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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
44
Five strips of test adhesive cream for upper denture, as per application instructions.
Three dabs of positive control adhesive cream for upper denture, as per application instructions.
No adhesive
GSK Investigational Site
Indianapolis, Indiana, United States
Area Over Baseline Over 12 Hours (AOB0-12) for the Incisal Bite Force (Positive Control Adhesive Versus [vs.] Negative Control)
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours \[AUC0-12\])/12 hours minus baseline bite force (pounds \[lbs\]). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
Time frame: Up to 12 hours
Area Over Baseline Over 12 Hours (AOB0-12) for the Incisal Bite Force (Test Adhesive vs. Negative Control)
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours \[AUC0-12\])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
Time frame: Up to 12 hours
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