At a glance
ClinicalIndex Comparison Record- ✓Age 18–85 years inclusive
- ✓Full dentures in both upper and lower arch that are well-fitting and well-made
- ✓Dentures have adequate retention and stability (Kapur Retention and Stability Index Sum Score ≥6)
- ✓Participant reports food trapped under dentures and has peanut particle migration rating >0 at screening
- ✕Pregnant or intending to become pregnant during study
- ✕Breastfeeding
- ✕History of swallowing difficulties or choking
- ✕Xerostomia (dry mouth) caused by current condition or medication
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Clinical Study to Evaluate the Ability of an Experimental Denture Adhesive to Prevent Food Particle Ingress Under Dentures
In Brief
A clinical study evaluating Experimental Denture Adhesive and Reference (Marketed) Denture Adhesive for Denture Retention. Completed, enrolled 83 participants across 1 site.
Detailed Summary
In this clinical study, an experimental denture adhesive with a precision tip nozzle was tested to evaluate the relative efficacy to reduce the ingress of food under the denture compared to use of no adhesive or a standard marketed adhesive.
Study Details
Timeline
Interventions
Participants received a single application of test denture adhesive with a Flat Ribbon Nozzle as 3 Continuous strips those were applied to upper denture and one continuous strip that was applied to the lower denture which were placed in the mouth.
Participants received a single application of marketed denture adhesive with a flat ribbon nozzle as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture, which were placed in the mouth.