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Mouthwash breakthrough? CPC rinse shows promise for gum health

NCT ID NCT06933368

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether using a mouthwash with cetylpyridinium chloride (CPC) along with regular brushing improves gum health and reduces plaque more than brushing alone. 136 adults with mild to moderate gingivitis used either the CPC mouthwash or just brushed with fluoride toothpaste for 12 weeks. Researchers measured bleeding gums and plaque buildup to see if the mouthwash made a difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cetylpyridinium chloride (CPC) mouthwash
What this could lead to
If it works, this could offer a simple, over-the-counter mouthwash to help control gum disease and plaque buildup.
What could go wrong
This is a small, completed study with 136 participants, so results may not apply to everyone. The improvement over brushing alone may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

136 people

The number who actually took part.

Started

Apr 2025

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. * Participant is of either sex and any gender who, at the time of screening, is at least 18 years old, inclusive. * A participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures. * A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements. * Participant oral health that meets all the following: * At screening (visit 1): 1. Participant with at least 20 natural, permanent teeth. 2. Participant with at least 40 evaluable surfaces for MGI, bleeding index (BI), and TPI. 3. A participant with plaque-induced gingivitis, in the opinion of the clinical examiner, as confirmed by a gross visual examination at the screening visit. * At baseline (visit 2; prior to dental prophylaxis) 1. A participant with 10% to 30% bleeding sites. 2. A participant with overall TPI score \>=1.5. Exclusion Criteria: * A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family. * A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation. * A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical, psychiatric condition or laboratory abnormality or any other clinical serious or unstable conditions (for example, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study. * A participant who is a pregnant female (self-reported) or intending to become pregnant over the duration of the study. * A female participant who is breastfeeding. * A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. * A participant unwilling or unable to comply with the Lifestyle Considerations described in this protocol. * A participant who is a current smoker or an ex-smoker (including vaping) who stopped within 6 months of Screening. * A participant who is using smokeless forms of tobacco (for example, chewing tobacco, gutkha, pan containing tobacco, nicotine-based e-cigarettes). * A participant who is diagnosed with xerostomia or is taking any medication that in the view of the investigator is causing xerostomia. * A participant who has a medical condition which could have directly influenced gingival bleeding (for example, type 2 diabetes). * A participant who has a bleeding disorder that could have affected study outcomes and/or participant safety. * A participant who has a recent history (within the last year) of alcohol or other substance abuse. * A participant who has a severe oral condition (for example, acute necrotizing ulcerative gingivitis or oral or peri-oral ulceration including herpetic lesions) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant/examiner if they participate in the study. * Presence of a tongue or lip piercing, or any other oral feature that could interfere with the usage of a toothbrush. * Medication exclusions: At screening (Visit 1): 1. A participant using any antibiotic medication within 4 weeks prior to screening or at any time during the study. 2. A participant currently taking an anti-inflammatory medication which, in the opinion of the Investigator, could affect gingival condition. 3. A participant currently taking a systemic medication (for example, anti-inflammatory, anticoagulant, immunosuppressants) or traditional/ herbal remedy or as a premedication requirement before an invasive examinations and prophylaxis (for example, knee replacement, Mitral valve prolapse etc.), which, in the opinion of the Investigator, could affect plaque/ gingival condition (for example, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers). 4. A participant who has used an antibacterial dentifrice or mouthwash (for example, chlorhexidine) or any oral care product that in the view of the investigator could interfere with plaque formation or measures of gingivitis, within 4 weeks prior to screening. * Medication exclusions: At baseline (Visit 2): 1. A participant who has taken (in the previous 4 weeks), any antibiotics. 2. A participant who requires the need for antibiotic premedication prior to a dental prophylaxis or taking some blood thinning medication that prohibit the safe conduct of a dental cleaning. Note: Medical consultation may need to be obtained from participant's physician at the examiner's discretion. 3. A participant who has taken (in the previous 4 weeks) a systemic medication (for example, anti-inflammatory, anti-coagulant, immunosuppressants) or traditional/ herbal remedy as a premedication requirement before an invasive examinations and prophylaxis (for example, knee replacement, Mitral valve prolapse etc.), which, in the opinion of the Investigator, could affect plaque/ gingival condition (for example, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers). 4. A participant who has used an antibacterial dentifrice or mouthwash (for example, chlorhexidine) or any oral care product that in the view of the investigator could interfere with plaque formation or measures of gingivitis, in the period between Screening and the Baseline visit. * Periodontal exclusions: 1. A participant who has more than three tooth sites with probing pocket depth \>=4 mm. 2. A participant who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening. 3. A participant who has gingivitis, which in the opinion of the investigator, is not expected to respond to treatment with an over the counter (OTC) dentifrice. * Dental exclusions: 1. A participant who has active caries that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they participate in the study. 2. A participant who has dentures (partial or full). 3. A participant who has an orthodontic appliance (bands, appliances, or fixed/ removable retainers). 4. A participant who received orthodontic therapy within 3 months of Screening. 5. A participant who has numerous restorations in a poor state of repair. 6. A participant who has any dental condition (for example, overcrowding) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they participate in the study. 7. A participant who has had dental prophylaxis within 12 weeks of Screening. 8. A participant who has had teeth bleaching within 12 weeks of Screening. 9. A participant who has high levels of extrinsic stain or calculus deposits, in the opinion of the investigator, that could have interfered with plaque assessments. * A participant who has previously been enrolled in this study. * A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.

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Conditions

The condition(s) this trial relates to.

Dental Plaque gingivitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Salus Research Inc

    Fort Wayne, Indiana, 46825, United States

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Other studies related to the condition(s) this trial covers.