| 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
|
|
|
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
|
|
|
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. |