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CTRI Number  CTRI/2024/06/069200 [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  Randomized, Crossover Trial 
Public Title of Study   Comparing Dental Treatment Quality, Time, and Pain in Childrens Back Teeth Using Different Methods 
Scientific Title of Study   Clinical Comparison of Obturation Quality, Instrumentation Time and Post-Operative Pain in Primary Posterior Maxillary Teeth using Single Rotary File, Sequential Rotary File, and Manual File System: A Single Blinded Randomised Clinical Trial 
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,Clinic-28,162,Poonamallee high road,Velappanchavadi Chennai

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,Clinic-28,162,Poonamallee high road,Velappanchavadi Chennai

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,Clinic-28,162,Poonamallee high road,Velappanchavadi Chennai

Chennai
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 
Healthy Human Volunteers  Pulpitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hand K File  Conventional manual file system from Mani company used to do pulpectomy 
Intervention  Kedo S Plus  Rotary single file system from KEDO Dental used to perform pulpectomy 
Intervention  Pro AF Baby  Rotary sequential file system from Kids-e-dental used to perform pulpectomy 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  healthy children requiring pulpectomy for one of their primary second mandibular molars.root length, available coronal structure, resorption, special needs, and systemic diseases. Inclusion criteria included primary mandibular molars, whether vital or non-vital, without a sinus tract, showing no signs of internal or external pathologic root resorption, and possessing adequate coronal tooth structure for stainless steel crown placement 
 
ExclusionCriteria 
Details  children lacking cooperative ability, those with underlying systemic diseases, and those with special healthcare needs 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Obturation Quality  Immediate post-operative 
 
Secondary Outcome  
Outcome  TimePoints 
Instrumentation time  seconds 
Post-operative pain  12, 24, and 48 hours 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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) 20/06/2024 
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 Applicable 
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 03-03-2025 and end date provided 03-03-2028?
    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   Pulpectomy can be done with manual or rotary, single or sequential file systems. Single file systems have advantages of faster completion of treatment and lesser pain after completion of treatment. 
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