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Polycaprolactone resorbable mesh (PCL) versus Titanium mesh for the management of orbital floor fracture - A comparative study

Polycaprolactone resorbable mesh (PCL) versus Titanium mesh for the management of orbital floor fracture - A comparative study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/04/085184
Enrollment
20
Registered
2025-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S023- Fracture of orbital floor

Interventions

Intervention1: Polycaprolactone Mesh: Polycaprolactone Mesh is composed of biocompatible plastic polycaprolactone belonging to the aliphatic polyester family. Approved by USFDA. It has osteoconductive

Sponsors

Vishesh Bhardwaj
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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 fractureTimepoint: Post operatively 1 week 1 month and 3 months

Secondary

MeasureTime frame
Clinical assessment of ocular functions Enophthalmous, Extra occular muscle movement impairment and diplopia Radiological assessment using CT/CBCTTimepoint: Post operatively 1 week 1 month and 3 months

Countries

India

Contacts

Public ContactVishesh Bhardwaj

AJ Institute of Dental Sciences

rithesh.kb@gmail.com9805523479

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026