| Eligibility |
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.
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