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CTRI Number  CTRI/2024/07/071685 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 30/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to compare the efficacy of various esthetic crowns in primary posterior teeth requiring full coverage restorations. 
Scientific Title of Study   Comparative clinical evaluation of the efficacy of various esthetic full coverage restorations in primary posterior teeth a randomized controlled 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 Ankita Mishra 
Designation  Post Graduate student 
Affiliation  Subharti Dental College and Hospital 
Address  Subharti dental college and hospital, Swami Vivekananda Subharti University

Meerut
UTTAR PRADESH
250005
India 
Phone  09934795930  
Fax    
Email  ankitamishra1012@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Noopur Kaushik 
Designation  Professor, Department of Pediatric and Preventive Dentistry 
Affiliation  Subharti Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry, Subharti dental college and hospital, Swami Vivekanand Subharti University, NH-58, Delhi-Haridwar Bypass Road

Meerut
UTTAR PRADESH
250005
India 
Phone  7830008899  
Fax    
Email  drnoopurkaushik@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ankita Mishra 
Designation  Post Graduate student 
Affiliation  Subharti Dental College and Hospital 
Address  Subharti dental college and hospital, Swami Vivekananda Subharti University

Meerut
UTTAR PRADESH
250005
India 
Phone  09934795930  
Fax    
Email  ankitamishra1012@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, NH-58, Delhi-Haridwar Bypass Road 
 
Primary Sponsor  
Name  Dr Ankita Mishra 
Address  Subharti Dental College and Hospital Swami Vivekananda Subharti University 
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 Ankita Mishra  Subharti Dental College and Hospital  Department of Pediatric and Preventive Dentistry, 1st floor, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, NH-58, Delhi-Haridwar Bypass Road
Meerut
UTTAR PRADESH 
09934795930

ankitamishra1012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
University Ethics Committee(Medical) Swami Vivekanand Subharti University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients requiring full coverage restorations on primary posterior teeth. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Full coverage restoration on primary molars with Prefabricated Zirconia crown (Group-I).  Primary molars requiring full coverage restorations will be prepared accordingly for the placement of the crown. The correct size of the preformed zirconia crown will be selected and luted according to the manufacturers instructions. The study has a follow-up period of 12 months to evaluate the crown retention, marginal integration, crown discoloration, secondary caries, gingival status and patient satisfaction at every 3-months. Edit || Delete  
Intervention  Full coverage restoration on primary molars with Resin polymer crown (Group-II) and Densely filled composite crown (Group-III).  Primary molars requiring full coverage restorations will be prepared for the placement of a crown. The correct size of the preformed crown will be selected and luted according to the manufacturers instructions. The study has a follow-up period of 12 months to evaluate the crown retention, marginal integration, crown discoloration, secondary caries, gingival status and patient satisfaction at every 3-months.  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Primary molars with adequate crown structure, requiring full coverage restorations.
Parents/patient’s esthetic requirements. 
 
ExclusionCriteria 
Details  Less than 1/3rd crown structure left, teeth indicated for extraction, uncooperative children.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Retention, marginal integrity, discoloration and patient satisfaction of full coverage restorations. Effect on gingival health and the ability of crowns to prevent secondary caries.  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Effect on gingival health and the ability of crowns to prevent secondary caries.  12 months 
 
Target Sample Size   Total Sample Size="57"
Sample Size from India="57" 
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)   15/08/2024 
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="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

In young children, caries more often involves the primary molars, and the early loss of these teeth has detrimental effects such as potentially compromising the dentition’s integrity, impaired nutrition due to pain, negative effects on growth and development, and producing an undesirable esthetic appearance. The fundamental objective of restorative therapy in primary dentition is to retain them until exfoliation, which is justified from the biological, functional, psychological, and esthetic point of view.

When a tooth undergoes endodontic intervention, it is advisable to place a dental crown subsequently as it maintains the form and function of the tooth, prevents microleakage and re-infection, maintains esthetics, and provides strength to the tooth. Hence, dental crowns have become a salient factor in the restoration of the extensively carious lesion. The preformed metal crowns, also known as stainless steel crowns have been the benchmark restoration for primary molars after pulpal treatment. However, their advantages are insufficient to compensate for their unappealing appearance, and their metallic aspect remains a problem. On that account, to overcome the esthetic concern Zirconia crowns were introduced in pediatric dentistry, to provide white full coronal restorations for primary teeth.  Zirconia crowns are anatomically contoured, metal-free, bio-inert, white-colored, and resistant to dental decay.  The most important advantage of the zirconia crown is its “gingival friendly” property compared to other crowns. However, these crowns have some drawbacks, including the need for extensive tooth preparation to achieve a passive fit, a higher price tag than most other crowns, and the inability to be adjusted, crimped, or shaped. To address these drawbacks, different pediatric crowns made up of densely filled composite with laser-sintered barium glass have been added to the array of pediatric esthetic full-coverage restorations in 2018. These crowns permit minimally invasive, quick, and safe treatment with maximum aesthetic results. They have an outline that resembles the primary tooth’s anatomy and features antibacterial and plaque-resistance properties. Additionally, these crowns are said to be biocompatible, and bio-functional, and exhibit natural abrasion behavior which prevents them from damaging their antagonists.  However, these crowns are expensive and they are yet to be clinically experimented.

The most recent introduction in the preformed esthetic crowns is the Bioflx crown - made up of high-impact hybrid resin polymer, they are metal and Bis-GMA free. The manufacturers claim that the Bioflx Crowns are the world’s first flexible, durable, self-adaptable with snug/active fit, and an ideal full coverage restoration that offer properties of both stainless steel crowns and zirconia crowns.

There is limited research available that directly compares the clinical outcomes of various aesthetic crowns. Therefore, this study is done to comparatively evaluate three esthetic crowns in primary molars in terms of their retention, marginal integrity, discoloration, secondary caries, gingival health, and patient satisfaction. 
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