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CTRI Number  CTRI/2021/06/033978 [Registered on: 03/06/2021] Trial Registered Prospectively
Last Modified On: 01/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Subciliary approach for treatment of infraorbital bone fracture  
Scientific Title of Study   "EVALUATION OF EFFICACY OF SUBCILIARY APPROACH FOR THE TREATMENT OF INFRAORBITAL BONE FRACTURES-A CLINICAL STUDY" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  kyamuna 
Designation  post graduate 
Affiliation  Government dental college and hospital , RIMS , kadapa 
Address  27-154-2B,santhi colony Ramnagar colony,chittoor
Department of oral and maxillofacial surgery, GDCH ,RIMS,KADAPA
Cuddapah
ANDHRA PRADESH
517002
India 
Phone  7981700437  
Fax    
Email  yamunayadavbds011@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Drkyamuna 
Designation  post graduate 
Affiliation  Government dental college and hospital , RIMS , kadapa 
Address  Department of oral and maxillofacial surgery, Government dental college and hospital,RIMS,Kadapa
Room no.8 , dental staff quarters, RIMS , kadapa
Cuddapah
ANDHRA PRADESH
516002
India 
Phone  7981700437  
Fax    
Email  yamunayadavbds011@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrDYesuratnam 
Designation  Associate professor 
Affiliation  Government dental college and hospital , RIMS , kadapa 
Address  Department of oral and maxillofacial surgery, Government dental college and hospital,RIMS,Kadapa
Department of oral and maxillofacial surgery, Government dental college and hospital,RIMS,Kadapa
Cuddapah
ANDHRA PRADESH
516002
India 
Phone  08374082674  
Fax    
Email  yesuratnam.duddu@gmail.com  
 
Source of Monetary or Material Support  
Government dental college and hospital,RIMS,kadapa  
 
Primary Sponsor  
Name  Government dental college and hospital 
Address  RIMS,putlampalli kadapa-516002 
Type of Sponsor  Government 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 
Drkyamuna  Government dental college and hospital ,RIMS  Department of oral and maxillofacial surgery,GDCH,RIMS,putlampalli kadapa-516002
Cuddapah
ANDHRA PRADESH 
7981700437

yamunayadavbds011@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Governmental dental college ,RIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Subciliary approach for reduction of infraorbital bone fracture  Surgical incision is made 2mm inferior to the eyelashes, along the entire length of the lower eyelid, which can be extended laterally for additional exposure of the entire lateral orbital rim , followed by fixation of infraorbital bone fracture with titanium miniplate. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.patients with infraorbital bone fractures planned for open reduction and miniplate fixation.
2.patients between 18-60years of age.
3.patients free of significant systemic diseases[ASAI] and deemed fit for surgery by General physician.
4.Surgical site free of active infection. 
 
ExclusionCriteria 
Details  1.Deemed medically unfit for surgery (ASA III & IV).
2.Hematological disorders.
3.Patient with soft tissue laceration of orbital region .
4.Patient with h/o keloid formation .
5.Scarophobic patients.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
presence of hypertrophic scar formation  1week,1month,3months, 
 
Secondary Outcome  
Outcome  TimePoints 
1.presence of postoperative scar formation.
2.presence of scleral show. 
1week,1month,3months 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   14/06/2021 
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="20" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The zygomatic bone is an essential element of facial configuration as it constitutes the prominence of the cheek bone. Because of its prominence and exposed location, the zygoma is highly susceptible to fractures in facial trauma.

The zygoma is geometrically unique because it articulates with four bones - the frontal, temporal, maxilla and sphenoid. Zygoma fractures are typically described as being tetrapod. zygomatic complex fractures present challenging diagnostic and reconstructive problems for the surgeon.

Anatomic reduction of lateral, inferior orbital rims and orbital floor are necessary to reestablish facial symmetry and position of the globe and to restore normal sensation to the structures innervated by the infraorbital nerve.

The increasing emphasis on open reduction and bone grafting techniques in the treatment of facial fractures needs a search for incisions which provide good exposure of fracture sites and minimal cosmetic deformity.

The lower orbital rim and orbital floor can be exposed transcutaneosly through the subciliary, subtarsal and infraorbital incisions or by means of transconjunctival incision with lateral canthotomy.

 The conventional subciliary incision which is a kind of transcutaneous incision was first described by converse in 1944. This approach spares the conjunctiva, bypasses the transconjunctival related complications, and eliminates the need for a lateral canthotomy. Furthermore the incision can be extended either to the medial or lateral sides to explore any associated fracture. 

In this study the following parameters are being studied: 

1.Time duration of the surgery

2.presence of visible postoperative scar formation by using modified vancouver scar scale

3.presence of scleral show using ectropion grading scale

 
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