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CTRI Number  CTRI/2023/06/054049 [Registered on: 16/06/2023] Trial Registered Prospectively
Last Modified On: 16/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Nasal Morphology in Maharashtrians residing in Mumbai & Thane. 
Scientific Title of Study   Nasal Morphology in Maharashtrians residing in Mumbai & Thane - An anthropometric descriptive cross-sectional study . 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anandrai Kamath 
Designation  pg student  
Affiliation  Terna dental college 
Address  terna dental college, oral surgery dept, room 131, nerul west, Navi Mumbai
terna dental college, nerul west, Navi Mumbai
Thane
MAHARASHTRA
400706
India 
Phone  7977167033  
Fax    
Email  anandraikamath11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sanjay Joshi 
Designation  professor & HOD 
Affiliation  Terna dental college 
Address  131, dept oral surgery, terna dental college, nerul west, Navi Mumbai
terna dental college, nerul west, Navi Mumbai
Thane
MAHARASHTRA
400706
India 
Phone  9869057337  
Fax    
Email  sanjoshi99@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anandrai Kamath 
Designation  pg student  
Affiliation  Terna dental college 
Address  131, dept oral surgery, terna dental college, nerul west, Navi Mumbai
terna dental college, nerul west, Navi Mumbai
Thane
MAHARASHTRA
400706
India 
Phone  7977167033  
Fax    
Email  anandraikamath11@gmail.com  
 
Source of Monetary or Material Support  
terna dental college 131, dept oral surgery, terna dental college, nerul west, Navi Mumbai  
 
Primary Sponsor  
Name  terna dental college 
Address  terna dental college, nerul west, Navi Mumbai  
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 
Anandrai Kamath  Terna dental college and hospital  Rom 131, department of oral surgery, Terna dental college, nerul west, Navi Mumbai
Thane
MAHARASHTRA 		 7977167033

anandraikamath11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
terna dental college ethics comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  HEALTHY HUMAN TO JUST RECORD THEIR NASAL MEASUREMENTS 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Patients who are willing to participate
Patients who have their mother tongue as Marathi.
Patients belonging to the city of Mumbai and thane district 
 
ExclusionCriteria 
Details  Abnormal body mass index
History if previous nasal trauma
History of previous nasal facial surgery 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Determine the nasal morphology & dimensions among Maharashtrians residing in Mumbai & Thane district  the outcome will be measured in 6 months of the start of trail 
 
Secondary Outcome  
Outcome  TimePoints 
To identify & classify the type of nose.  1 YEAR 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   28/06/2023 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  pubmed

  6. For how long will this data be available start date provided 01-01-2024 and end date provided 10-06-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - none
Brief Summary   anthropometric measurements of the face are important for plastic

surgeons, as those values can be used in the diagnosis, classification and

treatment of congenital or post-traumatic craniofacial disorders, providing

important data for facial plastic surgeons. Even though a surgeon with

clinical experience in facial analysis may detect various problems, with a

nose it still helps to follow certain rules and measurements to assess the

face quantitatively

 
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