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Can a special toothpaste tame gum disease?

NCT ID NCT07816406

Disease control Sponsor: HALEON Source: ClinicalTrials.gov ↗

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing whether a toothpaste containing isopropyl methyl phenol reduces plaque buildup and gum bleeding better than a regular fluoride toothpaste. The 12-week study enrolls 120 Chinese adults with plaque-induced gingivitis. Dentists measure gum bleeding at weeks 2, 6, and 12 using a standard probe, and compare the two groups to see which toothpaste keeps gums healthier.

What this could mean

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

Active substance
A toothpaste containing isopropyl methyl phenol (IPMP)
What this could lead to
If it works, this could offer a simple daily toothpaste option to help control plaque and gum inflammation.
What could go wrong
This is a short, single-population study of 120 people, so results may not apply broadly. Gum disease often returns without ongoing care, and the toothpaste may not outperform regular fluoride toothpaste.

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

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

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. * A participant who is willing and able to comply with scheduled visits, treatment plan, study restrictions, lifestyle considerations 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. * A participant with localized plaque-induced gingivitis, in the opinion of the clinical examiner or medically qualified designee, as confirmed by visual examination. 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 study 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 study 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 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 lifestyle considerations described in this protocol. * Participants with, in the opinion of the investigator or medically qualified designee, any clinically significant/relevant abnormalities in medical history or oral examination, or any other condition, that would affect the individual's ability to understand and follow study procedures and requirements. * A participant with any medical condition which, in the opinion of the investigator or medically qualified designee, are causing xerostomia. * Participants with any medical condition which, in the opinion of the investigator or medically qualified designee, could directly influence gingival bleeding. * A participant who habitually rinses with water during toothbrushing (self-reported at Screening (Visit 1)). * Participants with recent history (within the last year) of alcohol or other substance abuse. * A participant who is a current smoker or an ex-smoker who stopped within 6 months of Screening (self-reported at Screening (Visit 1)). * A participant who currently uses smokeless forms of tobacco (example \[e.g.\], chewing tobacco, nicotine-based e-cigarettes). * A participant with oral mucosa disease (e.g., oral lichen planus, oral leukoplakia etc.) or a severe oral condition (e.g., acute necrotizing ulcerative gingivitis or oral or peri-oral ulceration including herpetic lesions) that, in the opinion of the investigator or dentally qualified designee, would compromise study outcomes or the oral health of the Participant /clinical examiner if they were to participate in the study. * A participant with a tongue or lip piercing, or any other oral feature that, in the opinion of the investigator or dentally qualified designee, could interfere with toothbrush usage or act as a plaque retentive factor. * A Participant who has previously been enrolled in this study. * A Participant who has used an anti-bacterial mouthwash (e.g., chlorhexidine) or use of any oral care product within 14 days of Baseline (Visit 2) that, in the opinion of the investigator or dentally qualified designee, could affect plaque formation or gingival health. * Periodontal Exclusions: 1. A participant with severe periodontitis or signs of active periodontitis who, in the opinion of the investigator or dentally qualified designee, should not participate in the study. 2. A participant with gingivitis which, in the opinion of the investigator or dentally qualified designee, would not be expected to respond to treatment with an anti-Gingivitis toothpaste. 3. A participant who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening. * Dental Exclusions: 1. A participant with active caries that, in the opinion of the investigator or dentally qualified designee, could compromise study outcomes or the oral health of the participant if they were to participate in the study. 2. A participant with a partial or full denture and with an orthodontic appliance (bands, appliances or fixed/ removable retainers). 3. A Participant who has received orthodontic therapy within 12 months of Screening. 4. A participant with numerous restorations in a poor state of repair. 5. A participant with any dental condition (e.g., overcrowding) that, in the opinion of the investigator or dentally qualified designee, could compromise study outcomes or the oral health of the participant if they were to participate in the study. 6. A participant who has had dental prophylaxis or teeth bleaching within 12 weeks of Screening. 7. A participant with high levels of extrinsic stain or calculus deposits that, in the opinion of the investigator or dentally qualified designee, could interfere with Baseline (preprophylaxis) plaque assessments. * A participant currently taking any such medication or oral care product which in opinion of the investigator could affect gingival condition * A participant who is not eligible for dental prophylaxis based on investigator or medically qualified designee review of their laboratory (blood) test results which includes blood platelet; white blood cell out of normal range; Prothrombin Time (PT) exceeds 15 seconds; Activated Partial Thromboplastin Time (APTT) exceeds 35 seconds; positive HIV test; positive HBV test, Hepatitis B Surface Antigen (HbsAg) and positive syphilis test. * 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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shanghai Ninth People's Hospital, Shanghai Jiao Tong Universi-ty School of Medicine

    Shanghai, Shanghai Municipality, 200011, China

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