A Comparative Evaluation of the Efficacy of Submucosal Injections of Autologous Platelet-Rich Plasma Versus Placentrex® Combined with Hyaluronidase in the Management of Oral Submucous Fibrosis Following Immediate Surgical Release of Fibrous Bands: A Randomized Controlled Clinical Trial.

Oral Submucous Fibrosis is an insidious chronic disease affecting any part of the oral cavity and sometimes the pharynx Although occasionally preceded by and or associated with vesicle formation it is always associated with juxtaepithelial inflammatory reaction followed by a fibroelastic change of the lamina propria with epithelial atrophy leading to stiffness of the oral mucosa and causing trismus and inability to eat

This potentially malignant condition was first reported by Schwartz in 1952 in five Indian females from Kenya when he coined the term atropica idiopathica mucosae oris.

OSMF shows multifactorial pathogenesis. Factors such as areca nut chewing, excessive ingestion of chilies hereditary factors can trigger the juxtaepithelial inflammatory response of oral mucosa That is followed by a fibro elastic change of lamina propria and epithelial atrophy leading to stiffness of oral mucosa leading to trismus and difficulty in eating

Due to its stubborn nature the management of OSMF is difficult The lack of complete response to treatment aim is to reduce morbidity and risk of malignant transformation Most patients are treated with Pharmacological methods and oral physiotherapy

The main aim of treatment is to relieve symptoms, prevent malignant transformation, and improve mouth opening Surgical intervention is typically indicated in the late and irreversible stages of the condition It involves the release of fibrous bands followed by the placement of various grafts to restore function and prevent recurrence Placental extract Placentrex is an aqueous extract of human placenta that contains nucleotides enzymes like alkaline phosphatase acid phosphatase vitamins like Vit E B1 B2 B4 B6 pantothenic acid nicotinic acid P amino benzoic acid folic acid essential and non essential amino acids and certain trace elements Main effects of placental extract are anti-inflammatory and analgesic action that increases blood circulation tissue vascularity, arrest tissue growth stagnation and lower immune response factor

Platelet rich plasma  is a simple efficient and minimally invasive method of obtaining a natural concentration of autologous growth factors Formation of PRP involves centrifugation of autologous blood to separate and extract the plasma and buffy coat layer that contains high concentration of platelets

PRP has seven fundamental proteins that are platelet derived growth factors PDGF transforming growth factor TGF B vascular endothelial growth factor VEGF epidermal growth factor EGF and adhesive proteins  fibrin fibronectin and vitronectin

PDGF is a glycoprotein which emerges from degranulation of platelets at the site of injury It activates cell membrane receptors on target cell which in turn develop high energy phosphate bonds which activates the signal proteins to initiate specific activity of target cells These specific activities include mitogenesis angiogenesis and macrophage activationTGFb is secreted by platelets and also by macrophages and acts as an anti proliferative factor in normal epithelial cells It acts as paracrine and autocrine in natureThe target cells for TGF b are fibroblasts marrow stem cells and preosteoblasts They represent long term healing bone regeneration and bone modelling TGF b also inhibits osteoclast formationVEGF originally known as vascular permeability factor is a signal protein produced by cells that stimulates vasculogenesis and angiogenesis

EGF is a growth factor that stimulates cell growth proliferation and differentiation by binding to its receptor EGFR

Hyaluronidase is an enzyme that breaks down hyaluronic acid a key component of tissue cement thereby decreasing tissue density and enhancing permeability This enables injectables to disperse more easily facilitating localized absorption and promoting effective treatment outcomes

The aim of the present study is to comparatively evaluate the efficacy of submucosal injections of autologous platelet rich plasma PRP versus Placentrex combined with hyaluronidase in the management of oral submucous fibrosis OSMF following immediate surgical release of fibrous bands