The purpose of this study is to investigate the hold properties of two experimental denture adhesives using established maximum incisal BF methodology.
This will be a single-centre, controlled, randomized, single-blind (with respect to the examiner performing the incisal BF measurements), 4-treatment, 4- period, cross-over study to evaluate the maximum maxillary BF in a population of full maxillary denture wearers. A currently marketed denture adhesive will be used as a positive control, whilst use of no adhesive will be employed as a negative control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Enrollment
45
A single application of 1 gram of Super Poligrip Free will be applied topically to oral tissues via the upper denture.
A single application of 1 gram of Experimental Denture Adhesive 1 will be applied topically to oral tissues via the upper denture.
A single application of 1 gram of Experimental Denture Adhesive 2 will be applied topically to oral tissues via the upper denture.
Oral Health Research Institute Indiana University School of Dentistry
Indianapolis, Indiana, United States
Area Over Baseline Over 12 Hours (AOB 0-12) to Compare Maximum Incisal Bite Force
Natural logged incisal Bite Force (BF) measurements were performed to analyze the denture dislodgement as measure of denture adhesive hold efficacy. All BF measurements were conducted by an examiner. AOB 0-12 was used to assess the incisal BF and defined as (Area under the Curve \[AUC\]0-12) divided by 12 minus baseline BF (pounds \[lbs\]). AUC was calculated from 0 to 12 hours using the trapezoid method; denoted as AUC 0-12. This transformation was carried out to return the measurement to the same scale as the original observation. AOB 0-12 was analyzed for each of the three treatments in comparison to no denture adhesive treatment group. Higher values of AOB 0-12 demonstrate a stronger bite force over time than lower values. Baseline was defined as BF (lbs) recorded at hour 0 (pre-treatment).
Time frame: Baseline and up to 12 hours
Area Over Baseline at 0.5, 1, 3, 6 And 9 Hours to Compare Maximum Incisal BF
Natural logged incisal BF measurements were performed to analyze the denture dislodgement as measure of denture adhesive hold efficacy. All BF measurements were conducted by an examiner. AOB 0-t was defined as AUC 0-t divided by "t" minus baseline BF (lbs), where "t" is equal to 0.5, 1, 3, 6 and 9 hours. AUC was calculated from 0 to "t" hours using the trapezoid method; denoted as AUC 0-t. This transformation was carried out to return the measurement to the same scale as the original observation. AOB for 0.5, 1, 3, 6 and 9 hours were analyzed using the trapezoid method. AOB 0-0.5, AOB 0-1, AOB 0-3, AOB 0-6, AOB 0-9 were analyzed for each of the three treatments in comparison to no adhesive treatment group. Higher values of AOB demonstrate a stronger bite force over time than lower values. Baseline was defined as BF (lbs) recorded at hour 0 (pre-treatment).
Time frame: Baseline, at 0.5, 1, 3, 6 and 9 hours
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