| CTRI Number |
CTRI/2024/05/067958 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
OBSERVATIONAL STUDY |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Exploring the patterns on the roof of the mouth (called palatal rugae) using a special camera that takes 3D pictures for Forensic Identification of Children. |
|
Scientific Title of Study
|
Analysis of palatal rugae pattern and its correlation with other intraoral features for forensic record keeping of children by using 3D intra oral scanner. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bharath K |
| Designation |
Post graduate student |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
IDST Dental college
Kadrabad Modinagar Ghaziabad Uttar pradesh
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
8722548770 |
| Fax |
|
| Email |
bharathranadeepan12345@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nidhi Agarwal |
| Designation |
Professor and Head of Department |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of Pediatric and Preventive dentistry
Institute of dental studies and technologies
Kadrabad Modinagar Ghaziabad Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
8722548770 |
| Fax |
|
| Email |
doc.nagarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bharath K |
| Designation |
Post Graduate Student |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of Pediatric and Preventive dentistry
Institute of dental studies and technologies
Kadrabad Modinagar Ghaziabad Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
8722548770 |
| Fax |
|
| Email |
bharathranadeepan12345@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Dental Studies and Technologies
|
|
|
Primary Sponsor
|
| Name |
Bharath K |
| Address |
Post Graduate Student
Department of Pediatric and Preventive dentistry
Institute of dental studies and technologies
Kadrabad Modinagar Ghaziabad Uttar Pradesh 201201 |
| 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 Bharath K |
Institute of Dental Studies and Technologies |
Department of Pediatric and Preventive dentistry
Institute of dental studies and technologies
Kadrabad Modinagar Ghaziabad Uttar Pradesh 201201
Ghaziabad
UTTAR PRADESH |
8722548770
bharathranadeepan12345@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IDST Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
SCREENING OF ORAL CAVITY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil
|
nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children with complete permanent dentition. |
|
| ExclusionCriteria |
| Details |
Uncooperative physically and mentally challenged children not allowing to take intra oral scanner.
Children undergoing orthodontic treatment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation seen between rugae pattern in males and females, correlation between rugae pattern with cusp of carebeli, parastylid and other intra oral parameters. |
1 DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation seen between rugae pattern in males & females, correlation between rugae pattern with cusp of carebeli, parastylid & other intra oral parameters. |
1 day |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/05/2024 |
| Date of Study Completion (India) |
13/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bharathranadeepan12345@gmail.com].
- For how long will this data be available start date provided 22-06-2024 and end date provided 22-06-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
Brief Summary
Modification(s)
|
Intra oral scans of the 378 children up to age of 16yrs will be recorded, palatal rugae will be studied in detail using Thomas and Kotze classification, along with other nine intra oral features, and all the data obtained will be correlated for the final outcome. All the scans will be stored in STL files in drive for indefinite recovery.
|