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CTRI Number  CTRI/2024/12/077535 [Registered on: 02/12/2024] Trial Registered Prospectively
Last Modified On: 14/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening
Dentistry 
Study Design  Other 
Public Title of Study   Effect of AAC app on growth of oral bacteria and oral hygiene in mentally compromised children 
Scientific Title of Study   Comparative evaluation of the effect of picture exchange communication system and augmentative and alternative communication app on streptococcus mutans count and oral hygiene status in children with autism spectrum disorder: a randomized controlled trial 
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 Yogesh Kale  
Designation  Professor 
Affiliation  MIDSR Dental College Latur 
Address  Room no. 6 Ground floor Department of Pediatric and Preventive Dentistry, MIDSR Dental College, Latur, Maharashtra Latur MAHARASHTRA 413512 India
Department of Pediatric and Preventive Dentistry, MIDSR DC, Latur, 415512.
Latur
MAHARASHTRA
413512
India 
Phone  9890588705  
Fax    
Email  dryogesh77@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shraddha Nagnath Kasture 
Designation  Post Graduate Student 
Affiliation  MIDSR Dental College Latur 
Address  Room no. 6 Ground floor Department of Pediatric and Preventive Dentistry, MIDSR Dental College, Latur, Maharashtra Latur MAHARASHTRA 413512 India
Department of Pediatric and Preventive Dentistry MIDSR, DC, Latur.
Latur
MAHARASHTRA
413512
India 
Phone  09545463666  
Fax    
Email  drshraddhak02@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shraddha Kasture 
Designation  Post Graduate Student 
Affiliation  MIDSR Dental College Latur 
Address  Department of Pediatric and Preventive Dentistry MIDSR, DC, Latur.
Department of Pediatric and Preventive Dentistry MIDSR, DC, Latur.
Latur
MAHARASHTRA
413512
India 
Phone  09545463666  
Fax    
Email  drshraddhak02@gmail.com  
 
Source of Monetary or Material Support  
Room no. 6 Ground floor Department of Pediatric And Preventive Dentistry, MIDSR Dental College, Latur-413512, Maharashtra, India. 
 
Primary Sponsor  
Name  Dr Shraddha Nagnath Kasture 
Address  Room no. 6 Ground floor Department of Pediatric and Preventive Dentistry, MIDSR Dental College, Latur, Maharashtra Latur MAHARASHTRA 413512 India  
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 Yogesh kale  MIDSR Dental College,Latur, Maharashtra  Department of Pediatric and Preventive Dentistry MIDSR, DC, Latur.
Latur
MAHARASHTRA 
09890588705

dryogesh77@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, MIDSR Dental College, Latur.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: F79||Unspecified intellectual disabilities,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oral hygiene instructions to all children in the study using AAC App.  Demonstration of brushing technique and AAC App to parents and guardians/caregivers in the center will be given one week before the study. Parents will be asked to show/interact with the AAC App to children every time before brushing. Children will be instructed to brush their teeth twice a day before breakfast and after dinner using the AAC app.  
Comparator Agent  Oral hygiene instructions to all children in the study using PECS.  Demonstration of brushing technique and PECS to parents and guardians/caregivers in the center will be given one week before the study. Parents will be asked to show PECS cards to children every time before brushing. Children will be instructed to brush their teeth twice a day before breakfast and after dinner using PECS cards.  
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  1.children with autism spectrum disorder in the age group of 7 to 13 years (Both males and Females).
2. Children with Mild and Moderate Spectrum Autism.
3. Access to the Internet and WhatsApp social network.
4. Children/ parents willing to participate in the study.




 
 
ExclusionCriteria 
Details  1.Children with Severe Spectrum Autism.
2.Children who are on antibiotics.
3.Those who have severe debilitating medical conditions.
4.Children not willing to / able to cooperate.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
There is an inhibitory effect of PECS and AAC app on oral bacterial growth at baseline, after 1 month and after 3 months.  There is an inhibitory effect of PECS and AAC app on oral bacterial growth at baseline, after 1 month and after 3 months. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect on levels of Streptococcus Mutans in the saliva, and oral hygiene status of autistic children following the use of the PECS and AAC app.  03 months 
 
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   Phase 4 
Date of First Enrollment (India)   14/01/2025 
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="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  

Children with ASD are visual learners and respond better to visual support. To increase communication with autistic children in a dental operatory the use of Augmentative and Alternative Communication (AAC) devices and programs can be implemented. One of the most widely used AAC interventions is the Picture Exchange Communication System (PECS), it is a unique AAC training package for individuals with autism and similar developmental disabilities.  It is a communication technique developed for individuals with limited to no verbal communication abilities, to express requests or thoughts using symbolic imagery. PECS has been used in clinical, dental, and educational settings for children with ASD as it is relatively simple to use and teach, inexpensive, and is considered to be a promising intervention.   Jellow Communicator is a freely downloadable app (android and iOS) that can be used as AAC for communication by those having difficulty using speech for communication. It is primarily designed for children. The Jellow App has an easy-to-learn visual interface comprising nine central category buttons and six expressive side buttons. It may give promising results in SHCN patients for improving overall oral health. In the literature, there are no studies evaluating the effect of PECS versus Augmentative and Alternative Communication app on oral health maintenance with autism spectrum disorder. The purpose of this study is to compare the effect on levels of Streptococcus Mutans in the saliva, and oral hygiene status of autistic children following the use of the PECS and Augmentative and Alternative Communication app.


 


 
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