| CTRI Number |
CTRI/2026/04/108093 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
21/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Use of Artificial Intelligence for Assessing Space Availability for Erupting Teeth in Children |
|
Scientific Title of Study
|
Development and Validation of an AI-Tool for Mixed Dentition Space Analysis |
| 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. Ankita Taltia |
| Designation |
PG JR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR |
| Address |
Department of Dentistry, C B lock , Ground Floor, Gate no. 4, AIIMS, GE Road, Tatibandh, Raipur, Chhattisgarh, 492099 India.
Raipur CHHATTISGARH 492099 India |
| Phone |
9244018491 |
| Fax |
|
| Email |
anadroy15@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Virat Glahotra |
| Designation |
Head of the Department |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR |
| Address |
Department of Dentistry, C B lock , Ground Floor, Gate no. 4, All India Institute of Medical Sciences, GE Road, Tatibandh, Raipur, Chhattisgarh, 492099 India.
Raipur CHHATTISGARH 492099 India |
| Phone |
9216274600 |
| Fax |
|
| Email |
drviratgalhotra@aiimsraipur.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr. Virat Galhotra |
| Designation |
Head of the Department |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR |
| Address |
Department of Dentistry, C B lock , Ground Floor, Gate no. 4, All India Institute of Medical Sciences, GE Road, Tatibandh, Raipur, Chhattisgarh, 492099 India.
Raipur CHHATTISGARH 492099 India |
| Phone |
9216274600 |
| Fax |
|
| Email |
drviratgalhotra@aiimsraipur.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Dentistry, C Block , Ground Floor, Gate no. 4, All India of Medical Sciences, GE Road, Tatibandh, Raipur, Chhattisgarh, 492099 India. |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Great Eastern Rd, opposite Gurudwara, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099
|
| Type of Sponsor |
Government 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 Ankita Taltia |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Department of Dentistry, C B lock , Ground Floor, Gate no. 4, AIIMS,
GE Road, Tatibandh, Raipur, Chhattisgarh,
492099
India.
Raipur CHHATTISGARH |
09244018491
anadroy15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 6 to 10 yeras in the mixed dentition phase.
Good quality intra-oral photographs of maxillary and mandibular dental arches.
Willingness to participate and provide consent. |
|
| ExclusionCriteria |
| Details |
Poor-quality or distorted photographs unsuitable for reliable landmark detection (e.g.,
blurred or incomplete).
Presence of orthodontic appliances, or anatomical anomalies that could obscure
landmark visibility.
Patients with congenital craniofacial anomalies or syndromes affecting dental
development |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The AI tool will have accuracy comparable to the conventional manual digital space
analysis.
Time taken will be less as compared to manual digital space analysis. |
Baseline (manual measurements), and at the time of AI-based analysis during validation and final testing phases.
Time efficiency during final testing phase. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="293" Sample Size from India="293"
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)
|
15/04/2026 |
| 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="1" Months="6" Days="0" |
|
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
|
Mixed dentition space analysis is a critical component of early orthodontic diagnosis; however, conventional manual digital methods are time-consuming and technique-sensitive. This study aims to develop and validate an artificial intelligence (AI)–based tool capable of performing mixed dentition space analysis using standardized intra-oral photographs in children aged 6–10 years.
This development and validation study will include children in the mixed dentition phase attending the Department of Dentistry, AIIMS Raipur. High-quality standardized frontal and occlusal intra-oral photographs will be captured using a mirrorless camera with calibration aids. Images will be manually annotated by trained pediatric dentists to mark mesial and distal tooth landmarks. Data augmentation techniques will be applied to improve model robustness. The AI model will be trained and validated using a deep learning framework with five-fold cross-validation.
The AI tool will automatically detect teeth, identify landmarks, calculate arch space, and perform space analysis using established methods such as Tanaka-Johnston, Moyers, and Boston University analyses. The diagnostic accuracy of the AI tool will be compared with manual digital space analysis performed on intra-oral photographs and intra-oral scans. Accuracy will be assessed using mean absolute difference, reliability using kappa statistics, and efficiency by time comparison.
This study aims to establish a reliable and efficient AI-based alternative for early orthodontic space assessment using intra-oral photographs. |