Recruiting

Denture Adhesives

Sponsor:

HALEON

Code:

NCT07496164

Conditions

Denture Retention

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Experimental Denture Adhesive 1

Experimental Denture Adhesive 2

Experimental Denture Adhesive 3

Poligrip Power Hold + Seal

Study Details

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

Study ID

NCT07496164

Start date

Mar 30, 2026

Status verified date

Apr, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

no intervention: Negative Control

Denture adhesive will not be used.

Interventions

Experimental Denture Adhesive 1

Denture adhesive cream

Experimental Denture Adhesive 2

Denture adhesive cream

Experimental Denture Adhesive 3

Denture adhesive cream

Poligrip Power Hold + Seal

Denture adhesive cream

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Haleon Response Center

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

Locations

Oral Health Research Institute (OHRI)

Recruiting

Indianapolis, Indiana, United States, 46202

More Information

Sponsor

HALEON

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by HALEON on 2026-04-09.