Adjunctive Utility of Toluidine Blue in Detecting Dysplastic Cells in Oral Mucosal Lesions in Comparison with Histopathology


  • K.M. Chandrani Somaratne Department of Histopathology, District General Hospital, Gampaha, Sri Lanka
  • S.A.K.J. Kumara Department of Oral and Maxillofacial Surgery, District General Hospital, Gampaha, Sri Lanka
  • R.M.N.D. Ratnayake Department of Histopathology, District General Hospital, Kegalle, Sri Lanka
  • Priyantha Liyanage Directorate of Health care Quality and Safety, Ministry of Health, Colombo, Sri Lanka
  • N.A.A.P.D. Gunasekera Department of Histopathology, District General Hospital, Gampaha, Sri Lanka



Toluidine blue, Oral squamous cell carcinoma, Epithelial hyperplasia, dysplasia, biopsy


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 likelihood 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.


Cancer incidence and mortality data Sri Lanka, Sri Lanka cancer registry 17th publication 2015; 17.

Ather I, Siddiqui M, Farooq U, Ahmed R, Siddiqui SM, Rafi T. Role of Toluidine Blue in Early Detection of Oral Cancer. Pak J Med Sci 2006; 22(2): 184-7.

Awan KH, Yang YH, Morgan PR, Warnakulasuriya S. Utility of toluidine blue as a diagnostic adjunct in detecting potentially malignant disorders of the oral cavity – a clinical and histological assessment. Oral Diseases 2012; 18: 728-733. DOI:

Ali FM, Prasant MC, Ashok P, Kedar S, Vinit A, Safiya T, Deshpande R. Diagnostic Test for cancer Detection in Dental & E.N.T. Clinics: The Toluidine blue test. JK-Practitioner 2012; 17(4): 47-49.

Chaudhary A, Manjunatha M, Gupta I. Evaluation of Efficacy of Toluidine Blue in the Detection of Potentially Malignant Disorders. J Adv Med Dent Scie 2013; 1(2): 19-24.

Zhang L, Williams M, Catherine F, Poh, et al. Toluidine Blue Staining Identifies High-Risk Primary Oral Premalignant Lesions with Poor outcome. Cancer Res 2005; 65: 8017-8021. DOI:

Jayasinghe RD, Hettiarachchi PVKS, Amugoda D, Kumaraarachchi M, Liyanage RLPR, Siriwardena BSMM, Gunasena R, Karunatilake AHTS, Amerasinghe HK. Validity of Toluidine Blue test as a diagnostic tool for high risk oral potentially malignant disorders- a multicentre study in Sri Lanka. Journal of Oral Biology and Craniofacial Research 2020; 10: 547-551. DOI:

Thahriani A, Tripathi RM, Bhattachariya A, Awasti P, Seth P. Demonstration of Toluidine Blue in Oral Mucosal Lesions. Heal Talk 2019; 11(3): 53-54.

Epstein JB, Sciubba JJ. Early diagnosis and treatment of cancer series, Book: Head and Neck Cancer, Chapter 4-Strategies for oral cancer detection 2010; pp. 45-58. DOI:

Epstein JB, Siverman S Jr, Epstein JD, Lonky SA, Bride MA. Analysis of oral lesion biopsies identified and evaluated by visual examination, chemiluminescence, and toluidine blue. Oral Oncology 2008; 44(6): 538-44. DOI:

Sridharan G, Shankar AA. Toluidine blue: A review of its chemistry and clinical utility. J Oral Maxillofac Panthol 2012; 16: 251-5. DOI:

Nagaraju K, Prasad S, Ashok L. Diagnostic efficiency of toluidine blue with Lugol's iodine in oral premalignant and malignant lesions. Indian J Dent Res 2010; 21: 218-23. DOI:

Mashberg A, Samit AM. Early detection, diagnosis, and management of oral and oropharyngeal cancer. CA-A Cancer Journal for Clinician 1989; 39(2): 67-87. DOI:

Silverman S Jr, Migliorini C, Barbosa J. Toluidine blue staining in the detection of oral precancerous and malignant lesions. Oral Surg Oral Med Oral Pathol 1984; 57: 379-82. DOI:

Sue WWY, Yen AMF, Chi SYH, Chen THH. A community-based R.C.T. for Oral Cancer screening with toluidine blue. J Dent Rest 2010; 89(9): 933-7. DOI:

Epstein JB, Zhang L, Poh C, Nakamura H, Berean K, Rosin M. Increased allelic loss in Toluidine blue-positive oral premalignant lesions, Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology 2003; 95(1): 45-50. DOI:




How to Cite

Somaratne, K. C., Kumara, S., Ratnayake, R., Liyanage, P., & Gunasekera, N. (2021). Adjunctive Utility of Toluidine Blue in Detecting Dysplastic Cells in Oral Mucosal Lesions in Comparison with Histopathology. Journal of Analytical Oncology, 10, 26–31.