Denture RetentionNCT03345108

A Study to Investigate a Method to Measure Food Occlusion by Denture Adhesives in Denture Wearers

A study testing Denture Adhesive Cream (Conventional Application), Denture Adhesive (Continuous Strip Application) and No Adhesive 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 purpose of this study is to evaluate a methodology to determine the ability of a denture adhesive to restrict food ingress underneath dentures during eating. 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?: Denture Adhesive Cream (Conventional Application), Denture Adhesive (Continuous Strip Application) and No Adhesive
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteUnited States
Study dates: 20 Nov 2017to 15 Dec 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

Evidence of a personally 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.
Male or female who, at the time of screening, are between the ages of 18 and 85 years, inclusive.
Willing and able to comply with scheduled visits, treatment plan, and other study procedures.
Healthy, defined as in general good physical health, as judged by the investigator.
Self-reports experience of getting food trapped under their denture.
Is an habitual wearer of both of their dentures defined as participants who wear both of their dentures for the majority of their time whilst awake.

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Females of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for 1 day after the last dose of assigned treatment.
Female participants who are not of childbearing potential must meet following requirements: a) Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the post-menopausal state, b) Have undergone a documented hysterectomy and/or bilateral oophorectomy, and have medically confirmed ovarian failure.
Have denture prostheses that fulfil all of the following: a) A qualifying conventional acrylic full denture in both the upper and lower arch, b) Dentures are well fitting (Kapur (Olshan Modification) Retention and Stability Index Sum Score ≥6) (Olshan, 1992) with no individual stability or retention scores <1, c) Dentures are well made (according to the well-made assessment), and d) Has a peanut particle migration rating >0 for each denture.

Who cannot join

An investigational site staff member directly involved in the conduct of the study or their family member, site staff members otherwise supervised by the investigator, or an employee of the sponsor directly involved in the conduct of the study.
Participation in any other clinical study involving investigational drugs, cosmetics or medical devices within 30 days prior to study entry and/or during study participation.
Acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Pregnant female participants.
Breastfeeding female participants.
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.

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Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
History of swallowing difficulties or choking.
Currently taking or have taken a bisphosphonate drug (i.e., Fosamax®, Actonel®, Boniva®) for treatment of osteoporosis.
Any clinically significant or relevant oral abnormality (e.g. temporomandibular joint [TMJ] problems) that, in the opinion of the investigator, could affect the participants participation in the study.
Known allergy to peanuts or any other nut.
Any condition or medication which, in the opinion of the investigator, is currently causing xerostomia.
Recent history (within the last year) of alcohol or other substance abuse.
OST examination findings such as stomatitis, open sores, lesions, redness or swelling which in the opinion of the investigator, would interfere with the conduct of the study.
Use of any medication that, in the opinion of the investigator, would interfere with the conduct of the study.
A serious chronic disease requiring intermittent hospital visits.
Having been previously enrolled in this study.
Any participant who, in the opinion of the investigator, should not participate in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Fort Wayne, Indiana, 46825

Other trials in United States

About this study

Official title: A Randomized, Open-Label, Clinical Study to Evaluate a Methodology to Assess Food Occlusion Efficacy of a Denture Adhesive in Healthy, Edentulous Subjects

The purpose of this study is to evaluate a methodology to determine the ability of a denture adhesive to restrict food ingress underneath dentures during eating.

Read the detailed description

This will be a single centre, controlled, open label, randomized, three-treatment, three-period, cross-over design in participants with full upper and full lower dentures. Each treatment period will consist of one day of testing with at least two days between adjacent treatment visits. This study will consist of four visits: Visit 1 - Screening Visit; Visit 2 - Treatment 1 Visit; Visit 3 - Treatment 2 Visit and Visit 4 - Treatment 3 Visit. (Participants will use Test product (denture adhesive) applied to the dentures either in a pattern consistent with standard application or applied to the dentures in a pattern of continuous strips. Participants will also use no adhesive as a control. Participants will cross-over between treatments so that all participants will participate in all 3 treatment arms. An hour after the participant has worn their denture, they will chew a portion of peanuts in a controlled manner. The peanuts that migrate under the denture during this chewing procedure will be collected, washed, dried and weighed. Participant will also answer a short questionnaire on the procedure and record the number of times their denture dislodged during the chewing procedure. The study hypothesis is that this methodology will enable comparisons between denture adhesives and no adhesive to demonstrate the effectiveness of denture adhesives at restricting food ingress under dentures during eating.

Conditions: Denture Retention
Being tested: Denture Adhesive Cream (Conventional Application), Denture Adhesive (Continuous Strip Application), No Adhesive

What participants receive

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

Denture Adhesive Cream (Conventional Application)Device
The adhesive cream will be extruded from a pre-dosed syringe. 1.6 g of adhesive per treatment will be applied to each participant's dentures. This dose will be split as 1.00±0.05g for the maxillary and 0.60±0.05g for the mandibular dentures.
Denture Adhesive (Continuous Strip Application)Device
The adhesive cream will be extruded from a pre-dosed syringe. 1.6 g of adhesive per treatment will be applied to each participant's dentures. This dose will be split as 1.00±0.05 g for the maxillary and 0.60±0.05 g for the mandibular dentures.
No AdhesiveOther
No adhesive applied.

Study groups in NCT03345108
Study group	Role	What they receive
Test Denture Adhesive (Conventional Application)	Experimental	Test denture adhesive will be applied to participants' dentures via conventional pattern of application. Receives: Device: Denture Adhesive Cream (Conventional Application)
Test Denture Adhesive (Continuous strip Application)	Experimental	Test denture adhesive will be applied to participants' dentures via continuous strips pattern of application. Receives: Device: Denture Adhesive (Continuous Strip Application)
Negative Control	Other	Participants will not apply any denture adhesive in this treatment arm. Receives: Other: No Adhesive

What is being measured

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

Mass of Peanuts Under Combined Maxillary and Mandibular Dentures (Denture Adhesive Applied Per Conventional Pattern)
Participants received 1.6 grams (g) of test adhesive on their dentures in a conventional pattern. After 60 minutes (min), participants were provided with 30-32 g non-salted peanuts, divided into smaller portions of approximately eight peanut halves. Each portion chewed for approximately 20 seconds (s). After consumption of all peanuts, participants had rinse their mouth with water for approximately 5 s. Dentures were removed and any peanuts remaining in the mouth were collected using a gauze. Both denture and gauze were placed in a beaker with hot de-ionized water and sonicated for 30 minutes (min) after which the water was strained through a standard testing sieve. The collected particles were washed and air-dried and transferred to pre-weighed aluminium weighing pans using a spatula and then, were dried in an oven at 40-degree Celsius for 5 hours. The pans were removed, cooled to room temperature and then weighed to determine the mass of the particles collected from each denture.
Measured: Upto 9 weeks

Timeline

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

20 Nov 201715 Dec 2017

First posted17 Nov 2017
Study start20 Nov 2017
Primary completion15 Dec 2017
Study completion15 Dec 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.
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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03345108
Sponsor's protocol ID: 208397
Status last verified: Mar 2019
First submitted: 13 Nov 2017
Last updated: 29 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

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 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Clinical Study to Evaluate a Methodology to Assess Food Occlusion Efficacy of a Denture Adhesive in Healthy, Edentulous Subjects
ClinicalTrials.gov ID: NCT03345108
Acronym / sponsor ID: 208397
Conditions: Denture Retention
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 20 Nov 2017 (actual)
Primary completion: 15 Dec 2017 (actual)
Study completion: 15 Dec 2017 (actual)
First posted: 17 Nov 2017 (actual)
Results: Posted 29 Mar 2019

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 evaluate a methodology to determine the ability of a denture adhesive to restrict food ingress underneath dentures during eating.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Test Denture Adhesive (Conventional Application)	Experimental	Device: Denture Adhesive Cream (Conventional Application)Test denture adhesive will be applied to participants' dentures via conventional pattern of application.
Test Denture Adhesive (Continuous strip Application)	Experimental	Device: Denture Adhesive (Continuous Strip Application)Test denture adhesive will be applied to participants' dentures via continuous strips pattern of application.
Negative Control	Other	Other: No AdhesiveParticipants will not apply any denture adhesive in this treatment arm.

Who may qualify

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

Key inclusion criteria (9 listed)

Evidence of a personally 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.
Male or female who, at the time of screening, are between the ages of 18 and 85 years, inclusive.
Willing and able to comply with scheduled visits, treatment plan, and other study procedures.
Healthy, defined as in general good physical health, as judged by the investigator.
Self-reports experience of getting food trapped under their denture.

Key exclusion criteria (18 listed)

An investigational site staff member directly involved in the conduct of the study or their family member, site staff members otherwise supervised by the investigator, or an employee of the sponsor directly involved in the conduct of the study.
Participation in any other clinical study involving investigational drugs, cosmetics or medical devices within 30 days prior to study entry and/or during study participation.
Acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Pregnant female participants.
Breastfeeding female participants.

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
Denture Adhesive Cream (Conventional Application)The adhesive cream will be extruded from a pre-dosed syringe. 1.6 g of adhesive per treatment will be applied to each participant's dentures. This dose will be split as 1.00±0.05g for the maxillary and 0.60±0.05g for the mandibular dentures.	Device	Test Denture Adhesive (Conventional Application)
Denture Adhesive (Continuous Strip Application)The adhesive cream will be extruded from a pre-dosed syringe. 1.6 g of adhesive per treatment will be applied to each participant's dentures. This dose will be split as 1.00±0.05 g for the maxillary and 0.60±0.05 g for the mandibular dentures.	Device	Test Denture Adhesive (Continuous strip Application)
No AdhesiveNo adhesive applied.	Other	Negative Control

Primary outcome

Mass of Peanuts Under Combined Maxillary and Mandibular Dentures (Denture Adhesive Applied Per Conventional Pattern)
Time frame: Upto 9 weeks
Participants received 1.6 grams (g) of test adhesive on their dentures in a conventional pattern. After 60 minutes (min), participants were provided with 30-32 g non-salted peanuts, divided into smaller portions of approximately eight peanut halves. Each portion chewed for approximately 20 seconds (s). After consumption of all peanuts, participants had rinse their mouth with water for approximately 5 s. Dentures were removed and any peanuts remaining in the mouth were collected using a gauze. Both denture and gauze were placed in a beaker with hot de-ionized water and sonicated for 30 minutes (min) after which the water was strained through a standard testing sieve. The collected particles were washed and air-dried and transferred to pre-weighed aluminium weighing pans using a spatula and then, were dried in an oven at 40-degree Celsius for 5 hours. The pans were removed, cooled to room temperature and then weighed to determine the mass of the particles collected from each denture.

Results and safety

Results posted to the registry on 29 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A-B-C	8	8
A-C-B	8	8
B-A-C	8	8
B-C-A	8	8
C-A-B	8	8
C-B-A	8	8

Primary outcome: Mass of Peanuts Under Combined Maxillary and Mandibular Dentures (Denture Adhesive Applied Per Conventional Pattern)

Time frame: Upto 9 weeks. Mean (Standard Deviation). Unit: Grams

Measure	Conventional Application n = 48	Continuous Strip Application n = 48	No Adhesive n = 47
Value	0.01184 (0.016237)	0.00944 (0.013326)	0.07853 (0.158567)

Population analysed: The primary endpoint has been measured for intent-to-treat (ITT) population (N=48). The ITT population included all randomized participants who received at least 1 dose of study treatment during the study and consumed peanuts and had at least 1 mass of peanuts from both upper and lower dentures.

Adverse events

Time frame: 95 days. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Conventional Application	0 of 48 (0%)	0 of 48 (0%)	0 of 48
Continuous Strip Application	0 of 48 (0%)	0 of 48 (0%)	0 of 48
No Adhesive	0 of 47 (0%)	0 of 47 (0%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Denture Retention

Active, not recruiting
Single-implant Versus Two-implant Mandibular Overdentures
Edentulism
Not yet recruiting
Comparison of Open-Mouth and Closed-Mouth Impression Techniques for Complete Dentures
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Mandibular Implant Overdenture With OT Cap Bar vs Bar Attachment
Edentulous Mandible, Implant-Supported Overdentures
Active, not recruiting
Denture Retention of Intra-orally Scanned Versus Extra-orally Scanned Digitally Printed Maxillary Denture in Completely Edentulous Patients
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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

GSK Clinical Trials study director

GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

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

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 18 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 Mar 2019. 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 29 Mar 2019). 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?

Mass of Peanuts Under Combined Maxillary and Mandibular Dentures (Denture Adhesive Applied Per Conventional Pattern) (time frame: Upto 9 weeks). 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 NCT03345108.

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 Mar 2019.