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Active, not recruiting Phase 4

Assessing Gingivitis and Plaque From a Marketed Toothpaste

NCT07158112 · tracked via the Priya Life Science USA tracker
Sponsor
Procter and Gamble
Phase
Phase 4
Started
2025-08-30
Last updated
2025-09-23

Condition(s) studied

Gingivitis

Investigational drug(s) / intervention(s)

Stannous Fluoride Dentifrice →Test Stannous Fluoride DentifriceSodium monofluorophosphate dentifrice →

Stannous Fluoride Dentifrice: Each subject will be randomly assigned to one of three treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months.

Test Stannous Fluoride Dentifrice: Each subject will be randomly assigned to one of three treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months.

Sodium monofluorophosphate dentifrice: Each subject will be randomly assigned to one of three treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months.

Study summary

The primary objective of this study is to evaluate the effect of two 0.454% stannous fluoride dentifrices on gingivitis relative to a negative control (Colgate® Cavity Protection toothpaste) and the comparative anti-gingivitis efficacy of the two 0.454% SnF2 dentifrices after 12 weeks of product use.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: i. Be at least 18 years of age; ii. Provide consent prior to study participation and receive a signed copy of the Informed Consent form; iii. Be in good general health as determined by the Investigator/Designee based on a review of their medical history; iv. Have at least 16 gradable teeth; v. Have mild to moderate gingivitis with 10%-70% bleeding sites; vi. Agree to return for scheduled visits and follow the study procedures; vii. Agree to refrain from use of any non-study oral hygiene products for the duration of the study; viii. Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study; ix. Agree to refrain from any oral hygiene for 12 hours prior to their next visit; x. Agree to refrain from eating, drinking using tobacco in any form (including smoking substances such as marijuana, vaping products, e-cigarettes), flossing, using toothpicks, using medicated lozenges and/or breath mints, or chewing gum at least 4 hours from your next study visit (exception allowed: small sips of water up until 45 minutes prior to their appointment); and, xi. Agree not to participate in any other oral care studies for the duration of this study. Exclusion Criteria: i. Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit; ii. Have any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease; iii. Have any of the following: fixed orthodontic appliances or attachments for aligner treatment, lower bonded retainers; removable partial dentures, iv. Have a history of allergies or hypersensitivity to ingredients in commercial dental products or cosmetics; v. Had oral/gum surgery within the previous two months; vi. Nursing, self-reported pregnancy or the intention of becoming pregnant any time during the course of this study; vii. A condition requiring the need for antibiotic premedication prior to dental procedures or use within 2 weeks of the Baseline visit; or viii. Have any condition or disease, as determined by the Investigator/Designee based on a review of the medical history which could be expected to interfere with examination procedures or with the subject's safe completion of the study.

Primary outcome measure(s)

  • Number of Bleeding Sites — 1 month and 3 months
    Number of Bleeding Sites

Trial sites (1)

FacilityCityRegionStatus
University Health Resources Group Whitter California

More Procter and Gamble trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07158112 on ClinicalTrials.gov ↗ ← All trials in the USA