A randomized controlled trial assessing denture adhesive efficacy on denture retention across 13 hours

Abstract

PurposeTo compare the effects of two denture adhesive formulations on the bite force required to dislodge a maxillary denture in adult participants during a 13‐hour test period.Materials and methodsTwenty‐two participants with a fair‐to‐poor fitting maxillary denture opposed by natural dentition or a stable mandibular denture were enrolled in this single‐center, randomized, double‐blind, two‐treatment, 4‐period crossover study. Participants were randomly assigned a product usage sequence so that each participant used each product twice during the 4‐day test period. The test product was a denture cream adhesive formulated with an optimized calcium/zinc partial salt of polyvinyl methyl ether/maleic acid (Fixodent Ultra technology); the control product was a cream adhesive formulated with a calcium/zinc partial salt of polyvinyl methyl ether/maleic acid (Fixodent Original technology). On each study day, bite force at dislodgement was measured with a gnathodynamometer at baseline, representing the “no adhesive” score. Then, after standardized product application to the participant's existing maxillary denture by site staff, bite force measurements were retaken at 1, 3, 5, 7, 9, 11, and 13 hours. The change from baseline and the 13‐hour area under the bite‐force–change‐from‐baseline curve were analyzed via an analysis of variance.ResultsTwenty‐one participants completed all test periods; one additional participant completed 3 test periods so twenty‐two participants were included in the analysis. There were fifteen females and 7 males with a mean age of 70 years. The mean 13‐hour area under the bite‐force–change‐from‐baseline curve was 8% greater (p = 0.010) for the test adhesive (114.3 lb) than for the control adhesive (105.9 lb). Both adhesives showed a statistically significant increase in bite force (p < 0.001) at each time point compared to no adhesive.ConclusionsThe optimized calcium/zinc partial salt of polyvinyl methyl ether/maleic acid test adhesive provided superior maxillary denture retention relative to that of the control adhesive across 13 hours. Both adhesives increased bite force at dislodgement compared to no adhesive.This article is protected by copyright. All rights reserved