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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  
self  
 
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  
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 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  
Status 
Not Applicable 
 
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.


 
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