The aim of the proposed clinical study is to investigate the efficacy of three experimental denture adhesive creams to improve denture hold over a period of 13 hours.
This will be a single-center, controlled, randomized, single blind, 5 treatment-period, cross-over study to evaluate maximum maxillary bite force in a population of full maxillary denture wearers. A sufficient number of participants will be screened to randomize up to 60 participants to ensure at least 54 evaluable participants complete the entire study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Enrollment
60
Denture adhesive cream
Denture adhesive cream
Denture adhesive cream
Oral Health Research Institute (OHRI)
Indianapolis, Indiana, United States
RECRUITINGArea Over Baseline (AOB) in Bite Force Over 13 Hours (AOB0-13) to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Versus [Vs] No Denture Adhesive)
Higher values of AOB demonstrate a more improved stronger bite force over time than lower values.
Time frame: Baseline and up to 13 hours
AOB0-13 to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Vs Positive Control)
Higher values of AOB demonstrate a more improved stronger bite force over time than lower values.
Time frame: Baseline and up to 13 hours
AOB in Bite Force to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Vs No Adhesive)
Higher values of AOB demonstrate a more improved stronger bite force over time than lower values.
Time frame: Baseline and up to 1, 3, 6, 9, 12 hours
AOB in Bite Force to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Vs Positive Control)
Higher values of AOB demonstrate a more improved stronger bite force over time than lower values.
Time frame: Baseline and up to 1, 3, 6, 9, 12 hours
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Denture adhesive cream