Assessing Gingivitis and Plaque From a Marketed Toothpaste

Procter & Gamble (P&G)

Status and phase: Active, not recruiting; Phase 4

Conditions: Gingivitis

Treatments: Drug: Test Stannous Fluoride Dentifrice; Drug: Sodium monofluorophosphate dentifrice; Drug: Stannous Fluoride Dentifrice

Study type: Interventional

Funder types: Industry

Identifiers

NCT07158112

2025029

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups

Positive Control

Active Comparator group

Description:

0.454% stannous fluoride

Treatment:

Drug: Stannous Fluoride Dentifrice

Negative Control

Active Comparator group

Description:

0.76% Sodium Monofluorophosphate

Treatment:

Drug: Sodium monofluorophosphate dentifrice

Test Product

Active Comparator group

Description:

0.454% stannous fluoride

Treatment:

Drug: Test Stannous Fluoride Dentifrice