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NCT05441527 · ClinicalTrials.gov registry record · NA

Use of Two Dissolvable Therapeutics Under Removable Partial Dentures

A NA study, sponsored by University of Iowa.

Completed
Registry status
NA
Development phase
67
Enrollment target

NCT05441527 is a NA study that has completed, run by University of Iowa. The registered enrollment target is 67 participants.

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The verdict

NCT05441527, a NA study, has completed, sponsored by University of Iowa.

COMPLETED
Registry status
NA
Development phase
67 participants
Enrollment target

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 underneat

Interventions

  • DEVICE MI Paste, then, Biotene Dry Mouth Gel
  • DEVICE Biotene Dry Mouth Gel, then, MI Paste

Trial Details

FieldValue
Enrollment Target 67 participants
Start Date 2022-06-30
Est. Completion 2024-05-27
Phase NA

Sponsor

University of Iowa

228 total trials

What the Registry Record Tells You About NCT05441527

The ClinicalTrials.gov registry entry for NCT05441527 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which MI Paste, then, Biotene Dry Mouth Gel is the first listed.

NCT05441527 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05441527 about?

NCT05441527 is a clinical study titled "Use of Two Dissolvable Therapeutics Under Removable Partial Dentures". 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 ove...

What is the current status of trial NCT05441527?

This trial is currently completed. It is a NA study. The enrollment target is 67 participants. The study started on 2022-06-30. Estimated completion is 2024-05-27.

What interventions are being tested in trial NCT05441527?

The interventions under investigation include: MI Paste, then, Biotene Dry Mouth Gel (DEVICE), Biotene Dry Mouth Gel, then, MI Paste (DEVICE).

Who is sponsoring clinical trial NCT05441527?

This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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