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CTRI Number  CTRI/2024/06/069201 [Registered on: 19/06/2024] Trial Registered Prospectively
Last Modified On: 03/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Breakage Rates of Three Types of Pediatric Dental Tools 
Scientific Title of Study   Fracture Incidence of Three Different Pediatric Single Rotary File Systems: A Prospective Clinical 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  Nandini Devi M 
Designation  Postgraduate student 
Affiliation  Saveetha Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospital,162,Poonamallee high road,Velappanchavadi

Chennai
TAMIL NADU
600077
India 
Phone  6380593906  
Fax    
Email  mnandinidevi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ganesh Jeevanandan 
Designation  Professor 
Affiliation  Saveetha Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospital,162,Poonamallee high road,Velappanchavadi

Chennai
TAMIL NADU
600077
India 
Phone  9884293869  
Fax    
Email  helloganz@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ganesh Jeevanandan 
Designation  Professor 
Affiliation  Saveetha Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospital,162,Poonamallee high road,Velappanchavadi


TAMIL NADU
600077
India 
Phone  9884293869  
Fax    
Email  helloganz@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Dental College and Hospital , 162 , Poonamallee high road, Velapanchavadi, Chennai-600077 
 
Primary Sponsor  
Name  Saveetha Dental College and Hospital 
Address  162, Poonamallee high road,Velappanchavadi, Chennai-600077,Tamil Nadu 
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 Nandini Devi M  Saveetha Dental College and Hospital  162,Poonamallee high road,Velappanchavadi
Chennai
TAMIL NADU 		 6380593906

mnandinidevi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Dental College-Institutional Human Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kedo Nano Plus  Single rotary file system from KEDO Dental was used to perform pulpectomy 
Intervention  Kedo S Plus  Single rotary file system from KEDO Dental was used to perform pulpectomy 
Comparator Agent  Kedo S Square  Single rotary file system from KEDO Dental was used to perform pulpectomy. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  primary molars that had adequate crown structure and whose two-thirds of the root structure was at least intact 
 
ExclusionCriteria 
Details  Maxillary teeth with extra mesiobuccal canals or distobuccal canals were excluded. Mandibular teeth with two mesial canals or extra root other than mesial and distal were excluded.Those teeth with canal calcifications, sinus tract and pathological resorptions, or those that had been previously root treated, were excluded from the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Fracture incidence  Immediate post-operative after biomechanical preparation 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   28/06/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="20" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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 - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [152111002.sdc@saveetha.com].

  6. For how long will this data be available start date provided 04-03-2025 and end date provided 04-03-2028?
    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   Various determinants influence the safe reuse of rotary files, such as the total number of times the file is reused, preparation technique, glide path preparation, adequate orifice enlargement before rotary instrumentation, enlargement of the root canal using conventional hand files, and the utilization of adequate irrigants or lubrication along with the rotary files. 
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