FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
Close