Assessing Gingivitis and Plaque From a Marketed Toothpaste

NCT07158112 | Active Not Recruiting Phase 4

• 1 other identifier: 2025029
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

• Number of Bleeding Sites

  Number of Bleeding Sites

  1 month and 3 months

Secondary Outcomes (2)

• Loe-Silness Gingival Evaluation

  1 month and 3 months

• Turesky Plaque Evaluation

  1 month and 3 months

Study Arms (3)

Positive Control

ACTIVE COMPARATOR

0.454% stannous fluoride

Drug: Stannous Fluoride Dentifrice

Negative Control

ACTIVE COMPARATOR

0.76% Sodium Monofluorophosphate

Drug: Sodium monofluorophosphate dentifrice

Test Product

ACTIVE COMPARATOR

0.454% stannous fluoride

Drug: Test Stannous Fluoride Dentifrice

Interventions

Stannous Fluoride Dentifrice DRUG

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.

Positive Control

Test Stannous Fluoride Dentifrice DRUG

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 Product

Sodium monofluorophosphate dentifrice DRUG

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.

Negative Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

University Health Resources Group

Whitter, California, 90602, United States

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Nachnani

  University Health Resources Group, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: August 30, 2025
• Primary Completion: December 7, 2025
• Study Completion: December 7, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-08

Locations

US (1)