Comparison and Evaluation of the Reliability of Oratest and Generic Toluidine Blue in the Detection of Oral Malignancy and Premalignancy

Statement of Problem: Early diagnoses of oral malignancies and pre-malignancies have direct effect in the outcome of these lesions. Therefore the techniques for early diagnosis have been considered as useful method in practice. Purpose: The aim of this study was to evaluate the reliability of Oratest and Generic Toluidine Blue (GTB) in the detection of oral malignancy and premalignancy. Materials and Methods: The study group consisted of 30 patients with potentially malignant epithelial lesions and superficial oral ulcerations suggestive of malignancy; of these, 7 patients with oral squamous cell carcinomas (OSCCs) were considered as positive controls and 7 patients with benign epithelial lesions as negative controls. These cases were selected from patients who were referred to the Cancer Institute, Tehran University of Medical Science (TUMS), Department of Oral Medicine, Faculty of Dentistry, TUMS and Department of Oral Medicine, School of Dentistry, Azad University of Medical Science. All lesions (n=49) submitted to both rinses (with intervals of at least 24 hours), followed by biopsy and histological analysis. Results: The sensitivity of Oratest was 93.6%, the specificity 80%, the positive predictive value 76.6% and the negative predictive value 94.7%. These results for GTB were 84.8%, 81%, 77.7% and 86.3% respectively. Conclusion: Staining with Oratest and GTB is highly reliable for the detection of insitu and invasive carcinomas and as an adjunct to clinical judgment and not a substitute for biopsy. The results of Oratest are more reliable than GTB especially in the detection of dysplastic lesions.