search
Back to results

Use of Two Dissolvable Therapeutics Under Removable Partial Dentures

Primary Purpose

Edentulous Jaw, Edentulous Mouth

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MI Paste, then, Biotene Dry Mouth Gel
Biotene Dry Mouth Gel, then, MI Paste
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous Jaw

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Iowa College of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MI Paste, then, Biotene Dry Mouth Gel

Biotene Dry Mouth Gel, then, MI Paste

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 28, 2022
Last Updated
September 12, 2023
Sponsor
University of Iowa
search

1. Study Identification

Unique Protocol Identification Number
NCT05441527
Brief Title
Use of Two Dissolvable Therapeutics Under Removable Partial Dentures
Official Title
Use of Two Dissolvable Therapeutics Under Removable Partial Dentures: Reported Effects on Denture Comfort, Retention, and Dry Mouth Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Jaw, Edentulous Mouth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MI Paste, then, Biotene Dry Mouth Gel
Arm Type
Experimental
Arm Description
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.
Arm Title
Biotene Dry Mouth Gel, then, MI Paste
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MI Paste, then, Biotene Dry Mouth Gel
Intervention Description
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
Intervention Name(s)
Biotene Dry Mouth Gel, then, MI Paste
Intervention Description
1 milliliter of product will be applied daily to the intaglio (i.e., underside) of the patient's removable prosthesis and seated intraorally.
Primary Outcome Measure Information:
Title
Change from baseline in patient comfort for MI Paste as assessed by numerical scale.
Description
Comfort will be measured on a numerical scale of 0 to 10, where 0 is very dissatisfied and 10 is very satisfied.
Time Frame
Baseline, 1 week
Title
Change from baseline in patient comfort for Biotene Dry Mouth Gel as assessed by numerical scale.
Description
Comfort will be measured on a numerical scale of 0 to 10, where 0 is very dissatisfied and 10 is very satisfied.
Time Frame
Baseline, 1 week
Title
Change from baseline in retention for MI Paste as assessed by numerical scale.
Description
Comfort will be measured on a numerical scale of 0 to 10, where 0 is very dissatisfied and 10 is very satisfied.
Time Frame
Baseline, 1 week
Title
Change from baseline in retention for Biotene Dry Mouth Gel as assessed by numerical scale.
Description
Comfort will be measured on a numerical scale of 0 to 10, where 0 is very dissatisfied and 10 is very satisfied.
Time Frame
Baseline, 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Bowers, DDS
Organizational Affiliation
University of Iowa College of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa College of Dentistry
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Use of Two Dissolvable Therapeutics Under Removable Partial Dentures

We'll reach out to this number within 24 hrs