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CTRI Number  CTRI/2025/07/091993 [Registered on: 30/07/2025] Trial Registered Prospectively
Last Modified On: 29/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Bioflx crowns for baby teeth: Do they work and are they liked. 
Scientific Title of Study   Assessment of clinical efficacy, parental and child acceptance of prefabricated Bioflx crowns in primary molars. 
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 Harshitha V R 
Designation  Post Graduate  
Affiliation  The Oxford dental college and hospital. 
Address  The Oxford Dental College and Hospital, Department of Pediatric and Preventive Dentistry, 4th floor, Room No.8,Bommanahalli, Hongasandra, Bangalore.
The Oxford Dental College and Hospital, Department of Pediatric and Preventive Dentistry, 4th floor, Room No.8,Bommanahalli, Hongasandra, Bangalore
Bangalore
KARNATAKA
560068
India 
Phone  9398016508  
Fax    
Email  harshitha.v.r123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harshitha V R 
Designation  Post Graduate  
Affiliation  The Oxford dental college and hospital. 
Address  The Oxford Dental College and Hospital, Department of Pediatric and Preventive Dentistry, 4th floor, Room No.8,Bommanahalli, Hongasandra, Bangalore.
The Oxford Dental College and Hospital, Department of Pediatric and Preventive Dentistry, 4th floor, Room No.8,Bommanahalli, Hongasandra, Bangalore
Bangalore
KARNATAKA
560068
India 
Phone  9398016508  
Fax    
Email  harshitha.v.r123@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sneha Raj N 
Designation  Reader 
Affiliation  The Oxford Dental College 
Address  The Oxford Dental College and Hospital, Department of Pediatric and Preventive Dentistry, 4th floor, Room No.8,Bommanahalli, Hongasandra, Bangalore.
The Oxford Dental College and Hospital, Department of Pediatric and Preventive Dentistry, 4th floor, Room No.8,Bommanahalli, Hongasandra, Bangalore.
Bangalore
KARNATAKA
560068
India 
Phone  7259784347  
Fax    
Email  dr.sneharaj.n@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Harshitha VR 
Address  The Oxford Dental College and Hospital, Department of Pediatric and Preventive Dentistry, 4th floor, Room No.8,Bommanahalli, Hongasandra, Bangalore, Karnataka. pincode 560068. 
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 Harshitha V R  The Oxford Dental College and Hospital  room no.8, 4th floor, department of pediatric and preventive dentistry, the oxford dental college and hospital. bommanahalli,hosur road, bangalore.
Bangalore
KARNATAKA 		 9398016508

harshitha.v.r123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K041||Necrosis of pulp,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bioflx Crowns  Assessment of clinical efficacy, parental and child acceptance of prefabricated Bioflx crowns in primary molars at 1,3 and 6 months. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Children with good general health.
Age group: 4 to 9 years
Children who can be treated using behavior management techniques.
Primary molars with dental caries.
Pulpotomised or pulpectomised primary molars.
•Primary teeth with at least 2/3 rd. of the root length remaining
 
 
ExclusionCriteria 
Details  Children with history of para functional habits, bruxism or deep bite.
Absence of opposing primary molars in arch.
Primary molars with pre-shedding mobility.
Presence of attrition or abrasion on the opposing primary molars
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To assess the clinical efficacy of prefabricated bioflx crowns in primary molars using
marginal integrity, crown retention, gingival response, plaque accumulation & wear of opposing teeth  		 review at baseline, 1,3 and 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
2. To evaluate parental & child acceptance.  review at baseline,1,3 & 6 months. 
3. To evaluate the bite force pre & post-cementation of bioflx crown   review at baseline, 1,3 & 6 months. 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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/ Phase 4 
Date of First Enrollment (India)   01/09/2025 
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)  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  

Twenty five primary molars (upper/ lower) will be selected based on inclusion criteria, to receive prefabricated bioflx crown (Kids-e-Dental, Mumbai, India).The treatment procedure and nature of study will be explained to the parents of the children and their prior written informed consent will be taken. A questionnaire-type proforma will be used to record demographic information.

The prefabricated bioflx crown will be selected as per mesio-distal width and manufacturer’s instruction manual. Following application of topical local anesthesia gel, gingival retraction cords will be placed and tooth preparation will be checked to ensure crown will be a snug fit and occlusal height will be checked after placement of the crown. The crown will be cemented using luting type 1 glass ionomer cement. Patients will be given post-operative instructions and the crowns will be evaluated at 1, 3 and 6 months respectively.

Clinical evaluation of the prefabricated crown will be done according to criteria given by United State Public Health Service (USPHS). The prefabricated bioflx crown will be evaluated for color, marginal integrity, crown retention, restoration failure and opposing tooth wear through visual inspection and tactile examination using a dental explorer. A blunt periodontal probe (William’s periodontal probe) will be used to assess gingival health (Leo and Silness 1963) and plaque accumulation will be assessed using plaque index (Silness and Leo 1964) around the margins of prefabricated crown. Smith and Knight (1984) tooth wear index will be used to assess tooth wear in opposite teeth. Parental acceptance of prefabricated bioflx crowns for size, color and shape will be evaluated using 5 point Likert scale and child acceptance will be done by using 5 point Likert facial expression scale.

An occlusal force meter (GM 10 Nagano Keiki, Japan) will be used to measure the pre-operative and post-operative bite force by asking the child to bite on the gauge of an occlusal force meter as hard as possible without moving the head for 15 secs. Each child will be asked to sit in an upright position without head support and with Frankfort horizontal plane parallel to the floor. The bite force will be expressed in newton’s (N).

 
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