| CTRI Number |
CTRI/2025/02/080657 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
14/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation between lip patterns and Malpositioned jaws in South Kerala population |
|
Scientific Title of Study
|
Association of lip prints in different skeletal malocclusions in South Kerala population; A Cross sectional 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 ARYA J M |
| Designation |
PG Student, Department of Orthodontics |
| Affiliation |
Department of Orthodontics, PMS College of Dental Science And Research, Trivandrum |
| Address |
Department of Orthodontics, Room Number 6, PMS College of Dental Science And Research, Golden Hills, Vattappara, Venkode, Trivandrum
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9074048132 |
| Fax |
|
| Email |
aryajm95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ROOPESH R |
| Designation |
Professor and HOD, Department of Orthodontics |
| Affiliation |
Department of Orthodontics, PMS College of Dental Science And Research, Trivandrum |
| Address |
Department of Orthodontics, Room Number 6, PMS College of Dental Science And Research, Golden Hills, Vattappara, Venkode, Trivandrum
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9447051051 |
| Fax |
|
| Email |
dr.roopesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ROOPESH R |
| Designation |
Professor and HOD, Department of Orthodontics |
| Affiliation |
Department of Orthodontics, PMS College of Dental Science And Research, Trivandrum |
| Address |
Department of Orthodontics, Room Number 6, PMS College of Dental Science And Research, Golden Hills, Vattappara, Venkode, Trivandrum
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9447051051 |
| Fax |
|
| Email |
dr.roopesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| PMS College of Dental Science And Research, Trivandrum, Kerala, India, 695028 |
|
|
Primary Sponsor
|
| Name |
Dr. ARYA J M |
| Address |
PMS College of Dental Science And Research, Golden Hills, Vattappara, Venkode, Trivandrum,695028 |
| 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 ARYA J M |
PMS College of Dental Science and Research |
Department of Orthodontics, Room Number 6, Golden Hills, Vattappara, Venkode,Trivandrum, 695028 Trivandrum, 695028
Thiruvananthapuram
KERALA |
9074048132
aryajm95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PMS College of Dental Science and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Having Skeletal Class I, Class II Div 1 and Div 2 and Class III Malocclusion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are healthy without any medical conditions and congenital anomalies
2. Patients who have not undergone previous orthodontic treatments or orthognathic surgeries.
|
|
| ExclusionCriteria |
| Details |
1. The participants who are hypersensitive to lipsticks
2. The participants having lesions on the lips or has undergone plastic surgeries following accidents
3. The participants with congenital facial anomalies
4. The participants with borderline or contradictory ANB values obtained from Cephalometry
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find an association between lip-prints and skeletal malocclusions in South Kerala population |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify developing skeletal malocclusions early by recognising lip patterns in individuals |
2 months |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
25/02/2025 |
| 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="0"
Months="2"
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
|
Lip-prints are unique to an individual just like the fingerprints
and shows strong hereditary pattern . Therefore this study is designed to explore correlation of lip-prints with
skeletal base relationship and if possible, to establish lip-prints as relevant
diagnostic tool. This study aims to establish an association between lip patterns and
various malocclusions in South Kerala
population through a cross sectional study. Lip prints are recorded using maybelline lipstick , lip brush and cellophane paper and examined with magnifying lens. it is compared with Tsuchihashi classification of lip prints. Samples are divided equally into Skeletal CLASS I,Class II Div 1 nd Div 2, Class III based on ANB angle and the association between lip prints and skeletal malocclusion can be compared.
|