Introduction: Oral cancer is one of the most common cancers globally and in Sri Lanka, which follows premalignant lesions. It is curable if it is detected early. Several adjunctive methods to diagnose premalignant lesions early are available. Among these, Toluidine blue staining method before a biopsy is currently receiving much attention.

Method: This is a prospective study done by studying 103 patients presented to the Oral and Maxillofacial Surgery Unit, District General Hospital, Gampaha, Sri Lanka. The oral lesions of all the patients are categorized as benign, premalignant, and malignant by clinical examination. Toluidine Blue mouth wash is introduced to all the patients, followed by biopsy from the stained sites and the clinically decided sites in non-stained lesions. Histopathological diagnosis was obtained for all cases. The accuracy of diagnosis of premalignant, malignant, and benign cases by clinical assessment and by using Toluidine blue was assessed and compared statistically in relation to sensitivity, specificity, positive predictive and negative predictive values and like hood ratios (LR).

Results: Toluidine blue has no added advantage over clinical examination in our setup even though it might be helpful in screening. However, it has an added value to confirm clinically benign cases as benign.

Conclusion: Toluidine Blue can be used as an adjunct in screening and to confirm clinically benign cases so that those can be followed up in clinics without doing unnecessary biopsies.

Chandrani Somaratne has completed her MBBS at the Faculty of Medicine Colombo Sri Lanka, Diploma in Pathology and MD in Histopathology in Postgraduate Institute of Medicine, Colombo Sri Lanka. She completed the final two years of her postgraduate training in Liverpool Hospital, NSW Australia. She has experience as a histopathologist for 17 years in all range of hospitals in Sri Lanka including well facilitated tertiary care teaching hospitals. Her special intrest is in cytopathology.