A Clinical Study to Evaluate the Maximum Maxillary Bite Force (BF) When Using Two Novel Denture Adhesives Compared to Using No-Adhesive

Study Overview
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Brief Summary
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The purpose of this study is to investigate the hold properties of two experimental denture adhesives using established maximum incisal BF methodology.

Detailed Description
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This will be a single-centre, controlled, randomized, single-blind (with respect to the examiner performing the incisal BF measurements), 4-treatment, 4- period, cross-over study to evaluate the maximum maxillary BF in a population of full maxillary denture wearers. A currently marketed denture adhesive will be used as a positive control, whilst use of no adhesive will be employed as a negative control.

Official Title
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A Randomized, Single-Blind Clinical Study Assessing the Maximum Maxillary Bite Force When Using Two Novel Denture Adhesives Compared to Using No-Adhesive

Conditions
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Denture Retention

Intervention / Treatment
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* Device: Super Poligrip Free
* Device: Experimental Denture Adhesive 1
* Device: Experimental Denture Adhesive 2


Participation Criteria
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Eligibility Criteria
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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. A participant who is willing and able to comply with scheduled visits, and other study procedures. A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or 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. A participant with a completely edentulous maxillary arch restored with a conventional maxillary full denture with an acrylic base. The maxillary denture prosthesis must fulfil all of the following: At least moderately well-fitting (Kapur Index, Olshan Modification: retention score Greater than or equal to (>=)2, stability score >=2) at the Screening (V1) visit, Is well made (according to the well-made assessment). A participant with BF measurements which satisfy all the following criteria: The qualifying BF measurements (without adhesive) at V1 (Screening) must be less than or equal to (=<) 9lbs. At least 2 of the 4 qualifying BF measurements (without adhesive) at V1 (Screening) must be reproducible (within +-2lbs). The Baseline BF measurement (without adhesive) at V2-5 must be <=9lbs. The Baseline BF measurement (without adhesive) at V2-5 and at least 1 of the 3 practice BF measurements must be within +-2lbs of each other. A participant who is dentate in the mandibular arch or has a partial or full denture in the mandibular arch that is: sufficiently stable, in the opinion of the investigator, to enable the bite force determination to be performed. well made (according to the well-made assessment). 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 GlaxoSmithKline Consumer Healthcare (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 Visit 1 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 experimental 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 pregnant (self-reported) or intending to become pregnant over the duration of the study. A participant who is breastfeeding. 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 unwilling or unable to comply with the Lifestyle Considerations. A participant who is currently taking or has taken a bisphosphonate drug (that is (i.e.), Fosamax, Actonel, Boniva). A participant who uses any medication or has a condition (e.g. insulin dependent diabetes) that, in the opinion of the investigator, would interfere with the conduct of the study. A participant who has any clinically significant or relevant oral abnormality (for example (e.g.) temporomandibular joint [TMJ] problems or tooth abnormalities) that, in the opinion of the investigator, could affect the BF measurements or participant safety. A participant who has any condition or medication which, in the opinion of the investigator, is currently causing xerostomia or which could interfere with the conduct of the study. A participant with a recent history (within the last year) of alcohol or other substance abuse. A participant with Oral soft tissue (OST) examination findings (at V1) such as stomatitis, open sores, lesions, cavitied caries lesions, redness or swelling which in the opinion of the investigator, could interfere with the conduct of the study. A participant who has previously been enrolled in this study. A participant who is unable to comply with study requirements and/or who is not able to reliably perform a valid bite at the examiner's discretion. A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Negative Control<br>Denture adhesive will not be used. | |
| Active Comparator: Positive Control<br>A single application of 1 gram of Super Poligrip Free denture adhesive will be applied topically to oral tissues via the upper denture. | Device: Super Poligrip Free<br>* A single application of 1 gram of Super Poligrip Free will be applied topically to oral tissues via the upper denture.<br>|
| Experimental: Experimental Denture Adhesive 1<br>A single application of 1 gram of Experimental Denture Adhesive 1 will be applied topically to oral tissues via the upper denture. | Device: Experimental Denture Adhesive 1<br>* A single application of 1 gram of Experimental Denture Adhesive 1 will be applied topically to oral tissues via the upper denture.<br>|
| Experimental: Experimental Denture Adhesive 2<br>A single application of 1 gram of Experimental Denture Adhesive 2 will be applied topically to oral tissues via the upper denture. | Device: Experimental Denture Adhesive 2<br>* A single application of 1 gram of Experimental Denture Adhesive 2 will be applied topically to oral tissues via the upper denture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Over Baseline Over 12 Hours (AOB 0-12) to Compare Maximum Incisal BF | Incisal bite force measurements will be performed to analyse the denture dislodgement as measure of denture adhesive hold efficacy. All BF measurements will be conducted by an examiner. AOB0-12 will be used to assess the incisal bf and is defined as (AUC0-12)/12 minus baseline BF(pounds [lbs]). Area under the Curve (AUC) is calculated from 0 to 12 hours (hr) using the trapezoid method; denoted as AUC0-12. This transformation will return the measurement to the same scale as the original observations. Area over baseline in BF as measured by AOB0-12 will be analyzed for each of the three interventional products, compared to no adhesive. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values. | Up to 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Over Baseline (AOB) at 0.5, 1, 3, 6 And 9 Hours to Compare Maximum Incisal BF | Incisal bite force measurements will be performed to analyse the denture dislodgement as measure of denture adhesive hold efficacy. All BF measurements will be conducted by an examiner. This transformation will return the measurement to the same scale as the original observations. AOB for 0.5, 1, 3, 6 and 9 hours will be analyzed using the trapezoid method. Area over baseline in BF as measured by AOB will be analyzed for each of the three active products, compared to no adhesive. Higher values of AOB demonstrate a stronger bite force overtime than lower values. | Baseline, at 0.5, 1, 3, 6 and 9 hours |