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

NCT06892834 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2024026
• 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 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.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

• Number Bleeding Sites

  4 weeks (~1 month) and 12 weeks (~3 months)

Secondary Outcomes (1)

• Löe-Silness Gingivitis Evaluation

  4 weeks (~1 month) and 12 weeks (~3 months)

Study Arms (4)

Positive Control

ACTIVE COMPARATOR

0.454% stannous fluoride, 0.533% zinc citrate

Drug: Stannous Fluoride Dentifrice

Experimental #1

EXPERIMENTAL

0.243% NaF with 0.1% Hops, Humulus lupulus extract \[0.045% hops β-acids\]

Drug: Sodium Fluoride Dentifrice

Experimental #2

EXPERIMENTAL

0.243% NaF with 0.5% Hops, Humulus lupulus extract \[0.225% hops β-acids\]

Drug: Sodium Fluoride Dentifrice

Negative Control

ACTIVE COMPARATOR

0.76% Sodium Monofluorophosphate

Drug: Sodium monofluorophosphate dentifrice

Interventions

Stannous Fluoride Dentifrice DRUG

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).

Positive Control

Sodium Fluoride Dentifrice DRUG

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 #1; Experimental #2

Sodium monofluorophosphate dentifrice DRUG

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).

Negative Control

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

All Sum ResearchAll Sum Research Center Ltd.

Mississauga, Ontario, L5N 6J2, Canada

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Tao He
• Organization: Procter & Gamble

he.t@pg.com

513-622-2159

Study Officials

• All Sum Research

  All Sum Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 25, 2025
• Study Start: March 25, 2025
• Primary Completion: June 19, 2025
• Study Completion: June 19, 2025
• Last Updated: May 4, 2026
• Results First Posted: May 4, 2026

Record last verified: 2025-06

Locations

CA (1)