Oral cancer is an aggressive condition that kills more than 6000 Americans yearly. Early diagnosis of oral cancers decreases the extent of radical treatment and increases survival dramatically. Different clinical screening methodologies are used. These include visual and manual examination, toluidine blue (TB) staining, and the use of brush biopsies. To our knowledge, direct experimental comparison has not been made. Objective: Identifying the best methodology for oral cancer screening programs will help to improve early diagnosis and treatment. Hypothesis: We tested the null hypothesis that there is no difference between the three screening methods. Methods: As part of the NSU Oral Cancer Screening Program, visual and manual examination of the oral cavity was performed in 50 patients from the NSU Geriatric Institute. Oral lesions were identified and clinically diagnosed by one trained oral pathologist. Each epithelial lesion was analyzed with TB and by brush biopsy. TB positive lesions were re-tested with the stain one week later. Results: Lesions clinically diagnosed as premalignant were 2.5 fold more likely to be associated with an atypical brush biopsy result (43%) than were those lesions clinically diagnosed as non-premalignant (18%). The association of clinical diagnosis and TB staining was similar (premalignant, 43%, non-premalignant, 21%). These results suggest that brush biopsy and TB testing similarly correlate with clinical diagnosis made by visual and manual inspection. Accordingly, the incidence of an atypical brush biopsy result was positively associated with the incidence of a positive TB test result. Conclusion: No difference between diagnoses made by visual and manual inspection, TB staining, or brush biopsy were found in this pilot study. Therefore, either of these oral cancer screening methods might be useful in clinical screening protocols with equal efficacy. This work was supported by NSU Health Professions Division Research Grant and by The Retirement Research Foundation (#2002-221).

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