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

June 15, 2018 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test product
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.
Other: Test Product
Five strips of test adhesive cream for upper denture, as per application instructions.
Active Comparator: Positive Control
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.
Other: Positive Contol
Three dabs of positive control adhesive cream for upper denture, as per application instructions.
Other: Negative Control
Participants of this group will not be assigned to any treatment.
Other: Negative Control
No adhesive

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 12 hours
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.
Up to 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 4, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 4, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 207545

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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