NCT06962956

Evaluating Gingivitis and Systemic Biomarkers

An Exploratory Study to Evaluate the Relationship Between Gingivitis and Systemic Biomarkers

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Procter and Gamble · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This exploratory study will consist of two parts: Phase 1 (sample collection/screening) and Phase 2 (sample collection/product efficacy testing). The purpose of Phase 1 is to understand the association of gingivitis to systemic biomarkers and to screen subjects for Phase 2. The purpose of Phase 2 is to assess the causal effect of oral hygiene intervention on gingivitis and systemic biomarkers.

Conditions

• Gingivitis

Interventions

Type	Name	Description
DRUG	0.76% Sodium Monofluorophosphate Dentifrice	Brush two times a day for 1 minute with manual toothbrush
DRUG	0.454% Stannous Fluoride Dentifrice	Brush two times a day for 1 minute with manual toothbrush
DRUG	0.454% Stannous Fluoride Dentifrice	Brush two times a day for 2 minutes with electric toothbrush

Timeline

• Start date: 2025-04-30
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2025-05-08
• Last updated: 2025-06-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study