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

NCT02937870 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-05-23

Study results available
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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.

Conditions

  • Denture Retention

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-07
Primary Completion
2017-04-05
Completion
2017-04-05
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02937870 on ClinicalTrials.gov