Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-25 @ 2:26 PM
Study NCT ID:
NCT06602466
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2024-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study Investigating the Effect of an Experimental Toothpaste Containing Stannous Fluoride in Improving Gingival Health
Sponsor:
HALEON
Organization:
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:
COMPLETED
Status Verified Date:
2024-12
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 4-week clinical study is to evaluate the ability of an experimental toothpaste, containing 0.454 percent (%) Stannous Fluoride (SnF2), 0.3% 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 0.454% SnF2, 0.3% 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:
False
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?:
False
Is an FDA AA801 Violation?: