Randomized Controlled Clinical Study to Determine the Oral and Dermal Tolerability of an Experimental Denture Wipe

PURPOSE: To evaluate oral and dermal tolerance following use and user acceptability of an experimental denture‐cleansing wipe. An exploratory objective was to develop a method to assess denture wipe effectiveness in removing debris from denture surfaces. MATERIALS AND METHODS: This was a single‐center, randomized, controlled, parallel‐group, examiner‐blind study in participants with ≥1 full/partial denture. Participants were randomized to clean their dentures with the denture wipe (n = 76) or water (n = 76) up to 4 times per day for 14 days. Tolerability was assessed by treatment‐emergent adverse events (TEAEs), oral soft tissue examination, and lead hand dermatological assessment. Acceptability was assessed by questionnaire. The feasibility of a methodology to assess the efficacy of the wipe at removing food particles was also evaluated through determination of the mass of chewed peanut particles that the wipe removed after a single use (n = 31). RESULTS: The proportion of participants experiencing oral TEAEs by day 14 was 0.039% with the denture wipe (lip injury [n = 1], mouth injury [n = 2]) and 0.013% with the water rinse (coated tongue [n = 1]). There were no dermal TEAEs and no TEAE‐related study withdrawals. Skin irritation scores with the denture wipe remained unchanged from baseline. Comparing before vs. after cleaning with the denture wipe, a higher proportion of participants rated their dentures as feeling extremely/very fresh (28.9% pre‐/85.5% post‐cleaning), feeling extremely/very clean (34.2%/86.8%) and looking extremely/very clean (43.5%/85.5%). More denture‐wipe group participants than water‐rinse group participants were extremely/very satisfied with the amount of debris removed from their dentures (88.1% vs 72.4%). The methodology used to assess the weight of peanut particles captured from the wipes/dentures appeared to be a feasible investigation technique. CONCLUSIONS: The denture wipe was generally well‐tolerated and had good user acceptability. The methodology for assessing the mass of peanut particles removed by denture wipes was successful.