Study to Compare the Effectiveness of Three Experimental Denture Adhesives Versus No Adhesive on Maxillary Denture Bite Force

What this Trial Is About

Researchers are evaluating the effectiveness of three experimental denture adhesive creams in improving the hold of full maxillary dentures over a 13-hour period. This study is a randomized, controlled, single-blind, cross-over trial focused on measuring maximum maxillary bite force among full denture wearers. Up to 60 participants will be screened to ensure at least 54 complete the study. Participants will receive five different treatments during the study, including the application of one of three experimental denture adhesive creams, a marketed product, or no adhesive. Each treatment involves applying 1 gram of the adhesive cream topically, pressing the dentures into place, holding firmly, and biting down to secure the hold. The study design includes a 5 treatment-period cross-over, allowing each participant to try each adhesive and no adhesive. Throughout the study, participants will have their maximum incisal bite force measured up to 13 hours after application to assess denture hold and resistance to dislodgement. Bite force area over baseline will be compared across the adhesives and no adhesive. Researchers will monitor participants safety, compliance with study procedures, and overall well-being. The total study duration includes scheduled visits and procedures necessary to collect bite force data and complete all treatment periods.

A Clinical Study to Assess the Effectiveness of Use of Three Experimental Denture Adhesives Compared to Using No-Adhesive