It is a comparative study of two groups. In study group advanced bioabsorbable material (PLGA) is used to reconstruct the orbital floor fracture and in controlled group traditional Titanium plate, mesh and screw are used. Then comparison will be done and outcomes will be accessed

Comparative evaluation of functional and esthetic outcome of orbital floor reconstruction using poly Lactic co-glycolic acid mesh and titanium mesh in patient with orbital floor fracture- Randomized control trial. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075829

Enrollment

Registered

2024-10-24

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Poly Lactic co glycolic acid plates and mesh in orbital floor and rim fracture: Bioabsorbable material named as poly lactic co glycolic acid plates and mesh are used in orbital floor re

Eligibility

Inclusion criteria

Inclusion criteria: Patients with unilateral or bilateral orbital floor fractures. Patients ready for regular follow up. Patient fit for General Anesthesia.

Exclusion criteria

Exclusion criteria: Patients who do not fit in age group from 18 years to 85 years. Patients unwilling for regular follow up. Unfit patients for General Anesthesia. Patient with systemic bony diseases.

Design outcomes

Primary

Measure	Time frame
Less Post operative complications. Better functional and esthetic outcomes. Decreased possibility for secondary surgery surgeryTimepoint: 1 week, 1 month, 3 months	—

Secondary

Measure	Time frame
Slow bioabsorbable rate of intervened material, post op complications, low strength of materialTimepoint: 1 week, 1, month,3 months	—

Countries

India

Contacts

Public ContactDr Nitin Bhola

Datta Meghe Institute Of Higher Research And Education

drnitinbhola@gmail.com9970070607

Outcome results

None listed

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