CompletedNot Applicable

A Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste With a Cetylpyridinium Chloride Mouthwash in Improving Gingival Health and Reducing Plaque Accumulation

United States199 participantsStarted 2024-11-18

Plain-language summary

The aim of this study is to assess the ability of a marketed Cetylpyridinium Chloride (CPC) mouthwash alongside a marketed Stannous Fluoride (SnF2) toothpaste in improving gingival health and reducing plaque accumulation, compared to the use of a regular fluoride toothpaste alone in participants with clinically measurable plaque-induced gingivitis.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participant with at least 20 natural, permanent teeth.
. Participant with at least 40 evaluable surfaces for MGI, BI, and TPI.
. A participant with plaque-induced gingivitis, in the opinion of the clinical examiner, as confirmed by a gross visual examination at the Screening Visit.
. A participant with 10% - 30% bleeding sites.
. A participant with mean interproximal whole mouth TPI score \>=1.5.

Exclusion criteria

. A participant using any antibiotic medication within 4 weeks prior to screening or at any time during the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall Number of Bleeding Sites (NBS) at Week 12 (Toothpaste/Mouthwash Versus [vs.] Negative Control Toothpaste)

Timeframe: Week 12

Trial details

NCT IDNCT06660069

SponsorHALEON

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-11

Results submitted2026-02-25

View on ClinicalTrials.gov More Dental Plaque trials