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CTRI Number  CTRI/2025/08/093775 [Registered on: 27/08/2025] Trial Registered Prospectively
Last Modified On: 26/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison to assess the success rate between preformed dental crown and custom dental crown in pediatric patient 
Scientific Title of Study   Comparative Evaluation of Bioflx crown Vs 3D Printed Resin Crown among Adoloscence: A Multicentric study. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Himanshu thukral 
Designation  Dental officer  
Affiliation  Military dental centre  
Address  Military Dental Centre Secunderabad Gough lines, near AOC centre Thirumalghiri, Secunderabad, 500015.

Hyderabad
TELANGANA
500015
India 
Phone  9818377761  
Fax    
Email  him1308@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Himanshu thukral 
Designation  Dental officer  
Affiliation  Military dental centre  
Address  Military Dental Centre Secunderabad Gough lines, near AOC centre Thirumalghiri, Secunderabad, 500015.
Military Dental Centre Secunderabad Gough lines, near AOC centre Thirumalghiri, Secunderabad, 500015.

TELANGANA
500015
India 
Phone  9818377761  
Fax    
Email  him1308@gmail.com  
 
Details of Contact Person
Public Query  
Name  Himanshu thukral 
Designation  Dental officer  
Affiliation  Military dental centre  
Address  Military Dental Centre Secunderabad Gough lines, near AOC centre Thirumalghiri, Secunderabad, 500015.
Military Dental Centre Secunderabad Gough lines, near AOC centre Thirumalghiri, Secunderabad, 500015.

TELANGANA
500015
India 
Phone  9818377761  
Fax    
Email  him1308@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Armed forces medical research committee  
Address  DGAFMS Defence offices complex Africa avenue New Delhi 110023 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dhruv  Military dental centre Golconda   Ibrahim Road Pin code 500031
Hyderabad
TELANGANA 		 8800788030

Saggidhruv@gmail.com 
Tapan singh  Military dental centre Cannanore   Inside military hospital Payyambalam Kannur
Kannur
KERALA 		 8697212213

drtapansingh@gmail.com 
Himanshu thukral  Military dental centre Secunderabad   Gough lines, near AOC centre Thirumalghiri, Secunderabad, 500015.
Hyderabad
TELANGANA 		 9818377761

him1308@hmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Miilitary dental centre gl Secunderabad   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Custom dental crown   3 d printed poly methyl Meth acrylate crown 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1 Patients aged 7 to 14 years
2 At least one molar tooth indicated for full coverage post pulp therapy
3Good general health with no systemic conditions affecting oral health
4Patients guardians willing to provide informed consent and adhere to follow-up visits. 
 
ExclusionCriteria 
Details  1. Patients with systemic illnesses (e.g. bleeding disorders).
2. Teeth with mobility, extensive root resorption or non-restorable crowns.
3. Known allergies to dental materials used in the study.
4. Poor oral hygiene or uncooperative behaviour impeding treatment.
5. History of parafunctional habits (e.g bruxism) that may affect crown performance. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
The findings of this study will aid paediatric dental practitioners in evidence-based decision-making regarding aesthetic crown selection and may contribute to the development of clinical guidelines for restorative treatment in older children and adolescents  12 months  
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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   N/A 
Date of First Enrollment (India)   03/08/2026 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

The restoration of extensively decayed molars in paediatricpatients often relies on stainless steel crowns (SSCs), known for their durability but limited by poor aesthetics and potential gingival irritation. To address these concerns, aesthetic alternatives like Bioflx crowns, made of        fiber-reinforced composite material, offer improved flexibility, biocompatibility, and chairside efficiency. Similarly, 3D printed resin crowns have gained popularity due to their customizable fit, precision, and enhanced aesthetic appeal.

Despite individual clinical success, there is limited comparative evidence on the clinical performance of Bioflx versus 3D printed crowns, especially in older children and adolescents (7–14 years) where both aesthetics and function are critical. A multicentric studydesign provides a broader clinical perspective and minimizes operator bias.

This study aims to evaluate and compare the survival, biological response, and aesthetic outcomes of Bioflx and 3D printed resin crowns for molar restorations in patients aged 7–14 years.

 
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