to evaluate the clinical performance of a new

99
i TO EVALUATE THE CLINICAL PERFORMANCE OF A NEW CANAL INSTRUMENTATION TECHNIQUE “MIMERACI” ON THE INCIDENCE OF POST OPERATIVE PAIN: AN IN VIVO STUDY by Dr. SIMRAN BAJWA Dissertation Submitted to the Rajiv Gandhi University of Health Sciences, Karnataka, Bengaluru In partial fulfilment of the requirements for the degree of Master of Dental Surgery In Conservative Dentistry and Endodontics Under the guidance of Dr. B. S. KESHAVA PRASAD Professor and Head Department of Conservative Dentistry and Endodontics D. A Pandu Memorial R. V. Dental College and Hospital, Bengaluru 2017-2020

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Page 1: TO EVALUATE THE CLINICAL PERFORMANCE OF A NEW

i

TO EVALUATE THE CLINICAL PERFORMANCE OF A NEW

CANAL INSTRUMENTATION TECHNIQUE “MIMERACI” ON

THE INCIDENCE OF POST OPERATIVE PAIN: AN IN VIVO STUDY

by

Dr. SIMRAN BAJWA

Dissertation Submitted to the

Rajiv Gandhi University of Health Sciences, Karnataka, Bengaluru

In partial fulfilment

of the requirements for the degree of

Master of Dental Surgery

In

Conservative Dentistry and Endodontics

Under the guidance of

Dr. B. S. KESHAVA PRASAD

Professor and Head

Department of Conservative Dentistry and Endodontics

D. A Pandu Memorial R. V. Dental College and Hospital, Bengaluru

2017-2020

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vii

LIST OF ABBREVIATIONS USED:

ANOVA- Analysis Of Variance.

CFU- Colony Forming Unit

EDTA- Ethylene di- amine tetra acetic acid.

Fig- Figure

GG- Gates Glidden

Mm- Millimetre

Ni-Ti- Nickel-Titanium

n- Number of samples

NaOCl- Sodium Hypochlorite

p-value- Probability value.

SD- Standard deviation

VAS- Visual Analogue Scale

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viii

LIST OF TABLES AND GRAPHS:

Sl No

Table No/

Graph No

Title

Page No

1

Table - 1

Comparison of mean VAS scores between 03

groups during Pre-treatment time period

using Kruskal Wallis Test

37

2

Table-2

Comparison of mean VAS scores between 03

groups during Post treatment time period

using Kruskal Wallis Test

38

3

Table-3

Multiple comparison of mean VAS scores

between different groups using Mann

Whitney Post hoc Test

39

4

Table-4

Comparison of mean VAS scores between

Pre and Post treatment period in each study

group using Wilcoxon Signed Rank Test

40

5

Graph-1

Mean VAS score between 03 groups during

pre-treatment period

81

6

Graph-2

Mean VAS score between 03 groups during

post-treatment period

81

7

Graph-3

Mean VAS scores between pre and post

treatment period in each study group

82

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ix

LIST OF FIGURES

Sl No

Figure No

Title

Page No

1

Figure-1

Diagnostic Instruments

72

2

Figure-2

Irrigants

72

3

Figure-3

Electronic Pulp Tester

73

4

Figure-4

Electronic Apex Locator

73

5

Figure-5

Rubber Dam Kit

74

6

Figure-6

Endomotor

74

7

Figure-7

Armamentarium

75

8

Figure-8

Airotor and Micromotor Handpiece

75

9

Figure-9

Sealer and Glass Slab

76

10

Figure-10

Working Length Determination

76

11

Figure-11

Cleaning And Shaping With Stainless

Steel K Files

77

12

Figure-12

Cleaning And Shaping With Hero

Shaper Files

77

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x

13

Figure-13

Cleaning And Shaping With Protaper

Rotary Files

78

14

Figure-14

Master Cone

78

15

Figure-15

Radiograph of Root Canal Treatment

Done Using Stainless Steel Hand Files

79

16

Figure -16

Radiograph of Root Canal Treatment

Done Using Stainless Steel Hand Files

79

17

Figure-17

Radiograph of Root Canal Treatment

Done Using Protaper Rotary Files

80

18

Figure-18

Radiograph of Root Canal Treatment

Done Using Hero Shaper Files

80

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Structured Abstract

xii

STRUCTURED ABSTRACT

Title:

To evaluate the clinical performance of a new instrumentation technique with traditional

instrumentation technique on the incidence of post-operative pain: an in-vivo study

Background and objective:

The purpose of this study was to evaluate the clinical performance of a new

instrumentation technique MIMERACI (HERO Shaper files) with traditional hand

instrumentation technique (K-files) and Protaper Rotary instrumentation system on the

incidence of post-operative pain.

Methods:

42 permanent single rooted mandibular premolar teeth requiring endodontic treatment

were selected for the study. Baseline pre-operative VAS score were recorded and the

teeth were allocated into three groups of 14 teeth. After rubber dam isolation, access

opening was done. Working length was recorded using the Ingle’s technique and

confirmed by electronic apex locator. This was followed by canal instrumentation using

three different instrumentation techniques, irrigated with 3% sodium hypochlorite and

17% EDTA. Group 1: was instrumented with K-files using the step-back technique,

group 2: with Protaper rotary system using the crown-down technique and group 3: with

HERO Shaper files using the MIMERACI technique. All canals were cleaned, shaped

and obturated in a single visit. The assessment of pain was done 3 days post-operatively

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Structured Abstract

xiii

using the Visual analogue scale. Kruskal Wallis test followed by Mann Whitney Post hoc

test was used to compare the mean VAS scores at different time intervals.

Results:

The results showed that the maximum mean VAS score was recorded with group1 while

the lowest values were demonstrated with group 3. The mean difference between the

groups during post-treatment period was statistically significant.

Conclusion:

The type of instrumentation technique can significantly affect the probability and

intensity of post-operative pain. The expectations of postoperative pain from using the

stainless steel files were higher relative to Nickel-Titanium files. The MIMERACI

technique with HERO Shaper hand files significantly reduced post-operative pain.

Key words:

HERO-Shaper; K-file; MIMERACI technique; post-operative pain; Protaper

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Introduction

1

Apical periodontitis is the inflammation and destruction of the periradicular tissues which

occur as a sequel to the bacterial infection of the root canal system. It is a manifestation

of the host defense reaction to the colonizing bacteria comprising of cells, intercellular

messengers and antibodies. Apical periodontitis is not self-limiting.1 Therefore; the

treatment is directed towards eliminating the infection from the root canal and preventing

its re-infection.2

Root canal treatment is the most common endodontic procedure performed to prevent

apical periodontitis or create a favourable environment for periradicular tissue healing.3

This is achieved by chemo-mechanical preparation of root canal space through a

combination of mechanical instrumentation and antimicrobial irrigation.4 It is one of the

most important phases of the root canal therapy that aims to clean and shape the canal

space to promote disinfection by irrigants and medicaments, and enhance canal

geometries for adequate obturation. Mechanical instrumentation can alone contribute to a

100 to 1000 fold reduction in the microbial count. Consequently, the treatment has a high

degree of success rate.5

Root canal preparation is not only essential but also very demanding for the clinician as

it is affected by the anatomical complexities of the teeth and constraints of the endodontic

instruments.6 The complex anatomy includes variations in the number, length, curvature

and diameter of root canals, the intricacy of apical anatomy with accessory canals and

ramifications; communications between canal space and periodontium and the anatomy

of peripheral dentin.4

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Introduction

2

It often causes a great risk for iatrogenic errors. These include, instrument separation,

canal blockage, transportation, elbow, zipping or stripping which can have dramatic

repercussions on the outcome of the treatment.6 Others like apical extrusion of dentin

chips, pulp tissue fragments, necrotic tissue, microorganisms and intracanal irrigants is a

common inherent occurrence during canal instrumentation significantly contributing to

patient discomfort.3 Ingle and Taintor refer to this as “worm of necrotic debris”.

Chapman et al was the first to verify the correlation between the expulsion of infective

material during instrumentation.7

Many factors influence the amount of extruded intracanal material such as

instrumentation technique, type and size of instrument, preparation endpoint and

irrigation solution.8 This is of concern since the most important consequence related with

apical extrusion of debris during root canal procedure is inter-appointment flare up and

post-operative pain.9 Inter appointment flare-up represents development of pain, swelling

or both, which begins within a few hours or days post root canal procedures and is of

grave severity to require an unscheduled appointment for emergency treatment. The

reported incidence of flare-up is 1.4-16%. Anticipation and experience of root canal

associated pain is an undesirable event for the patient and an important concern for the

dentist.10

Acute periradicular inflammation is one of the most accepted causes of post-operative

pain.11

It includes mechanical, chemical/microbial and biological injury to pulpal and

periradicular tissues.12

It has been suggested that anaerobic bacteria play a significant part

in developing these symptoms. When periradicular tissues are injured, various chemical

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Introduction

3

mediators are released that bring about an increase in vascular permeability and

subsequent edema which leads to compression of nerve fibres. It results in foreign body

reaction that causes delayed healing or even treatment failure. Sequeira in 2003 described

the presence of a balance that exists between microbial challenge and host defense in

asymptomatic chronic peri-radicular lesion. In the event of debris extrusion, the peri-

radicular tissues are challenged by a larger number of irritants that disrupt the balance

and an acute reaction ensues to re-establish the equilibrium. The incidence and

importance of these symptoms depend on the amount of debris, the amount and type of

disease-causing pathogens, initial pathology and host response.6

All preparation techniques have been reported to have a correlation with extrusion of

infected debris even when preparation is kept short of the apical terminus.13

Thus, its

occurrence may not be inevitable, but to a great extent can be minimized by using

appropriate instrumentation technique and copious irrigation. Step back and crown down

are the two fundamental approaches to biomechanical preparation. Several studies have

concluded that crown down technique offers the advantage of lesser apical extrusion of

debris.14

The possible explanation is that this technique is designed to prepare the canal

system in a coronal –apical direction. It integrates rotation movement which tends to pull

dentinal debris into the flutes of the file and eliminates it coronally before any apical

instrumentation is done.15

In comparison, step back technique involves linear filing

motion in an apical-coronal direction which tends to push debris apically. The k file acts

like a piston in the apical one third that forces debris through the patent apical foramina

since less space is available to remove it coronally.16

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Introduction

4

In recent times there has been significant improvement in root canal instrumentation

since 1980’s with the manufacture of endodontic files with nitinol, a Ni-Ti alloy with

super elasticity. It is a term that describes the property of certain alloys to recover to their

original shape associated with stress-induced martensitic transformation.17

Use of these

flexible instruments enables a more centred canal preparation with fewer aberrations and

offers superior resistance to torsional fracture when compared to stainless steel hand

files.18

It is can also be regarded as a significant factor in diminished post-operative pain

due to less apical transportation and avoiding debris extrusion apically.

However, there exists a concern regarding the increased susceptibility of the instruments

to fracture and a lack of tactile feedback.19

This has led to the development of hand

operative version of some Ni-Ti rotary instruments. One such example is the HERO

shaper files that supplement the existing HERO 642 system, a second-generation Ni-Ti

instrument system. HERO shaper has a triple helix cross-section with constant taper and a

positive rake angle. HERO shaper is claimed to have an increased cutting efficiency,

flexibility and strength.20

The Protaper rotary system features a progressively tapered design that enhances cutting

efficiency while decreasing the contact between the blade of the file and dentin.21

It

includes a series of shaping and finishing files that cut and prepare a specific area within

the canal.22

Thus, it claims to possess greater resistance to cyclic fatigue. The semi-active

tip guides each instrument safely through the canal.23

The completion of root canal treatment in a single visit has currently been the norm.

Although the practice of completing endodontic therapy in a single appointment depends

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Introduction

5

on the convenience, patient acceptance, favorable canal anatomy and reduced post-

obturation pain. It offers several advantages, including a reduced flare-up rate, lesser

number of appointments, and decreased risk of short-term post-operative pain with no

inter-appointment leakage through temporary restorations.24

The attainment of excellent treatment is achieved more precisely by creating a well

cleaned and disinfected canal, by eliminating majority of inorganic and organic debris

and by employing instrumentation techniques that decrease the risk of expulsion of canal

contents during the process.

Therefore, a new clinical motion (which is the way the clinicians use an instrument

inside the canal), designed to improve the safety and efficiency of instruments have been

proposed: the MIMERACI technique.6

MIMERACI is an acronym for:

MI= Manual Insertion, ME=Minimal Engagement, R=Remove instrument from the

canal, AC=and Clean flutes, I=Irrigate.

The basic idea is to advance slowly (a maximum of 1 mm progression) inside the canal,

and after each 1 mm advancement to remove the instrument from the canal, clean flutes

and copiously irrigate. In such a way the instrument has a minimal engagement with the

canal walls that produce less debris, and most of the produced debris, which is entrapped

within the flutes, is predictably removed “outside” the canal by cleaning the flutes with a

sponge.

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Introduction

6

Moreover, an increased amount and frequency of irrigation will remove debris eventually

pushed apically or left inside canal in the middle or coronal parts, before instrument is

reaching the apex. The MIMERACI approach is a single-step approach, which must be

repeated many times till the instrument reaches the working length, aiming at reducing

the metal stress due to controlled minimal engagement and minimizing debris production

with improved debris removal.6

Hence, the aim of this study is to evaluate the clinical performance of a new

instrumentation technique MIMERACI with traditional instrumentation technique on the

incidence of post-operative pain.

Page 20: TO EVALUATE THE CLINICAL PERFORMANCE OF A NEW

Objectives

7

AIM OF THE STUDY

The aim of this study is to evaluate the clinical performance of new instrumentation

technique MIMERACI with traditional instrumentation technique on the incidence of

post-operative pain.

OBJECTIVE OF THE STUDY

1. To evaluate clinical performance of a new canal instrumentation technique

“MIMERACI” on the incidence of post-operative pain.

2. To evaluate clinical performance of a traditional instrumentation technique using

K-Files on the incidence of post-operative pain.

3. To evaluate the clinical performance of Protaper rotary instrumentation system on

the incidence of post-operative pain.

4. To evaluate any correlation between the clinical performance of “MIMERACI”

with traditional instrumentation technique and Protaper instrument system on the

incidence of post–operative pain.

Page 21: TO EVALUATE THE CLINICAL PERFORMANCE OF A NEW

REVIEW OF LITERATURE

8

Post-operative pain is one of the most common complications suffered by patients

during and after endodontic treatment. This prospective randomized clinical trial

aimed to evaluate the incidence and severity of post-operative pain following

instrumentation of root canals with Protaper Universal system, Protaper Next system

and Wave one system. Ninety patients requiring endodontic therapy on their

permanent mandibular molar teeth were selected and randomly distributed into three

groups of thirty patients each. They underwent access opening and root canal

instrumentation following the manufactures instructions, at the same visit. Group 1

was instrumented with Protaper system, group 2 with Protaper Next and group 3 with

Wave one instrumentation system. The post-operative pain was assessed at day 1, 2, 3

and 7 using verbal rating scale (4- point scale). The score was analyzed using chi-

square test. The results determined a significant difference among the groups, there

was a significant difference between Protaper next group and the Protaper and Wave

one group. While there was non-significant difference between Protaper and Wave

one groups. Hence, based on the study it was concluded that Protaper next system

caused the lowest incidence and severity of post-operative pain.25

An in-vitro study was done to correlate the amount of debris extruded apically from

forty five single rooted mandibular premolar teeth. The teeth were divided into three

groups, using K3, Protaper rotary instrument and K type stainless steel instruments

with manual step back technique, respectively. The amount was determined by

collecting the extruded debris from apical foramen into centrifuge tubes. Statistically

significant difference was observed between all three groups in terms of debris

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Review of literature

9

extrusion. Step back had the highest mean debris weight whereas K3 had the least.

The study concluded that all the instrumentation technique produced debris extrusion.

The Ni-Ti rotary system extruded comparatively lesser debris than the manual step

back technique. The Protaper group produced significantly higher debris than K3

rotary instrument.3

The purpose of this study was to evaluate different root canal instrumentation systems

for debris and volume extrusion. Root canal preparation causes extrusion of debris

into periradicular region leading to periapical inflammation and post-operative flare-

ups. Four groups of 20 mandibular premolars each were instrumented with one of the

systems: Protaper universal, Hero shaper, Race and K3. Extruded debris and irrigant

was collected in pre-weighed test tubes. The containers were incubated at 70 C for 2

days to evaporate the moisture content and weight of dry debris was recorded. The

data was analyzed using Kruskall-Wallis test. The results showed that all the

instrumentation systems invariably caused apical extrusion of debris. Protaper system

was associated with higher measurable amount of the same. However, all the other

system produced less debris than Protaper system.26

This study aimed to comparatively evaluate three rotary systems namely, Protaper,

Hero Shaper and Mtwo for the apical extrusion of debris and irrigant using crown-

down technique. 30 extruded human permanent mandibular premolars with minimal

root curvature (0-10 C) were divided into three groups. Sterile water (1mL) was used

as an irrigant. The extruded debris was contained in pre weighed vials and the irrigant

was measured by montogomery method. It was later evaporated and pre and post-

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Review of literature

10

instrumentation weight of the dry debris was calculated. Statistical analysis was

accomplished using Kruskal-Wallis One-way Anova test. A significant difference

was noted with Protaper and Mtwo group in comparison to Hero shaper. Hence, it

was concluded that Hero shaper systems showed a lesser apical extrusion of debris

and irrigant.27

The purpose of this prospective, randomized double blind study was to correlate post-

operative pain of root canal treatment using three different instrumentation

techniques: hand rotary files (Protaper) and reciprocating single file (wave-one)

instrumentation techniques. Ninety six patients were divided into three groups

according to the instrumentation technique. Single session endodontic treatment was

done and the severity of the post-operative pain was assessed by Heft Parker VAS at

6, 12, 18, 24, 48 and 72 hours post treatment. The results stated that the analgesic

intake was notably higher in group 1 with no difference between the other two

groups. At 6, 12 and 18 hours, group 3 reported significantly higher post-operative

pain levels as compared with the other groups. Also, the patients in group 2 recorded

lower post-operative pain at 6 and 12 hours in comparison with group 1 patient. It

was concluded that post-operative pain was lesser for wave-one as compared with

Protaper instrumentation system.28

A study comparing the Extrusion of Dentin Debris Using a New Instrumentation

Concept was performed by David E. Jaramillo. A total of 45 extracted human

mandibular lower incisors with mature apices were selected and divided into three

separate groups namely; T F Adaptive group, Wave One group and Step back

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Review of literature

11

technique group. A modified model used by Montgomery was used to assemble the

extruded debris and irrigants. It contains an Eppendorf’s microtube with two

perforations, one to seat the tooth and other to release the pressure. After

instrumentation, the microtubes were incubated at 37 C for five days to evaporate the

excess water. An electronic balance was utilized to check the weight of the sample.

Conclusion: The Step-back technique produced significantly more debris compared

with the TF adaptive system with no statistical significance between wave one and TF

Adaptive systems.29

This study was conducted with the objective to correlate the amount of extrusion of

bacteria beyond the apical foramen post instrumentation with manual and engine

driven Ni-Ti instruments with step-back and crown-down technique, respectively.

Seventy five mandibular premolar teeth were selected; access-cavity was prepared

followed by contamination with suspension of Enterococcus Faecalis. The teeth were

divided into three experimental groups: group 1 (crown-down) – group 1A – hand

files (k files) and group 1B – Rotary files (Protaper). Group 2 (step-back) further

divided into: group 2A – hand files (k files) and group 2B – Rotary (Light Speed LSX

instrument). Group 3 – control (no instrumentation). Vials were used to collect the

extruded bacteria. The samples were incubated for 24 hours after which the colony

forming units were determined. There was a significant difference in extrusion of

bacteria between both the groups. Step-back hand technique extruded more bacteria

as compared with crown-down hand technique. Overall, the hand instrumentation

done by using step-back technique extruded more bacteria apically when compared

with both engine driven instrumentation technique.30

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Review of literature

12

This study was carried out to quantitatively evaluate the apical extrusion of debris

caused by three different rotary instrumentation systems namely, Hero-shaper,

Protaper and Profile. Sixty mandibular central incisors were divided in three groups

with twenty teeth each. The teeth were instrumented as per the guidelines offered by

the manufacturer. The debris formed was collected in polyethylene tubes. The liquid

content was removed by lyophilization and the dry debris weight was calculated and

compared. There was statistically significant difference between the Protaper and

Hero shaper group, between Profile and Hero shaper in terms of extrusion of debris

even though Hero shaper produced relatively higher amount of debris. It was

concluded that Protaper caused significant higher debris of extrusion as compared to

profile rotary system. As debris extrusion is only one of the factors responsible for

acute exacerbations, future studies must be carried out to learn about the type of

bacteria responsible for flare-ups and their effective elimination.2

An in-vitro study compared the conventional, step back technique instrumentation

technique with step down technique in both straight and curved canals with respect to

amount of debris forced through the apical constriction during root canal

instrumentation. Twenty endodontic models, consisting both straight and curved

canals, with periapical wells were used in the study. They were divided into two

groups of ten teeth each, five models with straight canals and five models with curved

canals respectively. All the models were sectioned through the periapical wells using

a diamond saw. Following the root canal treatment, the debris collected was loosened

with the endodontic explorer. It was collected in a Millipore plastic filter disk. A

highly significant difference was observed the two instrumentation techniques.

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Review of literature

13

Results showed that an appreciable amount of debris was forced periapical in both

straight and curved canals when step back technique was used. In conclusion, neither

technique totally prevented the extrusion of debris.14

This in vitro investigation was executed to assess the canal blockages and dentin

debris from extracted human teeth using eight preparation techniques. Two hundred

and eight canals in extracted teeth were prepared by one type of file using one of the

techniques: standardized, step back with reaming, step back with anti curvature filing,

step back with circumferential filing, crown down pressureless, step down, and

balanced force technique. Dry weight of extruded debris was calculated. The level of

blockages differed notably between techniques (p<0.001) and occurred most

significantly in canals prepared with the step back techniques with anti curvature

(n=19) and circumferential filing (n=16) with dry weight 0.7 mg and 0.69 mg

respectively. It was minimum with balanced force technique (n=0). It was concluded

that technique involving a linear filing motion caused more blockages and

significantly forced more apical debris.15

A systematic review was conducted to assess the in-vivo and in-vitro effectiveness

(outcome) of using rotary Nickel Titanium verses manual stainless steel instruments

for root canal treatment. Searches were performed by two experienced clinical

scientists in four electronic databases (Medline/PubMed, Embase, Scopus and

Cochrane) using single or combined keywords to obtain the most relevant list of

references. Additionally, a manual search was carried out in the reference list of

selected articles. The studies satisfying the inclusion criteria underwent data

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Review of literature

14

extraction and risk of bias assessment. Primary outcome included pain reduction,

resolution of symptoms, and improvement of quality of life and occurrence of

complications. Secondary outcomes included parameters such as apical extrusion of

debris, microbial load reduction and cleansing ability of the root canal. Literature

emphasized that post-treatment pain may be caused by the apical extrusion of infected

debris, which can generate an acute inflammatory response. Findings from the present

review are in lieu with the other studies, which state that rotary Nickel Titanium

instruments extrude less debris than manual stainless steel instruments. Also, the

debris extrusion depends on device movement (rotary verses translational) and

instrumentation technique (step down verses step back).31

A study was conducted by G. Gambirini et al to assess the occurrence and intensity of

post-operative pain and periapical inflammation post endodontic treatment with two

different instrumentation techniques, namely a rotary crown-down technique (TF

instruments) and a reciprocating single-file technique (Reciproc instruments). Sixty

patients requiring endodontic treatment were included in the study. The postoperative

pain was evaluated at 3 days by using a visual analogue scale. There was a

statistically significant difference between the two techniques. When evaluating

patients experiencing extreme pain the incidence of symptoms was notably greater

with the Reciproc technique (chi-square =7.246P = 0.023). The different

instrumentation technique probably resulted in the difference in postoperative pain.32

This study was conducted to compare hand, rotary Protaper instruments and rotary

Profile instruments regarding the amount of apical debris formation. Forty five

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Review of literature

15

mandibular premolars were included and instrumented until the working length. The

extruded debris was collected in polyethylene vials and the irrigant was allowed to

evaporate. The weight of the debris was calculated as the difference between pre and

post instrumentation weight of the vials. A statistically significant difference was

noted between Protaper and Profile groups (p<0.001), when Protaper rotary extruded

a relatively higher amount of debris.33

The objective of this study was to estimate the quantity of debris and irrigant

extrusion with the Protaper system verses the profile and k-flexofiles. Thirty six

mesiobuccal root canals of human mandibular molars were included. They were

equally divided into three groups and instrumented according to the manufactures

instructions. A set amount of irrigant was used for each root canal. Pre-weighed vials

were used to collect the apically extruded debris and irrigant. The mean weight was

analyzed. There was no significant difference noted between the three groups. It was

learnt that all the instrumentation techniques led to formation of debris. But, NiTi

rotary systems were associated with lesser apical extrusion in correlation with step

back technique.34

An in-vitro study was carried out to investigate Protaper universal, Protaper next,

twisted file adaptive and Hyflex instruments to ascertain the instrumentation times

and relate the in-vitro amount of apically extruded debris. Sixty single rooted

mandibular premolars were instrumented up to size # 25. The apically extruded debris

was collected in Eppendorf tube and dried. The weight was assessed with an

electronic balance. The total time required for instrumentation was the longest with

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Review of literature

16

Protaper universal rotary system. The debris extrusion was significantly more with

Protaper universal and Hyflex systems as compared with Protaper next and twisted

file adaptive instrumentation system.35

In a study, two Hand (Protaper and k files) and Rotary (Protaper universal and k3)

instrumentation techniques were examined for the bacteria extruded apically during

root canal preparation. Eighty mandibular premolars were mounted in an apparatus. A

pure culture of Enterococcus Faecalis was used to contaminate the root canals.

Bacteria extruded from the canals were collected and incubated in BHI Agar for 24

hours at 36 C. The colony forming units (CFU) were counted. The mean number of

colony forming units was calculated by one-way Anova. Results showed that among

all the instrumentation techniques, the step back technique extruded the maximum

number of bacteria as compared to other rotary NiTi systems. K3 exhibited the least

apical extrusion of debris.36

Extrusion of debris during root canal preparation can potentially result in post-

operative complications such as post-operative pain or flare up. This in-vitro study

was undertaken to analyze the amount of apically extruded debris during root canal

treatment. Sixty mandibular first premolars were divided in 3 groups (n=20

teeth/group) namely, Protaper, Hyflex CM and reciprocating single file system Wave-

one. The canals were instrumented according to the manufacturer’s instructions and

irrigated using bidistilled water. Apically extruded debris was collected in pre-

weighed Eppendorf’s tubes and measured by an electronic balance. All

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instrumentation techniques resulted in production of debris with Protaper and wave-

one rotary instruments values being significantly more than Hyflex rotary.37

Endodontic instrumentation is accountable to result in some post-instrumentation

pain. This randomized clinical trial aimed to determine the incidence of post-

operative pain with three rotary systems distinctive in their design, Protaper, Mtwo

and K3, respectively. A total of 150 patients were selected for the study and randomly

divided into three groups according to the instrumentation technique used. Post-

instrumentation pain was assessed every 12 hours for five days. Tenderness to

percussion was checked at 1,3 and 7 days. Statistical analysis was preferred using

Mann Whiteny U test. The resulting values were lesser for Mtwo group up to 84

hours and 72 hours respectively. There was no significant difference between

Protaper and k3 both in post-instrumentation pain and tenderness to percussion.38

This in-vitro study was done to comparatively evaluate Protaper Hand, Protaper

Rotary with Profile instrumentation systems. Thirty human mandibular premolars

were randomly divided into three groups as per the instrumentation technique used.

Irrigation was done using sterile water (5mL). Extruded debris was collected in vials

and irrigant was evaporated. The weight of the dry extruded debris was determined as

difference between the pre and post instrumentation weight of vials. The statistical

analysis was done by using Kruskal-Wallis non-parametric test and Mann-Whitney U

test. Protaper rotary extruded significantly higher amount of debris and no notable

difference was observed between Protaper hand and rotary instruments.39

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An in-vitro study was conducted to evaluate the effect of irrigation on the production

of extruded material from the apex during standard instrumentation. Sixty four root

canals were included in the study. They were divided into two groups; the first group

of thirty two teeth was treated in absence of irrigation whereas the second group was

instrumented under 5.25% NaOCl irrigation solution. The extruded material, if

present in collectible amounts, was gathered on a waxed weighing paper and

weighed. The authors concluded that there was no significant collectible material

extruded from the group of teeth instrumented in absence of irrigation. The canals

prepared in presence of irrigation showed some extrusion of debris.8

A randomized clinical trial was undertaken to relate the incidence of post-operative

pain and the intake of analgesic medication (frequent and quantity) post root canal

treatment of posterior teeth using rotary and reciprocating systems (Protaper next,

Wave one or Reciproc). Two hundred and ten patients with vital teeth were randomly

assigned to one of the three groups (n=70) and treated in a single visit by five

specialists as per the pre-established protocol. The patients were prescribed ibuprofen

400mg to be taken every 6 hours if pain occurred. The intensity of post-operative pain

was recorded at 24 hours, 48 hours, 72 hours and 7 days using VAS. Patients were

also instrumented to record the intake of analgesic medication tablets taken at these

time points. The results showed no statistically significant difference among the three

groups in relation to post-operative pain or analgesic tablet intake at the different time

intervals (p>0.05). Both reciprocating and continuous rotary systems were found to

be equivalent in regard to post-operative pain.40

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A randomized clinical trial was done to compare the effect of root canal preparation

by using Protaper and Wave one on post-operative pain. 42 patients who fulfilled the

inclusion criteria were allotted to the respective group. Root canal treatment was done

in two appointments, and the numerical rating scale (NRS) was used to assess the

severity of the post-operative pain after each session until pain relief was achieved.

Treatment time, consumption of analgesic and duration of pain was also documented.

Wave one group recorded the shortest canal preparation time with significantly higher

mean NRS score and duration of pain after both appointments. The analgesic

consumption was significantly lower in patients treated with Protaper universal rotary

as opposed to Wave One reciprocating single file technique.41

This study was directed to evaluate the occurrence of bacteria extrusion during root

canal cleaning and shaping using four rotary instrumentation techniques. A total of 50

mandibular premolars were picked and embedded in 10 mL glass vials. A suspension

of Enterococcus Faecalis (ATCC) 29219 was used to contaminate the root canals.

The vials were incubated for 24 hours at 37 C. Debris extrusion from the apical

foramen post instrumentation was collected and the number of colony forming units

was calculated for individual sample. The statistical analysis was done using One-

way Anova. There was a statistically significant difference in the number of colony

forming units between experimental instrumentation groups (p<0.001). Bacterial

extrusion was higher in Mtwo group and the least in K3 group.42

This study was undertaken to assess the post-operative pain after rotary or

reciprocating NiTi instrumentation of root canals in a prospective randomized clinical

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trial. 78 male patients, aged 18-64 years requiring endodontic treatment in mandibular

molar teeth were included. Single visit root canal therapy was performed by the same

endodontist using either Protaper or Reciproc instrumentation system. Post-operative

pain was recorded at three definite time intervals: 24 hours, 72 hours and 7 days after

completion of root canal treatment using verbal rating scale (VRS) and verbal

description of the pain. It comprised of well-defined categories as no pain, mild pain,

moderate pain and severe pain or flare-up. The incidence of post-operative pain in

Protaper group was 17.9%, 24 hours after endodontic procedure and 5.1% after 72

hours whereas Reciproc group, 15.3% and 2.5% at 24 hours and 72 hours

respectively. None of the patients presented with severe pain at any given time

interval.43

Incidence of post-operative pain after intra canal procedures based on an

antimicrobial strategy was evaluated in this prospective study. Six hundred and

twenty seven teeth with either necrotic pulps or requiring retreatment were included

and data obtained was examined. Presence of pre-operative pain and periradicular

bone destruction detected by radiographs was also recorded. The operators were

undergraduate students in their first years of clinical training. Root canals were

treated with hand/rotary instrumentation and medicated with calcium hydroxide or

camphorated paramonochloro phenol paste. The level of discomfort and occurrence

of post-operative pain was assessed one week after their initial appointment. Data

were analyzed using the chi-square test. Mild pain was recorded in 10% of cases,

moderate in 3.3% and severe in 1.9%. Post-operative pain was significantly

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associated with cases with pre-operative pain. No other correlations were drawn with

other clinical conditions.44

A Clinical trial by Bita Talebzadeh et al compares the severity of postoperative pain

after root canal preparation with RaCe rotary system and hand K-Flexofile. A total of

96 mandibular first and second molars were divided into two groups (n=48) based on

root Canal preparation technique. The teeth in both groups underwent single visit root

canal treatment and the severity of postoperative pain was assessed using visual

analogue scale (VAS). The variation between the two groups at subsequent intervals

was not significant. Considering the absence of significant difference, it was deduced

that use of the crown-down technique is more effective in postoperative pain than the

file type. Therefore, it is suggested that future studies evaluate the hand and rotary

files with the same crown-down technique in both groups.45

An in-vitro study was carried out for comparison between three Ni-Ti rotary systems

(Protaper universal, Mtwo and Bio Race) for production of debris and its extrusion

beyond apical foramen. Sixty extracted single-rooted mandibular premolars were

allotted to three groups on the basis of the instrumentation system used. During

instrumentation, the extruded debris and liquid were collected in pre-weighed tubes

and the liquid component was drawn away by lyophilization. The remaining dry

debris was calculated for individual groups and compared. A significant difference

was recorded between all the three groups with Protaper extruding the greatest

amount of apical debris. Bio Race group had the least values.46

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This is an ex-vivo study performed to investigate root canal instrumentation of two

rotary Ni-Ti systems (Protaper Universal and Alpha) in comparison to stainless steel

hand instruments. Forty five mesial root canals of mandibular molars were selected

and divided into three groups on the basis of degree of curvature. Group 1 – the

canals were enlarged up till size 30 using manual preparation techniques, in Group 2

and 3 – rotary instruments were used according to the manufacturing instructions.

Instrumentation time, procedural errors and straightening of the canal was examined

by superimposing pictures of pre and post-operative canals. Based on this, portion of

uninstrumented canal was evaluated. Alpha system showed less active

instrumentation time, lesser apical straightening and less uninstrumented areas

compared with stainless steel files.47

An insight into the various causes of flare-ups and its appropriate preventive

measures is significant in the reduction of this highly undesirable clinical

phenomenon. This review highlights the causative factors of inter appointment flare-

ups. It comprises of mechanical, chemical or microbial injury to the pulp or

periradicular tissues that disrupt the balance between the microbial aggression and

host defense resulting in acute periradicular inflammation. Factors such as apical

extrusion, changes in the microbial environment due to incomplete root canal

preparation and increase in oxidation-reduction potential favor the growth of

facultative bacteria. Therefore, appropriate preventive measures must be adopted to

reduce the occurrence of post-operative discomfort. These include selection of an

instrumentation technique that reduce the extrusion of debris beyond the apical

foramen, adoption of single-visit root canal treatment, usage of an intracanal

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medicament in between appointments and maintenance of aseptic conditions during

endodontic treatment. Even though it has been observed that post-operative pain or

flare-up has no significant effect on the treatment outcome, its occurrence is

disturbing to both the patient and the clinician.12

This study was carried out to assess the quantity of debris extruded from the apical

foramen during cleaning and shaping procedures using the manual technique and with

the use of rotary systems (Profile, Race and Flex master). One hundred single rooted

premolar teeth were included in the study and divided into four groups namely H, P,

R and F. Vials containing distilled water were weighed before and after canal

preparation. The weight of debris collected was calculated as the difference between

the weight of the vial before and after canal preparation. Group H (manual system)

had the highest mean debris weight and group R (Race system) had the lowest mean

debris weight which was significantly different from that of group F but not group P.

It was concluded that the Race system extruded less debris than the manual technique

and the flex master system.9

An in-vitro study was done to determine apical extrusion of irrigants and debris using

two hand and three engine-driven instrumentation techniques. Hundred extracted

teeth with single canals were divided into five groups according to the

instrumentation technique used: balanced force technique, hybrid hand

instrumentation technique and three engine driven technique utilizing Ni-Ti

instruments (Profile .04, Quantec 2000 and Pow-R). 1.5ml tubes were used to collect

the debris extruded from apical foramen during instrumentation. The volume of

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24

irrigant extruded was ascertained by visual comparison to centrifuge tubes used as

controls. The volume of irrigant extruded was directly proportional with the weight of

extruded debris. The hybrid technique showed the highest extrusion of both irrigant

and debris but there was no statistically notable difference between the engine driven

method and balanced force technique.13

Experience of root canal associated pain is a major cause of fear for the patient and a

significant concern for the clinician. The purpose of this systematic review was to

assess the influence of root canal treatment on prevalence and severity of pain.

Searches were performed in Medline, Embase, Cochrane and PsycINFO databases

which provided seventy two studies for meta-analysis. Many studies in the literature

relate post-treatment pain to the following factors: pretreatment pain, single verses

multi visit treatment, different treatment protocols. Root canal treatment reduced pain

severity but four out of the twelve studies showed immediate post-treatment severity

levels slightly more than the pretreatment severity levels. This may be attributed to

the ongoing inflammatory process and the apical instrumentation resulting in

extrusion of apical debris. Post-treatment pain severity decreased over time.

Supplemental anesthesia was often requires while performing root canal treatment.48

The aim of this in-vitro study was to determine the effect of root canal

instrumentation techniques and preparation tapers on the amount of apically extruded

bacteria. Ninety eight extracted human mandibular incisors were contaminated with a

suspension of enterococcus faecalis. The teeth were incubated at 37C for 24 hours

following which they were instrumented in a crown down (CD) or full length linear

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(FL) instrumentation technique by using three different root canal tapers (0.02, 0.04

and 0.06). During instrumentation, the infected debris was collected in vials

containing saline. The microbial samples were then incubated in brain heart agar

medium for 24 hours and the number of colony forming units were calculated. The

results were analyzed using T test and one way anova test. Statistically significant

difference was determined between FL and CD techniques when the preparation taper

was 0.02 (p<0.05). Whereas with preparation taper of 0.04 and 0.06, there was no

significant difference observed with any of the instrumentation technique. The

preparation taper had no effect on the number of colony forming units when the root

canal treatment was performed using FL instrumentation system. Hence, it was

concluded that the instrumentation technique did not affect the amount of bacterial

extrusion when 0.04 and 0.06 tapered instruments were used.49

The objective of this study was to compare the amount of apically extruded debris

using balanced force instrumentation, step-back filing and endosonic technique. It

also aimed to evaluate the impact of other aspects such as tooth type, apical canal size

and length on the production of infected debris. Sample for the study included forty

five single canal extracted human teeth which were instrumented by one of the

techniques. The apically extruded debris was lavaged from the root apex using

absolute alcohol into pre-weighed filter. Anhydrous calcium sulphate crystals were

used to desiccate the filter paper and collect debris. Weight of the debris was

determined by an electro balance. A one factor analysis of variance was performed on

the debris weight data reporting that the endosonic technique extruded more debris

than the balanced force technique. Further, it was demonstrated that balanced force

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26

technique extruded less debris than either endosonic or step-back filling technique

(p<0.05). No significant difference was recorded between endosonic and step-back

filling motion.50

An in vivo study was performed to check the influence of varied instrumentation

techniques on the occurrence of post-operative pain following endodontic therapy.

Ninety patients requiring endodontic treatment were assigned into three groups of

thirty patients each. Group 1 was instrumented with TF instrument, while group 2

used wave one. The third group was instrumented using file TF Adaptive sequence.

All the teeth were treated in a single visit by the same operator. The post-operative

pain was assessed at 3 days using visual analogue scale. Results showed statistically

significant difference between wave one technique and the other two techniques.51

An in-vitro study was done to estimate the amount of apically extruded debris using

rotary and reciprocating Nickel Titanium instrumentation systems. Eighty human

mandibular central incisors were randomly allotted to four groups divided according

to the instrumentation technique. The root canals were prepared according to the

manufactures instructions using Reciproc and Wave one (reciprocating systems) and

Mtwo and Protaper (full sequence rotary systems) instruments. The extruded debris

was collected and dried according to the Myers and Montogomery method. Statistical

analysis was performed using analysis of variance and post hoc student test. There

was no statistically significant difference observed between the two rotary systems,

the reciprocating system Reciproc extruded significantly more debris compared with

the other instruments (p<0.05). Under the conditions of this study, it was concluded

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that full sequence rotary instrumentation system, Protaper extruded less debris than

with the use of single file reciprocating systems.52

This in-vitro study was undertaken to evaluate the extrusion of debris in flat-oval root

canal systems during root canal preparation with varied instrumentation systems.

Seventy two mandibular incisors were divided into four groups according to the

instrumentation system used: the wave one reciprocating system, Protaper next rotary

system, the twisted file adaptive and self adjusting file. The extruded debris was

collected in pre-weighed Eppendorf tubes and subsequently dried. The data was

analyzed using the T test and analysis of variance. The result stated that the self

adjusting file produced significantly more debris compared with the other systems

(p<0.05). No significant difference was recorded amongst the Protaper next , wave

one and twisted file adaptive systems. It was concluded that regardless of the

instrumentation system used, apical extrusion of debris is an invariable occurrence.

Under the conditions of the study, the Self Adjusting File recorded the maximum

amount of apically extruded debris as compared with other systems.53

The objective of this study was to evaluate the effect of three different Nickel

Titanium file systems on the incidence of post-operative pain after single visit

endodontic treatment. Ninety patients with necrotic pulp were included in the

investigation and divided into three groups. Group 1 was instrumented with Wave

one reciprocating systems, group 2 was instrumented with Protaper next system and

group 3 with twisted file adaptive system. The treatment was completed in a single

visit. Visual Analogue Scale was utilized to analyze the post-operative pain

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experienced by the patient. A statistically significant difference was found between

Protaper next and wave one technique, and also between twisted file and wave one

technique. It was concluded that post-operative pain depends on the type of

instrumentation technique. Maximum pain was experienced after instrumentation

with reciprocating and wave one followed by twisted file and Protaper next system.54

The purpose of this randomized clinical trial was to assess the post-operative pain

after endodontic treatment of asymptomatic teeth using two different rotary

instruments. a total of seventy eight mandibular first and second molars were divided

into two groups of thirty nine teeth each. The root canal preparation was done with

Race or Protaper rotary instrument, respectively. Single-visit treatment was

performed and the severity of post-operative pain was evaluated using the Visual

Analogue Scale at 4, 12, 24, 48 and 72 hours and one week intervals. In addition, the

intake of analgesic was also recorded. The data was analyzed with Mann-Whiteny U

test and Anova and the statistical significance was set at 0.05. The resulting pain

score between the two groups at various post-operative time intervals did not reveal

any significant difference. Also, the amount of analgesic intake was not statistically

significant. Hence, it was concluded to state that both the systems are clinically

acceptable.55

This longitudinal, prospective study investigated the prevalence and factors affecting

post-obturation pain in patient undergoing root canal treatment. A total of twenty

practitioners, including general dental clinicians, endodontist and MSc graduates

participated in the study. A total of 504 patients consented to participate in the study

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who had visited the practitioner for either primary root canal treatment or re-

treatment. Demographic, medical history was also recorded with pain experienced on

day one and two after root canal obturation. Visual Analogue Scale was used to

record the severity of pain. The resulting data was analyzed and stated that less than

12% of patient experienced severe pain in either day 1 or 2. The prevalence of post-

obturation pain within two days was 40.2% (n=167). The prevalence of post-

obturation pain was influenced by six independent variables (gender, tooth type, size

of periapical lesion, history of post-instrumentation pain, and history of swelling and

single-visit treatment). Hence, it was concluded that post-treatment pain has a

relatively high prevalence (40.2%) and therefore appropriate preventive measure must

be adopted to reduce its severity.56

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Methodology

30

MATERIALS AND METHODS:

ETHICAL APPROVAL

Approval for this study was obtained from the Institutional Ethical Committee.

SOURCE OF DATA

The subjects for the present study were selected from the outpatient department of

Conservative Dentistry and Endodontics, DAPM R V Dental College and Hospital,

Bangalore, Karnataka.

METHOD OF COLLECTION OF DATA

A written consent was obtained from all selected patients who satisfied the inclusion

criteria. A detailed case history was recorded followed by a thorough examination under

adequate illumination and aseptic conditions.

Blinding

Although the patients were explained about the study design and the treatment that was

used in the study, they were unaware about which system was being used for the

particular treatment. The evaluators were blinded from knowing to which group the

endodontically treated teeth belonged.

INCLUSION CRITERIA:

• Patients who were willing to participate in the study and agreed to come for

the follow-up visits and sign in the informed consent were included.

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31

• Presenting with a medical history that would not complicate the outcome of

the result.

• Had low to moderate caries rate, normal periodontal status with good home

care and possess an uncompromised dentition.

• Single rooted permanent teeth requiring endodontic treatment which were

indicated for single visit root canal therapy.

EXCLUSION CRITERIA:

• Individuals who were unwilling to come for follow up visits.

• Individuals with a chronic disease with oral manifestations.

• Individuals who exhibited gross oral pathology, poor oral hygiene or poor

dental health.

• Individuals with gross dental caries or periodontal status that would

compromise the result, or subjects with an allergy to any material that was

used in the study.

• Multi rooted teeth.

• Patients who were on analgesics or antibiotics.

• Individuals with TMJ disorders.

• Painful non vital teeth or asymptomatic teeth with apical lesion.

• Teeth with limited accessibility or procedural difficulties.

• Acute alveolar abscess.

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MATERIALS:

1. Assessment : Exploring instruments

i. Radiographs

ii. Electric pulp tester (Parkell )

2. Rubber dam

3. Access cavity preparation burs (Endo Z bur , Endo access bur, no. 2 or 4 round

bur )

4. Airotor hand-piece (NSK)

5. Micromotor hand-piece (NSK)

6. 3% Sodium Hypochlorite (Vensons India)

7. 17% EDTA (Premier dental)

8. GG Drill (Mani)

9. K Files (Mani)

10. HERO Shaper Hand Files (Micro Mega)

11. Protaper Rotary Files (Denstply)

12. Absorbent paper points (Denstply)

13. Gutta Percha cones (Dentsply)

14. Grossman’s Sealer (DPI)

15. Electronic apex locator (Dentsply)

16. X-Smart (Dentsply)

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METHODOLOGY:

After the primary clinical assessment, 42 permanent single-rooted teeth requiring

endodontic treatment were selected for the study.

The teeth were allocated into three groups of 14 teeth each. Pre-operative VAS score was

recorded for baseline data.

Prior to isolation with a rubber dam, appropriate nerve block was administered. After

complete caries removal was performed, access cavity was prepared using Endo access,

Endo Z or no. 2 or 4 round bur. Coronal pre-flaring was done using GG drill #2 to #4.

An initial K file #10 or #15 was used to check patency of canal. Working length was

recorded using the Ingle’s technique and confirmed by electronic apex locator. This was

followed by canal instrumentation using three different instrumentation techniques,

irrigated with 3% sodium hypochlorite and 17% EDTA with side vented needle.

GROUP 1 (n=14)

The teeth were cleaned and shaped using step-back technique with k files.

Traditional instrumentation technique was performed using watch winding motion with

circumferential filing.

GROUP 2 (n=14)

The teeth under this group were cleaned and shaped using crown down technique with

Protaper rotary files according to the manufacturer’s instructions.

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GROUP 3 (n=14)

The teeth under this group were cleaned and shaped using crown down technique with

HERO Shaper hand files but a MIMERACI instrumentation technique was performed.

The basic idea was to progress slowly (by 1 mm advancement) and after each 1mm to

remove the instrument from the canal, clean the flutes with a sponge and irrigate

copiously. This technique was repeated until it reached working length.

All canals were cleaned, shaped and obturated in a single visit using the cold lateral

compaction technique.

The assessment of post-operative pain was done 3 days after the single visit root canal

therapy using the Visual analogue scale.

1. NO pain (0) – patients don’t have any pain

2. MILD pain (1-3) – pain recognisable but not discomforting

3. MODERATE pain (4-6) - discomforting but bearable pain

4. SEVERE pain (7-9) - difficult to bear pain ( required analgesics )

5. WORST pain (10) – worst pain imaginable

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Sample size estimation

35

SAMPLE SIZE ESTIMATION

Analysis: A priori: Compute required sample size

Input: Effect size f = 0.50

α err prob = 0.05

Power (1-β err prob) = 0.80

Number of groups = 3

Output: Noncentrality parameter λ = 10.5000000

Critical F = 3.2380961

Numerator df = 2

Denominator df = 39

Total sample size = 42

Actual power = 0.8034136

The sample size has been estimated using the GPower software v. 3.1.9.2

Considering the effect size to be measured (f) at 50%, power of the study at 80% and the

margin of the error at 5%, the total sample size needed is 42. Each group will consist

of 14 samples. [14 x 3 groups = 42 samples].

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POWER ANALYSIS CURVE

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Results

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Results

Statistical Analysis:

Statistical Package for Social Sciences [SPSS] for Windows was used to perform

statistical analyses.

Descriptive Statistics:

Descriptive analysis includes expression of VAS scores in Mean & SD in each study

group.

Inferential Statistics:

Kruskal Wallis test followed by Mann Whitney Post hoc test was used to compare the

mean VAS scores between 03 groups at different time intervals.

Wilcoxon Signed Rank test was used to compare the mean VAS scores between pre and

post treatment period in each study group.

The level of significance [P-Value] was set at P<0.05

Table no. 1 Comparison of mean VAS scores between 03 groups during Pre-treatment

time period using Kruskal Wallis Test

Groups N Mean SD Min Max P-Value

Group 1 14 2.21 2.46 0 7

0.83 Group 2 14 2.43 2.50 0 7

Group 3 14 2.71 2.56 0 8

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The test results demonstrate the mean VAS scores between 03 study groups during pre-

treatment period, in table no. 1.

The mean VAS score in Group 1 was 2.21 ± 2.46, Group 2 was 2.43 ± 2.50 and Group 3

was 2.71 ± 2.56. The mean difference between 03 study groups during pre-treatment

period was not statistically significant [P=0.83] [Refer Table no. 1 & Fig. no. 1]

Table no. 2 Comparison of mean VAS scores between 03 groups during Post treatment

time period using Kruskal Wallis Test

Groups N Mean SD Min Max P-Value

Group 1 14 3.29 1.54 0 5

<0.001* Group 2 14 1.21 1.25 0 4

Group 3 14 0.64 1.01 0 3

* - Statistically Significant

The test results demonstrate the mean VAS scores between 03 study groups during post

treatment period, in table no. 2.

The mean VAS score in Group 1 was 3.29 ± 1.54, Group 2 was 1.21 ± 1.25 and Group 3

was 0.64 ± 1.01. The mean difference between 03 study groups during post-treatment

period was statistically significant [P<0.001] [Refer Table no. 2 & Fig. no. 2]

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Table no. 3 Multiple comparison of mean VAS scores between different groups using

Mann Whitney Post hoc Test

(I) Group (J) Group Mean Diff. (I-J)

95% CI for the Diff.

P-Value Lower Upper

Group 1 Group 2 2.07 0.89 3.25 0.001*

Group 3 2.64 1.46 3.83 <0.001*

Group 2 Group 3 0.57 -0.61 1.75 0.21

* - Statistically Significant

Multiple comparison of mean difference in VAS scores between groups is presented in

table no. 3.

The mean VAS score of Group 1 was significantly higher as compared to Group 2 &

Group 3 at P=0.001 & P<0.001 respectively. However, the mean VAS score between

Group 2 & Group 3 was not statistically significant [P=0.21].

In conclusion, Group 1 showed significantly highest VAS score, followed by Group 2

and the least has been observed in Group 3. [Refer Table no. 3]

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Table no. 4 Comparison of mean VAS scores between Pre and Post treatment period in

each study group using Wilcoxon Signed Rank Test

Group Time N Mean SD Mean Diff P-Value

Group 1 Pre 14 2.21 2.46

-1.08 0.09

Post 14 3.29 1.54

Group 2 Pre 14 2.43 2.50

1.22 0.03*

Post 14 1.21 1.25

Group 3 Pre 14 2.71 2.56

2.07 0.005*

Post 14 0.64 1.01

* - Statistically Significant

The test results demonstrate the comparison of mean VAS scores between Pre and post

treatment period in each group in table no. 4.

The mean VAS score in Group 3 and Group 2 was significantly reduced in Post treatment

period as compared to pre-treatment period at P=0.005 & P=0.03 respectively.

Contrastingly, the mean VAS score in Group 1 relatively increased in Post treatment

period as compared to pre-treatment period. However, this mean difference in VAS score

between pre and post treatment periods in Group 1 was not statistically significant at

P=0.09.

[Refer Table no. 4 & Fig. no. 3]

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Discussion

41

The anticipation of pain during and following treatment procedure is one of the principle

reasons for dental apprehension.24

The reported incidence of post-operative pain ranges

from 3% to as high as 50% of patients. It is also regarded as a significant factor for

missed or delayed dental appointments. Hence, as endodontists, our goal should be to

control this frequently occurring complication and prevent its further exacerbation.57

The probable etiological factors for post-operative pain can be subdivided into three

major areas 1) operator-controlled treatment procedures 2) microbial factors and 3) host

factors such as age, gender, tooth type, immunological and psychological aspects of the

treatment.39

The rate of post-operative pain has been correlated with the following

variables: presence of pre-operative signs and symptoms, inadequate instrumentation,

level of the root filling, traumatic occlusion, missed canals, presence of periapical

pathosis, operator skill, type of treatment (conventional or rotary), pulp/periapical status,

extrusion of apical debris, extrusion of intracanal medicaments and irrigating solutions.58

Evidence shows that pushing infected debris beyond the apex during chemo-mechanical

instrumentation is the most significant cause for periapical inflammation and post-

operative pain.58

During the occurrence of such an event, the balance between the

microbial challenge and host defense is disrupted and an acute reaction ensues to re-

establish the equilibrium.24

Apical extrusion of debris, also referred to as “worm of necrotic debris”, is an inevitable

event that occurs during the instrumentation of the root canal system, no matter how

much caution is given to confine the preparation within the apical terminus.59

Extrusion

of debris is determined by several factors such as irrigation protocol, final preparation

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Discussion

42

size, design and size of instrument, time spent on the instrumentation and the technique

employed for it.39

A systematic review and meta-analysis carried out by Caviedes and

Bucheli stated that it is not the number of files that govern the inflammatory reaction due

to apical extrusion of debris but it is the type of movement and the instrument design

used to prepare the root canal system.59

Therefore, post-operative pain or Flare-up can be

prevented to a large extent by selection of an appropriate instrumentation technique that

extrudes less amount of debris apically.

The objective of this study was to evaluate the performance of a new instrumentation

technique (HERO Shaper hand files with MIMERACI) on the incidence of post-operative

pain and compare its efficacy with conventional hand (K-files) and rotary (Protaper)

instrumentation systems.

Chemo-mechanical preparation of the root canal system through a combination of

mechanical instrumentation and antibacterial irrigation is recognised to be the most

important phase in endodontic therapy.2 It involves the elimination of vital and necrotic

tissues along with infected root dentin and facilitates disinfection by irrigants and

medicaments.3

K-files are stainless steel hand files which were manufactured for the first time by Kerr

Company in 1904. They are resistant to corrosion and offer superior cutting efficiency.

They have a square cross-section and are designed to give smooth tactile sensation during

instrumentation. Nevertheless, Weine et al stated that instrumentation with stainless steel

files can produce undesirable results, especially in narrow and curved canals. Procedural

errors such as transportation of canal, zipping, stripping or ledge, the inherent

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Discussion

43

inflexibility of stainless steel instruments and longer duration of treatment have resulted

in a search for new materials from which to fabricate endodontic instruments.60

During the last few years, root canal preparation using Ni-Ti instruments has been the

norm. Compared with their stainless steel counterpart, Nitinol files exhibit superior

flexibility and greater resistance to torsional fracture.19

These materials have the capacity

to recover from deformation of up to 10% in comparison to a maximum of 1% in

conventional steel alloys. They maintain the original shape and curvature with reduced

likelihood of procedural errors. Also, there is significant reduction in the time required

for biomechanical preparation contributing to operator and patient comfort. Recent

advances in instrument design include non-cutting tip, varying cross-sections and taper

and radial lands to better working safety, greater flare of preparation and shorter working

time.3

The Protaper rotary system has a convex triangular cross-sectional design with non-

cutting tip design and a progressively increasing taper from tip to coronal in the shaping

files whereas the finishing files have a decreasing taper. The shaping files have increased

flexibility in the middle and top part while the finishing files are stiffer and have a larger

taper at the apical part. These features intend to enhance its cutting efficiency and

consequently reduce contact areas and torsional load.61

However, there exists a concern regarding the increased susceptibility of the instruments

to fracture and a lack of tactile feedback.19

This has led to the development of hand

operative version of some Ni-Ti rotary instruments. One such example is the HERO

shaper files that supplement the existing HERO 642 system, a second-generation Ni-Ti

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Discussion

44

instrument system. Hero-shaper has a constant taper with a positive rake angle that may

have a better cutting efficiency and a superior cleaning ability relative to those with

negative rake angle. There is an increase in the helix angle from the tip to the shank

which claims to reduce instrument binding on the root canal wall. There is a reported

increase in efficiency, flexibility and strength since the pitch varies according to the

taper. The reduced length of the cutting portion allows better working ability in the

posterior region.62

Therefore, in our study, post-operative pain on instrumentation with these three groups

was assessed: HERO Shaper manual files, Protaper rotary files and stainless steel K-files.

Single rooted permanent mandibular premolars requiring endodontic therapy were

included in the study for standardization purposes. The patients were randomly divided

into three respective groups. Baseline pre-operative VAS score was recorded from each

patient since several studies have published that the presence of preoperative pain can

significantly affect the probability and intensity of postoperative pain.24

Visual analogue

scale was used to assess both the pre-operative and post-operative pain values. The VAS

is a simple and widely used tool to assess subjective phenomenon. It results in higher

response rate since it is easily comprehended by patients. It was popularized for pain

measurement by Huskisson. It only takes a minute to complete. For this study, it was

presented as a 10cm horizontal line with numbers on it where the patient was asked to

mark a point on the line depending on the severity of the pain felt by them. It provided a

quantitative variable that could be used for statistical analysis.63

Root canal treatment was performed under a rubber dam in a single visit. Although, there

have been contradictory opinions on single-visit verses multi-visit endodontics; however

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Discussion

45

more recent reports demonstrate that patients generally tolerate and request single-visit

endodontic therapy. Therefore, patient’s expectations for treatment have made single-

visit root therapy popular among dental practitioner. They offer several advantages,

reduced flare-up rate, lesser number of appointment, more economical, and no risk of

leakage between appointments. However, it has a potential for post-operative pain and

healing may be compromised since bacterial eradication cannot be maximized through

use of intracanal medicaments. In this study root canal treatment was done in a single-

visit to assess the VAS score at the third day.57

In the present study, among the three instrumentation systems used; the maximum mean

VAS score was recorded with group1 (stainless steel K-files used in a step-back

approach) while the lowest values were demonstrated with group 3 (HERO Shaper files

used in a crown-down approach with MIMERACI technique). The mean difference

between 03 study groups during post-treatment period was statistically significant

[P<0.001]. The difference in the mean VAS score was found to be statistically significant

between group1 and group 2 (p<0.001) and group 3 and group 1 (p<0.001). However, the

mean VAS score between Group 2 & Group 3 was not statistically significant [P=0.21].

In conclusion, Group 1 showed significantly highest VAS score, followed by Group 2

and the least has been observed in Group 3, which is in accordance with a study done by

Alper Kustarci et al wherein the step-back technique extruded higher debris as compared

to the NiTi instruments.3

Group 1 (K-files used in a step-back approach) recorded the highest pain values post-

operatively and the mean VAS score in Group 1 relatively increased in Post treatment

period as compared to pre-treatment period. This may be due to the fact that step back

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Discussion

46

technique involves push-pull motion in an apical-coronal direction which tends to push

debris apically. The k file acts like a piston that forces debris ahead of the file. As it does

not incorporate cervical pre-flaring, less space is available to remove the debris

coronally.16

Seltzer et al. stated that dentin debris in the periradicular area was associated

with persistent inflammation and post-operative pain.66

Additionally, manual stainless

steel files are associated with an increased probability of procedural errors due to its

inherent inflexibility and longer duration is taken to instrument the canals. This leads to

dwindling success of periapical healing. The results are in lieu with a study conducted by

Ahmad Mustafa et al, wherein the patients who underwent root canal treatment using

conventional step-back technique and hand files reported a significantly higher incidence

of postoperative pain after 2 days compared to ProTaper system in both one- and multiple

visits.57

The reasoning for the better performance of group 2; Protaper rotary instrument relative

to group 1 and the significant reduction in mean VAS score in Group 2 in Post-treatment

period as compared to pre-treatment period (at P=0.03), may be attributed to the

difference in design of the instrument and the crown-down approach. A lack of radial

land and limited contact with the apical area causes a decreased extrusion of debris. It

features a progressively tapered design that ensures decreased rotational friction between

the blade of the files and dentin. The continuous rotation in a rotary Protaper instrument

may improve coronal transportation of debris. Moreover, the use of more flexible NiTi

instruments in a sequential manner can be an important determinant in lower incidence

and intensity of post-operative pain since it ensures a more centered preparation with

lesser incidence of canal aberrations.22, 59

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Discussion

47

Crown-down technique was first described by Goerig et al, which principally instruments

the canal in a coronal-apical direction. The coronal access accomplishes a straight-line

path through the crown to the canal orifices followed by the radicular preparation before

the apical part of the canal is instrumented. This allows for straighter access to the apical

part and better penetration of irrigating solutions. Moreover, it promptly eliminates

dentinal interferences in coronal two-thirds allowing for more efficient instrumentation.

In the process, the bulk of the pulp tissue and debris are removed, greatly reducing the

chance of extrusion of infected material during apical instrumentation that could cause

periapical inflammation.64

Pre-flaring of the cervical part of the preparation may improve

control of instrument for preparation of the apical third of the canal, and the continuous

rotation accounts for coronal transportation of debris, avoiding its compactation in the

root canal.59

Group 3 recorded the lowest pain values probably due to the inclusion of MIMERACI

technique. This is probably due to; a more efficient protocol of irrigation with better

mechanical removal of debris and minimal engagement of the file and consequently the

production of debris. All the factors combined will result in lesser risk of pushing debris

beyond the apical foramen, thus achieving a more efficient debridement of the canals.

The MIMERACI technique focuses on minimal (1mm) advancement inside the canal.

This not only aids in predictable engagement but also minimizes mechanical stress on the

instrument. After each 1 mm engagement, the file is withdrawn and cleaned with a

sponge outside the canal. This helps in more predictable and effective removal of the

debris entrapped within the flutes of the file. It is accompanied with copious amount of

irrigation which dissolves and flushes out any residual debris left inside the root canal

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Discussion

48

system before the instrument reaches the apex. This is a single step procedure which is

performed until the file reached the working length.6

Within the limitations of this study it can be concluded that the type of instrumentation

technique can significantly affect the probability and intensity of post-operative pain.

Results state that expectations of postoperative pain from using the stainless steel hand

(K type) files were higher relative to Nickel-Titanium files (p<0.001). The present study

also showed that MIMERACI technique in conjunction with HERO Shaper hand files

significantly reduced post-operative pain. Whereas, Protaper rotary system was effective

in reducing the intensity of pre-operative pain values. These clinical findings should also

be correlated with further in-vitro studies aimed at showing the quantity of debris

production following different instrumentation techniques.

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Conclusion

49

Within the limitations of this study, it can be concluded that:-

The type of instrumentation technique can significantly affect the probability and

intensity of post-operative pain.

The expectations of postoperative pain from using the stainless steel hand (K

type) files was higher relative to Nickel-Titanium files

The present study also showed that MIMERACI technique in conjunction with

HERO Shaper hand files significantly reduced post-operative pain.

Protaper rotary system was effective in reducing the intensity of pre-operative

pain values.

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Summary

50

The anticipation of pain during and following treatment procedure is one of the principle

reasons for dental apprehension. Evidence shows that pushing infected debris beyond the

apex during chemo-mechanical instrumentation is the most significant cause for

periapical inflammation and post-operative pain. Apical extrusion of debris is an

inevitable event that occurs during the instrumentation of the root canal system, no matter

how much caution is given to confine the preparation within the apical terminus.

Extrusion of debris is determined by several factors such as, irrigation protocol, final

preparation size, design and size of instrument, time spent on the instrumentation and the

technique employed for it. Therefore, post-operative pain or Flare-up can be prevented to

a large extent by selection of an appropriate instrumentation technique that extrudes less

amount of debris apically.

This in-vivo study was done to evaluate the performance of a new instrumentation

technique (HERO Shaper hand files with MIMERACI) on the incidence of post-operative

pain and compare its efficacy with conventional hand (K-files) and rotary (Protaper)

instrumentation systems.

42 permanent single rooted teeth requiring endodontic treatment were selected for the

study. Baseline pre-operative VAS score were recorded from each patient. The teeth were

allocated into three groups of 14 teeth each according to the instrumentation technique

used. Group 1: was instrumented with K-files using the step-back technique, group 2:

was instrumented with the Protaper rotary system using the crown-down technique and

group 3: was instrumented with HERO Shaper files using the MIMERACI technique. All

canals were cleaned, shaped and obturated in a single visit using the cold lateral

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Summary

51

compaction technique. The assessment of post-operative pain was done 3 days after the

single visit root canal therapy using the Visual analogue scale.

Kruskal Wallis test followed by Mann Whitney Post hoc test was used to compare the

mean VAS scores between 03 groups at different time intervals. Wilcoxon Signed Rank

test was used to compare the mean VAS scores between pre and post treatment period in

each study group. The level of significance [P-Value] was set at P<0.05

The results showed, among the three instrumentation systems used; the maximum mean

VAS score was recorded with group1 (stainless steel K-files used in a step-back

approach) while the lowest values were demonstrated with group 3 (HERO Shaper files

used in a crown-down approach with MIMERACI technique). The mean difference

between 03 study groups during post-treatment period was statistically significant

[P<0.001].

It was concluded that the type of instrumentation technique can significantly affect the

probability and intensity of post-operative pain. Results state that expectations of

postoperative pain from using the stainless steel hand (K type) files was higher relative to

Nickel-Titanium files (p<0.001). The present study also showed that MIMERACI

technique in conjunction with HERO Shaper hand files significantly reduced post-

operative pain. Whereas, Protaper rotary system was effective in reducing the intensity of

pre-operative pain values.

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Consent form

62

INFORMED CONSENT

Why do this study?

A new Clinical motion has been introduced which claims to have reduced post-operative

pain values. We are interested in clinically comparing the new canal instrumentation

technique MIMERACI with the traditional technique. We need to collect data from

people in terms of post-operative pain after 3 days and compare the two.

What will participation involve?

This research involves clinically comparing the instrumentation techniques during routine

endodontic therapy.

How long will participation take?

A single visit root canal treatment will performed which will last for about 1 hr. 15 mins.

The follow up will be done after three days which lasts for about 20mins each for the

assessment.

As an informed participant of this experiment, I understand that:

My participation is voluntary and I may cease to take part in this experiment at any time,

without penalty.

I am aware of what my participation involves.

There are no risks involved in the participation of this study.

All my questions about the study have been satisfactorily answered.

I have read and understood the above, and give consent to participate:

Participant’s signature: Date:

I have explained the above and answered all the questions asked by the patient:

Researcher’s signature: Date:

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Proforma

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Case History Sheet

DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS

D A P M R.V DENTAL COLLEGE & HOSPITAL, 24 TH MAIN, J.P NAGAR,

BANGALORE

THESIS- CASE SHEET

NAME: SL.No:

AGE/SEX: DATE:

ADDRESS:

TEL No:

OCCUPATION:

CHIEF COMPLAINT:

SYMPTOMS:

CHRONOLOGY: INCEPTION (SINCE) CONSTANT/ INTERMITTENT

LOCATION: LOCALIZED/ DIFFUSED/ REFERRED/ RADIATING

QUALITY: SHARP/ DULL/ PULSATING/ THROBBING/ STEADY/ ANY OTHER

INTENSITY: SPONTANEOUS/ PROVOKED/ REPRODUCIBLE

AFFECTED BY:

HOT/ COLD/ BITING/ CHEWING/ PALPATION/ PERCUSSION/ HEAD POSITION/

TIME OF THE DAY

PRIOR TREATMENT:

RESTORATIVE/ EMERGENCY ROOT CANAL TREATMENT

MEDICAL HISTORY:

HYPERTENSION / RHEUMATIC FEVER/ ANGINA/ PROSTHETIC VALVE/ ANY

SURGERIES/ JAUNDICE/ DIGESTIVE DISORDERS/ FAINTING TENDENCIES/

INFECTIOUS DISEASES/ DIABETES/ ASTHMA/ EPILEPSY/ BLEEDING

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DISORDERS/ RESPIRATORY DISORDERS/ HIV/ AIDS/ TB/ SYPHILIS/ LEPROSY/

GASTRITIS.

ALLERGIES:

DRUGS/ L.A/ SULFA DRUGS/ ANTIBIOTICS/ ASPIRIN/ PATACETEMOL/

IBUPROFEN/ PENICILLIN/ ALGINATE/ EUGENOL/ LATEX/ MERCURY/

METALS: Ni-Cr, Co-Cr.

OTHER DETAILS:

RECENT HOSPITILIZATION/ CURRENT MEDIATION, IF ANY/ PREGNANCY

EXAMINATION:

CLINICAL/ RADIOGRAPHIC

TOOTH:

WNL/ CARIES/ CALCIFICATION/ RESORPTION/ FRACTURE/ PERFORATION/

PRIOR RCT/ SEPARATED INSTRUMENT/ CANAL OBSTRUCTION/ WIDE OPEN

APEX/ PRIOR ACCESS/ RESTORATION

SOFT TISSUE:

WNL/ INTRA ORAL SWELLING/ EXTRA ORAL SWELLING/ SINUS TRACT/

DISCHARGE/ LYMPHADENOPATHY

PERIODONTAL:

WNL/ PDL THICKENING/ APICAL/ LATERAL/ HYPERCEMENTOSIS/

PERIODONTAL POCKET/ GINGIVAL RECESSION/ GINGIVITIS/ ACUTE/

CHRONIC/ PLAQUE

CLINICAL TEST:

PERIODONTIUM/ WNL/ MOBILITY

REACTIONS/ RESULTS:

PALPATION:

PERCUSSION:

HOT TEST:

COLD TEST:

EPT:

TRANSILLUMINATION:

TEST CAVITY:

ANESTHETIC TEST:

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DIAGNOSIS:

PULPAL:

WNL/ REVERSIBLE PULPITIS/ IRREVERSIBLE PULPITIS/ NECROSIS/ NON-

VITAL/ CALCIFIED/ HYPERPLASTIC PULPITIS

PERIPAICAL:

WNL/ ACUTE APICAL PERIODONTITIS/ ACUTE APICAL ABSCESS/ CHRONIC

APICAL ABSCESS/ PHOENIX ABSCESS/ PERIAPICAL GRANULOMA/

PERIPICAL CYST/ OTHERS

PROGNOSIS:

FAVOURABLE/ QUESTIONABLE/ POOR/ UNFAVOURABLE/ HOPELESS

TREATMENT PLAN:

RCT/ SURGERY/ BLEACHING/ INTERMEDIARY RESTORATION/

ORTHODONTIC TREATMENT/ PERIODONTAL TRETAMENT

FINAL RESTORATION:

POST & CORE/ CERAMIC CROWN/ GOLD CROWN/ AMALGAM/ COMPOSITE

BUILDUP/ ONLAY/ OTHERS

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CONSENT FORM FOR RESTORATIVE PROCEDURES AND ENDODONTIC

TREATMENT

NAME: DATE:

AGE: TEL. NO. :

ADDRESS: O.P. NO:

I,...................................................................................the undersigned give consent for the

Restorative or Endodontic procedure which has been explained to me by Dr. Simran

Bajwa. I acknowledge that I have answered all the questions about my health and

revealed details of systemic health, allergies, medication, previous treatment etc. and I

will not hold my dentist or any member of staff/student responsible for any error of

omissions that I have made during clinical examination.

It has been explained to me that there are certain inherit and potential risks in any

treatment procedure and I understand that a perfect result is not guaranteed or warranted

and cannot be guaranteed or warranted.

The doctor has explained to me in detail the medication and the postoperative

complications which may arise due to the operative procedure or anesthesia and also that

the response may vary from patient to patient.

I give my consent that in the event of any unforeseen complications, I may be shifted to

any hospital for further treatment and I will not hold the dental student and staff

responsible for any damages, liabilities and expenses that will be incurred. I understand

that the doctors, hospital staff and students are acting in good faith and intentions. I also

understand that the students of this institution will be working under the direct

supervision of the faculty members of the department. I give my consent for the use of

approved and standardized materials for conservative and restorative procedures. I also

give my consent for filming, video graphing of the operative procedures for the purpose

of medical education, records, periodic records and articles.

Patient’s signature Staff signature Attendant’s signature

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VISUAL ANALOGUE SCALE

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Serial

Number

Group

Pre-operative VAS

score

Post-operative VAS

score

1. Group 1

2. Group 1

3. Group 1

4. Group 1

5. Group 1

6. Group 1

7. Group 1

8. Group 1

9. Group 1

10. Group 1

11. Group 1

12. Group 1

13. Group 1

14. Group 1

15. Group 2

16. Group 2

17. Group 2

18. Group 2

19. Group 2

20. Group 2

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21. Group 2

22. Group 2

23. Group 2

24. Group 2

25. Group 2

26. Group 2

27. Group 2

28. Group 2

29. Group 3

30. Group 3

31. Group 3

32. Group 3

33. Group 3

34. Group 3

35. Group 3

36. Group 3

37. Group 3

38. Group 3

39. Group 3

40. Group 3

41. Group 3

42. Group 3

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Comparison of mean VAS scores between 03 groups during Post treatment time period using

Kruskal Wallis Test

Groups N Mean SD Min Max P-Value

Group 1 14

Group 2 14

Group 3 14

Comparison of mean VAS scores between 03 groups during Pre-treatment time period using

Kruskal Wallis Test

Groups N Mean SD Min Max P-Value

Group 1 14

Group 2 14

Group 3 14

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Multiple comparison of mean VAS scores between different groups using Mann Whitney

Post hoc Test

(I) Group (J) Group Mean Diff. (I-J)

95% CI for the Diff.

P-Value Lower Upper

Group 1 Group 2

Group 3

Group 2 Group 3

Comparison of mean VAS scores between Pre and Post treatment period in each study group

using Wilcoxon Signed Rank Test

Group Time N Mean SD Mean Diff P-Value

Group 1 Pre 14

Post 14

Group 2 Pre 14

Post 14

Group 3 Pre 14

Post 14

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Annexure

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List of figures

Figure 1: Diagnostic Instruments

Figure 2: Irrigants

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Annexure

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Figure 3: Electronic Pulp Tester

Figure 4: Electronic Apex Locator

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Figure 5: Rubber Dam Kit

Figure 6: Endomotor

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Figure 7: K-Files, Hero-Shaper and Protaper Rotary Files

GG Drill and Peeso Drill

Gutta percha points and Paper Points

Access cavity preparation burs

Figure 8: Airotor and Micromotor Handpiece

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Annexure

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Figure 9: Sealer and Glass Slab

Figure 10: Working Length Determination

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Figure 12: Cleaning And Shaping With Hero

Shaper Files

Figure 11: Cleaning And Shaping With

Stainless Steel K Files

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Figure 13: Cleaning And Shaping With

Protaper Rotary Files

Figure 14: Master Cone

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Figure 15: Radiograph of Root Canal Treatment Done Using

Stainless Steel Hand Files

Figure 16: Radiograph of Root Canal Treatment Done Using

Stainless Steel Hand Files

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Figure 17: Radiograph of Root Canal Treatment Done Using

Protaper Rotary Files

Figure 18: Radiograph of Root Canal Treatment Done

Using Hero Shaper Files

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0

0.5

1

1.5

2

2.5

3

Group 1 Group 2 Group 3

2.21

2.43

2.71

Mea

n V

AS

Sco

res

Fig. no. 1 Mean VAS scores between 03 groups during Pre treatment time period

0.00

0.50

1.00

1.50

2.00

2.50

3.00

3.50

Group 1 Group 2 Group 3

3.29

1.21

0.64

Mea

n V

AS

Sco

res

Fig. no. 2 Mean VAS scores between 03 groups during Post treatment time period

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Annexure

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0.00

0.50

1.00

1.50

2.00

2.50

3.00

3.50

Group 1 Group 2 Group 3

2.21 2.43

2.71

3.29

1.21

0.64

Mea

n V

AS

Sco

res

Fig no. 3 Mean VAS scores between Pre and Post treatment period in each study group

Pre Rx Post Rx