FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
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 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  
Status 
Not Applicable 
 
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.

 
Close