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

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

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).

Study Overview

• Status: Completed
• Conditions: Partial Denture
• Intervention / Treatment: Device: Experimental Denture Adhesive; Device: Fixodent True Feel Denture Adhesive

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Salus Research, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Denture Adhesive	Device: Experimental Denture Adhesive; Adhesive will be applied to the partial denture(s) by a dental professional separate from the examiner and subject.
Active Comparator: Marketed Denture Adhesive	Device: Fixodent True Feel Denture Adhesive; Adhesive will be applied to the partial denture(s) by a dental professional separate from the examiner and subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Poppy Seed Count 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.	Immediately following consumption of the muffin before treatment application
Poppy Seed Count 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.	Immediately following consumption of the muffin after treatment application

Collaborators and Investigators

• Sponsor: Procter and Gamble

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2019
• Primary Completion (Actual): October 3, 2019
• Study Completion (Actual): October 3, 2019

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Estimated): June 19, 2023

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2018129

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No