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CTRI Number  CTRI/2017/06/008749 [Registered on: 05/06/2017] Trial Registered Retrospectively
Last Modified On: 21/04/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing three different root canal filling methods in milk teeth 
Scientific Title of Study   Comparative Evaluation of Three Obturating Techniques in Primary Molars- An in vivo study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ellana Jermiah Joseph 
Designation  Post graduate student  
Affiliation  Manipal College of Dental Sciences  
Address  Manipal College Of Dental Sciences,Paedontics and preventive Dentistry, room no.5,Light House Hill Road, Mangalore - 575001

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9819550693  
Fax    
Email  ellana_j@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arathi Rao  
Designation  HOD and Guide 
Affiliation  Manipal College of Dental Sciences  
Address  Manipal College Of Dental Sciences,Paedontics and preventive Dentistry, room no.5,Light House Hill Road, Mangalore - 575001 Dakshina Kannada KARNATAKA 575001 India

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9845242079  
Fax    
Email  arathi.rao@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Arathi Rao  
Designation  HOD and Guide  
Affiliation  Manipal College of Dental Sciences  
Address  Manipal College Of Dental Sciences,Paedontics and preventive Dentistry, room no.5,Light House Hill Road, Mangalore - 575001 Dakshina Kannada KARNATAKA 575001 India

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9845242079  
Fax    
Email  arathi.rao@manipal.edu  
 
Source of Monetary or Material Support  
Manipal college of dental sciences, Mangalore 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 
Ellana Jermiah Joseph  Manipal College of Dental Sciences  Light House Hill Road,,Department of Pedodontics and Preventive Dentistry, room no 5. Mangalore - 575001 Dakshina Kannada KARNATAKA
Dakshina Kannada
KARNATAKA 
9833814041

ellana_j@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,MCODS Mangalore   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Teeth indicated for pulpectomy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1.Lentulospiral  1. Mani Co, Tokyo, Japan- zinc oxide eugenol will be used as the obturating material in the powder liquid ratio of 1:2. Treatment will take 1 hour 
Intervention  1.NaviTip® 2.NaviTip®  1.Ultradent Products, Inc., South Jordan, Utah, USA- zinc oxide eugenol will be used as the obturating material in the powder liquid ratio of 1:3. 2.Double Sideport, Ultradent Products, Inc., South Jordan, Utah, USA- zinc oxide eugenol will be used as the obturating material in the powder liquid ratio of 1:3. Treatment will take 1 hour 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1.All the teeth indicated for pulpectomy
2. Parents who have signed the informed consent form
3. Children who have signed the assent form 
 
ExclusionCriteria 
Details  1.Children with known allergy to zinc oxide eugenol
2. Medically compromised children
3. Physiologic root resorption greater than half of the root length 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical sucess, Radiographic success  Immediately after the treatment ( 1 hour ) 
 
Secondary Outcome  
Outcome  TimePoints 
Radiographic success, clinical success  1 hour 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/05/2017 
Date of Study Completion (India) 15/03/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Pulpectomy is one of the treatment options for deciduous teeth where the inflammation has reached the radicular pulp or teeth that have become non- vital.The function of a root canal filling is to obturate the canal and eliminate the portals of entry between the periodontium and the root canal.
The obturating material as well as obturation technique used that is capable of densely filling the entire root canal system and providing a fluid tight seal to prevent reinfection also significantly influences the success rate of the endodontic therapy.
Several methods have been used to deliver obturating materials into the root canals. Various studies have been conducted using different obturating techniques to fill the pulpectomized canals of primary teeth such as motor driven lentulospiral, hand held lentulospiral, reamer, local anesthetic syringe and a 27-gauge needle, NaviTip® system, endodontic pressure syringe, tuberculin syringe, absorbent paper point etc. .
There have been studies where NaviTip® has been proved to create less voids as compared to lentulospiral when used as an obturating technique in primary teeth . Navitip®, Navitip® (Double Sideport) have been used in endodontics for irrigation and has shown good results. It consists of a small cannula which navigates the most intricate canals and the double sideports horizontally express the material toward the canal walls and not to the apex. Navitip® (Double Sideport) has not yet been used for obturation.
The present study is thus proposed to evaluate and compare the filling quality of three delivery systems for root canal obturation in primary teeth, that is, Navitip®, Navitip® (Double Sideport) and rotary lentulospiral.
 
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