A Clinical Study to Evaluate the Maximum Maxillary Bite Force (BF) When Using Two Novel Denture Adhesives Compared to Using No-Adhesive
Condition: Denture Retention
Intervention: Super Poligrip Free; Experimental Denture Adhesive 1; Experimental Denture Adhesive 2
Intervention description: A single application of 1 gram of Super Poligrip Free will be applied topically to oral tissues via the upper denture.; A single application of 1 gram of Experimental Denture Adhesive 1 will be applied topically to oral tissues via the upper denture.; A single application of 1 gram of Experimental Denture Adhesive 2 will be applied topically to oral tissues via the upper denture.
Phase: Phase 3
Study type: Interventional
Primary purpose: Device Feasibility
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

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

Eligibility criteria:

        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:

               1. 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,

               2. Is well made (according to the well-made assessment).

          -  A participant with BF measurements which satisfy all the following criteria:

               1. The qualifying BF measurements (without adhesive) at V1 (Screening) must be less
                  than or equal to (=<) 9lbs.

               2. At least 2 of the 4 qualifying BF measurements (without adhesive) at V1
                  (Screening) must be reproducible (within +-2lbs).

               3. The Baseline BF measurement (without adhesive) at V2-5 must be <=9lbs.

               4. 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:

               1. sufficiently stable, in the opinion of the investigator, to enable the bite force
                  determination to be performed.

               2. 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.