Rajiv Gandhi University of Health Sciences, Bangalore

Karnataka

M.D.S Conservative Dentistry and Endodontics

Synopsis for Registration of Dissertation

MARATHA MANDAL’S
NATHAJIRAO G. HALGEKAR INSTITUTE
OF DENTAL SCIENCES & RESEARCH CENTRE
BAUXITE ROAD, BELGAUM

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE,

KARNATAKA
 ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. NAME OF CANDIDATE AND DR RANMALE ROOPALI

ADDRESS
SAVANT COLONY, AKOL ROAD,

FIRST LANE, NEAR SAI MANDIR

NIPANI- 591237

2. NAME OF THE INSTITUTION MARATHA MANDAL’S NATHAJIRAO G.

HALGEKAR INSTITUTE OF DENTAL SCIENCES &

RESEARCH CENTRE, BELAGAVI.

3. COURSE OF STUDY AND MASTER OF DENTAL SURGERY IN

SUBJECT
CONSERVATIVE DENTISTRY & ENDODONTICS.

4. DATE OF ADMISSION TO 29/10/2022

COURSE

5. TITLE OF TOPIC COMPARATIVE EVALUATION OF THE

FRACTURE RESISTANCE OF ENDODONTICALLY

TREATED TEETH, OBTURATED WITH

DIFFERENT ROOT CANAL SEALERS WITH AND

WITHOUT SMEAR LAYER REMOVAL: AN

INVITRO STUDY.
6. BRIEF RESUME OF INTENDED WORK:
6.1 NEED FOR THE STUDY:
An endodontically treated tooth is weaker and more prone to fracture than vital tooth.
Strength of an endodontically treated tooth is directly related to the amount of remaining sound
tooth structure and dentin1. There are several other factors that affect the endodontic therapy and
make the tooth susceptible to root fracture like overzealous instrumentation, dehydration of
dentin, uncontrolled pressure during obturation, trauma to the tooth. All these factors
cumulatively influence the tooth loading and ultimately increasing the possibility of catastrophic
factors.2
Furthermore, synergetic actions of intracanal medicaments and irrigants also influence
the physical and mechanical properties of root dentin.1
Success of an endodontic therapy depends on execution of all the steps beginning from
microbial control, cleaning, and shaping to effective sealing of the root canal system. The main
components of a root filling are a solid core material and a sealer. Gutta-percha occupies bulk of
the canal space while the root canal sealer fills the interface.3 Low elastic modulus of GP has
little effect in reinforcing roots after root canal treatment.1Hence the use of sealer with the
ability to bond to the root canal dentin surface will strengthen the tooth structure, thus
increasing resistance to fracture.2,4
Removal of smear layer allows for more cleaning and disinfecting root canal walls and
better adaptation of root canal filling materials. However, the presence of smear layer can also
act as a seal to the dentinal tubules and minimize the ability of bacteria and its toxins from
penetrating the dentinal tubules.4
The purpose of this study is to determine whether Nanoseal –S root canal sealer, DIA Root
bio sealer, Safe Endo Bioactive root canal sealers can reinforce the root and further to determine
whether pretreatment of the dentin in absence or presence the smear layer enhances any
reinforcing capability.

6.2 REVIEW OF LITERATURE:

Wadhwani and Gurung et al (2000) evaluated the fracture resistance of root canals filled with
Resilon and Epiphany (Pentron Clinical Technologies LLC, Wallingford), gutta-percha and AH
plus (Dentsply DeTrey, Konstanz, Germany), gutta-percha with Endomethasone sealer using
Instron Machine. They concluded that all materials significantly increased the fracture
toughness of the instrumented roots after obturation.5

Pecora et al (2001) 36 compared the effect of Er:YAG laser(KaVo Key laser II,
Warthausen, Germany at 2.25 W potency; 11 mm focal distance; 4 Hz frequency; 200mJ
energy; 62 J total ener gy; 313 mean impulse) application and EDTAC on the adhesion of epoxy
resin-based endodontic sealers -AH Plus(De Trey-Dentsply, Konstanz, Germany), Topseal
(Dentsply-Maillefer), Sealer 26 (Dentsply,Petrópolis, RJ, Brazil), AH 26 (Dentsply, Konstanz,
Germany), and Sealer Plus (Dentsply, Petrópolis, RJ, Brazil) to human dentin. The adhesion
was measured with a Universal testing machine. The results showed that the dentin treated with
Er:YAG laser showed an adhesion of 4 MPa for AH Plus to dentin than EDTAC.6

Hatibovic-Kofman et al (2008) 47 studied the effect of two endodontic materials; Calcium

hydroxide (Ultradent–UltraCal XS, South Jordan, UT, USA) and ProRoot MTA system
(Dentsply, Woodbridge, ON, Canada) on the fracture strength of root dentin after apexification
treatment for different length of time (2 weeks, 2 months, and 1 year) using Instron Universal
testing machine. They also histologically evaluated the degradation of dentin organic matrix at
different time period and concluded that MTA treated teeth after the initial decrease in fracture
strengths reverse the process, and the strength increased between 2 months and 1 year as MTA
induced the expression of TIMP-2 in the dentin matrix.7

Arora et al (2015) in an invitro study compared the fracture resistance of roots obturated
with three hydrophilic systems - novel CPoint system, Resilon/ Epiphany system, and
EndoSequence BC sealer; and one hydrophobic gold standard gutta-percha/AHPlus system
using universal testing machine. They concluded that hydrophilic systems showed higher
fracture resistance than hydrophobic systems; among the hydrophilic systems C Point system
and EndoSequence BC sealer had the highest fracture resistance.8

Tuncel, Nagas, Cehreli, Uyanik, Vallittu, and Lassila (2015) an in vitro study evaluated the
effect of 17%Ethylenediamine tetra acetic acid (EDTA) (Pulp dent Corporation, Watertown,
MA ), 9% etidronic acid (Zschimmer & Schwarz Mohsdorf GmbH & Co. KG, Burgstädt,
Germany), and 1% peracetic acid (PAA) (Sigma-Aldrich, Steinheim, Germany ) chelating
solutions on the bond strength of iRoot SP((Innovative BioCeramix Inc. Vancouver, Canada)
and a resin-based root canal sealer (AH Plus(Dentsply DeTrey GmbH, Konstanz, Germany) to
radicular dentin. The canal openings were sealed with Cavit™-G (3M ESPE, GmbH, Seefeld,
Germany) and the push out bond strength was tested by using Universal Testing machine. They
concluded that the tested chelating solutions do not improve the bond strength of AH Plus and
iRoot SP to the radicular dentin.9

Madhuri et al. (2016) compared the bond strength of four different endodontic sealers to
root dentin, that is, Bioceramic sealer (Endosequence Brasseler, Savannah, GA, USA), MTA-
based sealer (MTA Fill apex, Angelus, Londrina, Brazil) epoxy resin-based sealer (MM-Seal,
Micro Mega, France), and dual cure resin-based sealer (Hybrid Root Sealer, Mitsui Chemicals,
New Delhi, India) using universal testing machine at a speed of 0.5 mm/ min until deboning
occurred. They concluded that the push-out bond strength of Bioceramic sealer was highest
followed by resin-based sealer and lowest bond strength was observed in MTA-based sealer.10

Abeer Ahmed Saba et al (2019) compared the in vitro effect of three different root canal
sealers using with gutta-percha, on the fracture resistance of endodontically treated teeth. The
unprepared-unfilled group showed the highest mean fracture resistance followed by AH Plus
group, Bioroot RCS group, then the Endoseal MTA group. While the prepared-unfilled group
showed the least mean fracture resistance. There was no statistically significant difference
between all groups.It could be concluded that Bioroot RCS and Endoseal MTA are able to
reinforce the tooth against fracture as good as AH Plus.11

6.3 THE AIM OF THE STUDY:

To evaluate and compare the fracture resistance of mandibular premolar teeth, obturated with
gutta-percha using Nanoseal –S root canal sealer, DIA Root bio sealer, Safe Endo Bioactive root
 canal sealer, with and without smear layer removal.

6.4 OBJECTIVES OF THE STUDY:

1) To evaluate the fracture resistance of an endodontically treated tooth using Nanoseal-S
root canal sealer with and without smear layer removal.
2) To evaluate the fracture resistance of an endodontically treated tooth using DIA Root bio
sealer, with and without smear layer removal.
3) To evaluate the fracture resistance of an endodontically treated tooth using Safe Endo
Bioactive sealer with and without smear layer removal.
4) To compare fracture resistance of an endodontically treated tooth using Nanoseal-S root
canal, DIA Root bio sealer, Safe Endo Bioactive sealer with and without smear layer
removal.

7 MATERIALS AND METHODOLOGY

7.1 SOURCE OF DATA:
1) Type of study: An in-vitro study
2) Source: Extracted human teeth will be collected from the department of Oral and
Maxillofacial Surgery from Maratha Mandals Nathajirao.G. Halgekar Institute of dental
Science & Research Centre, Belagavi.
The study will be conducted in Department of Conservative Dentistry and Endodontics,
Maratha Mandals Nathajirao.G. Halgekar Institute of dental Science & Research Centre,
Belagavi.

7.2 METHOD OF COLLECTION OF DATA:

MATERIALS:
SAMPLES:
1) Freshly extracted mandibular premolars were stored in physiological normal saline
2) Sodium Hypochlorite 3% (Novo Dental Products PVT LTD, Mumbai)
3) Ethylene diamine tetra acetic acid - EDTA 17% (Orikam Healthcare India PVT Ltd.)
4) Saline (0.9% NS- 5OO ml, Claris Otsuka, Ahamedabad)
5) Nanoseal-S-Root canal sealer (Prevest Denpro)
6) Diadent DIA Root bio sealer. (Diadent).
7) Safe Endo Bioactive RCS (Safe Endo)
 8) ProTaper Gutta Percha cones – Size F3 (Dentsply Maillefer; Ballaigues, Switzerland)
9) Universal testing machine (100kN & 400kN Models, Department of Mechanical
Engineering, K.L.E Gogte Institute of Technology, Belgaum, Karnataka)
10) Diamond Saw
11) DPI-RR cold cure acrylic resin
12) Diamond Round Burs (Mani, Japan)
13) Size 10, 15 – K Files (Mani, Japan)
14) 5 ml Disposable syringe (Dispovan, Hindusthan Syringes and Medical Device
Faridabad, India)
15) ProTaper universal rotary files sizes - SX, S1, S2, F1, F2, F3 (Dentsply Maillefer)
16) X Smart EndoMotor (Dentsply Maillefer; Ballaigues, Switzerland)
17) ProTaper paper points
18)Lentulospirals
19) Contra-angled Micromotor Hand Piece (NSK, Japan)
20) Tweezers
21) Mixing pad, Spatula
22) Hand Pluggers
23) GP Condenser

Inclusion criteria:
 Intact human mandibular premolars with a single straight root canal
Exclusion criteria:
 Teeth with external/internal/apical root resorption
 Teeth with developmental defects
 Endodontically treated teeth
 Root canals with calcifications
 Severe root curvatures, cracks in root
 Open apices

SAMPLE SIZE ESTIMATION.

 Sample size was determined using the following formula:
n = Z α2 σ2
e2
  Where,
Z α = 1.96 (constant)
σ = pooled standard deviation
e = margin of error
n = Sample size
σ = 8.33
e = 4%
α error = 0.04
number of groups=5

Thus, on calculating, = (1.96)2 x (5.89)2 =8.32

(4)2

 Based on the above calculations, the sample size was fixed to 10 samples per 8 sub
group, thus the effective sample size is 80
 Null hypothesis: There is no difference between the different sealers used and the smear
layer removed on the fracture resistance of endodontically treated tooth.

M ETHODOLOGY:
Sample Selection
In this invitro study, 80 extracted mandibular premolars with single root canal will be selected.
Teeth will be mechanically cleaned to remove any calculus and soft tissue remnants and
preserved in normal saline. The teeth will be sectioned using diamond disk to obtain a
standardized root length of 13mm. Working length will be confirmed using 15 K file. The
canals will be instrumented with rotary files till F3 followed by hybrid instrumentation
technique. Throughout the instrumentation phase canals will be irrigated thoroughly with 5.25%
NaOCl and saline alternatively delivered through a 30-gauge side venting irrigating tip. Further,
the samples will be divided into 5 groups based on the sealers used.

Group I (Positive control)

10 samples will be selected and will be neither instrumented nor obturated.

Group II (negative control)

10 samples will be selected and instrumented using standardized technique but will not be
obturated.

Group III
In group III, 20 samples will be taken. Samples will be obturated using Nanoseal-S- Root canal
sealer with lateral condensation obturation technique. These groups will be further subdivided
into two groups (A and B) 10 samples each.
In subgroup A, instrumented canals will be irrigated with 30-gauge side venting irrigating tip
with 10 ml of 17% EDTA solution to apical 3mm of the root canal where the needle is binding
to the root canal.
The root canal will be agitated with master cone GP points in upward and downward motion to
aid in removal of smear layer. Followed by a final rinse with 10 ml of saline, canals will be
dried with paper points. Gutta percha master cone will be fit to working length with good tug-
back.
Sealer will be mixed according to manufactures instruction and the canals will be obturated
with lateral condensation by using Nanoseal-S-Root canal sealer.
In subgroup B after a final rinse of 10ml of 5.25% NaOCl, canals will be dried with paper points
and treated as in subgroup A. No EDTA will be used and smear layer will be left intact.

Group IV.
In group IV, 20 samples will be taken. Samples will be obturated using DIA Root Bio sealer
with lateral condensation obturation technique. These groups will be further subdivided into two
groups (A and B) 10 samples each.
In subgroup A, instrumented canals will be irrigated with 30-gauge side venting irrigating tip
with 10 ml of 17% EDTA solution to apical 3mm of the root canal where the needle is binding
to the root canal.
The root canal will be agitated with master cone GP points in upward and downward motion to
aid in removal of smear layer. Followed by a final rinse with 10 ml of saline, canals will be
dried with paper points. Gutta percha master cone will be fit to working length with good tug-
back.
Sealer will be mixed according to manufactures instruction and the canals will be obturated with
lateral condensation by using DIA Root Bio sealer.
In subgroup B after a final rinse of 10ml of 5.25% NaOCl, canals will be dried with paper points
and treated as in subgroup A. No EDTA will be used and smear layer will be left intact.
Group V
In group V, 20 samples will be taken. Samples will be obturated using Safe Endo Bioactive
sealer with lateral condensation obturation technique. These groups will be further subdivided
into two groups (A and B) 10 samples each.
In subgroup A, instrumented canals will be irrigated with 30-gauge side venting irrigating tip
with 10 ml of 17% EDTA solution to apical 3mm of the root canal where the needle is binding
to the root canal.
The root canal will be agitated with master cone GP points in upward and downward motion to
aid in removal of smear layer. Followed by a final rinse with 10 ml of saline, canals will be
dried with paper points. Gutta percha master cone will be fit to working length with good tug-
back.
Sealer will be mixed according to manufactures instruction and the canals will be obturated
with lateral condensation by using Safe Endo Bioactive root canal sealer.
In subgroup B after a final rinse of 10ml of 5.25% NaOCl, canals will be dried with paper points
and treated as in subgroup A. No EDTA will be used and smear layer will be left intact.
The specimens will be then placed in cotton moistened with sterile water to attain 100%
humidity and then shall be placed in an incubator at 37°C for 8 days.
Each tooth will be then mounted vertically into acrylic resin exposing only 2mm from the root
using a plastic ring as a mold for packing acrylic. Fracture resistance will be then tested using
universal testing machine. Force will be applied along the long axis of roots with the velocity of
1mm/min until fracture occurs. The force upon sample breaking will be recorded in Newton and
converted to Mpa.

STATISTICAL ANALYSIS:
 Data will be compiled on MS excel sheet.
 Statistical Package for Social Sciences [SPSS] for Windows Version 22.0 Released
2013. Armonk, NY: IBM Corp., will be used to perform statistical analyses.
  Descriptive statistics will be done and the results will be described as mean and
percentages.
  After applying normality test for data further One way ANOVA test will be done for
intergroup comparison followed by Turkey's post hoc test.
 Level of significance: p value < 0.05 will be considered significant.

7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO

BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS? IF, SO
PLEASE DESCRIBE BRIEFLY.
NO
7.4 HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTE IN
CASE OF 7.3?
YES

REFERENCES:
1) Mohammed YT, Al-Zaka IM. Fracture resistance of endodontically treated teeth
obturated with different root canal sealers (a comparative study). J Contemp Dent Pract.
2020 May 1;21(5):490-3.
2) Lertchirakarn V, Timyam A, Messer HH. Effects of root canal sealers on vertical root
 fracture resistance of endodontically treated teeth. Journal of Endodontics. 2002 Mar
1;28(3):217-9.
3) Singh H, Markan S, Kaur M, Gupta G, Singh H, Kaur MS. Endodontic sealers: Current
concepts and comparative analysis. Dent Open J. 2015;2(1):32-7.
4) Alamoudi RA. The smear layer in endodontic: To keep or remove–an updated overview.
Saudi Endodontic Journal. 2019 May 1;9(2):71.
5) Wadwani K, Gurung S. Evaluation of root canal sealers on the fracture resistance of root
canal treated teeth - An in vitro study. Endodontology. 2010(1):53–8.
6) Pécora JD, Cussioli AL, Guerişoli DM, Marchesan MA, Sousa-Neto MD, Brugnera
Júnior A. Evaluation of Er:YAG laser and EDTAC on dentin adhesion of six endodontic
sealers. Braz Dent J. 2001;12(1):27–30.
7) Hatibović-Kofman S, Raimundo L, Zheng L, Chong L, Friedman M, Andreasen JO.
Fracture resistance and histological findings of immature teeth treated with mineral
trioxide aggregate. Dent Traumatol. 2008 Jun;24(3):272–6
8) Hegde V, Arora S. Fracture resistance of roots obturated with novel hydrophilic
obturation systems. J Conserv Dent. 2015 Jun;18(3):261–4.
9) Tuncel B, Nagas E, Cehreli Z, Uyanik O, Vallittu P, Lassila L. Effect of endodontic
chelating solutions on the bond strength of endodontic sealers. Braz Oral Res. 2015;29.
10) Madhuri GV, Varri S, Bolla N, Mandava P, Akkala LS, Shaik J. Comparison of bond
strength of different endodontic sealers to root dentin: An in vitro push-out test. J
Conserv Dent. 2016;19(5):461–4.
11) Saba AA, ElAsfouri HA. Fracture resistance of endodontically treated teeth obturated
with different root canal sealers (in vitro study). Egyptian Dental Journal. 2019 Apr
1;65(2-April (Fixed Prosthodontics, Dental Materials, Conservative Dentistry &
Endodontics)):1567-75.

9. Signature of the candidate

10. Remarks of the Guide

Dr. Veerendra Uppin

11. 11.1) Name and Designation of the Guide Professor
 Department of Conservative Dentistry &
Endodontics
Maratha Mandals Nathajirao. G. Halgekar
Institute of Dental Sciences and Research
Centre, Belagavi

11.2) Signature

11.3) Head of the Department Dr. Madhu Pujar

Department of Conservative Dentistry &
Endodontics
Maratha Mandals Nathajirao. G. Halgekar
Institute of Dental Sciences and Research
Centre, Belagavi

11.4) Signature

12. 12.1) Remarks of the Principal

12.2) Signature