Use of Two Dissolvable Therapeutics Under Removable Partial Dentures

NCT05441527 | Completed Results FDA Device

• 1 other identifier: 202104384
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Edentulous Jaw; Edentulous Mouth

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

MI Paste, then, Biotene Dry Mouth Gel

EXPERIMENTAL

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

Biotene Dry Mouth Gel, then, MI Paste

EXPERIMENTAL

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

Interventions

MI Paste, then, Biotene Dry Mouth Gel DEVICE

1 milliliter of product will be applied daily to the intaglio (i.e., underside) of the patient's removable prosthesis and seated intraorally.

MI Paste, then, Biotene Dry Mouth Gel

Biotene Dry Mouth Gel, then, MI Paste DEVICE

1 milliliter of product will be applied daily to the intaglio (i.e., underside) of the patient's removable prosthesis and seated intraorally.

Biotene Dry Mouth Gel, then, MI Paste

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa College of Dentistry

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Jaw, Edentulous; Mouth, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases

Results Point of Contact

• Title: Dr. Robert Bowers
• Organization: University of Iowa

robert-bowers@uiowa.edu

(319) 467-3199

Study Officials

• Robert Bowers, DDS

  University of Iowa College of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: June 30, 2022
• Primary Completion: May 27, 2024
• Study Completion: May 27, 2024
• Last Updated: November 25, 2025
• Results First Posted: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)