Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602466
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
A Clinical Study Investigating the Effect of an Experimental Toothpaste Containing Stannous Fluoride in Improving Gingival Health
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A 4-Week Randomised Controlled Examiner-blind Clinical Study Investigating the Efficacy of an Experimental Toothpaste Containing Stannous Fluoride in Improving Gingival Health
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this 4-week clinical study is to evaluate the ability of an experimental toothpaste containing 0454 percent Stannous Fluoride SnF2 03 Zinc Chloride ZnCl2 and 1 Alumina to improve gingival health and plaque accumulation compared to a regular fluoride toothpaste negative control in participants with plaque-induced mild to moderate gingivitis
Detailed Description:
This will be a single-center 4 weeks randomized controlled examiner-blind 2 treatment arms stratified parallel group design clinical study investigating gingival health and supra-gingival plaque reduction on healthy participants after using an experimental toothpaste containing 0454 SnF2 03 ZnCl2 and 1 Alumina Sufficient participants will be screened so that at least 160 participants are randomized approximately 80 per group to ensure approximately 144 approximately 72 per group evaluable participants complete the entire study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None