NCT03345108

A Study to Investigate a Method to Measure Food Occlusion by Denture Adhesives in Denture Wearers

A Randomized, Open-Label, Clinical Study to Evaluate a Methodology to Assess Food Occlusion Efficacy of a Denture Adhesive in Healthy, Edentulous Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate a methodology to determine the ability of a denture adhesive to restrict food ingress underneath dentures during eating.

Detailed description

This will be a single centre, controlled, open label, randomized, three-treatment, three-period, cross-over design in participants with full upper and full lower dentures. Each treatment period will consist of one day of testing with at least two days between adjacent treatment visits. This study will consist of four visits: Visit 1 - Screening Visit; Visit 2 - Treatment 1 Visit; Visit 3 - Treatment 2 Visit and Visit 4 - Treatment 3 Visit. (Participants will use Test product (denture adhesive) applied to the dentures either in a pattern consistent with standard application or applied to the dentures in a pattern of continuous strips. Participants will also use no adhesive as a control. Participants will cross-over between treatments so that all participants will participate in all 3 treatment arms. An hour after the participant has worn their denture, they will chew a portion of peanuts in a controlled manner. The peanuts that migrate under the denture during this chewing procedure will be collected, washed, dried and weighed. Participant will also answer a short questionnaire on the procedure and record the number of times their denture dislodged during the chewing procedure. The study hypothesis is that this methodology will enable comparisons between denture adhesives and no adhesive to demonstrate the effectiveness of denture adhesives at restricting food ingress under dentures during eating.

Conditions

• Denture Retention

Interventions

Type	Name	Description
DEVICE	Denture Adhesive Cream (Conventional Application)	The adhesive cream will be extruded from a pre-dosed syringe. 1.6 g of adhesive per treatment will be applied to each participant's dentures. This dose will be split as 1.00±0.05g for the maxillary and 0.60±0.05g for the mandibular dentures.
DEVICE	Denture Adhesive (Continuous Strip Application)	The adhesive cream will be extruded from a pre-dosed syringe. 1.6 g of adhesive per treatment will be applied to each participant's dentures. This dose will be split as 1.00±0.05 g for the maxillary and 0.60±0.05 g for the mandibular dentures.
OTHER	No Adhesive	No adhesive applied.

Timeline

• Start date: 2017-11-20
• Primary completion: 2017-12-15
• Completion: 2017-12-15
• First posted: 2017-11-17
• Last updated: 2019-03-29
• Results posted: 2019-03-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study