NCT03037307

A Clinical Bite Force Study of Two Marketed Adhesives Against no Adhesive

A Bite Force Study Assessing Two Currently Marketed Denture Adhesive Products Compared to No-Adhesive Control

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The objective of this study will be to compare bite force (BF) measurements over a 12-hour period of a currently marketed denture adhesive cream based on carbomer technology (test), with a positive control and a negative/no treatment control.

Detailed description

This will be a single centre, randomized, crossover, 3-treatment, 3-period study to compare BF measurements over a 12 hour period of a currently marketed denture adhesive cream based on carbomer technology (test), with a positive control, and a negative/no treatment control. A short questionnaire regarding the flavor and texture characteristics of each denture adhesive after a single use will also be used to generate data for these attributes. This study included four visits: Visit 1 (screening visit), Visit 2, 3, 4 (treatment visits).

Conditions

• Denture Retention

Interventions

Type	Name	Description
OTHER	Test Product	Five strips of test adhesive cream for upper denture, as per application instructions.
OTHER	Positive Contol	Three dabs of positive control adhesive cream for upper denture, as per application instructions.
OTHER	Negative Control	No adhesive

Timeline

• Start date: 2017-02-13
• Primary completion: 2017-05-04
• Completion: 2017-05-04
• First posted: 2017-01-31
• Last updated: 2018-08-31
• Results posted: 2018-08-31

Locations

1 site across 1 country: United States