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CTRI Number  CTRI/2025/12/098458 [Registered on: 04/12/2025] Trial Registered Prospectively
Last Modified On: 04/12/2025
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 cleaning efficacy of conventional toothbrush and T shaped toothbrush for children  
Scientific Title of Study   Comparing plaque removal efficacy of conventional and T shaped toothbrush 
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 Aswathi R 
Designation  Post graduate student 
Affiliation  Sathyabama Dental College and Hospital 
Address  Room No 4 Department of Pediatric and Preventive Dentistry. Sathyabama Dental College. Sathyabama Institute of Science and Technology. Jeppiaar Nagar Semmancheri Chennai 600119

Chennai
TAMIL NADU
600119
India 
Phone  08592909416  
Fax    
Email  aswathiaravind2018@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr C Vishnu rekha 
Designation  Professor and Head of the Department, Department of Pediatric and Preventive Dentistry, 
Affiliation  Sathyabama Dental College and Hospital 
Address  Room No 4 Department of Pediatric and Preventive Dentistry. Sathyabama Dental College. Sathyabama Institute of Science and Technology. Jeppiaar Nagar Semmancheri Chennai 600119


TAMIL NADU
600119
India 
Phone  08592909416  
Fax    
Email  drvishnurekha@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Aswathi R 
Designation  Post graduate student 
Affiliation  Sathyabama Dental College and Hospital 
Address  Room No 4 Department of Pediatric and Preventive Dentistry. Sathyabama Dental College. Sathyabama Institute of Science and Technology. Jeppiaar Nagar Semmancheri Chennai 600119


TAMIL NADU
600119
India 
Phone  08592909416  
Fax    
Email  aswathiaravind2018@gmail.com  
 
Source of Monetary or Material Support  
Sathyabama Dental College Jeppiaar nagar Semmanjeri Chennai 600119 
 
Primary Sponsor  
Name  Dr Aswathi R 
Address  Room no 4. Department of pediatric and preventive dentistry. Sathyabama Dental College. Semmancheri. Chennai 600119 
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 Aswathi R  Sathyabama Dental College and Hospital  Room No 4 Department of Pediatric and Preventive Dentistry Sathyabama Dental college Sathyabama Institute of Science and Technology Jeppiaar Nagar Semmancheri Chennai
Chennai
TAMIL NADU 		 08592909416

aswathiaravind2018@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sathyabama Institutional Human Ethical Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Systemically healthy children between 8-10 years with normal motor and cognitive development 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brushing tooth with T shaped toothbrush  T shaped toothbrush will be provided to children between 8-10 years and plaque score will be assessed after 3 months 
Comparator Agent  Conventional toothbrush  Conventional toothbrush will be provided to children between 8-10 years and plaque score will be assessed after 3 months 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children with good systemic health
children with normal motor and cognitive development 
 
ExclusionCriteria 
Details  Children with acute intraoral lesion.
History of antibiotic or antiseptic therapy in the past one month.
Recent visit to dentist or prophylaxis.
Presence of 3 or more missing tooth in one quadrant 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Plaque score assessment for plaque removal efficacy evaluation of conventional and T shaped toothbrush  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   28/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/12/2025 
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 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   Brushing is a widely accepted plaque control method. Different toothbrush designs are introduced to improve better handling and thereby better plaque control. T shaped toothbrush is a novel toothbrush. In this study plaque removal efficacy of T shaped toothbrush is comparing with that of conventional toothbrush in children between 8-10 years of age.  Children will be divided into two groups . Group one of conventional toothbrush and group 2 of T shaped toothbrush. After demonstration children will be provided the assigned toothbrush and instructed to brush for 3 months. After 3 months plaque score will be recorded in all children in modified quigley hein index. 
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