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CTRI Number  CTRI/2024/06/068362 [Registered on: 05/06/2024] Trial Registered Prospectively
Last Modified On: 05/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   A clinical study assessing the effect of various cleaning agents on the strength of dentin in root canals of teeth 
Scientific Title of Study   Influence Of Various Chelating Agents On The Microhardness Of Dentin In Root Canals - An Observational 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 R H Reiveinai 
Designation  MDS First Year 
Affiliation  Institute of Dental Scienes 
Address  Room Number-124, Conservative Dentistry and Endodontics, Institute of Dental Sciences, BIU, Bareilly-243006, Uttar Pradesh
Institute of dental sciences, BIU, Bareilly, 243006.
Bareilly
UTTAR PRADESH
243006
India 
Phone  8730981904  
Fax    
Email  reiveihenry@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  MANOJ KUMAR HANS 
Designation  Professor and Head 
Affiliation  Institute of dental scienes 
Address  Conservative Dentistry and Endodontics, Institute of dental sciences, BIU, Bareilly, Uttar Pradesh
Institute of dental sciences, Bareilly, Uttar Pradesh
Bareilly
UTTAR PRADESH
243006
India 
Phone  9829779528  
Fax    
Email  hansie51@yahoo.com  
 
Details of Contact Person
Public Query  
Name  MANOJ KUMAR HANS 
Designation  Professor and Head 
Affiliation  Institute of dental scienes 
Address  Conservative Dentistry and Endodontics, Institute of dental sciences, BIU, Bareilly, Uttar Pradesh
Institute of dental sciences, BIU, Bareilly, Uttar Pradesh

UTTAR PRADESH
243006
India 
Phone  9829779528  
Fax    
Email  hansie51@yahoo.com  
 
Source of Monetary or Material Support  
Institute of Dental Sciences, Bareilly, Uttar Pradesh, 243006 
 
Primary Sponsor  
Name  Institute of Dental SciencesBareilly 
Address  Institute of Dental Sciences, Bareilly, Uttar Pradesh.243006 
Type of Sponsor  Other [PRIVATE DENTAL COLLEGE] 
 
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 R H REIVEINAI  INSTITUTE OF DENTAL SCIENCES  Department Of Conservative Dentistry And Endodontics, Institute of Dental Sciences, Bareilly, Uttar Pradesh, 243006
Bareilly
UTTAR PRADESH 		 05812526244

reiveihenry@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, IDS, Bareilly, U.P.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z049||Encounter for examination and observation for unspecified reason,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Single rooted mandibular premolar with single canal
Teeth with intact root morphology
Teeth with completely formed roots 
 
ExclusionCriteria 
Details  Teeth with root caries
Severely curved root
Root fracture
Teeth with calcified canals 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Microhardness of dentin in root canal  Fifty two weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Cleanliness of the root canal  Fifty two weeks 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   18/06/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [reiveihenry@gmail.com].

  6. For how long will this data be available start date provided 31-12-2026 and end date provided 31-12-2031?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
There is a scarcity of studies that have compared the outcome of using CHD-FA and HEBP on the microhardness property of dentin in root canals. Hence, this invitro study aims to evaluate and compare the influence of CHD-FA, HEBP, and EDTA on root canal dentin microhardness using a Vickers hardness tester.

 
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