A Study to Determine the Efficacy of a Denture Adhesive to Seal Out Food Particles From Under the Mandibular Partial Denture

Procter & Gamble (P&G)

Status

Completed

Conditions

Partial Denture

Treatments

Device: Fixodent True Feel Denture Adhesive

Device: Experimental Denture Adhesive

Study type

Interventional

Funder types

Industry

Identifiers

NCT05908890

2018129

Details and patient eligibility

About

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).

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.