Assessing Gingivitis of 3 Different Dentifrices Compared to a Negative Control.

A Three-month Clinical Study to Assess the Gingivitis Effect of Various Dentifrices.

The primary objective of this study is to evaluate the effect of two experimental hops extract-containing dentifrices on gingivitis relative to a positive control 0.454% SnF2 dentifrice and a negative control dentifrice after 12 weeks of product use.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Drug: Stannous Fluoride Dentifrice; Drug: Sodium Fluoride Dentifrice; Drug: Sodium monofluorophosphate dentifrice

Detailed Description

The participants will be enrolled and use their assigned treatment products for 12 weeks (~3 months).

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L5N 6J2
      • All Sum ResearchAll Sum Research Center Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Be at least 18 years of age;
• Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
• Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial; If female of child-bearing potential, agree to use a medically approved method of birth control for the duration of the study. Acceptable methods of medically approved birth control include: at least 3 months of use of a hormonal birth control (including oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant), double-barrier method, intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s), vasectomy of partner at least 6 months prior to screening. Not applicable to females not of child-bearing potential (females who have undergone a sterilization procedure including hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior;
• If female and of child-bearing potential, agree to immediately inform the study investigator if they become pregnant;
• Have at least 20 gradable teeth;
• Have mild to moderate gingivitis with a range of 10 to 70% bleeding sites;
• Agree to return for scheduled visits and follow the study procedures;
• Agree to refrain from use of any non-study oral hygiene products for the duration of the study; regular floss users can continue to floss in their customary manner.
• Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study; and
• Agree to refrain from any oral hygiene the morning of each visit.

Exclusion Criteria:

• Having taken antibiotic, anti-inflammatory, or anticoagulant medications within 4 weeks of the baseline visit;
• Having 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, severe gingivitis, or advanced periodontal disease;
• Females of child-bearing potential who are not using a medically approved method of birth control (i.e., hormonal contraceptives including oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant, double-barrier method, intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s), vasectomy of partner at least 6 months prior to screening) or who have not been using hormonal birth control for a minimum of 3 months prior to study enrollment;
• Taking medication that alters gingival appearance or gingival bleeding (e.g., calcium channel blockers, anticonvulsants, or immunosuppressants) within one month prior to study initiation;
• Regularly (>5x/week) using anti-gingivitis treatments (e.g., stannous fluoride toothpaste, or anti-gingivitis mouthwashes, such as those containing chlorohexidine) in the month prior to screening;
• Removable oral appliances;
• Fixed facial or lingual orthodontic appliances;
• Have a positive pregnancy test (Clearblue) at baseline or self-reported pregnancy during the study; ;
• Any diseases or condition that might interfere with the safe participation in the study according to the study investigator;
• Inability to undergo study procedures; and
• Allergic reactions to any of the study toothpastes and/or ingredients in the study toothpastes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Positive Control; 0.454% stannous fluoride, 0.533% zinc citrate	Drug: Stannous Fluoride Dentifrice; Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (~3 months).
Experimental: Experimental #1; 0.243% NaF with 0.1% Hops, Humulus lupulus extract [0.045% hops β-acids]	Drug: Sodium Fluoride Dentifrice; Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (~3 months).
Experimental: Experimental #2; 0.243% NaF with 0.5% Hops, Humulus lupulus extract [0.225% hops β-acids]	Drug: Sodium Fluoride Dentifrice; Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (~3 months).
Active Comparator: Negative Control; 0.76% Sodium Monofluorophosphate	Drug: Sodium monofluorophosphate dentifrice; Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (~3 months).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number Bleeding Sites	4 weeks (~1 month) and 12 weeks (~3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Löe-Silness Gingivitis Evaluation	scored on a scale of 0-3; 0 Normal gingiva; 1 Mild inflammation - slight change in colour, slight edema. No bleeding on probing; 2 Moderate inflammation - redness, edema, and glazing. Bleeding on probing; 3 Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding	4 weeks (~1 month) and 12 weeks (~3 months)

Collaborators and Investigators

• Sponsor: Procter and Gamble
• Investigators: Principal Investigator: All Sum Research, All Sum Research

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Actual): June 19, 2025
• Study Completion (Actual): June 19, 2025

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Gingivitis; Anti-Infective Agents; Physiological Effects of Drugs; Protective Agents; Anti-Infective Agents, Local; Cariostatic Agents; Fluorides; Listerine; Sodium Fluoride; Tin Fluorides; Fluorophosphate
• Other Study ID Numbers: 2024026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes