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CTRI Number  CTRI/2018/04/013313 [Registered on: 17/04/2018] Trial Registered Retrospectively
Last Modified On: 12/04/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluation of Zinc oxide-Propolis mixture as root canal filling material in primary molars - A 2 year clinical trial 
Scientific Title of Study   Invivo evaluation of Zinc oxide-Propolis mixture as root canal filling material in primary molars 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KAKARLA SRI ROJA RAMYA 
Designation  MDS 
Affiliation  Vishnu Dental College 
Address  Dr KS Roja Ramya, Department of pedodontics, Block III, Room no. 5, Vishnu dental college, Bhimavaram, West Godavari district
Dr KS Roja Ramya, Department of pedodontics, Block III, Room no. 5, Vishnu dental college, Bhimavaram, West Godavari district
West Godavari
ANDHRA PRADESH
534202
India 
Phone  8985774540  
Fax    
Email  roja.ramya86@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  K SRI ROJA RAMYA 
Designation  MDS 
Affiliation  Vishnu Dental College 
Address  Dr KS Roja Ramya, Department of pedodontics, Block III, Room no. 5, Vishnu dental college, Bhimavaram.
Dr KS Roja Ramya, Department of pedodontics, Block III, Room no. 5, Vishnu dental college, Bhimavaram - 534202
West Godavari
ANDHRA PRADESH
534202
India 
Phone  8985774540  
Fax    
Email  roja.ramya86@gmail.com  
 
Details of Contact Person
Public Query
 
Name  K SRI ROJA RAMYA 
Designation  MDS 
Affiliation  Vishnu Dental College 
Address  Dr KS Roja Ramya, Department of pedodontics, Block III, Room no. 5, Vishnu dental college, Bhimavaram.
Dr KS Roja Ramya, Department of pedodontics, Block III, Room no. 5, Vishnu dental college, Bhimavaram, West Godavari district
West Godavari
ANDHRA PRADESH
534202
India 
Phone  8985774540  
Fax    
Email  roja.ramya86@gmail.com  
 
Source of Monetary or Material Support  
Vishnu Dental College 
 
Primary Sponsor  
Name  KAKARLA SRI ROJA RAMYA 
Address  Dr KS Roja Ramya, Department of pedodontics, Block III, Room no. 5, Vishnu dental college, Bhimavaram, West Godavari District, 534202 
Type of Sponsor  Other [Self] 
 
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 K Sri Roja Ramya  Vishnu Dental college  Department of pedodontics, Block III, Room no. 5, Bhimavaram
West Godavari
ANDHRA PRADESH 
8985774540

roja.ramya86@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Infected primary molars,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Zinc oxide-Eugenol  Zinc oxide powder, Deepak enterprises, Mumbai, India; Eugenol,Prime Dental Products Pvt. Ltd, Thane, India.  
Intervention  Zinc oxide-Propolis mixture  Zinc oxide powder, Deepak enterprises, Mumbai, India; Brazilian Green Propolis alcohol free 60%, Uniflora Health foods, Brazil.  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Primary molars with signs of chronic irreversible pulpitis with extra-oral or intra-oral swelling, sinus opening, grade I mobility due to periradicular infection, radiographic evidence of minimum bone degeneration were included in the study. 
 
ExclusionCriteria 
Details  Primary molars with less than two thirds of remaining root length and teeth with non-restorable crown structure, molars demonstrating extensive external or internal resorption, molars exhibiting greater than grade I mobility and children who are allergic to propolis were excluded.
 
 
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 
Success of Zinc oxide-Propolis mixture filled teeth
Success of Zinc oxide Eugenol filled teeth 
24 months 
 
Secondary Outcome  
Outcome  TimePoints 
Success of Zinc oxide-Propolis mixture filled teeth
Success of Zinc oxide Eugenol filled teeth 
6 months and 12 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   16/07/2014 
Date of Study Completion (India) 21/07/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="5" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study was conducted to evaluate and compare the clinical efficacy of Zinc oxide-Propolis mixture with Zinc oxide Eugenol as root canal filling material in infected primary molars. This study is a randomized, double blind, trial comprising of 40 primary molars from the children aged 4-8yrs which were divided into two groups according to the obturating material used: Test group: Zincoxide-Propolis mixture; control group: Zinc oxide Eugenol. All the pulpectomy treated teeth were finally restored with stainless steel crowns and the children were recalled at 6, 12 and 24 months for post-operative clinical and radiographic evaluation to assess the success rate. The primary outcome measures were success at 24 months. The secondary outcome measures were success at 6 and 12 months. 

At 6 month follow-up, Zincoxide–Propolis mixture has shown 100% success, while Zincoxide Eugenol has shown a success of 80% and the difference was statistically significant(p= 0.035). At 12 month follow-up, Zincoxide–Propolis mixture has shown a success of 95%, while Zincoxide Eugenol has shown a success of 80%. At 24 month follow-up, Zincoxide–Propolis mixture has shown 95% success, while Zincoxide Eugenol has shown a success of 70% and the difference was statistically significant(p= 0.037). Zincoxide–Propolis mixture demonstrated good clinical and radiographic success at 24 months follow-up and hence it can be used as an alternate root canal filling material in primary teeth.

 
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