| CTRI Number |
CTRI/2025/04/084909 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Diagnostic
Screening
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on Training BeVigilant™ OraFusion System to Improve Dental AI Accuracy |
|
Scientific Title of Study
|
BeVigilant™ OraFusion System Clinical Calibration and Classification Training Data Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashok Dhoble |
| Designation |
Secretary General |
| Affiliation |
Indian Dental Association |
| Address |
Department of Research Dr A P J Abdul Kalam Education Research and Incubation Centre Indian Dental Association DGP House Prabhadevi
Mumbai
MAHARASHTRA
400025
India |
| Phone |
09820094499 |
| Fax |
|
| Email |
ashokdhoble@ida.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Lakshmi Balraj |
| Designation |
Chief Officer & Head Research |
| Affiliation |
Dr A P J Abdul Kalam Education Research and Incubation Centre |
| Address |
Department of Research Dr A P J Abdul Kalam Education Research and Incubation Centre Indian Dental Association DGP House Prabhadevi
Department of Research Dr A P J Abdul Kalam Education Research and Incubation Centre Indian Dental Association DGP House Prabhadevi
Mumbai
MAHARASHTRA
400025
India |
| Phone |
09820094499 |
| Fax |
|
| Email |
drlakshmi@idrf.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Pooja Kunjan |
| Designation |
Research Assistant |
| Affiliation |
Dr A P J Abdul Kalam Education Research and Incubation Centre |
| Address |
Department of Research Dr A P J Abdul Kalam Education Research and Incubation Centre Indian Dental Association DGP House Prabhadevi
Department of Research Dr A P J Abdul Kalam Education Research and Incubation Centre Indian Dental Association DGP House Prabhadevi
Mumbai
MAHARASHTRA
400025
India |
| Phone |
8788172710 |
| Fax |
|
| Email |
pooja_k@ida.org.in |
|
|
Source of Monetary or Material Support
|
| Vigilant Biosciences Inc
1008 Ranch Rd 620 Suite 204 Lakeway TX 78734 United States |
|
|
Primary Sponsor
|
| Name |
Vigilant Biosciences Inc |
| Address |
1008 Ranch Road 620 Suite 204
Lakeway Texas 78734 |
| Type of Sponsor |
Other [Biotechnology Company] |
|
|
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 Ashok Dhoble |
Dr APJ Abdul Kalam Education Research and Incubation Centre |
3rd Floor DPG House Unit No 3 A & B Zone 1
88 C Old Prabhadevi Road
Prabhadevi
Mumbai
MAHARASHTRA |
09820094499
ashokdhoble@ida.org.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Sibar Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K132||Leukoplakia and other disturbancesof oral epithelium, including tongue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BeVigilant™ OraFusion System – Ora-3D BeVigilant™ Reader OraFusion Software |
By comparing this innovative approach to standard biopsy the study aims to evaluate its potential as a semi quantitative pre-diagnostic tool This device designed for chairside use intends to support dentists in identifying high risk lesions facilitating timely referrals to specialists and improving early intervention outcomes for patients with visible oral mucosal abnormalities
Duration is 6 months |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Aged 22 years or older.
Presence of visible oral abnormalities such as leukoplakia erythroplakia or other lesions suggestive of early-stage oral cancer
Ability and willingness to provide informed consent, saliva samples, and complete questionnaires
Self-reported cancer-free status (no prior history of oral cancer)
Demonstrated ability to participate in the study procedures including follow-up visits
|
|
| ExclusionCriteria |
| Details |
Known history of oral cancer or other head and neck cancers
Presence of conditions that could interfere with the collection or analysis of saliva samples (e g active oral infections severe dry mouth etc)
Pregnant or lactating women
Inability or unwillingness to provide informed consent or participate in follow-up procedures
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Enhanced accuracy in referrals and early cancer detection leading to improved survival rates |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Streamlined processes for both patients & healthcare providers improving efficiency & reducing wait times
|
Baseline (Pre-implementation): Capture current process duration (e g sample collection to results consultation turnaround)
At Point-of-Care (Day 0): During first use of the device – measure time from sample to result
2 Weeks Post-Implementation: Evaluate efficiency from both provider & patient perspectives
3 Months Post-Implementation: Assess process improvements sustained over time including overall reduction in wait times & throughput |
Increased peace of mind for patients & clinicians especially when the care pathway is unclear
|
Pre-Test (Day 0): Use patient/clinician-reported scales (eg anxiety or decisional conflict scales) before bioassay
Immediately Post-Test (Within 30 minutes): Assess psychological response to near-instant results
1 Week Post-Test: Evaluate peace of mind based on diagnostic clarity or follow-up planning
1 Month Post-Test: Longer-term reflection on the emotional impact & confidence in care pathway decisions |
A sense of urgency for clinicians & patients to address high-risk cases promptly
|
At Diagnosis (Day 0): Measure time to communicate result once bioassay indicates high-risk biomarkers
Within 24–48 Hours: Record initiation of referral imaging biopsy or additional diagnostics
1 Week Post-Result: Assess scheduling of definitive management steps (e g specialist appointment treatment planning)
1 Month Post-Result: Track any delay or completion in initiating management |
| A point-of-care device that provides near-instant results (approximately 10 minutes) empowering clinicians with timely decision-making |
Day 0 (First Use): Record time between sample collection & clinical decision-making
Immediately Post-Test: Collect clinician-reported confidence & decisiveness (via short survey or rating scale)
1 Week Post-Test: Evaluate whether early decisions were upheld or altered with confirmatory tests
Monthly Audit (1–3 Months): Review decision timelines & correlation with outcomes or follow-up pathways |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/04/2025 |
| 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 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
|
This study aims to enhance the diagnostic capabilities of the OraFusion system by training algorithms to detect oral health biomarkers (EGFR and p16) linked to early stage oral cancer. The primary objective are to refine algorithm accuracy validate diagnostic classification across diverse patient groups amd assess the tool’s effectiveness in identifying pre-cancerous and cancerous conditions
Participants will provide saliva samples for analysis using the Ora- 3D platform which tests for biomarkers EGFR and p16. The system delivers rapid,real time results aiding in early cancer detection and improving patient referral accuracy. High risk participants will be referred for further diagnostic procedures such as biopsy.
Statistical analyses including logistic regression and sensitivity analysis will ensure robust evaluation and data integrity throughout the study.
|