A Study of Toluidine Blue Staining in Suspected Oral Malignancies in Patients Presenting to Tertiary Care Hospital in Central India

  • K. M. Prajeesh
  • Smita SoniEmail author
Original Article


Oral malignancies are a major cause of morbidity and mortality in worldwide and especially in Indian subcontinent. India stands at first position in total number of oral cancers in worldwide. Hence it is the need of hour to have safe and reliable screening test for early diagnosis of oral malignancies. Toluidine blue (TB) staining is an ideal screening test with high sensitivity and specificity. This study carried out in our department with objective to study efficacy of TB in oral malignancies and potential oral malignant lesions and also to evaluate and compare TB staining with histopathological examination of lesion. This prospective study conducted on 183 patients who attended ENT department. Out of 183 patients 146 (79.8%) were positive with TB and 37 (20.2%) were not stained with TB. Out of 146 positive patients 134 were turned out to be positive for malignancy in histopathological examination. Out of 37 negative patients 5 were positive for malignancy in histopathological examination and 32 were negative. Out of 183 patients 139 (76%) were positive whereas 44 (24%) were found negative for malignancy. In present study clinical examination of oral cavity reveal most of the patients had leukoplakis (37.7%) followed by swelling (26.8%), ulcer (26.2%). Positive and negative predictive value of TB was 91.8% and 86.5% respectively whereas positive and negative predictive value of histopathology was 96.4% and 72.7% respectively. TB stain is cheap, quick and easily available readymade kit and no side effects and so have excellent patient compliance so it can be best utilized as a premier tool in initial detection of suspected oral malignancy.


Oral malignancy Screening test Toluidine blue 


Compliance with Ethical Standard

Conflict of interest

The authors declare that they have no conflict of interest.

Informed Consent

Informed consent was obtained by all individual participating in this study.


  1. 1.
    Gomez I, Warnakulasuriya S, Varela-Centelles PI et al (2010) Is early diagnosis of oral cancer a feasible objective? Who is to blame for diagnostic delay. Oral Dis 16:333–342CrossRefGoogle Scholar
  2. 2.
    Ali FM, Prasant MC, Ashok P, Kedar S, Vinit A, Safiya T, Rashmi D (2012) Diagnostic test for cancer detection in dental and ENT clinics: the toluidine blue test. JK-Practitioner 17(4):47–49Google Scholar
  3. 3.
    Warnakulasuriya S, Reibel J, Bouquot J, Dabelsteen E (2008) Oral epithelial dysplasia classification systems: predictive value, utility, weakness and scope for improvement. J Oral Pathol Med 37:127–133CrossRefGoogle Scholar
  4. 4.
    Neville B, Day TA (2002) Oral cancer and precancerous lesions. Cancer J Clin 52:195–215CrossRefGoogle Scholar
  5. 5.
    Das BR, Nagpal JK (2002) Understanding the biology of oral cancer. Med Sci Monit 8:258–267Google Scholar
  6. 6.
    Wilson JMG, Junger JY (1968) Principles and practice of mass screening for disease. Public Health Pap No 34Google Scholar
  7. 7.
    Sciubba JJ (2001) Oral cancer. The importance of early diagnosis and treatment. Am J Clin Dermatol 2:239–251CrossRefGoogle Scholar
  8. 8.
    Lo’pez ML, del Valle MO, Cueto A (1994) Knowledge of the European code against cancer in sixth—form pupils and teachers in Asturias (Spain). Eur J Cancer Prev 3:207–213CrossRefGoogle Scholar
  9. 9.
    Epstein JB, Sciubba J, Silverman S Jr, Sroussi HY (2007) Utility of toluidine blue in oral premalignant lesions and squamous cell carcinoma: continuing research and implications for clinical practice. Head Neck 29:948–958CrossRefGoogle Scholar
  10. 10.
    Ferlay J, Parkin DM, Steliarova-Foucher E (2010) Estimates of cancer incidence and mortality in Europe in 2008. Eur J Cancer 46:765–781CrossRefGoogle Scholar
  11. 11.
    Cancela-Rodríguez P, Cerero-Lapiedra R, Esparza-Gómez G, Llamas-Martínez S, Warnakulasuriya S (2011) The use of toluidine blue in the detection of pre-malignant and malignant oral lesions. J Oral Pathol Med 40:300–304CrossRefGoogle Scholar
  12. 12.
    Pallagatti S, Sheikh S, Aggarwal A, Gupta D, Singh R, Handa R (2013) Toluidine blue staining as an adjunctive tool for early diagnosis of dysplastic changes in the oral mucosa. J Clin Exp Dent 5(4):e187–e191CrossRefGoogle Scholar
  13. 13.
    Crăcană A, Şulea D, Nicolau A, Popa E, Popescu E (2016) Risk factors in the emergence of oral cancer—retrospective study. Rom J Oral Rehabil 8(3):48–63Google Scholar
  14. 14.
    Allegra E, Lombardo N, Puzzo L, Garozzo A (2009) The usefulness of toluidine staining as a diagnostic tool for precancerous and cancerous oropharyngeal and oral cavity lesions. Acta Otorhinolaryngol Italica 29:187–190Google Scholar
  15. 15.
    Mashberg A (1980) Re-evaluation of toluidine blue application as a diagnostic adjunct UN the DEOF asymptomatic oral squamous carcinoma. Cancer 46:758–763CrossRefGoogle Scholar

Copyright information

© Association of Otolaryngologists of India 2019

Authors and Affiliations

  1. 1.Department of OtorhinolaryngologyGandhi Medical CollegeBhopalIndia

Personalised recommendations