A Study to Investigate Food Occlusion Efficacy of a Denture Adhesive in Denture Wearers

February 28, 2020 updated by: GlaxoSmithKline

A Randomized, Single-Blind, Clinical Study to Assess Food Occlusion Efficacy of a Marketed Denture Adhesive in Healthy, Edentulous Subjects

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

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 is a single center, controlled, single-blind, randomized, two-treatment, two-period, cross-over design in participants with full upper and lower dentures. The study hypothesis is that this methodology will enable comparisons between denture adhesives and no adhesive to demonstrate the effectiveness of denture adhesives in restricting food ingress under dentures during eating. This study will consist of three visits: Visit 1 - Screening Visit; Visit 2 - Treatment 1 Visit; Visit 3 - Treatment 2 Visit. Participants will use test product which is a marketed denture adhesive (Super Poligrip Max Seal [SPMS]) (application will be controlled by weight) to the dentures in a pattern of continuous strips which will be applied to upper and lower denture and will be then placed in mouth and participants will also use no adhesive as a control. Participants will cross-over between treatments so that all participants will participate in all 2 treatment arms. An hour after the participant has worn their denture, they will chew a portion of peanuts in a controlled manner. After a rinsing procedure with water, the dentures will be removed, and any peanuts that have been migrated under each denture will be collected and weighed after a drying process. Participants will also answer a short questionnaire on the procedure and record the number of times their denture dislodged during the chewing procedure. The number of denture dislodgments reported by the participants during the chewing of the peanuts will also be collected and analyzed and this, and the questionnaire data, will be used to support the findings of the peanuts mass measure.

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.
49

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.
  • Phase 4

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
      • Fort Wayne, Indiana, United States, 46825
        • 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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • Participant is male or female who, at the time of screening, is between the ages of 18 and 85 years, inclusive.
  • Participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures.
  • Participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant/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.
  • Self-reports experience of getting food trapped under their denture.
  • Is a habitual wearer of both of their dentures defined as participants who wear both of their dentures for the majority of their time whilst awake.
  • Have denture protheses 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) with no individual stability or retention scores <1; c) Dentures are well made (according to the well-made assessment); d) Has a peanut particle migration rating >0 for each denture.

Exclusion Criteria:

  • 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 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 study entry 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 investigational 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 a pregnant female (self-reported).
  • A Participant who is a breastfeeding female.
  • A Participant with known or suspected intolerance or hypersensitivity to the study materials(or closely related compounds) or any of their stated ingredients.
  • A Participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
  • A Participant unwilling or unable to comply with the Lifestyle Considerations such as a) During the entire study Participants will not be permitted to have any dental/denture work performed during the time they are in the study, unless discussed and permitted by the examiner. This is to assure that the denture fit will not be altered during the study; b) During the treatment visits Participants will not be allowed to use tobacco or nicotine or nicotine-containing products following denture insertion until after their dentures are returned at completion of the food occlusion testing and Participants will not be allowed to use tobacco or nicotine or nicotine-containing products following denture insertion until after their dentures are returned at completion of the food occlusion testing.
  • History of swallowing difficulties or choking.
  • Currently taking or have taken a bisphosphonate drug (i.e., Fosamax, Actonel, Boniva).
  • 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.
  • 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.
  • Oral soft tissue 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 or the safety of the Participant.
  • 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, in the opinion of the investigator, who should not participate in the study.

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • 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 Denture Adhesive
Test denture adhesive will be applied directly from the tubes using a continuous strip pattern to the upper and lower denture which will then be placed in mouth of the participants.
Combination product: Marketed Denture Adhesive (Super Poligrip Max Seal)
The denture adhesive will be applied directly from the tubes. 1.6 g of adhesive per treatment will be applied to each participant's dentures. This dose will be split as 1.00±0.1 g for the maxillary and 0.6±0.1g for the mandibular dentures.
OTHER: Control
Participants will not apply any denture adhesive in this treatment arm.
Other: No Adhesive
No adhesive will be applied.

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
Food Occlusion Analysis of Combined Mass of Peanuts Under Combined Maxillary (Upper) and Mandibular (Lower) Dentures
Time Frame: Upto 16 days
On each test day(Visit2,3)participants underwent an Oral Soft Tissue (OST) exam,dentures cleaned using denture cleanser.Product application controlled by weight:1g(+/-0.1g)to upper denture ,0.6g (+/-0.1g)to lower denture by dispensing staff. After60+/-5minutes(min) of replacing denture in the mouth,participants consumed 30-32g of non-salted peanuts, divided into smaller portions of approximately(app) 8nut halves. Each portion was chewed for app20 seconds(sec). After which mouth rinsed with water for app10sec. Both upper and lower dentures were removed,any nuts remaining in mouth were collected using gauze.Dentures and gauzes placed in beaker with warm de-ionized water and sonicated for 30min,water was strained by sieve.Collected nuts washed,air-dried and transferred to pre-weighed aluminium weighing pans,dried at 40-degree Celsius (deg C)for 5 hours(h). Pans removed,cooled to room temperature,weighed to determine mass of nuts collected from each denture.
Upto 16 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Food Occlusion Analysis of Mass of Peanuts Under Maxillary Denture
Time Frame: Upto 16 days
On each test day (Visit2,3) participants underwent an OST exam, dentures cleaned using denture cleanser. Product application controlled by weight:1g(+/-0.1g)to upper denture ,0.6g (+/-0.1g)to lower denture by dispensing staff. After 60+/-5 min of replacing denture in the mouth, participants consumed 30-32g of non-salted peanuts, divided into smaller portions of app 8nut halves. Each portion was chewed for app20 sec. After which mouth rinsed with water for app10sec. Both upper and lower dentures were removed, any nuts remaining in mouth were collected using gauze. Dentures and gauzes placed in beaker with warm de-ionized water and sonicated for 30min, water was strained by sieve. Collected nuts washed, air-dried and transferred to pre-weighed aluminium weighing pans, dried at 40-deg C for 5h. Pans removed, cooled to room temperature, weighed to determine mass of nuts collected from each denture.
Upto 16 days
Food Occlusion Analysis of Mass of Peanuts Under Mandibular Denture
Time Frame: Upto 16 days
On each test day (Visit2,3) participants underwent an OST exam, dentures cleaned using denture cleanser. Product application controlled by weight:1g(+/-0.1g)to upper denture ,0.6g (+/-0.1g)to lower denture by dispensing staff. After 60+/-5 min of replacing denture in the mouth, participants consumed 30-32g of non-salted peanuts, divided into smaller portions of app 8nut halves. Each portion was chewed for app20 sec. After which mouth rinsed with water for app10sec. Both upper and lower dentures were removed, any nuts remaining in mouth were collected using gauze. Dentures and gauzes placed in beaker with warm de-ionized water and sonicated for 30min, water was strained by sieve. Collected nuts washed, air-dried and transferred to pre-weighed aluminium weighing pans, dried at 40-deg C for 5h. Pans removed, cooled to room temperature, weighed to determine mass of nuts collected from each denture.
Upto 16 days
Number of Denture Dislodgements During Chewing as Reported by Participants
Time Frame: Upto 16 days
On each test day (Visit 2,3) participants had an OST exam and their dentures were cleaned before study product was applied to the dentures. 1g (+/-) was applied to the upper denture and 0.6g (+/-) was applied to the lower dentures by dispensing staff. After insertion of the dentures into participants mouths, they were required to wait 60 mins (+/- 5mins) after which they were required to chew 30-32g of non-salted peanuts, divided into smaller portions of approximately 8 nut halves. Participants were required to chew each portion of peanuts for approximately 20 secs. Whilst consuming the peanuts, participants were required to tick a box every time they felt their denture dislodge. The total number of dislodgments were recorded by study site staff.
Upto 16 days
Mean Scores From Participant Completed Questionnaire
Time Frame: Upto 16 days
On each test day(Visit 2,3)participants underwent an OST exam,dentures cleaned using denture cleanser. Product application controlled by weight:1g(+/-0.1g)to upper denture,0.6g (+/-0.1g)to lower denture by dispensing staff. After 60+/-5min of replacing denture in the mouth, participants consumed 30-32g of non-salted peanuts, divided into smaller portions of app8nut halves. Each portion chewed for app20 sec. After eating all,participants answered a questionnaire for chewing experience by questions (Q):Q1,were you aware of nuts pieces under your denture:yes/no.Participants answered no to Q1 were not required to answerQ2,3;they were automatically assigned 0 score for Q2,3. Participants who answered yes to Q1 were asked Q2,3;Q2,rate amount of nuts pieces under your denture on0-10scale;Q3,how bothered were you by nuts pieces went under your denture on0-10scale.Q2score:0=none,10=lots of nuts pieces;Q3score:0=not at all bothered,10=extremely bothered. Lower scores indicate better results.
Upto 16 days

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.

Helpful Links

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.
January 7, 2019

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.
January 24, 2019

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.
January 24, 2019

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).
October 15, 2018

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.
October 15, 2018

First Posted (ACTUAL)

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.
October 17, 2018

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.
March 2, 2020

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.
February 28, 2020

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.
February 1, 2020

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.
  • 209649

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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