Use of Two Dissolvable Therapeutics Under Removable Partial Dentures

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

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.

Study Overview

• Status: Completed
• Conditions: Edentulous Jaw; Edentulous Mouth
• Intervention / Treatment: Device: MI Paste, then, Biotene Dry Mouth Gel; Device: Biotene Dry Mouth Gel, then, MI Paste

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MI Paste, then, Biotene Dry Mouth Gel; 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; 1 milliliter of product will be applied daily to the intaglio (i.e., underside) of the patient's removable prosthesis and seated intraorally.
Experimental: Biotene Dry Mouth Gel, then, MI Paste; 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; 1 milliliter of product will be applied daily to the intaglio (i.e., underside) of the patient's removable prosthesis and seated intraorally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Patient Comfort for 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 as Assessed by Numerical Scale.	Retention will be measured on a numerical scale of 0 to 10, where 0 is very dissatisfied and 10 is very satisfied.	Baseline, 1 week

Collaborators and Investigators

• Sponsor: University of Iowa
• Investigators: Principal Investigator: Robert Bowers, DDS, University of Iowa College of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): May 27, 2024
• Study Completion (Actual): May 27, 2024

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Estimated): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Jaw Diseases; Tooth Diseases; Mouth, Edentulous; Jaw, Edentulous; Anti-Infective Agents; Muramidase
• Other Study ID Numbers: 202104384

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes