Abstract
ObjectivesThis proof‐of‐principle, single‐center, randomized, examiner‐blind, crossover study compared two experimental polyvinyl acetate (PVA)‐based denture adhesives (Test Adhesives 1 and 2) with a marketed reference polymethyl vinyl ether/maleic anhydride (PMV/MA)‐based adhesive and no adhesive using incisal bite force area over baseline over 12 hr (AOB0–12) in participants with an at least moderately well‐fitting complete maxillary denture. Previous in vitro studies suggested the experimental denture adhesives provided superior performance.Materials and MethodsParticipants were randomized to a treatment sequence such that each received each treatment once. Prior to treatment application (baseline) and at 0.5, 1, 3, 6, 9, and 12 hr following the application, participants bit on a force transducer until their maxillary denture dislodged. Between‐treatment differences in AOB0–12 were analyzed using analysis of covariance. For study validity, the reference adhesive was compared with no adhesive. Participants were asked to rate sensory experiences and ease of denture removal.ResultsTwenty‐three participants were included in the modified intent‐to‐treat population. Although Test Adhesives 1 and 2 had a higher mean AOB0–12 than no adhesive, differences were not statistically significant. No statistically significant difference was also found between the reference adhesive and no adhesive; hence, study validity was not attained. Participants did not report any clear differences between the test or reference adhesives in terms of taste or feel; however, dentures were easier to remove with the test adhesives versus reference. No treatment‐related adverse events were reported.ConclusionNeither the experimental PVA‐based denture adhesives nor the PMV/MA‐based reference product demonstrated a statistically significant difference in incisal bite force AOB0‐12 compared with no adhesive. The reasons for these unexpected results is unclear; they suggest that findings of in vitro tests for denture adhesive performance are not always translated to in vivo performance (http://Clinicaltrials.gov: NCT02937870).
Highlights
Edentulous individuals can be dependent on dental prostheses to carry out the basic oral function of mastication
Retention of complete dentures in the oral cavity is mediated by the interplay of a number of factors, with two of the most important being the establishment of an intimate fit of the intaglio surface of the prosthesis to the underlying tissues and the achievement of an adequate peripheral seal (Felton et al, 2011)
Complete denture retention can be negatively affected by changes in hard and soft tissue that comprise the adaptation of the denture surface to the oral tissue, age‐ or medication‐related decline in saliva consistency and volume, and age‐related reductions in bite force and neuromuscular control (Felton et al, 2011)
Summary
Edentulous individuals can be dependent on dental prostheses to carry out the basic oral function of mastication. Not a substitute for continued denture maintenance to ensure best fit, denture adhesives are widely used to enhance hold and retention of removable dentures, improve mastication, and prevent accumulation of food beneath the denture (Grasso, 2004; Grasso et al, 2000; Marin et al, 2014; Rendell, Gay, Grasso, Baker, & Winston, 2000; Zarb & Felton, 2013) These adhesives are formulated with synthetic hydrophilic polymers that absorb saliva and provide a viscous layer between the oral mucosa of the denture‐bearing tissue and the denture itself (Kumar et al, 2015). One marketed copolymer frequently used in denture adhesive formulations is based on polymethyl vinyl ether/maleic anhydride (PMV/MA) combined with carboxymethyl cellulose (CMC), which hydrates, swells, and becomes sticky on contact with water/saliva
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