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CTRI Number  CTRI/2024/11/076888 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 23/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study done to check the antimicrobial properties of various irrigation solution in non-vital single rooted tooth during root canals. 
Scientific Title of Study   A microbiological evaluation of disinfection of the root canal system using sodium hypochlorite and its combination as irrigants -an in vivo 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 Tarun kumar 
Designation  Professor 
Affiliation  Dasmesh institute of research and dental sciences 
Address  Department of conservative dentistry and endodontics, dasmesh institute of research and dental sciences, faridkot
Talwandi Road, Faridkot
Faridkot
PUNJAB
151203
India 
Phone  9888666699  
Fax    
Email  drtarunkumar@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Muskaan Garg 
Designation  Post graduate student 
Affiliation  dasmesh institute of research and dental sciences 
Address  department of conservative dentistry and endodontics, dasmesh institute of research and dental sciences, faridkot
department of conservative dentistry and endodontics, dasmesh institute of research and dental sciences, faridkot
Faridkot
PUNJAB
151203
India 
Phone  9464601000  
Fax    
Email  muskngarg@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Tarun Kumar 
Designation  Professor 
Affiliation  Dasmesh institute of research and dental sciences, faridkot 
Address  Department of conservative dentistry and endodontics, Dasmesh institute of research and dental sciences, faridkot
Talwandi road, Faridkot
Faridkot
PUNJAB
151203
India 
Phone  9888666699  
Fax    
Email  drtarunkumar@hotmail.com  
 
Source of Monetary or Material Support  
Department of conservative dentistry and endodontics,Dasmesh institute of research and dental sciences,faridkot , punajb, India 151203 
 
Primary Sponsor  
Name  Dasmesh institute of research and dental sciences 
Address  Dasmesh institute of research and dental sciences, talwandi road faridkot, India, 151203 
Type of Sponsor  Research institution and hospital 
 
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 Tarun Kumar  Department of conservative dentistry and endodontics  Dasmesh institute of research and dental sciences, talwandi road faridkot
Faridkot
PUNJAB 		 9888666699

drtarunkumar@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The institutional review board(Ethical Committee)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K041||Necrosis of pulp,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  distilled water  distilled water will be checked with the sodium hypochlorite and its various combinations as an endodontic irrigant at the time of root canal treatment on the first appointment of the patient only. 
Intervention  sodium hypochlorite   sodium hypochlorite 5% will be used to check its anti-microbial activity against control group of distilled water as an endodontic irrigant at the time of root canal treatment on the first appointment of the patient only  
Intervention  Triton irrigant  a mixture of sodium hypochlorite, EDTA and Chlorhexidine will be used to check its anti-microbial activity against control group of distilled water as an endodontic irrigant at the time of root canal treatment on the first appointment of the patient only. 
Intervention  TwinKleen  this irrigant contains etidronic acid (HEBP/HEDP) 9 % and 10 ml of Sodium hypochlorite (5%) will be used to check its anti-microbial activity against control group of distilled water as an endodontic irrigant at the time of root canal treatment on the first appointment of the patient only. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient age should be between 15-60 years with no medical history and teeth with necrotic pulp of either carious or non-carious origin and with closed apex 
 
ExclusionCriteria 
Details  immunocompromised patient , patient with open apex, internal and external resorption, and patients who are allergic  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
to evaluate the antibacterial effectiveness of sodium hypochlorite and its different combination when used as irrigating solutions in non-vital single rooted tooth by counting the bacterial colony count.  the microbial sample will be taken on the first treatment appointment of the patient after the access opening is done in the tooth and after the biomechanical preparation and irrigation of the tooth.
the sample will be taken using sterile paper point and will be stored in thiogycolate solution and will be allowed to grow for 24 hours. then microbial colony count will be done to check for the antimicrobial efficacy of the each irrigant.  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil
 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/12/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  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) - 

  6. For how long will this data be available start date provided 18-09-2024 and end date provided 06-02-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary    For endodontic study chemicomechanical preparation is must. The purpose of this in-vivo study will be to compare the antimicrobial properties of four different irrigating solutions.100 sample will be randomly collected and divided into four groups. The initial root canal sample will be obtained post accessing the canal and confirming its patency. Subsequently, the second sample will be collected following biomechanical preparation utilizing one of the irrigants. The root canal samples will be analyzed microbiologically, followed by a comparative assessment of the antimicrobial effectiveness root canal irrigants using statistical methods 
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