A Randomized Controlled Trial on Efficacy of Surgical Excision of non-dysplastic Leukoplakia to Prevent Oral Cancer

The aim of this study was to evaluate the effectiveness of surgical excision to prevent cancer in patients with nondysplastic oral leukoplakia (OL). This study was the first randomized controlled clinical trial comparing surgical treatment with standard care in this group of patients. Patients were divided into two groups. The first group underwent standard care, that is smoking counseling, follow-up visits every 6 months, and control biopsy when indicated. The second group underwent surgical excision, together with standard care. Oral cancer onset was the primary outcome; secondary outcomes included healing, recurrence after surgery, onset of new lesions, and worsening of the primary lesions. The differences in distribution of the patients' and lesions' characteristics were investigated through nonparametrical tests (Wilcoxon rank-sum and Fisher exact). Univariate and multivariate logistic regressions have been performed to estimate the odds ratio of the treatment on the recurrence or worsening of the lesions. A total of 260 patients took part in the study of which 132 were women (50.8%); during the follow-up period, two subjects developed oral cancer, one for each arm. Surgical treatment, when compared with standard care, was associated with a lower probability of the treated zone to remain healed during the follow up period (OR = 7.43; 95% confidence interval, 2.96-22.66). In conclusion, it is possible to assumed that regular clinical follow-up could be considered a reliable standard of care among patients with nondysplastic OLs. PREVENTION RELEVANCE: Oral white patches can transform into cancer and none has provided clinical guidelines to prevent it. For the first time ever, we have showed that the clinical follow up of non dysplastic lesions was able to provide benefits if compared with surgical excision.