Rajiv Gandhi University of Health Sciences, Bangalore s1

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA ANNEXURE II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. NAME OF THE CANDIDATE AND Dr. MODIMI VENKATESH KUNAL

ADDRESS POSTGRADUATE STUDENT,

DEPARTMENT OF PEDODONTICS AND

PREVENTIVE DENTISTRY,

RAJARAJESWARI DENTAL COLLEGE &

HOSPITAL, BANGALORE-560074,

KARNATAKA. RAJARAJESWARI DENTAL COLLEGE &

2. NAME OF THE INSTITUTION HOSPITAL, BANGALORE-560074,

KARNATAKA.

MASTER OF DENTAL SURGERY IN

3. COURSE OF STUDY AND SUBJECT PEDODONTICS AND PREVENTIVE

DENTISTRY.

4. DATE OF ADMISSION TO COURSE 29-05-2013

MICROBIOLOGICAL ASSESSMENT OF

CARIOUS DENTINE USING

CHEMOMECHANICAL CARIES

5 TITLE OF THE TOPIC: REMOVAL AND CONVENTIONAL HAND

EXCAVATION IN PRIMARY AND

PERMANENT TEETH: A CLINICAL

STUDY. 6. BRIEF RESUME OF THE INTENDED WORK:

6.1 NEED FOR THE STUDY:

The main aim of restoring a decayed tooth is to reinforce by preserving as much

tooth structure as possible, limiting the extent of cavity preparation and removing only

affected dentin.1 Conventional caries removal is considered painful and unpleasant to

many patients, especially children and may require the use of local anesthesia to control

pain.2

Papacarie, a chemomechanical caries removal agent introduced in 2003 consists

of papain, an endoprotein with bacteriostatic, bactericidal and anti-inflammatory

activity; chloramines T and Toluidine blue.3

Among the cariogenic microorganisms, Streptococcus mutans and

Lactobacillus are detected in significant quantities in carious dentine that shows a

softened, damp appearance. The presence of microbes on the floor of cavities in

primary teeth represents a greater risk due to the high dentinal permeability of these

teeth, which makes them vulnerable.4

There are no gold standard criteria for determining when a cavity is caries free.

Therefore in defining the efficacy of the different methods of caries excavation and

restoration, studies on the bacteriological content of the dentin carious lesion is

important.2

Hence the aim of the study is to assess the effectiveness of caries removal using

chemomechanical agent (Papacarie) and conventional hand excavation methods in

primary and permanent molars on the residual cariogenic bacteria.

2 6.2 REVIEW OF LITERATURE:

A study to assess the acceptance and success of Caridex, a chemomechanical caries removal agent, in 20 young nervous patients aged between 4 to 10 years with a high level of dental anxiety, showed that the need for local anesthesia was greatly reduced and the children did not complain of pain during the procedure. It was concluded that chemomechanical caries removal in primary teeth is an effective alternative to conventional mechanical caries removal and is advantageous in patients who have a phobia to dental hand piece and injections.5

An in vivo study conducted to compare the dentinal structure of primary molars before and after the removal of carious tissue by mechanical low speed drills, conventional dental curettes and chemomechanical procedures (Carisolv) based on quantitative culture for cariogenic bacteria found no significant difference between any of the methods. However, the chemomechanical method was more efficient in complete elimination of S. mutans.4

An in vivo study to evaluate the effectiveness of 2 chemomechanical caries removal methods – Carisolv and Papacarie- and traditional hand excavation on the residual cariogenic bacteria in the dentin of primary teeth found that Papacarie is significantly more efficient in reducing the residual cariogenic bacteria in dentin of primary teeth than

Carisolv and hand excavation method.2

A study conducted on 30 children to determine the effectiveness of Papacarie

for caries removal as compared to the conventional method with respect to microbial flora,

time, the amount of tissue removal, child’s behavior, pain perception and preference of

treatment inferred that the chemomechanical caries removal method is an effective method

to control pain and preserve sound tooth structure during caries excavation.1

An in vitro study was done to compare the efficacy of mechanical and

chemomechanical (Carisolv) methods of caries removal in 15 deciduous and 15 permanent

extracted teeth. The samples analyzed under scanning electron microscope found no

significant difference for the presence of bacterial colonies in both deciduous and

permanent teeth. The time taken for caries removal by the chemomechanical method was

twice than that of the mechanical method. It was concluded that, chemomechanical method

was easy to introduce, was painless, did not form smear layer and conserved the sound

tooth structure.6

A randomized clinical trial was conducted to assess: the effectiveness of

Papacarie Duo gel in chemomechanical caries removal in primary teeth with traditional

method (low speed bur) in a split mouth design; to analyze the time required for the

procedure; the need for local anesthesia; retention of restorative material in the cavity

(Ketac Molar); and the presence of secondary caries after a period of 30 days. The results

found no significant difference regarding time required for the procedure; the occurrence

of pain; and restoration retention after a 30-day evaluation. The advantage of minimal

invasive treatment are its ease in use, patient comfort and also the fact that it causes less

damage to dental tissues.7

4 6.3 OBJECTIVES OF THE STUDY:

To evaluate and compare:

- the efficiency of chemomechanical agent - Papacarie with the conventional hand

excavation method on residual cariogenic bacteria of carious dentine in primary

molars and permanent 1st molars;

- the time taken for complete removal of caries with Papacarie and hand excavation

methods;

- the need for anesthesia in caries excavation for primary molars and permanent 1st

molars.

7. MATERIALS AND METHODS:

7.1 SOURCE OF DATA:

The present in vivo study will be conducted on 30 children of the age groups

between 4 to 8 years visiting the Department of Pedodontics and Preventive Dentistry,

Rajarajeswari Dental College and Hospital, Bangalore.

7.2. METHOD OF COLLECTION OF DATA:

Using split-mouth design thirty primary molars and thirty permanent 1st molars

with presence of occlusal caries extending into the dentin will be selected from 30 children

by random sampling technique. Bitewing radiographs will be taken to confirm the extent

of the lesion. A written informed consent will be taken from the patient’s parent/guardian

prior to the procedure. INCLUSION CRITERIA:

1. Primary molars and permanent 1st molars with broad cavitated caries lesions

extending into dentin (confirmed through bitewing radiographs).

2. Primary molars and permanent 1st molars with no defects in formation or

development.

3. Systemically healthy patients.

EXCLUSION CRITERIA:

Teeth involving pulpal and/or periapical pathology (mobility or root resorption).

Teeth involving multi-surface carious lesions.

Patients on antibiotic therapy.

Restored or fractured teeth.

DURATION OF STUDY:

Two years.

MATERIALS

- Surgical gloves

- Mouth mask

- Head cap

- Mouth mirror

- Probe

- Instrument tray

6 - Sterile cotton swabs

- Saline

- Topical anesthetic gel (procaine)

- Local anesthesia (XYNOVA2%)

- Tweezers

- Cotton pellets

- Stop watch (Timex)

- Rubber dam kit

- Spoon excavators

- Papacarie gel (Formula and Acao, Brazil)

- Airotor hand piece

- Round diamond 303 bur (MANI,INC)

- Restorative instruments

- Etchant (37% phosphoric acid, 3M ESPE, Scotch bond )

- Bonding agent (3M ESPE, Adper, Scotch bond)

- Light cure composite (3M ESPE, Filtek Z350)

- Sterile screw cap vials

- Culture media- MRS agar, Mitis salivarius & bacitracin agar

SAMPLE PREPARATION

Teeth were randomly divided into 2 groups of 30 each.

Experimental group І [30 teeth] – Primary molars

Experimental group Π [30 teeth] – Permanent 1st molars Both the experimental groups [group І and group Π] will be further randomly

subdivided into the following groups-

Experimental group ІA [15 teeth] - Primary molars treated by chemomechanical caries

removal (Papacarie).

Experimental group ІB [15 teeth] - Primary molars treated by hand excavation method of

caries removal.

Experimental group ΠA [15 teeth] - Permanent 1st molars treated by chemomechanical

caries removal (Papacarie).

Experimental group ΠB [15 teeth] - Permanent 1st molars treated by hand excavation

method of caries removal.

All clinical procedures will be done under complete isolation using rubber

dam and saliva ejector. Topical anesthesia will be applied around all the teeth to be

isolated. No local anesthesia will be administered, as it would alter the pain perception of

the patient.

BASE LINE SAMPLE:

Before sampling, the outermost layer of carious dentin will be removed with a

sharp sterile excavator and discarded to avoid contamination. Sampling will be performed

using a sharp sterile excavator. One scoop of carious dentin will be taken with the same

sized excavator for all cases to standardize the size of the sample as much as possible. The

amount of dentin removed will only be sufficient enough to cover the surface of the

excavator. Samples will be immediately placed in a sterile vial containing transporting

media.

8 CARIES REMOVAL IN GROUP I A AND II A:

The cavity will be filled with Papacarie gel which will be allowed to work for 60 seconds. At application, fresh gel is clear, which then turns opaque or turbid with debris from the lesion. The softened decayed dentin will be scraped away with a blunt excavator. The gel will be reapplied whenever a darkish color appeared, which indicated that the decomposition of the decayed tissue was still in process. The procedure will be repeated until the gel no longer turned turbid and the surface felt hard. The cavity will be tested according to visual and tactile clinical criteria. Finally the remaining gel will be removed with sterile cotton pellets soaked in water and the cavity will be repeatedly washed until the gel is completely removed. The time taken for entire caries removal shall be recorded using a digital stopwatch.

CARIES REMOVAL IN GROUP I B AND II B:

The carious tissue will be completely removed from the cavity by the hand excavation method using a sterile sharp hand excavator. The cavity will be tested to be caries free according to visual and tactile clinical criteria. The time taken for the caries removal will be recorded using a digital stopwatch.

EVALUATION CRITERIA FOR COMPLETE REMOVAL OF CARIES:

[Ericson D, 1999]8

1. The visual criteria - absence of any discoloration.

2. The tactile criteria - the smooth passage of the explorer and absence of a catch or

a tug-back sensation. SECOND DENTINE SAMPLES:

In all the groups, after complete caries removal, each of the cavities will be

cleaned with sterile cotton pellets washed and dried and the second sample will be taken

from caries free dentin using a sterile, sharp excavator. To obtain a sufficient amount of

sound dentin after caries removal, at least some visible dentin particles would be removed

from different sites of the cavity, including the walls and the floor. The samples will then

be placed in sterile vials containing transporting media.

The cavity outline will be adjusted with burs; any undermined enamel

around the cavity walls will be removed with a small round bur. Etchant gel will be

applied to all teeth. The gel will then be washed, the cavity dried, the bonding agent

applied and cured before restoring the teeth with composite resin according to the

manufacturer’s instructions.

MICROBIAL CULTIVATION AND EVALUATION:

Immediately after removal, the samples will be transferred into the sterile

vials with a cap and processed in the laboratory for microbiological investigation. The

samples will be diluted and plated on two different agar plates. Mitis salivarius &

bacitracin agar and MRS agar (himedia) culture media will be used to determine

Streptococcus mutans and Lactobacillus acidophillus respectively. Then, the number of

colonies will be microbiologically assessed.

10 STATISTICAL ANALYSIS:

Results will be evaluated statistically by one-way Anova analysis.

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.

The presence of occlusal caries extending into the dentin in primary molars and permanent 1st molars will be confirmed by bitewing radiographs.

7.4. Has ethical clearance been obtained from your institution in case of 7.3?

Yes. Ethical clearance letter has been attached. REFERENCES:

1. Anegundi RT, Patil SB, Tegginmani V, Shetty SD. A comparative microbiological

study to assess caries excavation by conventional rotary method and a chemo-

mechanical method. Contemp Clin Dent 2012;388-92.

2. El-Tekeya M, El-Habashy L, Mokhles N, El-Kimary E. Effectiveness of 2

Chemomechanical Caries Removal Methods on Residual Bacteria in Dentin of

primary teeth. Pediatr Dent 2012;34(4):325-30.

3. Bussadori SK, Castro LC, Galvao AC. Papain Gel: A new chemomechanical caries

removal agent. J Clin Pediatr Dent 2005;30:115-9.

4. Lima GQ, Oliveira EG, Souza JI, Neto VM. Comparison of the efficacy of

chemomechanical and mechanical methods of caries removal in the reduction of

Streptococcus mutans and Lactobacillus spp in carious dentine of primary teeth. J

Appl Oral Sci 2005;13(4):399-405.

5. Ansari G, Beeley JA, Fung DE. Chemomechanical caries removal in primary teeth

in a group of anxious children. J Oral Rehabil 2003;30:773-9.

6. Avinash A, Grover SD, Koul M, Nayak MT, Singhvi A, Singh RK. Comparison of

mechanical and chemomechanical methods of caries removal in deciduous and

permanent teeth: A SEM study. J Indian Soc Pedod Prev Dent 2012;30:115-121.

12 7. Matsumoto SB, Motta LJ, Alfaya TA, Guedes CC, Fernandes KS, Bussadori SK.

Assessment of chemomechanical removal of carious lesions using Papacarie

DUOTM: Randomized longitudinal clinical trial. Indian J Dent Res 2013;24:488-92.

8. Ericson D. Efficacy of a new gel for chemomechanical removal. J Dent Res

[Abstract 360] 1999;77:1252. 9. SIGNATURE OF CANDIDATE

10. REMARKS OF THE GUIDE

Dr. B. S. SHAKUNTALA. , M.D.S 11. 11.1 NAME & DESIGNATION OF PROFESSOR, GUIDE DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY, RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL, BANGALORE-560074. KARNATAKA.

11.2 SIGNATURE

Dr. NAGARATHNA. C. , M.D.S 11.3 CO-GUIDE PROFESSOR AND HOD, DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY, RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL, BANGALORE-560074. KARNATAKA.

11.4 SIGNATURE

Dr. NAGARATHNA. C. , M.D.S 11.5 HEAD OF THE PROFESSOR, DEPARTMENT DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY, RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL, BANGALORE-560074. KARNATAKA.

11.6 SIGNATURE

14 Dr. SAVITA. S. , M.D.S 12. 12.1 PRINCIPAL PROFESSOR AND HOD, DEPARTMENT OF PERIODONTICS, RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL, BANGALORE-560074. KARNATAKA.

12.2 SIGNATURE DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY

RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL, BANGALORE

INFORMED CONSENT FORM

I ______Address: ______

______

Dentist name: ______

The dentist has informed me about the study procedure and my involvement in it. 1. I agree to give my personal details such as my name, age, gender, address, medical history, previous dental history and other details required for the study to the best of my knowledge.

2. I permit the operator to utilize the information given by me and results obtained from this study for presentation and publication.

3. I permit the doctor to take my photographs to utilize them for the study purpose if required.

4. I will not claim any returns for my co-operation in the study, even if it is being sponsored by any agency. I am participating with my own will and wish for the betterment of the community.

5. If for any reason I am unable to participate in the study, for reasons unknown, I can withdraw from the study.

I have read and understood the information given by the doctor about the study. I have entered and signed this application.

Dentist name: Address:

Phone no:

Dentist signature: Patients signature

Witness Witness

Place: