Dentine hypersensitivity (DH) is a common condition that can significantly impact an individual's ability to eat, drink and brush their teeth, or participate in social interactions (Gibson et al., 2010). Individuals may report short, sharp pain or sensitivity. Differential diagnosis is confirmed after clinical examination and exclusion of other dental pathologies (Absi, Addy, & Adams, 1987; Addy, 2000). The aetiology of the condition is linked to dentine exposure, commonly following gingival recession or enamel loss. The hydrodynamic theory is currently the accepted mechanism for DH-related pain (Brännström, 1962).
Objectives
This 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 Methods
Participants 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.
Results
Twenty‐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.
Conclusion
Neither 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).
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.