| 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
|
|
|
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
|
|
|
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. | |