A Study to Assess the Effectiveness of a Marketed Denture Adhesive in Real-World Setting
NCT ID: NCT07273149
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
375 participants
INTERVENTIONAL
2025-12-05
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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HALEON
INDUSTRY
Responsible Party
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Locations
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Lindus Health (virtual site)
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Dr. Aaron S Weinberg, MD
Role: primary
Other Identifiers
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400027
Identifier Type: -
Identifier Source: org_study_id