Protocol for Managing Antimicrobial Activity in the Patients with Maxillary Defect by Functionalization of Silicone Using Different Nanoparticles: A Randomized Control Trial

Abstract

Background: Patients with facial or intraoral defects are mostly reconstructed by prosthesis for which maxillofacial silicone considered as a material of choice for better aesthetics. Silicones are widely used medical materials. One of the major problems associated with the use of maxillofacial silicone material is microorganisms and fungal growth especially Candida albicans, which can result in chronic infection, inflammation and degradation of silicone material that's why the development of antimicrobial silicone elastomer became so important. So, a multiple study is performed trying to improve this property. Nanoparticle technology is rapidly advancing and is used for a wide range of applications in medicine. The potential of metal nanoparticles as antimicrobial agents is widely studied and is considered as an alternative approach to overcome the challenge posed by multidrug resistance in bacteria.
 Objective: The present study aims at to evaluate compare the antimicrobial activity of different nanoparticles through functionalization of silicone in the patients with maxillary defect.
 Methods: A prospective interventional study will be conducted for two years. The subjects in the study will be randomly selected comprising of 21 number of patients undergoing a surgical intervention of maxilla (developmental or acquired defect), after which obturators as a rehabilitation prosthesis is the treatment of choice. Relining of interim obturator incorporate with two different nanoparticles is planned and accordingly subjects will be divided in two interventional group and one control group. For control group, that means were prosthesis is fabricated in a conventional manner without any interventions, so in such patients swab will be taken from the intaglio surface of prosthesis after a specific intervals (after 2,6,12weeks). For interventional group in which prosthesis is relined with two different functionalized silicones, swab will be made again from defect site and from intaglio surface of obturator (after 2,6,12 weeks) with paper points to check microbial colonization growth after which comparative evaluation of antimicrobial activity will be performed.
 Results: Descriptive and analytical statistics will be done. SPSS (Statistical package for social sciences) Version 20.1 will be used as statistical software. The statistical significance between control group and interventional group in particular intervals will be evaluated at p<0.05 as P value is considered as level of significance.
 Conclusion: Functionalized silicone prosthesis which will thus be given to a patient of maxillary defects to prevent further adhesion of microbial growth on surgical site and which ultimately helps in wound healing. Hypothesis of present study is antimicrobial property of functionalized silicone using Hybrid nanoparticle may be more effective as compared to that of Chitosan nanoparticles in the interim obturators.