Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2025-12-28 @ 4:49 AM
Study NCT ID:
NCT07211061
Status:
COMPLETED
Last Update Posted:
2025-10-07
First Post:
2025-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study is to Evaluate a Regimen on Gingivitis Using Traditional and Novel Assessment Methods
Sponsor:
Procter and Gamble
Organization:
Study Overview
Official Title:
A SIX WEEK CLINICAL STUDY TO EVALUATE THE EFFECT OF A REGIMEN ON GINGIVITIS
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:
Subjects who have shown evidence of gingivitis and plaque will be enrolled in this study. Each subject will be randomly assigned to one of two treatment products. The regimen group will be asked to brush 2x a day in using a power brush (2 minutes of brushing), followed by using 20 ml of mouth rinse for 30 seconds for 6 weeks. The negative control group will be asked to brush 2x a day using a manual toothbrush in their customary manner for 6 weeks. Oral Soft Tissue (OST) assessments, gingivitis and plaque measurements will be taken at 4 time-points: Baseline (BL); Week 1; Week 3; and Week 6.
Detailed Description:
None
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?: