Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06143670
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2023-11-16
Brief Title:
A Clinical Study Investigating the Effects of a Dentifrice Containing 0454 Stannous Fluoride on Gingivitis Treatment and Plaque Reduction When Used Twice Daily for 12 Weeks
Sponsor:
HALEON
Organization:
HALEON
Study Overview
Official Title:
A Randomized Controlled Examiner-Blind Clinical Study Investigating the Effects of a Dentifrice Containing 0454 ww Stannous Fluoride on Gingivitis Treatment and Plaque Reduction When Used Twice Daily for 12 Weeks
Status:
COMPLETED
Status Verified Date:
2024-03
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 clinical study is to investigate the efficacy of a dentifrice containing 0454 percent weight by weight ww stannous fluoride SnF2 on gingivitis treatment and plaque reduction compared to a regular fluoride dentifrice after 12 weeks twice daily brushing in a population of clinically diagnosed gingivitis without undergoing dental prophylaxis
Detailed Description:
This will be a single center randomized controlled single blind examiner blind two-treatment arm parallel study Study participants will be over 18 years old non-smokers in good general health with clinically measurable levels of gingivitis that meet all study criteria at the Screening and Baseline visits Approximately 160 participants approximately 80 per group will be randomized to ensure approximately 144 evaluable participants approximately 72 per group complete the study
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