Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-26 @ 11:30 PM
Study NCT ID:
NCT06933368
Status:
COMPLETED
Last Update Posted:
2025-09-17
First Post:
2025-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Evaluate the Efficacy of a Cetylpyridinium Chloride Mouthwash in Improving Gingival Health and Reducing Plaque Accumulation
Sponsor:
HALEON
Organization:
Study Overview
Official Title:
A 12-Week, Randomized, Controlled, Examiner-blind, Clinical Study to Evaluate the Efficacy of a Cetylpyridinium Chloride Mouthwash in Improving Gingival Health and Reducing Plaque Accumulation
Status:
COMPLETED
Status Verified Date:
2025-09
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 12-week clinical study is to evaluate the ability of an experimental mouthwash, containing 0.085 percent (%) Cetylpyridinium chloride (CPC) as an adjunct to toothbrushing with a regular fluoride toothpaste, to improve gingival health and plaque accumulation compared to a regular fluoride toothpaste alone in participants with plaque-induced mild to moderate gingivitis.
Detailed Description:
This will be a single-center, 12-week, randomized, controlled, single blind (examiner only), 2-treatment arms, parallel group, stratified (by sex \[male/female\]) study, investigating gingival health and subgingival plaque reduction on healthy participants after twice daily using of an experimental mouthwash containing 0.085% weight/weight (w/w) CPC in combination with a commercially available regular toothpaste containing 0.243% w/w Sodium Fluoride (NaF) compared to a commercially available regular toothpaste containing 0.243% w/w NaF with no known anti-gingivitis nor anti plaque efficacy properties as control group. Approximately 132 participants (approximately 66 per group) will be randomized to ensure approximately 120 evaluable participants (approximately 60 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?:
False
Is an FDA AA801 Violation?: