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CTRI Number  CTRI/2018/09/015573 [Registered on: 04/09/2018] Trial Registered Prospectively
Last Modified On: 30/08/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Root canal preparation in primary teeth 
Scientific Title of Study   Comparison of hand, reciprocating and rotary instrumentation technique in primary teeth -A double blinded randomized control trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ganesh Jeevanandan 
Designation  Reader 
Affiliation  Saveetha Dental College 
Address  No 28, 5 th floor, 162, Saveetha Dental College, Poonamallee high road, Velappanchavadi,

Chennai
TAMIL NADU
600077
India 
Phone  09884293869  
Fax    
Email  helloganz@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ganesh Jeevanandan 
Designation  Reader 
Affiliation  Saveetha Dental College 
Address  No 28, 5 th floor, 162, Saveetha Dental College, Poonamallee high road, Velappanchavadi,

Chennai
TAMIL NADU
600077
India 
Phone  09884293869  
Fax    
Email  helloganz@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ganesh Jeevanandan 
Designation  Reader 
Affiliation  Saveetha Dental College 
Address  No 28, 5 th floor, 162, Saveetha Dental College, Poonamallee high road, Velappanchavadi,

Chennai
TAMIL NADU
600077
India 
Phone  09884293869  
Fax    
Email  helloganz@gmail.com  
 
Source of Monetary or Material Support  
Reeganz Dental Care Pvt Ltd 2182/2 Abirami apartment, Shanthi colony, 12th Main road, Anna nagar , chennai -40 
 
Primary Sponsor  
Name  Reeganz Dental Care Pvt Ltd 
Address  2182/2 Abiramai apartments 12th main road shanthi colony  
Type of Sponsor  Private hospital/clinic 
 
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 Ganesh Jeevanandan  Saveetha Dental College  Department of Pediatric and Preventive Dentistry , Room No 28, 162 Ponnamallee High Road Velapanchavadi,
Thiruvallur
TAMIL NADU 
9884293869

helloganz@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethical Commitee, Saveetha Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R52||Pain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 1  Hand files 
Intervention  Group 2  Reciprocating files 
Intervention  Group 3  kedo rotary files 
Comparator Agent  hand file vs rotary files  comparing a new pediatric specific rotary file ( kedo files ) with hand k-files and reciprocating files 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  patients with

pain in primary molar teeth with any sign and symptoms of irreversible pulpitis due to caries 
 
ExclusionCriteria 
Details  patients with

primary molars with internal or external resorption
Medically compromised patients  
 
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 
Quality of obturation with its clinical and radiographic sucess and instrumentation time   3,6,9,12,15,18,21,24,27,30,33,36 months 
 
Secondary Outcome  
Outcome  TimePoints 
instrumentation time, instrument fracture, post operative infection  baseline, 3, 6,9,12,15,18,21,24,27,30,33,36 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2 
Date of First Enrollment (India)   10/09/2018 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Submit to International Journal to Pediatric Dentistry 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Pulpectomy is the intervention of choice for treating infected pulp tissues in pediatric dental patients. Earlier this treatment was performed with hand instruments. Rotary instruments were introduced to pediatric endodontics in the year 2000. However, morphological challenges posed by the primary root canals demand an improvement in the quality and design of contemporary rotary instruments so as to avoid undesirable complications, viz., canal transportation, ledges, strip perforations, zips, etc.  Rotary NiTi files follow the original anatomy of curved canals in primary teeth, and hence minimize the risk of procedural errors. Also, a funnel-shaped canal preparation is obtained, and thus a uniform and more predictable obturation with pastes can be achieved. More importantly, rotary files shorten the preparation time considerably and, therefore, suit the shorter attention spans of children, thus, increasing their cooperation for the endodontic procedure. Recently reciprocating files system has been used in primary teeth for root canal preparation in primary teeth. So, it is necessary to evaluate the best system which results in successful pulpectomy procedure in primary teeth.

 
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