| CTRI Number |
CTRI/2025/06/088372 [Registered on: 06/06/2025] Trial Registered Prospectively |
| Last Modified On: |
06/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Making dental visits easier for children with visual and communication support |
|
Scientific Title of Study
|
Assessment of augmentative alternative communication in patients first dental visit : A randomised 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 |
Mithula Raj |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Saveetha Dental College and Hospitals
162,Poonamallee High Road
Velappanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
09539655505 |
| Fax |
|
| Email |
mithularaj96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pooja Ravi |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha Dental College and Hospitals Tamilnadu |
| Address |
Saveetha Dental College and Hospitals
162,Poonamallee High Road
Velappanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
8940844133 |
| Fax |
|
| Email |
poojavr.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Ravi |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha Dental College and Hospitals Tamilnadu |
| Address |
Saveetha Dental College and Hospitals
162,Poonamallee High Road
Velappanchavadi, Chennai
TAMIL NADU
600077
India |
| Phone |
8940844133 |
| Fax |
|
| Email |
poojavr.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals
162,Poonamallee High Road
Velappanchavadi, Chennai
Tamil Nadu, India ,600077 |
|
|
Primary Sponsor
|
| Name |
Saveetha dental college and hospitals |
| Address |
Saveetha Dental College and Hospitals
162,Poonamallee High Road Velappanchavadi, Chennai, Tamil Nadu,India,600077 |
| 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 Mithula Raj |
Saveetha dental college and hospitals |
Clinic 28
Department of pedodontics and preventive dentistry
Chennai
Tamil Nadu
600077
Chennai
TAMIL NADU |
09539655505
mithularaj96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College - Institutional Human Ethical Committee (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: X||New Technology, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High tech augmentative and alternative communication system |
Electronic devices and software used to help individuals communicate when they have difficulty speaking or writing.
5 minutes for one session |
| Intervention |
Low tech augmentative and alternative communication system |
Communication methods that dont rely on electronic devices or batteries. These systems use simple, often hand-made or readily available tools like communication boards, picture exchange systems, or sign language.
5 minutes for one session |
| Comparator Agent |
No tech communication |
Using a persons own body and movements to communicate, without the need for any external devices or tools
5 minutes for one session |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Childrens having their first dental visit
Children who are healthy
Children under ASA 1
|
|
| ExclusionCriteria |
| Details |
Children who have sysytemic health issues
Children who had multiple dental visits
Children other than ASA1 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Communication |
baseline
after 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
20/06/2025 |
| 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="2"
Days="7" |
|
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
|
Children often experience fear and anxiety during their first dental visit, which can make communication and cooperation challenging. Augmentative and alternative communication (AAC) refers to strategies and tools such as visual aids, pictograms, gesture based cues, and simplified language that support or replace spoken communication. In pediatric dentistry, AAC can help children, especially those who are young, anxious, or have communication difficulties, better understand dental procedures and feel more in control. By improving communication, AAC tools can reduce anxiety, enhance behavior, and create a more positive dental experience for both the child and the clinician. |