| CTRI Number |
CTRI/2025/09/093974 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Diagnostic
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Novel Technique to detect elements in tobacco products and human body fluids. |
|
Scientific Title of Study
|
Elemental analysis of saliva, serum and oral tissue in individuals with habitual use of areca nut, betel quid and commercially packed tobacco |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Salian Varsha Vittal |
| Designation |
PhD Research Scholar |
| Affiliation |
Department of Oral Medicine and Radiology |
| Address |
Department of Oral Medicine and Radiology,
Manipal College of Dental Sciences,
Light House Hill road,
Mangalore
Manipal College of Dental Sciences,
Light House Hill road,
Mangalore.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9535544595 |
| Fax |
|
| Email |
varsha.mcodsmlr2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravikiran Ongole |
| Designation |
Professor |
| Affiliation |
Department of Oral Medicine and Radiology |
| Address |
Department of Oral Medicine and Radiology,
Manipal College of Dental Sciences,
Light House Hill road,
Mangalore
Manipal College of Dental Sciences,
Light House Hill road,
Mangalore.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9448430387 |
| Fax |
|
| Email |
ravikiran.ongole@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Salian Varsha Vittal |
| Designation |
PhD Research Scholar |
| Affiliation |
Department of Oral Medicine and Radiology |
| Address |
Department of Oral Medicine and Radiology,
Manipal College of Dental Sciences,
Light House Hill road,
Mangalore
Manipal College of Dental Sciences,
Light House Hill road,
Mangalore.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9535544595 |
| Fax |
|
| Email |
varsha.mcodsmlr2022@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Dr TMA Pai Scholarship,
Manipal Academy of Higher Education, Manipal - 576104
Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Manipal University |
| Address |
Department of Oral Medicine and Radiology, Manipal college of Dental Sciences Mangalore-575001. |
| Type of Sponsor |
Other [Private Dental 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 Varsha Salian |
Manipal College of Dental Sciences Mangalore |
Department of Oral Medicine and Radiology, Ground floor,
Light House Hill Road.
Dakshina Kannada
KARNATAKA |
9535544595
varsha.mcodsmlr2022@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Manipal College of Dental Sciences, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Collection of human body fluids and tissue samples. |
Samples of saliva, blood and oral tissues from biopsy will be collected from stud subjects and analyzed using LIBS. |
| Comparator Agent |
Collection of human body fluids and tissue samples. |
Samples of saliva, blood and oral tissues will be collected from healthy control subjects and analyzed using LIBS. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects who are current users of areca nut, betel quid and commercially packed form of tobacco.
2. Subjects having OMPDs or malignant lesion in the oral cavity.
|
|
| ExclusionCriteria |
| Details |
1. Subjects using smoked form of tobacco.
2. Patients currently on any kind of antioxidant therapy or mineral dietary supplements (Ca, Fe, Zn etc.).
3. Where sample collection is not feasible or patient not willing to consent.
4. Patients without remarkable medical history (suffering from systemic illnesses).
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| concentration of Individual elements in saliva, blood, oral tissue, chewing products. |
6 months chewing products.
12 months saliva
18 months serum
24 months oral tissue. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mapping of elemental composition between chewing product and its presence in body fluids and tissues. |
6 months for chewing products.
12 months saliva
18 months serum
24 months oral tissue. |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
01/10/2025 |
| 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="3"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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 - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 [varsha.mcodsmlr2022@learner.manipal.edu].
- For how long will this data be available start date provided 15-07-2026 and end date provided 15-07-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Rationale/ gaps in existing knowledge: There seems to exist knowledge gap in the link between elements and oral cancer occurrence, severity, and prognosis. This study aims to qualitatively characterize the presence of elements in individuals with oral cancer, chewing products consumed and healthy controls. and verify the possible association of these elements with the occurrence and severity of OMPDs and oral cancer. Novelty: Currently, there are no studies to evaluate the elemental composition of the chewing products (Arecanut, Betel quid, Gutkha) and relate them with the elemental composition of saliva, blood and oral tissues of chewers which is the major aim of this study. More importantly, this study makes use of Laser induced breakdown spectroscopy (LIBS) for elemental analysis in chewing products as well as body fluids and tissues which has NEVER BEEN used in previous studies in this context. Objectives: To correlate the elements in areca nut, betel quid and commercially packed tobacco used by habitual individuals with the presence of elements in their saliva, serum, and oral tissue using Laser induced breakdown spectroscopy (LIBS). Methods: Elemental composition in habitual chewing products and their presence in saliva, blood and oral tissue using novel spectroscopic technique. Expected outcome: Insights into the role of elements (early diagnostic marker) in causing oral potentially malignant disorders and cancer. |