| CTRI Number |
CTRI/2026/04/109428 [Registered on: 27/04/2026] Trial Registered Prospectively |
| Last Modified On: |
10/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
TINY SMILES, SMART APP: REAL-TIME AI VS TRADITIONAL FACIAL IMAGE SCALE IN PEDIATRIC DENTISTRY |
|
Scientific Title of Study
|
Comparative evaluation of accuracy and reliability of an AI powered emotion detection application and facial image scale in assessing dental anxiety in children: an observational study |
| Trial Acronym |
NEW |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Riya Surana |
| Designation |
Post Graduate Student |
| Affiliation |
Maitri College of Dentistry and Research, Anjora, Durg, Chhattisgarh |
| Address |
302, Department of Pediatric and Preventive Dentistry, Maitri College Of Dentistry and Research Centre, Anjora
Durg
CHHATTISGARH
491001
India |
| Phone |
7999850221 |
| Fax |
|
| Email |
riyasurana16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Riya Surana |
| Designation |
Post Graduate Student |
| Affiliation |
Maitri College of Dentistry and Research, Anjora, Durg, Chhattisgarh |
| Address |
302, Department of Pediatric and Preventive Dentistry, Maitri College Of Dentistry and Research Centre, Anjora
Durg
CHHATTISGARH
491001
India |
| Phone |
7999850221 |
| Fax |
|
| Email |
riyasurana16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Riya Surana |
| Designation |
Post Graduate Student |
| Affiliation |
Maitri College of Dentistry and Research, Anjora, Durg, Chhattisgarh |
| Address |
302, Department of Pediatric and Preventive Dentistry, Maitri College Of Dentistry and Research Centre, Anjora
Durg
CHHATTISGARH
491001
India |
| Phone |
7999850221 |
| Fax |
|
| Email |
riyasurana16@gmail.com |
|
|
Source of Monetary or Material Support
|
| 302, Department of Pediatric and Preventive Dentistry, Maitri College Of Dentistry and Research Centre, Anjora |
|
|
Primary Sponsor
|
| Name |
Dr Riya Surana |
| Address |
Maitri College of Dentistry and Research Centre, Anjora, Durg, Chhattisgarh, 491001 |
| 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 Ankita Ukey |
Maitri College of Dentistry and research Centre |
302, Department of Pediatric and Preventive Dentistry, Maitri College Of Dentistry and Research Centre, Anjora
Durg
CHHATTISGARH |
9584105040
ankita8700@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients reporting to Department of pediatric and preventive dentistry |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AI application |
AI based emotion detection application to check the emotional status of individual.
total duration per child 10 to 15 minutes |
| Comparator Agent |
FIS scale |
Manual detection of emotions using FIS scale |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children age between 6to12 years
Children with no history of major illness
First dental visit
Children whose parents or guardians provide informed consent
Children able to understand and cooperate during dental procedures
|
|
| ExclusionCriteria |
| Details |
Patients seeking emergency dental care or urgent interventions
Children with developmental delays, cognitive impairments, or facial deformities
Children under medication affecting mood or facial expression
Non-cooperative children or those with extreme dental phobia requiring sedation.
Children whose parents do not provide consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| AI based emotion detection shows promise as feasible non invasive adjunct tool for pediatric dental anxiety assessment |
8 weeks to 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in anxiety level before & after treatment |
8 weeks to 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
16/05/2026 |
| 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="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
|
This study is an analytical cross-sectional observational comparative study designed to evaluate the agreement between an Artificial Intelligence (AI)–based emotion detection application and the Facial Image Scale (FIS) in assessing dental anxiety among children aged 6–12 years attending their first dental visit. A total of 40 participants will be assessed twice—before treatment in the waiting area and after completion of the dental visit. Anxiety levels recorded through FIS (self-reported pictorial scale) will be compared with AI-detected emotion scores derived from facial analysis. The primary outcome measure will be the level of agreement and correlation between FIS scores and AI-based scores. The secondary outcomes will include changes in anxiety levels before and after treatment and the feasibility of using AI-based assessment in a clinical pediatric dental setting. |