Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-28 @ 8:09 AM
Study NCT ID:
NCT04601103
Status:
TERMINATED
Last Update Posted:
2024-10-01
First Post:
2020-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
3M Oral Rinse Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes
Sponsor:
Solventum US LLC
Organization:
Study Overview
Official Title:
3M Oral Rinse Evaluation of Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes
Status:
TERMINATED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Device Deficiency
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to evaluate the incidence of oral tissue sloughing through self-report by study subjects and by professional dental examinations.
Detailed Description:
The primary objective of this study is to evaluate the incidence of oral tissue sloughing through self-report by study subjects and by professional dental examinations. Adverse events will be tracked through study dental examinations and subject diaries with twice daily use of the 3M Oral Rinse used in combination with toothpaste containing one of three levels (no, medium, high) of Sodium Lauryl Sulfate (SLS).
Determine the subjects' acceptance of sloughing and/or other side effects
Determine the subjects' acceptance of sloughing and/or other side effects
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: