Gum fluid test could catch early inflammation before damage shows
NCT ID NCT07842042
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.
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
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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
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2026
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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University of Birmingham
RECRUITINGBirmingham, B5 7EG, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Effectiveness of oil pulling using oils in comparison mouthwash for gingivitis
- Efficacy of an essential oil-based mouthwash in improving oral hygiene among the elderly community: a randomized clinical trial
- St. John's wort oil vs. chlorhexidine: which rinse better soothes gums after jaw expansion?
- Spit test for gum disease? scientists probe saliva and Gum-Fluid proteins
- Can a Light-Based home device keep teenage teeth and gums healthy?
- Gum health and body weight: scientists probe a possible shared link