Ablative fractional laser-assisted photodynamic therapy vs. ablative fractional laser for oral leukoplakia treatment: A randomized, controlled pilot study.

BACKGROUND: Ablative fractional laser-assisted photodynamic therapy (AFL-PDT) is explored as an effective method in some premalignant diseases, whereas the effect of AFL-PDT on oral leukoplakia (OL), the best-known precursor of oral squamous cell carcinoma, remains undetermined. METHODS: Forty-eight patients, histologically diagnosed with OL, were randomized (1:1) to receive either AFL-PDT or ablative fractional laser (AFL) treatment. All patients were followed up at 1, 3, 6 and 12 months postoperatively. The primary endpoints of efficacy and clinical recurrence and the secondary endpoint of side effects were assessed. RESULTS: Forty-four patients completed the study. The 100% effective cure rate in the AFL-PDT group was higher than that in AFL group (80.9%, P<0.05) with 19.1% difference (95%CI: 0.7-40.0%). Compared to AFL group, recurrence observed at 6 and 12 months post-treatment tended to occur in fewer patients in the AFL-PDT group (P<0.05). No severe adverse events or systemic side effects were observed in either group. CONCLUSIONS: AFL-PDT may effectively reduce recurrence of OL with high clinical efficacy and good tolerability, suggesting it may be a promising treatment for OL.