Comparative Evaluation of Conventional Nasolabial Flap with and without Fishtail Modification in Patients with Oral Submucous Fibrosis: A Research Protocol

Abstract

Introduction: Oral Submucous Fibrosis (OSMF) is a longterm condition characterised by the gradual buildup of fibrous tissue in the oral cavity, often extending to the throat and upper oesophagus. The primary symptoms include progressive limitation in mouth opening due to the formation of stiff fibrous bands in the oral mucosa, accompanied by muscle atrophy. However, the most concerning aspect of this restriction, known as trismus, is its hindrance to effective cancer monitoring. Surgical approaches typically aim to release these fibrotic bands, while medical interventions focus on managing inflammation and preventing further fibrosis. Need of the Study: A modification of the nasolabial flap has been suggested for the reconstruction of intraoral defects following ablative surgery for OSMF. The study will assess its merits in comparison to the conventional nasolabial flap. Aim: To evaluate and compare the aesthetic and functional outcomes of the rima oris between the Conventional Nasolabial Flap and the Nasolabial Flap with Fishtail Modification in patients undergoing surgical intervention for OSMF. Materials and Methods: A prospective, double-blinded, randomised controlled trial will be conducted in the Department of Oral and Maxillofacial Surgery at Acharya Vinoba Bhave Rural Hospital, associated with Jawaharlal Nehru Medical College, Wardha, Maharashtra, India, from November 2023 to November 2024. Patients older than 18 years of age diagnosed with OSMF, without any superimposing cancerous lesions, will be included in the study. They will be divided into two groups: Group A will be treated with bilateral fibrotomy, coronoidotomy and reconstruction with the conventional nasolabial flap, while Group B will undergo the same surgical intervention, except that the reconstruction will be performed using the fishtail modification of the nasolabial flap. The parameters that will be compared include interincisal mouth opening, intercommissural width, dehiscence and flap necrosis. The analysis will be conducted using the Chi-square test and Fisher’s-exact test for categorical data and the independent t-test for continuous data that follow a normal distribution. These statistical tests will help evaluate the association between different demographic, clinical and etiological factors and the outcomes under consideration. A p-value of <0.05 will be considered statistically significant.