Efficacy of a glycopolymer-based oral rinse upon pain associated with ulcerative and erosive lesions of the oral mucosa: A within-subject pilot study.

OBJECTIVES: The purpose of this pilot study was to assess the magnitude of effect for a new topical rinse that may impact oral soreness and function in ulcerative oral mucosal lesions. STUDY DESIGN: Twenty-five consecutive patients with ulcerative/erosion lesion and moderate pain visual analogue pain score (>/=4) rated their mouth and throat soreness and oral symptoms at baseline and at 24, 48, and 72 hours after open-label use of a chitosan-based, nonanesthetic oral rinse (Synvaza) at least twice a day. No changes in prior therapy, including analgesics, were allowed during the trial. RESULTS: All measures of oral soreness decreased in severity from baseline to 72 hours, and overall oral soreness decreased by 28% (P < .01). Oral soreness associated with talking decreased by 67% (P < .01), drinking by 62% (P < .01), swallowing by 56% (P = .04), sleeping by 51% (P = .02) and eating by 50% (P < .01). The product was rated favorably for texture, flavor, soothing relief, mouth feel, and burning/stinging with use. CONCLUSIONS: Oral rinsing with the study product reduced mucosal pain without anesthetic effect and improved oral function.