Poligrip Power Max Hold + Seal to prevent food getting under dentures

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

This 6-week test will see if Poligrip Power Max Hold + Seal helps adults who wear full or partial dentures keep food from getting trapped under their dentures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 375 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Haleon (Industry-sponsored)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT07273149 on ClinicalTrials.gov

What this trial studies

This open-label, decentralized 6-week protocol asks habitual full or partial denture wearers to report daily on food getting under their dentures for three weeks without adhesive followed by three weeks using Poligrip Power Max Hold + Seal. Participants complete daily food occlusion questions via digital platforms and attend a virtual screening visit before enrollment. Approximately 375 people will be screened to achieve around 300 completers, and study materials and visits are managed remotely by a Boston-based virtual site. The primary outcome is participant-reported frequency of food occlusion comparing the no-adhesive and adhesive periods.

Who should consider this trial

Good fit: Adults aged 18 and older who habitually wear partial or full dentures, are in generally good physical and mental health, and can complete daily online questionnaires and virtual visits are ideal candidates.

Not a fit: People with active oral disease or poorly fitting dentures that require clinical adjustment, those unable to follow virtual procedures, or who cannot use adhesive as directed may not receive benefit from this study.

Why it matters

Potential benefit: If successful, regular use of the adhesive could reduce food entrapment under dentures and improve eating comfort and confidence.

How similar studies have performed: Prior controlled research has shown denture adhesives can improve retention and reduce food entrapment, but large decentralized, self-reported real-world comparisons are less common.

Eligibility criteria

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.

Where this trial is running

Boston, Massachusetts

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

Study contacts

• Study coordinator: Haleon Response Center

Conditions Denture Retention