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A Study to Investigate a Method to Measure Food Occlusion by Denture Adhesives in Denture Wearers

NCT03345108 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-03-29

Study results available
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Summary

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

Conditions

  • Denture Retention

Interventions

DEVICE

Denture Adhesive Cream (Conventional Application)

The adhesive cream will be extruded from a pre-dosed syringe. 1.6 g of adhesive per treatment will be applied to each participant's dentures. This dose will be split as 1.00±0.05g for the maxillary and 0.60±0.05g for the mandibular dentures.

DEVICE

Denture Adhesive (Continuous Strip Application)

The adhesive cream will be extruded from a pre-dosed syringe. 1.6 g of adhesive per treatment will be applied to each participant's dentures. This dose will be split as 1.00±0.05 g for the maxillary and 0.60±0.05 g for the mandibular dentures.

OTHER

No Adhesive

No adhesive applied.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

  • 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
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-11-20
Primary Completion
2017-12-15
Completion
2017-12-15
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 NCT03345108 on ClinicalTrials.gov