| CTRI Number |
CTRI/2025/03/083529 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Impact Of AI-Based Diagnostic Tool |
|
Scientific Title of Study
|
Evaluating The Impact Of AI-Based Diagnostic Tools On Diagnostic Accuracy And Efficiency Among Dental Undergraduates – A Randomised 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 |
Raja Sekhar Potluri |
| Designation |
Assistant Professor |
| Affiliation |
SIBAR Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry, Room No - 10, SIBAR Institute of Dental sciences, Takkellapadu, Guntur
Guntur, Takkellapadu
Guntur
ANDHRA PRADESH
522 509
India |
| Phone |
07993480941 |
| Fax |
|
| Email |
sekharpotluri91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Srinivas Ravuri |
| Designation |
Professor |
| Affiliation |
SIBAR Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry, Room No 10, SIBAR Institute of Dental Sciences, Takkellapadu
Takkellapadu
ANDHRA PRADESH
522 509
India |
| Phone |
07993480941 |
| Fax |
|
| Email |
srnvs.ravuri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Srinivas Pachava |
| Designation |
Professor |
| Affiliation |
Sibar |
| Address |
Department of Public Health Dentistry, Room No - 10, SIBAR Institute of Dental sciences, Takkellapadu, Guntur
D.No 11-03-175
Pattabhipuram
ANDHRA PRADESH
522 509
India |
| Phone |
07993480941 |
| Fax |
|
| Email |
s_pachava@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Public Health Dentistry, Room No - 10, SIBAR Institute of Dental sciences, Takkellapadu, Guntur |
|
|
Primary Sponsor
|
| Name |
SIBAR Institute of Dental sciences |
| Address |
Department of Public Health Dentistry, Room No - 10, SIBAR Institute of Dental sciences, Takkellapadu, Guntur |
| Type of Sponsor |
Research institution and hospital |
|
|
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 RAJA SEKHAR P |
SIBAR Institute of Dental Sciences |
Department of Public Health Dentistry, Room No - 10, SIBAR Institute of Dental sciences, Takkellapadu, Guntur
Guntur
ANDHRA PRADESH |
07993480941
drrajasekharpphd@sids.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SIBAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, (2) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AI-based diagnostic tool |
study duration will be 06 months. Students in the intervention group will use an AI-based diagnostic tool. They will receive a brief tutorial on how to use the tool effectively.
They will then diagnose a set of dental conditions using the AI tool, providing their analysis for each image or X-ray.
A timer will track the time taken for each diagnosis. |
| Comparator Agent |
manual inspection and basic radiographic analysis |
Total study duration will be 06 months. Students in the control group will use traditional methods (manual inspection and basic radiographic analysis) to diagnose the same set of cases.
Like the intervention group, the time taken for each diagnosis will be recorded.
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate were included
aged above 16 years and below 26 years
those without any systemic illness
familiar with usage of diagnostic tools
clinical undergraduate students
|
|
| ExclusionCriteria |
| Details |
those not willing were excluded
absent on the day of recruitment
remained in study till end |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Early detection of dental caries
Accuracy of diagnosing periodontal disease
|
at baseline and after 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Treatment success rates.
Patient satisfaction with diagnostic methods.
Cost-effectiveness of using AI versus traditional methods |
at baseline & after 1 week |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="6"
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 procedure outlines how the
study will be implemented, ensuring a controlled and standardized approach to
evaluating the impact of AI diagnostic tools on dental undergraduates. The
feedback from the students, combined with the comparison of diagnostic accuracy
and time efficiency between AI and traditional methods, will provide valuable
insights into the role of AI in dental education. |