Randomized Clinical Study Comparing Three Experimental Denture Adhesives and Fixodent® versus No Adhesive.

OBJECTIVES: Denture adhesives can improve function, retention, stability, and bite force in well-fitting dentures. This single-center, randomized, five-arm, examiner-blind, crossover clinical study aimed to compare three experimental adhesives ("Adhesive 1," "Adhesive 2," "Adhesive 3") with slightly different formulations and a commercially marketed "Positive control" with a "No Adhesive" arm using incisal bite force measurements over 12 hours in subjects with a moderately well- to well-fitting maxillary denture. METHODS: Institutional review and informed consent were obtained and qualified subjects were randomly assigned to a treatment sequence. Prior to adhesive application, subjects were asked to bite on a transducer with increasing force until their maxillary denture dislodged (bite force measurement). This procedure was repeated at 0.5, 1, 3, 6, 9, and 12 hours after adhesive application, with results recorded electronically. Treatment differences in the area over baseline (AOB) were analyzed using an ANCOVA model. RESULTS: A total of 48 subjects completed the study. All experimental formulations showed statistically significantly higher bite force measurements compared to the No Adhesive arm at all time points (p < 0.0001 for Adhesive 1 and Adhesive 2 at all times; p < 0.003 for Adhesive 3 at all times). While numerical values for bite force favored the Positive control for the duration of the study, there were no significant statistical differences at any time point between Adhesive 2 and the Positive control, and only over three and six hours compared to Adhesive 1. However, differences favored the Positive control compared to Adhesive 3 at all time points. CONCLUSIONS: All denture adhesives gave statistically significantly better bite force AOB in moderately well- to well-fitting dentures compared to no adhesive. All denture adhesives tested were generally well tolerated.

A randomized clinical trial in subjects with dry mouth evaluating subjective perceptions of an experimental oral gel, an oral rinse and a mouth spray compared to water.

PURPOSE: This multicenter, randomized, parallel group study analyzed the effectiveness of an experimental oral gel, a commercially available oral rinse and a commercially available mouth spray versus water alone at relieving self-reported symptoms of dry mouth over a 28-day home use treatment period. The effects of the study treatments on dry mouth-related quality of life (QoL) were also investigated. METHODS: Eligible subjects were stratified by dry mouth severity (mild, moderate or severe) and randomized to receive one of the study treatments. Prior to first use they completed a questionnaire designed to assess their baseline dry mouth-related QoL. Following first use and on Day 8 (2 hours post-treatment only) and Day 29, subjects completed the modified Product Performance and Attributes Questionnaire (PPAQ) I at 0.5, 1, 2 and 4 hours post-treatment. Subjects further assessed treatment performance using the PPAQ II questionnaire on Days 8 and 29 and the dry mouth-related QoL questionnaire on Day 29. RESULTS: In 396 randomized subjects almost all comparisons of responses to PPAQ I, including those for the primary endpoint (response to PPAQ I Question 1 'Relieving the discomfort of dry mouth' after 2 hours on Day 29), were statistically significant in favor of active treatment groups versus water (P < 0.05). All comparisons of responses to PPAQ II on Days 8 and 29 were statistically significant in favor of active treatments versus water (P < 0.05). Moreover, nearly all comparisons for dry mouth-related QoL scores on Day 29 were statistically significant in favor of the active treatments versus water. All the dry mouth management strategies in this trial were well tolerated.

A proof-of-principle bite force study using two experimental test denture adhesives and a currently marketed denture adhesive.

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 (Clinicaltrials.gov: NCT02937870).