| CTRI Number |
CTRI/2020/01/022745 [Registered on: 14/01/2020] Trial Registered Prospectively |
| Last Modified On: |
27/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic Preventive Screening Dentistry Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
IMPROVEMENT OF ORAL HYGIENE BY VIDEO MODELLING IN AUTISTIC CHILDREN. |
|
Scientific Title of Study
|
EVALUATION OF IMPROVEMENT OBSERVED IN ORAL HYGIENE STATUS OF CHILDREN WITH AUTISM SPECTRUM DISORDER USING VIDEO MODELLING . |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sakshi Chawla |
| Designation |
Post Graduate Student |
| Affiliation |
ITS Dental College |
| Address |
Department of pediatric and preventive dentistry
ITS Dental College
Greater Noida
Gautam Buddha Nagar UTTAR PRADESH 201308 India |
| Phone |
9711120059 |
| Fax |
|
| Email |
sakshichawla21@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mousumi Goswami |
| Designation |
HOD & Professor |
| Affiliation |
ITS Dental College |
| Address |
Department of pediatric and preventive dentistry
ITS Dental College
Greater Noida
Gautam Buddha Nagar UTTAR PRADESH 201308 India |
| Phone |
8588854190 |
| Fax |
|
| Email |
mousumi87goswami@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mousumi Goswami |
| Designation |
HOD & Professor |
| Affiliation |
ITS Dental College |
| Address |
Department of pediatric and preventive dentistry
ITS Dental College
Greater Noida
Balrampur UTTAR PRADESH 201308 India |
| Phone |
8588854190 |
| Fax |
|
| Email |
mousumi87goswami@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
sakshi chawla |
| Address |
department of pediatric and preventive dentistry
ITS Dental College
Greater Noida |
| Type of Sponsor |
Other [self] |
|
|
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 sonali |
Sunrise Learning School |
Noida Gautam Buddha Nagar UTTAR PRADESH |
9873749118
drsonalisunriselearning@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ITS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
video based intervention |
Indigenous filmed video of tooth brushing technique. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Mild & moderate levels of autistic children,
They should not be under any medication that impacts oral health.
|
|
| ExclusionCriteria |
| Details |
uncooperative children ,
parental consent not obtained,
good (1) plaque score. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Plaque index
Evaluation questionnaire form for caregiver parent
DMFT index |
Baseline
3 month
6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| level of salivary interleukin 6 |
baseline
6 month |
|
|
Target Sample Size
|
Total Sample Size="52" Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/01/2020 |
| Date of Study Completion (India) |
20/10/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Children
diagnosed with Autism or related developmental disorders exhibits varying
degree of cognitive impairment, lack of verbal and non-verbal communication
skills and limited skills for social interaction. Their fixity to repetitive
patterns of behaviours /interests/activities, and unpredictable response have
been documented in literature as a virtue of cognitive delay.
Previous
studies have reported the inadequacy of dental care in children with SCHN
including children with ASD. The challenge faced by parents in providing proper
home hygiene care and visit to dentist becomes a great task due to the sensory
sensitivities in such children. This Complex and complicated behaviour lands a
child into multiple dental ailment for which a comprehensive treatment plan is
required. To overcome such challenges, clinicians suggests introduction of home
dental care early in life which includes correct toothbrushing.
As
a part of their teaching strategies, visual pedagogy has been used since years.
Various types of pedagogical techniques have been found to be effective in
teaching daily life skills. Incorporation of such techniques in teaching dental
skills and establishing independency in that task can prove to be beneficial
for the children in the long run. However, evidence suggests that efficacy of these communication aids to
improve oral hygiene is still insufficient.
Thus,
Electronically delivered Video modelled Toothbrushing intervention was designed
and planned to support and teach children with ASD proper at-home oral hygiene
care. The effectiveness and efficacy of the devised intervention was compared
from baseline at 3rd and 6th months. Reversible
parameters such as plaque score, toothbrushing ability , salivary cytokine
levels ( IL-6) and parental perception for the improvement was assessed.
After
using the toothbrushing visual modelled intervention for 6 months, the
plaque score , toothbrushing ability and cytokine levels had significantly
improved. Intragroup Comparison within
the severity subgroup also showed statistically significant improvement at 3rd
and 6th month of the study . Parental perception reported improved
brushing compliance and behaviour towards oral hygiene. Many children started
brushing twice daily which was a tedious task to accomplish before the program.
The results highlight the use of video modelling for rapid acquisition of the skills,
which can in turn reduces the overall dependency of the child towards
toothbrushing.
Such
video-modelled toothbrushing intervention may serve as an easily comprehendible
, evidence based education tool in establishing independency in various
tasks. This promising approach should be
encouraged for further development and utilization of similar intervention
tools among clinicians and other dental personnel in promoting oral health
awareness in special care dentistry. |