NCT07501455

Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Kenvue Brands LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study is a six-week, double-blind, randomized, parallel-group controlled clinical study. The objective of this study is to evaluate the changes to the oral microbiome, inflammatory mediators, gingival health indices and to assess oral tolerance after 4 weeks of twice daily use of differing oral hygiene regimens including mouthwash compared to a control group. A follow-up assessment will be completed 2 weeks after cessation of treatments.

Conditions

• Microbiome
• Cytokines
• Plaque
• Gingivitis
• Gingival Bleeding

Interventions

Type	Name	Description
OTHER	Distilled Water	Subjects will brush and rinse with distilled water twice daily.
OTHER	Marketed Comparator 1	Subjects will brush and rinse with their assigned mouthwash twice daily.
OTHER	Marketed Comparator 2	Subjects will brush and rinse with their assigned mouthwash twice daily.
OTHER	Prototype Rinse 1	Subjects will brush and rinse with their assigned mouthwash twice daily.
OTHER	Prototype Rinse 2	Subjects will brush and rinse with their assigned mouthwash twice daily.

Timeline

• Start date: 2026-02-26
• Primary completion: 2026-05-05
• Completion: 2026-05-05
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States