A Clinical Study to Assess the Effectiveness of Use of Three Experimental Denture Adhesives Compared to Using No-Adhesive

April 6, 2026 updated by: HALEON

A Randomized, Controlled, Single-Blind, Cross Over Clinical Study Assessing the Maximum Maxillary Bite Force When Using Three Denture Adhesives Compared to Using No-Adhesive

The aim of the proposed clinical study is to investigate the efficacy of three experimental denture adhesive creams to improve denture hold over a period of 13 hours.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This will be a single-center, controlled, randomized, single blind, 5 treatment-period, cross-over study to evaluate maximum maxillary bite force in a population of full maxillary denture wearers. A sufficient number of participants will be screened to randomize up to 60 participants to ensure at least 54 evaluable participants complete the entire study.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Oral Health Research Institute (OHRI)
        • Contact:
          • Ana Gossweiler

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
  • A male or female participant who, at the time of screening, is aged 18+ years.
  • A participant who is willing and able to comply with scheduled visits, and other study procedures.
  • A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
  • A participant with a completely edentulous maxillary arch restored with a conventional maxillary full denture with an acrylic base.

  • A participant who is dentate in the mandibular arch or has a partial or full denture in the mandibular arch that is:

    1. sufficiently stable, in the opinion of the investigator, to enable the bite force determination to be performed.
    2. well made (according to the well-made assessment).

Exclusion Criteria:

  • A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
  • A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to Visit 1 and/or during study participation.
  • A participant who is pregnant (self-reported) or intending to become pregnant or who is breastfeeding over the duration of the study.
  • A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
  • A participant unwilling or unable to comply with the Lifestyle Considerations described in this protocol.
  • A participant who is currently taking or has taken a bisphosphonate drug.
  • A participant who uses any medication or has a condition that, in the opinion of the investigator, would interfere with the conduct of the study.
  • A participant with a recent history (within the last year) of alcohol or other substance abuse.
  • A participant who has previously been enrolled in this study.
  • A participant who, in the opinion of the investigator, is unable to comply with study requirements and/or who is not able to reliably perform a valid bite.
  • A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Negative Control
Denture adhesive will not be used.
Experimental: Experimental Denture Adhesive 1
A single application of 1 gram of Experimental Denture Adhesive 1 will be applied topically, and participants will be instructed to press dentures into place, hold firmly, and bite down for a few seconds to secure hold.
Device: Experimental Denture Adhesive 1
Denture adhesive cream
Experimental: Experimental Denture Adhesive 2
A single application of 1 gram of Experimental Denture Adhesive 2 will be applied topically, and participants will be instructed to press dentures into place, hold firmly, and bite down for a few seconds to secure hold.
Device: Experimental Denture Adhesive 2
Denture adhesive cream
Experimental: Experimental Denture Adhesive 3
A single application of 1 gram of Experimental Denture Adhesive 3 will be applied topically, and participants will be instructed to press dentures into place, hold firmly, and bite down for a few seconds to secure hold.
Device: Experimental Denture Adhesive 3
Denture adhesive cream
Active Comparator: Positive Control
A single application of 1 gram of marketed product will be applied topically, and participants will be instructed to press dentures into place, hold firmly, and bite down for a few seconds to secure hold.
Device: Poligrip Power Hold + Seal
Denture adhesive cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Over Baseline (AOB) in Bite Force Over 13 Hours (AOB0-13) to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Versus [Vs] No Denture Adhesive)
Time Frame: Baseline and up to 13 hours
Higher values of AOB demonstrate a more improved stronger bite force over time than lower values.
Baseline and up to 13 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AOB0-13 to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Vs Positive Control)
Time Frame: Baseline and up to 13 hours
Higher values of AOB demonstrate a more improved stronger bite force over time than lower values.
Baseline and up to 13 hours
AOB in Bite Force to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Vs No Adhesive)
Time Frame: Baseline and up to 1, 3, 6, 9, 12 hours
Higher values of AOB demonstrate a more improved stronger bite force over time than lower values.
Baseline and up to 1, 3, 6, 9, 12 hours
AOB in Bite Force to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Vs Positive Control)
Time Frame: Baseline and up to 1, 3, 6, 9, 12 hours
Higher values of AOB demonstrate a more improved stronger bite force over time than lower values.
Baseline and up to 1, 3, 6, 9, 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HALEON

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 400325

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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