Use of Two Dissolvable Therapeutics Under Removable Partial Dentures

Study Overview
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Brief Summary
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Older removable denture wearing adults suffer from a complex set of oral health challenges, with relatively few solutions identified at this time. This is substantiated by statistics concerning the geriatric population on the correlation of poor oral health and the degradation of an individual's overall quality of life. The most recent National Health and Nutrition Examination Survey data found that 1 in 8 U.S. adults over the age of 65 are completely edentulous. A shift from complete edentulism to partial edentulism was also seen in this survey data, as the average individual over 65 had only 21 teeth remaining. Thus, partial edentulism remains a significant burden on seniors as well. Clearly, there exists both a great need and desire for improved implementation of proven oral-health strategies among this population, as well as the development of new preventive interventions and minimally invasive treatment strategies beyond traditional denture adhesive products. This proposed clinical trial intends to investigate two such potential treatment aids. In follow-up from our recent pilot study investigating MI Paste's application on the intaglio of complete dentures, in which our current findings have shown that the use of MI Paste can predictably increase the buffering capacity of a patient's saliva, our current proposal targets to further increase the study's sample size to improve the statistical power regarding subjective patient reports. The primary aims of this proposed study are to collect further data on how MI Paste affects patients' subjective evaluations of the comfort and retention of their denture, as well as dry mouth symptoms in patients reporting xerostomia. Furthermore, this study will include a second therapeutic intervention, Biotene Dry Mouth Gel (OTC), which will provide an additional contrast variable involving patient preferences regarding therapeutics under their removable prostheses. We hypothesize that the use of both therapeutics underneath removable dentures will provide added retention and stability to the prosthesis on patient reports, further coinciding with improved evaluations of comfort and function. Additionally, we hypothesize that the subjective improvements in patients self-reporting xerostomia will be of a statistically greater magnitude than those noticed by patients with normal salivary function, as xerostomia has been associated with increased denture discomfort in past literature.

Official Title
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Use of Two Dissolvable Therapeutics Under Removable Partial Dentures: Reported Effects on Denture Comfort, Retention, and Dry Mouth Conditions

Conditions
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Edentulous Jaw, Edentulous Mouth

Intervention / Treatment
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* Device: MI Paste, then, Biotene Dry Mouth Gel
* Device: Biotene Dry Mouth Gel, then, MI Paste


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-99 Patients with a removable prosthesis (e.g., partial denture, complete denture) Removable prosthesis must have been made at the University of Iowa College of Dentistry's Department of Family Dentistry clinic within the past 10 years. Exclusion Criteria: Casein (i.e., protein found in milk or other dairy products) allergy Lactose intolerance Multiple food or cosmetic ingredient allergies in their health history Ill-fitting dentures that need to be remade or relined

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MI Paste, then, Biotene Dry Mouth Gel<br>Subjects in this arm will use 1 milliliter of MI Paste daily for 7 days. Then, the subjects in this arm will use 1 milliliter of Biotene Dry Mouth gel daily for 7 days. There will be no wash-out period between the two products. | Device: MI Paste, then, Biotene Dry Mouth Gel<br>* 1 milliliter of product will be applied daily to the intaglio (i.e., underside) of the patient's removable prosthesis and seated intraorally.<br>|
| Experimental: Biotene Dry Mouth Gel, then, MI Paste<br>Subjects in this arm will use 1 milliliter of Biotene Dry Mouth gel for 7 days. Then, the subjects in this arm will use 1 milliliter of MI Paste for 7 days. There will be no wash-out period between the two products. | Device: Biotene Dry Mouth Gel, then, MI Paste<br>* 1 milliliter of product will be applied daily to the intaglio (i.e., underside) of the patient's removable prosthesis and seated intraorally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in patient comfort for MI Paste as assessed by numerical scale. | Comfort will be measured on a numerical scale of 0 to 10, where 0 is very dissatisfied and 10 is very satisfied. | Baseline, 1 week | 
| Change from baseline in patient comfort for Biotene Dry Mouth Gel as assessed by numerical scale. | Comfort will be measured on a numerical scale of 0 to 10, where 0 is very dissatisfied and 10 is very satisfied. | Baseline, 1 week | 
| Change from baseline in retention for MI Paste as assessed by numerical scale. | Comfort will be measured on a numerical scale of 0 to 10, where 0 is very dissatisfied and 10 is very satisfied. | Baseline, 1 week | 
| Change from baseline in retention for Biotene Dry Mouth Gel as assessed by numerical scale. | Comfort will be measured on a numerical scale of 0 to 10, where 0 is very dissatisfied and 10 is very satisfied. | Baseline, 1 week |