A Randomized Proof-of-Principle Bite Force Study of Two Experimental Denture Adhesives and a Commercially Available Adhesive.

Abstract

To assess the efficacy of two experimental denture adhesive gels (adhesives 1 and 2) compared to a commercially available denture adhesive cream (positive control) and no adhesive (negative control). This was a single-center, randomized, four-treatment, examiner-blind, crossover study in participants with well-made and at least moderately well-fitting maxillary complete dentures. Incisal bite force until denture dislodgment was measured before application (baseline) and over the following 12 hours for each of the treatments. Between-treatment differences in the area over baseline (AOB) for the bite force at each time point were analyzed using an analysis of covariance model. The efficacy and safety analyses were based on results from 48 participants. Compared to the negative control, adhesive 1 showed a statistically significantly higher bite force AOB over 12 hours (AOB0-12h; primary endpoint), as well as for AOB0-6h and AOB0-9h (all P < .05), but not for AOB0-1h or AOB0-3h. Adhesive 2 was not significantly different from the negative control or from adhesive 1 for any measure of AOB. The positive control was associated with a significantly higher bite force AOB than either of the experimental adhesives for all time points (P < .05). Although the positive control was well tolerated, both experimental adhesives were associated with a larger number of oral adverse events. Only adhesive 1 was significantly better than the negative control, and its performance did not match that of the positive control. Adhesives 1 and 2 showed the largest number of oral adverse events.