Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:15 AM
Study NCT ID:
NCT07415733
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Toothpaste Containing a Gum Health Active in Participants With Gingival Problem
Sponsor:
Unilever R&D
Organization:
Study Overview
Official Title:
A Randomized Clinical Study on the Effect of a Toothpaste Containing a Gum Health Active in Participants With Gingival Problem
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
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 primary objective of this clinical study is to evaluate the impact on gingival health when participants switch to a fluoride toothpaste without gum-health actives for 4 weeks after using a proven gum-health toothpaste for 13 weeks.
Detailed Description:
This is a double-blind, randomized, controlled, parallel design study. A minimum of 150 participants (75 per group) will be enrolled according to the inclusion and exclusion criteria. The accepted participants will be randomly allocated to one of the two test products, which they will use at home twice daily for 13 weeks, followed by a switch to use a fluoride toothpaste without gum-health actives (the same formulation as the negative control) for an additional 4 weeks. Dental assessments of gingival condition, plaque levels and gingival bleeding will be performed at baseline, Weeks 4, 13 and 17. Gingival crevicular fluid (GCF) samples will be taken to detect biomarkers, and supragingival plaque samples will be collected to evaluate changes in microbial species relevant to gingival health. The Oral Health Impact Profile applied to Periodontal Disease (OHIP-14-PD) questionnaire will also be administered.
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?:
None
Is an FDA AA801 Violation?: