NCT05173974

A Clinical Study to Evaluate the Maximum Maxillary Bite Force (BF) When Using Two Novel Denture Adhesives Compared to Using No-Adhesive

A Randomized, Single-Blind Clinical Study Assessing the Maximum Maxillary Bite Force When Using Two Novel Denture Adhesives Compared to Using No-Adhesive

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the hold properties of two experimental denture adhesives using established maximum incisal BF methodology.

Detailed description

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.

Conditions

• Denture Retention

Interventions

Type	Name	Description
DEVICE	Super Poligrip Free	A single application of 1 gram of Super Poligrip Free will be applied topically to oral tissues via the upper denture.
DEVICE	Experimental Denture Adhesive 1	A single application of 1 gram of Experimental Denture Adhesive 1 will be applied topically to oral tissues via the upper denture.
DEVICE	Experimental Denture Adhesive 2	A single application of 1 gram of Experimental Denture Adhesive 2 will be applied topically to oral tissues via the upper denture.

Timeline

• Start date: 2022-02-08
• Primary completion: 2022-07-12
• Completion: 2022-07-12
• First posted: 2021-12-30
• Last updated: 2024-02-16
• Results posted: 2024-02-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study