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

NCT04473521 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-01-22

No results posted yet for this study

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.

Conditions

  • Denture Retention

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-04
Primary Completion
2021-01-10
Completion
2021-01-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04473521 on ClinicalTrials.gov