Denture RetentionNCT07496164
A Clinical Study to Assess the Effectiveness of Use of Three Experimental Denture Adhesives Compared to Using No-Adhesive
A study testing Experimental Denture Adhesive 1, Experimental Denture Adhesive 2 and Experimental Denture Adhesive 3 in people with Denture Retention, run by HALEON at 1 site in United States.
Trial 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. 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?
- Experimental Denture Adhesive 1, Experimental Denture Adhesive 2 and Experimental Denture Adhesive 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2026to 1 Oct 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 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:
- sufficiently stable, in the opinion of the investigator, to enable the bite force determination to be performed.
- well made (according to the well-made assessment).
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oral Health Research Institute (OHRI)
Indianapolis, Indiana, 46202
About this study
Official title: 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
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.
Read the detailed description
This will be a single-center, controlled, randomized, single blind, 5 treatment-period, cross-over study to evaluate maximum maxillary bite force in a population of full maxillary denture wearers. A sufficient number of participants will be screened to randomize up to 60 participants to ensure at least 54 evaluable participants complete the entire study.
- Conditions
- Denture Retention
- Being tested
- Experimental Denture Adhesive 1, Experimental Denture Adhesive 2, Experimental Denture Adhesive 3, Poligrip Power Hold + Seal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Denture Adhesive 1Device
Denture adhesive cream
Experimental Denture Adhesive 2Device
Denture adhesive cream
Experimental Denture Adhesive 3Device
Denture adhesive cream
Poligrip Power Hold + SealDevice
Denture adhesive cream
| Study group | Role | What they receive |
|---|---|---|
| Experimental Denture Adhesive 1 | Experimental | 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. Receives: Device: Experimental Denture Adhesive 1 |
| Experimental Denture Adhesive 2 | Experimental | 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. Receives: Device: Experimental Denture Adhesive 2 |
| Experimental Denture Adhesive 3 | Experimental | 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. Receives: Device: Experimental Denture Adhesive 3 |
| Positive Control | Active comparator | 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. Receives: Device: Poligrip Power Hold + Seal |
| Negative Control | No intervention | Denture adhesive will not be used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Higher values of AOB demonstrate a more improved stronger bite force over time than lower values.
Measured: Baseline and up to 13 hours
Secondary outcomes (3)
AOB0-13 to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Vs Positive Control)
Higher values of AOB demonstrate a more improved stronger bite force over time than lower values.
Measured: Baseline and up to 13 hours
AOB in Bite Force to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Vs No Adhesive)
Higher values of AOB demonstrate a more improved stronger bite force over time than lower values.
Measured: Baseline and up to 1, 3, 6, 9, 12 hours
AOB in Bite Force to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Vs Positive Control)
Higher values of AOB demonstrate a more improved stronger bite force over time than lower values.
Measured: Baseline and up to 1, 3, 6, 9, 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start30 Mar 2026
- Primary completion1 Oct 2026
- Study completion1 Oct 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496164
- Sponsor's protocol ID
- 400325
- Status last verified
- Oct 2026
- First submitted
- 23 Mar 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07496164
- Acronym / sponsor ID
- 400325
- Conditions
- Denture Retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 27 Mar 2026 (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 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.
Detailed description
This will be a single-center, controlled, randomized, single blind, 5 treatment-period, cross-over study to evaluate maximum maxillary bite force in a population of full maxillary denture wearers. A sufficient number of participants will be screened to randomize up to 60 participants to ensure at least 54 evaluable participants complete the entire study.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Experimental Denture Adhesive 1 | Experimental | Device: Experimental Denture Adhesive 1A 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 Denture Adhesive 2 | Experimental | Device: Experimental Denture Adhesive 2A 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 Denture Adhesive 3 | Experimental | Device: Experimental Denture Adhesive 3A 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. |
| Positive Control | Active comparator | Device: Poligrip Power Hold + SealA 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. |
| Negative Control | No intervention | –Denture adhesive will not be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Experimental Denture Adhesive 1Denture adhesive cream | Device | Experimental Denture Adhesive 1 |
| Experimental Denture Adhesive 2Denture adhesive cream | Device | Experimental Denture Adhesive 2 |
| Experimental Denture Adhesive 3Denture adhesive cream | Device | Experimental Denture Adhesive 3 |
| Poligrip Power Hold + SealDenture adhesive cream | Device | Positive Control |
Primary outcome
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
Higher values of AOB demonstrate a more improved stronger bite force over time than lower values.
3 secondary outcomes
AOB0-13 to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Vs Positive Control)
Time frame: Baseline and up to 13 hours
AOB in Bite Force to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Vs No Adhesive)
Time frame: Baseline and up to 1, 3, 6, 9, 12 hours
AOB in Bite Force to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Vs Positive Control)
Time frame: Baseline and up to 1, 3, 6, 9, 12 hours
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 29 Oct 2026.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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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 Experimental Denture Adhesive 1, Experimental Denture Adhesive 2 and Experimental Denture Adhesive 3 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 11 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 29 Oct 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?
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). 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 29 Oct 2026.