Denture RetentionPhase 3NCT05173974

A Clinical Study to Evaluate the Maximum Maxillary Bite Force (BF) When Using Two Novel Denture Adhesives Compared to Using No-Adhesive

A Phase 3 study testing Super Poligrip Free, Experimental Denture Adhesive 1 and Experimental Denture Adhesive 2 in people with Denture Retention, run by HALEON at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to investigate the hold properties of two experimental denture adhesives using established maximum incisal BF methodology. Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Denture Retention
What is being tested?: Super Poligrip Free, Experimental Denture Adhesive 1 and Experimental Denture Adhesive 2
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteUnited States
Study dates: 8 Feb 2022to 12 Jul 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 85 years
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 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. The maxillary denture prosthesis must fulfil all of the following:
At least moderately well-fitting (Kapur Index, Olshan Modification: retention score Greater than or equal to (>=)2, stability score >=2) at the Screening (V1) visit,
Is well made (according to the well-made assessment).

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A participant with BF measurements which satisfy all the following criteria:
The qualifying BF measurements (without adhesive) at V1 (Screening) must be less than or equal to (=<) 9lbs.
At least 2 of the 4 qualifying BF measurements (without adhesive) at V1 (Screening) must be reproducible (within +-2lbs).
The Baseline BF measurement (without adhesive) at V2-5 must be <=9lbs.
The Baseline BF measurement (without adhesive) at V2-5 and at least 1 of the 3 practice BF measurements must be within +-2lbs of each other.
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 GlaxoSmithKline Consumer Healthcare (GSK CH) 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 with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or experimental product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
A participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study.
A participant who is breastfeeding.
A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.

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A participant unwilling or unable to comply with the Lifestyle Considerations.
A participant who is currently taking or has taken a bisphosphonate drug (that is (i.e.), Fosamax, Actonel, Boniva).
A participant who uses any medication or has a condition (e.g. insulin dependent diabetes) that, in the opinion of the investigator, would interfere with the conduct of the study.
A participant who has any clinically significant or relevant oral abnormality (for example (e.g.) temporomandibular joint [TMJ] problems or tooth abnormalities) that, in the opinion of the investigator, could affect the BF measurements or participant safety.
A participant who has any condition or medication which, in the opinion of the investigator, is currently causing xerostomia or which could 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 with Oral soft tissue (OST) examination findings (at V1) such as stomatitis, open sores, lesions, cavitied caries lesions, redness or swelling which in the opinion of the investigator, could interfere with the conduct of the study.
A participant who has previously been enrolled in this study.
A participant who is unable to comply with study requirements and/or who is not able to reliably perform a valid bite at the examiner's discretion.
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 Indiana University School of Dentistry
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: A Randomized, Single-Blind Clinical Study Assessing the Maximum Maxillary Bite Force When Using Two Novel Denture Adhesives Compared to Using No-Adhesive

The purpose of this study is to investigate the hold properties of two experimental denture adhesives using established maximum incisal BF methodology.

Read the detailed description

This will be a single-centre, controlled, randomized, single-blind (with respect to the examiner performing the incisal BF measurements), 4-treatment, 4- period, cross-over study to evaluate the maximum maxillary BF in a population of full maxillary denture wearers. A currently marketed denture adhesive will be used as a positive control, whilst use of no adhesive will be employed as a negative control.

Conditions: Denture Retention
Being tested: Super Poligrip Free, Experimental Denture Adhesive 1, Experimental Denture Adhesive 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Super Poligrip FreeDevice
A single application of 1 gram of Super Poligrip Free will be applied topically to oral tissues via the upper denture.
Experimental Denture Adhesive 1Device
A single application of 1 gram of Experimental Denture Adhesive 1 will be applied topically to oral tissues via the upper denture.
Experimental Denture Adhesive 2Device
A single application of 1 gram of Experimental Denture Adhesive 2 will be applied topically to oral tissues via the upper denture.

Study groups in NCT05173974
Study group	Role	What they receive
Negative Control	No intervention	Denture adhesive will not be used.
Positive Control	Active comparator	A single application of 1 gram of Super Poligrip Free denture adhesive will be applied topically to oral tissues via the upper denture. Receives: Device: Super Poligrip Free
Experimental Denture Adhesive 1	Experimental	A single application of 1 gram of Experimental Denture Adhesive 1 will be applied topically to oral tissues via the upper denture. 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 to oral tissues via the upper denture. Receives: Device: Experimental Denture Adhesive 2

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Over Baseline Over 12 Hours (AOB 0-12) to Compare Maximum Incisal Bite Force
Natural logged incisal Bite Force (BF) measurements were performed to analyze the denture dislodgement as measure of denture adhesive hold efficacy. All BF measurements were conducted by an examiner. AOB 0-12 was used to assess the incisal BF and defined as (Area under the Curve [AUC]0-12) divided by 12 minus baseline BF (pounds [lbs]). AUC was calculated from 0 to 12 hours using the trapezoid method; denoted as AUC 0-12. This transformation was carried out to return the measurement to the same scale as the original observation. AOB 0-12 was analyzed for each of the three treatments in comparison to no denture adhesive treatment group. Higher values of AOB 0-12 demonstrate a stronger bite force over time than lower values. Baseline was defined as BF (lbs) recorded at hour 0 (pre-treatment).
Measured: Baseline and up to 12 hours

Secondary outcomes (1)

Area Over Baseline at 0.5, 1, 3, 6 And 9 Hours to Compare Maximum Incisal BF
Natural logged incisal BF measurements were performed to analyze the denture dislodgement as measure of denture adhesive hold efficacy. All BF measurements were conducted by an examiner. AOB 0-t was defined as AUC 0-t divided by "t" minus baseline BF (lbs), where "t" is equal to 0.5, 1, 3, 6 and 9 hours. AUC was calculated from 0 to "t" hours using the trapezoid method; denoted as AUC 0-t. This transformation was carried out to return the measurement to the same scale as the original observation. AOB for 0.5, 1, 3, 6 and 9 hours were analyzed using the trapezoid method. AOB 0-0.5, AOB 0-1, AOB 0-3, AOB 0-6, AOB 0-9 were analyzed for each of the three treatments in comparison to no adhesive treatment group. Higher values of AOB demonstrate a stronger bite force over time than lower values. Baseline was defined as BF (lbs) recorded at hour 0 (pre-treatment).
Measured: Baseline, at 0.5, 1, 3, 6 and 9 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Feb 202212 Jul 2022

First posted30 Dec 2021
Study start8 Feb 2022
Primary completion12 Jul 2022
Study completion12 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Denture RetentionStudies of the same condition, open and under way.
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 3
Primary purpose: Device feasibility
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05173974
Sponsor's protocol ID: 218042
Status last verified: Jun 2023
First submitted: 17 Dec 2021
Last updated: 16 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Single-Blind Clinical Study Assessing the Maximum Maxillary Bite Force When Using Two Novel Denture Adhesives Compared to Using No-Adhesive
ClinicalTrials.gov ID: NCT05173974
Acronym / sponsor ID: 218042
Conditions: Denture Retention
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: HALEONIndustry (pharma, biotech, devices)
Study start: 8 Feb 2022 (actual)
Primary completion: 12 Jul 2022 (actual)
Study completion: 12 Jul 2022 (actual)
First posted: 30 Dec 2021 (actual)
Results: Posted 16 Feb 2024

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 study is to investigate the hold properties of two experimental denture adhesives using established maximum incisal BF methodology.

Detailed description

Study design

Primary purpose: Device feasibility
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Negative Control	No intervention	–Denture adhesive will not be used.
Positive Control	Active comparator	Device: Super Poligrip FreeA single application of 1 gram of Super Poligrip Free denture adhesive will be applied topically to oral tissues via the upper denture.
Experimental Denture Adhesive 1	Experimental	Device: Experimental Denture Adhesive 1A single application of 1 gram of Experimental Denture Adhesive 1 will be applied topically to oral tissues via the upper denture.
Experimental Denture Adhesive 2	Experimental	Device: Experimental Denture Adhesive 2A single application of 1 gram of Experimental Denture Adhesive 2 will be applied topically to oral tissues via the upper denture.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 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 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. The maxillary denture prosthesis must fulfil all of the following:
A participant with BF measurements which satisfy all the following criteria:

Key exclusion criteria (16 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 GlaxoSmithKline Consumer Healthcare (GSK CH) 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 with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or experimental product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
A participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study.
A participant who is breastfeeding.

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
Super Poligrip FreeA single application of 1 gram of Super Poligrip Free will be applied topically to oral tissues via the upper denture.	Device	Positive Control
Experimental Denture Adhesive 1A single application of 1 gram of Experimental Denture Adhesive 1 will be applied topically to oral tissues via the upper denture.	Device	Experimental Denture Adhesive 1
Experimental Denture Adhesive 2A single application of 1 gram of Experimental Denture Adhesive 2 will be applied topically to oral tissues via the upper denture.	Device	Experimental Denture Adhesive 2

Primary outcome

Area Over Baseline Over 12 Hours (AOB 0-12) to Compare Maximum Incisal Bite Force
Time frame: Baseline and up to 12 hours
Natural logged incisal Bite Force (BF) measurements were performed to analyze the denture dislodgement as measure of denture adhesive hold efficacy. All BF measurements were conducted by an examiner. AOB 0-12 was used to assess the incisal BF and defined as (Area under the Curve [AUC]0-12) divided by 12 minus baseline BF (pounds [lbs]). AUC was calculated from 0 to 12 hours using the trapezoid method; denoted as AUC 0-12. This transformation was carried out to return the measurement to the same scale as the original observation. AOB 0-12 was analyzed for each of the three treatments in comparison to no denture adhesive treatment group. Higher values of AOB 0-12 demonstrate a stronger bite force over time than lower values. Baseline was defined as BF (lbs) recorded at hour 0 (pre-treatment).

1 secondary outcome

Area Over Baseline at 0.5, 1, 3, 6 And 9 Hours to Compare Maximum Incisal BF
Time frame: Baseline, at 0.5, 1, 3, 6 and 9 hours

Results and safety

Results posted to the registry on 16 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental Denture Adhesive 1/Negative Control/Positive Control/Experimental Denture Adhesive 2	11	11
Experimental Denture Adhesive 2/Positive Control/Negative Control/Experimental Denture Adhesive 1	10	10
Negative Control/Experimental Denture Adhesive 2/Experimental Denture Adhesive 1/Positive Control	11	11
Positive Control/Experimental Denture Adhesive 1/Experimental Denture Adhesive 2/Negative Control	11	11

Primary outcome: Area Over Baseline Over 12 Hours (AOB 0-12) to Compare Maximum Incisal Bite Force

Time frame: Baseline and up to 12 hours. Mean (Standard Deviation). Unit: lbs

Measure	Experimental Denture Adhesive 1 n = 41	Experimental Denture Adhesive 2 n = 42	Positive Control n = 42	Negative Control n = 42
Value	0.87 (0.80)	0.69 (0.70)	0.89 (0.86)	0.59 (0.71)

Experimental Denture Adhesive 1 vs Negative Control: Mean Difference (Final Values): 0.15 (95% CI 0.01 to 0.29), p = 0.037, ANCOVA
Experimental Denture Adhesive 2 vs Negative Control: Mean Difference (Final Values): 0.14 (95% CI 0.00 to 0.28), p = 0.044, ANCOVA
Positive Control vs Negative Control: Mean Difference (Final Values): 0.18 (95% CI 0.06 to 0.30), p = 0.005, ANCOVA

Population analysed: mITT population. Only those participants available at the indicated timepoints were analyzed.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental Denture Adhesive 1	0 of 41 (0%)	6 of 41 (14.6%)	0 of 41
Experimental Denture Adhesive 2	0 of 42 (0%)	3 of 42 (7.1%)	0 of 42
Positive Control	0 of 42 (0%)	4 of 42 (9.5%)	0 of 42
Negative Control	0 of 42 (0%)	3 of 42 (7.1%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 Phase 3 study testing Super Poligrip Free, Experimental Denture Adhesive 1 and Experimental Denture Adhesive 2 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 14 inclusion and 16 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 16 Feb 2024. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Over 12 Hours (AOB 0-12) to Compare Maximum Incisal Bite Force (time frame: Baseline and up to 12 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05173974.

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 16 Feb 2024.