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CTRI Number  CTRI/2024/05/067773 [Registered on: 21/05/2024] Trial Registered Prospectively
Last Modified On: 12/05/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of prefabricated zirconia crowns and 3D printed resin crowns in children of 4-10 years as a permanent restoration after endodontic treatment. 
Scientific Title of Study   Comparative evaluation of efficiency of 3D printed resin and prefabricated zirconia crown as a final restoration for endodontically treated primary molars-: A randomised controlled 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  DR NIDHI SHARMA 
Designation  Post Graduate Student 
Affiliation  Government Dental College and Hospital,Nagpur 
Address  Department of pediatric Dentistry Government Dental College and Hospital, Nagpur Government Medical Campus Hanuman Nagar

Nagpur
MAHARASHTRA
440003
India 
Phone  9836634488  
Fax    
Email  nidssharma927@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR NIDHI SHARMA 
Designation  Post Graduate Student 
Affiliation  Government Dental College and Hospital,Nagpur 
Address  Department of pediatric dentistry Government Dental College and Hospital Nagpur Government Medical Campus Hanuman Nagar

Nagpur
MAHARASHTRA
440003
India 
Phone  9836634488  
Fax    
Email  nidssharma927@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR RITESH KALASKAR 
Designation  PROFESSOR AND HOD 
Affiliation  Government Dental College and Hospital Nagpur 
Address  Department of pediatric dentistry Government Dental College and Hospital Nagpur Government Medical Campus Hanuman Nagar

Nagpur
MAHARASHTRA
440003
India 
Phone  8550938585  
Fax    
Email  riteshpedo1@gmail.com  
 
Source of Monetary or Material Support  
Government Dental College and Hospital Nagpur, Maharashtra,440003,India 
 
Primary Sponsor  
Name  Dr Nidhi Sharma 
Address  Department of pediatric dentistry Government Dental College and Hospital Hospital Nagpur Government Medical Campus Hanuman Nagar Nagpur MAHARASHTRA 440003 India Nagpur MAHARASHTRA 440003 India 
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 Nidhi Sharma  Government Dental College & Hospital,Nagpur  Room 108 Department of Pediatric & Preventive Dentistry
Nagpur
MAHARASHTRA 		 9836634488

nidssharma927@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Dental College and Hospital Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Primary molars having dental caries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  3D printed resin crowns  Fabricated using digital light printing. The crown will be prepared on the 1st day and placed on the subsequent appointment within the next 2 days. The patient will be on a followup period of 12 months. 
Comparator Agent  Prefabricated Zirconia crowns  Prefabricated and available in different sizes. The crown will be prepared and placed on the same appointment. The patient will be kept on followup for a 12 month period. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1.Systematically healthy children of age group- 4-10 years.

2.Endodontically treated primary mandibular second molars (pulpotomy/pulpectomy)

3.Cooperative Children with Frankl Behaviour Scale 3 or 4 
 
ExclusionCriteria 
Details  1.Children with ASA physical status ≥ III, systemic illness.

2.Grossly decayed teeth indicated for extraction.

3.Highly uncooperative children.

4.Children with very poor oral hygiene. 
 
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 
To evaluate the functional properties of 3D printed resin crowns and prefabricated zirconia crown.

To evaluate biological properties of 3D printed resin crowns and prefabricated zirconia crown.

To evaluate aesthetic properties of 3D printed resin crowns and prefabricated zirconia crown.
 		 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the patients parent perception regarding the aesthetic of 3D printed resin crowns & Prefabricated zirconia crowns.
 		 12 months 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="44" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/06/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 This study is a double blind, prospective randomised controlled trial evaluating the efficacy of 3D printed resin crown and prefabricated zirconia crown as a permanent restoration in primary molars. This study is the first study to use 3D printed resin crown using NEXT DENT C&B microfilled hybrid as a final restoration in primary molars after endodontic treatment. The 3D printed resin crowns are being routinely used in adults as an interim prosthesis and the fact that the bite force in children is almost 3 times less than in adults it would suffice as a final restoration in children. Furthermore, invitro studies have proven that NEXT DENT C&B microfilled hybrid resin have sufficient fracture resistance which exceeds the maximum bite force in mixed dentition by almost three times. Thus, using 3D printing resin crowns will give a more precise accurate proximal contact points and marginal fit according to the patient’s morphology which is not possible with prefabricated crowns.The primary objective is to assess the functional,biological and aesthetic parameters of the crowns in primary molars. 
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