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CTRI Number  CTRI/2025/07/091042 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On: 15/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparison of two different preformed crowns in young permanent teeth 
Scientific Title of Study   Comparative evaluation of clinical success of stainless steel and Kids e Bioflx crowns in permanent teeth – A prospective randomized clinical 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  Dr Amol Suresh Patil 
Designation  Associate Professor 
Affiliation  M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India. 
Address  M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India.

Pune
MAHARASHTRA
411001
India 
Phone  09561042279  
Fax    
Email  amolpatil2526@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amol Suresh Patil 
Designation  Associate Professor 
Affiliation  M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India. 
Address  M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India.

Pune
MAHARASHTRA
411001
India 
Phone  09561042279  
Fax    
Email  amolpatil2526@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amol Suresh Patil 
Designation  Associate Professor 
Affiliation  M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India. 
Address  M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India.

Pune
MAHARASHTRA
411001
India 
Phone  09561042279  
Fax    
Email  amolpatil2526@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Department of Pedodontics 
Address  Department of Pedodontics, M A Rangoonwala College of Dental Sciences and Research Institute, Azam Campus, Camp, Pune, Maharashtra, India - 411001 
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 Amol Suresh Patil  M.A. Rangoonwala Dental College and Hospital  Department of Pedodontics, M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India.
Pune
MAHARASHTRA 
09561042279

amolpatil2526@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee MCE Society, Azam Campus, Pune -01  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bioflx Crown  The tooth will be anesthetized, crown selection will be carried out first for Kids-e-bioflx crowns. Then the PM will be prepared following the manufacturer’s guidelines by occlusal, peripheral, and subgingival reduction. The occlusion will be assessed for occlusal clearance. Prepared tooth should be free from blood, saliva, residues prior to crown cementation and Type -1 glass ionomer luting cement will be employed for luting of Kids-e-Bioflx crowns. After cementation, the crown surface will be cleaned and flossing will be done in the interdental area to remove excess cement. Post-operative radiographs will be recorded. The samples will be assessed as follows by the same operator. Crown assessment: A Clinical (criteria) B Radiographic Patient and parent satisfaction according to USPHS criteria will be recorded Occlusion ( using a articulating paper) The crown integrity will be assessed and signs of fracture of the crown will be checked for. Opposing tooth and crown wear will be checked using photographs of each recall. The patient will be recalled after 1, 3, 6, and 12 months for assessment of all the parameters. 
Intervention  Stainless Steel Crown  The stainless steel crown selection will be carried out. Then the tooth will be prepared by occlusal and proximal reduction as per the guideline given by Mathewson; an SCC will be tried and adjusted to fit the tooth. According to the manufacturing instructions, tooth preparation will be done and occlusion will be assessed. Prepared tooth should be free from blood, saliva, residues prior to crown cementation and Type -1 glass ionomer luting cement will be employed for luting of Stainless steel crowns. After cementation, the crown surface will be cleaned and flossing will be done in the interdental area to remove excess cement. Post-operative radiographs will be recorded. The samples will be assessed as follows by the same operator. Crown assessment Patient and parent satisfaction according to USPHS criteria will be recorded Occlusion ( using a articulating paper) The crown integrity will be assessed and signs of fracture of the crown will be checked for. Opposing tooth and crown wear will be checked using photographs of each recall. (Canon 1500 D DSLR, AUTO MODE) 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  Parents willing to give consent.
Permanent teeth indicated for full
coverage restoration.
Each permanent molar must have antagonist tooth present
Frankel’s positive and definitely positive
patients
Children aged between 7 to 13 years.
No significant medical history.
Patients willing to return for
follow-up examinations and evaluation.
Medically free patients
or with controlled systemic disease ASA I or II. No active periodontal diseases. 
 
ExclusionCriteria 
Details  Any subject that does not fall under the inclusion criteria were
excluded.
Parents not willing to give consent.
Children with special needs.
Severely decayed permanent molar prohibiting the retention and the sealing of the restoration.
permanent molar in infraocclusion.
Presence of malocclusion like cross bite, crowding, scissor bite etc.
Child allergic to local anesthesia, chromium, or nickel 
 
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 
The primary outcome is the success of the
treatment. Success will be defined by the
absence of major failure fracture, wear, color
change
Duration, occlusion, gingival margin extension
and parent
acceptance will be clinically evaluated at
baseline and at last appointment 
1 year 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcomes are parental and child
satisfaction (size, form, and function), retention
and fracture of the crown.
The wear of the antagonist tooth will be
recorded.
gingival condition, the wear of the antagonist
teeth, as well as both parental and child
satisfaction. 
1 year 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3 
Date of First Enrollment (India)   15/08/2025 
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)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Dental caries is a biofilm-mediated, sugar-driven, multifactorial, dynamic disease that results in the phasic demineralization and remineralization of dental hard tissues. Even now the treatment of decayed primary teeth presents significant challenges in Pediatric dentistry. The prevalence of dental caries in children worldwide in primary teeth is 46.2% and permanent teeth is 53.8%. [1] Among school-going children in India, the prevalence of dental caries in primary teeth is 64 to 78%, and in permanent teeth, it is 18 to 67%. [2] An appropriate treatment strategy is essential to overcome such a high prevalence of disease in pediatric patients. A variety of restorative materials have been explored to date. Full-coverage restorations have demonstrated the highest success rates when compared to other treatment modalities. A retrospective study by Erica Wu et.al, (2021) showed a long-term survival rate of 2 years for primary teeth with multi-surface caries. The survival rate of teeth treated with SSC was 92.8% and with intra-coronal restoration was 80%. [3] A literature search by Chisin LA et.al (2018) found a success rate of 96.1% associated with Stainless Steel Crown (SSC) in primary teeth. The main reason for the failure of treatment with intra-coronal restoration was secondary caries (36.5%). [4]

Full coverage restorations have proven effective in managing primary teeth with extensive caries. [2] Previous studies have shown that crowns significantly reduce the risk of long-term failure and pain in deciduous molars. [5] Thus SSC were proposed as the sole restorative option for caries involving more than two surfaces in primary molars. The  SSC are durable, relatively inexpensive and minimally invasive; with a success rate of around 96%. [6] However, the Nickel chromium allergies associated with SSCs, and its constitution of heavy metals increases the risk of corrosion and are known to be cytotoxic, Also the esthetics is compromised which makes it unacceptable in anterior region [7]. With an increase in demand for aesthetic restorations, various tooth-coloured crowns have been introduced. Polycarbonate crowns, Strip crowns, Pedo jacket crowns, New millennium crowns, Pedo pearl crowns, Artglass crowns, Preformed Zirconia Crowns (PZC), Figaro Crowns and the recently launched BioFlx crowns (BFC).

PZC possesses numerous advantages over the conventional SSC. It is notably strong and provides excellent aesthetic qualities and biocompatibility. Additionally, PZC exhibits high resistance to wear and corrosion. [8] SM Alaki et al. reported that PZC accumulates less plaque, as observed during follow-up visits. [9] Whereas, according to Agarwal et al. SSC were better in terms of retention, gingival response, and tooth wear in opposing teeth when compared to PZC during clinical evaluation of these crowns in paediatric patients. [10]  BFC introduced in 2021 by Kids-e-Dental LLP, are monochromatic, metal-free crowns that resemble tooth-coloured crowns. They are made from a high-strength resin polymer commonly used in the medical device industry, offering strength, flexibility, and durability. These crowns are autoclavable and the manufacturer claims them to be comparable to stainless steel crowns in tooth preparation. Recently published and only randomized clinical trial with 12 months follow-up comparing BFC and SSC showed that the clinical performance of BFC was similar to SSC for the restoration of primary molars, with an edge over SSC in providing better esthetics. [11]

Akin to their clinical properties, physical and mechanical properties are an important aspect to be studied. Clinical studies to test these properties are time-consuming and difficult to perform. Thus, in-vitro studies have been proven to be valuable while carrying out such tests.

The current study aimed to determine the physical properties of BFC and compare them with SSC and PZC; as previous studies have assessed the physical properties of SSC and PZC, but not those of the recently launched BFC. The null hypothesis of this study was, there is no difference in the compressive strength, microhardness, wear, and antimicrobial resistance of BFC, PZC, and SSC.

 
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