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CTRI Number  CTRI/2024/08/071830 [Registered on: 02/08/2024] Trial Registered Prospectively
Last Modified On: 01/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   DELAYED SURGICAL TREATMENT OUTCOMES IN MAXILLOFACIAL FRACTURES 
Scientific Title of Study   OUTCOMES OF DELAYED SURGICAL INTERVENTION IN MAXILLOFACIAL FRACTURES 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Singam Kasinatha Reddy 
Designation  1st year post graduate 
Affiliation  Manipal college of dental sciences,Manipal 
Address  Room no:4,Department of Oral and Maxillofacial surgery,Manipal college of dental sciences,Manipal

Udupi
KARNATAKA
576104
India 
Phone  9493600570  
Fax    
Email  Skreddyvmp@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR.SUNIL S NAYAK 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Manipal college of dental sciences,Manipal 
Address  Room no:4,Department of Oral and Maxillofacial surgery,Manipal college of dental sciences,Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845308590  
Fax    
Email  sunil.nayak@manipal.edu  
 
Details of Contact Person
Public Query  
Name  DrSrikanth G 
Designation  PROFESSOR 
Affiliation  Manipal college of dental sciences,Manipal 
Address  Room no:4,Department of Oral and Maxillofacial surgery,Manipal college of dental sciences,Manipal

Udupi
KARNATAKA
576104
India 
Phone  9986455201  
Fax    
Email  srikanth.mds@manipal.edu  
 
Source of Monetary or Material Support  
Room no:4,Department of Oral and Maxillofacial surgery,Manipal college of dental sciences,Manipal,Karnataka,India-576104 
 
Primary Sponsor  
Name  DrSingam Kasinatha Reddy 
Address  Room no:-4,Department of Oral and maxillofacial Surgery,MCODS,Manipal 
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 
DrSingam Kasinatha Reddy  Manipal college of Dental Sciences,Manipal  Room no:-4,Dept of Oral and Maxillofacial Surgery,Manipal college of Dental Sciences,Manipal
Udupi
KARNATAKA 		 9493600570

skreddyvmp@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 
Patients  (1) ICD-10 Condition: S029||Fracture of unspecified skull andfacial bones,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients with maxillofacial fractures
2. Patients aged between 18 to 65.
3. Patients who will be managed surgically.
4. Patients who are willing to participate in the study.

 
 
ExclusionCriteria 
Details  1. Patients with infected fractures
2. Patients with Pathological fractures
3. Maxillofacial fractures managed conservatively.
4. Maxillofacial fractures are limited to only the dentoalveolar region.
5. Patients who are not willing to participate in the study.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
PRIMARY:
To assess the Postoperative outcomes of delayed surgical intervention in the form of Presence or absence of infection, occlusion, Nerve injury, Malunion and nonunion, Hardware failure, Need for osteotomy.
 		 ONE WEEK,1 MONTH,3 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
1. To help create a consensus among the clinicians on the effect of timing in treating Maxillofacial fractures.
2. Formulating guidelines for decision making in the appropriate amount of time taken in managing various Maxillofacial fractures
 		 1 WEEK,1 MONTH,3 MONTHS 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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)   12/08/2024 
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="8"
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 -  Study Protocol
    Response - Informed Consent Form

  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 [skreddyvmp@gmail.com].

  6. For how long will this data be available start date provided 30-06-2024 and end date provided 30-06-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a Prospective , longitudinal study of To evaluate postoperative outcomes of delayed surgical intervention in maxillofacial fractures .The primary outcomes are Presence or absence of infection, occlusion, Nerve injury, Malunion and nonunion, Hardware failure, Need for osteotomy .Secondary outcomes are To help create a consensus among the clinicians on the effect of timing in treating Maxillofacial fractures .and formulating guidelines for decision making in the appropriate amount of time taken in managing various Maxillofacial fractures. 
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