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CTRI Number  CTRI/2025/03/082709 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Childs Acceptance of Conventional Rubber Dam vs. Novel Kiddo Dam (cartoon printed) During Dental Procedures 
Scientific Title of Study   Comparative Evaluation of Childs Acceptance Towards Conventional Rubber Dam and Novel Kiddo Dam Sheet during dental procedure– 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 Anija CK  
Designation  PG Student 
Affiliation  Government dental college & Hospital, Nagpur 
Address  Department of Pediatric and Preventive Dentistry Government dental college & Hospital, GMC Campus Medical square Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  9400217916  
Fax    
Email  anijacekey916@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anija CK  
Designation  PG Student 
Affiliation  Government dental college & Hospital, Nagpur 
Address  Department of Pediatric and Preventive Dentistry Government dental college & Hospital, GMC Campus Medical square Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  9400217916  
Fax    
Email  anijacekey916@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nupur Ninawe 
Designation  Associate Professor 
Affiliation  Government dental college & Hospital, Nagpur 
Address  Department of Pediatric and Preventive Dentistry Government dental college & Hospital, GMC Campus Medical square Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  09400217916  
Fax    
Email  nupurgovind@gmail.com  
 
Source of Monetary or Material Support  
Self funded, Name of institute- Government Dental College and Hospital, Nagpur GMC Campus, Medical square, Maharashtra, 440003, INDIA 
 
Primary Sponsor  
Name  Dr Anija C K 
Address  Department of Pediatric and Preventive Dentistry Government Dental College and Hospital, GMC Campus, Medical Square, Nagpur 440003 
Type of Sponsor  Other [Government Dental 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 Anija C K  Government Dental College and Hospital  108,Department of Pediatric and Preventive Dentistry Government dental college & Hospital GMC Campus Medical square Nagpur
Nagpur
MAHARASHTRA 		 9400217916

anijacekey916@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Dental College and Hospital, Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy children of age 6 to 10 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional rubber dam  Class I restoration of the mandibular molar will be performed following the placement of Conventional rubber dam sheets to ensure isolation during the procedure. 
Intervention  Novel Kiddo dam  Class I restoration of the mandibular molar will be performed following the placement of novel Kiddo Dam sheets (modified with cartoon printing on sheets) to ensure isolation during the procedure. 
 
Inclusion Criteria  
Age From  6.00 Day(s)
Age To  10.00 Day(s)
Gender  Both 
Details  • Healthy children (ASA I) of age six to ten years
• Children requiring bilateral class I restoration of primary mandibular second molars.
• Children with no prior experience of rubber dam application for dental treatment
• Presence of sufficient tooth structure to securely anchor the rubber dam clamp in
place
• Frankl’s behaviour rating scale, score three or four
• Completion of informed consent to participate in the study by parents 
 
ExclusionCriteria 
Details  1. Medically compromised children
2. Frankl’s behaviour rating scale, score I or II
3. Children known to have colour vision deficiency, blindness
4. Children known to have allergy to latex 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Acceptability of children towards conventional rubber dam
sheets and novel Kiddo dam sheets while performing dental procedures. 		 at the time of procedure 
 
Secondary Outcome  
Outcome  TimePoints 
Impact on the rubber dam application sequence  After procedure 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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)   05/04/2025 
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="0"
Months="2"
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   Healthy children (ASA I), aged 6–10 years, reporting to the Department of Pediatric and Preventive Dentistry and requiring Class I restoration of bilateral primary mandibular molars, will be included in the study. Participants will be randomly allocated into two groups (Group 1 and Group 2) using a computer-generated random sequence. In Group 1, children will receive a Class I restoration of one mandibular molar using a conventional rubber dam during their first visit, followed by a restoration of the contralateral mandibular molar using the novel Kiddo dam after one week. In Group 2, the sequence will be reversed, with the novel Kiddo dam used in the first visit and the conventional rubber dam in the second visit. Children will have the option to select the design of the Kiddo dam based on their favorite cartoon character. After completing restorations with both types of rubber dams, children will complete a validated questionnaire to assess their acceptance and preference for the rubber dam sheets. 
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