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

Not Applicable

Completed

• Conditions: Partial Denture
• Interventions: Device: Experimental Denture Adhesive; Device: Fixodent True Feel Denture Adhesive

• Registration Number: NCT05908890
• Lead Sponsor: Procter and Gamble

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-08
• Primary Completion: 2019-10-03
• Study Completion: 2019-10-03
• Status Verified: 2023-06
• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-14
• Last Update Submitted: 2023-06-14
• Study First Posted: 2023-06-18
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental Denture Adhesive	Experimental Denture Adhesive	-
Marketed Denture Adhesive	Fixodent True Feel Denture Adhesive	-

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Salus Research, Inc; 🇺🇸 Fort Wayne, Indiana, United States