KLE VK INSTITUTE OF DENTAL SCIENCES,

KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH,

(KLE UNIVERSITY)
BELAGAVI

PROFORMA FOR REGISTRATION OF SUBJECT FOR MAIN

DISSERTATION
1. NAME OF THE CANDIDATE DR. RUCHA. N. DAVALBHAKTA
AND ADDRESS
DEPARTMENT OF PEDODONTICS AND
PREVENTIVE DENTISTRY,

KLE V. K. INSTITUTE OF DENTAL SCIENCES,

KLE ACADEMY OF HIGHER EDUCATION AND
RESEARCH, (KLE UNIVERSITY), NEHRU
NAGAR, BELAGAVI - 590010.

KLE V. K. INSTITUTE OF DENTAL SCIENCES,

2. NAME OF THE INSTITUTE
KLE ACADEMY OF HIGHER EDUCATION AND
RESEARCH, (KLE UNIVERSITY) NEHRU
NAGAR, BELAGAVI - 590010.

3. COURSE OF THE STUDY AND MASTER OF DENTAL SURGERY (M.D.S.) IN

SUBJECT. PEDODONTICS AND PREVENTIVE DENTISTRY

4. DATE OF ADMISSION TO THE

02 MAY, 2017
COURSE

5. TITLE COMPARATIVE EVALUATION OF ROOT ZX

MINI® APEX LOCATOR AND
RADIOVISIOGRAPHY IN DETERMINING THE
WORKING LENGTH OF PRIMARY MOLARS:
AN IN VIVO STUDY.
NEED FOR THE STUDY:

Endodontic treatment of primary teeth provides a mechanism to maintain the

teeth in the dentition until their normal exfoliation time. Most root canals

requiring pulpectomy are contaminated with bacteria and the working length

determination is a crucial step in pulp treatment to decrease the bacterial charge

and avoid periapical lesions and damage to the permanent tooth bud.1

Common techniques to determine working length are digital tactile sensation

and radiography. Radiovisiography is the universally accepted, available and

reliable method of working length assessment.2

However, a radiographic image provides only a two-dimensional image of three

dimensional structures, giving limited information about apical foramen and has

other disadvantages and limitations such as limited mouth opening of children,

poor patient co-operation, increasing appointment time and exposure to ionizing

radiations. Also, there might be distortion and sometimes position of the apical

constriction may not be detected. Recent technological advances have turned

digital radiography into a viable option for the determination of endodontic

working length. The reliability of digital radiography is seemingly comparable

to or even better than that of conventional radiography. 3 The accuracy of

radiovisiography was said to be 85.6% in a study conducted by Patino et. Al.

Electronic apex locators do not produce pain, help to reduce the treatment time,

and help avoid unnecessary radiation which makes it more superior in pediatric

endodontic procedures. Thus, they are recommended for endodontic treatment

in children. They are particularly useful when the apical portion of the canal is

obscured by certain anatomic structures, such as impacted teeth, tori, zygomatic

arch, excessive bone density, overlapping roots or shallow palatal vaults. Root

ZX mini® apex locator is a fourth-generation apex locator based on the ratio

method. It calculates impedance at two frequencies and quotient of the

impedance indicates the position of file in the canal. It has many advantages like

equal efficacy in wet/dry canal, shock resistance, auto-calibration, portable

design etc. In vitro studies conducted for working length determination in

permanent teeth showed that the accuracy was 99.6%.4

It was found that no in vivo studies were done in primary teeth with Root ZX

mini® apex locator. Few in vitro studies conducted in primary teeth on Root ZX

mini apex locator showed an accuracy of about 100%. 5, However, there is scarce

literature about working length determination in primary teeth in vivo.

Hence, the aim of this study is to evaluate and compare radiovisiography and

Root ZX mini® apex locator for determining working length in primary molars.
REVIEW OF LITERATURE:

1. An in vitro study was done to clinically evaluate the accuracy of

conventional radiography and two apex locators (Root ZX and ProPex) in

determining the working length of root canal in primary teeth and to

compare the results with scanning electron microscopy. It concluded that

the most accurate in determining working length was Root ZX, followed

by ProPex and the least accurate was conventional radiography.5

2. An in vivo study was done to evaluate the accuracy and reliability of

electronic apex locater (Endomaster) and radiographic determination of

root canal length in primary teeth. The results indicated that there is no

significant difference between the use of electronic apex locator

(Endomaster) and radiography for determining the working length in

primary teeth. The use of electronic apex locator may be useful for

protecting children from exposure to recurrent ionizing radiation, over

instrumentation, overfilling, damage to the permanent tooth germs and

need of extra radiographs and might be useful in cases where

radiographic determination of root length has some limitations.6

3. A study was done to compare the accuracy of conventional radiography,

radiovisiography and the Root ZX mini apex locator in determining the

working length in primary teeth and determine effect of wet/dry condition

on the accuracy of electronic apex locator in vivo/in vitro. It showed that

the readings obtained by the apex locator were not affected by resorption
 or the medium. The Root ZX mini apex locator showed the most

promising results with an accuracy of 99.6%, followed by

radiovisiography with an accuracy of 89% and conventional

radiography.7

4. An in vivo study done to evaluate the effectiveness of two different

varieties of electronic apex locators and radiovisiography (RVG) for

working length determination in primary teeth showed, a strong

correlation between apex locators and radiovisiography. It was seen that

apex locators are an effective tool in determination of working length in

primary teeth. Two different varieties of apex locators used in the present

study were equally effective in doing the same. Moreover, they were as

effective as radiovisiography for working length estimation in primary

teeth.8

5. In an in vivo study conducted to evaluate the accuracy of a new-

generation electronic apex locator (iPex) to determine working length in

primary teeth with or without root resorption as compared with the

conventional radiographic method, it was found that there is no

statistically significant difference between iPex and conventional

radiography when determining the working length. Working length

determined by iPex apex locator is comparable with that of conventional

radiographic method, hence, can be used as an alternative in determining

the working length of primary teeth.9

Null hypothesis:

There is no statistically significant difference between radiovisiography and

Root ZX mini® apex locator for determination of working length in primary

molars.

Alternative Hypothesis:

There is a statistically significant difference between radiovisiography and Root

ZX mini® apex locator for determination of working length in primary molars.

AIM OF THE STUDY:

 The aim of the study is to evaluate and compare between

radiovisiography and Root ZX mini® apex locator for working length

determination in primary molars.

OBJECTIVES:

1. To evaluate the radiovisiography and Root ZX mini® apex locator for

determination of working length of primary molars.

2. To compare the radiovisiography and Root ZX mini® apex locator for

determination of working length of primary molars.

MATERIALS AND METHOD:

STUDY DESIGN:
It is an In Vivo, Comparative study
SOURCE OF DATA:

The study will be conducted in the Department of Pedodontics & Preventive

Dentistry at KLE VK Institute of Dental Sciences, KLE Academy of Higher

Education and Research, (KLE University), Belagavi.

Patients reporting to the outpatient department of the Department of Pedodontics

& Preventive Dentistry at KLE VK Institute of Dental Sciences, KLE Academy

of Higher Education and Research, (KLE University), Belagavi who fulfill

inclusion criteria will be selected for the study.

SELECTION CRITERIA: The following inclusion and exclusion criteria will

be followed.

INCLUSION CRITERIA:

 Primary molars with minimum two third of root length remaining

indicated for pulpectomy.

 Age group- 4-8 years

 Frankl’s behavior rating scale: Definitely positive (++), Positive (+)

EXCLUSION CRITERIA:

 Children with systemic diseases and special health care needs.

 Primary molars with developmental anomalies of roots.

 Primary molars with caries involving furcation.

 Primary molars with calcified root canals.

 Evidence of root fracture, trauma.

PERMISSIONS TO BE TAKEN:

 Before starting the study, permission will be obtained from the

Institutional Review Board.

 Written informed consent will be obtained from all the parents of children

participating in the study. (ANNEXURE Ia & Ib)

 Assent will be obtained from all the children participating in the study.

(ANNEXURE II)

SAMPLE SIZE ESTIMATION:

 The estimated sample size is 30 patients.

(Z1-α/2 + Z1-β)2
n= +3
2
[FZ(ρ1) – FZ(ρ0)]

Where,
ρ
0 = 0, ρ1 = 0.754, Z1-α/2 = 2.58, Z1-β = 1.682

n= sample size
ρ
0: Population correlation coefficient.
ρ
1: Sample correlation coefficient.

α: Significance level.

1-β: Power.
METHODOLOGY:

SELECTION OF SUBJECTS:

The subjects reporting to the Department of Pedodontics and Preventive

Dentistry will be selected according to the inclusion and exclusion criteria.

Groups:

30 patients will be included in the study and will be subjected to Working

length determination by two modalities.

Group I: (Control group)

Each tooth indicated for pulpectomy according to inclusion criteria in all 30

patients will be subjected to working length determination by radiovisiography.

Group II: (Experimental group)

The same tooth in all 30 patients will be subjected to working length

determination by Root ZX Mini ® apex locator.

INSTRUMENTS AND MATERIALS:

 Examination gloves, mouth mask, head cap

 Kidney tray, mouth mirror, explorer, pair of tweezers.

 Spoon excavator.

 Rubber dam kit

 Cotton pellet

 Airotor

 Burs- Round bur (no. 4), No. 330 tungsten carbide bur.

 K-Files - Nos. 6,10,15,20,25,30,35 (21mm) (Mani Medical India Private

Limited, Delhi)

 Paper points

 Normal saline

 Radiovisiograph Sensor #1

 Root ZX mini® (J. Morita. Mfg. Corp) apex locator:

DETAILS OF THE PROCEDURES TO BE CONDUCTED DURING THE

STUDY:

1. SELECTION OF CASE AND RECORDING OF CASE HISTORY:

 A case history will be recorded in a special format prepared for this study

(Annexure III).

 The extent for caries and the root canal anatomy will be assessed and

recorded with pre-operative radiovisiographs.

 The complete procedure of pulpectomy will be carried out by principal

investigator(PI), the interpretation of working length will be carried out

by principal investigator(PI) and two trained examiners to avoid bias.

2. CLINICAL PROCEDURE:

 Local anaesthesia will be administered using 2% lignocaine with

adrenaline (1:80,000).

 The teeth will then be isolated with rubber dam. The caries will be

removed using no. 330 pear shaped tungsten carbide bur.

 The deep caries will be excavated with a spoon excavator, first removing

peripheral caries then proceeding towards the pulp.

 A straight fissure bur no. 2 in a slow speed handpiece will be used to

remove the roof of pulp chamber.

 Removal of the coronal pulp will be done with a large excavator or a

slowly rotating no. 4 round bur following which the canal will be

negotiated using K-File and the radicular pulp will be removed.10

 Each of the selected tooth will then be subjected to working length

determination by two modalities. (Radiovisiography and Root ZX mini ®

apex locator)

3. DETERMINATION OF WORKING LENGTH BY

RADIOVISIOGRAPHY:

 The digital radiograph will be obtained using a computed dental

radiography system, #1 sensor and X-ray system. The radiovisiographs

will be made using paralleling technique. The position and angulation

will be kept constant throughout the study.8

 Working length will be determined using K- File and radiovisiography.

 Electronic ruler which is available in the software will be used for the

measurement of working length. The measurement will be made on the

screen.

 The calibration of working length on radiovisiograph will be done by

placement of 5mm stainless steel wire (0.7mm) on the sensor vertically.

After the radiovisiograph is taken, calibration will be done and then the

length will be measured on the screen by the Kodak software.11

 The actual working length will be calculated by using Ingle’s method and

in cases of resorption Weine’s correction will be used.12

 Two trained examiners will record the working length and the

measurements will be put in the master chart (Annexure IV).

4. DETERMINATION OF WORKING LENGTH IN PRIMARY

MOLARS BY ROOT ZX MINI® APEX LOCATOR:

 The electronic working length will be determined by using Root ZX

mini® apex locator.

 Before the electronic measurements, the root canals will be irrigated and

dried with paper points.

 The ground lead of the locator will be placed on each patient’s labial

commissure and endodontic file will be clasped to the opposite electrode.

 The K-file will be advanced apically until the apex locator signals that the

apex has been reached. 7

 The working length will be determined according to the manufacturer’s

instructions. Three measurements will be recorded and the mean of it will

be considered as working length. Two trained examiners will further

assess the working length. This will be recorded in the master chart.

(Annexure IV).
 5. COMPLETION OF TREATMENT:

 After the measurements, pulp debridement will be carried out in

conjunction with copious irrigation followed by obturation with a

biocompatible material.

 Final restorations will be made with stainless steel crown.

STATISTICAL TEST:

1. Paired t test/ Wilcoxon matched pairs test: to determine the difference of

means among the methods in the qualitative variables.7

2. Karl Pearson’s correlation coefficient: to measure the correlation between

the variables.7

3. Cohen’s Kappa coefficient: to measure the inter-rater agreement for

qualitative items.7

FUNDING DETAILS:

TOTAL BUDGET

 Material cost: 100 (Pulpectomy) for 30 patients = 3000/-

 Equipment cost

 Cost incurring during investigation:60 (3 radiovisiographs) for 30 patients

= 1800/-

 Cost incurring for statistical analysis: 1500/-

 Miscellaneous: 3700/-
 Total cost 10,000/-

Name of funding agency

 External Funding

Detail address of the funding agency

 Internal / Self-Funding

I Miss Rucha. N. Davalbhakta agree to take up the financial responsibility of

my research and will bear all the expenses incurred during the study

Signature of the student Signature of the guide

Does the study require any investigation or intervention to be conducted on

patients or any other human or animals, if so, please describe briefly?

Yes, the study will consist of examination of the subjects, followed by

necessary dental treatment including Access opening, Working length

determination, biomechanical preparation and obturation.

Disposable materials will be used wherever applicable and appropriate

sterilization will be maintained.

Has ethical clearance been obtained from your institution?

Applied for.
 Annexure Ia

Department of Pedodontics and Preventive Dentistry

K.L.E. V.K. Institute of Dental Sciences

KLE Academy of Higher Education and Research, (KLE University)

BELAGAVI.

“COMPARATIVE EVALUATION OF ROOT ZX MINI® APEX LOCATOR AND

RADIOVISIOGRAPHY IN DETERMINING THE WORKING LENGTH OF
PRIMARY MOLARS: AN IN VIVO STUDY.

Date -

I, the undersigned, authorize the performance upon my son/ daughter, Mst. / Miss
………………………. the advised treatment to be performed under the direction of Dr:
…………………………… and by Dr. Rucha. N. Davalbhakta

I consent to the administration of anesthetics as may be considered necessary or advisable by the

doctor responsible for this service, access opening and working length determination

I consent to the photographing or video recording of the operation or procedures to be performed

including appropriate portions of my child’s body, for medical, scientific or educational purposes
provided his/ her identity is not revealed by the pictures or by the descriptive texts accompanying
them.

For the purpose of advancing dental education I consent to the admittance of observers to the
operating room.

At any time if I don’t like I will quit from the study without any guarantee.

I give my consent to publications and presentations of this study.

The nature and purpose of the operation, possible alternative methods of treatment, the risk
involved, and the possibility of complications have been fully explained to me in my vernacular
language. No guarantee or assurance has been given by anyone as to the results that may be
obtained.

(Relation to the patient) (Signature)

 Annexure Ib

ಡಾ. ರುಚಾ
CONSENT FORM:

Annexure II

ASSENT FORM

DEPT.OF PEDODONTICS AND PREVENTIVE DENTISTRY

K.L.E. UNIVERSITY’S K.L.E. V.K. INSTITUTE OF DENTAL

SCIENCES. BELAGAVI.

My name is Dr. Rucha. I am a Pedodontist.

You can ask questions at any time that you might have about this study. Also, if

you decide at any time not to finish, you may stop whenever you want. Signing

this paper means that you have read this, or had it read to you and that you want

to be in the study. If you don’t want to be in the study, don’t sign the paper.

Your parent(s) know that I am asking you to do these things. Remember, being

in the study is up to you, and no one will be angry if you don’t sign this paper or

even if you change your mind later.

Signature of participant ____________________ Date _____________

Signature of investigator ____________________ Date ____________

 Annexure III

CASE-HISTORY
DEPARTMENT OF PEDODONTICS AND PREVENTIVE
DENTISTRY

PATIENT INFORMATION:
NAME: SEX:
AGE: PARENT/GUARDIAN:
ADDRESS: CONTACT NUMBER:
HISTORY:
CHIEF COMPAINT:
HISTORY OF PRESENT ILLNESS:
RELEVANT MEDICAL HISTORY:
PREVIOUS DENTAL HISTORY:
NATAL HISTORY:
POST NATAL HISTORY:
GENERAL EXAMINATION:
INTRA-ORAL EXAMINATION
Soft Tissue Examination:
Hard Tissue Examination:
Tooth no:
No of Teeth:
Decayed Teeth:
Filled Teeth:
Missing Teeth:
Root Stumps:
Mobility:
PROVISIONAL DIAGNOSIS:
INVESTIGATION:
FINAL DIAGNOSIS:
TREATMENT PLANNING:
 Annexure IV
Master Chart for Determination of working length by Radiovisiography

and Root ZX mini® apex locator:

Sr. OPD Tooth Canal Age/ Working length by radiovisiography Working length determination by Root ZX mini® apex locator.
No No. no. sex
. Principal Examiner Examiner Reading Reading Reading Mean Examiner Examiner

Investigator 1 2 1 2 3 1 2
REFERENCES:

1. Leonardo MR, Silva LA, Nelson-Filho P, Silva RA, RA fini MS. Ex Vivo

evaluation of the accuracy of two electronic apex locators during root

canal length determination in primary teeth. Int. Endod J 2008; 41:317-

21.

2. Subramaniam P, Konde S, Mandanna DK. An in vitro comparison of root

canal measurement in primary teeth. J Indian Soc Pedod Prev Dent 2005;

23: 124–125.

3. Versteeg KH, Sanderink GCH, Van Ginkel FC, Van der Stelt PF.

Estimating distances on direct digital images and conventional

radiographs. J Am Dent Assoc 1997;128(4):439-443.

4. Kim E, Lee S-J. Electronic apex locator. Dent Clin North Am

2004;48(1):35-54.

5. Patiño-Marín N, Zavala-Alonso NV, Martínez-Castañón GA, Sánchez-

Benavides N, Villanueva-Gordillo M, Loyola-Rodríguez JP, Medina-

Solís CE. Clinical evaluation of the accuracy of conventional radiography

and apex locators in primary teeth. Pediatr Dent. 2011;33(1):19-22.

6. Oznurhan F, Ünal M, Kapdan A, Ozturk C, Aksoy S. Clinical evaluation

of apex locator and radiography in primary teeth. Int J Paediatr Dent.

2015;25(3):199-203.

7. Kumar LV, Sreelakshmi N, Reddy ER, Manjula M, Rani ST, Rajesh A.

Clinical evaluation of conventional radiography, radiovisiography, and an

 electronic apex locator in determining the working length in primary

teeth. Pediatr Dent. 2016;38(1):37-41.

8. Abdullah A, Singh N, Rathore MS, Tandon S, Rajkumar B. Comparative

Evaluation of Electronic Apex Locators and Radiovisiography for

Working Length Determination in Primary Teeth in vivo. Int. J Clin

Pediart Dent. 2016;9(2):118.

9. Bhat KV, Shetty P, Anandakrishna L. a Comparative Evaluation of

Accuracy of New-generation Electronic Apex Locator with Conventional

Radiography to determine Working Length in Primary Teeth: An in vivo

Study. Int. J Clin Pediatr Dent. 2017;10(1):34.

10.Andlaw R, Rock W. Pulp treatment of primary teeth. In: A manual of

paediatric dentistry, 4th edn. London, 1996 pgs:108-114.

11.Khojastepour L, Rahimizadeh N, Khayat A. Morphologic measurements

of anatomic landmarks in pulp chambers of human first molars: a study of

bitewing radiographs. Ir Endo J. 2008;2(4):147.

12.Bhatt A, Gupta V, Rajkumar B, Arora R. Working length determination-

the soul of root canal therapy: a review. Int J Dent Health Sci 2015;

2(1):105-115.
6. Signature of the candidate

7. Remarks of the guide

8. Name and designation of (in block)

8.1 Guide DR. NIRAJ GOKHALE M.D.S.

READER

DEPARTMENT OF PEDODONTICS AND

PREVENTIVE DENTISTRY,

KLE V. K. INSTITUTE OF DENTAL SCIENCES,

KLE ACADEMY OF HIGHER EDUCATION AND
RESEARCH, (KLE UNIVERSITY) NEHRU
NAGAR,
BELAGAVI - 590010.
8.2 Signature

8.3 Head of department DR. SHIVAYOGI M. HUGARM.D.S.

PROFESSOR AND HEAD

DEPARTMENT OF PEDODONTICS AND

PREVENTIVE DENTISTRY,

KLE V. K. INSTITUTE OF DENTAL SCIENCES,

KLE ACADEMY OF HIGHER EDUCATION AND
RESEARCH, (KLE UNIVERSITY) NEHRU
NAGAR,
BELAGAVI - 590010.

8.4 Signature
9. 9.1 Remarks of the Chairman and
Principal

9.2 Signature