Denture Retention Clinical Trial
Official title:
A Randomized, Single-Blind, Clinical Study to Assess Food Occlusion Efficacy of a Marketed Denture Adhesive in Healthy, Edentulous Subjects
The purpose of this study is to determine the ability of a marketed denture adhesive to restrict food ingress underneath dentures during eating.
This is a single center, controlled, single-blind, randomized, two-treatment, two-period, cross-over design in participants with full upper and lower dentures. The study hypothesis is that this methodology will enable comparisons between denture adhesives and no adhesive to demonstrate the effectiveness of denture adhesives in restricting food ingress under dentures during eating. This study will consist of three visits: Visit 1 - Screening Visit; Visit 2 - Treatment 1 Visit; Visit 3 - Treatment 2 Visit. Participants will use test product which is a marketed denture adhesive (Super Poligrip Max Seal [SPMS]) (application will be controlled by weight) to the dentures in a pattern of continuous strips which will be applied to upper and lower denture and will be then placed in mouth and participants will also use no adhesive as a control. Participants will cross-over between treatments so that all participants will participate in all 2 treatment arms. An hour after the participant has worn their denture, they will chew a portion of peanuts in a controlled manner. After a rinsing procedure with water, the dentures will be removed, and any peanuts that have been migrated under each denture will be collected and weighed after a drying process. Participants will also answer a short questionnaire on the procedure and record the number of times their denture dislodged during the chewing procedure. The number of denture dislodgments reported by the participants during the chewing of the peanuts will also be collected and analyzed and this, and the questionnaire data, will be used to support the findings of the peanuts mass measure. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT04473521 -
A Clinical Study to Assess Force Required to Dislodge Upper Denture With and Without Use of a Novel Denture Adhesive
|
Phase 3 | |
| Completed |
NCT03345108 -
A Study to Investigate a Method to Measure Food Occlusion by Denture Adhesives in Denture Wearers
|
N/A | |
| Completed |
NCT02937870 -
A Bite Force Study Comparing Two New Test Adhesives With Currently Marketed Denture Adhesive
|
N/A | |
| Completed |
NCT02928380 -
Evaluation of a Experimental Denture Adhesive to Prevent Food Ingress
|
N/A | |
| Completed |
NCT05173974 -
A Clinical Study to Evaluate the Maximum Maxillary Bite Force (BF) When Using Two Novel Denture Adhesives Compared to Using No-Adhesive
|
Phase 3 | |
| Completed |
NCT03807700 -
To Evaluate Oral Health and Quality of Life Associated With Use of a Denture Adhesive
|
Phase 3 | |
| Completed |
NCT03037307 -
A Clinical Bite Force Study of Two Marketed Adhesives Against no Adhesive
|
N/A | |
| Completed |
NCT04991064 -
Retention of Maxillary Complete Dentures Modified With Titanium Dioxide Nanoparticles: A Randomized Crossover Clinical Trial.
|
N/A |