Clinical evaluation of a toothpaste containing lysozyme for the treatment of recurrent aphthous stomatitis: A 3-month, double-blind, randomized study.

PURPOSE: To assess the efficacy and safety of a toothpaste containing lysozyme for the treatment of minor recurrent aphthous stomatitis (MiRAS) in a 3-month clinical trial. METHODS: 71 participants with MiRAS were recruited to this randomized, parallel-controlled, double-blind clinical trial. Participants were allocated randomly to the test group or the control group. Demographic data and pain score (visual analogue scale, VAS) were recorded at baseline. Healing time of MiRAS, recurrence frequency and side effects were recorded at the 1-, 2- and 3-month follow-up visits. All data were analyzed using SAS software version 8.0. RESULTS: There was no significant difference (P>0.05) in pain score between the treatment group (3.00 +/- 1.66) and the control group (2.66 +/- 1.51). The average healing time was significantly reduced (P< 0.01) in the treatment group (5.66 +/- 2.02) compared with the control group (7.46 +/- 2.69), while the recurrence frequency also showed a significant reduction from 4.40 +/- 2.89 in the control group to 3.06 +/- 1.48 in the treatment group (P< 0.05). No obvious side effects were observed. CLINICAL SIGNIFICANCE: The results of this clinical study supported the conclusion that a toothpaste containing lysozyme was effective in promoting healing and reducing recurrence frequency without significant side effects in the treatment of minor recurrent aphthous stomatitis.