MuGard, an oral mucoadhesive hydrogel, reduces the signs and symptoms of oral mucositis in patients with lichen planus: a double-blind, randomized, placebo-controlled pilot study

Objective To determine if MuGard, a mouthwash shown to reduce the severity of oral mucositis when started before initiating antineoplastic therapy for head and neck cancers, is effective when painful, oral lesions are present in patients with biopsy-proven erosive oral lichen planus. Study Design This was a double-blind, randomized, placebo-controlled pilot study at a college of dental medicine. Twenty patients with oral lichen planus were randomly assigned to receive either MuGard (n = 10) or saline-bicarbonate control (n = 10). One teaspoonful of the assigned mouthwash was swished for 1 minute, 5 times a day, for 14 days. Outcome measures (Oral Mucositis Assessment Scale scores and visual analog scale pain scores) were obtained before the start of treatment and repeated on days 2, 7, and 14. Results Significant reductions in all outcome measures occurred in the MuGard-treated group. Number-needed-to-treat (NNT) to achieve a >50% reduction in averaged pain from baseline was 1.25, and to obtain complete relief, the NNT was 2.5. Conclusions MuGard significantly reduces pain and ulceration associated with oral mucositis in patients with lichen planus. To determine if MuGard, a mouthwash shown to reduce the severity of oral mucositis when started before initiating antineoplastic therapy for head and neck cancers, is effective when painful, oral lesions are present in patients with biopsy-proven erosive oral lichen planus. This was a double-blind, randomized, placebo-controlled pilot study at a college of dental medicine. Twenty patients with oral lichen planus were randomly assigned to receive either MuGard (n = 10) or saline-bicarbonate control (n = 10). One teaspoonful of the assigned mouthwash was swished for 1 minute, 5 times a day, for 14 days. Outcome measures (Oral Mucositis Assessment Scale scores and visual analog scale pain scores) were obtained before the start of treatment and repeated on days 2, 7, and 14. Significant reductions in all outcome measures occurred in the MuGard-treated group. Number-needed-to-treat (NNT) to achieve a >50% reduction in averaged pain from baseline was 1.25, and to obtain complete relief, the NNT was 2.5. MuGard significantly reduces pain and ulceration associated with oral mucositis in patients with lichen planus.