Denture RetentionNCT03037307

A Clinical Bite Force Study of Two Marketed Adhesives Against no Adhesive

A study testing Test Product and Positive Contol 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 study will be to compare bite force (BF) measurements over a 12-hour period of a currently marketed denture adhesive cream based on carbomer technology (test), with a 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 and Positive Contol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteUnited States
Study dates: 13 Feb 2017to 4 May 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; absence of any condition that could affect the participant's safety or wellbeing or their ability to understand and follow study procedures and requirements.
Diagnosis: a) Completely edentulous maxillary arch restored with a conventional full acrylic based upper complete denture, b) Dentate, partial or full edentulous mandibular arch. Partial or full edentulous arch may be restored with a stable complete, partial or implant supported denture, c) Maxillary dentures must be considered to be moderately well-fitting at the screening visit (Kapur Index, Olshan Modification: retention score >2, stability score >2) d) Maxillary dentures and mandibular dentures, if present, must be considered to be well-made based on design and construction criteria specified in the protocol e) The qualifying maxillary incisal BF readings (without adhesive) must be less than or equal to 9 pounds at the Screening Visit and subsequent visit pretreatment baseline bites. f) 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.
a) Implanted with a cardiac pacemaker, b) Daily doses of medication that might interfere with the ability to perform the study according to protocol (as determined by the Investigator), c) Insulin dependent diabetics, d) Taking or have taken a bisphosphonate drug for treatment of osteoporosis, e) A serious chronic disease requiring hospitalization, f) 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.
a) 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, b) Any participant clinically identified as having an incisal bite relation which could affect the bite force measurements, c) Severe dry mouth that may affect denture retention in the opinion of the Investigator, d) 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. e) A serious chronic disease requiring hospitalization. f) 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.

Show all 11Show fewer

a) 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, b) Any participant clinically identified as having an incisal bite relation which could affect the bite force measurements, c) Severe dry mouth that may affect denture retention in the opinion of the Investigator, d) 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.
a) Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit, b) 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
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: A Bite Force Study Assessing Two Currently Marketed Denture Adhesive Products Compared to No-Adhesive Control

Read the detailed description

This will be a single centre, randomized, crossover, 3-treatment, 3-period study to compare BF measurements over a 12 hour period of a currently marketed denture adhesive cream based on carbomer technology (test), with a 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 used to generate data for these attributes. This study included four visits: Visit 1 (screening visit), Visit 2, 3, 4 (treatment visits).

Conditions: Denture Retention
Being tested: Test Product, Positive Contol, Negative Control

What participants receive

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

Test ProductOther
Five strips of test adhesive cream for upper denture, as per application instructions.
Positive ContolOther
Three dabs of positive control adhesive cream for upper denture, as per application instructions.
Negative ControlOther
No adhesive

Study groups in NCT03037307
Study group	Role	What they receive
Test product	Experimental	Participants will topically apply the test product to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions. Receives: Other: Test Product
Positive Control	Active comparator	Participants will topically apply the positive control to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions. Receives: Other: Positive Contol
Negative Control	Other	Participants of this group will not be assigned to any treatment. 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 the Incisal Bite Force (Positive Control Adhesive Versus [vs.] Negative Control)
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 the Incisal Bite Force (Test Adhesive vs. Negative Control)
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.

13 Feb 20174 May 2017

First posted31 Jan 2017 (estimated)
Study start13 Feb 2017
Primary completion4 May 2017
Study completion4 May 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03037307
Sponsor's protocol ID: 207545
Status last verified: Apr 2018
First submitted: 27 Jan 2017
Last updated: 31 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

Varghese R, Burnett GR, Souverain A, Patil A, Gossweiler AG. A randomised bite force study assessing two currently marketed denture adhesive products compared with no-adhesive control. Clin Exp Dent Res. 2019 May 14;5(3):276-283. doi: 10.1002/cre2.182. eCollection 2019 Jun.
PubMed 31249709

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 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Bite Force Study Assessing Two Currently Marketed Denture Adhesive Products Compared to No-Adhesive Control
ClinicalTrials.gov ID: NCT03037307
Acronym / sponsor ID: 207545
Conditions: Denture Retention
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 13 Feb 2017 (actual)
Primary completion: 4 May 2017 (actual)
Study completion: 4 May 2017 (actual)
First posted: 31 Jan 2017 (estimated)
Results: Posted 31 Aug 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Test product	Experimental	Other: Test ProductParticipants will topically apply the test product to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
Positive Control	Active comparator	Other: Positive ContolParticipants will topically apply the positive control to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
Negative Control	Other	Other: Negative ControlParticipants of this group will not be assigned to any treatment.

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; absence of any condition that could affect the participant's safety or wellbeing or their ability to understand and follow study procedures and requirements.
Diagnosis: a) Completely edentulous maxillary arch restored with a conventional full acrylic based upper complete denture, b) Dentate, partial or full edentulous mandibular arch. Partial or full edentulous arch may be restored with a stable complete, partial or implant supported denture, c) Maxillary dentures must be considered to be moderately well-fitting at the screening visit (Kapur Index, Olshan Modification: retention score >2, stability score >2) d) Maxillary dentures and mandibular dentures, if present, must be considered to be well-made based on design and construction criteria specified in the protocol e) The qualifying maxillary incisal BF readings (without adhesive) must be less than or equal to 9 pounds at the Screening Visit and subsequent visit pretreatment baseline bites. f) 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 (11 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.
a) Implanted with a cardiac pacemaker, b) Daily doses of medication that might interfere with the ability to perform the study according to protocol (as determined by the Investigator), c) Insulin dependent diabetics, d) Taking or have taken a bisphosphonate drug for treatment of osteoporosis, e) A serious chronic disease requiring hospitalization, f) 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.
a) 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, b) Any participant clinically identified as having an incisal bite relation which could affect the bite force measurements, c) Severe dry mouth that may affect denture retention in the opinion of the Investigator, d) 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. e) A serious chronic disease requiring hospitalization. f) Any condition not previously mentioned that in the Investigator's opinion may impair the study evaluation.

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 ProductFive strips of test adhesive cream for upper denture, as per application instructions.	Other	Test product
Positive ContolThree dabs of positive control adhesive cream for upper denture, as per application instructions.	Other	Positive Control
Negative ControlNo adhesive	Other	Negative Control

Primary outcome

Area Over Baseline Over 12 Hours (AOB0-12) for the Incisal Bite Force (Positive Control Adhesive Versus [vs.] Negative Control)
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 the Incisal Bite Force (Test Adhesive vs. Negative Control)
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.

Results and safety

Results posted to the registry on 31 Aug 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
Test Adhesive/No Treatment/Positive Control Adhesive	7	7
Test Adhesive/Positive Control Adhesive/No Treatment	7	7
No Treatment/Test Adhesive/Positive Control Adhesive	8	8
No Treatment/Positive Control Adhesive/Test Adhesive	7	6
Positive Control Adhesive/Test Adhesive/No Treatment	7	7
Positive Control Adhesive/No Treatment/Test Adhesive	8	8

Primary outcome: Area Over Baseline Over 12 Hours (AOB0-12) for the Incisal Bite Force (Positive Control Adhesive Versus [vs.] Negative Control)

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

Measure	Positive Control Adhesive n = 44	Negative Control n = 44
Value	4.78 (0.657)	2.03 (0.657)

Positive Control Adhesive vs Negative Control: Least square (LS) mean difference: 2.76 (95% CI 1.89 to 3.63), p <.0001, ANCOVA

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

Primary outcome: Area Over Baseline Over 12 Hours (AOB0-12) for the Incisal Bite Force (Test Adhesive vs. Negative Control)

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

Measure	Test Adhesive n = 44	Negative Control n = 44
Value	4.15 (0.659)	2.03 (0.657)

Test Adhesive vs Negative Control: Least Square (LS) mean difference: 2.12 (95% CI 1.25 to 3.00), p <.0001, 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.

Adverse events

Time frame: up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Adhesive	0 of 42 (0%)	2 of 42 (4.8%)	0 of 42
Positive Control Adhesive	0 of 43 (0%)	2 of 43 (4.7%)	0 of 43
Negative Control	0 of 44 (0%)	0 of 44 (0%)	0 of 44
Overall Participants	0 of 44 (0%)	4 of 44 (9.1%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31249709Varghese R, Burnett GR, Souverain A, Patil A, Gossweiler AG. A randomised bite force study assessing two currently marketed denture adhesive products compared with no-adhesive control. Clin Exp Dent Res. 2019 May 14;5(3):276-283. doi: 10.1002/cre2.182. eCollection 2019 Jun.

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
Edentulism
Not yet recruiting
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
Complete Edentulism
Active, not recruiting
Compare the Difference in Occlusal Force Distribution and Denture Retention Using 2 Different Denture Base Materials in Implant Retained Overdenture
Edentulous Alveolar Ridge In Mandible, Complete Edentulism

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 and Positive Contol 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 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 31 Aug 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 31 Aug 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 the Incisal Bite Force (Positive Control Adhesive Versus [vs.] Negative Control) (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 NCT03037307, 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 31 Aug 2018.