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Clinical Trial Summary

In this clinical study, an experimental denture adhesive with a precision tip nozzle was tested to evaluate the relative efficacy to reduce the ingress of food under the denture compared to use of no adhesive or a standard marketed adhesive.


Clinical Trial Description

The aim of this study is to explore the mass of food particle ingress when an adhesive is extruded through the new nozzle with directed application compared to the use of no adhesive and a marketed adhesive (extruded through a flat ribbon nozzle [FRN]) with standard application as per product label, utilizing a peanut occlusion methodology. This was a single center, controlled, single blind (to the examiner performing the safety assessments (oral soft tissue [OST] examination) and the laboratory staff weighing the peanut particles), randomized, three-treatment, three-period, cross-over design in participants with full upper and lower dentures. Each treatment period consisted of one day of testing with at least two days between treatment visits. This study consisted four visits: Visit 1 - Screening Visit; Visit 2 - Treatment 1 Visit; Visit 3 - Treatment 2 Visit and Visit 4 - Treatment 3 Visit. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02928380
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase N/A
Start date July 25, 2016
Completion date September 16, 2016

See also
  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Withdrawn NCT04473521 - A Clinical Study to Assess Force Required to Dislodge Upper Denture With and Without Use of a Novel Denture Adhesive Phase 3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 NCT03709810 - A Study to Investigate Food Occlusion Efficacy of a Denture Adhesive in Denture Wearers Phase 4
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