Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-01-01 @ 7:23 PM
Study NCT ID:
NCT06406751
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-11-10
First Post:
2024-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbiome Effects of Extended Use of MI Paste in Elderly Removable Denture Wearers
Sponsor:
University of Iowa
Organization:
Study Overview
Official Title:
Microbiome Effects of Extended Use of MI Paste in Elderly Removable Denture Wearers
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if MI Paste affects the bacteria and fungus present within the mouth, as well as to determine if MI Paste increases denture comfort and retention. MI Paste is a water-based topical dental product that is available without a prescription. It is generally used to treat dental/tooth hypersensitivity (sensitive teeth) in patients and/or to help re-mineralize the tooth enamel in patients. Within this study, there is an off-label use for research subjects to apply above the upper denture.
Detailed Description:
Potentially-eligible subjects will be invited to the research study that involves consenting and 4 in-person visits (Screening Visit, Visit 1, Visit 2, Visit 3) where the following will be performed at each visit: (i) upper denture/mouth tissues swab sample collected, (ii) survey questions being administered, and (iii) brief oral dental exam (clinical assessment). Furthermore, at Visit 2, subjects will be provided and instructed on how to use MI Paste under their removable upper denture for 14 days and instructed to monitor symptoms of comfort, retention, and dry mouth (if applicable).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: