Gum fluid test could catch early inflammation before damage shows

NCT ID NCT07842042

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Recruitment status, easiest to join first

Recruiting now This study
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.
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Paused for now. It may or may not start again.
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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 Results may not be published yet.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.
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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

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Status unknown
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First seen Sep 25, 2026 · Last updated Oct 09, 2026 · Updated 1 time

Summary

Researchers are testing whether proteins in gum crevicular fluid can serve as early signals of tissue recovery after brushing with a stannous fluoride toothpaste. Twenty healthy participants use either the stannous fluoride toothpaste or a regular fluoride toothpaste twice daily for 14 days in an experimental gingivitis model. The team collects gum fluid samples at several points and measures protein markers and fluid volume to see whether these tools are feasible and sensitive enough to track early changes.

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 stannous fluoride
What this could lead to
If the markers prove reliable, dentists could one day detect early gum inflammation and healing with a simple gum fluid test rather than waiting for visible damage.
What could go wrong
This is a small, early method-development study of 20 people, so the markers may prove too variable or too weak to be useful. It tests measurement tools, not whether the toothpaste prevents disease.

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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 20 people

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

Started

Sep 2026

Expected to finish

Nov 2026

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: * 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. * A participant is willing and able to comply with scheduled visits, and other study procedures and restrictions including the lifestyle restrictions. * A participant is 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 probing pocket depths of less than (\<) 3.5mm and a minimum of four teeth from maxillary canine to third molar in both maxillary quadrants that are scorable (including two molars and at least one premolar) at screening. * A participant has, localized, plaque induced gingivitis at screening, defined as \>= 10 and less than equal to (\<=) 30% of sites exhibiting bleeding on probing (BOP). * A participants have a canine, one or two premolars, and two or three molars present in each maxillary quadrant (right and left side). 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 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 is breast feeding, is pregnant (self-reported) or intending to become pregnant over the duration of the study. * 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 with a recent history (within the last year) of alcohol or other substance abuse. * Participant who: 1. Is taking antibiotics during the study or has taken antibiotics in the two weeks prior to the screening visit. 2. Is using or has used an anti-bacterial toothpaste/mouthwash (e.g., chlorhexidine) or another oral care product within 2 weeks of Screening that, in the opinion of the investigator or dentally qualified designee, could affect plaque formation or gingival health. 3. Currently taking a systemic medication (e.g., anti-inflammatory, anticoagulant, immunosuppressants) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (e.g., ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers). 4. Smokes or uses smokeless forms of tobacco (example \[e.g.\] chewing tobacco, gutkha, pan containing tobacco, e-cigarettes \[vapes\]). 5. Is diagnosed with xerostomia or who the investigator believes might suffer from xerostomia based upon medications or oral examination. 6. Has a tongue or lip piercing, or any other oral feature that, in the opinion of the investigator, could interfere with the proper usage of a toothbrush. 7. Has, in the opinion of the investigator or medically qualified designee, signs of active periodontal disease or who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening. 8. Requires immediate dental intervention to resolve any oral condition. 9. Has dentures (partial or full) or has an orthodontic appliance (bands, appliances, or fixed/ removable retainers) that, in the opinion of the investigator, could interfere with the proper usage of a toothbrush. 10. A participant who has had teeth bleaching within 12 weeks of Screening. * 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.

How to take part

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  1. The places running it

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

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • University of Birmingham

    RECRUITING

    Birmingham, B5 7EG, United Kingdom

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