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CTRI Number  CTRI/2025/03/082080 [Registered on: 10/03/2025] Trial Registered Prospectively
Last Modified On: 10/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Lip prints: Comparison in between North and South Indian Population 
Scientific Title of Study   CHEILOSCOPY: A Comparative Analysis pertaining to geomorphological variance in the lip prints in the North and South Indian population. 
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 Swapnil Mishra 
Designation  Junior Resident (Post Graduate) 
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Department of Forensic Medicine and Toxicology, Kasturba Medical College, MAHE, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka Manipal, Karnataka.

Udupi
KARNATAKA
576104
India 
Phone  7355382961  
Fax    
Email  swapnil.mishra84@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashwini Kumar 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Department of Forensic Medicine and Toxicology, Kasturba Medical College, MAHE, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka Manipal, Karnataka.

Udupi
KARNATAKA
576104
India 
Phone  9964139848  
Fax    
Email  kumar.ashwini@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Swapnil Mishra 
Designation  Junior Resident (Post Graduate) 
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Department of Forensic Medicine and Toxicology, Kasturba Medical College, MAHE, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka Manipal, Karnataka.

Udupi
KARNATAKA
576104
India 
Phone  7355382961  
Fax    
Email  swapnil.mishra84@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104, India 
 
Primary Sponsor  
Name  Dr Swapnil Mishra 
Address  Department of Forensic Medicine and Toxicology, MAHE, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 
Type of Sponsor  Other [self] 
 
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 Swapnil Mishra  Kasturba Medical College, Manipal  Department of Forensic medicine and Toxicology, Kasturba Medical College, MAHE, Manipal.
Udupi
KARNATAKA 
7355382961

swapnil.mishra84@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1) Individuals from age group between 18-25 years
2) Individuals with both parents belonging to same region i.e. either North India or South India.
 
 
ExclusionCriteria 
Details  1. Less than 18 years and more than 25 years.
2. People with any lip pathology e.g. cheilosis, cleft lip, ulcerations, inflammation, malformation, deformity, surgical scars, facial palsy, and active lesions.
3. Burn cases.
4. People allergic to lip balms and lipsticks.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To establish the prevalence and predominance of a distinct pattern of lip print in a specific region ( North or South India) and specificity pertaining to the gender.
To frame a positive correlation between the pattern of lip prints of the two regions studied and between the gender, amongst the age group under consideration.
 
8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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   N/A 
Date of First Enrollment (India)   21/03/2025 
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="2"
Months="0"
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  

After obtaining the written informed consent, the lips of the individuals who already had lipstick over the lips were cleaned with a cotton ball dipped in lipstick remover. Lip tint/Lipstick was applied with a lipstick applicator uniformly starting from center and moving laterally in a single motion. The individuals were asked to maintain a relaxed position of their lips. After one-two minutes, once the lip tint/lipstick had dried, the glued portion of the adhesive cellophane tape strip that was slightly larger than the thickness of the lip, was placed over the upper lip and the individual was asked to make a lip impression in the normal rest position of the lips by dabbing it in the center first and then pressing it uniformly toward the corners of the lips. The same procedure was used for the lower lip. Henceforth, the cellophane strip was then stuck to the executive bond paper for permanent record purpose and then visualized by magnifying lens. The lip prints were coded based on the name, sex and region ( North Indian or South Indian) of the individuals. Each of the lip print collected were kept in a separate file with details of the subjects.  The middle segment of the lip print was observed and the predominant pattern as per Suzuki and Tsuchihashi classification observed was recorded as finding. The peripheral segment of the lip print was avoided as there are chances of overlapping and smudging. To circumvent bias, all the lip prints were compiled, analyzed, and interpreted only once by a single researcher well versed with the classification of lip prints. A comprehensive analysis of the lip prints were later done, based on the patterns described by Suzuki and Tsuchihashi. Further, the length and thickness of the lips were measured using standard sliding callipers. Separate measurements were taken for the upper and the lower lip. Measurement of the length of the lips were calculated  between the outermost visible points on the lip print at the angle of the mouth. Width/ thickness of the lip was measured for the upper and lower lip in the midline, at the philtrum. All the measurements were taken by one person using the same callipers and the findings were tabulated.

 
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