Polycaprolactone resorbable mesh (PCL) versus Titanium mesh for the management of orbital floor fracture - A comparative study
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- To evaluate the effectiveness of polycaprolactone Mesh and Titanium mesh in management of orbital floor fracture
Study Overview
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
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
To evaluate the effectiveness of polycaprolactone Mesh and Titanium mesh in management of orbital floor fracture
Time Frame: Post operatively 1 week 1 month and 3 months
To evaluate and compare polycaprolactone Mesh and Titanium mesh in the management of orbital floor fracture
Time Frame: Post operatively 1 week 1 month and 3 months
Secondary Outcomes
- Clinical assessment of ocular functions Enophthalmous, Extra occular muscle movement impairment and diplopia(Radiological assessment using CT/CBCT)
Investigators
Vishesh Bhardwaj
AJ Institute of Dental Sciences