Development, Evaluation, and Comparison of an Indigenous ‘APDS’ AI-based Digital Application for Effective Shade Selection of Silicone Maxillofacial Prosthesis: Protocol for A Cross-sectional Study

Abstract

Introduction: Reconstruction of maxillofacial defects is challenging in achieving aesthetic results. Replicating natural skin colour in maxillofacial prosthesis has been traditionally done using trial-and-error methods. However, with their respective limitations, multiple methods have been developed recently, like colourimeter and spectrophotometer. Need for the study: The natural appearance of the prosthesis affects the patient’s emotional and psychological well-being. Therefore, aesthetics is a prime concern now. So, the problem with colour matching of the maxillofacial prosthesis is profound. So, there is a need to develop customised shade guides and more advanced digitised shade-matching applications with Artificial Intelligence (AI) help. Therefore, a concoction of a customised silicon shade guide was contemplated with Advanced Programme in Data Sciences (APDS) AI-based digital application, and its reproducibility in clinical practice will be analysed. Aim: Phase 1- To develop and validate a customised broad spectrum silicon shade guide and APDS AI-based digital application on a survey of the Indian population. Phase 2- Comparative evaluation of the efficacy of indigenous APDS AI-based digital application with available shade guide systems for shade selection for silicone maxillofacial prosthesis. Methodology: A cross-sectional study. The shade guide will be fabricated with medical grade room temperature vulcanising silicone based on an observational survey. The shade guide will consist of three main groups ABC, divided into different subgroups from lighter to darker skin shades, and its accuracy evaluation is done by spectrophotometer. APDS AI-based digital application will be developed using reference from broadspectrum customised maxillofacial shade guide, and efficacy will be evaluated with visual assessment of colour matching by fabricating facial veneers for participants through investigators to investigate the consent of perfect colour match. Data will be statistically analysed.