Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06354270
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-04-03
Brief Title:
A Clinical Study to Evaluate the Anti-Sensitivity Efficacy of a Stannous Fluoride Toothpaste in a Population of Dentin Hypersensitivity Sufferers
Sponsor:
HALEON
Organization:
HALEON
Study Overview
Official Title:
An 8-Week Randomized Controlled Examiner-Blind Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentin Hypersensitivity in a Population of Dentin Hypersensitivity Sufferers
Status:
COMPLETED
Status Verified Date:
2024-07
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 aim of this study is to confirm the clinical Dentin Hypersensitivity DH efficacy of a 0454 percent Stannous Fluoride SnF2 toothpaste
Detailed Description:
This will be a single center 8-week randomized controlled examiner-blind 2-treatment arm parallel design stratified by maximum baseline Schiff sensitivity score of the two selected test teeth clinical study to evaluate the anti-sensitivity efficacy of a 0454 SnF2 toothpaste in healthy participants with DH The clinical efficacy of the 0454 SnF2 toothpaste test toothpaste will be compared with that of a reference toothpaste a commercially available regular fluoride toothpaste with no known anti-sensitivity properties negative control Sufficient participants will be screened to randomize approximately 110 participants to investigational product approximately 55 per treatment group and to ensure approximately 100 evaluable participants complete the entire study approximately 50 per treatment group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None