Partial Denture
Conditions
Brief summary
The objective of this study is to evaluate the effectiveness of two denture adhesives at keeping food particles (seeds) from becoming trapped underneath partial denture(s).
Interventions
Adhesive will be applied to the partial denture(s) by a dental professional separate from the examiner and subject.
DEVICEFixodent True Feel Denture Adhesive
Adhesive will be applied to the partial denture(s) by a dental professional separate from the examiner and subject.
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* give written informed consent prior to their participation; * be 18 years of age or older; * have a Kennedy Class I or class II partial mandibular denture with a minimum of three consecutive teeth on the prosthesis; * have a history of food particles getting under their partial, mandibular denture; * agree not to use any denture adhesive on the day of their study visits, prior to the visit; * agree to not participate in any other oral/dental product studies during the study; * be willing to use or not use denture adhesive as instructed during the treatment periods; * be willing to eat a poppy seed muffin; * be in good general health as determined by the Investigator/designee based on a review of the medical history/update; and * have a minimum of 4 total poppy seeds on their mandibular denture base and gingiva after eating the muffin.
Exclusion criteria
* present with any disease or conditions that could be expected to interfere with examination procedures or the subject's safe completion of the study; * self-report that they are allergic to denture adhesives or to the test food (gluten intolerance to muffin or intolerance to poppy seeds); or * have appliances with intracorneal attachments, crowns with precision attachments or implant overdentures: * have any condition or medication which, in the opinion of the investigator, is currently causing xerostomia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Poppy Seed Count Before Treatment Application | Immediately following consumption of the muffin before treatment application | Subjects ate 1/2 top of a poppy seed muffin. After eating the muffin, subjects were instructed to remove their partial mandibular denture and a dental professional counted the number of poppy seeds remaining on the subject's partial denture base and gingiva. |
| Poppy Seed Count After Treatment Application | Immediately following consumption of the muffin after treatment application | Subjects ate 1/2 top of a poppy seed muffin. After eating the muffin, subjects were instructed to remove their partial mandibular denture and a dental professional counted the number of poppy seeds remaining on the subject's partial denture base and gingiva. |
Countries
United States
Outcome results
None listed