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CTRI Number  CTRI/2024/11/077418 [Registered on: 27/11/2024] Trial Registered Prospectively
Last Modified On: 08/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative evaluation of three full coverage restorations in pediatric dentistry. 
Scientific Title of Study   Comparative evaluation of Hybrid Resin Polymer, Nano Hybrid Composite and preformed Stainless-steel crowns in primary second molars- A Randomized Control 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  Irin Mariam Zachariah 
Designation  Junior Resident II 
Affiliation  PMS College of Dental Science and Research  
Address  Department Of Pediatric And Preventive Dentistry PMS College of Dental Science and Research, Golden Hills, Vattapara, Venkode, Thiruvananthapuram 2nd year Junior Resident

Thiruvananthapuram
KERALA
695028
India 
Phone  9656430149  
Fax    
Email  irinzachariah@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Anandraj S 
Designation  Professor 
Affiliation  PMS College of Dental Science and Research  
Address  Department Of Pediatric And Preventive Dentistry PMS College of Dental Science and Research, Golden Hills, Vattapara,Venkode, Thiruvananthapuram

Thiruvananthapuram
KERALA
695028
India 
Phone  9447343206  
Fax    
Email  dranandraj@gmail.com  
 
Details of Contact Person
Public Query  
Name  IRIN MARIAM ZACHARIAH 
Designation  Junior Resident II 
Affiliation  PMS College of Dental Science and Research  
Address  Department Of Pediatric And Preventive Dentistry PMS College of Dental Science and Research, Golden Hills, Vattapara, Venkode, Thiruvananthapuram 2nd year Junior Resident

Thiruvananthapuram
KERALA
695028
India 
Phone  9656430149  
Fax    
Email  irinzachariah@gmail.com  
 
Source of Monetary or Material Support  
PMS College of Dental Science and Research, Golden Hills, Vattapara, Venkode, Thiruvananthapuram Kerala India 695028 
 
Primary Sponsor  
Name  Irin Mariam Zachariah 
Address  PMS College of Dental Science and Research, Golden Hills, Vattapara, Venkode, Thiruvananthapuram Kerala India 695028 
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 Irin Mariam Zachariah  PMS College of Dental Science And Research  Department Of Pediatric And Preventive Dentistry
Thiruvananthapuram
KERALA 		 9656430149

irinzachariah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTE, PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z012||Encounter for dental examination and cleaning,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hybrid- Resin- Polymer Crown   Hybrid- resin- polymer crown (Bioflx crown, kids-e-dental, India) Used as pediatric crown Intervention time period is 1 year  
Intervention  Nano-Hybrid-Composite Crown   Nano-Hybrid-Composite Crown (Edelweiss crown, Austria) Used as pediatric crown Intervention time period is 1 year 
Comparator Agent  Preformed stainless-steel crown  Preformed stainless-steel crown (3M Stainless Steel Crown) Used as pediatric crowns 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1. Patients within age group of 5 – 9 years
2. Apparently healthy children free of any systemic disease or any developmental disturbances
3. Pulpotomized or pulpectomized primary mandibular second molars
4. Cooperative children
 
 
ExclusionCriteria 
Details  1. Children having any parafunctional habits
2. Children allergic to nickel, resin polymer and nano hybrid composite.
3. Patients not willing to take part in the study.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
•To evaluate the gingival and periodontal health of tooth among hybrid resin polymer crown, nano hybrid composite crown and stainless-steel crown in mandibular primary second molars.
•To evaluate the retention of hybrid resin polymer crown, nano hybrid composite crown and stainless-steel crown in mandibular primary second molars
•To evaluate the attrition of crown/opposing tooth among hybrid resin polymer crown, nano hybrid composite crown and stainless-steel crown in mandibular primary second molars
•To compare the gingival and periodontal health of tooth, retention and attrition of crown/opposing tooth among hybrid resin polymer crown, nano hybrid composite crown and stainless-steel crown in mandibular primary second molars
 		 2 YEARS
 
 
Secondary Outcome  
Outcome  TimePoints 
•To evaluate the chair side time & patient & parent satisfaction of hybrid- resin- polymer crown, nano-hybrid-composite crown & stainless-steel crown in mandibular primary second molars.
•To compare the chair side time & patient & parent satisfaction of hybrid- resin- polymer crown, nano hybrid composite crown & stainless-steel crown in mandibular primary second molars
 		 2 YEARS 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/12/2024 
Date of Study Completion (India) 27/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 27/11/2025 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Not published 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  should be directed to email id irinzachariah@gmail.com

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

The present study is to evaluate and compare clinical success of these full coverage restorations, hybrid resin polymer crown and nano hybrid composite crown with the gold standard stainless steel crown on mandibular primary second molars. The study concluded that Stainless steel crowns are considered as gold standard in pediatric crown because of its better clinical performance while Bioflx crowns and Edelweiss crowns can be considered as an alternative when esthetics is prime concern.

 
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