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

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.

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.

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.

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.