Annexure- II synopsis for registration of subject for dissertation



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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA


Annexure- II


SYNOPSIS FOR REGISTRATION OF SUBJECT FOR

DISSERTATION

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NAME OF THE CANDIDATE AND ADDRESS

DR. PRASANNAKUMARI

POST GRADUATE STUDENT,

DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY,

D. A. PANDU MEMORIAL R. V. DENTAL COLLEGE AND HOSPITAL,

CA-37, 24TH MAIN, 1ST PHASE, J.P.NAGAR, BANGALORE-560078.



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NAME OF THE INSTITUTION

D. A. PANDU MEMORIAL R. V. DENTAL COLLEGE

AND HOSPITAL

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COURSE OF STUDY AND SUBJECT

MASTER OF DENTAL SURGERY

DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY

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DATE OF ADMISSION TO COURSE

01.06.2012



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TITLE OF THE TOPIC

“COMPARATIVE ASSESSMENT OF PULSE OXIMETER AND ELECTRIC PULP TESTING IN EVALUATING PULP VITALITY AND ITS CORRELATION WITH THE CLINICAL AND HISTOLOGICAL FINDINGS IN PRIMARY MOLARS INDICATED FOR PULPOTOMY”.



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BRIEF RESUME OF THE INTENDED WORK

6.1 NEED FOR STUDY
The assessment of pulp vitality is required to know the status of the pulp and treatment needs. The tests most commonly used for this purpose are Thermal and Electric pulp tests. However, these methods have limitations in providing an accurate diagnosis, because they subjectively imply vitality through sensory responses from the patient, leading to inconclusive results, especially when used in children.1
Recent research and advances prove higher accuracy of Pulse oximetry irrespective of age of patient as they give reliable results in young patients. Newer tests have shown promising results even in children as they measure vitality of pulp based on pulpal blood flow and not rely on stimulation of nerve fibers.7

Pulse oximeter is a noninvasive technique to measure oxygen saturation levels within the blood of patients. This device has been modified to assess vitality of pulp. A direct measure of the pulpal circulation is the only real measure of pulp vitality.4

Recent studies have shown that the pulse oximeter with modified sensor probe represents an efficient instrument for determination of pulp vitality.6

The purpose of this study is to assess the vitality of primary molars which are indicated for pulpotomy using pulse oximeter and electric pulp tester and its correlation with clinical and histological findings.


6.2 REVIEW OF LITERATURE
A study was conducted  which compared the efficacy of a custom-made pulse oximeter dental probe with the electric pulp testing and thermal testing for measuring pulp vitality status of recently traumatized permanent teeth. The proportion of recently traumatized teeth showing a positive responsiveness in thermal/electric pulp tests increased from no teeth showing responsiveness on day 0 to 29.4% teeth on the 28th day, 82.35% of teeth at 2 months, and 94.11% teeth at 3 months. However, pulse oximeter gave positive vitality readings that remained constant over the study period from day 0 to 6 months in all patients.2

A study was conducted to design and build a custom-made pulse oximeter dental probe and to evaluate its efficacy in comparison with electric pulp tester, cold spray, and a rubber cup in pulp vitality testing. Result showed that Pulp testing by using pulse oximetry is more reliable than the electric test, rubber cup, and cold spray. The custom-made pulse oximeter dental probe is an effective and objective method for pulp vitality assessment.3

A study was conducted to compare the clinical effectiveness of the novel pulse oximeter(Oxy Tip+) probe over conventional technique of electric pulp tester and thermal testing of tooth vitality. Datex ohmeda 3800 pulse oximeter, with novel probe Oxy Tip+, has immediate clinical value in providing base line vitality data, since reproducible SaO2 readings were obtained on the teeth. In view of limitations of conventional pulp testing methods, pulse oximeter with Oxy Tip+ offered an objective evaluation of pulpal circulation.4

Another study was done to investigate correlations between pulp oxygenation rates (%SpO2) and clinical diagnoses of reversible pulpitis (RP), irreversible pulpitis (IP), or pulp necrosis (PN).The study concluded that evaluation of pulp oxygenation rates by Pulse oximeter may be a useful tool to determine the different inflammatory stages of the pulp to aid in endodontic diagnosis.5


Another study was done to analyze pulp vascularization at the level of permanent maxillary incisors and canines, registering the values of pulp oxygen saturation with a specially adapted pulse oximeter, and to evaluate its efficiency for the determination of pulp vitality. the pulse oximeter with modified sensor represents an efficient instrument for the determination of pulp vitality; analysis of pulp vascularization at tooth level is a better method for the investigation of pulp vitality, comparatively with testing of pulp innervations, which as a function of patient’s sensitivity, may have several variables.6

    1. OBJECTIVES OF THE STUDY




  • To assess the correlation between readings of pulse oximeter and electric pulp tester.

  • To compare the pulse oximeter and electric pulp tester readings with the clinical findings of pulp on access opening.

  • To compare the results of vitality testing using the above two methods with histological findings of the amputated pulp.



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MATERIALS AND METHODS:

Materials:

Radiographs

Absorbent cotton rolls

Electric pulp tester

Electrolytic medium

Pulse oximeter with modified sensor probe

Local anaesthesia

Rubber dam kit

Airotor hand piece and burs

Spoon excavator

10% formalin for pulp fixation



7.1 SOURCE OF DATA

This study will include 30 children aged between 5 to 9 years, visiting the Department of

Pedodontics and Preventive Dentistry of D.A.P.M.R.V.DENTAL COLLEGE AND HOSPITAL, BANGALORE who require pulpotomy of primary molars.

7.2 METHOD OF COLLECTION OF DATA

Sample selection


  • Inclusion criteria: Children aged between five to nine years.

Primary molars indicated for pulpotomy.

Children with healthy contralateral tooth.

Informed consent duly signed by parent / guardian.



  • Exclusion criteria: Medically compromised patients.

Un-cooperative patients.

Children with cardiac pacemakers.


Methodology:

Patient fulfilling all the criteria will be selected and informed consent obtained. The radiographs of the teeth requiring pulp therapy will be taken. The teeth selected will be divided into two groups:

Group A (Study group): Primary molars indicated for pulp vitality testing and pulpotomy.

Group B (Control group): Healthy contralateral primary molar for vitality assessment alone.


Tooth from the control group, is isolated using cotton rolls and tested using the modified sensor probe of pulse oximeter for measurement of oxygen saturation. Then, electric pulp testing will be done on the same tooth after application of electrolyte medium and both readings will be recorded.

The Same assessment will be carried out for the study group.


After pulp testing by using these methods, local anesthesia is administered to the tooth which is indicated for pulp therapy. Tooth is isolated using rubber dam and access opening procedure will be carried out using high speed airotor handpiece and burs. Pulp is amputated using a sharp endodontic spoon excavator and then will be sent for histological examination. Clinically the radicular pulp stumps are assessed based on hemorrhage and color of blood. Following this, formocresol pulpotomy procedure is completed. The clinical and histological assessment will be compared with pulse oximeter and electric pulp tester to assess the accuracy of pulp testing methods.

Statistical test used-

The data obtained will be tabulated and subjected to statistical analysis using students ‘t’ test.



7.3

Does the study require any investigation or interventions to be made on patients or other humans or animals? if yes , please describe briefly

Yes, this will be done on patient’s primary molars which require pulpotomy only.




7.4

Has ethical clearance been obtained from your institution , if yes for 7.3

Yes


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References:
1. Pozzobon MH, de Sousa Vieira R, Alves AM, Reyes-Carmona J, Teixeira CS, de Souza

BD, Felippe WT. Assessment of pulp blood flow in primary and permanent teeth using

pulse oximetry. Dent Traumatol 2011 Jun;27(3):184-8.

2. Gopikrishna V, Tinagupta K, Kandaswamy D. Comparison of electrical, thermal,

and pulse oximetry methods for assessing pulp vitality in recently traumatized teeth.

J Endod 2007 May;33(5):531-5.


3. Dastmalchi N, Jafarzadeh H, Moradi S. Comparison of the Efficacy of a Custom-made

Pulse Oximeter Probe with Digital Electric Pulp Tester, Cold Spray, and Rubber Cup

for Assessing Pulp Vitality. J Endod 2012 Sep;38(9):1182-6.

4. Siddheswaran V, Adyanthaya R, Shivanna V. Pulse oximetry: A Diagnostic Instrument

in Pulpal Vitality Testing- An In Vivo Study. World J Dent 2011 Jul- Sep;2(3):225-30.

5. Setzer FC, Kataoka SH, Natrielli F, Gondim-Junior E, Caldeira CL. Clinical Diagnosis

of Pulp Inflammation Based on Pulp Oxygenation Rates measured by pulse oximetry.

J Endod 2012 Jul;38(7):880-3.

6. Ciobanu G, Ion I, Ungureanu L. Testing of pulp vitality by Pulsoximetry. Int

J Med Dent Apr-Jun 2012;2(2):94-8.

7. Diwanji A, Mathur J, Sharma D, Akhani J. Assessment of pulp vitality in children.

J Dent sciences 2010-2011;2(2):44-6.




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Signature of Candidate




10

Remarks of Guide





11

Name and designation of

11.1)Guide



DR ANANTHARAJ. A

PROFESSOR AND HOD






11.2)Signature of Guide







11.3)Co-Guide (if any)







11.4)Signature of Co-Guide







11.5)Head of Department

DR. ANANTHARAJ. A




11.6)Signature of Head of Department




12

12.1)Remarks of Chairman and Principal







12.2)Signature





PATIENT INFORMATON SHEET

ANNEXURE I

You are been requested to permit your child/ ward to take part in a study entitled

“COMPARATIVE ASSESSMENT OF PULSE OXIMETER AND ELECTRIC PULP TESTING IN EVALUATING PULP VITALITY AND ITS CORRELATION WITH THE CLINICAL AND HISTOLOGICAL FINDINGS IN PRIMARY MOLARS INDICATED FOR PULPOTOMY”.
Aim of this study is to compare the accuracy of pulse oximeter and electric pulp tester in checking pulp vitality and compare it with clinical and histological findings.

VOLUNTARY PARTICIPATION
Your child’s participation in this study is voluntary and you can withdraw from this study at any time and this will not affect your subsequent treatment or the relationship with the doctor.

PROCEDURE

In this procedure, pulp vitality of the teeth requiring pulp therapy will be checked using two different methods which are pulse oximeter and electric pulp tester. After this, assessing the opposite side normal tooth will be done. The amputated pulp tissue will be sent for histological evaluation.


Risk if any to the subjects – NIL
CONSENT FORM

ANNEXURE II

I, Mr./Mrs.……………………parent/ guardian/ caretaker of Master/ Miss ……………., have been provided by Dr. Prasannakumari with a copy of patient information sheet for taking part in the study entitled


“COMPARATIVE ASSESSMENT OF PULSE OXIMETER AND ELECTRIC PULP TESTING IN EVALUATING PULP VITALITY AND ITS CORRELATION WITH THE CLINICAL AND HISTOLOGICAL FINDINGS IN PRIMARY MOLARS INDICATED FOR PULPOTOMY”.
I have also been explained about this study to my satisfaction in the language known to me.

I hereby give consent for my ward to be enrolled in this study.


SIGNATURE OF PARENT/ GUARDIAN SIGNATURE OF INVESTIGATOR
Name:
Address:
Contact no:

Date:


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