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CTRI Number  CTRI/2024/03/064787 [Registered on: 27/03/2024] Trial Registered Prospectively
Last Modified On: 26/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Advancements in pediatric posterior crowns. 
Scientific Title of Study   Evaluation of preformed BioFlx crowns, Zirconia crowns and Stainless-steel crowns on primary molars: A 12-month randomized clinical 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 S Shetty 
Designation  Post Graduate Student 
Affiliation  RajaRajeswari Dental College and Hospital 
Address  Dept of Paediatrics and Preventive Dentistry No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru

Bangalore
KARNATAKA
560074
India 
Phone  9740636863  
Fax    
Email  nidhishetty2099@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amrutha Ujjamma B 
Designation  Reader 
Affiliation  RajaRajeswari Dental College and Hospital 
Address  RajaRajeswari Dental College and Hospital No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru

Bangalore
KARNATAKA
560074
India 
Phone  8105700221  
Fax    
Email  amrutha.b87@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nidhi S Shetty 
Designation  Post Graduate Student 
Affiliation  RajaRajeswari Dental College and Hospital 
Address  Dept of Paediatrics and Preventive Dentistry No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru

Bangalore
KARNATAKA
560074
India 
Phone  9740636863  
Fax    
Email  nidhishetty2099@gmail.com  
 
Source of Monetary or Material Support  
RajaRajeswari Dental College and Hospital 
 
Primary Sponsor  
Name  Dr. Nidhi S Shetty 
Address  RajaRajeswari Dental College and Hospital Dept of Pediatric and Preventive Dentistry No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru 560074 
Type of Sponsor  Other [Self-funded] 
 
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 S Shetty  RajaRajeswari Dental College and Hospital  Dept of Pediatric and Preventive Dentistry No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru
Bangalore
KARNATAKA 
9740636863

nidhishetty2099@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RajaRajeswari Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Modified USPHS criteria  Total time required for preparation, fitting and cementation; plaque accumulation; retention of crown; tooth wear in opposing teeth; radiographic findings at baseline, 3months, 6 months and 12 months interval. 
Intervention  Posterior crown  Stainless-steel crown, Zirconia crown, BioFlx crown for 1 year 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Children of 3-9 years of age
Children healthy and free of any systemic diseases
Primary teeth requiring full coronal restorations following pulpotomy/pulpectomy
Primary teeth with at least 2/3rd of the root length remaining
Children who are co-operative (Frankl rating of 3 and 4)
Children for whom consent was obtained from parents 
 
ExclusionCriteria 
Details  Teeth with tooth resorption.
Infection/ inflammation involving the furcation area.
Teeth with inadequate crown structure.
Children with any underlying diseases.
Children who are non-co-operative (Frankl rating of 1 and 2)
Parents who are not willing to participate.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the clinical outcome of preformed BioFlx crowns, Zirconia crowns and Stainless-Steel crowns over a period of 0, 3, 6 and 12 months when used to restore primary molars.  The crown will be clinically assessed for: the total time required for preparation, fitting and cementation; plaque accumulation; retention of the crown; tooth wear in opposing teeth; and radiographic findings at baseline, 3 months, 6 months and 12 months. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the child and parental satisfaction of preformed BioFlx crowns, Zirconia crowns and Stainless-Steel crowns.  A questionnaire will be asked to fill at the end of 12 months 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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   Phase 4 
Date of First Enrollment (India)   05/04/2024 
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="1"
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 present study will be done on children aged 3-9 years with extensive dental caries requiring full coverage restorations. A thorough clinical examination will be done for active dental caries using a plain dental mirror and explorer on the dental chair with optimal light, after which 45 primary teeth requiring crowns will be distributed randomly into three groups consisting of 15 participants in each: Group 1: Preformed Stainless-Steel crowns; Group 2: Preformed Zirconia crowns; Group 3: Preformed BioFlx crowns.

Informed consent will be obtained from parents or guardians of children participating in this study. Patients having extensive dental caries who require full coverage restoration will then be shortlisted, who will undergo either pulpotomy or pulpectomy procedure after which they will be randomly distributed into the above mentioned three groups for crown placement. The operator would be blinded to the type of the crown until the beginning of tooth preparation.

All the crowns will be clinically assessed by a single evaluator immediately after crown placement, at three months, six months and twelve months follow-up using United States Public Health Service (USPHS) criteria. The crown will be assessed for: the total time required for preparation, fitting and cementation; plaque accumulation; retention of the crown; tooth wear in opposing teeth; and radiographic findings.  The outcome assessor will be blinded at the data entry level to avoid bias. Also, at 12 months the parents will be asked to complete a simple six-item Likert scale questionnaire to evaluate their satisfaction with the procedure.

 
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