| CTRI Number |
CTRI/2026/03/106211 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Screening for Anemia in Adults Using a Non-Contact Infrared Thermometer Inside the Mouth |
|
Scientific Title of Study
|
Infrared thermometry of oral mucosa as a Non-Invasive Screening tool for anemia: a pilot 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 |
Dr K U Vigneshmani |
| Designation |
Post graduate |
| Affiliation |
KAHER KLE VK Institute of Dental Sciences |
| Address |
Department of Oral Maxillofacial Pathology and Microbiology, KAHER KLE VK Institute of Dental Sciences, Belgaum.
Belgaum KARNATAKA 590010 India |
| Phone |
9962526826 |
| Fax |
|
| Email |
vigneshmaniku@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Veena N Naik |
| Designation |
Professor |
| Affiliation |
KAHER KLE VK Institute of Dental Sciences |
| Address |
Department of Oral Maxillofacial Pathology and Microbiology, KAHER KLE VK Institute of Dental Sciences, Belgaum.
Belgaum KARNATAKA 590010 India |
| Phone |
9448942266 |
| Fax |
|
| Email |
veenavnaik2@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Veena N Naik |
| Designation |
Professor |
| Affiliation |
KAHER KLE VK Institute of Dental Sciences |
| Address |
Department of Oral Maxillofacial Pathology and Microbiology, KAHER KLE VK Institute of Dental Sciences, Belgaum.
Belgaum KARNATAKA 590010 India |
| Phone |
9448942266 |
| Fax |
|
| Email |
veenavnaik2@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER, KLE VK INSTITUTE OF DENTAL SCIENCES, Belgaum, Karnataka, India, 590010. |
|
|
Primary Sponsor
|
| Name |
KAHER KLE VK INSTITUTE OF DENTAL SCIENCES Belgaum Karnataka India |
| Address |
No 4, Department of Oral and Maxillofacial pathology and microbiology, KLE VK INSTITUTE OF DENTAL SCIENCES, JNMC campus, Nehru Nagar, Belgaum, Karnataka, India, 590010. |
| 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 K U Vigneshmani |
KAHER KLE VK Institute of Dental Sciences, Nehru Nagar, Belgaum. |
Room no 4, Department of Oral Maxillofacial Pathology and Microbiology, KAHER KLE VK Institute of Dental Sciences, Nehru Nagar, Belgaum. Belgaum KARNATAKA |
9962526826
veenavnaik2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
nil |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Report to the Department of Oral and Maxillofacial Pathology and Microbiology for Blood examination.
Are willing to undergo oral thermometry and CBC testing on the same visit.
Have no active oral lesions at the temperature-recording sites (buccal, sublingual, gingival mucosa).
|
|
| ExclusionCriteria |
| Details |
Acute Medical Conditions such as Patients presenting with fever or acute illness affecting the respiratory system, gastrointestinal tract, or urinary tract.
Recent Trauma or Surgery.
Oral Mucosal Pathology, Systemic Diseases, Autoimmune diseases.
Substance Use Prior to Testing.
Pregnancy and Lactation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnostic accuracy of oral mucosal temperature measured using an infrared thermometer for screening of anemia, assessed by sensitivity and specificity compared with hemoglobin estimation. |
0 days
7 days
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
01/04/2026 |
| 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="0" 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
|
The study titled Infrared thermometry of oral mucosa as a Non-Invasive Screening tool for anemia is a pilot investigation aimed at evaluating whether measuring the temperature of the oral mucosa can accurately detect anemia. Currently, anemia is diagnosed through invasive and resource-intensive blood tests, while visual checks for mucosal pallor are often subjective and unreliable. This research utilizes infrared thermometry, a non-contact and radiation-free technology, to map surface temperature patterns that relate to blood perfusion and hemoglobin levels. The study is designed as a prospective cross-sectional observational study involving forty participants between the ages of 18 and 60, divided into anemic and non-anemic groups. Researchers will record temperature readings from three specific sites—the buccal, sublingual, and gingival mucosa—using a non-contact infrared thermometer. These readings will then be correlated with hemoglobin concentrations obtained through a standard complete blood count analysis. The investigators hypothesize that anemic individuals will exhibit lower oral temperatures due to reduced local blood perfusion. By comparing the diagnostic performance across the three mucosal sites, the study seeks to identify the most reliable anatomical location for anemia screening. If successful, this method could provide a rapid, low-cost, and accessible screening alternative for use in dental clinics and community health settings, facilitating earlier detection and referral for systemic disease. |