NCT04473521

A Clinical Study to Assess Force Required to Dislodge Upper Denture With and Without Use of a Novel Denture Adhesive

A Clinical Study Assessing Maximum Maxillary Bite Force When Using a Novel Denture Adhesive Compared to Using No-adhesive

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the hold properties of an investigational denture adhesive using an established methodology called the maximum incisal bite force (BF), and Kapur-Olshan (KO) index for denture retention and stability. The effects of hot drinks and two questionnaires relating to participants' perception will also be assessed for the investigational denture adhesive.

Detailed description

This study will be a single-centre, controlled, randomized, single blind, 4-treatment, 4-period, cross-over study to evaluate maximum maxillary bite force in a population of full maxillary denture wearers. This study consists of 5 visits (1 screening visit and 4 treatment periods including minimum washout period of 2 days between treatment visits). Participant's maxillary and mandibular dentures will be assessed for retention and stability using KO index and whether they are well made. Participants will be randomized to one of the 4 treatment groups i.e. No adhesive, Super Poligrip Free (SPF), Investigational Adhesive and Investigational Adhesive + Hot drink arm group and will undergo an oral soft tissue (OST) and Oral Hard Tissue (OHT) examination. Participants who will meet all the inclusion and no exclusion criteria will continue the study. Participants will complete the BF measurement, KO assessment, OST, OHT examination and participants 'perception questionnaire as per the schedule.

Conditions

• Denture Retention

Interventions

Type	Name	Description
DEVICE	Investigational denture adhesive cream	The denture adhesive application will be controlled by weight (1.00g +/-0.05g) applied to the maxillary denture only.
DEVICE	Super Poligrip Free	The denture adhesive application will be controlled by weight (1.00g +/- 0.05g) applied to the maxillary denture only.

Timeline

• Start date: 2020-10-04
• Primary completion: 2021-01-10
• Completion: 2021-01-10
• First posted: 2020-07-16
• Last updated: 2021-01-22

Locations

1 site across 1 country: United States