To Evaluate Oral Health and Quality of Life Associated With Use of a Denture Adhesive
Condition: Denture Retention
Intervention: Experimental Denture Adhesive
Intervention description: In this arm, participants will apply the experimental adhesive on their dentures once per day when the denture is placed in mouth.
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Denture, Adhesive, Gum-Health, Lifestyle

Summary:

      The aim of this study is to evaluate the use of a denture adhesive and its ability to
      demonstrate the improvement in overall gum-health and to improve the oral health related
      quality of life (OHrQoL) in participants who wear full dentures.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. A participant who is willing and able to comply with scheduled visits, treatment plan,
             and other study procedures.

          3. A 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.

          4. Pregnant women: must agree to use a highly effective method of contraception
             throughout the study and for 5 days after the last dose of assigned treatment.

          5. Participant has denture prostheses that fulfill all of the following:

               1. A conventional acrylic full denture in either or both of the upper and lower
                  arches. The full denture may be opposed by a partial denture, natural teeth or
                  another full denture.

               2. Dentures are well fitting (Kapur (Olshan Modification) Retention and Stability
                  Index Sum Score ≥ 3 for each denture [maxillary and/or mandibular] with no
                  individual stability or retention scores <1.

             c Denture(s) are well made (according to the well-made assessment).

          6. Participant is a habitual wearer of their denture(s) defined as participants who wear
             their dentures for the majority of their time whilst awake.

          7. Participant has worn their full denture(s) for at least a year.

          8. Participant has not used any denture adhesive in the last year.

          9. Participant currently adopts acceptable denture cleansing habits and routine (a
             minimum would include daily brushing with a chemical cleaner such as toothpaste or
             soap, in addition to at least once a week soaking in commercial denture cleansing
             product). Unacceptable cleaning would include cleaning with water alone or using other
             non-specialized cleaning methods.

        Exclusion Criteria:

          1. 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 (GSKCH) employee directly involved in the conduct
             of the study or a member of their immediate family.

          2. 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.

          3. 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.

          4. A participant who is a pregnant female.

          5. A participant who is a breastfeeding female.

          6. A participant with known or suspected intolerance or hypersensitivity to the study
             materials (or closely related compounds) or any of their stated ingredients.

          7. A participant who, in the opinion of the investigator or medically qualified designee,
             should not participate in the study.

          8. A participant unwilling or unable to comply with the Lifestyle Considerations:

               1. 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 ensure that the denture fit will not be altered during the
                  study.

               2. Participants will not be able to use any denture adhesive product other than that
                  supplied by the investigator.

               3. Participants should continue using their usual denture cleansing methodology
                  throughout the study.

          9. A participant who has previously been enrolled in this study.

         10. A participant who has had recent (within 30 days) gingival surgery.

         11. Taking or have taken a bisphosphonate drug (i.e. Fosamax, Actonel, Boniva).

         12. A participant with any clinically significant or relevant oral abnormality (e.g.
             temporomandibular joint problems) that, in the opinion of the investigator, could
             affect the Participant's participation in the study.

         13. A participant with any condition or medication which, in the opinion of the
             investigator, is currently causing xerostomia.

         14. A participant with recent history (within the last year) of alcohol or other substance
             abuse.

         15. A participant with OST examination findings such as stomatitis, open sores, lesions,
             or swelling which in the opinion of the investigator, would interfere with the conduct
             of the study. Mild, chronic conditions commonly expected from the use of dentures in
             the investigators opinion, are acceptable in this study.

         16. A participant who is using any medication that, in the opinion of the investigator,
             would interfere with the conduct of the study