Denture RetentionNCT07273149
A Study to Assess the Effectiveness of a Marketed Denture Adhesive in Real-World Setting
A study testing Poligrip Power Max Hold + Seal in people with Denture Retention, run by HALEON at 1 site in United States.
Trial summary
The purpose of this decentralised study in a real-world setting is to assess the effectiveness of a marketed denture adhesive (Poligrip Power Max Hold + Seal) in preventing food entrapment under dentures (self-assessed). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Denture Retention
- What is being tested?
- Poligrip Power Max Hold + Seal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2025to 21 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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:
- 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.
- Participants who have been informed by Health Care Professional (HCP) that they have active periodontitis.
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- Participants who have been informed by HCP that they have active candida infection.
- Participants who have been informed by HCP that they have active caries.
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lindus Health (virtual site)
Boston, Massachusetts, 02111
About this study
Official title: 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
The purpose of this decentralised study in a real-world setting is to assess the effectiveness of a marketed denture adhesive (Poligrip Power Max Hold + Seal) in preventing food entrapment under dentures (self-assessed). The study will evaluate participants perceived food occlusion of a marketed denture adhesive over three weeks compared to no adhesive use over three weeks in a real-world setting.
Read the detailed description
This will be an open-labelled, decentralised, 6-week study to assess the effectiveness of food occlusion of a marketed denture adhesive in healthy partial and/or full denture wearers aged 18 and above in a real-world setting. Study comprises of 3 weeks of no adhesive use (Day 1 to 21) followed by 3 weeks of adhesive use (Day 22 to 42). Participants will complete Daily Food Occlusion Questions for 3 weeks without using adhesive cream and another 3 weeks with using adhesive cream. Sufficient participants will be screened to enroll approximately 375 participants to ensure that around 300 of these participants will successfully complete the entire study. Participants will be recruited through digital platforms through pre-screening questionnaires followed by a screening virtual visit.
- Conditions
- Denture Retention
- Being tested
- Poligrip Power Max Hold + Seal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poligrip Power Max Hold + SealDevice
Poligrip Power Max Hold + Seal denture adhesive cream containing sodium-calcium mixed partial salt of poly(methylvinylether/maleic acid) and carboxymethylcellulose.
| Study group | Role | What they receive |
|---|---|---|
| No Adhesive Use Followed by Adhesive Use | Experimental | 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. Receives: Device: Poligrip Power Max Hold + Seal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Score of the Food Occlusion Question Assessed Using the Numerical Rating Scale (NRS)
Participants will answer specific food related question on a daily basis throughout the study. Participants scored the Food Occlusion Question using the NRS.
Measured: Up to Week 6
Secondary outcomes (3)
Mean Daily Responses of Full-day Food Occlusion Question
Participants will answer the Food Occlusion Question related to occlusion of food particles under denture using a Yes/No response.
Measured: Up to Week 6
Mean Food Particle Bothersomeness Score of Food Occlusion Question Assessed Using the NRS
Participants will answer specific food related question on a daily basis throughout the study using the NRS.
Measured: Up to Week 6
Mean Comfort Score of Food Occlusion Question Assessed Using the NRS
Participants will answer specific food related question on a daily basis throughout the study using the NRS.
Measured: Up to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start5 Dec 2025
- Primary completion21 May 2026
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Denture RetentionStudies of the same condition, open and under way.
- More trials run by HALEONThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273149
- Sponsor's protocol ID
- 400027
- Status last verified
- Jun 2026
- First submitted
- 28 Nov 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07273149
- Acronym / sponsor ID
- 400027
- Conditions
- Denture Retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this decentralised study in a real-world setting is to assess the effectiveness of a marketed denture adhesive (Poligrip Power Max Hold + Seal) in preventing food entrapment under dentures (self-assessed). The study will evaluate participants perceived food occlusion of a marketed denture adhesive over three weeks compared to no adhesive use over three weeks in a real-world setting.
Detailed description
This will be an open-labelled, decentralised, 6-week study to assess the effectiveness of food occlusion of a marketed denture adhesive in healthy partial and/or full denture wearers aged 18 and above in a real-world setting. Study comprises of 3 weeks of no adhesive use (Day 1 to 21) followed by 3 weeks of adhesive use (Day 22 to 42). Participants will complete Daily Food Occlusion Questions for 3 weeks without using adhesive cream and another 3 weeks with using adhesive cream. Sufficient participants will be screened to enroll approximately 375 participants to ensure that around 300 of these participants will successfully complete the entire study. Participants will be recruited through digital platforms through pre-screening questionnaires followed by a screening virtual visit.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Adhesive Use Followed by Adhesive Use | Experimental | Device: Poligrip Power Max Hold + SealParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (20 listed)
- 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:
- A participant who is diagnosed with xerostomia or is taking any medication that is causing xerostomia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Poligrip Power Max Hold + SealPoligrip Power Max Hold + Seal denture adhesive cream containing sodium-calcium mixed partial salt of poly(methylvinylether/maleic acid) and carboxymethylcellulose. | Device | No Adhesive Use Followed by Adhesive Use |
Primary outcome
Mean Score of the Food Occlusion Question Assessed Using the Numerical Rating Scale (NRS)
Time frame: Up to Week 6
Participants will answer specific food related question on a daily basis throughout the study. Participants scored the Food Occlusion Question using the NRS.
3 secondary outcomes
Mean Daily Responses of Full-day Food Occlusion Question
Time frame: Up to Week 6
Mean Food Particle Bothersomeness Score of Food Occlusion Question Assessed Using the NRS
Time frame: Up to Week 6
Mean Comfort Score of Food Occlusion Question Assessed Using the NRS
Time frame: Up to Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Poligrip Power Max Hold + Seal in people with Denture Retention, run by HALEON at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Score of the Food Occlusion Question Assessed Using the Numerical Rating Scale (NRS) (time frame: Up to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.