NCT02928380

Evaluation of a Experimental Denture Adhesive to Prevent Food Ingress

A Clinical Study to Evaluate the Ability of an Experimental Denture Adhesive to Prevent Food Particle Ingress Under Dentures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed description

The aim of this study is to explore the mass of food particle ingress when an adhesive is extruded through the new nozzle with directed application compared to the use of no adhesive and a marketed adhesive (extruded through a flat ribbon nozzle \[FRN\]) with standard application as per product label, utilizing a peanut occlusion methodology. This was a single center, controlled, single blind (to the examiner performing the safety assessments (oral soft tissue \[OST\] examination) and the laboratory staff weighing the peanut particles), randomized, three-treatment, three-period, cross-over design in participants with full upper and lower dentures. Each treatment period consisted of one day of testing with at least two days between treatment visits. This study consisted four visits: Visit 1 - Screening Visit; Visit 2 - Treatment 1 Visit; Visit 3 - Treatment 2 Visit and Visit 4 - Treatment 3 Visit.

Conditions

• Denture Retention

Interventions

Type	Name	Description
DEVICE	Experimental Denture Adhesive	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.
DEVICE	Reference (Marketed) Denture Adhesive	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.

Timeline

• Start date: 2016-07-25
• Primary completion: 2016-09-01
• Completion: 2016-09-16
• First posted: 2016-10-10
• Last updated: 2018-08-27
• Results posted: 2017-12-06

Locations

1 site across 1 country: United States