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CTRI Number  CTRI/2024/03/063689 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On: 05/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Relationship between injuries and fracturs of factures after a road traffic accident 
Scientific Title of Study   Correlation between facial soft tissue injuries and facial fractures following a road traffic accident. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR LOVELEEN KAUR 
Designation  POST GRADUATE  
Affiliation  MANIPAL COLLEGE OF DENTAL SCIENCES 
Address  Room No.4 Department of oral and maxillofacial surgery, Manipal collage of dental sciences, Manipal
Room No.4 Department of oral and maxillofacial surgery, Manipal collage of dental sciences, Manipal
Udupi
KARNATAKA
576104
India 
Phone  7837518046  
Fax    
Email  loveleenkaur89726@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SRIKANTH G 
Designation  prof and hod 
Affiliation  MANIPAL COLLEGE OF DENTAL SCIENCES 
Address  Room No.4 Department of oral and maxillofacial surgery, Manipal collage of dental sciences, Manipal
Room No.4 Department of oral and maxillofacial surgery, Manipal collage of dental sciences, Manipal
Udupi
KARNATAKA
576104
India 
Phone  9986455201  
Fax    
Email  srikanth.mds@manipal.edu  
 
Details of Contact Person
Public Query  
Name  DR LOVELEEN KAUR 
Designation  POST GRADUATE  
Affiliation  MANIPAL COLLEGE OF DENTAL SCIENCES 
Address  Room No.4 Department of oral and maxillofacial surgery, Manipal collage of dental sciences, Manipal
Room No.4 Department of oral and maxillofacial surgery, Manipal collage of dental sciences, Manipal
Udupi
KARNATAKA
576104
India 
Phone  7837518046  
Fax    
Email  loveleenkaur89726@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  MANIPAL COLLEGE OF DENTAL SCIENCES MANIPAL 
Address  ROOM NO 4 DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY MANIPAL COLLEGE OF DENTAL SCIENCES MANIPAL 
Type of Sponsor  Private medical college 
 
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 LOVELEN KAUR  KMC, MANIPAL  ROOM NO 4 DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY MANIPAL COLLEGE OF DENTAL SCIENCES MANIPAL
Udupi
KARNATAKA 		 7837518046

loveleenkaur89726@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  facial fractures 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. To be aged 18 years or above. 2. Sustained facial injuries due to road traffic accidents. 3. Have facial bone computed tomography scans performed within one week of the injury. Have complete facial injury assessment and record available.  
 
ExclusionCriteria 
Details  1. Age less than 18 years. 2. GCS less than 8.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the patterns of STI sustained in a road traffic accident. The clinical and radiological evaluation will help in establishing a correlation between facial STIs and facial fractures.  baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Helps in providing better patient care by prioritizing the patients on the basis of severity of soft tissue injury. Helps in identifying the etiology of road traffic accident.  baseline 
 
Target Sample Size   Total Sample Size="79"
Sample Size from India="79" 
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)   15/03/2024 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 - Proposals should be directed to [loveleenkaur89726@gmail.com].

  6. For how long will this data be available start date provided 15-02-2024 and end date provided 25-04-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   RTAs are known to involve a high velocity impact and have been reported to have a high likelihood of facial injuries and fatality. Establishing a correlation between soft tissue injuries and facial fractures will help in early diagnosis of the facial fractures, more focused approached of the surgeon towards the treatment plan. Due to lack of specific studies in literature, more research regarding the same is highly recommended. 
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