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Active, not recruitingNCT07158112Updated Sep 23, 2025

Assessing Gingivitis and Plaque From a Marketed Toothpaste

A Phase 4 interventional study of Stannous Fluoride Dentifrice and Test Stannous Fluoride Dentifrice in Gingivitis, sponsored by Procter and Gamble. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-23.

Sponsored by Procter and Gamble · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Gingivitis

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.

04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Positive Control

    0.454% stannous fluoride

    Drug: Stannous Fluoride Dentifrice

  • Active comparator
    Negative Control

    0.76% Sodium Monofluorophosphate

    Drug: Sodium monofluorophosphate dentifrice

  • Active comparator
    Test Product

    0.454% stannous fluoride

    Drug: Test Stannous Fluoride Dentifrice

Interventions

  • DrugStannous 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.

  • DrugTest 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.

  • DrugSodium 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.

05

What researchers measure

Primary outcomes

  1. Number of Bleeding Sites

    Number of Bleeding Sites

    Time frame: 1 month and 3 months

Secondary outcomes

  1. Loe-Silness Gingival Evaluation

    Evaluation of bleeding and gum inflammation

    Time frame: 1 month and 3 months

  2. Turesky Plaque Evaluation

    Evaluation of Plaque

    Time frame: 1 month and 3 months

06

Study locations

1 site
  • University Health Resources Group
    Whitter, California 90602, United States
07

Registry details

Key details

Study ID
NCT07158112
Lead sponsor
Procter and Gamble
Responsible party
Sponsor
First posted
Sep 5, 2025
Start date
Aug 30, 2025
Primary completion
Dec 7, 2025 (estimated)
Completion
Dec 7, 2025 (estimated)
Last update
Sep 23, 2025

Study contacts

Nachnani
principal investigator · University Health Resources Group, Inc.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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