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Completed

NCT Number: NCT05908890

A Study to Determine the Efficacy of a Denture Adhesive 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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salus Research, Inc

Fort Wayne, Indiana, 46825, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental Denture Adhesive

Device

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

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.

Primary outcomes

  1. Poppy Seed Count Before Treatment Application

    Time frame: 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.

  2. Poppy Seed Count After Treatment Application

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 18, 2023
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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