Three experimental denture adhesives and a commercial adhesive compared with no adhesive to improve upper denture hold
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
This test tries three new denture adhesive creams (and a commercial adhesive) to see if they help people with full upper dentures keep their dentures held in place for up to 13 hours.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Haleon Industry-sponsored |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT07496164 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized, single-blind, five-period crossover trial has each participant try five treatments across separate visits, including three experimental adhesive creams, a commercial adhesive (Poligrip Power Hold + Seal), and no adhesive. The primary outcome is maximum maxillary bite force as a measure of denture retention measured over a 13-hour period. Up to 60 full maxillary denture wearers will be randomized to ensure at least 54 evaluable participants complete all treatment periods. The crossover design means each participant serves as their own control to compare hold between adhesives and no-adhesive conditions.
Who should consider this trial
Good fit: Adults aged 18 and older who wear a conventional acrylic-based full upper (maxillary) denture and can attend study visits and follow procedures are ideal candidates.
Not a fit: People who do not wear a full maxillary denture (for example, those with partial dentures, implant-retained dentures, or only lower dentures) are unlikely to benefit from the results.
Why it matters
Potential benefit: If successful, one or more adhesives could provide longer-lasting denture hold and greater comfort across a full day without frequent reapplication.
How similar studies have performed: Commercial denture adhesives have previously been shown to improve retention compared with no adhesive, but the specific experimental formulations in this trial are novel and untested in humans.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Indianapolis, Indiana
- Oral Health Research Institute (OHRI) — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Haleon Response Center
- Email: ww.clinical-trial-register@haleon.com
- Phone: +441932 95 95 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.