| 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
|
|
|
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
|
|
|
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. |