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

NCT05908890 | Completed

• 1 other identifier: 2018129
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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).

Conditions

Partial Denture

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Experimental Denture Adhesive

EXPERIMENTAL

Device: Experimental Denture Adhesive

Marketed Denture Adhesive

ACTIVE COMPARATOR

Device: Fixodent True Feel Denture Adhesive

Interventions

Experimental Denture Adhesive DEVICE

Adhesive will be applied to the partial denture(s) by a dental professional separate from the examiner and subject.

Experimental Denture Adhesive

Fixodent True Feel Denture Adhesive DEVICE

Adhesive will be applied to the partial denture(s) by a dental professional separate from the examiner and subject.

Marketed Denture Adhesive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Salus Research, Inc

Fort Wayne, Indiana, 46825, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 18, 2023
• Study Start: July 8, 2019
• Primary Completion: October 3, 2019
• Study Completion: October 3, 2019
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

US (1)