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CTRI Number  CTRI/2025/01/079196 [Registered on: 22/01/2025] Trial Registered Prospectively
Last Modified On: 21/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical Comparison of Anterior Aesthetic Flexible Crowns and Strip Crowns in Primary Teeth: A 12-Month RCT 
Scientific Title of Study   Comparative clinical evaluation of flexible crowns and strip crowns in primary anterior teeth: a 12-month randomized 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  Aditi Hagwane 
Designation  Post graduate student 
Affiliation  Pacific Dental College And Hospital, Debari, Udaipur 313024 Rajasthan India 
Address  Pacific Dental College And Hospital, room no 9 department of pediatric and preventive dentistry, Debari, Udaipur 313024 Rajasthan India

Udaipur
RAJASTHAN
313024
India 
Phone  7447473539  
Fax    
Email  aditihagwane98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dinesh Rao 
Designation  HOD PG guide 
Affiliation  Pacific Dental College And Hospital, Debari, Udaipur 313024 Rajasthan India 
Address  Pacific Dental College And Hospital, room no 9 department of pediatric and preventive dentistry, Debari, Udaipur 313024 Rajasthan India

Udaipur
RAJASTHAN
313024
India 
Phone  9414158235  
Fax    
Email  pedodinesh2003@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dinesh Rao 
Designation  HOD PG guide 
Affiliation  Pacific Dental College And Hospital, Debari, Udaipur 313024 Rajasthan India 
Address  Pacific Dental College And Hospital, room no 9 department of pediatric and preventive dentistry, Debari, Udaipur 313024 Rajasthan India

Udaipur
RAJASTHAN
313024
India 
Phone  9414158235  
Fax    
Email  pedodinesh2003@gmail.com  
 
Source of Monetary or Material Support  
Pacific Dental College And Hospital Debari Udaipur 313024 
 
Primary Sponsor  
Name  Aditi Hagwane 
Address  Pacific Dental College And Hospital, Debari, Udaipur 313024 Rajasthan India 
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 Aditi Hagwane  Pacific Dental College And Hospital Debari Udaipur 313024  Department of pediatric and preventive dentistry first floor room number nine Pacific Dental College And Hospital Debari Udaipur 313024
Udaipur
RAJASTHAN 
7447473539

aditihagwane98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional research review board (Pacific dental college and hospital debari udaipur 313024 rajasthan  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 
Intervention  anterior flexible crown bioflx crowns  new prefabricated aesthetic flexible crowns, made up of Bis -GMA free and metal free high strength resin polymer has been introduced as Bioflx crowns 12 months follow up study 
Comparator Agent  Resin composite strip crowns   Widely used crown Prefabricated Transparent Reasonable success Aesthetic full coverage 12 months follow up study  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Healthy three to six years old children
Primary anterior teeth indicated for full coverage restoration
Those having opposed anterior teeth
Minimal of two surfaces of caries in the targeted teeth
Patient with Early Childhood Caries as defined by AAPD, 2016
Cooperative patients who had behaviour rating positive or definitely positive followed the Frankl behaviour classification scale
 
 
ExclusionCriteria 
Details  Teeth with proximity to exfoliation and resorption of the root passed its half
Presence of single surface caries not involving the proximal surfaces
Teeth that have been subjected to trauma
Anxiety and lack of cooperation which required treatment under general anaesthesia
Bruxism
Special health needs
Presences of teeth wear on the opposing teeth, or absence of opposing
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Bioflx crown is superior aesthetically and in retention than the anterior strip crowns.
 
Outcome will be analyzed at 1 week, 1month, 3months, 6 months, and 12 months.
 
 
Secondary Outcome  
Outcome  TimePoints 
There might be chances of staining in strip crown and would be more technique sensitive than bioflx crown.
 
Evaluation will be done at interval of 1 week, 1, 3, 6&12 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/02/2025 
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  

Early childhood caries (ECC) is a chronic multifactorial disorder which continues to be dominant in children, especially in families of low socioeconomic status. Early childhood caries is defined as the existence of one or more tooth decays (non-cavitated or cavitated lesions), missing (due to caries), or filled tooth surfaces in any primary dentition of children under the age of six years. Severe early childhood caries (S-ECC) is a progressive carious form in children, categorized in accordance to the number of affected teeth and the age of patient. Providing care to children who are considered to be at risk from ECC, can be achieved by a specialist who received adequate training and has experience in treating children as well as disease process.

Primary incisors with large or multi-surface caries can be restored with resin composite strip crowns if there is sufficient tooth structure after removing all carious tissues. When remaining tooth structure is minimal and not enough for bonding, pre-veneered aesthetic crowns is a favorable solution. Stainless steel crowns with cosmetic facing have good aesthetics and good retention even with minimal remaining tooth structure. Moisture and hemorrhage control are not critical with these restorations which need minimal chair time and offer full coverage and protection. The findings indicate that stainless steel crowns (SSCs) are valued for durability and cost-effectiveness, but they may cause hypersensitivity. Resin composite strip crowns are used for the rehabilitation of the primary anterior teeth using the celluloid forms of the crowns and resin composite. For many years, Strip crowns had been considered as the most aesthetic option for the mutilated primary anterior teeth. But strip crowns are highly technique sensitive, which require proper moisture control during bonding and the placement of the crowns. This isolation is difficult to obtain in children oral cavity not only due to fewer technique and materials are available for isolation in children but also because children who require these belong to the younger age group and most difficult to manage in operatory.

As an alternative to all these crowns, a new prefabricated aesthetic flexible crowns, made up of hybrid polymer resin and which is Bis -GMA free and metal free high strength resin polymer has been introduced as Bioflx crowns. According to the manufacturers, they can withstand high compressive forces, and are highly durable. These flexible crowns allow the paediatric dental practitioner to provide aesthetics of new age crowns with easy manipulation, conservative preparation similar to stainless steel crowns. However, no clinical studies have yet been published looking at the clinical performance of these Bioflx crowns in the anterior region.

Thus, the main purpose of this prospective, randomized clinical study is to compare the clinical efficacy of aesthetic flexible composite crown (Bioflx crowns) with a commercially available anterior composite strip crowns. The null hypothesis is that there is no difference in the clinical performance of the two-crown types.

Therefore, this study will be conducted to compare and evaluate a clinical success of anterior aesthetic flexible crowns with anterior strip crowns in primary anterior teeth among children aged 3-6 years.

 
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