FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/076924 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 08/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of 3 different Rotary File Systems with hand files. 
Scientific Title of Study   "Cormparative Eva!uation of Clinical Outcome, Radiographie Success and Antimicrobiat Efficacy of Hand Files With Reciprocating Handpiece V/s 3 Different Rotary File Systems in Primary Teeth: A Randomized Clinical Study". 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amol Patil 
Designation  Associate Professor 
Affiliation  Department of Pedodontics, M a Rangoonwala Dental College 
Address  Department of Pedodontics , Room No 406, M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India.
Department of Pedodontics , Room No 406, M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India.
Pune
MAHARASHTRA
411001
India 
Phone  09561042279  
Fax    
Email  amolpatil2526@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Amol Patil 
Designation  Associate Professor 
Affiliation  Department of Pedodontics, M a Rangoonwala Dental College 
Address  Department of Pedodontics, Room No 406, M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India.
Department of Pedodontics, Room No 406, M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India.
Pune
MAHARASHTRA
411001
India 
Phone  09561042279  
Fax    
Email  amolpatil2526@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Amol Patil 
Designation  Associate Professor 
Affiliation  Department of Pedodontics, M a Rangoonwala Dental College 
Address  M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India.
Department of Pedodontics, Room Number 406, M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India.
Pune
MAHARASHTRA
411001
India 
Phone  09561042279  
Fax    
Email  amolpatil2526@gmail.com  
 
Source of Monetary or Material Support  
Department of Pedodontics, M A Rangoonwala Dental College and Hospital 
 
Primary Sponsor  
Name  Department of Pedodontics 
Address  Department of Pedodontics, M A Rangoonwala College of Dental Sciences and Research Institute 
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 Sumaiyya Shaikh   M.A. Rangoonwala Dental College and Hospital  Department of Pedodontics, Room no 406, M.A. Rangoonwala College of Dental Sciences and Research Centre Pune, Maharashtra India.
Pune
MAHARASHTRA 
9561042279

amolpatil2526@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee MCE Society, Azam Campus, Pune -01  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  Hand Files  Patient selection as per the inclusion and exclusion criteria, Randomization, Allocation, oral prophylaxis, Administration of local anaesthesia will be done, followed by rubber dam placement, Access cavity preparation will be carried out, then Canal patency will be done using 10 no k file, then working length will be determined. microbial sample will be collected ( by 15 no paper point) irrigation will be done after each file. cleaning and shaping will be done upto 35 no file with reciprocating handpiece. collection of fluid sample for microbial content will be taken from the root canal space. instrumentation time will be measured with the help of stop watch from the time of start of cleaning and shaping till the end of cleaning and shaping. canals will be dried and obturation will be carried out. 
Comparator Agent  Rotary files  Preparation of canals will be carried out with rotary files in this group after the patency filing and initial filing upto 15# with hand files. Patient selection as per the inclusion and exclusion criteria, Randomization, Allocation, oral prophylaxis, Administration of local anaesthesia will be done, followed by rubber dam placement, Access cavity preparation will be carried out, then Canal patency will be done using 10 no k file, then working length will be determined. microbial sample will be collected ( by 15 no paper point) irrigation will be done after each file. cleaning and shaping will be done with rotary file. collection of fluid sample for microbial content will be taken from the root canal space. instrumentation time will be measured with the help of stop watch from the time of start of cleaning and shaping till the end of cleaning and shaping. canals will be dried and obturation will be carried out. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Absence of periapical or interradicular
radiolucency.
Radiographic absence of external or internal
pathological resorption.
Primary teeth with at least 2/3 of the root intact.
Adequate tooth structure to support a rubber
dam.
Children with Frankle + and++ Behaviour 
 
ExclusionCriteria 
Details  Any subject that does not fall under the inclusion
criteria were excluded
Parents not willing to give consent
Children with Special Health Care needs
(SHCN)
Children with systemic diseases 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is the success of the
treatment. Success will be defined by the
absence of major failure Clinically and Radiographically. i.e.
absence of pain, abscess, swelling, interfurcal radiolucency, root resorption etc. and patient and/or parent
acceptance will be clinically evaluated at
baseline and at last appointment 
evaluation will be carried out at baseline, 3 months, 6 months and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome is the success of the
treatment
Success will be defined by the
evaluation of anti-microbial efficacy. i.e. reduction in aerobic and/or anaerobic microbial count (CFU) 
12 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   Phase 3 
Date of First Enrollment (India)   04/12/2024 
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="1" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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-identification.

  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 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 [amolpatil2526@gmail.com].

  6. For how long will this data be available start date provided 23-10-2024 and end date provided 23-10-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
Successful pulp therapy (SPT) requires
absolute aseptic condition of the root canals
by adequately cleaning and shaping of the
root canal.[1] Convoluted pulpal canals often
make the biomechanical preparation a
challenging process in primary teeth.[2] Ideal
obturation should provide fluid impervious
seal for the successful pulp therapy.[3] There
are numerous factors which are responsible
for achieving the ideal quality of obturation
such as, preparing the root canal walls to
achieve adequate filling of the obturating
material till the apex and the presence of
three- dimensional seal of the root canal.[4]
One of the main complications faced by
children following pulp therapy is the
presence of postoperative pain.[5]
Postoperative pain is due to the apical
extrusion of the debris during
instrumentation producing inflammatory
reaction. The biological objective is to
eliminate necrotic pulp, bacteria, and
bacterial toxins using instrumentation and
irrigation, followed by filling the sterile canal
with a resorbable material. [4] Besides
thorough cleaning and debridement of the
root canal, the treatment duration is
particularly important in pediatric dentistry.
The use of hand instruments is very time
consuming and produces unwanted
complications like apical transportation and
ledge formation.[7] Adequately tapered
preparations are required to seal the root
canals till the apex with the obturating
material.[8] To provide high-quality treatment
more efficiently, rotary instrumentation has
been introduced.[5] Rotary instrumentation
was introduced for primary teeth by Barr et
al. in 2000.[6] This technique offers both
advantages and disadvantages for primary
and permanent teeth. The use of rotary
systems facilitates uniform preparation and
thorough debridement of root canals. Silva et
al. reported that using rotary instrumentation
in primary teeth significantly reduces the
time required for root canal preparation.[7]
Studies have also demonstrated that nickeltitanium
(NiTi) rotary instruments provide a
good taper to the preparation, improving
obturation quality with minimal risk of canal
transportation.[8,9] However, Drukteinis and
Balciuniene noted that rotary instruments
might not completely clean the isthmus and
fins of primary teeth due to their centering
ability in the root canal. They recommended
additional use of an H-file to remove infected
tissue from ribbon-shaped canals and
mitigate this disadvantage.[10] Other
drawbacks of rotary instrumentation include
increased cost and the potential for
instrument breakage.[11]Exclusive rotary file
systems for primary teeth have been
developed over the time to overcome the
disadvantage of the existing rotary files like
Kedo s square File, Rainbow File, Fanta af
file etc. Hence,the aim of this clinical trial is
Comparative evaluation of Clinical
outcome, Radiographic success and
Antimicrobial efficacy of hand files with
reciprocating handpiece v/s 3 different types
of rotary file systems in primary teeth : A
randomized Clinical study
 
Close