Effects of a Hydrogel Patch on Denture‐Related Traumatic Ulcers; an Exploratory Study

Abstract Purpose The aim of this exploratory study was to evaluate the effects of hydrogel patch wound dressing on healing time and pain level of denture‐related lesions of the oral mucosa in edentulous individuals. Materials and Methods Twenty‐three adults with newly fabricated complete sets of dentures who subsequently developed at least two ulcerative lesions related to their complete dentures were included in the study. For each participant, the smaller lesion (control lesion) was allocated to usual care, that is, adjustment of the denture's margins, whereas the larger lesion (test lesion) was assigned to receive usual care plus application of a hydrogel patch. In the latter, a patch was applied directly on the affected area three times within the first 24 hours, followed by application of three additional patches, namely one during each of the following 3 days. Participants were monitored until complete healing of all ulcers. The primary outcome measures were changes since baseline in each lesion's greatest dimension at days 1 and 7, as well as improvement in ulcer‐related pain experienced. Results Participants were on average about 70 years old, about half were women, and just over 40% had type 2 diabetes. Lesions treated with the hydrogel patch extended between 4.3 and 10.2 mm (mean 7.1 mm) in their greatest dimension, and the smaller lesions receiving usual care were initially 4 mm on average, ranging from 2.0 to 7.0 mm. The hydrogel patch lesions attained 25% to 75% reductions in their greatest lesion extent from baseline to days 1 and 7, respectively, compared to 10% and just over 50% reduction in the lesions that received usual care. Healing rates were similar in patients with and without diabetes. The participants reported significant improvement in pain level 1 day following treatment initiation for 30% of the control lesions, compared to 65% of the lesions treated with the hydrogel patch. Conclusions The results of this exploratory study suggest that application of hydrogel patches may represent a novel, effective treatment for accelerating the healing process and pain reduction in mucosal lesions associated with complete dentures also in people with type 2 diabetes; however, larger studies need to confirm these findings.