A Study to Investigate Food Occlusion Efficacy of a Denture Adhesive in Denture Wearers
Condition: Denture Retention
Intervention: Marketed Denture Adhesive (Super Poligrip Max Seal); No Adhesive
Intervention description: 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.; No adhesive will be applied.
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

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

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.

          -  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.