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CTRI Number  CTRI/2025/04/085184 [Registered on: 21/04/2025] Trial Registered Prospectively
Last Modified On: 16/04/2025
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Polycaprolactone resorbable mesh (PCL) versus Titanium mesh for the management of orbital floor fracture - A comparative study  
Scientific Title of Study   Polycaprolactone resorbable mesh (PCL) versus Titanium mesh for the management of orbital floor fracture - A comparative study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vishesh Bhardwaj 
Designation  Post graduate student 
Affiliation  AJ Institute of Dental Sciences  
Address  AJ institute of dental science, Kuntikana,NH66

Dakshina Kannada
KARNATAKA
173212
India 
Phone  09805523479  
Fax    
Email  visheshbhardwaj.sharma21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rithesh KB 
Designation  Reader 
Affiliation  AJ Institute of Dental Sciences  
Address  AJ institute of dental science, Kuntikana,NH66

Dakshina Kannada
KARNATAKA
173212
India 
Phone  9805523479  
Fax    
Email  rithesh.kb@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vishesh Bhardwaj 
Designation  Post graduate student 
Affiliation  AJ Institute of Dental Sciences  
Address  AJ institute of dental science, Kuntikana,NH66

Dakshina Kannada
KARNATAKA
173212
India 
Phone  9805523479  
Fax    
Email  vishesh.bhardwaj@yahoo.com  
 
Source of Monetary or Material Support  
AJ Institute of Dental Sciences, Kuntikana, NH 66, Mangalore, Karnataka, India 575004 
 
Primary Sponsor  
Name  Vishesh Bhardwaj 
Address  AJ Institute of Dental Sciences Kuntikana NH 66 Mangalore, Karnataka, India 575004 
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 Vishesh Bhardwaj  AJ institute of Dental Science   room no.2, Department of OMFS
Dakshina Kannada
KARNATAKA 		 9805523479

visheshbhardwaj.sharma21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AJIDS ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S023||Fracture of orbital floor,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Polycaprolactone Mesh  Polycaprolactone Mesh is composed of biocompatible plastic polycaprolactone belonging to the aliphatic polyester family. Approved by USFDA. It has osteoconductive properties and is supposed to be slow biodegradable with a rate of 2 to 3 years To be used in patients indicated for orbital floor fracture, who consent for its use  
Comparator Agent  Titanium mesh   Titanium mesh is the most preferred permanent alloplastic reconstruction material for orbital floor reconstruction. Known as the gold standard for orbital floor reconstruction, it will be used in all patients who consent to its use for orbital floor reconstruction. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Orbital floor fractures indicated for reconstruction
Patients should be medically fit in accordance with ASA grade assessment (limited to ASA grade 1 and grade 2)
Size of the defect should be limited between 6mm to 20mm 
 
ExclusionCriteria 
Details  Patients with comminuted fractures in orbital region
Any pathologies or infections in orbital region
Fracture older than 2 weeks
Patient with loss of vision following trauma
Non compliant patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of polycaprolactone Mesh and Titanium mesh in management of orbital floor fracture
To evaluate and compare polycaprolactone Mesh and Titanium mesh in the management of orbital floor fracture  		 Post operatively 1 week 1 month and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical assessment of ocular functions Enophthalmous, Extra occular muscle movement impairment and diplopia
Radiological assessment using CT/CBCT 		 Post operatively 1 week 1 month and 3 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   27/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  27/04/2025 
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)   Open to Recruitment 
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 -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  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 [visheshbhardwaj.sharma21@gmail.com].

  6. For how long will this data be available start date provided 06-05-2025 and end date provided 05-05-2027?
    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   Resorbable mesh has been in use for many years with advancements over the years. Polycaprolactone is a new material that has been introduced for the reconstruction purposes of orbital floor. However there have not been many studies in the literature regarding this material for its use in orbital floor reconstruction. Review of literature shows there have been very few studies comparing polycaprolactone mest to titanium mesh. Hence the purpose of this study is to compare the functional and structural outcomes of orbital floor reconstruction using polycaprolactone resorbable mesh against the titanium mesh 
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