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New toothpaste aims to fight gum disease in just 4 weeks

NCT ID NCT06602466

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether an experimental toothpaste with stannous fluoride, zinc chloride, and alumina can improve gum health better than a regular fluoride toothpaste. 175 adults with mild to moderate gingivitis used the toothpaste for 4 weeks. Researchers measured gum bleeding and plaque to see if the new formula helps control gum disease.

What this could mean

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

Active substance
stannous fluoride toothpaste with zinc chloride and alumina
What this could lead to
If it works, this toothpaste could offer a better option for managing gum inflammation and plaque at home.
What could go wrong
This is a small, short-term study (175 people, 4 weeks) testing a toothpaste, not a cure. Results may not apply to severe gum disease or long-term use.

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

175 people

The number who actually took part.

Started

Sep 2024

Finished

Dec 2024

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 to 70 years

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: * 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. * Biological sex at birth was male or female. * Aged 18 to 70 years inclusive, at the signing of the informed consent. * Willing and able to comply with scheduled visits, treatment plan, saliva sample collection, study restrictions, Lifestyle Considerations and other study procedures. * 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): * Participant with at least 20 natural, permanent teeth, (excluding 3rd molars). * Participant with at least 40 evaluable surfaces for MGI, BI, and TPI. * A healthy participant with mild to moderate plaque-induced gingivitis in the opinion of the clinical examiner. * Overall MGI less than or equal to (\<=) 1.75 to \<= 2.30 At Baseline (Visit 2): * Overall MGI greater than or equal to (\>=) 1.75 to \<= 2.30 * Overall TPI score \>= 1.5 Exclusion Criteria: * 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 or psychiatric condition or laboratory abnormality 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 has any other clinical serious or unstable conditions (for example, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) which could have affected study outcomes and/or participant safety. * A participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study. * A participant who is breastfeeding. * A participant with known or suspected intolerance or hypersensitivity to any 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 vaper) 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 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. * 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. * Medications exclusions: At Screening (Visit 1): 1. A participant using any antibiotic medication within 28 days prior to screening or at any time during the study. 2. Participant who has used an anti-bacterial toothpaste/mouthwash (for example, chlorhexidine) or another oral care product within 2 weeks of Screening that, in the opinion of the investigator or dentally qualified designee, could affect gingival health, plaque formation or oral bacteria. 3. A participant currently taking an anti-inflammatory medication which, in the opinion of the Investigator, could affect gingival condition. 4. A participant currently taking a systemic medication (for example, anti-inflammatory, anticoagulant, immunosuppressants) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (for example, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers, statins). * Medications exclusions: At Baseline (Visit 2): 1. A participant who has taken any antibiotics during the washout period (between Screening and Baseline). 2. A participant who has taken (in the previous 14 days) a systemic medication (for example, anti-inflammatory, anti-coagulant, immunosuppressants) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (for example, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers). 3. 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 gingival health, plaque formation and oral bacteria, in the period between Screening and the Baseline visit. * Periodontal exclusions: 1. A participant who shows signs of periodontitis \[at both Screening (Visit 1) and Baseline visits (Visit 2)\]. 2. A participant with a Basic Periodontal Examination (BPE) score of 4 or above in one or more sextants. 3. A participant with BPE score \>= 3, if with probing pocket, a single tooth dept is \>= 5 mm. 4. A participant who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening. 5. 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

  • Birmingham University Dental School

    Birmingham, United Kingdom

More trials for these conditions

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