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CTRI Number  CTRI/2024/04/065350 [Registered on: 08/04/2024] Trial Registered Prospectively
Last Modified On: 04/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   twinky star tales - enhancing sparkling smiles in children  
Scientific Title of Study   Evaluating the impact of coloured compomer on oral hygiene in 5 to 8 year old and assessment of parental acceptance – A cohort study 
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 J Jasmin Winnier  
Designation  Associate Professor  
Affiliation  Dr D Y Patil School of Dentistry , Deemed to be University  
Address  Dept. of Pediatric and Preventive Dentistry, Dr D Y Patil School of Dentistry , Deemed to be University , Nerul, Navi Mumbai

Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone  9773284371  
Fax    
Email  jasmin.winnier@dypatil.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Aastha Sharma 
Designation  Post Graduate Student  
Affiliation  Dr D Y Patil School of Dentistry , Deemed to be University  
Address  Dept. of Pediatric and Preventive Dentistry, Dr D Y Patil School of Dentistry , Deemed to be University , Nerul, Navi Mumbai

Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone  7208712815  
Fax    
Email  aastha2409@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr J Jasmin Winnier  
Designation  Associate Professor  
Affiliation  Dr D Y Patil School of Dentistry , Deemed to be University  
Address  Dept. of Pediatric and Preventive Dentistry, Dr D Y Patil School of Dentistry , Deemed to be University , Nerul, Navi Mumbai

Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone  9773284371  
Fax    
Email  jasmin.winnier@dypatil.edu  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry Dr. D.Y. Patil Deemed to be University, School of Dentistry, Sector 7, Highway Road, , Nerul, Navi Mumbai, Thane, Maharashtra. 400706 
 
Primary Sponsor  
Name  Dept of Pediatric and Preventive Dentistry  
Address  Dr. D.Y. Patil Deemed to be University, School of Dentistry, Sector 7, Highway Road, , Nerul, Navi Mumbai, Thane, Maharashtra. 400706 
Type of Sponsor  Private medical college 
 
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 J JASMIN WINNIER   Dr. D.Y. Patil Deemed to be University, School of Dentistry  Post graduate clinic , Department of Pediatric and Preventive Dentistry , Dr. D.Y. Patil Deemed to be University, School of Dentistry, Sector 7, Highway Road, , Nerul, Navi Mumbai, Thane, Maharashtra. 400706
Mumbai (Suburban)
MAHARASHTRA 		 9773284371

jasmin.winnier@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional research and ethical board, D. Y. Patil Deemed to be University School of Dentistry, Navi Mumbai.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional compomer   material placed in cavity as childs preferred restorative material. duration - 3 months  
Intervention  twinky star colored compomer   restorative material placed in deciduous second molar based on childs preferred color of restoration . duration - 3 months  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Children who do not have past dental history
Should have class 1 cavity in 2nd deciduous molars and depth in dentin (D1)
Patient with at least 1-2 decayed teeth
 
 
ExclusionCriteria 
Details  Patient with high caries rate
Children with special health care needs
Children whose parent did not give consent
Patient with any systemic disease
Patient with Frankel rating 1 and 2
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1) motivation effect of colored compomer on childs oral hygiene (OHIS and silness and loe plaque index)
 		 at baseline and after three months  
 
Secondary Outcome  
Outcome  TimePoints 
parental acceptance of colored compomer   before and after three months  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   15/04/2024 
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="0"
Months="3"
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  

After assessment for eligibility, 40 children meeting the inclusion criteria will be divided into two groups of 20 each according to child’s preferred restorative material.

Group 1 (study group) -twinky star (coloured compomer)

Group 2 (control group) –conventional compomer restoration

Before starting the procedure, assessment of oral hygiene will be done using OHI-S and Plaque index(Silness and Loe). Simultaneously a pre-procedure questionnaire will be given to parent.

Child’s preference to the colour of the compomer will be noted (green, lemon and gold or conventional compomer)

Treatment will be done by a single operator. Standard procedure for cavity preparation and restoration will be followed.

After three month  follow-up , assessment of oral hygiene will be done using OHI-S index and Plaque index and a post procedure of questionnaire will be given to the parent.

 
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