe and biologically active. The specific gravity of pure ethanol is 0.794 as compared to 1.00 for water. Therefore one liter of 70 % ethanol weights 860g.37

17

Review of Literature

Applications of propolis – in dentistry

Transport media

Propolis is found to be effective in maintaining the viability of periodontal ligament of avulsed tooth. A study conducted comparing different avulsion agents in which viability of periodontal ligament cell were determined using trypan blue exclusion has shown that propolis is more effective. 38

Cariostatic Agent

Propolis is found to be effective on streptococcus mutans and glucosyl transferases which make it an effective anti caries agent. 39

Pulp Capping Agent

Propolis with its anti inflammatory properties can be used as a pulp capping agent. In a study in rats exposed dental pulp was treated using zinc oxide-based filler as a control

(group I), or with propolis flavonoids (group II) or non-flavonoids (group III) as pulp capping agent. The histological results showed that pulp inflammation occurred in groups I and III as early as first week without dentin bridge formation whereas no evident inflammatory response in group II with partial dentin bridge formation was seen at fourth week. 39

Intra Canal Irrigant and Medicament

Propolis can be used as an irrigant during root canal treatment. A study comparing propolis, sodium hypo chlorite and saline has shown that antimicrobial effect of propolis is equal to that of sodium hypo chloride. Another study showed that propolis was significantly more effective than calcium hydroxide against E. faecalis after short-term application. 40

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Review of Literature

Antifungal Agent

A study by Santos et al has compared the efficacy of Brazilian propolis in denture stomatitis with miconazole. Results showed that both are equally effective in complete remission of palatal erythema and edema.

Martins et al (2012)41 assessed the susceptibility of C. albicans strains, collected from HIV-positive patients with oral candidiasis, to a commercial 20% ethanol propolis extract (EPE) and compare it to the inhibitory action of antifungal agents nystatin, clotrimazole, econazole and fluconazole. Ethanol propolis extract inhibited all the strains of

Candida albicans similar to nystatin whereas other antifungal agents showed some resistance.

Anti Plaque Agent

Propolis is shown to inhibit the formation of plaque, calculus and also prevent the periodontitis related bone loss. In a study by Hidaka et al (2008)42 propolis has shown to reduce the rate of amorphous calcium phosphate transformation to hydroxyapatite by

12 - 35%. These results suggested that propolis may have potential as anti calculus agents in toothpastes and mouthwashes.

Toker et al (2008)43study has shown that propolis when taken systemically will inhibit the periodontitis related bone loss in rat periodontitis model.

Adjuvant to Periodontal Treatment

Elaiiie Cristina Escobar Gebara et al (2003) 44 has shown that the irrigation with propolis extract as adjuvant to periodontal treatment was able to bring more benefits than the utilization of a placebo irrigant solution or scaling and root planing alone.

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Review of Literature

In Dentinal Hypersensitivity

Propolis acts by blocking the dentinal tubules. This effect of propolis could be due to high content of flavonoids. Flavonoids are well known plant compounds which have antibacterial, antifungal, antiviral, antioxidant, and anti-inflammatory properties. Flavonoids are the most common group of polyphenolic compounds in the human diet and are found ubiquitously in plants.45

Silvia Helena de Carvalho et al (2009)10 have done a in vitro study to measure the hydraulic conductance of dentin after treatment with 3% potassium oxalate, 1.23 % acidulated phosphate fluoride, 10 % propolis and 30 % propolis. The study used 36 dentin discs which are randomly divided into 4 groups of 9 specimens each. This study used the method which is described by Pashley which involves four steps. First the deionized water is measured in the presence of smear layer created by 320 – grit, second it is measured after removal of smear layer with EDTA, third after 4min passive application of desensitizing agents and finally after treatment with 6 % citric acid at PH 2.1 for 1 min to check its resistance. Results showed that all four groups equally reduce the hydraulic conductance with no significant difference. SEM studies on morphology of dentinal tubules subjected to treatment shows 10 % propolis has more homogenous dentin surface with obliteration of dentinal tubules whereas 30 % propolis has produced partial obliteration of tubules.

Souparna Madhavan et al (2012)11 have evaluated and compared the casein phosphopeptide amorphous calcium phosphate fluoride, sodium fluoride, propolis and distilled water in treating dentinal hypersensitivity. The study has 30 subjects in each group making a total of 120 subjects. They are subjected to air test and tactile test and measured using visual analog scale during 1st, 7th, 15th, 28th, 60th, and final assessment was done on the 90th day. The study results showed that all the three groups other than the control group

20

Review of Literature are significantly effective in reducing the sensitivity over the three months follow up. Inter group comparison showed propolis is significantly more effective and rapid in its action than the other groups whereas CPP-ACP is least effective among the three groups.

Nilesh Arjun Torwane et al (2013)46 have done a randomized, split mouth, double blind controlled trail in patients residing in central jail to compare the efficacy of 30 % ethanolic extract of propolis and casein phosphopeptide amorphous calcium phosphate and sterile water. Among the 100 individuals screened for study, 13 patients with 74 teeth are selected for study based on inclusion criteria. All teeth received two stimuli tactile & thermal and based on discomfort by the patient it is scored using verbal rating scale. All scores are recorded before and after application on 1, 7, 14 & 21 day. Results showed that CPP-ACP is most effective in reducing the dentinal hypersensitivity followed by 30 % propolis and sterile water is found to be least effective. None of the groups showed rapid action but up on repeated application has positive effect in reducing the sensitivity.

IONTOPHORESIS

Iontophoresis is the process of depositing ionic drugs into body surfaces with low voltage electric current. Iontophoresis is highly suited for therapy of conditions at or near the body surface. This method can able to achieve deeper penetration of drug ions in to the desired target area than obtained with only topical application. In the treatment of dentinal hypersensitivity fluoride iontophoresis is most commonly used.8

Fluoride Iontophoresis

Fluoride iontophoresis is applied to allow F- ions penetration more deeply in the dentinal tubules. The exact mechanism by which fluoride iontophoresis produces desensitization of dentine is not known. The desensitization could occur by two mechanisms:

21

Review of Literature

Intratubular micro precipitation of CaF2 affecting dentin permeability and an effect of the fluoride on the neural transduction mechanism.47

Armamentarium

Iontophoresis unit is a 12-V DC battery-operated instrument and is a modification of a unit used by Holman (personal communication, 1982). Essentially, the components consist of

(1) Two electrodes: an applicator electrode to carry ionic medication and return indifferent electrode to complete the circuit;

(2) An on-off switch/linear potentiometer to control the amount of current;

(3) A pilot light to indicate when the unit is operational; and

(4) A panel meter to measure the amount of current

The polarity of the applicator electrode is determined by ionic charge of the medicament. Normally, the applicator is connected to the negatively charged electrode

(cathode), and it is used to apply medications that contain negative ions (anions). If the medicaments to be used contain positive ions (cations), the electrodes should be switched, making the applicator positively charged.8

Applications of Iontophoresis – In Dentistry

To treat aphthous ulcers

Aphthous ulcer can be effectively treated with iontophoresis using steroids like methyl prednisolone and sodium succinate which gives immediate relief and rapid healing.

One step method: In this method steroid is applied at negative electrode and current of 0.5 mA for normal size lesions and 1 mA for broad lesions is recommended.

22

Review of Literature

Two step method: In the first step vasoconstriction is achieved by lidocaine and epinephrine under positive electrode and in second step steroid application is done with negative electrode.

In treating lichenplanus

Lichenplanus can be treated by drying the lesion first followed by a layer of cotton soaked with methyl prednisolone and sodium succinate to cover the lesion. Active electrode is placed against the cotton and current is applied for 2 mA / min / cm2.

For herpes labialis

Herpes labialis can be effectively treated with antiviral drug idoxuridine which effectively accelerates the subsequent stages and reduce the healing time to 3- 4 days

As local anesthetic

Iontophoresis can act as pre injection topical anesthetic agent. Eliminates the need for palatal injection and can also be used in deciduous teeth extractions. Current is applied at rate of 1 mA for 3 to 5 minutes.48

In dentinal hypersensitivity

Fluoride is found to be effective when used with iontophoresis in reducing the dentinal hypersensitivity. The most commonly used are sodium fluoride and acidulated phosphate fluoride.

Mechanism of Action

The three possible mechanisms by which iontophoresis can produce desensitizing effect are as follows

23

Review of Literature

1 Reparative dentin formation following application of current to dentin

2 Paraesthesia by altering sensory mechanism of pain conduction

3 Increase in concentration of fluoride in the dentinal tubules which cause micro

precipitation of calcium fluoride that blocks hydro dynamic pain inducing stimuli 47.

Methods of application

Single tooth application

Sodium fluoride is soaked with cotton and applied over tooth. Active electrode should contact the tooth surface and return electrode should touch the skin. A current of 0.5 mA is applied for a period of 2 minutes.

Multiple teeth application

This can be done using a tray technique along with alginate impression which acts as active electrode and the return electrode which is held by the patient. The procedure is performed at 1.0 mA for one minute.

Gedalia et al (1970)49 conducted an in vitro study in eighty caries free teeth which are extracted to measure the fluoride uptake after iontophoretic application of fluoride. All teeth are divided in to two groups in one group sodium fluoride alone is applied for 4 minutes and in second group sodium fluoride along with iontophoresis is done alternatively. The tooth surface is immersed in 0.2 N HCl at room temperature for two periods of seven minutes to remove about 50 µm enamel thickness each. Fluoride concentration is measured during both immersions. Results showed that iontophoretic treated teeth showed significantly higher fluoride than the topically treated teeth. This study implies the ability of fluoride to get incorporated in to enamel when applied topically along with iontophoresis.

24

Review of Literature

Neil Lutins et al (1983)17 in his study has compared effect of sodium fluoride in reducing dentinal hypersensitivity with and without iontophoresis. Out of 54 teeth treated in

11 patients, 36 teeth are experimental teeth which are treated with 2 % freshly prepared sodium fluoride which is applied over tooth followed by placement of electrode to deliver 1 mA/min and adjacent control teeth is treated with only application of sodium fluoride.

Sensitivity is measured using a mechanical stimulating device in a reproducible position and cold test recorded using FTS direct contact probe which is capable of producing desired temperature. Results showed improvement in both groups compared to before treatment but test teeth showed statistically significant improvement compared to control teeth.

Gangrosa et al (1984)50 in his in vitro study compared the amount of fluoride in successive layers of dentin between fluoride treated tooth and untreated tooth. Out of 24 teeth 7 teeth were treated only with 2% sodium fluoride, 4 teeth with 0.1mA, 8 teeth with

0.3mA and 5 teeth with 0.5mA 2 % sodium fluoride iontophoresis respectively. Results showed topical fluoride treated tooth has 13 times more fluoride in its outer etch and about 18 times higher fluoride in 4th etch than the control. Whereas fluoride application along with iontophoresis showed 33 times higher concentration in the outer etch with 62 times higher than the control during 4th etch which showed significance of iontophoresis in fluoride uptake.

David Kern et al (1989)51 carried out a, split mouth study for sixteen patients who are blinded to the two different modalities are treated with 2 % sodium fluoride for one tooth and

2 % sodium fluoride with iontophoresis for another tooth, both of which are matched for sensitivity. The sensitivity is objectively assessed for tactile response using an adjustable pressure probe with different amount of pressure 20 g, 40 g, 60g till the patient responded.

Followed by that air blast test is done for one second at 30 psi from 2 cm and subjectively sensitivity was graded. The results showed tooth treated with iontophoresis has immediate

25

Review of Literature reduction of sensitivity which last up to 3 months and tooth treated only with sodium fluoride showed no effect.

Michael McBride et al (1991)52 investigated a study with sodium fluoride iontophoresis in which 95 teeth were treated. The teeth selected for study are isolated with cotton rolls and subjected to iontophoresis with current of 0.5 mA for 2 minutes resulting in a

1-mA/min dose. Out of which 47 teeth were treated using 2 % sodium fluoride and 48 teeth are treated using deionized water. The results showed statistically significant reduction of sensitivity for teeth treated with sodium fluoride iontophoresis but no statistically significant reduction was found in teeth subjected to placebo. The teeth which did not respond to placebo were again retreated with sodium fluoride and statistically significant reduction of sensitivity is found.

Trivedi and Meshran (1995)53 has performed a histological study to analyze the reaction of pulp to iontophoretic application by normal saline, 2 % & 4 % sodium fluoride and 1.23 % acidulated phosphate fluoride. This in vitro study involves 80 non carious sound premolars extracted for orthodontic reasons which are divided in to four groups according to the type of solution used for application. Each patient is subjected to scaling followed by cavity preparation with standard depth in the premolar followed by iontophoretic application of respective solution and after 7 days tooth is extracted and subjected to histological analysis. Results showed that 2% sodium fluoride showed less degeneration of odontoblasts which is clinically significant than others. Secondary dentin formation found to be more with

2% sodium fluoride followed by 4% sodium fluoride and 1.23 % APF. It was concluded that

2% sodium fluoride is least irritant to the pulp tissue.

Modupeola Arowojolu et al (2002)54 has treated 62 teeth of 13 patients in split design. 40 are experimental teeth which are treated with sodium fluoride with parkell

26

Review of Literature desensitron I1 device and remaining 22 teeth act as control which were treated with only sodium fluoride without use of any electrical device. Clinical parameters were assessed at 7th

& 14th day by scratch and air test for presence of pain or total abolition of pain. A statistically significant reduction in sensitivity was found in test teeth than control at 7th and 14th day.

Sharn Pal Sandhu et al (2010)55 has compared different strength of electrical current in iontophoresis unit by keeping the drug and dosage constant. The study has three groups 0.25 mA current for 4 min, 0.5 mA for 2 min and 1 mA for 1 min. Sensitivity score was recorded with air blast and cold water test and rated using verbal rating scale. Scores are recorded before & after treatment, 1, 2 weeks & 2 month. The results showed that all three groups are equally effective and current up to 1mA has shown no adverse effects.

Grover Vishakha et al (2010)56 has carried out a comparative split mouth design study. 20 patients with bilateral gingival recession not exceeding 3 mm participated in this study. In each patient right quadrant are treated with iontophoretic application of 1% sodium fluoride solution at 1 mA current for 1 minute while left quadrant are treated with combined treatment of iontophoresis along with coronally repositioned flap. Based on the stimuli used for testing the patients are divided and sub grouped as those tested for air stimuli and those tested for cold stimuli during baseline, 1, 2, 4, 8 and 12 weeks. Results showed that both groups showed gradual reduction of sensitivity with no significant difference between two groups based on stimuli used and treatment. However the left side had additional aesthetic benefit

27

Materials and Methods

Materials and Methods

ARMAMENTARIUM

PREPARATION OF SOLUTION

1. Sodium Fluoride ( FISCHER SCIENTIFIC )

2. Acidulated Phosphate fluoride gel ( MEDICAL)

3. Raw Propolis ( HI – TECH MANUFACTURERS LIMITED, NEW DELHI )

4. Absolute Ethanol ( CHANGSHU YANGYUAN )

5. Digital weighing machine ( SHIMADZU )

6. Distilled Water

7. BOROSIL 1000 ml beaker

8. BOROSIL 500 ml cylinder

9. BOROSIL 250 ml cylinder

10. BOROSIL 50 ml cylinder

11. Stirrer

12. What man Filter Paper No 1

13. Amber bottle

14. Plastic bottle

FORMULATION

2 % SODIUM FLUORIDE

Sodium Fluoride is obtained in powder form from a commercially available product

Fischer scientific. 10 mg of sodium fluoride power was weighed using digital weighing

machine. (FIGURE 1) 500 ml of distilled water is taken using borosil beaker. 10 mg sodium

fluoride was added in the 500 ml distilled water and it was carefully stirred with stirrer until it

28

Materials and Methods dissolved completely. The resulting solution consists of 500 ml of 2 % sodium fluoride. The solution was transferred to the plastic bottle and it was stored and used for the study.

1.23 % ACIDULATED PHOSPHATE FLUORIDE

APF gel which is a commercial available product from MEDICAL, Italy has been used in this study. (FIGURE 2) The ingredients are

1 Sodium fluoride = 0.33 % calculated fluoride = 0:15 % D.M. 27/01/79, ART 2-3.

Regulatory adjustment C.E.E.

2 Orthophosphoric acid

3 Hydroxy ethyl cellulose

4 Sodium Benzoate

5 Aqua aloe Vera

6 Saccharin

10 % PROPOLIS

Propolis is prepared based on the extraction methods described by Krell et al. 37 The raw propolis is obtained commercially from Hi tech industries private limited, New Delhi which was already in prepared from by removing coarse debris and excessive wax. Propolis was stored in the refrigerator. During its preparation it was taken out and pulled into thin sheets or strips in order to increase the contact surface between propolis and solvent, to promote dissolution.

70 % ethanol was used as a solvent in this study as it is more biologically active when compared with absolute alcohol and other solvents. The specific gravity of pure ethanol is

0.794 as compared to 1.00 for water. Therefore one litre of 100 % alcohol weighs 800 g, one litre of 70% alcohol weights approximately 860 g. 10 % propolis was prepared by adding 50g

29

Materials and Methods of propolis in 450g of 70% ethanol. Due to the specific gravity of ethanol 523ml of 70% ethanol is equal to 450g of 70% ethanol.

50 g of propolis was weighed using digital weighing machine. Before weighing the propolis it is spread in to thin sheets. 420 ml of absolute ethanol and 180 ml of distilled water is measured using the borosil cylinder and added together in a one litre borosil cylinder to prepare 600 ml of 70% ethanol. 523 ml of 70% ethanol is measured and taken in the borosil beaker. Now 50 g of propolis is added in the 523 ml of 70 % ethanol which is equal to 450 g of 70 % ethanol which will give 10 % propolis. Propolis is added one by one in thin sheets and it is allowed to dissolve in the ethanol.

The mixture is stirred well and transferred to a container. The container was kept in the dark place for two weeks and it was stirred daily to allow the mixtures to settle down.

After two weeks it was filtered through Whatman filter paper twice to remove any particles and remnants. The filtrate obtained was clean and pure which was transferred to a dark amber bottle and used for this study. No preservative is added as the ethanol extract of propolis has the shelf life of three years. (FIGURE 3)

SOURCE OF DATA

Patients with generalized chronic gingivitis having at least two hypersensitive teeth were selected from department of Periodontics, K.S.R Institute of Dental Science and

Research. Study population consisted of male and female subjects. Study was explained to the patients and written informed consent and institutional ethical clearance was obtained.

DESIGN OF THE STUDY

Patients were randomly allocated in to any one of the three treatment groups. Patients are treated with ultrasonic scaling first followed by application of iontophoresis in both upper

30

Materials and Methods and lower arch with any one of the three desensitizing agents according to the group selected.

The patients were blinded by keeping the three agents in identical bottles, differentiated only by lid colours blue, green and red containing 2% sodium fluoride, 1.23% APF and

10% propolis respectively.

INCLUSION CRITERIA

1. Systemically healthy & age: 18 to 60 yrs

2. Need for ultrasonic scaling with moderate calculus

3. Two hypersensitive teeth which is not adjacent to each other with qualifying response

to air blast stimulus as defined by a score of ≥1 (Schiff scale)

4. Minimum of 10 evaluable natural teeth excluding third molars

EXCLSION CRITERIA

1. Dental caries

2. Non- Vital teeth

3. Attrition, Abrasion and erosion

4. Gingival Recession

5. Patient undergoing orthodontic therapy

6. Patient under treatment for dentin hypersensitivity/using desensitizing paste

7. Pregnant women

8. History of periodontal treatment before 3 months

9. Asthma patients

10. Patients allergic to honey bee products and pollen

31

Materials and Methods

ARMAMENTARIUM

APPLICATION (FIGURE 4, 5)

1. Iontophoresis Unit (JONOFLUOR SCIENTIFIC)

2. Trays (JONOFLUOR SCIENTIFIC)

3. Sponge (JONOFLUOR SCIENTIFIC)

4. Pressure sensitive probe (AXE)

5. Vaseline

6. Mouth mirror

7. Cotton

8. Three way syringe

9. 2 ml Disposable syringe

10. Cold water

PROCEDURE FOR APPLICATION (FIGURE 6)

The study has three groups and patient was randomized in any one of the three groups by using the lottery method. Based on this patient is allotted either to a blue or green or red group which corresponds to 2% NaF, 1.23 % APF & 10 % propolis which is kept blinded to the patient.

In all the three groups, after completing the ultrasonic scaling, clinical parameters are recorded first before the gel application is done. Vaseline was generally applied all over the gingiva and mucosa with cotton pellet to prevent the soft tissues from any undesired effect.

32

Materials and Methods

Based on the patient arch size corresponding tray among the different tray sizes is selected for application. Application sponge is used over the tray for placing the gel / solution. Based on the group selected that particular gel/solution is applied in the sponge which is placed in the tray. Now the tray along with sponge is positioned in the patient mouth.

The positive electrode of the iontophoresis unit was held by the patient palms. The negative electrode is now connected to the metal plate in the tray. The unit is now switched on and current of 2 mA is applied for one minute based on manufacturer specifications. After one minute the unit is switched off and same procedure is applied for opposing arch. Patient is advised not to drink/eat or rinse the mouth for another half an hour.

COLLECTION OF DATA (FIGURE 7)

Clinical parameters recorded are tactile stimuli first, followed by air blast test and finally cold water stimuli test. The parameters are recorded at the baseline immediately after ultrasonic scaling and immediately after gel application and postoperative 14 days before and after application and postoperative 28 days without any application.

TACTILE TEST

Tactile test is recorded using the pressure sensitive probe (AXE TPS Probe). The probe tip was placed perpendicular to the evaluable tooth surfaces, just apical to the cemento enamel junction and drawn slowly across the surface in a distal to mesial direction to ensure application of the stimulus across all patent tubules. Based on the discomfort patient is asked to grade with the visual analog scale from 1 to 10.

33

Materials and Methods

AIR TEST

Air blast hypersensitivity was assessed by applying a one-second blast of air from a standard dental unit air syringe directed to the exposed buccal site of the hypersensitive tooth using a 4-point scale:

SCHIFF SCALE

0 No Response

1 Response + Subject does not request discontinuation of stimulus

2 Response + Subject requests discontinuation of stimulus

3 Pain + Subject requests discontinuation of stimulus

COLD WATER TEST

Cold water test is recorded with the ice cold water which is slowly expelled from a

2ml syringe over the tooth surface. The amount of patient discomfort is graded in the visual analog scale from 1 to 10.

PROCEDURE

Patients who are willing to participate are selected for the study based on the inclusion criteria and explained about the study and obtained informed consent from the patients. All the patients first underwent ultrasonic scaling and then randomly allocated into one of the three groups.

34

Materials and Methods

All the clinical parameters are recorded immediately after the scaling before the gel application. Now corresponding gel is applied according to the group selected. Immediately after the gel application the clinical parameters are again recorded which implies the rapidity of action. Patient is now recalled after 14 days and second application is done and again same parameters are recorded before and after application. Patient is now recalled after 28 days and clinical parameters are recorded without any application. All values are recorded and tabulated.

35

Materials and Methods

FIGURE 1: SODIUM FLUORIDE FORMULATION

A. SODIUM FLUORIDE B. 10 GM OF SODIUM FLUORIDE

FIGURE 2: ACIDULATED PHOSPHATE FLUORIDE

36

Materials and Methods

FIGURE 3: PROPOLIS GEL FORMULATION

A. RAW PROPOLIS B. SPREADED PROPOLIS

C. ABSOLUTE ETHANOL D. DISTILLED WATER

37

Materials and Methods

FIGURE 3: PROPOLIS GEL FORMULATION

E. 180 ML OF DISTILLED WATER F. 420 ML OF ABSOLUTE ETHANOL

G. 600 ML OF 70 % ETHANOL H. 523 ML (450 GM) OF 70 % ETHANOL

38

Materials and Methods

FIGURE 3: PROPOLIS GEL FORMULATION

I. 50 GM OF PROPOLIS J. MIXING OF PROPOLIS

K. WHATMAN FILTER PAPER L. FILTERATION OF PROPOLIS

39

Materials and Methods

FIGURE 4: ARMAMENTARIUM

FIGURE 5: IONTOPHORESIS UNIT

40

Materials and Methods

FIGURE 6: DESENSITIZING AGENTS APPLICATION WITH IONTOPHORESIS

A. VASELINE APPLIED OVER SOFT TISSUES B. PATIENT HOLDING POSITIVE ELECTRODE

C. NEGATIVE ELECTRODE CONNECTED TO TRAY D. GEL APPLICATION THROUGH SPONGE IN TRAY

41

Materials and Methods

FIGURE 7: EVALUATION OF CLINICAL PARAMETERS

A. TACTILE TEST B. AIR TEST

C. COLD WATER TEST

42

Statistical Analysis

Statistical analysis

STATISTICAL ANALYSIS

WILCOXON SIGNED RANK TEST

The Wilcoxon signed-rank test is a non-parametric statistical hypothesis test used when comparing two related samples, matched samples, or repeated measurements on a single sample to assess whether their populations mean ranks differ.

MANN–WHITNEY U TEST:

The Mann–Whitney U test is a nonparametric test of null hypothesis that two populations are the same against an alternative hypothesis, especially that a particular population tends to have larger values than the other.

KRUSKAL WALLIS TEST

The Kruskal–Wallis one-way analysis of variance by ranks is a non-parametric method for testing whether samples originate from the same distribution. It is used for comparing two or more samples that are independent, and that may have different sample sizes, and extends the Mann–Whitney U test to more than two groups.

P VALUE

The P value or calculated probability is the estimated probability of rejecting the null hypothesis of a study question when that hypothesis is true. Differences between the two populations were considered significant when p < 0.05.

43

Results

Results

RESULTS

The present study was undertaken to evaluate root dentin sensitivity following application of three different desensitizing agents 2% sodium fluoride, 1.23 % acidulated phosphate fluoride and 10 % propolis with iontophoresis which are mentioned as blue, green and red group respectively. Clinical parameters were assessed using three different stimuli test air test (Schiff scale), tactile test and cold water test using visual analog scale. All these tests are performed before and after application in baseline and postoperative 14th day and in postoperative 28th day scores are recorded without any application.

87 patients who were fulfilled the inclusion and exclusion criteria participated in the study. Informed consent was obtained from the patients. All the patients were randomly allocated in any one of the treatment group. Out of which 13 patients who could not able to report during follow up visits for various reasons are excluded. Another two patients are excluded for the purpose of matching. The remaining 72 patients who completed the entire study their values are tabulated and subjected to statistical analysis.

Table 3 shows the descriptive statistics for all the three groups in the baseline before application of desensitizing agents.

Table 4 shows the descriptive statistics for all the three groups in the baseline after application of desensitizing agents.

Table 5 shows the descriptive statistics for all the three groups 14 days postoperative before application of desensitizing agents.

Table 6 shows the descriptive statistics for all the three groups 14 days postoperative after application of desensitizing agents.

Table 7 shows the descriptive statistics for all three groups 28 days postoperative.

44

Results

Table 8 shows statistically significant reduction in sensitivity before and after application during baseline for all three groups for tactile, air and cold water tests.

Table 9 shows statistically significant reduction in sensitivity between baseline and postoperative 14th day before application for all three groups for tactile, air and cold water tests.

Table 10 shows statistically significant reduction in sensitivity before and after application on postoperative 14th day for all three groups for tactile, air and cold water tests.

Table 11 shows statistically significant reduction in sensitivity between baseline and postoperative 28th day for all three groups for tactile, air and cold water tests.

Table 12 shows the comparison between two groups which infers that sodium fluoride has significantly reduced the sensitivity better than acidulated phosphate fluoride and propolis for tactile test during postoperative 14th day after application. Similarly acidulated phosphate fluoride has significantly reduced the sensitivity than the propolis for cold water test during baseline after application.

Table 13 shows the comparison between three groups which infers there was no statistically significant difference between NaF, APF and propolis group for air, tactile and cold water test during baseline and postoperative 14th day both before and after application and also in the postoperative 28th day.

Graph 1 shows the age and sex distribution of the samples. 31 females and 41 males participated in the study. Samples aged from 19 to 48 years with median age of 31.5 years.

Graph 2 shows the mean scores of NaF, APF and propolis group for air, tactile and cold water test at baseline before and after application, 14 days postoperative before and after application and 28 days postoperative.

45

Results

Graph 3 shows comparison of mean scores of NaF, APF and propolis group for tactile test using subjective visual analog scale at baseline before and after application, 14th day postoperative before and after application and 28th day postoperative.

Graph 4 shows comparison of mean scores of NaF, APF and propolis group for air test using objective Schiff scale at baseline before and after application, 14th day postoperative before and after application and 28th day postoperative.

Graph 5 shows comparison of mean scores of NaF, APF and propolis group for cold water test using subjective visual analog scale at baseline before and after application,

14th day postoperative before and after application and 28th day postoperative.

Graph 6 shows comparison of mean scores of NaF, APF and propolis group for tactile test using subjective visual analog scale at baseline before and after application, 14th day postoperative before and after application and 28th day postoperative.

Graph 7 shows comparison of mean scores of NaF, APF and propolis group for air test using objective Schiff scale at baseline before and after application, 14th day postoperative before and after application and 28th day postoperative.

Graph 8 shows comparison of mean scores of NaF, APF and propolis group for tactile test using subjective visual analog scale at baseline before and after application, 14th day postoperative before and after application and 28th day postoperative.

46

Results

TABLE 3: DESCRIPTIVE STATISTICS FOR BASELINE BEFORE APPLICATION OF DESENSITIZING AGENTS FOR ALL THREE GROUPS

Test done Group Time Statistics Air test Tactile test Cold water test Total Count 48 48 48 144 Mean 1.67 2.60 5.63 3.30 Baseline - Standard Deviation .48 1.87 2.50 2.48 NaF Before test 1st Quartile 1.00 1.00 4.00 2.00 Median 2.00 2.00 6.00 2.00 3rd Quartile 2.00 3.00 8.00 5.00 Count 48 48 48 144 Mean 1.62 3.31 5.88 3.60 Baseline - Standard Deviation .57 1.89 1.89 2.35 APF Before test 1st Quartile 1.00 2.00 4.00 2.00 Median 2.00 3.00 6.00 3.00 3rd Quartile 2.00 5.00 7.00 5.00 Count 48 48 48 144 Mean 1.63 3.11 5.35 3.36 Baseline - Standard Deviation .49 1.89 1.92 2.19 Propolis Before test 1st Quartile 1.00 2.00 4.00 2.00 Median 2.00 3.00 5.00 3.00 3rd Quartile 2.00 4.00 7.00 5.00 Count 144 144 144 432 Mean 1.64 3.01 5.62 3.42 Baseline - Standard Deviation .51 1.89 2.12 2.34 Total Before test 1st Quartile 1.00 2.00 4.00 2.00 Median 2.00 3.00 6.00 3.00 3rd Quartile 2.00 4.00 7.00 5.00

47

Results

TABLE 4: DESCRIPTIVE STATISTICS FOR BASELINE AFTER APPLICATION OF DESENSITIZING AGENTS FOR ALL THREE GROUPS

Test done Group Time Statistics Air test Tactile test Cold water test Total Count 48 48 48 144 Mean .44 1.15 2.52 1.37 Baseline - Standard Deviation .50 1.29 1.71 1.53 NaF After test 1st Quartile .00 .00 1.00 .00 Median .00 1.00 2.00 1.00 3rd Quartile 1.00 2.00 4.00 2.00 Count 48 48 48 144 Mean .58 1.06 3.23 1.63 Baseline - Standard Deviation .54 1.00 1.88 1.71 APF After test 1st Quartile .00 .00 2.00 .00 Median 1.00 1.00 3.00 1.00 3rd Quartile 1.00 1.50 5.00 2.00 Count 48 48 48 144 Mean .48 1.28 2.46 1.41 Baseline - Standard Deviation .51 1.11 1.66 1.43 Propolis After test 1st Quartile .00 .00 1.00 .00 Median .00 1.00 2.00 1.00 3rd Quartile 1.00 2.00 3.00 2.00 Count 144 144 144 432 Mean .50 1.16 2.74 1.47 Baseline - Standard Deviation .52 1.13 1.78 1.56 Total After test 1st Quartile .00 .00 1.00 .00 Median .00 1.00 2.50 1.00 3rd Quartile 1.00 2.00 4.00 2.00

48

Results

TABLE 5: DESCRIPTIVE STATISTICS FOR 14TH DAY BEFORE APPLICATION OF DESENSITIZING AGENTS FOR ALL THREE GROUPS

Test done Group Time Statistics Air test Tactile test Cold water test Total Count 48 48 48 144 Mean .77 1.10 3.27 1.72 14th day - Standard Deviation .47 1.08 1.41 1.53 NaF Before test 1st Quartile .50 .00 2.00 1.00 Median 1.00 1.00 3.00 1.00 3rd Quartile 1.00 2.00 4.00 3.00 Count 48 48 48 144 Mean .85 1.54 3.56 1.99 14th day - Standard Deviation .62 1.25 1.34 1.60 APF Before test 1st Quartile .00 1.00 2.00 1.00 Median 1.00 1.00 3.50 2.00 3rd Quartile 1.00 2.00 4.50 3.00 Count 48 48 48 144 Mean .91 1.50 3.02 1.81 14th day - Standard Deviation .46 1.17 1.29 1.36 Propolis Before test 1st Quartile 1.00 1.00 2.00 1.00 Median 1.00 1.00 3.00 1.00 3rd Quartile 1.00 2.00 4.00 3.00 Count 144 144 144 432 Mean .85 1.38 3.29 1.84 14th day - Standard Deviation .52 1.18 1.36 1.50 Total Before test 1st Quartile 1.00 .00 2.00 1.00 Median 1.00 1.00 3.00 1.00 3rd Quartile 1.00 2.00 4.00 3.00

49

Results

TABLE 6: DESCRIPTIVE STATISTICS FOR 14TH DAY – AFTER APPLICATION OF DESENSITIZING AGENTS FOR ALL THREE GROUPS

Test done Group Time Statistics Air test Tactile test Cold water test Total Count 48 48 48 144 Mean .17 .33 1.56 .69 14th day - Standard Deviation .38 .56 1.25 1.03 NaF After test 1st Quartile .00 .00 1.00 .00 Median .00 .00 1.50 .00 3rd Quartile .00 1.00 2.00 1.00 Count 48 48 48 144 Mean .21 .60 1.33 .72 14th day - Standard Deviation .46 .71 1.14 .94 APF After test 1st Quartile .00 .00 1.00 .00 Median .00 .00 1.00 .00 3rd Quartile .00 1.00 2.00 1.00 Count 48 48 48 144 Mean .13 .65 1.24 .67 14th day - Standard Deviation .34 .77 .95 .86 Propolis After test 1st Quartile .00 .00 1.00 .00 Median .00 .50 1.00 .00 3rd Quartile .00 1.00 2.00 1.00 Count 144 144 144 432 Mean .17 .53 1.38 .69 14th day - Standard Deviation .39 .69 1.12 .94 Total After test 1st Quartile .00 .00 1.00 .00 Median .00 .00 1.00 .00 3rd Quartile .00 1.00 2.00 1.00

50

Results

TABLE 7: DESCRIPTIVE STATISTICS FOR 28TH DAY FOR ALL THREE GROUPS

Test done Group Time Statistics Air test Tactile test Cold water test Total Count 48 48 48 144 Mean .25 .69 1.79 .91 28th Standard Deviation .44 .75 1.44 1.16 NaF day 1st Quartile .00 .00 1.00 .00 Median .00 1.00 2.00 1.00 3rd Quartile .50 1.00 2.50 1.00 Count 48 48 48 144 Mean .38 .79 1.65 .94 28th Standard Deviation .49 .82 1.28 1.06 APF day 1st Quartile .00 .00 1.00 .00 Median .00 1.00 1.50 1.00 3rd Quartile 1.00 1.00 2.00 1.00 Count 48 48 48 144 Mean .35 .78 1.41 .85 28th Standard Deviation .48 .73 1.09 .91 Propolis day 1st Quartile .00 .00 1.00 .00 Median .00 1.00 1.00 1.00 3rd Quartile 1.00 1.00 2.00 1.00 Count 144 144 144 432 Mean .32 .75 1.62 .90 28th Standard Deviation .47 .76 1.28 1.05 Total day 1st Quartile .00 .00 1.00 .00 Median .00 1.00 1.00 1.00 3rd Quartile 1.00 1.00 2.00 1.00

51

Results

TABLE 8: WILCOXON SIGNED RANKS TEST TO COMPARE AIR, TACTILE AND COLD WATER TEST FOR NAF, APF AND PROPOLIS GROUPS AT BASELINE BEFORE AND AFTER APPLICATION

Test done Group P-Value NaF <0.001 Air test APF <0.001 Propolis <0.001 NaF <0.001 Tactile test APF <0.001 Propolis <0.001 NaF <0.001 Cold water test APF <0.001 Propolis <0.001

TABLE 9: WILCOXON SIGNED RANKS TEST TO COMPARE AIR, TACTILE AND COLD WATER TEST FOR NAF, APF AND PROPOLIS GROUPS AT BASELINE BEFORE APPLICATION AND 14TH DAY BEFORE APPLICATION

Test done Group P-Value NaF <0.001 Air test APF <0.001 Propolis <0.001 NaF <0.001 Tactile test APF <0.001 Propolis <0.001 NaF <0.001 Cold water test APF <0.001 Propolis <0.001

52

Results

TABLE 10: WILCOXON SIGNED RANKS TEST TO COMPARE AIR, TACTILE AND COLD WATER TEST FOR NAF, APF AND PROPOLIS GROUPS AT 14TH DAY BEFORE AND AFTER APPLICATION

Test done Group P-Value NaF <0.001 Air test APF <0.001 Propolis <0.001 NaF <0.001 Tactile test APF <0.001 Propolis <0.001 NaF <0.001 Cold water test APF <0.001 Propolis <0.001

TABLE 11: WILCOXON SIGNED RANKS TEST TO COMPARE AIR, TACTILE AND COLD WATER TEST FOR NAF, APF AND PROPOLIS GROUPS AT BASELINE BEFORE APPLICATION AND 28TH DAY

Test done Group P-Value NaF <0.001 Air test APF <0.001 Propolis <0.001 NaF <0.001 Tactile test APF <0.001 Propolis <0.001 NaF <0.001 Cold water test APF <0.001 Propolis <0.001

53

Results

TABLE 12: MANN-WHITNEY TEST TO COMPARE AIR, TACTILE AND COLD WATER TEST IN BETWEEN TWO GROUPS AT BASELINE BEFORE AND AFTER APPLICATION, AT 14TH DAY BEFORE AND AFTER APPLICATION AND AT 28TH DAY

P-Value Test done Time points NaF Vs APF Vs NaF Vs APF Propolis Propolis Baseline - Before appl 0.582 0.714 0.840 Baseline - After appl 0.193 0.693 0.366 Air test 14th day - Before appl 0.556 0.150 0.536 14th day - After appl 0.757 0.624 0.432 28th day 0.189 0.302 0.785 Baseline - Before appl 0.051 0.116 0.733 Baseline - After appl 0.893 0.352 0.321 Tactile test 14th day - Before appl 0.092 0.095 0.994 14th day - After appl 0.045 0.029 0.828 28th day 0.576 0.490 0.882 Baseline - Before appl 0.782 0.450 0.245 Baseline - After appl 0.099 0.755 0.049 Cold water test 14th day - Before appl 0.298 0.548 0.113 14th day - After appl 0.307 0.261 0.940 28th day 0.720 0.282 0.458

54

Results

TABLE 13: KRUSKAL-WALLIS TEST TO COMPARE AIR, TACTILE AND COLD WATER TEST IN BETWEEN THREE GROUPS AT BASELINE BEFORE AND AFTER APPLICATION, AT 14TH DAY BEFORE AND AFTER APPLICATION AND AT 28TH DAY

Test done Time points P-Value Baseline - Before appl 0.852 Baseline - After appl 0.407 Air test 14th day - Before appl 0.423 14th day - After appl 0.732 28th day 0.391 Baseline – Before appl 0.117 Baseline - After appl 0.540 Tactile test 14th day - Before appl 0.152 14th day - After appl 0.058 28th day 0.746 Baseline - Before appl 0.516 Baseline - After appl 0.107 Cold water test 14th day - Before appl 0.267 14th day - After appl 0.458 28th day 0.544

GRAPH 1: AGE AND SEX DISTRIBUTION OF THE SAMPLES

45 40 12 35 > 30 YEARS 30 10 25 - 30 YEARS 25 13 21 - 25 YEARS 20 10 15 < 20 YEARS 10 10 8 6 5 3 0 MALES FEMALES

55

Results

GRAPH 2: MEAN SCORES FOR AIR, TACTILE AND COLD WATER TEST FOR NaF, APF AND PROPOLIS GROUPS

Mean scores Cold water test

1.4 Tactile test 28 Day 0.8 0.3 Air test 1.2 14d-Aft 0.7 0.1 3.0 14d-Bef 1.5

Red 0.9 2.5 BL-Aft 1.3 0.5 5.3 BL-Bef 3.1 1.6

1.8 28 Day 0.7

0.3

1.6 14d-Aft 0.3 0.2 3.3

Green 14d-Bef 1.1 0.8 2.5 BL-Aft 1.1 Time pointsp Time 0.4 5.6 BL-Bef 2.6 1.7

1.6 28 Day 0.8 0.4 1.3 14d-Aft 0.6 0.2 3.6 Blue 14d-Bef 1.5 0.9 3.2 BL-Aft 1.1 0.6 5.9 BL-Bef 3.3 1.6 0.0 2.0 4.0 6.0 8.0 Mean value

56

Results

GRAPH 3: COMPARISON BETWEEN NaF, APF AND PROPOLIS GROUPS FOR TACTILE TEST AT BASELINE BEFORE AND AFTER APPLICATION, 14TH DAY BEFORE AND AFTER APPLICATION AND AT 28TH DAY

10 TACTILE TEST

9 3.1

8

7

6 2.6

5 PROPOLIS APF 4 1.5 NaF 1.3 3.3 3 1.1 VISUAL ANALOG SCALE ANALOG VISUAL 0.8 2 1.1 1.5 0.7 0.7 1 1.1 0.3 0.8 0.6 0 Bl- Bef Bl-Aft 14 Day - Bef 14 Day - Aft 28 Day TIME PERIOD RECORDED

57

Results

GRAPH 4: COMPARISON BETWEEN NaF, APF AND PROPOLIS GROUPS FOR AIR TEST AT BASELINE BEFORE AND AFTER APPLICATION, 14TH DAY BEFORE AND AFTER APPLICATION AND AT 28TH DAY.

6 AIR TEST

5 1.6

4

1.7 3 PROPOLIS 0.9 APF NaF SCHIFF SCALE SCHIFF 2 0.8 1.6 0.5

1 0.4 0.9 0.3 0.6 0.3 0.20.1 0.4 0.2 0 Bl- Bef Bl-Aft 14 Day - Bef 14 Day - Aft 28 Day TIME PERIOD RECORDED

58

Results

GRAPH 5: COMPARISON BETWEEN NaF, APF AND PROPOLIS GROUPS FOR COLD WATER TEST AT BASELINE BEFORE AND AFTER APPLICATION, 14TH DAY BEFORE AND AFTER APPLICATION AND AT 28TH DAY

18 COLD WATER TEST 5.3 16

14

12 5.6

10 3 PROPOLIS 8 2.5 APF 3.3 NaF 6 5.9 2.5

1.4 VISUAL ANALOG SCALE ANALOG VISUAL 4 1.2 3.6 1.8 3.2 1.6 2 1.3 1.6

0 Bl- Bef Bl-Aft 14 Day - Bef 14 Day - Aft 28 Day TIME PERIOD RECORDED

59

Results

GRAPH 6: COMPARISON BETWEEN NaF, APF AND PROPOLIS GROUP FOR TACTILE TEST AT BASELINE BEFORE AND AFTER APPLICATION, 14TH DAY BEFORE AND AFTER APPLICATION AND AT 28TH DAY.

TACTILE TEST 3.5 3.3 3.1

3

2.6

2.5

2 NaF 1.5 1.5 APF 1.5 1.3 PROPOLIS 1.1 1.1 1.1

1 0.8 0.8 VISUAL ANALOG SCALE ANALOG VISUAL 0.7 0.7 0.6

0.5 0.3

0 Bl- Bef Bl-Aft 14 Day - Bef 14 Day - Aft 28 Day TIME PERIOD RECORDED

60

Results

GRAPH 7: COMPARISON BETWEEN NaF, APF AND PROPOLIS GROUPS FOR AIR TEST AT BASELINE BEFORE AND AFTER APPLICATION, 14TH DAY BEFORE AND AFTER APPLICATION AND 28TH DAY.

AIR TEST 1.8 1.7 1.6 1.6 1.6

1.4

1.2

1 0.9 0.9 NaF 0.8 0.8 APF PROPOLIS

0.6 SCHIFF SCALE SCHIFF 0.6 0.5 0.4 0.4 0.4 0.3 0.3 0.2 0.2 0.2 0.1

0 Bl- Bef Bl-Aft 14 Day - Bef 14 Day - Aft 28 Day TIME PERIOD RECORDED

61

Results

GRAPH 8: COMPARISON BETWEEN NaF, APF AND PROPOLIS GROUPS FOR COLD WATER TEST AT BASELINE BEFORE AND AFTER APPLICATION, 14TH DAY BEFORE AND AFTER APPLICATION AND AT 28TH DAY.

5.9 COLD WATER TEST 6 5.6 5.3

5

4 3.6 3.2 3.3 3 NaF 3 2.5 2.5 APF PROPOLIS 2 1.8 1.6 1.6 1.3 1.4 VISUAL ANALOG SCALE ANALOG VISUAL 1.2

1

0 Bl- Bef Bl-Aft 14 Day - Bef 14 Day - Aft 28 Day TIME PERIOD RECORDED

62

Discussion

Discussion

DISCUSSION

Removal of local etiological factors from the tooth surfaces through professional ultrasonic scaling is the key to successful outcome of periodontal therapy. Root dentin hypersensitivity caused by ultrasonic scaling has been reported in various studies.4,5,6,14 This objectionable side effect occurs due to iatrogenic denudation of enamel or layer of cementum on exposed root surfaces lead to opening of dentinal tubules.3 This undesirable effect should be explained to patient before starting the treatment. Failure to explain this transient root dentin hypersensitivity may result in distrust and loss of motivation of patient to continue further therapy.57

The present study aimed to compare three different desensitizing agents 2% sodium fluoride, 1.23 % acidulated phosphate fluoride and 10 % propolis with iontophoresis in reducing root dentin sensitivity. To evaluate the effect of desensitizing agents on root dentin sensitivity, various parameters such as stimuli tests (tactile test, air blast test, cold water test) have been carried out in this study.

Group 1: 2 % Sodium fluoride iontophoresis has shown reduction of sensitivity

(p < 0.01) which was statistically significant immediately applied after ultrasonic scaling and assessment of sensitivity was done by the three stimuli tests which were similar to the previous studies conducted by Nilam Brahmbhatt et al (2012)58 which showed significant reduction (p < 0.01) immediately after application for air, tactile and cold water test and

David Kern et al (1989) 51 which showed significant reduction in sensitivity to both pressure test ( p < 0.0005) and air test (p < 0.0001) immediately after treatment. This immediate significant reduction of sensitivity could be due to electrically driven fluoride ions in to dentinal tubules with iontophoresis which increases the concentration of fluoride followed by micro precipitation of calcium and fluoride in the dentinal tubules leading to formation of

63

Discussion insoluble compound which blocks the dentinal tubules.34 Intra group comparison from baseline to 14th day and 28th day also showed significant reduction of sensitivity which was statistically significant (p < 0.01). Arowojolo et al (2002)54 in their study assessed sensitivity by mechanical and pressure stimuli which were concurrent with our study significant reduction ( p < 0.05 ) of sensitivity at day 7 and day 14 and in another study in which

Adeyami oluniyi olusile et al (2008)29 showed significant reduction at postoperative 7th day using tactile test. This sustained effect after sodium fluoride iontophoresis could be due to reparative dentin formation which occurs only one to four weeks after its application. 50

Group 2: 1.23 % APF iontophoresis also showed reduction of sensitivity

(p < 0.01) which was statistically significant immediately after application for all the three stimuli which is not concurrent with previous study conducted by Ana Cecilia Correa

Aranha et al (2009)34 in which reduction of sensitivity occurred only at end of three months after APF gel application. In our study iontophorosis was used where the passage and deposition of fluoride might have caused the immediate blocking of dentinal tubules. Another study by Aparna et al (2010)35 in which APF gel is used with iontophoresis but immediate assessment was not done. Result of that study at 14th day showed significant reduction of sensitivity (p < 0.001) for air, tactile and cold water stimuli which are concurrent with present study results. Apart from fluoride precipitation in the dentinal tubules APF gel, when applied forms calcium fluoride and fluor hydroxyapatite over the dentin which prevents the loss of phosphate ions from the dentin. These effects might have caused the reduction of root dentin sensitivity after APF gel application.46

Group 3: 10 % Propolis iontophoresis also showed statistically significant reduction of sensitivity (p < 0.01) immediately after application and in the postoperative 14th day and

28th day compared to baseline for all the three stimuli tested. This study results is similar to results obtained by Souparna madhvan et al (2012)11 which showed statistically significant

64

Discussion reduction on 7, 14, 28, 60 and 90th day for air jet and tactile stimulation and Nilesh Arjun

Torwane et al (2013)47 which showed significant reduction (P<0.01) at 7, 14 and 21st day for air test and tactile stimulation. Based on the in vitro study results obtained by Silvia Helena

De Carvalho Sales-Peres et al (2010)10 it is showed that 10 % propolis being more fluid in nature produces homogenous dentin surface with obliteration of dentinal tubules and gained easy access to dentinal tubules. Flavonoids which are present in propolis may interact with dentinal tubules forming crystals thereby blocking it and reduce dentinal hypersensitivity.10, 11

These flavonoids are found to be negatively charged making it possible to move with cathode.59 This property makes the propolis to possibly use along with iontophoresis for controlling dentinal hypersensitivity.

In this study intergroup comparison has showed that 2 % sodium fluoride iontophoresis has significantly (P < 0.05) reduced the sensitivity better than 1.23 % acidulated phosphate fluoride and 10 % propolis during the postoperative 14th day after application for tactile test.

Intergroup comparison between 1.23 % acidulated phosphate fluoride and 10 % propolis has showed significant (P < 0.05) better reduction in sensitivity in the APF group in the baseline after application for cold water test

Assessment of reduction of sensitivity by various tests plays crucial role in evaluating different desensitizing agents as there will be variation in subjective opinion expressed by different individuals. According to Ide et al (2001)60 in their study it is recommended to use more than one stimuli test and also referred that subjective reproducibility will be less in single test. In one more study by Sowinski et al (2001)61, air test and tactile test will be accurate for measurement of dentinal hypersensitivity. Price et al (1983)62 has shown that visual analog scale is one of the widely used method found to be more accurate when

65

Discussion compared with other methods to assess intensity of pain. Based on these results three different stimuli tests air test by objective method with Schiff scale, tactile and cold water test using subjective visual analog scale were used to measure the root dentin sensitivity in this study. Further based on the study design for dentinal hypersensitivity guidance by

Holland et al (1997)63 the stimulus which is least severe is used first, based on that tactile test followed by air blast test and finally cold water test done in the order for all three groups.

In a similar study conducted by Klaus W. Neuhaus et al (2013)64 in which root dentin sensitivity following scaling and root planning is controlled with single application of prophylaxis paste containing 15% calcium sodium phosphosilicate (Novamin) with and without fluoride. Results showed that significant reduction (p < 0.0001) immediately following application and 28 days postoperative compared with baseline for tactile test with yeaple probe and air test using Schiff scale. In another similar kind of study conducted by

David Hamlin et al (2009)65 in which desensitizing paste containing 8% arginine and calcium carbonate was applied pre procedurally before scaling and found significant reduction of sensitivity ( P< 0.05 ) compared with baseline for tactile test with yeaple probe and air test using Schiff scale.

The practice of modern dentistry continues to seek measures for pain reduction. The negative impact after scaling procedures due to sensitivity should be reduced.65 In the previous studies by Klaus W Neuhaus et al, David Hamlin et al they have used a prophylactic paste to reduce this root dentin sensitivity after scaling. In the present study instead of desensitizing prophylaxis paste iontophoresis is used with desensitizing agents.

Iontophoresis is a method by which ionic drugs such as fluorides; flavonoids are applied over the tooth surfaces with a minimum voltage current to enhance penetration of drug ions in blocking the dentinal tubules. Use of fluorides is found to be ideal for treating dentinal hypersensitivity.8, 9 In the present study two fluoride containing agents was compared with a

66

Discussion newer agent propolis. All the three agents are found to be equally effective in reducing the root dentin sensitivity. With the limited studies available it is not possible to compare the desensitizing prophylaxis pastes with the iontophoresis. But iontophoresis can also be used effectively in reducing root dentin sensitivity after ultrasonic scaling.

67

Summary and Conclusion

Summary and Conclusion

SUMMARY AND CONCLUSION

The results of present study support the following conclusions.

1. Treatment for reducing root dentin sensitivity is needed to increase the patient

comfort and decrease the negative impact after ultrasonic scaling.

2. A statistically significant reduction in root dentin sensitivity immediately after

application, 14 days and 28 days postoperatively for 2 % sodium fluoride,

1.23 % acidulated phosphate fluoride and 10 % propolis along with iontophoresis

when evaluated using pressure sensitive probe for tactile stimuli.

3. 2 % sodium fluoride showed much significant reduction when compared with

1.23 % acidulated phosphate fluoride and 10 % propolis during postoperative 14th day

for tactile stimuli test.

4. A statistically significant reduction in root dentin sensitivity immediately after

application, 14 days and 28 days postoperatively for 2 % sodium fluoride,

1.23 % acidulated phosphate fluoride and 10 % propolis along with iontophoresis

when evaluated for air stimuli using three way syringe.

5. All the three agents are equally effective and no significant difference is found when

they were compared with air stimuli test.

6. A statistically significant reduction in root dentin sensitivity immediately after

application, 14 days and 28 days postoperatively for 2 % sodium fluoride,

1.23 % acidulated phosphate fluoride and 10 % propolis with iontophoresis when

evaluated with cold water stimuli.

7. 1.23 % acidulated phosphate fluoride showed significant reduction when compared

with 10 % propolis on the baseline day after application for cold water stimuli test.

68

Summary and Conclusion

8. An In office Iontophoresis along with any one of the three desensitizing agents can be

used after scaling to reduce the root dentin sensitivity and thereby enhance patient

motivation to seek further periodontal treatment.

9. Further long term studies with larger sample sizes are needed to support the use of

iontophoresis along with desensitizing agents in reducing root dentin sensitivity after

ultrasonic scaling.

10. Further studies are needed to support the use of iontophoresis along with desensitizing

agents after surgical periodontal therapy in controlling root dentin sensitivity.

69

Bibliography

Bibliography

BIBLIOGRAPHY

1. Lang, N. P. & Loe H. Clinical management of periodontal disease. Periodontology 2000.

1993; 2:128–139.

2. Walmsley AD, Walsh TF, Laird WRE and Williams AR. Effects of cavitational activity

on the root surface of teeth during ultrasonic scaling. J Clin Periodontol. 1990; 17:306-

312.

3. U. Zappa, J. Cadosch, C. Simona, H. Graf and D Case: In vivo scaling and root planning

forces. J Periodontol. 1991; 62:335-340.

4. Gillam D G & Orchardson R. Advances in the treatment of root dentine sensitivity:

mechanisms and treatment principles. Endodontic Topics. 2006; 13:13–33.

5. Tammaro S, Wennstrom JL, Bergenholtz G: Root-dentin sensitivity following

nonsurgical periodontal treatment. J Clin Periodontol. 2000; 27:690–697. .

6. Jyoti Ajay Khade, Satish Doiphode. Root Dentin Sensitivity. Indian medical gazette

2012; 146(7):269-273

7. Dina Al-Tayeb. Management of root-dentine hypersensitivity following non-surgical

periodontal therapy: clinical and scanning electron microscopic study. Egyptian Dental

Journal. 2008; 54(3):1-15.

8. Olan D, Parr. Economical iontophoresis for dentistry. Quintessence Int 1989; 20:841 -

845.

9. Louis P. Gangarosa. How Modern Iontophoresis Can Improve Your Practice ?

Quintessence International. 1982; 10:1027 – 1038.

10. Silvia Helena De Carvalho Sales-Peres, Flávia Negreiros De Carvalho, Juliane Avansini

Marsicano , Maria Cecília Mattos, José Carlos Pereira, Moacir Rossi Forim, Maria Fatima

Das Graças Fernandes Da Silva. Effect of propolis gel on the in vitro reduction of dentin

permeability. J Applied oral sciences. 2010; 2:318 – 323.

70

Bibliography

11. Sauparna Madhavan, Moksha Nayak and Krishna Prasad. Dental hypersensitivity: A

comparative clinical evaluation of CPP-ACP, sodium fluoride, pro polis and placebo.

J Conserv Dent. 2012; 15(4):315-318.

12. Martin Addy, Micheal Edgar, Graham embery, Taylor & Francis. Tooth wear and

sensitivity: Clinical advances in restorative dentistry. London :Martin Dunitz :Blackwell

Science;2000.

13. Noel Claffey, Ioannis Polyzois & Paraskevi Ziaka. An overview of non-surgical and

surgical therapy. Periodontology 2000. 2004; 36:35–44.

14. Von Troil B, Needleman I, Sanz M. A systematic review of the prevalence of root

sensitivity following periodontal therapy. J Clin Periodontol. 2002; 29(3):173–177.

15. Dowell and Addy. Dentine hypersensitivity A review - Aetiology, symptoms and theories

pain production. J Clin Periodontol. 1983; 10:341-350.

16. Navid N. Knight, Tryggve Lie, Stephen M. Clark, and Donald F. Adams. Hypersensitive

Dentin: Testing of Procedures for Mechanical and Chemical Obliteration of Dentinal

Tubuli. J Periodontol.1993; 64(5):366 – 372

17. Lutin ND, Greco GW, McFall JE WT. Effectiveness of sodium fluoride on tooth

hypersensitivity with and without iontophoresis. J. Periodontal.1984; 55:285-288.

18. Cuesta Frechoso S, Menendez, Guisasola, Arregui, Tejerina, Sicilia. Evaluation of the

efficacy of two potassium nitrate bioadhesive gels (5% and 10%) in the treatment of

dentine hypersensitivity. A randomised clinical trial. J Clin Periodontol.2003; 30: 315–

320.

19. Barry lee green, Margaret green, Walter t. Mcfall. Calcium Hydroxide and Potassium

Nitrate as Desensitizing Agents for Hypersensitive Root Surfaces. J. Periodontal.1977;

48: 667-672.

71

Bibliography

20. Shapiro WB, Kaslick RS, Chasens AL, Weinstein D. Controlled clinical comparison

between a strontium chloride and sodium monofluorophosphate toothpaste in diminishing

root hypersensitivity. J Periodontol. 1970; 41:523-525.

21. Gedalia I, Bayer L, Kalter N, Richter M, Stabhjolz A. The effect of sodium fluoride and

strontium application on dentine: in vivo and in vitro studies. J Periodontol 1978; 49:269-

272.

22. Yates R. Owens J. Jackson R. Newcombe RG. Addy M: A split-mouth placebo controlled

study to determine the effect of amorphous calcium phosphate in the treatment of dentine

hypersensitiviiy. J Clin Periodontol. 1998; 25:687-692.

23. Addy M, Mostafa P. Dentine hypersensitivity: Effects produced by the uptake in vitro of metal ions, fluoride and formaldehyde on to dentin. J Oral Rehab. 1988; 15:575-585. 24. Alessandra Bühler Borges, Daphne Câmara Barcellos, Carlos Rocha Gomes Torres,

Alexandre Luiz Souto Borges Ana Lucia Marsilio, Cláudio Antonio Talge Carvalho.

Dentin Hypersensitivity – Etiology, Treatment possibilities and other related factors. A

literature review. World Journal of Dentistry. 2012; 3(1):60-67.

25. Miller JT, Shannon IL, Kilgore WG, Brookman JE. Use of a water-free stannous fluoride-

containing gel in the control of dentinal hypersensitivity. J Periodontol 1969; 40:490-491.

26. Aigueperse, J., Mollard, P., Devilliers, D., Chemla, M., Faron, R., Romano, R. and Cuer,

J. P. Fluorine Compounds, Inorganic. Ullmann's Encyclopedia of Industrial Chemistry. Weinham:Wiley;2000. 27. Yeung CA. A systematic review of the efficacy and safety of fluoridation. Evid Based Dent. 2008; 9(2):39–43. 28. P Singal, R Gupta, and N Pandit. 2 % sodium fluoride Iontophoresis compared to a commercially available desensitizing agent. J Periodontol. 2005; 76(3):351 – 357.

72

Bibliography

29. Olusile, Bamisse, Ogiini, Dosumo. Short term clinical evaluation of four desensitizing agents. Journal of contemporary dental practice. 2008; 9(1):1-10. 30. E. Newbrun. Finn Brudevold: Discovery of Acidulated Phosphate Fluoride in Caries Prevention. J Dent Res 2011; 90(8):977-980. 31. JGC Saunders, JM McIntyre. The ability of 1.23% acidulated phosphate fluoride gel to

inhibit simulated endogenous erosion in tooth roots. Australian Dental Journal. 2005; 50(4):263-266. 32. Cesar Augusto Galvao Arrais, Daniel Chi Ngai Chan, Marcelo Giannini. Effects Of Desensitizing Agents On Dentinal Tubule Occlusion. J Appl Oral Sci. 2004; 12(2):144-8. 33. Jose C. Pereiraa, Angela D. Segalaa, David G. Gillam. Effect of desensitizing agents on

the hydraulic conductance of human dentin subjected to different surface pre-treatments- an in vitro study. Dental Materials .2005; 21:129–138 34. Ana Cecilia Correa Aranha, Luiz Andre friere pimento, Giselle Maria marchi. Clinical

Clinical evaluation of desensitizing treatments for cervical dentin hypersensitivity. Braz Oral Res. 2009; 23(3):333-339. 35. Aparna S, Swati Setty, Srinath Thakur. Comparative efficacy of two treatment modalities

for dentinal hypersensitivity: A clinical trial. Indian J Dent Res. 2010; 21(4):544 – 549.

36. Stefan Bogdanov. Propolis: Composition, Health, Medicine: A Review. 2014:Bee product

science.

37. Krell. Value–added products from bee keeping.1996; Rome: Food and Agriculture

Organization of the United Nations.

38. Margaret.p.Martin, Roberta Pillegi. A quantitative analysis of propolis : A promising new

storage media following avulsion. Dental traumatology. 2004; 20:85 – 89.

73

Bibliography

39. Abhishek Parolia, Manuel S. Thomas, M. Kundabala & Mandakini Mohan. Propolis and

its potential uses in oral health. International Journal of Medicine and Medical Sciences

2010; 2(7):210-215.

40. Lama Awawdeh, Maha betawi, Mohammed hammad. Effectiveness of propolis and

calcium hydroxide as a short-term intracanal medicament against Enterococcus faecalis:

A laboratory study. Aust Endod J. 2009; 35:52–58

41. Vijay D Wagh & Rameshwar D Borkar. Indian Propolis: A Potential Natural

Antimicrobial And Antifungal Agent. International Journal of Pharmacy and

Pharmaceutical Sciences. 2012 ; Vol 4(4):12 – 17.

42. Hidaka S, Okamoto Y, Ishiyama K, Hashimoto K. Inhibition of the formation of oral

calcium phosphate precipitates: the possible effects of certain honeybee products. J

Periodont Res. 2008; 43:450–458.

43. Hulya Toker, Fatih Ozan, Hatice Ozer, Hakan Ozdemir, Kaya Eren, and Hasan Yeler. A

Morphometric and Histopathologic Evaluation of the Effects of Propolis on Alveolar

Bone Loss in Experimental Periodontitis in Rats. J Periodontol. 2008; 79(6):1089 – 1094.

44. Elaiiie Cristina Escobar Gebara, AIessandro Nautiii Pustigiioni, Luiz Antonio Pugíiesi

Alves de Lima, Marcia Pinto Alves Mayer. Propolis Extract as an Adjuvant to Periodontal

Treatment. Oral Health & Preventive Dentistry. 2003; 1(1):29 – 36.

45. Rathod S, Brahmankar R, Kolte A. Propolis - A natural remedy. Indian Journal Of Dental

Research And Review 2011; 22:50-52

46. NA Torwane, Sudhir H, Pankaj G, B. R. Chandrashekar, Manish J, E Saxena. A clinical

efficacy of 30 % ethanolic extract of Indian propolis and recaldent in management of

dentinal hypersensitivity. A comparative randomized clinical trail. European Journal of

Dentistry. Oct-Dec 2013; 7(4):461 – 467.

74

Bibliography

47. Surender Sachdeva, Rajan Gupta, Gaurav Gupta. Iontophoresis and Dentistry. Journal of Indian Dental Ass. 2011; 5(1):46 – 48. 48. Louis Gangrosa. Newer Local Anesthetics and Techniques for Administration. J Dent Res. 1981; 60(8):1471-1480. 49. Gedalia, j. Weinman, j. Hermel and d. Feit. Fluoride Uptake by Enamel After Immersion in 2% Sodium Fluoride Solution with Iontophoresis. J Dent Res 1970; 49(6):1555 – 1556. 50. J. M. Wilson, B. W. Fry, E. Walton, and P. Gangarosa. Fluoride Levels in Dentin after lontophoresis of 2% NaF. J Dent Res June 1984; 63(6):897 – 900. 51. David A. Kern, Michael J. McQuade, Michael J. Scheidt, Benjamin Hanson and Thomas

E. Van Dyke. Effectiveness of Sodium Fluoride on Tooth Hypersensitivity With and Without Iontophoresis. J Periodontol. 1989; 60(7):386 – 389. 52. Michael A. McBride, Russell 0. Gilpatrick, Wiley L. Fowler. The effectiveness of sodium

fluoride iontophoresis in patients with sensitive teeth. Quintessence International. 1991; 22(6):637 – 640. 53. Trivedi , Meshran. Human pulp reaction to sodium fluoride 2 %, 4 % and acidulated

phosphate fluoride 1.23%- A comparative clinic histological study. Endodontology. 1995; 7:11 – 17. 54. Modupeola 0. Arowojolu. Fluoride iontophoresis versus topical fluoride application in the

treatment of dentine hypersensitivity. Nigerian Journal of Clinical Practice. December 2002; 5(2): 87-90. 55. Sharn Pal Sandhu, Roshan Lal Sharma, Vipin Bharti. Comparative evaluation of different

strengths of electrical current in the management of dentinal hypersensitivity. Indian J Dent Res 2010; 21(2): 207 – 212. 56. Grover Vishakha, Sikri Poonam, Kapoor Anoop. Comparison Of The Clinical

Effectiveness Of Iontophoresis Versus Iontophoresis Combined With Coronally

75

Bibliography

Repositioned Flap In The Management Of Hypersensitivity On Exposed Root Surfaces. Indian Journal of Dental Sciences 2010; Vol 2(3):10 – 14. 57. Micheal newman, Henry Takei, Pery Klokkevold, Fermin Carranza. Carranza ‘s Clinical

Periodontology 12th ed.2011;India:Elseveir.

58. Nilam Brahmbhatt, Neeta Bhavsar, Vishal Sahayata, Aneesha Acharya, Payal Kshatriya.

A double blind controlled trail comparing three treatment modalities of dentin

hypersensitivity. Med oral patol oral cir bucal. 2012 May; 17(3):483 – 490.

59. Heftmann. Fundamentals and applications of chromatography and related differential

migration methods. 5th ed.1992; Amsterdam: Elseveir.

60. Ide M, Wilson RF, Ashley FP. The reproducibility of methods of assessment for cervical

dentine hypersensitivity. J Clin Periodontol. 2001; 28:16–22.

61. Sowinski J, Ayad F, Petrone M, DeVizio W, Volpe A, Ellwood R, Davies R.

Comparative investigations of the desentising efficacy of a new dentifrice. J Clin

Periodontol.2001; 28:1032–1036.

62. Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales

as ratio scale measures for chronic and experimental pain. Pain. 1983; 17:45-56.

63. Holland GR, Narhi MN, Addy M, Gangarosa L, Orchardson R: Guidelines for the design

and conduct of clinical trials on dentine hypersensitivity.J Clin Periodontol 1997; 24:

808-13.

64. Klaus W. Neuhaus, Jeffery L. Milleman, Kimberly R. Milleman, Kimberly A. Mongiello,

Thomas C. Simonton, Courtney E. Clark, Howard M. Proskin and Rainer Seemann.

Effectiveness of a calcium sodium phosphosilicate containing prophylaxis paste in

reducing dentine hypersensitivity immediately and 4 weeks after a single application: a

double-blind randomized controlled trial. J Clin Periodontol. 2013; 40:349–357.

76

Bibliography

65. David hamlin, Kathleen phelan williams, Evaristo delgado, Yun po zhang, William

devizio, & Luis r. mateo. Clinical evaluation of the efficacy of a desensitizing paste

containing 8% arginine and calcium carbonate for the in-office relief of dentin

hypersensitivity associated with dental prophylaxis. American Journal of Dentistry. 2009;

22(Spl Iss):16 A – 20 A.

77

Annexure

Annexure

ANNEXURE 1

INFORMATION SHEET

We are conducting a study on COMPARATIVE EVALUATION –

IN OFFICE TREATMENT OF ROOT DENTIN SENSITIVITY WITH

IONTOPHORESIS: A RANDOMIZED CLINICAL TRAIL.

The identity of the patients participating in the research will be kept confidential throughout the study. In the event of any publication or presentation resulting from the research, no personally identifiable information will be shared.

Taking part in the study is voluntary. You are free to decide whether to participate in the study or to withdraw at any time; your decision will not result in any loss of benefits to which you are otherwise entitled.

The results of the special study may be intimated to you at the end of the study period or during the study if anything is found abnormal which may aid in the management or treatment.

Name of the patient Signature / Thumb impression

Name of the investigator Signature

Date

78

Annexure

ANNEXURE 2

INFORMED CONSENT FORM

COMPARATIVE EVALUATION – IN OFFICE TREATMENT OF ROOT DENTIN

SENSITIVITY WITH IONTOPHORESIS: A RANDOMIZED CLINICAL TRAIL.

Name : Age/Sex: O.P.no:

Address:

I, age years exercising my free power of choice, hereby give my consent to be included as a participant in the study “Comparative evaluation – In office treatment of root dentin sensitivity with iontophoresis: A

Randomized Clinical Trail”. I agree to the following:

I have been informed to my satisfaction on about the purpose of the study and study procedures and different tests to be performed on the study.

I agree to co-operate fully and to inform my doctor immediately if I suffer any unusual symptom. I agree to report for further follow up visits and complete the entire study. I understand that one of the medications used in this study has pollen which may be allergic to few people and to my best knowledge i am not allergic to it.

I hereby give permission to use my medical records for research purpose. I am told that the investigating doctor and institution will keep my identity confidential.

79

Annexure

Name of the patient Signature / Thumb impression

Name of the investigator Signature

Date

80

Annexure

81

Annexure

ANNEXURE 3

PROFORMA

KSR INSTITUTE OF DENTAL SCIENCES & RESEARCH

DEPARTMENT OF PERIODONTICS

PATIENT NAME AGE SEX

OPNO CASE NO DATE

GROUP SELECTED PHONE NO.

TEETH SELECTED

AIR PRESSSURE TEST

TEETH NO TEETH NO

BEFORE AFTER BEFORE AFTER

BASELINE

14 TH DAY

28 TH DAY

82

Annexure

BASELINE – TEETH NO.

TACTILE TEST

BEFORE APPLICATION

AFTER APPLICATION

COLD WATER TEST BEFORE APPLICATION

AFTER APPLICATION

83

Annexure

14TH POST OP DAY– TEETH NO.

TACTILE TEST

BEFORE APPLICATION

AFTER APPLICATION

COLD WATER TEST BEFORE APPLICATION

AFTER APPLICATION

84

Annexure

28TH POST OP DAY– TEETH NO.

TACTILE TEST

COLD WATER TEST

85

Annexure

86