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CTRI Number  CTRI/2024/08/072111 [Registered on: 08/08/2024] Trial Registered Prospectively
Last Modified On: 06/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing different types of Pediatric crowns for primary molar teeth: Stainless Steel, Bioflx, and Zirconia. 
Scientific Title of Study   Comparative evaluation of preformed Stainless steel, Bioflx and Zirconia crowns in restoring primary molars – A Randomized 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. Akansha Gupta 
Designation  Post Graduate Student 
Affiliation  Maulana Azad Institute of Dental Sciences 
Address  5th floor, Department of Pediatric and Preventive Dentistry, Maulana Azad Institute of Dental Sciences, BSZ Marg, New Delhi.

Central
DELHI
110002
India 
Phone  9582418066  
Fax    
Email  guptaakansha.8105@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Mridula Goswami 
Designation  Professor(SAG) and Head of Department 
Affiliation  Maulana Azad Institute of Dental Sciences 
Address  Department of Pediatric and Preventive Dentistry, Maulana Azad Institute of Dental Sciences, BSZ Marg, New Delhi.

Central
DELHI
110002
India 
Phone  9654700977   
Fax    
Email  mm_goswami@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr. Akansha Gupta 
Designation  Post Graduate Student 
Affiliation  Maulana Azad Institute of Dental Sciences 
Address  5th floor, Department of Pediatric and Preventive Dentistry, Maulana Azad Institute of Dental Sciences, BSZ Marg, New Delhi

Central
DELHI
110002
India 
Phone  9582418066  
Fax    
Email  guptaakansha.8105@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry, Maulana Azad Institute of Dental Sciences, BSZ Marg, New Delhi, Delhi, India, 110002 
 
Primary Sponsor  
Name  none 
Address  none 
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 Akansha Gupta  Maulana Azad Institute Of Dental Sciences  Post Graduate clinic, 5th floor, Department of Pediatric and Preventive Dentistry
Central
DELHI 		 9582418066

guptaakansha.8105@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Institute of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Preformed Bioflx Crowns  Use of preformed Bioflx crowns in primary molars being evaluated for 6 months in every patient. 
Comparator Agent  Preformed Stainless Steel Crown  Use of preformed Stainless Steel Crowns in primary molars being evaluated for 6 months in every patient. 
Intervention  Preformed Zirconia Crowns  Use of preformed Zirconia crowns in primary molars being evaluated for 6 months in every patient. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1. Children with atleast one primary molar having signs of irreversible pulpitis indicated for pulpectomy.
2. Children with atleast one primary molar having either abscess, sinus tract or periapical pathology indicated for pulpectomy.
3. Children with primary molar having atleast 2/3rd of its root length.
 
 
ExclusionCriteria 
Details  1. Children with any Special Health Care needs or systemic disease.
2. Children with primary molar having developmental anomalies such as amelogenesis imperfecta, dentinogenesis imperfecta, etc.
3. Children with primary molars having less than 2/3rd of its root length.
4. Children with non-restorable primary molars.
5. Children with parafunctional oral habits. 
 
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 Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Satisfactory clinical and radiographic performance of preformed Stainless steel crowns in primary molars.
2. Satisfactory clinical and radiographic performance of preformed Bioflx crowns in primary molars.
3. Satisfactory clinical and radiographic performance of preformed Zirconia crowns in primary molars. 		 baseline (T0), 1 month (T1), 3 months (T2) and 6 months (T3)
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Preformed Bioflx crowns show comparable clinical and radiographic performance as Stainless steel and Zirconia crowns in primary molars.  baseline (T0), 1 month (T1), 3 months (T2) and 6 months (T3)  
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   18/08/2024 
Date of Study Completion (India) 11/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   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   This study is a randomized, single-blinded, single-centre trial comparing the clinical and radiographic performance of 3 types of preformed crowns- Stainless Steel, Bioflx and Zirconia in restoring primary molars in children in the age group of 4-8 years in the Department of Pediatric and Preventive Dentistry, MAIDS. The primary outcome will depict the clinical and radiographic performance of 3 types of crowns and the secondary outcome will compare the 3 types of crowns. All patients will be evaluated at baseline, 1, 3, and 6 months. The need for this study arises from the lack of comprehensive data on their respective clinical performances in vivo. 
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