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

Study Overview
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Brief Summary
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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).

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

Conditions
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Partial Denture

Intervention / Treatment
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* Device: Experimental Denture Adhesive
* Device: Fixodent True Feel Denture Adhesive


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |