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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: Completed NA study, sponsored by University of Iowa.

NCT05441527 is a NA study that has completed, run by University of Iowa. The registered enrollment target is 67 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Comfort will be measured on a numerical scale of 0 to 10, where 0 is very dissatisfied and 10 is very satisfied.

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
University of Iowa

228 total trials

What the finished NCT05441527 record still lists

NCT05441527 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

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

NCT05441527 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT05441527's enrollment target sits among peer trials

67 1139th of 2000 higher than 862 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05441527, the US trial registry maintained by the National Library of Medicine. NCT05441527 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.