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CTRI Number  CTRI/2021/06/033975 [Registered on: 03/06/2021] Trial Registered Prospectively
Last Modified On: 01/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two systems of full-coronal restoration for primary maxillary anterior teeth. 
Scientific Title of Study   "To compare the clinical success rate of two systems of full-coronal restoration for primary maxillary anterior teeth: A Split mouth study" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nishima 
Designation  PG student 
Affiliation  SGT Medical Hospital And Research Center, SGT University, Gurugram, Haryana. 
Address  Room no. 6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University, Gurugram, Haryana, India. 122505

Gurgaon
HARYANA
122505
India 
Phone  8872184744  
Fax    
Email  nishima.raheja23@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ankit Srivastava 
Designation  Professor 
Affiliation  SGT Medical Hospital And Research Center, SGT University, Gurugram, Haryana. 
Address  Room no. 6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University, Gurugram, Haryana, India. 122505

Gurgaon
HARYANA
122505
India 
Phone  8930093844  
Fax    
Email  drankitsri@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nishima 
Designation  PG student 
Affiliation  SGT Medical Hospital And Research Center, SGT University, Gurugram, Haryana. 
Address  Room no. 6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University, Gurugram, Haryana, India. 122505

Gurgaon
HARYANA
122505
India 
Phone  8872184744  
Fax    
Email  nishima.raheja23@gmail.com  
 
Source of Monetary or Material Support  
SGT Dental College, Hospital and Research Center, SGT University, Budhera, Gurugram. 
 
Primary Sponsor  
Name  SGT University 
Address  Faculty of Dental Sciences, SGT University, Gurugram-122505 
Type of Sponsor  Research institution and hospital 
 
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 
Nishima  SGT hospital and research center,SGT University, Chandu Bhudera, Gurugram, Haryana  Room no. 6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences , SGT university, Gurugram, Haryana
Gurgaon
HARYANA 
8872184744

nishima.raheja23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI GURUGOBIND SINGH TRICENTENARY UNIVERSITY, GURUGRAM,HARYANA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dental caries  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Direct system pediatric crowns  These are prefabricated crowns that are contoured to mimic the anatomy of the primary tooth and are supplied in various sizes for both anterior and posterior teeth for different clinical situations. 
Comparator Agent  Strip crowns  To compare the clinical success rate of two systems of full-coronal restoration for primary maxillary anterior teeth with a follow up at baseline, 3,6,9 and 12 months. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  1. Children of age 2-5 years.
2. Teeth affected due to caries or trauma with more than 1/3rd crown structure remaining and fulfilling the criteria for full coronal restoration.
3. Children without any evidence of systemic disease. 
 
ExclusionCriteria 
Details  1. Any tooth nearing exfoliation or not fit for full coronal restoration.
2. Radiological signs of internal/external resorption.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The aim of this split-mouth study is to compare the clinical success rate of two systems of full-coronal restoration for primary maxillary anterior teeth.  clinical evaluation to be done at baseline, further at 3,6,9 and 12 months. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the clinical performance of direct system paediatric crowns (Edelweiss) when used for primary maxillary anterior teeth.
2. To evaluate the clinical performance of Strip crowns (3M) when used for primary maxillary anterior teeth.
3. To compare the clinical performance of direct system paediatric crowns and strip crowns when used for primary maxillary anterior teeth. 
clinical evaluation to be done at baseline, further at 3,6,9 and 12 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   N/A 
Date of First Enrollment (India)   12/06/2021 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Restoring decayed primary anterior teeth presents a challenge for the pediatric dentist. It is difficult to obtain an esthetic, long-lasting restoration capable of withstanding masticatory forces. In this modern civilised cosmetically conscious world, esthetic concerns more than pain and it is being considered as one of the main reason for seeking dental care. In our daily practice, it is common to come across patients with mutilated primary anterior teeth due to problems such as Early Childhood Caries, malformation and discoloration, hypoplastic defects, tooth fractures, bruxism and trauma.Structural loss of these teeth not only affect esthetics, but also leads to compromised mastication, poor phonetics along with a difficulty in social and physiological adjustment. Hence, esthetic and functional rehabilitation of these decayed/traumatized primary maxillary anterior teeth should always be the main treatment obje
ctive.
Advancements in restorative materials and techniques have greatly broadened the range of treatment options available for pediatric patients who need both esthetic and functional repairs. These options have distinct esthetic characteristics, difficulty levels and costs.
The restoration of primary anterior teeth can be an intracoronal or a full coronal restoration.
Intracoronal restorations include class III, class IV and class V preparations. The best suitable materials for these restorations are composite and glass ionomer cements.(5-7) However, the outcome for the long lasting and successful management of these modalities to restore esthetics, form and function are lacking.
With the improvements in materials and techniques coupled with growing awareness among patients and parents, it becomes more prudent to restore a carious or traumatic tooth as soon as detected with full-coronal restoration to preserve the integrity of primary dentition until its exfoliation and eruption of permanent teeth.These restorations exhibit good esthetics and high success rate. Full-coronal restorations include preveneered stainless steel crowns, pedo pearl crowns, pedo jacket crowns, polycarbonate crowns, prefabricated zirconia crowns, strip crowns and newly introduced direct system pediatric crowns.
Preveneered stainless-steel crowns are traditional stainless steel crowns with acceptable esthetics and durability. However, it is technique sensitive, adequate tooth structure is required and any lapses in case selection, moisture and haemorrhage control, tooth preparation and resin placement can lead to failure.
Some beautiful crowns are being introduced; named Pedo Pearls which are aluminium based and coated with Food and Drug Administration food grade powder and epoxy-resin. Characteristics include universal anatomy, easy to cut and crimp without chipping or peeling, but these crowns are relatively soft and less durable.
Pedo jacket crowns are another such crowns formed of tooth colored copolyester material which is filled with resin and left on tooth after polymerization. It does not split, stain or crack. But their disadvantage is that only one size is available and it cannot be trimmed with bur. Polycarbonates are aromatic linear polyesters of carbonic acids. They exhibit high impact strength and rigidity and are known as thermoplastic resins. But this polycarbonate material is brittle and does not resist strong abrasive forces, exhibiting frequent fracture and dislodgement.
Zirconia crowns are also considered to be a good treatment choice for esthetic restoration of primary anterior teeth. These are biocompatible crowns and possess a polished and smooth surface leading to less plaque accumulation. Because zirconia crowns cannot be crimped, the clinician must prepare the teeth to fit the zirconia crowns. Therefore, an increase in preparation and fitting time is necessary. Furthermore, preparation of subgingival margins can often result in gingival haemorrhage, which can compromise the retention of zirconia crowns.
Among the most esthetic and popular restorations for carious primary anterior incisors are composite resin strip crowns. Resin composite strip crowns have been used to restore decayed primary anterior teeth for more than 30 years. This is the first choice of many clinicians due to the superior esthetics and the ease of repair if the crown gets chip off or fracture. Parental satisfaction was found to be excellent for strip crowns.But some amount of gingival inflammation was noticed with these crowns. Among all the shortcomings of crowns mentioned above, strip crowns are still found to be the best.
Recently; a minimally invasive, highly esthetic direct system pediatric crown is being introduced in the pediatric dentistry. It is produced from a laser-sintered and laser-vitrified composite. This process improves the flexural strength of the crown to 550 MPa and produces a highly esthetic glossy surface. Edelweiss Pediatric Crowns are prefabricated crowns that are contoured to mimic the anatomy of the primary tooth and are supplied in various sizes for both anterior and posterior teeth for different clinical situations. 
These crowns are produced in Austria and first clinical trial was done in 2018 in Austria only. Edelweiss crowns are introduced in India in the year 2019.Although there is high acceptance of these direct system paediatric crowns, the literature lacks solid proof for their pediatric clinical performance. There are limited clinical studies that are currently ongoing. However, until the outcomes of adequate number of prospective clinical trials with enough long-term follow-up periods is available, it is uncertain to ensure clinical success and durability of these crowns. Hence present study is planned to evaluate the clinical success rate of Edelweiss pediatric crowns and strip crowns in the Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University, Gurugram, Haryana.
 
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