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Evaluating Gingivitis and Systemic Biomarkers

NCT06962956 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2025-06-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Procter and Gamble

    lead INDUSTRY

Principal Investigators

  • Salus Research · Salus Research

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2025-10-31
Completion
2025-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06962956 on ClinicalTrials.gov