A Study to Assess the Effectiveness of a Marketed Denture Adhesive in Real-World Setting

June 1, 2026 updated by: HALEON

A Decentralised, Open-labelled, Clinical Study to Assess the Effectiveness of a Marketed Denture Adhesive in Food Occlusion in Denture Wearers in a Real-world Setting

The purpose of this decentralised study in a real-world setting is to assess the effectiveness of a marketed denture adhesive (Poligrip Power Max Hold + Seal) in preventing food entrapment under dentures (self-assessed). The study will evaluate participants perceived food occlusion of a marketed denture adhesive over three weeks compared to no adhesive use over three weeks in a real-world setting.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This will be an open-labelled, decentralised, 6-week study to assess the effectiveness of food occlusion of a marketed denture adhesive in healthy partial and/or full denture wearers aged 18 and above in a real-world setting. Study comprises of 3 weeks of no adhesive use (Day 1 to 21) followed by 3 weeks of adhesive use (Day 22 to 42). Participants will complete Daily Food Occlusion Questions for 3 weeks without using adhesive cream and another 3 weeks with using adhesive cream. Sufficient participants will be screened to enroll approximately 375 participants to ensure that around 300 of these participants will successfully complete the entire study. Participants will be recruited through digital platforms through pre-screening questionnaires followed by a screening virtual visit.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
375

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Lindus Health (virtual site)

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participant's 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.
  • Participants from all genders (male, female, not specified).
  • Participant who, at the time of screening is 18 years old and above.
  • Participants who are willing and able to comply with all study related activities as shown in the schedule of activities, study restrictions, and other study procedures.
  • A participant in good general and mental health with no self-reported clinically significant or relevant abnormalities in medical history or upon a previous oral examination, or condition, that would impact on 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 who is a habitual wearer of partial or full denture defined as participant who wear their dentures for the majority of their time whilst awake.
  • Participants should have a relatively well-fitted denture (self-assessed).
  • Participants who reside in the United States (except for Hawaii and Alaska).

Exclusion Criteria:

  • An employee either directly involved in the conduct of the study or a member of their immediate family; or an employee of Lindus Health 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 study entry and/or during study participation.
  • A participant who has been previously enrolled in this study.

  • Participants who have a clinical condition as self-reported on the screening questionnaire, which include:

    1. Participants who have undergone treatment for periodontal or gum disease within 6 months of screening or are currently undergoing treatment for periodontal or gum disease.
    2. Participants who have been informed by Health Care Professional (HCP) that they have active periodontitis.
    3. Participants who have been informed by HCP that they have active candida infection.
    4. Participants who have been informed by HCP that they have active caries.
    5. Participants with any chronic and/or severe painful health condition(s) which lead to regular use of pain relief medications more than 3 days a week.
    6. Participants who have any clinically significant or relevant oral abnormality (example, temporomandibular joint problems) or palate problem that could have impact on their participation in the study.
    7. In the opinion of the investigator, participants with an acute or chronic medical or psychiatric condition or laboratory abnormality that may impact their safety, ability to follow study procedures or integrity of the study.
  • A participant who is diagnosed with xerostomia or is taking any medication that is causing xerostomia.
  • 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 who has a recent history (within the last year) of alcohol or other substance abuse.
  • A participant who has history of swallowing difficulties or choking.
  • Participants must not receive any denture-related adjustments or treatments that alter fit, comfort or structure of their denture during the study.
  • Currently taking or have taken a bisphosphonate drug (that is., Fosamax, Actenol, Boniva).
  • A participant who reports a planned surgery during the study duration.
  • A participant who, in the opinion of the investigator or delegate, should not participate in the study.
  • A participant who is unable to read and understand English.

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: No Adhesive Use Followed by Adhesive Use
Participants will wear their dentures without any denture adhesive cream for 3 weeks from Day 1 to Day 21 of the study. Participants will wear their dentures with the denture adhesive cream (Poligrip Power Max Hold + Seal) as per the label instructions, once daily for 3 weeks from Day 22 to Day 42 of the study.
Device: Poligrip Power Max Hold + Seal
Poligrip Power Max Hold + Seal denture adhesive cream containing sodium-calcium mixed partial salt of poly(methylvinylether/maleic acid) and carboxymethylcellulose.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Score of the Food Occlusion Question Assessed Using the Numerical Rating Scale (NRS)
Time Frame: Up to Week 6
Participants will answer specific food related question on a daily basis throughout the study. Participants scored the Food Occlusion Question using the NRS.
Up to Week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Daily Responses of Full-day Food Occlusion Question
Time Frame: Up to Week 6
Participants will answer the Food Occlusion Question related to occlusion of food particles under denture using a Yes/No response.
Up to Week 6
Mean Food Particle Bothersomeness Score of Food Occlusion Question Assessed Using the NRS
Time Frame: Up to Week 6
Participants will answer specific food related question on a daily basis throughout the study using the NRS.
Up to Week 6
Mean Comfort Score of Food Occlusion Question Assessed Using the NRS
Time Frame: Up to Week 6
Participants will answer specific food related question on a daily basis throughout the study using the NRS.
Up to Week 6

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 21, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 21, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 400027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com

IPD Sharing Time Frame

IPD will be made available within 6 months of publishing the results of the primary and key secondary endpoints and the safety data for 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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