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CTRI Number  CTRI/2024/03/064802 [Registered on: 27/03/2024] Trial Registered Prospectively
Last Modified On: 22/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study on new cartoon printed stainless steel cap on the milk teeth of the children. 
Scientific Title of Study   Evaluation of behaviour and acceptance of child towards novel laser cartoon printed stainless steel crown verses conventional stainless steel crown- A randomized clinical 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 Avani Ramesh Doiphode 
Designation  Postgraduate Student 
Affiliation  Government Dental College and Hospital, Nagpur. 
Address  Room No - 108, Department of Paediatric and Preventive Dentistry, Government Dental College and Hospital, Medical Square, Hanuman Nagar, Nagpur.

Nagpur
MAHARASHTRA
440003
India 
Phone  9075725395  
Fax    
Email  avanidoiphode5@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ritesh Kalaskar 
Designation  Professor and Head of the Department 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  Room NO- 108, Department of Paediatric and Preventive Dentistry, Government Dental College and Hospital, Medical Square, Hanuman Nagar, Nagpur.

Nagpur
MAHARASHTRA
440003
India 
Phone  8550938585  
Fax    
Email  riteshpedo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Avani Ramesh Doiphode 
Designation  Postgraduate Student 
Affiliation  Government Dental College and Hospital, Nagpur. 
Address  Room no - 108, Department of Paediatric and Preventive Dentistry, Government Dental College and Hospital, Medical Square, Hanuman Nagar, Nagpur.

Nagpur
MAHARASHTRA
440003
India 
Phone  9075725395  
Fax    
Email  avanidoiphode@gmail.com  
 
Source of Monetary or Material Support  
Government Dental College and Hospital, Nagpur. 
 
Primary Sponsor  
Name  Dr Avani Ramesh Doiphode 
Address  Swamiraj Niwas, At post-Varse, Tal-Roha, Dist-Raigad, Maharashtra, India. 
Type of Sponsor  Other [Self Sponsored] 
 
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 Avani Ramesh Doiphode  Government Dental College and Hospital, Nagpur.  Room No- 108, Department of Paediatric and Preventive Dentistry.
Nagpur
MAHARASHTRA 
9075725395

avanidoiphode5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics comitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K042||Pulp degeneration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Stainless steel crown  Conventional stainless steel crowns are most commonly used to restore the deciduous teeth in children. These stainless steel crowns are available as pre fabricated crowns that are ready to use. These crowns have metallic silver colour appearance.  
Intervention  Laser Cartoon Printed Stainless Steel Crown  The conventional stainless steel crown was modified by printing cartoon characters on the surface using the laser printing technique so that the children will get attracted to the cartoon present on the stainless steel crown and will cooperate while placing the crowns on the teeth.  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1-Healthy children between 4 to 8 years of age
2-Bilateral primary first and second molars requiring pulpectomy procedure

 
 
ExclusionCriteria 
Details  1-Primary mandibular molars indicated for extraction.
2-Children with ASA physical status ≥ III, systemic illness, highly uncooperative children.
3-Children with very poor oral hygiene.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Behaviour of children  Behaviour of children before and during placement of laser cartoon printed stainless steel crown and conventional stainless steel crown will be assessed at baseline. 
 
Secondary Outcome  
Outcome  TimePoints 
Acceptance of children towards novel laser cartoon printed stainless steel crown  After placement of the laser cartoon printed stainless steel crown & conventional stainless steel crown the outcome will be assessed at baseline. 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   01/04/2026 
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="0"
Months="6"
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  

A stainless steel crown (SSC) is a pre-fabricated metallic tooth-shaped crown that fits over the remaining tooth structure to protect the tooth from further breakdown. SSC is most commonly used to restore the form and function of severely damaged and decayed teeth. They are used extensively in the primary dentition.

The cooperation of pediatric patients is important for any successful treatment in pediatric dentistry. Before or during treatment patients’ behavior needs to be modified using various behavior management techniques. Lack of cooperation during the placement of SSC has been identified as one of the major factors for improper placement of SSC. As we know children’s are very fond of cartoons and there is always a positive relation seen between the attractiveness of objects and children’s attitude towards them. Till date, no technique has been developed using SSC that can modify or influence the behavior of a child.

To reduce anxiety and to gain the cooperation of the child while placement of SSC, we will laser print a cartoon and the name of a child on SSC. The pictures/ cartoon will be customized according to the child’s wish and will be printed on the SSC. Also, the name of the child can be printed on SSC which can be helpful for forensic purposes too. This novel printed SSC will be more attractive and pleasing to the patient when compared with the conventional SSC. There will be the active involvement of a child in process of selecting pictures, cartoon, or their name also. This novel method will positively influence the child’s attitude toward the treatment.

 
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