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Aim: This study aimed to treat smoker's palate (SP) using 5-aminolevulinic acid (5-ALA)-mediated photodynamic therapy (PDT)., Methods: A total of 24 patients with SP were divided into two groups: group-I (test group; n = 12); and group-II (control group; n = 12). Group-I patients were treated with 5-ALA-mediated PDT, while group-II patients were advised to cease the smoking habit during the entire duration of the study and later. PDT was repeated on days 3, 7, and 14 (i.e., a total of four sittings including day 0 [baseline]). Later, the participants were called for follow-up after week-4 (1st follow-up), week-6 (2nd follow-up), and week-8 (3rd follow-up) after the completion of the treatment. The SPSS version 22.0 was used for data analysis., Results: Group-I patients showed a statistically significant improvement when all three time points were assessed (p < 0.0001). Similarly, the same trend was observed in the group-II participants (p < 0.001), however, the difference between both groups (i.e., group-I [test group] and group-II [control group]) was larger., Conclusion: The findings of this clinical trial indicated a promising and satisfactory decrease in the clinical features of the smoker's palate without any adverse impacts utilizing 5-aminolevulinic acid-mediated photodynamic therapy. Hence, 5-ALA-mediated PDT appeared to be a promising treatment option together with smoking cessation., (Copyright © 2022 Elsevier B.V. All rights reserved.)