MI Paste, then, Biotene Dry Mouth Gel for Mouth, Edentulous

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Iowa College of Dentistry, Iowa City, IA
Mouth, Edentulous+1 More
Biotene Dry Mouth Gel, then, MI Paste - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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.

Eligible Conditions

  • Mouth, Edentulous
  • Jaw, Edentulous

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: Baseline, 1 week

Baseline, 1 week
Change from baseline in patient comfort for Biotene Dry Mouth Gel as assessed by numerical scale.
Change from baseline in patient comfort for MI Paste as assessed by numerical scale.
Change from baseline in retention for Biotene Dry Mouth Gel as assessed by numerical scale.
Change from baseline in retention for MI Paste as assessed by numerical scale.

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

MI Paste, then, Biotene Dry Mouth Gel
1 of 2
Biotene Dry Mouth Gel, then, MI Paste
1 of 2
Experimental Treatment

130 Total Participants · 2 Treatment Groups

Primary Treatment: MI Paste, then, Biotene Dry Mouth Gel · No Placebo Group · N/A

MI Paste, then, Biotene Dry Mouth Gel
Device
Experimental Group · 1 Intervention: MI Paste, then, Biotene Dry Mouth Gel · Intervention Types: Device
Biotene Dry Mouth Gel, then, MI Paste
Device
Experimental Group · 1 Intervention: Biotene Dry Mouth Gel, then, MI Paste · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1 week

Trial Background

Prof. Robert Bowers, Assistant Professor
Principal Investigator
University of Iowa
Closest Location: University of Iowa College of Dentistry · Iowa City, IA
Photo of Iowa City  1Photo of Iowa City  2Photo of Iowa City  3
2014First Recorded Clinical Trial
1 TrialsResearching Mouth, Edentulous
5 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a removable prosthesis.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.