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CTRI Number  CTRI/2024/03/063951 [Registered on: 11/03/2024] Trial Registered Prospectively
Last Modified On: 14/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparison of amount of root canal filling by three different methods in permanent anterior teeth 
Scientific Title of Study   A Comparative Evaluation Of Root Canal Filling With Cold Lateral Condensation, Thermoplasticized Gutta-percha Obturation Technique And Thermomechanical Compaction Using Revo-s Condenser In Human Permanent Single-rooted Teeth Using Spiral CT Scan: An In-vitro Volumetric Analysis Study.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rishabh Shamkant Patel 
Designation  PG student 
Affiliation  Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College 
Address  Room no 5 Second floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College

Dhule
MAHARASHTRA
424001
India 
Phone  9421407873  
Fax    
Email  Rishabhptl25@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prashant Bondarde 
Designation  Professor and Head of the Department 
Affiliation  Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College 
Address  Room no 5 Second floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College

Dhule
MAHARASHTRA
424001
India 
Phone  9370309008  
Fax    
Email  bondardeprashant@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rishabh Shamkant Patel 
Designation  PG student 
Affiliation  Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College 
Address  Room no 5 Second floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College

Dhule
MAHARASHTRA
424001
India 
Phone  9421407873  
Fax    
Email  Rishabhptl25@gmail.com  
 
Source of Monetary or Material Support  
Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College 
 
Primary Sponsor  
Name  Dr Rishabh Shamkant Patel 
Address  Room no 5 Second floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College 
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 Rishabh Patel  Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College  Department of Pedodontics Room no 5 second floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule
Dhule
MAHARASHTRA 		 9421407873

Rishabhptl25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NA 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Extracted human single-rooted permanent teeth with vertucci type 1 configuration
Teeth with mature apical foramen
Teeth extracted due to compromised periodontal status
Teeth with no apical curvature
Teeth with no developmental anomaly 
 
ExclusionCriteria 
Details  Gross caries involving the roots
Fractured teeth
Root with sclerosed canals with more than one canal or those with root curvature
Teeth with restorations
Exceptionally short roots will be excluded
Teeth with history of endodontic treatment 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Evaluate Percentage of Obturated Volume and volume of voids present in the root canal obturated with cold lateral condensation, thermoplasticized gutta-percha technique and thermomechanical compaction using Revo-S condenser.  After the obturation of root canal. 
 
Secondary Outcome  
Outcome  TimePoints 
To Compare the Percentage of Obturated Volume (POV) and volume of voids present in root canal obturated with cold lateral condensation, thermoplasticized gutta-percha technique and thermomechanical compaction using Revo-S condenser.  After the obturation of root canal 
 
Target Sample Size   Total Sample Size="39"
Sample Size from India="39" 
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   N/A 
Date of First Enrollment (India)   19/03/2024 
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="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
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 - 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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [Rishabhptl25@gmail.com].

  6. For how long will this data be available start date provided 10-07-2024 and end date provided 10-07-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Introduction- An ideal root canal filling should three-dimensionally and homogenously obliterate the root canal system; however, most completed root canal fillings are not fully able to do so. The unfilled spaces within the root canal system may lead to some complications because they might be comprised of remaining microorganisms that may nourished and multiply when they come in contact with lateral canals and the periapical region. Hence, the aim of the study is to evaluate and compare total voids in root canal filled with gutta-percha by using 3 different methods; such as 1) Cold lateral compaction. 2) Thermoplasticized gutta-percha obturation technique. 3) Thermomechanical condensation using Revo-S condenser.
Methodology- 39 extracted human permanent single rooted teeth will be decoronated to obtain a standardized root length by using a diamond disc. The working length will be determined by subtracting 1mm from the length at which size 10 stainless steel K-file tip extruded apically. Rotary ProTaper instruments will be used to prepare the root canal with the crown down technique. After canal preparation, the first scan will be done to obtain the pre-obturation volume of the canal. Then the teeth will be obturated using the above-mentioned techniques as per the respective groups. Then the obturated teeth will be scanned under a Spiral Computed Tomography machine for evaluation of the percentage of volume (POV) and voids present.
 
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