NCT07415733

Evaluation of a Toothpaste Containing a Gum Health Active in Participants With Gingival Problem

A Randomized Clinical Study on the Effect of a Toothpaste Containing a Gum Health Active in Participants With Gingival Problem

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Unilever R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gingival Inflammation
• Gingival Bleeding
• Dental Plaque

Interventions

Type	Name	Description
OTHER	Test Toothpaste	Toothpaste containing a gum-heath active and fluoride
OTHER	Control Toothpaste	Toothpaste containing fluoride

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: Indonesia