NCT03807700

To Evaluate Oral Health and Quality of Life Associated With Use of a Denture Adhesive

A Randomized, Single-blind, Efficacy Study to Evaluate Oral Health and Quality of Life Associated With Use of a Denture Adhesive

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the use of a denture adhesive and its ability to demonstrate the improvement in overall gum-health and to improve the oral health related quality of life (OHrQoL) in participants who wear full dentures.

Detailed description

This study will be a single center, controlled, single-blind, randomized, two-treatment, parallel design in healthy participants with a full conventional, acrylic denture in either or both dental arches, with a treatment period of 12 weeks. The study will assess the effectiveness of an experimental denture adhesive in the improvement of denture-bearing tissue irritation related measures, and the participant's oral health related quality of life. Participants will be randomized to one of the 2 treatment groups i.e. experimental denture arm group and control arm group and will undergo an oral soft tissue (OST) examination. Participants with satisfactory dentures, adequate retention and stability and who qualify all the inclusion and exclusion criteria will continue in the study. Participants will complete the Gum Comfort, OHIP-Edent questionnaires and GOHAI questionnaire. The assessments will be made at Baseline, and after 1, 4, 8 and 12 weeks treatment.

Conditions

• Denture Retention

Interventions

Type	Name	Description
DRUG	Experimental Denture Adhesive	In this arm, participants will apply the experimental adhesive on their dentures once per day when the denture is placed in mouth.

Timeline

• Start date: 2019-02-04
• Primary completion: 2019-05-04
• Completion: 2019-05-04
• First posted: 2019-01-17
• Last updated: 2021-09-05
• Results posted: 2020-05-01

Locations

1 site across 1 country: Canada