Denture RetentionNCT02937870

A Bite Force Study Comparing Two New Test Adhesives With Currently Marketed Denture Adhesive

A study testing Test Product 1, Test Product 2 and Reference Product in people with Denture Retention, run by GlaxoSmithKline 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 objective of this 4-treatment, 4-period, randomized, crossover, proof of principle bite force study will be to compare bite force measurements over a 12 hour period across two (test) cream denture adhesives, with a currently marketed cream denture adhesive (positive control), and a negative/no treatment control. 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?: Test Product 1, Test Product 2 and Reference Product
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: 7 Mar 2017to 5 Apr 2017
Phase: Interventional
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

Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
Aged between 18 to 85 years.
Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities in medical history or upon oral examination and absence of any condition that could affect the participant's safety or wellbeing or their ability to understand and follow study procedures and requirements.
Completely edentulous maxillary arch restored with a conventional full acrylic based upper complete denture. Dentate, partial or full edentulous mandibular arch. Partial or full edentulous arch may be restored with a stable complete, partial or implant supported denture. Maxillary dentures must be considered to be moderately well-fitting at the screening visit (Kapur Index, Olshan Modification: retention score >=2, stability score >=2). Maxillary dentures and mandibular dentures, if present, must be considered to be well-made based on design and construction criteria specified in the protocol. The qualifying maxillary incisal bite force readings (without adhesive) must be less than or equal to 9 pounds (lb) at the Screening Visit and subsequent visit pre-treatment baseline bites. At least 2 of the 4 qualifying bite readings at the Screening Visit must be reproducible (+/- 2lb). At subsequent visits the bite force readings must be within +/-2lb for 1 of the 3 practice bites and the pre-treatment baseline bite.
Understands and is willing, able and likely to comply with all study procedures and restrictions.

Who cannot join

A woman who is known to be pregnant or who is intending to become pregnant (self reported) over the duration of the study.
A woman who is breast-feeding.
Implanted with a cardiac pacemaker.
Daily doses of medication that might interfere with the ability to perform the study according to protocol (as determined by the Investigator).
Taking or have taken a bisphosphonate drug for treatment of osteoporosis.
A serious chronic disease requiring hospitalization.

Show all 17Show fewer

Any condition not previously mentioned that in the Investigator's opinion may impair the study evaluation.
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Any clinically significant or relevant oral abnormality (e.g. temporomandibular joint [TMJ] problems) that, in the opinion of the investigator, could affect the participant's participation in the study.
Any participant clinically identified as having an incisal bite relation which could affect the bite force measurements.
Severe dry mouth that may affect denture retention in the opinion of the Investigator.
OST examination findings such as stomatitis, open sores, lesions, redness or swelling that, in the opinion of the investigator, could affect the participant's participation in the study.
Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
Previous participation in this study.
Recent history (within the last year) of alcohol or other substance abuse.
A participant who is unwilling to refrain from smoking, including e-cigarettes and the use of chewing tobacco or other tobacco products for the duration of screening and each treatment day (12-14 hours).
An employee of the sponsor or the study site or members of their immediate family.

Trial locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Bloomfield, New Jersey, 07003

Other trials in United States

About this study

Official title: A Proof of Principle Bite Force Study Using Two New Test Adhesives and a Currently Marketed Denture Adhesive.

Read the detailed description

This will be a 4-treatment, 4-period, randomized, crossover, proof of principle bite force study which will compare bite force measurements over a 12 hour period across two cream denture adhesives with a currently marketed cream denture adhesive (positive control), and a negative/no treatment control. A short questionnaire regarding the flavor and texture characteristics of each denture adhesive after a single use will also be administered to give an indication of participant satisfaction of these attributes.

Conditions: Denture Retention
Being tested: Test Product 1, Test Product 2, Reference Product, Negative Control

What participants receive

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

Test Product 1Device
Test adhesive 1 with a thin nozzle
Test Product 2Device
Test adhesive 2 with a thin nozzle
Reference ProductDevice
Adhesive Cream
Negative ControlOther
No adhesive

Study groups in NCT02937870
Study group	Role	What they receive
Test Product 1	Experimental	Applied topically to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions. Receives: Device: Test Product 1
Test Product 2	Experimental	Applied topically to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions. Receives: Device: Test Product 2
Reference Product	Active comparator	Applied topically to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions. Receives: Device: Reference Product
Negative Control	Other	Not described Receives: Other: Negative Control

What is being measured

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

Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 Versus (vs.) No Adhesive
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (pounds [lbs]). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
Measured: up to 12 hours
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 2 vs. No Adhesive
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
Measured: up to 12 hours

Secondary outcomes (3)

Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Positive Control Adhesive
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
Measured: up to 12 hours
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 2 vs. Positive Control Adhesive
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
Measured: up to 12 hours
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Test Adhesive 2
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
Measured: up to 12 hours

Timeline

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

7 Mar 20175 Apr 2017

First posted19 Oct 2016 (estimated)
Study start7 Mar 2017
Primary completion5 Apr 2017
Study completion5 Apr 2017

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Denture RetentionStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02937870
Sponsor's protocol ID: 206233
Status last verified: Feb 2018
First submitted: 17 Oct 2016
Last updated: 23 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Atassi M, Ling MR, Oneglia K, Dilauro TS. A proof-of-principle bite force study using two experimental test denture adhesives and a currently marketed denture adhesive. Clin Exp Dent Res. 2020 Apr;6(2):266-273. doi: 10.1002/cre2.256. Epub 2020 Feb 6.
PubMed 32026625

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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All Denture Retention trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Proof of Principle Bite Force Study Using Two New Test Adhesives and a Currently Marketed Denture Adhesive.
ClinicalTrials.gov ID: NCT02937870
Acronym / sponsor ID: 206233
Conditions: Denture Retention
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 7 Mar 2017 (actual)
Primary completion: 5 Apr 2017 (actual)
Study completion: 5 Apr 2017 (actual)
First posted: 19 Oct 2016 (estimated)
Results: Posted 26 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

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

Arm	Type	Receives
Test Product 1	Experimental	Device: Test Product 1Applied topically to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
Test Product 2	Experimental	Device: Test Product 2Applied topically to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
Reference Product	Active comparator	Device: Reference ProductApplied topically to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
Negative Control	Other	Other: Negative Control

Who may qualify

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

Key inclusion criteria (5 listed)

Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
Aged between 18 to 85 years.
Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities in medical history or upon oral examination and absence of any condition that could affect the participant's safety or wellbeing or their ability to understand and follow study procedures and requirements.
Completely edentulous maxillary arch restored with a conventional full acrylic based upper complete denture. Dentate, partial or full edentulous mandibular arch. Partial or full edentulous arch may be restored with a stable complete, partial or implant supported denture. Maxillary dentures must be considered to be moderately well-fitting at the screening visit (Kapur Index, Olshan Modification: retention score >=2, stability score >=2). Maxillary dentures and mandibular dentures, if present, must be considered to be well-made based on design and construction criteria specified in the protocol. The qualifying maxillary incisal bite force readings (without adhesive) must be less than or equal to 9 pounds (lb) at the Screening Visit and subsequent visit pre-treatment baseline bites. At least 2 of the 4 qualifying bite readings at the Screening Visit must be reproducible (+/- 2lb). At subsequent visits the bite force readings must be within +/-2lb for 1 of the 3 practice bites and the pre-treatment baseline bite.
Understands and is willing, able and likely to comply with all study procedures and restrictions.

Key exclusion criteria (17 listed)

A woman who is known to be pregnant or who is intending to become pregnant (self reported) over the duration of the study.
A woman who is breast-feeding.
Implanted with a cardiac pacemaker.
Daily doses of medication that might interfere with the ability to perform the study according to protocol (as determined by the Investigator).
Taking or have taken a bisphosphonate drug for treatment of osteoporosis.

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
Test Product 1Test adhesive 1 with a thin nozzle	Device	Test Product 1
Test Product 2Test adhesive 2 with a thin nozzle	Device	Test Product 2
Reference ProductAdhesive Cream	Device	Reference Product
Negative ControlNo adhesive	Other	Negative Control

Primary outcome

Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 Versus (vs.) No Adhesive
Time frame: up to 12 hours
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (pounds [lbs]). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 2 vs. No Adhesive
Time frame: up to 12 hours
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.

3 secondary outcomes

Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Positive Control Adhesive
Time frame: up to 12 hours
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 2 vs. Positive Control Adhesive
Time frame: up to 12 hours
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Test Adhesive 2
Time frame: up to 12 hours

Results and safety

Results posted to the registry on 26 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Study	23	20

Primary outcome: Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 Versus (vs.) No Adhesive

Time frame: up to 12 hours. Least squares mean (Standard Error). Unit: lbs

Measure	Test Adhesive 1 n = 20	No Adhesive n = 20
Value	2.09 (0.34)	1.43 (0.33)

Test Adhesive 1 vs No Adhesive: Least square (LS) mean difference: 0.66 (95% CI -0.14 to 1.47), p = 0.1770, ANCOVA

Population analysed: Analysis for this outcome was performed on intent-to-treat (ITT) population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome.

Primary outcome: Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 2 vs. No Adhesive

Time frame: up to 12 hours. Least squares mean (Standard Error). Unit: lbs

Measure	Test Adhesive 2 n = 21	No Adhesive n = 20
Value	1.23 (0.33)	1.43 (0.33)

Test Adhesive 2 vs No Adhesive: LS mean difference: -0.20 (95% CI -0.98 to 0.59), p = 0.8321, ANCOVA

Population analysed: Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 61 days (AEs were collected from OST examination from screening to last study visit). Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Adhesive 1	0 of 21 (0%)	1 of 21 (4.8%)	0 of 21
Test Adhesive 2	0 of 22 (0%)	3 of 22 (13.6%)	0 of 22
Positive Control Adhesive	0 of 21 (0%)	2 of 21 (9.5%)	0 of 21
Negative Control	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32026625Atassi M, Ling MR, Oneglia K, Dilauro TS. A proof-of-principle bite force study using two experimental test denture adhesives and a currently marketed denture adhesive. Clin Exp Dent Res. 2020 Apr;6(2):266-273. doi: 10.1002/cre2.256. Epub 2020 Feb 6.

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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.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Test Product 1, Test Product 2 and Reference Product in people with Denture Retention, run by GlaxoSmithKline 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 5 inclusion and 17 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 23 May 2018. 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?

Yes. Results are posted in the registry (first posted 26 Mar 2018). 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 (AOB0-12) for Test Adhesive 1 Versus (vs.) No Adhesive (time frame: up to 12 hours). The study lists 2 primary outcomes in all. 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 NCT02937870, which also lists 1 linked publication.

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 23 May 2018.