Design development,Biomechanical validation and Clinical evaluation of a novel miniplate design for Mandible angle fracture management:Two phase study

The angle is one of the most frequent fractured sites after traumatic events involving the mandible.The optimal treatment of angle fractures remains controversial. Biomechanical studies on champy’s technique revealed that single miniplate on superior border has least resistance to lateral displacement and torsional force. Placement of two miniplate needs intraoral and extraoral approach/transbuccal approach. This practice increases periosteal stripping and compromises blood supply. Simultaneous intraoral and extraoral approach/transbuccal approach increases the risk of bacterial contamination , infection, increases operating time, risk of facial nerve injury and hypertrophic scar. The proposed research project aims to develop a novel single miniplate design that can be easily adapt and fix across fracture segments of mandible angle in biplanar fashion by intraoral approach. It shouId have minimal implant volume, but provides optimal biomechanical stability, functional stability and patient tolerance.

Objective To design a new miniplate system for mandible angle fracture management, evaluate and compare its efficacy biomechanically and clinically.

Study design-Two stage study

 Stage 1: Randomised control trial using Computational mandible models & polyurethane mandible models.

Evaluation and comparison of biomechanical stability and stress distribution of miniplate, screws and underlying bone using Finite element analysis. Validation of biomechanical characteristics using UTM machine.

 Stage 2: Randomised control clinical trial

Patients with Mandible angle fracture are selected into group A and B. Group A: Single straight miniplate fixation group(conventional) Group B: New miniplate design fixation group

Treatment outcome(Plate fixation time, Neurosensory function, Wound healing status) and Functional stability assessment are assessed and compared in both groups.

RESEARCH QUESTION

Is there any difference in biomechanical stability and clinical efficacy between single miniplate and new miniplate design for mandible angle fracture management?