NCT02937870

A Bite Force Study Comparing Two New Test Adhesives With Currently Marketed Denture Adhesive

A Proof of Principle Bite Force Study Using Two New Test Adhesives and a Currently Marketed Denture Adhesive.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The objective of this 4-treatment, 4-period, randomized, crossover, proof of principle bite force study will be to compare bite force measurements over a 12 hour period across two (test) cream denture adhesives, with a currently marketed cream denture adhesive (positive control), and a negative/no treatment control.

Detailed description

This will be a 4-treatment, 4-period, randomized, crossover, proof of principle bite force study which will compare bite force measurements over a 12 hour period across two cream denture adhesives with a currently marketed cream denture adhesive (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 administered to give an indication of participant satisfaction of these attributes.

Conditions

• Denture Retention

Interventions

Type	Name	Description
DEVICE	Test Product 1	Test adhesive 1 with a thin nozzle
DEVICE	Test Product 2	Test adhesive 2 with a thin nozzle
DEVICE	Reference Product	Adhesive Cream
OTHER	Negative Control	No adhesive

Timeline

• Start date: 2017-03-07
• Primary completion: 2017-04-05
• Completion: 2017-04-05
• First posted: 2016-10-19
• Last updated: 2018-05-23
• Results posted: 2018-03-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study