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

NCT07496164 | Recruiting FDA Device

• 1 other identifier: 400325
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Denture Retention

Outcome Measures

Primary Outcomes (1)

• 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)

  Higher values of AOB demonstrate a more improved stronger bite force over time than lower values.

  Baseline and up to 13 hours

Secondary Outcomes (3)

• AOB0-13 to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Vs Positive Control)

  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)

  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)

  Baseline and up to 1, 3, 6, 9, 12 hours

Study Arms (5)

Experimental Denture Adhesive 1

EXPERIMENTAL

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

Experimental Denture Adhesive 2

EXPERIMENTAL

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

Experimental Denture Adhesive 3

EXPERIMENTAL

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

Positive Control

ACTIVE COMPARATOR

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

Negative Control

NO INTERVENTION

Denture adhesive will not be used.

Interventions

Experimental Denture Adhesive 1 DEVICE

Denture adhesive cream

Experimental Denture Adhesive 1

Experimental Denture Adhesive 2 DEVICE

Denture adhesive cream

Experimental Denture Adhesive 2

Experimental Denture Adhesive 3 DEVICE

Denture adhesive cream

Experimental Denture Adhesive 3

Poligrip Power Hold + Seal DEVICE

Denture adhesive cream

Positive Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

Oral Health Research Institute (OHRI)

Indianapolis, Indiana, 46202, United States

RECRUITING

Central Study Contacts

Haleon Response Center

CONTACT

+441932 95 95 00; ww.clinical-trial-register@haleon.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

US (1)