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CTRI Number  CTRI/2024/10/075165 [Registered on: 11/10/2024] Trial Registered Prospectively
Last Modified On: 11/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Two‑point versus three‑point Fixation in the management of zygomaticomaxillary complex fractures: A comparative study 
Scientific Title of Study   A comparative study between reduction and fixation of zygomaticomaxillary complex fractures using 2 point and 3 point fixation. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Raval Kaushal Mitesh 
Designation  Junior Resident 
Affiliation  Manipal College of Dental Sciences 
Address  Room no- 4 Department of Oral and Maxillofacial Surgery Manipal College of Dental Sciences Manipal Udupi 576104

Udupi
KARNATAKA
576104
India 
Phone  6352385568  
Fax    
Email  kaushalmaheofficial@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Srikanth G 
Designation  Professor and Head 
Affiliation  Manipal College of Dental Sciences 
Address  Room no- 4 Department of Oral and Maxillofacial Surgery Manipal College of Dental Sciences Manipal Udupi 576104

Udupi
KARNATAKA
576104
India 
Phone  9986455201  
Fax    
Email  srikanth.mds@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Chitra 
Designation  Professor 
Affiliation  Manipal College of Dental Sciences 
Address  Room no- 4 Department of Oral and Maxillofacial Surgery Manipal College of Dental Sciences Manipal Udupi 576104

Udupi
KARNATAKA
576104
India 
Phone  9481939772  
Fax    
Email  chitra.a@manipal.edu  
 
Source of Monetary or Material Support  
Room no- 4 Department of Oral and Maxillofacial Surgery Manipal College of Dental Sciences Manipal Udupi 576104 
 
Primary Sponsor  
Name  Dr Raval Kaushal Mitesh 
Address  Room no- 4 Department of Oral and Maxillofacial Surgery Manipal College of Dental Sciences Manipal Udupi 576104 
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 
Dr Raval Kaushal Mitesh  Manipal college of Dental Sciences,Manipal  Room no- 4 Department of Oral and Maxillofacial Surgery Manipal College of Dental Sciences Manipal Udupi 576104
Udupi
KARNATAKA 		 6352385568

kaushalmaheofficial@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba medical college and hospiyal 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  2 point fixation  Open reduction and internal fixation under general anesthesia for fixation of frontozygomatic suture and zygomatic buttress. 
Intervention  3 point fixation  Open reduction and internal fixation under general anesthesia for fixation of frontozygomatic suture, zygomatic buttress and infraorbital rim. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  a)Patients with Zygomaticomaxillary complex fractures (with or without arch) (Knight and North
classification 2, 3, and 4)
b) Patients aged between 18 to 70.
c) Patients who will be managed surgically  
 
ExclusionCriteria 
Details  a) Patients with infected fractures
b) Patients with tissue loss
c) Patients who are medically compromised and are not fit to undergo the surgery.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Assessment of post operative functional abilities, aesthetic deformities, neurological defecits

2.Total time taken for the surgery

3.The clinical evaluation will help in determining need for further management of zygomaticomaxillary fractures
 		 1 week, 1 month and 3 month 
 
Secondary Outcome  
Outcome  TimePoints 
1. To help create a consensus among the clinicians on postoperative aesthetic & functional
complications with respect to zygomaticomaxillary fractures
2. Formulating guidelines for decision making in the fixation which would be appropriate in managing
zygomaticomaxillary fractures. 		 3 months 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   24/10/2024 
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 -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kaushalmaheofficial@gmail.com].

  6. For how long will this data be available start date provided 23-12-2026 and end date provided 23-12-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Zygomaticomaxillary complex fractures may be a challenge in Oral and Maxillofacial surgery. The surgical approach is formulated based on the discoveries from the physical examination and imaging studies. Satisfactory introduction and mobilization of the fracture fragments are basic for guaranteeing suitable anatomical reduction .It is necessary to compare so it can draw us to conclusion that what will be way better for the understanding. Due to lack of specific studies in literature, more research regarding the same is highly recommended. This is a observational study where we compare 2-point and 3-point fixation on the basis of Facial assessment,  Radiological assessment,  Neurological assessment,  Duration of surgery,  Intraoperative stability and  Mouth opening.  
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