Comparative Evaluation of the Functional and Aesthetic Outcomes of Orbital Floor Reconstruction Using Poly Lactic Co-glycolic Acid and Titanium Mesh: A Randomised Controlled Trial Research Protocol

Introduction: Orbital floor fractures are common facial injuries that often result in functional and aesthetic impairment. Open Reduction and Internal Fixation (ORIF) using various materials, like Poly Lactic-Co-glycolic Acid (PLGA) mesh and titanium mesh, have been employed to repair these fractures. Need of the study: Recent advancements in hybrid bone mesh, including bioactive materials or elements to promote fracture healing, show significant promise. One such innovation involves using biodegradable PLGA material to create a bone screw mesh, which has demonstrated benefits for fracture healing and has gained interest recently. These developments aim to enhance treatment plans for patients by offering superior aesthetic and functional properties. However, evidence comparing their functional and aesthetic outcomes is limited. Aim: The present randomised controlled trial aims to compare and evaluate the functional and aesthetic outcomes of ORIF using PLGA mesh and titanium mesh in patients with orbital floor fractures. Materials and Methods: A randomised single-blinded controlled trial will be conducted at Siddharth Gupta Memorial Cancer Hospital (AVBRH), Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha, Maharashtra, India, from September 2024 to December 2025. A total of 12 patients presenting with orbital floor fractures will be included and two parallel groups, A and B, will be allocated by randomisation and they undergo ORIF using either or titanium mesh (Group A- Control group) or PLGA mesh (Group B-Experimental group). Functional outcomes, including diplopia, enophthalmos, ocular motility, and infraorbital nerve function, will be assessed using standardised clinical measures. Aesthetic outcomes will be evaluated based on facial symmetry, globe position, and patient satisfaction using validated scoring systems. Followup assessments will be conducted at regular intervals of 10-15 days. An unpaired t-test will be applied for intergroup comparison, and a p-value of less than 0.05 will be considered statistically significant.