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CTRI Number  CTRI/2021/07/034545 [Registered on: 02/07/2021] Trial Registered Prospectively
Last Modified On: 01/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of decay removal using four different methods. 
Scientific Title of Study   Comparative evaluation of clinical and microbiological assessment of caries excavation using conventional bur, smart bur, chemomechanical method and ErCr:YSGG laser : An invivo study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prerana Kothari S 
Designation  Post Graduate 
Affiliation  Rajarajeswari Dental College And Hospital 
Address  Rajarajeswari Dental College And Hospital No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka
Roon No 6 Department of Conservative Dentistry and Endodontics 2nd Floor Rajarajeswari Dental College And Hospital No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka
Bangalore
KARNATAKA
560074
India 
Phone  09901365788  
Fax  08028437468  
Email  preranakothari1996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Annapoorna Kini 
Designation  Professor 
Affiliation  Rajarajeswari Dental College And Hospital 
Address  Room No 6 Department of Conservative Dentistry and Endodontics 2nd floor Rajarajeswari Dental College And Hospital No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka
Room No 6 Department of Conservative Dentistry and Endodontics 2nd floor Rajarajeswari Dental College And Hospital No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka
Bangalore
KARNATAKA
560074
India 
Phone  9916917852  
Fax  08028437468  
Email  kinimai@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Annapoorna Kini 
Designation  Professor 
Affiliation  Rajarajeswari Dental College And Hospital 
Address  Room No 6 Department of Conservative Dentistry and Endodontics 2nd floor Rajarajeswari Dental College And Hospital No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka
Room No 6 Department of Conservative Dentistry and Endodontics 2nd floor Rajarajeswari Dental College And Hospital No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka
Bangalore
KARNATAKA
560074
India 
Phone  9916917852  
Fax  08028437468  
Email  kinimai@gmail.com  
 
Source of Monetary or Material Support  
Rajarajeswari Dental College and Hospital 
 
Primary Sponsor  
Name  Dr Prerana Kothari S 
Address  Rajarajeswari Dental College And Hospital No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prerana Kothari S  Rajarajeswari Dental College and Hospital  Room No 6 Department of Conservative Dentistry and Endodontics 2nd floor No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka 560074
Bangalore
KARNATAKA 
09901365788

preranakothari1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chemo mechanical method using Brix 3000 gel.  BRIX3000 gel (Brix Srl Argentina) will be applied with a blunt spoon excavator allowing it to work for 2 mins. Once the applied gel turned turbid, it will be removed by using Hu-Friedy spoon excavator in pendulum motion without pressure. This procedure will be repeated till the healthy dentin is obtained. When applied for a second or third time, no color change in the gel will be observed, which indicates that there is no presence of carious infected tissue. 
Intervention  Er:Cr:YSGG Laser method.  Er:Cr:YSGG laser with a frequency of 20 Hz will be set to obtain a power of 800W.Caries excavation will be carried out under non-contact mode using MZ8 laser tip under continuous water spray to decrease energy density. This facilitates the excavation of caries without change of operating parameters once set. Clinical evaluation of caries excavation will be done using Ericson’s visual and tactile criteria for the absence of discoloration and smooth passage of a William’s Probe with no tug back or catches.  
Intervention  Polymer Bur method.  Caries excavation will be done by using (SS White Smart Burs II) sizeRA4, RA6 and RA8 with a micromotor handpiece according to the size of the lesion, running at slow speed without a water coolant. Caries will be excavated in circular movements starting from the center of the lesion to the periphery, as recommended by the manufacturer. Excavation will be stopped when the instrument becomes macroscopically abraded and blunted and will no longer be able to remove the tissue. New polymer burs will be used for each tooth. 
Comparator Agent  Tungsten Carbide No 330-bur method.  Caries excavation will be done by using Tungsten Carbide No 330 bur with an NSK Airotor handpiece. Intermittent cutting along with water coolant will be done until all the caries are excavated. The complete removal of caries will be checked according to Erickson criteria, i.e., optical(color) and tactile hardness. The color will be checked visually and hardness of the lesion lesion will be checked by the William’s Probe until a leather-hard texture and sharp scratching sound is heard. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1)Class 1 dentinal caries with broad occlusal cavitated lesion on permanent molars.

2)Radiographically carious lesion has to be confined to outer dentin of occlusal surface.

3)Patient aged between 18-40 years old.

4)Teeth with intact buccal/lingual surface.

5)RDT ≥ 1.5 mm
 
 
ExclusionCriteria 
Details  1)Permanent molars with clinical and radiological signs and symptoms of pulpal and periapical lesions.

2)Teeth with any developmental anomaly.

3)Teeth with proximal caries and pulpal involvement.

4)Teeth with previous restoration and fractured crown.

5)Presence of white spot lesions.

6)Hypoplastic or hypomineralized teeth.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the caries removal efficacy in terms of microbiological assessment and efficiency in terms of time taken by Tungsten Carbide No 330 bur,Polymer bur,Brix 3000 gel,Er:Cr:YSGG laser  Patient recalled for the follow up appointments at 3,6 and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Good oral hygiene is achieved.  Patient recalled for the follow up appointments at 3,6 and 12 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   20/07/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  preranakothari1996@gmail.com

  6. For how long will this data be available start date provided 20-07-2021 and end date provided 20-07-2022?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   TITLE OF THE TOPIC: COMPARATIVE EVALUATION OF CLINICAL AND MICROBIOLOGICAL ASSESSMENT OF CARIES EXCAVATION USING CONVENTIONAL BUR,SMART BUR,CHEMOMECHANICAL METHOD AND ErCr:YSGG LASER : AN INVIVO STUDY.

Dental caries is the most prevalent chronic disease in the global population. It is characterised by the destruction of inorganic and dissolution of organic material from tooth structure. The conventional dentistry approach to caries treatment has been removing diseased tissue and replacing it with a dental restorative material. Mechanical caries removal traditionally involves the use of conventional tungsten carbide or round steel burs and hand instruments. The disadvantages of these methods are overpreparation of cavities, pain sensitivity and possible damage to the pulp. Since the dentistry has advanced so much in 21st century that G.V.Blacks “Extension for prevention” has transformed to “Prevention for Extension.” With the advent of adhesive materials and greater understanding of the disease process we are moving into era of  Minimal intervention dentistry.The newer method for caries removal which follows the principle of minimally invasive dentistry has developed recently since last decades.These include laser, chemo-mechanical method, air abrasion, air polishing, ultrasonic, ozone method, polymer burs and enzymes.

The aim of the study is to compare the caries removal efficacy in terms of microbiological assessment and efficiency in terms of time taken by Tungsten Carbide Bur No.330,Polymer bur,BRIX 3000 and ErCr:YSGG Laser.

INCLUSION CRITERIA:

1)Class 1 dentinal caries with broad occlusal cavitated lesion on permanent molars. (2)Radiographically carious lesion has to be confined to outer dentin of occlusal surface. (3)Patient aged between 18-40 years old. (4)Teeth with intact buccal/lingual surface. 5)RDT ≥ 1.5 mm.

EXCLUSION CRITERIA:

1)Permanent molars with clinical and radiological signs and symptoms of pulpal and periapical lesions. (2)Teeth with any developmental anomaly. (3)Teeth with proximal caries and pulpal involvement. (4)Teeth with previous restoration and fractured crown. (5)Presence of white spot lesions. (6)Hypoplastic or hypomineralized teeth.

A total of 60 patients between the age group 18 to 40 years fulfilling the inclusion criteria will be included in the study after obtaining informed consent. Before starting the procedure, preoperative radiograph will be taken and RDT will be determined. All potential participants will be selected randomly and will be divided into 4 groups depending on caries excavation methods. Rubber Dam will be used for isolation of the respective tooth. Local anesthesia will be given if the patient experiences pain or sensitivity during caries excavation. Caries excavation will be done with the following methods mentioned above. Time taken will be measured using a stopwatch from the beginning of caries removal to confirmation of complete excavation of caries clinically. For Microbiological Evaluation two samples of carious material will be collected (one before caries excavation and one after) in Eppendorf tubes that contains saline. They will be transported to the laboratory within 2 hrs. The samples will then be placed on blood agar plates and will be incubated aerobically at 37ºC for 48 hrs. Using the Digital Colony Counter total number of colonies formed will be determined and expressed as CFU/ml. Colony forming units per sample will be estimated before and after the treatment and will then be processed according to S.O.P of RRMCH.


 
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