BACKGROUND: The aim of the present study was to evaluate the effect of low-level laser therapy (LLLT) combined with photochemotherapy (PCT) for the treatment of chemotherapy-induced oral mucositis in young patients. METHODS: A randomized, blind, clinical trial with a split-mouth design was conducted involving a sample of 15 cancer patients aged three to 16 years at the Aldenora Bello Hospital in the city of Sao Luis, Brazil. The treatments (PCT+LLLT and LLLT alone) were randomly determined for each side of the oral cavity. The patients were blinded to the type of therapy performed on each side. The outcome was the area of the lesion measured in cm(2) over an eight-day evaluation period. Treatment and follow up of the lesions under evaluation as well as other lesions occurred until complete remission. Friedman and Wilcoxon tests were employed. Significance was set at a 95% confidence level (alpha=0.05) and the effect size was calculated. RESULTS: A statistically significant difference was found between therapies for lesion area on Days 6-8 (p=0.020, 0.011 and 0.005, respectively), which was confirmed by the moderate effect size. Lesions submitted to PCT+LLLT had a smaller area at the end of the evaluation period. CONCLUSION: Based on the present findings, PCT+LLLT had a greater therapeutic effect in comparison to LLLT alone regarding the reduction in the degree of severity of chemotherapy-induced oral mucositis.
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