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Background: There is a potential risk for malignancy in patients with diabetes mellitus. Theoretically, a noninvasive method for detection of precancerous changes can be conducted on oral exfoliated cell smears. Objectives: In this study, the immunocytochemistry of p53 in exfoliated oral mucosal cells in patients with type 2 diabetes was investigated. Patients and Methods: Oral mucosal smears were prepared from 50 patients with type 2 diabetes (D) and 50 healthy participants (C). The immunocytochemistry of p53 was assessed according to the kit instructions on oral smears. The Mann-Whitney nonparametric test was used to compare the p53 expression in D and C groups. Results:The results showed a significant increase in p53 expression in exfoliated cells of oral mucosa in D group compared with C group (P < 0.05). There was a significant correlation between the intensity of p53 expression and level of fasting blood sugar (FBS) (r = 0.816, P < 0.001), as well as between the percentage of p53 positive cells and FBS. The nucleus area (NA) and the cytoplasm to nuclear ratio (CNR) had significant correlations with p53 expression (r = 0.272, P = 0.08) NA, and CNR (r = -0.434, P = 0.005). Conclusions: This study showed that there was a significant expression of p53 in oral mucosal exfoliated cells of group D patients compared with C group. It seems that this noninvasive technique could be useful to detect premalignancy changes of oral mucosa as well as for early detection of malignancies.

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