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

Denture Retention Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Denture Retention

• NCT number: NCT03807700
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Completed
• Phase: Phase 3
• Start date: February 4, 2019
• Completion date: May 4, 2019