Early detection of oral precancerous and malignant lesions is still a diagnostic challenge for most of clinicians, and ideal adjuncts for detection of these lesions are currently unavailable. Our preliminary study has indicated that rose bengal (RB) staining might have the potency as a diagnostic aid; however, its clinical significance and reliability in hospital-based population are still not clear. In the present study, we investigated the efficacy of RB staining in detection of oral precancerous and malignant lesions. RB staining was conducted in 132 patients, and staining results were determined by a 4-graded shade guide, which had been quantitatively measured in the 1976 CIEL*a*b* space by instrumental colorimetry. Histological examination was performed in 128 of 132 patients after RB staining. The sensitivity and specificity to detect epithelial dysplasia (DP) and oral squamous cell carcinoma were 93.9 and 73.7%, respectively. The positive and negative likelihood ratios were 3.570 and 0.082, respectively. Moreover, RB staining seemed promising to detect DP in oral leukoplakia, lichen planus and leukokeratosis. In this study, 5 of 6 DP or oral squamous cell carcinoma were identified by RB staining before histological examination. In conclusion, RB staining may be a valuable diagnostic test in detection of oral precancerous and malignant lesions. ' 2007 Wiley-Liss, Inc.Key words: rose bengal; early detection; oral squamous cell carcinoma; epithelial dysplasia; colorimetry It was estimated that cancer of the head and neck, including all oral, laryngeal and pharyngeal sites, is the fifth most common cancer, accounting for about 615,000 new cases annually. 1 About 40% of head and neck malignancies are known to be squamous cell carcinomas (SCCs) arising in the oral cavity, 1 and it has one of the lowest survival rates, 50%, within a 5-year period. 2 These survival rates have remained relatively unchanged for the past 3 decades, probably because of late recognition of the disease. Consequently, emphasis has been placed on early detection and diagnosis of precancerous lesions and early stages of oral cancer. Nevertheless, oral epithelial lesions have many different presentations, such that clinical variants require diagnostic tests beyond visual examination to obtain definitive diagnoses. [3][4][5] Adjuncts for detection of lesions and selection of biopsy sites include toluidine blue staining, exfoliative cytology and other recently emerging techniques. But because of various reasons, such as less effective when used in oral precancerous lesions, inevitably bewildered when equivocal results occurred, 4,6 these techniques have not been accepted all over the world at present.Rose bengal (RB), the 4,5,6,7-tetrachloro-2 0 ,4 0 ,5 0 ,7 0 -tetraiododerivative of fluorescein, has been widely used to diagnose various ocular surface disorders. 7 It has been believed to stain desquamated ocular epithelial cells, dead or degenerated cells but not healthy epithelial cells, or wherever there is poor protection of the surface e...