Evaluation of tolonium chloride as an aid in diagnosis of dysplastic changes in oral mucosa among tobacco smokers

Background & Objectives: To evaluate the clinical utility of Tolonium chloride as a diagnostic aid amongst high-risk patients i.e. patients with tobacco smoking habit, to identify potential areas that might proceed into cancer and which are not otherwise identified during clinical examination and thus guide to select the biopsy site. Materials and Methods: A total of 180 individuals were selected for the study, Out of these 180 individuals, 95 individuals showed areas of stain retention in their oral mucosa and these 95 individuals constituted the study group. However, 62 individuals out of the study group were not willing to undergo biopsy. Only the remaining 32 individuals volunteered to participate in the study, from these volunteers’ biopsy specimens were obtained involving both stained and unstained area. Which were considered separately, making a total of 64 specimens. Results: The results of the present study showed sensitivity and specificity of 56.34% and 50.56% respectively for the Tolonium chloride mouth rinse to be used as a routine screening agent in detecting premalignant areas in otherwise apparent normal oral mucosa in high-risk group of people. In this study 0.403 P value shows insignificant correlation between the histopathological evaluation of the stained and the unstained areas. Conclusion: Tolonium chloride rinse is more sensitive as compared to the clinical examination alone, in detecting dysplastic changes in clinically apparent normal oral mucosa, among tobacco smokers. Tolonium chloride vital staining cannot be used to delineate the biopsy margins. Tolonium chloride might be used as a diagnostic tool in the biopsy site selection. The procedure cannot be performed on routine basis for high-risk group of people. Keywords: Tolonium chloride, Vital staining, Normal oral mucosa.