Use of Two Dissolvable Therapeutics Under Removable Partial Dentures

NCT ID: NCT05441527

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2024-05-27

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MI Paste, then, Biotene Dry Mouth Gel

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Biotene Dry Mouth Gel, then, MI Paste

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Robert Bowers

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Bowers, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Iowa College of Dentistry

Locations

University of Iowa College of Dentistry

Iowa City, Iowa, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

202104384

Identifier Type: -

Identifier Source: org_study_id