Yilin Yao1, Linjun Shi1, Yufeng Wang1, Xuemin Shen2, Sai Ye1, Guoyao Tang3, Lan Wu4. 1. Department of Oral Mucosal disease, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; National Clinical Research Center for Oral Diseases, Shanghai 200011, China; Shanghai Key Laboratory of Stomatology, Shanghai 200011, China. 2. Department of Oral Mucosal disease, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; College of Stomatology, Shanghai Jiao Tong University, Shanghai 200011, China; National Center for Stomatology, Shanghai 200011, China. 3. Department of Oral Mucosal disease, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; College of Stomatology, Shanghai Jiao Tong University, Shanghai 200011, China; National Center for Stomatology, Shanghai 200011, China; National Clinical Research Center for Oral Diseases, Shanghai 200011, China; Shanghai Key Laboratory of Stomatology, Shanghai 200011, China.. Electronic address: tanggy@shsmu.edu.cn. 4. Department of Oral Mucosal disease, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; National Clinical Research Center for Oral Diseases, Shanghai 200011, China; Shanghai Key Laboratory of Stomatology, Shanghai 200011, China.. Electronic address: teana_wu@sina.com.
Abstract
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.
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.