FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/081130 [Registered on: 21/02/2025] Trial Registered Prospectively
Last Modified On: 11/02/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Influence of attention span on effectiveness of toothbrushing in children 
Scientific Title of Study   Impact of sustained attention and working memory on toothbrushing efficacy in typically developing children: A cross-sectional 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 Diksha Patil 
Designation  Post graduate student 
Affiliation  D Y Patil University School of Dentistry 
Address  Post graduate clinic, Department of Pediatric and Preventive Dentistry-Basement, D Y Patil University, School of Dentistry, Navi Mumbai, Sector-7 , D Y Patil Vidyanagar, Nerul, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  8286686912  
Fax    
Email  diksha.d.patil@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jasmin Winnier 
Designation  Associate Professor 
Affiliation  D Y Patil University School of Dentistry 
Address  Post graduate clinic, Department of Pediatric and Preventive Dentistry-Basement, D Y Patil University, School of Dentistry, Navi Mumbai, Sector-7, D Y Patil Vidyanagar, Nerul, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9773284371  
Fax    
Email  jasmin.winnier@dypatil.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Jasmin Winnier 
Designation  Associate Professor 
Affiliation  D Y Patil University School of Dentistry 
Address  Post graduate clinic, Department of Pediatric and Preventive Dentistry-Basement, D Y Patil University, School of Dentistry, Navi Mumbai, Sector-7, D Y Patil Vidyanagar, Nerul, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9773284371  
Fax    
Email  jasmin.winnier@dypatil.edu  
 
Source of Monetary or Material Support  
D.Y. Patil University School of Dentistry, Navi Mumbai, 400706, India 
 
Primary Sponsor  
Name  D Y Patil School of Dentistry 
Address  Department of Pediatric and Preventive Dentistry- Basement,D Y Patil University School Of Dentistry, Dr D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai, 400706, India 
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 Jasmin Winnier  D Y Patil University School of Dentistry, Navi Mumbai  Post Graduate Clinic, Department of Pediatric and Preventive Dentistry, Dr. D Y Patil Vidyanagar, sector 7, Nerul Navi Mumbai
Thane
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, DY Patil University School of Dentistry, Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Typically developing children in the age range of 9-12 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  9.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Children between the age range of 9-12 years
2. No history of developmental delays
3. Parents and children willing to participate in the study
 
 
ExclusionCriteria 
Details  1. Children with history of medical or physical disabilities
2. Children with cognitive impairment 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
d2 test score,
Corsi block tapping test score, plaque index 
Before toothbrushing;
After toothbrushing 
 
Secondary Outcome  
Outcome  TimePoints 
N/A  N/A 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   03/03/2025 
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="1"
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  

Introduction: Toothbrushing is the most basic and fundamental means of plaque control. Ideally parent-supervised twice-daily brushing has proved to be highly effective in preventing dental caries in children below 8 years of age. However, efficacy of unsupervised toothbrushing in older children depends on factors such as toothbrushing duration, frequency, technique, manual dexterity and cognitive skills, etc. Higher level of cognitive functions known as executive functions are required for effective toothbrushing. These include sustained attention and working memory. Studies have reported poor oral hygiene and higher prevalence of dental caries in children with neurodevelopmental disorders due to impairment of cognitive skills. Therefore, present study will aim to assess the influence of sustained attention and working memory on toothbrushing efficacy in 9-12 year old typically developing children.

Aim: To assess the influence of sustained attention and working memory on toothbrushing efficacy in 9-12 year old typically developing children.

Materials & Methodology: 60 typically developing children in age group of 9-12 years will be included. Informed consent will be obtained from parents. Oral health status of children will be recorded using DMFT index. Plaque disclosing agent will be applied and Turesky modification of Quigley-Hein Plaque Index (TQHPI) will be recorded (P1). The children will be asked to brush their teeth with standard toothbrush and toothpaste. After brushing, TMQHI will be recorded again (P2). The mean plaque score difference will be used to determine the efficacy of toothbrushing. The sustained attention will be evaluated using the d2 test and working memory using the Corsi Block Tapping test. 1.     d2 test- This is a paper and pen-based letter cancellation test, consisting of 14 trials. Each trial consists of a row with 47 “p” and “d” characters adjacent to one another. The target symbol is a “d” with two dashes. The task is to cancel out as many target symbols as possible, moving from left to right, with a time limit of 20 seconds per trial. Attention performance will be obtained by subtracting errors from correctly crossed out relevant items. Higher scores will indicate higher sustained attention. 2.     Corsi block tapping test- This is a digital test that begins with a sequence of 2 blocks. Once the sequence has been shown on the screen the participant needs to click on the blocks in exact same order as shown. If done correctly, then next higher number of block sequence is displayed. The Corsi block span displayed at the end is the final score. Higher the Corsi block span, better will be the working memory. Evaluation Parameters- DMFT score, Difference in plaque score before and after toothbrushing, d2 test score, Corsi block tapping test score.

 
Close