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The aim of this study was to evaluate the usefulness of low-level laser therapy (LLLT) for the control of painful stomatitis in patients with hand-foot-and-mouth disease (HFMD).LLLT has been successfully applied to various painful oral mucosal diseases, although there have been few reports on LLLT for HFMD patients.Through a randomized double-blind placebo controlled trial, the painful period of HFMD stomatitis was compared between the LLLT group (n=11) and the placebo LLLT one (n=9), which had similar clinical backgrounds. The LLLT parameters supplied were as follows: wavelength of 830 nm, power of 30 mW, frequency of 30 Hz, and energy output of 1.1 J/cm2. Acceptability and safety of the treatment were also evaluated.The painful period was shorter in the LLLT group (4.0 +/- 1.3 days) than in the placebo LLLT one (6.7 +/- 1.6 days) with a statistically significant difference (p0.005). The treatment was judged acceptable for 90.0% (18 of 20) of patients. No adverse events were observed in any cases.LLLT is a useful method to control HFMD stomatitis by shortening the painful period, with its high acceptability and lack of adverse events.