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A Study to Investigate Food Occlusion Efficacy of a Denture Adhesive in Denture Wearers

NCT03709810 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2020-03-02

Study results available
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Summary

The purpose of this study is to determine the ability of a marketed denture adhesive to restrict food ingress underneath dentures during eating.

Conditions

  • Denture Retention

Interventions

COMBINATION_PRODUCT

Marketed Denture Adhesive (Super Poligrip Max Seal)

The denture adhesive will be applied directly from the tubes. 1.6 g of adhesive per treatment will be applied to each participant's dentures. This dose will be split as 1.00±0.1 g for the maxillary and 0.6±0.1g for the mandibular dentures.

OTHER

No Adhesive

No adhesive will be applied.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2019-01-24
Completion
2019-01-24
FDA Device
Yes

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 NCT03709810 on ClinicalTrials.gov