A Study to Determine the Efficacy of a Denture Adhesive to Seal Out Food Particles From Under the Mandibular Partial Denture
Completed · Not applicable
Conditions studied: Partial Denture
In brief
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).
Key facts
- Study ID
- NCT05908890
- Run by
- Procter and Gamble
- People needed
- 29
- Starts
- 2019-07-08
- Expected to finish
- 2019-10-03
- Last updated by the study team
- 2023-06-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Salus Research, Inc — Fort Wayne, Indiana, United States
Full record on ClinicalTrials.gov
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