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CTRI Number  CTRI/2025/10/095738 [Registered on: 08/10/2025] Trial Registered Prospectively
Last Modified On: 21/05/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of clinical performance of Stainless Steel and metal free Resin polymer milk tooth crown in children aged 4-8 years. 
Scientific Title of Study   Assessing Clinical Outcomes of Stainless Steel Crown and Bioflx Crowns in Primary Molars: a Prospective Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Singh Trisha Kumari Ravindra Kumar 
Designation  Post Graduate 
Affiliation  Saraswati Dental College and Hospital 
Address  Dept. of Pedodontics, 3rd Floor, Room Number 6,Room colour code orange Saraswati Dental College and Hospital 233 Tiwari Ganj, Faizabad Road, Lucknow.
Dept. of Pedodontics, 3rd Floor, Room Number 6,Room Colour code orange Saraswati Dental College and Hospital 233 Tiwari Ganj, Faizabad Road, Lucknow.
Lucknow
UTTAR PRADESH
226028
India 
Phone  8529263489  
Fax    
Email  trishakumari989@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kavita Dhinsa 
Designation  Professor  
Affiliation   
Address  Dept. of Pedodontics, 3rd Floor, Room Number 6,Room colour code orange Saraswati Dental College and Hospital 233 Tiwari Ganj, Faizabad Road, Lucknow.

Lucknow
UTTAR PRADESH
226028
India 
Phone  9721222260  
Fax    
Email  grover.kavita@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Singh Trisha Kumari Ravindra Kumar 
Designation  Post Graduate 
Affiliation  Saraswati Dental College and Hospital 
Address  Dept. of Pedodontics, 3rd Floor, Room Number 6,Room colour code orange Saraswati Dental College and Hospital 233 Tiwari Ganj, Faizabad Road, Lucknow.

Lucknow
UTTAR PRADESH
226028
India 
Phone  8529263489  
Fax    
Email  trishakumari989@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Dr Singh Trisha Kumari Ravindra Kumar  
Address  Dept. of Pedodontics, 3rd Floor, Room Number 6,Room colour code orange Saraswati Dental College and Hospital 233 Tiwari Ganj, Faizabad Road, Lucknow.  
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 Singh Trisha Kumari  Saraswati Dental College and Hospital  Dept. of Pedodontics, 3rd Floor, Room Number 6,Room colour code orange Saraswati Dental College and Hospital 233 Tiwari Ganj, Faizabad Road, Lucknow.
Lucknow
UTTAR PRADESH 		 8529263489

trishakumari989@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Buman Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Physically and psychologically healthy human participants with mild to moderate dental caries involving primary 1st and 2nd molars. 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bioflx Pediatric Dental Prosthesis  As compared to Gold Standard SS Pediatric Dental Prosthesis, Bioflx has a better adaptability with slight resistance that can be described as an Flex or an Active fit as it has the ability to flex over small convexities of the dental structure. 
Comparator Agent  Stainless Steel Pediatric Dental Prosthesis  From ages in the history of Dentistry, Stainless steel crown has been used as a semipermanent dental prosthetic restoration, and is a Gold Standard. With the newer trends in the restorative materials in Pediatric Dentistry, newer variants like Bioflx have emerged claiming advanced Restorative Properties as compared to Gold Standard Stainless Steel crowns 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Multi-surface carious molar
Endodontically treated molars
Bilateral molars present
Willing to participate in study
Frankl positive children
 
 
ExclusionCriteria 
Details  parafunctional habits
Special needs child
Child with any known allergy to nicke
Crossbite/scissor bite present
Near exfoliation teeth
Unwilling participants
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Resistace to dislodgement, Colour match, Staining of crown, Gingival health, Retention of crown, Plaque retention, Occlusal wear of luted crown, Secondary caries at crown margin.  baseline , 3rd month post crown placement, 6th month post crown placement and 12th month post crown placement. 
 
Secondary Outcome  
Outcome  TimePoints 
Time taken for procedure,Parental satisfaction.  baseline and 12th month post crown placement. 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   20/10/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

RESEARCH DESIGN-

The split-mouth Randomization Controlled Trial will be conducted following Consolidated Standards of Reporting Trials (CONSORT) flow checklist.

A total of 55 Healthy children,aged between 4-7 years,were enrolled,contributing 55paired primary molars requiring crown placement .The study protocol will be thoroughly explained to all participant ,and written consent will be obtained from parents on behalf of their children.  

 

RESEARCH SETTING

The present in-vivo study will be conducted in the Department of Pediatric Dentistry,Saraswati Dental College and Hospital,Lucknow after obtaining clearance from Institutional Ethical Committee.

 

STUDY POPULATION: Pediatric patients  aged 4-8years requiring full-coverage crowns on contra-lateral molars.

 

INTERVENTION: Placement of Bioflx crown and Stainless-steel crown on contralateral sides in the same dental arch of each patient.

 

COMPARISON: Newly introduced tooth colored Bioflx crown with conventional Stainless-Steel crown as full-coverage restoration in primary molars.

 

Randomization: Randomization will be performed using computerized software.

Allocation sequence generation: Each number from the randomization list will be written on a white paper and placed in an envelope by a third person not involved in the study. Allocation will occur only after the envelope is opened.

Allocation sequence concealment: Opaque envelopes, numbered consecutively, will be used to conceal the allocation. The envelopes will be opened by an assistant who will not be part of the research team.

Outcome assessment blinding: Blinding of the operator and participants will not be possible due to differences in the material and color of the crowns.

All clinical procedures in the trial will be performed by a single operator, who will be calibrated for crown selection, tooth preparation, and crown cementation. Evaluation will be conducted by one assessor, while data entry will be carried out by a third evaluator who will remain completely blinded.

 

 OUTCOME: Multiple clinical and patient-related factors such as:

 

1) Time taken for   procedure.     

2) Resistace to dislodgement.

3) Colour match.

4) Staining of crown.

5) Gingival  health.

6) Retention of crown.

7) Plaque retention.

8)  Occlusal wear of luted crown.

9) Secondary caries at crown margin.

10) Parental satisfaction.

 

Assessed by using United States Public Health Services(USPHS) criteria ,for direct clinical evaluation.


For Gingival index : Loe and Silness scoring criteria  (1963)  will be used 

both types of groups at baseline, 6 months and 12 months’ followup visit. 

 

Plaque index  will be determined by simplified Greene and Vermillion oral hygiene index. 

 

INCLUSION CRITERIA

 

1.Children aged between 4 to 8 years. 

2.Primary Molars having large carious lesion involving multiple surfaces. 

3.Endodontically treated Primary Molars. 

4.Child with at least two Primary Molars contra-laterally. 

5.Parents willing to provide written consent.  

6.Frankl’s positive and definitely positive patients..

 

EXCLUSION CRITERIA

 

1.Child with parafunctional habit. 

2.Child with special needs. 

3. Any known allergy to nickle.  

4.Presence of Malocclusion such as crossbite or scissor bite. 

5.Physiologic mobility of tooth/teeth near exfoliation period. 

6.Severly decayed primary molar prohibiting retention and sealing of restoration.

7.children/parents not willing to participate in the study.

 
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